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Maximum Flu Strength Caplets

Document: leaflet MAH BRAND_PL 29831-0436 change

PACKAGE LEAFLET: INFORMATION FOR THE USER Maximum Flu Strength Caplets

Paracetamol, Caffeine and Phenylephrine hydrochloride

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 Maximum Flu Strength Caplets carefully to get the best results from them.

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please ask your pharmacist.

-    You must contact a doctor if your symptoms worsen or do not improve after 3 days.

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

In this leaflet:

1.    What Maximum Flu Strength Caplets are and what they are used for

2.    Before you take Maximum Flu Strength Caplets

3.    How to take Maximum Flu Strength Caplets

4.    Possible side effects

5.    How to store Maximum Flu Strength Caplets

6.    Further information

1. What Maximum Flu Strength Caplets are and what they are used for

The name of your medicine is Maximum Flu Strength Caplets. These caplets contain a combination of paracetamol (a painkiller), caffeine (a mild stimulant) and phenylephrine hydrochloride (a decongestant).

Maximum Flu Strength Caplets are used to relieve the symptoms of the common cold and flu; including fever, aches and pains, headaches, tiredness and drowsiness, nasal congestion (blocked nose and sinus) and reducing temperatures.

2. Before you take Maximum Flu Strength Caplets

You should not take Maximum Flu Strength Caplets if you:

•    are allergic (hypersensitive) to paracetamol, caffeine, phenylephrine hydrochloride or any of the other ingredients in Maximum Flu Strength Caplets (see section 6, Further information)

•    are hypersusceptible to phenylephrine

•    have had ulcers of the stomach or small intestine (peptic ulcer disease)

•    have an overactive thyroid

•    have swelling of blood vessels (aneurysms) or narrowing of blood vessels

•    suffer from heart disease, including high blood pressure

•    suffer from a tumour called a phaeochromocytoma

•    suffer from an enlarged prostate

•    suffer from diabetes

•    suffer from an eye condition called closed angle glaucoma

•    are taking sympathomimetic decongestants

•    are taking beta blockers (used to treat high blood pressure)

•    are taking antidepressants called monoamine oxidase inhibitors (MAOIs) including moclobemide or if you have taken MAOIs within the past 14 days.

Do not give to children under 6 years.

Talk to your doctor or pharmacist before taking Maximum Flu Strength Caplets if you:

•    suffer from severe kidney disease or liver disease, particularly if caused by alcohol

•    suffer from alcoholism

•    suffer from asthma, particularly if your asthma is worsened by aspirin

•    suffer from heart disease such as prinzmetal angina (chest pain) or thromboembolic disorders following myocardial infarction (reduced blood supply in veins or arteries following a heart attack) or a history of ischemic heart disease.

This medicine contains paracetamol; do not take with any other paracetamol-containing products at the same time.

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. The following medicines can affect or be affected by Maximum Flu Strength Caplets:

•    medicines used to treat bacterial infections (e.g. quinolone antibiotics and isoniazid used to treat tuberculosis)

•    medicines used to treat epilepsy (fits) (e.g. carbamazepine, phenobarbital, phenytoin, primodone and lamotrigine)

•    medicines used to treat depression (e.g. fluvoxamine, tricyclic antidepressants such as imipramine, reversible inhibitors of monoamine oxidase (RIMAs) such as moclobemide and monoamine oxidase inhibitors (MAOIs) or if you have taken MAOIs within the past 14 days)

•    metoclopramide and domperidone (used to treat sickness and nausea)

•    oral contraceptives (“The Pill”, mini-pill), hormonal implants and HRT

•    warfarin and other coumarin medicines (used to thin the blood) due to increased risk of bleeding

•    probenecid (used to treat gout)

•    diflunisal (an anti-inflammatory painkiller)

•    colestyramine (used to treat high cholesterol and in diseases of the intestine and liver)

•    benzodiazepine medicines (sedatives e.g. diazepam)

•    disulfaram (used to treat alcoholism)

•    lithium (used to treat manic depression/bipolar disorder)

•    mexilitine (used to treat abnormal heart rhythms)

•    phenylpropanolamine (a decongestant)

•    theophylline (used in the treatment of asthma)

•    alpha-blockers (used in high blood pressure and problems associated with enlarged prostate)

•    beta-blockers (used to treat high blood pressure)

•    medicines used to decrease appetite

•    amphetamine-like psychostimulants also known as ‘uppers’ or ‘speed’

•    anticholinergic drugs (e.g. tricyclic antidepressants used to treat depression)

•    atropine (used in anaesthesia or to increase the heart rate)

•    cardiac glycosides (used to treat heart failure)

•    ergot alkaloids (used in the treatment of migraines e.g. ergotamine and methysergide)

•    oxytocin (used to induce childbirth)

•    sympathomimetics (used to maintain blood pressure in critically ill patients).

Pregnancy and breast-feeding

If you are pregnant or are breast-feeding you should only take this medicine if your doctor has specifically recommended it.

Driving and using machinery

It is possible that Maximum Flu Strength Caplets may cause dizziness. Do not drive or operate machinery if affected.

Important information about some of the ingredients in Maximum Flu Strength Caplets

This medicine contains ethylhydroxybenzoate, methylhydroxybenzoate and propylhydroxybenzoate all of which may cause allergic reactions (possibly delayed).

3. How to take Maximum Flu Strength Caplets

Always follow the instructions on the label. If you are not sure then ask your doctor or pharmacist for advice. Swallow caplets whole with a glass of water.

Adults and children over 12 years

•    1 to 2 caplets every 4-6 hours as required

•    do not take more than 8 caplets in 24 hours

•    do not exceed the recommended dose.

Children between 6 and 12 years

•    1 caplet every 4-6 hours as required

•    do not take more than 4 caplets in 24 hours

•    do not exceed the recommended dose.

If symptoms persist see your doctor, do not take for more than 3 days unless you have been told to do so by your doctor.

Do not give to children under 6 years.

If you take more Maximum Flu Strength Caplets than you should

If you (or anybody else, including a child) takes more Maximum Flu Strength Caplets than you should, immediate medical advice should be sought even if you feel well, because of the risk of delayed, serious liver damage. You should contact your nearest hospital casualty department or your doctor immediately. Always take the container and this leaflet with you.

If you forget to take Maximum Flu Strength Caplets

If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

4. Possible side effects

Like all medicines, Maximum Flu Strength Caplets can cause side effects, although not everybody gets them.

As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, stop taking Maximum Flu Strength Caplets:

•    rash, itching and/or difficulty breathing, seek medical help immediately

•    hallucinations    • restlessness    • sleep disturbances.

Side effects that have been reported with Maximum Flu Strength Caplets are:

•    rash

•    anxiety

•    excitability

•    irritability

•    irregular heart beat

•    dizziness


•    tremor

•    restlessness

•    high blood pressure

•    nausea or vomiting

•    changes in blood cells.


worsening of asthma

sleep disturbance or insomnia

hallucinations or paranoia

palpitations

headache

problems passing water

The use of this medicine over a long time can cause kidney problems. If you experience any side effects or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately.

5. How to store Maximum Flu Strength Caplets

Keep out of the reach and sight of children.

•    Maximum Flu Strength Caplets should be stored in a dry place below 25°C

•    Store in the original container to protect from light; do not transfer to another container

•    Maximum Flu Strength Caplets should not be taken after the expiry date on the label; the expiry date refers to the last day of the month.

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 protect the environment.

6. Further information

What Maximum Flu Strength Caplets contain

The active ingredients are: paracetamol 500mg, caffeine 25mg and phenylephrine hydrochloride 6mg.

The other ingredients are: povidone, crospovidone, magnesium stearate, steric acid, talc, colloidal silicon dioxide, hydroxypropyl methylcellulose, nipasept (containing ethylhydroxybenzoate (E214), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216)).

What Maximum Flu Strength Caplets look like and the contents of the pack

Maximum Flu Strength Caplets are white, coated, capsule shape tablets.

Maximum Flu Strength Caplets are available from the pharmacy in blister pack sizes of 24, 28 and 32 caplets or in polypropylene/polyethylene containers pack sizes 28 and 32 caplets.

Treating cough and cold in children

It’s normal for children to get 8 or more colds in a year. Gradually they build up immunity and get fewer colds. Because colds are caused by viruses, not bacteria, antibiotics don’t help. Here are simple steps to help your child who has a cough or cold.

1.    If they are hot/feverish : Increase the amount of fluid your child normally drinks.

2.    For coughs : Although it is distressing to hear your child cough, in fact coughing serves a purpose. It helps to clear phlegm on the chest or mucus from the nose. Give the child plenty of warm clear fluids to drink.

3.    To help with breathing : Plain saline nose drops, available from your pharmacy, can help babies with blocked noses who are having trouble feeding.

Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham LL13 9UF, UK. Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only).

Please be ready to give the following information:

Product name

Reference number

Maximum Flu Strength Caplets

29831/0436

This is a service provided by the Royal National Institute of Blind People. Leaflet Prepared: October 2009

WOCKHARDT