AVIL (R) TABLETS, RETARD, SYRUP AND DECONGESTANT

Pheniramine maleate CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common questions about AVIL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. So please discuss these with your pharmacist or doctor to make sure that the benefits of taking AVIL outweigh any possible risks. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again.

AVIL is one of a group of medicines called 'antihistamines' which works by blocking the action of histamine.

Do not give AVIL to a premature or newborn baby. If you are not sure whether you should start taking AVIL, contact your doctor or pharmacist.

Before taking AVIL

AVIL must not be taken if
1. you have an allergy to: * AVIL (pheniramine maleate) or any of the ingredients listed at the end of this leaflet (Product Description). Symptoms of an allergic reaction may include: * asthma, wheezing or shortness of breath

Before you start to take it

Tell your pharmacist if: 1. you have allergies to: * any other medicines * any other substances 2. you have or have had any of the following medical conditions: * an enlarged prostate * glaucoma (high pressure in the eye) * asthma

What AVIL is used for

AVIL Tablets, Retard and Syrup contain pheniramine maleate, a medicine used to treat allergic conditions such as hayfever, runny nose, itching skin and skin rashes. It is also used in the prevention and treatment of inner ear disorders (eg. Meniere's disease) and travel sickness. AVIL Decongestant also contains pheniramine maleate, ammonium chloride and menthol. It is used to treat chesty coughs, or chest or nasal congestion due to an infection or allergy.

* swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing * hives, itching or skin rash * fainting 2. you are taking an antidepressant medicine known as a MAO Inhibitor. 3. if you are male and you have an enlarged prostate. 4. the packaging is torn or shows signs of tampering. 5. the expiry date on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well.

Taking other medicines

Before you take AVIL you should tell your pharmacist if you are taking any other medicines as some medicines and AVIL may interfere with each other. These include:* antidepressants known as MAO inhibitors * atropine and other anticholinergic drugs * alcohol * sedative drugs AVIL may cause drowsiness and may increase the effects of alcohol and other sedative drugs. If affected, do not drive a motor vehicle or operate machinery.

AVIL(R) TABLETS, RETARD, SYRUP AND DECONGESTANT

You might get used to the sedative effect after a few days of treatment, however you may prefer to change to a non-sedating antihistamine. Please discuss this option with your pharmacist.

may have taken too much AVIL. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Other side effects not listed above may occur in some patients. Do not be alarmed by this list of possible side effects. You may not experience any of them.

Things to be careful of
AVIL can cause drowsiness so you should not drive a motor vehicle or operate machinery after taking a dose. This effect may decrease with time.

How to take AVIL

Follow all directions given to you by your doctor or pharmacist carefully. These directions may differ from the information contained in this leaflet.

After using AVIL

Storage

Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking AVIL, even if the problem is not listed below. AVIL helps many people with allergic conditions, travel sickness and inner ear problems and AVIL Decongestant helps a cough, chest and nasal congestion, but there may be unwanted side-effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. Medical treatment may be required for some of the side effects. Tell your pharmacist or doctor if you notice any of the following and they worry you: * drowsiness * nervousness, irritability, incoordination, lack of concentration * dizziness * tinnitus (ringing in the ears) * nausea and vomiting * difficulty passing urine Tell your doctor immediately if you notice any of the following: * changes in your usual behaviour or mood * severe sedation, confusion or restlessness * hallucinations * vision problems * irregular heart beat

Keep your Avil Tablets, Retard tablets, Syrup or Decongestant in the container until it is time to take it. Keep AVIL in a cool dry place where the temperature stays below 30 degrees C. Do not store AVIL or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines. Keep AVIL where children cannot reach it.

How to take AVIL

AVIL Tablets and Avil Retard tablets should be swallowed whole with plenty of water. Do not chew them. Drink some water after taking your dose of Avil Syrup or Decongestant.

When to take AVIL

Avil should be taken with or soon after food. Do not take the medicine on an empty stomach. If you are taking Avil to prevent travel sickness, take a dose at least 30 minutes before travelling.

Disposal
If your doctor or pharmacist tells you to stop taking or giving AVIL or the expiry date has passed, ask your pharmacist what to do with any medicine which is left over.

If you forget to take or give a dose

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your dose as you would normally. Do not take a double dose to make up for the dose that you missed.

Product description
What AVIL looks like
Avil Tablets AVIL tablets are round white tablets with a single breakline on one face and DAR inscribed on both sides of the line. They come in packs of 10 and 50 tablets.

If too much is taken (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to casualty at your nearest hospital if you think that you or anyone else

AVIL(R) TABLETS, RETARD, SYRUP AND DECONGESTANT

Avil Retard (sustained-release tablets) Avil Retard sustained-release tablets are round red tablets. They come in packs of 50 tablets. Avil Syrup Avil syrup is a clear, almost colourless liquid supplied in 100mL bottles. Avil Decongestant AVIL Decongestant is a clear, red syrup with a cherry-menthol smell supplied in 100mL bottles.

hydroxybenzoate, propyl hydroxybenzoate and water. Avil Decongestant contains the active ingredients pheniramine maleate, ammonium chloride and menthol. There is 15 mg of pheniramine maleate in every 5 mL of syrup. It also contains sucrose, glucose, amaranth, ethanol, sorbitol, cherry and raspberry flavouring, methyl hydroxybenzoate, propyl hydroxybenzoate and water.

Manufacturer/ Distributor
AVIL Tablets, Retard tablets, Syrup and Decongestant syrup are supplied by: AVENTIS PHARMA Pty Ltd 27 Sirius Road Lane Cove NSW 2066 AVIL Tablets: AUST R 58687 and 58691 AVIL Retard (sustained-release tablets): AUST R 12394 AVIL Syrup: AUST R 12395 AVIL Decongestant syrup: AUST R 12392 Date of preparation: 14 November 2003

Ingredients
AVIL preparations do not contain gluten, tartrazine or azo dyes. Diabetics should note that Avil syrup contains 60% w/v of sugar. One 5mL measure contains 3.0g of sugar. AVIL Decongestant contains 50%w/v (sucrose 40%w/v and glucose 10%w/v) of sugar. One 5mL measure contains 2.5g of sugar. Avil Tablets contain the active ingredient pheniramine maleate. There is 45.3 mg of pheniramine maleate in every tablet. Each tablet also contains maize starch, sodium starch glycollate, lactose, colloidal silica, microcrystalline cellulose and magnesium stearate. Avil Retard (sustained-release tablets) contain the active ingredient pheniramine maleate. There is 75 mg of pheniramine maleate in every tablet. Each tablet also contains lactose, aluminium hydroxide, montan wax, colloidal silica, microcrystalline cellulose, magnesium stearate, polyvinyl acetate, sucrose, acacia gum, gelatin, glucose, calcium carbonate, titanium dioxide, erythrosine, iron oxide yellow, talc, glycerol and macrogol 6000. Avil Syrup contains the active ingredient pheniramine maleate. There is 15 mg of pheniramine maleate in every 5 mL of syrup. It also contains sucrose (60% w/v), passionfruit flavouring, methyl

AVIL(R) TABLETS, RETARD, SYRUP AND DECONGESTANT