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TRAVEL SICKNESS & NAUSEA 25mg TABLETS

Promethazine Teodate

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Vantage Travel Sickness & Nausea 25mg Tablets (hereinafter referred to as Promethazine Teodate) carefully to get the best results from them.

■    Keep this leaflet You may need to read it again.

■    Ask your pharmacist if you need more information or advice.

■    You must contact a doctor if your symptoms worsen or do not improve.

■    If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1.    What Promethazine Teodate is and what it is used for

2.    Before you take Promethazine Teodate

3.    How to take Promethazine Teodate A. Possible side effects

5.    How to store Promethazine Teodate

6.    Further information

1. What Promethazine Teodate is and what it is used for

Promethazine Teodate Tablets are an anti-emetic (anti-sickness drug) which helps to prevent, and treat nausea and vomiting, including travel sickness, and vertigo. Promethazine Teodate contains promethazine which belongs to a group of medicines called phenothiazines. Your doctor may prescribe this medicine for giddiness or light-headedness (vertigo), or for sickness after an operation, and in such cases the tablets should be taken as instructed by your doctor.

2. Before you take Promethazine Teodate

Do not give to a child under 2 years old.

Do not take Promethazine Teodate if you have:

■    ever had an allergic reaction to promethazine, any phenothiazine

or any of the ingredients (see section 6 for more details)

■    taken medicines for depression, known as Monoamine Oxidase Inhibitors (MAOIs) within the last 1A days

■    CNS depression. People with CNS depression will seem sleepy or unconscious (including coma).

Take special care with Promethazine Teodate and tell your doctor or pharmacist if you suffer with:

■    glaucoma (increased pressure in the eye)

■    epilepsy

■    heart problems

■    liver problems

■    kidney or bladder problems

■    a chest condition such as asthma or bronchitis

■    severe headaches with blurred vision, severe stomach pains with vomiting, dizziness, difficulty with keeping your balance, ringing in the ears or other ear problems as well as feeling sick

■    a bad cough

■    Reye’s Syndrome or symptoms of Reye’s Syndrome (including persistent vomiting, feeling tired or sleepiness).

Do not take Promethazine Teodate for more than 7 days without contacting your doctor.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

You must tell your doctor or pharmacist if you are already taking any of the following medicines:

■    anticholinergic agents

■    medicines to help you sleep (hypnotics)

■    medicines for depression, mental illness or anxiety (tricyclic antidepressants, sedatives)

■    medicines for crampy stomach pains, Parkinson’s disease or bladder problems.

If you are having skin tests for allergy, do not take this medicine as it interferes with the results. You should stop taking this medicine at least 72 hours before the skin tests. Taking Promethazine Teodate with food and drink While taking Promethazine Teodate, you should avoid drinking alcohol as the tablets will add to the effects of alcohol. Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are breast-feeding your baby, you should not take Promethazine Teodate, unless they have been recommended for you by a doctor.

If you are breast-feeding your baby, Promethazine Teodate may cause your baby to be irritable and excited.

If you are having a pregnancy test, do not take this product as it interferes with the results.

Driving and operating machinery These tablets may make you feel dizzy, sleepy, disorientated or confused or cause you to have a headache. You should not drive or operate machinery for the first few days, and until you are sure that you are not affected by these unwanted effects.

Important information about some of the ingredients in this product

These tablets contain sodium metabisulphite which may rarely cause hypersensitivity (allergic) reactions and bronchospasm (difficulty breathing). These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

3. How to take Promethazine Teodate

Always take Promethazine Teodate exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure. The usual dose is:

Adults

For the prevention of travel sickness on long journeys

Take one tablet each night at bedtime starting the night before you travel.

For the prevention of travel sickness on short journeys

Take one tablet one or two hours before travelling.

Treatment of travel sickness Take one tablet as soon as you feel sick followed by a second tablet the same evening. Take a third tablet the next evening if necessary.

Nausea and vomiting due to other causes One tablet each night is usually enough, but two or three tablets may be required by some patients. These can be taken at intervals during the day, but it is often not necessary for more than k tablets to be needed in any 2k hour period.

Children over 10 years old

Give the lower adult dose (one tablet).

Children 5 -10 years old

Give half the lower adult dose (half a tablet).

Do not take Promethazine Teodate for more than seven days. Should symptoms persist for or do not improve after 7 days, talk to your doctor or pharmacist.

Promethazine Teodate is not suitable for children under 2 years of age.

Avoid strong sunlight while taking this product as your skin may be more sensitive to the effect of the sun.

If you take more Promethazine Teodate than you should: Talk to your doctor, pharmacist or go to the nearest hospital casualty department immediately.

If you forget to take Promethazine Teodate If you forget to take a tablet, take one as soon as you remember. Do not take a double dose to make up for a forgotten dose.

A. Possible side effects

Some people may have side effects when taking this medicine. If you experience any of the following side effects, stop taking this medicine and speak to your doctor immediately:

■    severe rash, itching, swelling of the face, lips or mouth

■    shortness of breath or difficulty breathing

■    irregular heartbeats, low blood pressure (light-headed feeling when standing).

If you notice any of the following side effects speak to your doctor or pharmacist

■    infections, fevers or sore throats which seem to go on a long time

■    unexplained bruising or nose-bleeds

■    if you develop a yellow colour of your skin, dark urine and yellowing of the whites of the eyes.

Other side effects may include:

■    headache, dizziness, restlessness, confusion, you may feel tired or sleepy

■    children may become over excited while taking this product

■    occasionally some people, especially the elderly, may experience blurred vision, dry mouth or have difficulty passing water

■    loss of appetite, upset stomach, nightmares

■    cramp or muscles twitching or jerking, or the muscles become rigid

■    unusual movements of the head and face muscles. Reporting of Side Effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store Promethazine Teodate

Keep this product out of the sight and reach of children.

Do not use after the expiry date printed on your pack.

Store in the original container.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further Information

What Promethazine Teodate contains

Each tablet contains the active ingredient Promethazine Teodate 25mg.

Promethazine Teodate also contains: lactose, sodium metabisulphite (E223), potato starch, dextrin, microcrystalline cellulose, stearic acid and magnesium stearate.

What Promethazine Teodate looks like and contents of the

pack: Promethazine Teodate are white to pale cream, plain, circular biconvex tablets marked 'AVOMINE' on one side with a score line on the reverse. They are available in cartons of 10 tablets.

Marketing Authorisation Holder: Manx Pharma Ltd., Taylor Group House, Wedgnock Lane, Warwick, C\l3k 5YA, United Kingdom.

Manufacturer: Manx Healthcare Ltd., Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA, United Kingdom.

Other Formats:To request a copy of this leaflet in Braille, large print or audio please call 01926 482511.

This leaflet was revised in September 201 k