lidocaine and hydrocortisone Topical application, Rectal

LYE-doe-kane hye-droe-KLOR-ide, hye-droe-KOR-ti-sone AS-e-tate

Commonly used brand name(s)

In the U.S.

• AnaMantle HC


• Lida Mantle HC


• LidaMantle HC Relief


• LidoCort


• Peranex HC

Available Dosage Forms:

• Cream


• Pad


• Gel/Jelly


• Lotion

Therapeutic Class: Anesthetic Combination

Pharmacologic Class: Hydrocortisone

Chemical Class: Lidocaine

Uses For lidocaine and hydrocortisone

Lidocaine and hydrocortisone combination is used to relieve pain and itching caused by conditions such as hemorrhoids, sunburn, minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.

Lidocaine belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. lidocaine and hydrocortisone does not cause unconsciousness as general anesthetics do when used for surgery.

Hydrocortisone is a corticosteroid (cortisone-like medicine) that is used to relieve the redness, itching, and swelling caused by skin conditions.

lidocaine and hydrocortisone is available only with your doctor's prescription.

Before Using lidocaine and hydrocortisone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For lidocaine and hydrocortisone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lidocaine and hydrocortisone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lidocaine and hydrocortisone combination in children. However, because of lidocaine and hydrocortisone's toxicity, it should be used with caution, after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Geriatric

No information is available on the relationship of age to the effects of lidocaine and hydrocortisone combination in geriatric patients. However, elderly patients are more likely to have age-related liver problems, which may require caution in patients receiving lidocaine and hydrocortisone combination.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of lidocaine and hydrocortisone. Make sure you tell your doctor if you have any other medical problems, especially:

• Chickenpox infection or


• Fungal infection or


• Herpes simplex infection or


• Liver disease, severe or


• Tuberculosis, active—Should not be used in patients with these conditions.

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar)—Use with caution. May make these conditions worse.

• Infection at or near the place of application or


• Large sores, broken skin, or severe injury at the area of application—The chance of side effects may be increased.

Proper Use of lidocaine and hydrocortisone

Use lidocaine and hydrocortisone exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. lidocaine and hydrocortisone may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

Wash your hands with soap and water before and after using lidocaine and hydrocortisone.

Unless otherwise directed by your doctor, do not apply lidocaine and hydrocortisone to open wounds, burns, or broken or inflamed skin.

lidocaine and hydrocortisone should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. lidocaine and hydrocortisone should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Be careful not to get any of lidocaine and hydrocortisone in your nose, mouth, ears, and especially in your eyes, because it can cause severe eye irritation. If any of the medicine does get in these areas, wash the area with water for at least 15 minutes and check with your doctor right away.

To use the Anamantle® HC kit:

• Remove the cap from the tube of cream and firmly screw the applicator tip on to the end of the tube.


• Squeeze the tube until a small amount of cream comes out. Lubricate the end of the applicator tip with the cream.


• Gently insert the applicator tip with the attached tube into the anal area.


• Continue squeezing the tube until the cream is applied to the affected areas.


• Do not insert the applicator tip and tube completely into the anus or deep into the rectum.


• Gently remove the applicator tip and throw it in the trash. Make sure to dispose of it out of the reach of children and pets.

Dosing

The dose of lidocaine and hydrocortisone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of lidocaine and hydrocortisone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage forms (cream, lotion):
  
  • For pain and itching from hemorrhoids or minor skin conditions:
    
    • Adults—Apply a thin film to the affected area two or three times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of lidocaine and hydrocortisone, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using lidocaine and hydrocortisone

It is very important that your doctor check your progress at regular visits for any problems or unwanted effects that may be caused by lidocaine and hydrocortisone.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Using too much of lidocaine and hydrocortisone or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and for patients who use large amounts for a long time. Talk to your doctor if you or your child have more than one of these symptoms while you are using lidocaine and hydrocortisone: blurred vision; dizziness or fainting; fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

After applying lidocaine and hydrocortisone to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine in the eyes or mouth. lidocaine and hydrocortisone can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.

Stop using lidocaine and hydrocortisone and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated skin areas.

lidocaine and hydrocortisone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Burning or stinging sensation of the skin


• paleness or redness of the skin


• swelling of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: lidocaine and hydrocortisone Topical application, Rectal side effects (in more detail)

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More lidocaine and hydrocortisone Topical application, Rectal resources

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• Lidocaine and hydrocortisone Topical application, Rectal Drug Interactions
• Lidocaine and hydrocortisone Topical application, Rectal Support Group
• 1 Review for Lidocaine and hydrocortisone Topical application, Rectal - Add your own review/rating

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Little Fevers Children's Fever/Pain Reliever

Generic Name: acetaminophen (oral) (a SEET a MIN oh fen)

Brand Names: Acetaminophen Quickmelt, Actamin, Adprin B, Anacin AF, Apra, Bromo Seltzer, Children's Tylenol, Children's Tylenol Meltaway, Ed-APAP, Elixsure Fever/Pain, Genebs, Infants Tylenol Concentrated Drops, Leader 8 Hour Pain Reliever, Little Fevers, Little Fevers Children's Fever/Pain Reliever, Mapap, Mapap Arthritis Pain, Mapap Extra Strength Rapid Burst, Mapap Infant Drops, Mapap Infants', Mapap Meltaway, Mapap Rapid Release Gelcaps, Mapap Rapid Tabs, Medi-Tabs, Q-Pap, Q-Pap Extra Strength, Silapap Childrens, Silapap Infants, St. Joseph Aspirin-Free, Tactinal, Tempra, Tempra Quicklets, Triaminic Fever & Pain, Triaminic Infant Drops, Tycolene, Tylenol, Tylenol Arthritis Caplet, Tylenol Arthritis Gelcap, Tylenol Caplet, Tylenol Caplet Extra Strength, Tylenol Childrens, Tylenol Cool Caplet Extra Strength, Tylenol Extra Strength, Tylenol Extra Strength Cool Caplet, Tylenol Extra Strength EZ, Tylenol Gelcap Extra Strength, Tylenol Geltab Extra Strength, Tylenol Infant's Drops, Tylenol Junior Meltaway, Tylenol Rapid Release Gelcap, Tylenol Sore Throat Daytime, Vitapap

What is acetaminophen?

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.

Acetaminophen is a pain reliever and a fever reducer.

Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Acetaminophen may also be used for purposes not listed in this medication guide.

What is the most important information I should know about acetaminophen?

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Know the amount of acetaminophen in the specific product you are taking.

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking acetaminophen?

You should not take acetaminophen if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen if you have:

• liver disease; or


• 
  

  a history of alcoholism.

  
  

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. It is not known whether acetaminophen will harm an unborn baby. Before taking acetaminophen, tell your doctor if you are pregnant. Acetaminophen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

How should I take acetaminophen?

Take exactly as directed on the label, or as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you are treating a child, use a pediatric form of acetaminophen. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label. Acetaminophen made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of acetaminophen. Never mix and match dosing devices between infant formulations of acetaminophen. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Stop taking acetaminophen and call your doctor if:

• 
  

  you still have a fever after 3 days of use;

  
  


• 
  

  you still have pain after 7 days of use (or 5 days if treating a child);

  
  


• 
  

  you have a skin rash, ongoing headache, or any redness or swelling; or

  
  


• 
  

  if your symptoms get worse, or if you have any new symptoms.

  
  

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen.

Store at room temperature away from heat and moisture.

What happens if I miss a dose?

Since acetaminophen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking acetaminophen?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Acetaminophen side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  nausea, upper stomach pain, itching, loss of appetite;

  
  


• 
  

  dark urine, clay-colored stools; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect acetaminophen?

Ask a doctor or pharmacist if it is safe for you to use acetaminophen if you are also using any of the following drugs:

• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  cancer medications;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medications;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medications.

  
  

This list is not complete and there may be other drugs that can interact with acetaminophen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Little Fevers Children's Fever/Pain Reliever resources

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• Little Fevers Children's Fever/Pain Reliever Drug Interactions
• 0 Reviews for Little Fevers Children's Fever/Pain Reliever - Add your own review/rating

• acetaminophen Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Acetaminophen MedFacts Consumer Leaflet (Wolters Kluwer)


• Acetaminophen Monograph (AHFS DI)


• Acetazolamide Monograph (AHFS DI)


• Apra Advanced Consumer (Micromedex) - Includes Dosage Information


• Apraclonidine Hydrochloride Monograph (AHFS DI)


• Genapap Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Mapap Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)


• Ofirmev Consumer Overview


• Ofirmev Injection MedFacts Consumer Leaflet (Wolters Kluwer)


• Ofirmev Prescribing Information (FDA)


• Paracetamol Consumer Overview


• Tempra 1 Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Tylenol Consumer Overview


• Tylenol MedFacts Consumer Leaflet (Wolters Kluwer)

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Where can I get more information?

• Your pharmacist can provide more information about acetaminophen.

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Nicotinell Icemint 2mg medicated chewing gums

1. Name Of The Medicinal Product

Nicotinell^® Icemint 2 mg medicated chewing-gum

2. Qualitative And Quantitative Composition

One piece of medicated chewing gum contains 2 mg nicotine (as 10 mg nicotine – polacrilin (1:4)).

For excipients, see section 6.1

3. Pharmaceutical Form

Medicated chewing gum.

Each piece of coated chewing gum is off-white in colour and rectangular in shape.

4. Clinical Particulars

4.1 Therapeutic Indications

Nicotinell gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

Nicotinell gum is indicated in pregnant and lactating women making a quit attempt.

Nicotinell gum should preferably be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

Adults and elderly

Users should stop smoking completely during treatment with Nicotinell gum.

One piece of Nicotinell gum to be chewed when the user feels the urge to smoke. Normally, 8-12 pieces per day can be used, up to a maximum of 25 pieces per day.

The 2 mg chewing gum may not be well suited to smokers with a strong or very strong nicotine dependency.

The 4 mg chewing gum is intended to be used by smokers with a strong or very strong nicotine dependency and those who have previously failed to stop smoking with the aid of nicotine replacement therapy.

The optimal dosage form is selected according to the following table:

If an adverse event is noted when high dose forms are initiated, this should be replaced by the lower dosage form.

The characteristics of chewing-gum as a pharmaceutical form are such that individually different nicotine levels can result in the blood. Therefore, dosage frequency should be adjusted according to individual requirements within the stated maximum limit.

Directions for use:

1. One piece of gum should be chewed until the taste becomes strong.

2. The chewing gum should be rested between the gum and cheek.

3. When the taste fades, chewing should commence again.

4. The chewing routine should be repeated for 30 minutes.

The treatment time is individual. Normally, treatment should continue for at least 3 months.

After three months, the user should gradually cut down the number of pieces chewed each day until they have stopped using the product.

Treatment should be discontinued when the dose has been reduced to 1-2 pieces of gum per day. Nicotinell gum is sugar free.

Adolescents (aged 12-18 years of age)

The above recommendation can be used for adolescents aged between 12 and 18 years of age. As data are limited in this age group, medical advice should be obtained should it be found necessary to use the gum beyond 12 weeks.

Concomitant use of acidic beverages such as coffee or soda may decrease the buccal absorption of nicotine. Acidic beverages should be avoided for 15 minutes prior to chewing the gum.

4.3 Contraindications

Hypersensitivity to nicotine or any components of the gum.

Nicotinell gum should not be used by non-smokers.

4.4 Special Warnings And Precautions For Use

Any risks that may be associated with nicotine replacement therapy are substantially outweighed by the well established dangers of continued smoking.

Precautions: Users should stop smoking completely during therapy with Nicotinell gum. They should be informed that if they continue to smoke while using the gums they may experience increased adverse effects due to the hazards of smoking, including cardiovascular effects.

Cardiovascular disease

In stable cardiovascular disease Nicotinell gum presents a lesser hazard than continuing to smoke. However dependant smokers currently hospitalised as a result of a recent myocardial infarction, severe disrythmia, or recent cerebrovascular accident who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicotinell gum may be considered but as data on safety in this patient group are limited, initiation should only be under medical supervision.

Diabetes mellitus

Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when nicotine replacement therapy is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Allergic reactions

Angioedema and urticaria have been reported.

Gastro-intestinal disease

Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis, or peptic ulcers and oral nicotine replacement therapy preparations should be used with caution in these conditions. Ulcerative stomatitis have been reported.

Renal and or hepatic impairment

Should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

Danger in small children

Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotinell gum should be disposed of with care.

Pheochromocytoma and uncontrolled hyperthyroidism

Nicotinell gum should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma as nicotine causes the release of catecholamines.

Transferred dependence

Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking

Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly CYP 1A1). When a smoker stops, this may result in slower metabolism and a consequential rise in blood levels of drugs such as theophylline, tacrine, olanzaprine and clozaprine.

Other warnings

If denture wearers experience difficulty in chewing the gum, it is recommended that they use a different pharmaceutical form of nicotine replacement therapy.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Nicotinell Icemint 2 mg coated chewing-gum contains sorbitol (E420) 0.1 g per chewing-gum, a source of 0.02 g fructose. Calorific value 1.2 kcal/piece of chewing-gum.

Nicotinell Icemint 2 mg coated chewing-gum contains sodium 11.44 mg per piece.

The gum base contains butylhydroxytoluene (E321) which may cause local irritation to mucous membranes.”

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No information is available on interactions between Nicotinell gum and other drugs. No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.

4.6 Pregnancy And Lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the fetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but Nicotinell gums may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the fetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Some symptoms such as dizziness, headache and sleep disturbances may be related to the withdrawal of nicotine associated with stopping smoking.

In principle, Nicotinell gums can cause adverse reactions similar to those associated with nicotine administered by other means (including smoking) and these are mainly dose dependant. At recommended doses Nicotinell gum has not been found to cause any serious adverse effects. Excessive consumption of Nicotinell gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Most of the side effects which are reported by patients occur generally during the first 3-4 weeks after initiation of therapy.

Nicotine from gums may sometimes cause a slight irritation of the throat and increase salivation at the start of the treatment.

The gum may stick to and in rare cases damage dentures and dental appliances.

Common (> 1/100).

Nervous system disorders: headache, dizziness

Gastrointestinal disorders: hiccups, gastric symptoms e.g. nausea, vomiting, indigestion, heartburn, increased salivation, irritation or sore mouth or throat

Musculoskeletal, connective and bone disorders: jaw muscle ache.

Uncommon (>1/1,000, <1/100)

Cardiac disorders: palpitations

Skin and subcutaneous tissue disorders: erythema, urticaria

Rare (<1/1,000)

Cardiac disorders: cardiac arrhythmias (e.g. atrial fibrillation)

Immune system disorders: hypersensitivity, angioneurotic oedema and anaphylactic reactions.

4.9 Overdose

In overdose, symptoms corresponding to heavy smoking may be seen, however the toxicity of nicotine cannot be directly compared with that of smoking, because tobacco smoke contains additional toxic substances (eg. carbon monoxide and tar).

Overdose with Nicotinell gum may only occur if many pieces are chewed simultaneously. Nicotine toxicity after ingestion will most likely be minimized as a result of early nausea and vomiting that occur following excessive nicotine exposure. Risk of poisoning by swallowing the gum is small. Since the release of nicotine from the gum is slow, very little nicotine is absorbed from the stomach and intestine, and if any is, it will be inactivated in the liver.

Chronic smokers can tolerate doses of nicotine that, in a non-smoker, would be more toxic, because of the development of tolerance.

Symptoms

The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40-60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of overdose

Following overdose, symptoms may be rapid particularly in children. All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: N07B A01

Pharmacotherapeutic group: Drugs used in nicotine dependence

Nicotine, the primary alkaloid in tobacco products and a naturally occurring autonomous substance, is a nicotine receptor agonist in the peripheral and central nervous systems and has pronounced CNS and cardiovascular effects. On consumption of tobacco products, nicotine has proven to be addictive, resulting in craving and other withdrawal symptoms when administration is stopped. This craving and these withdrawal symptoms include a strong urge to smoke, dysphoria, insomnia, irritability, frustration or anger, anxiety, concentration difficulties agitation and increased appetite or weight gain. The gum replaces part of the nicotine that would have been administrated via tobacco and reduces the intensity of the withdrawal symptoms and smoking urge.

“The gum contains a number of ingredients that are recognized as having properties for removal of dental staining. Studies have shown that the gum helps to improve tooth whiteness”

5.2 Pharmacokinetic Properties

When the gum is chewed, nicotine is steadily released into the mouth and is rapidly absorbed through the buccal mucosa. A proportion, by the swallowing of nicotine containing saliva, reaches the stomach and intestine where it is inactivated.

The nicotine peak plasma mean concentration after a single dose of the 2 mg coated gum is approximately 6.4 nanograms per ml (after 45 minutes) (average plasma concentration of nicotine when smoking a cigarette is 15-30 nanograms per ml).

Nicotine is eliminated mainly via hepatic metabolism; small amounts of nicotine are eliminated in unchanged form via the kidneys. The plasma half-life is approximately three hours. Nicotine crosses the blood-brain barrier, the placenta and is detectable in breast milk.

5.3 Preclinical Safety Data

No definite conclusion can be drawn on the genotoxic activity of nicotine in vitro. Nicotine was negative in in-vivo tests.

Animal experiments have shown that nicotine induces post-implantation loss and reduces the growth of foetuses.

The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Gum base (containing butylhydroxytoluene (E321))

Calcium carbonate (E170)

Sorbitol (E420)

Sodium carbonate anhydrous

Sodium hydrogen carbonate (E500)

Polacrilin

Glycerol (E422)

Purified water

Levomenthol

Natural mint flavouring

Mint millicaps

Sucralose (E955)

Acesulfame potassium (E950)

Xylitol (E967)

Mannitol (E421)

Gelatin

Titanium dioxide (E171)

Carnauba wax (E903)

Talc (E553b)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

The chewing-gum is packed in PVC/PVdC/aluminium blisters each containing either 2 or 12 pieces of gum. The blisters are packed in boxes containing 2, 12, 24, 36, 48, 60, 72, 84, 96 108, 120 and 204 pieces of gum.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd

Trading as Novartis Consumer Health

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB

8. Marketing Authorisation Number(S)

PL 00030/0441

9. Date Of First Authorisation/Renewal Of The Authorisation

09/03/2010

10. Date Of Revision Of The Text

2/2/2011

Legal Category: GSL

Disprin Direct

1. Name Of The Medicinal Product

Disprin Direct

2. Qualitative And Quantitative Composition

Active Ingredient	mg/Tablet	Specification
Aspirin	300	Ph Eur

3. Pharmaceutical Form

Dispersible tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of mild to moderate pain in headaches including tension headaches, migraine headaches, toothache, neuralgia, period pains, rheumatic pain, lumbago and sciatica. To relieve the symptoms of influenza, feverishness, feverish colds and ease sore throats.

4.2 Posology And Method Of Administration

Disprin Direct disperses on the tongue without water.

Adults and children 16 years and over: One to three tablets to a maximum of 13 tablets in 24 hours. The dose may be repeated after 4 hours, but the maximum dose in 24 hours must not be exceeded.

Elderly: There is no indication that dosage need be modified in the elderly.

Do not give to children aged under 16 years unless specifically indicated (e.g. for Kawasaki's disease).

4.3 Contraindications

Should not be given to patients suffering from active peptic ulceration or haemophilia.

4.4 Special Warnings And Precautions For Use

If you are receiving medical treatment, are asthmatic, allergic to aspirin or have or have had a stomach ulcer, seek your doctor's advice before taking this product.

The product labelling will include “Do not give to children aged under 16 years unless on the advice of a doctor”.

There is a possible association between aspirin and Reye's Syndrome when given to children. Reye's Syndrome is a very rare disease which affects the brain and liver and can be fatal. For this reason aspirin should not be given to children aged under 16 years unless specifically indicated (e.g. for Kawasaki's disease).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Aspirin may enhance the effects of anticoagulants and inhibit the effects of uricosurics.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

4.6 Pregnancy And Lactation

There is clinical and epidemiological evidence of the safety of aspirin in human pregnancy, but it may prolong labour and contribute to maternal and neonatal bleeding and is best avoided at term and during breastfeeding.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

May precipitate bronchospasm and induce attacks of asthma or

hypersensitivity in susceptible subjects. May also induce gastrointestinal haemorrhage, occasionally major.

4.9 Overdose

Salicylate poisoning is usually associated with plasma concentrations>350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.

Symptoms

Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.

A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.

Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.

Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.

Management

Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.

Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations>700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Aspirin:

Aspirin inhibits the cyclo-oxygenase enzyme involved in conversion of phospholipids to prostaglandins and its effects on the body are believed to result primarily from prevention of prostaglandin production. These effects include peripheral analgesia, fever reduction, reduction in inflammation and inhibition of platelet aggregation.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be like for occasional ibuprofen use.

5.2 Pharmacokinetic Properties

Aspirin is rapidly absorbed from the stomach and upper gastrointestinal tract with peak levels after around 20-30 minutes following dissolution. It is subject to first-pass metabolism with an overall bioavailability of around 70%. Metabolism is by conversion to salicylic acid and then by further conversion to other metabolites. These are excreted by the kidneys in both free and conjugated form. The plasma half life of aspirin is around 15-20 minutes and that of salicylic acid is 2-3 hours.

5.3 Preclinical Safety Data

No preclinical findings of relevance have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycine

Maize starch

Microcrystalline cellulose

Purified talc

Saccharin

Lemon flavour 51124

6.2 Incompatibilities

None stated

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store below 35°C.

6.5 Nature And Contents Of Container

Polypropylene tubes (16 tablet pack) or vinyl coated heat sealed foils (4, 6, 8, 16, 24 and 48 tablet packs). (Only the packs printed in bold are currently marketed).

6.6 Special Precautions For Disposal And Other Handling

Disprin Direct disperses on the tongue without water.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0018.

9. Date Of First Authorisation/Renewal Of The Authorisation

24/04/1995 / 20/05/2005

10. Date Of Revision Of The Text

26/01/2009

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