PACKAGE LEAFLET: INFORMATION FOR THE USER Health Essentials MAX STRENGTH COLD AND FLU RELIEF CAPSULES

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 Health Essentials MAX STRENGTH COLD AND FLU RELIEF CAPSULES carefully to get the best results from them.

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

-    If you have 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.

The name of your medicine is Health Essentials MAX STRENGTH COLD AND FLU RELIEF CAPSULES. In the rest of this leaflet it is called Max Strength Cold & Flu Relief Capsules.

In this leaflet:

1.    What Max Strength Cold & Flu Relief Capsules are and what they are used for

2.    Before you take Max Strength Cold & Flu Relief Capsules

3.    How to take Max Strength Cold & Flu Relief Capsules

4.    Possible side effects

5.    How to store Max Strength Cold & Flu Relief Capsules

6.    Further information

1. What Max Strength Cold & Flu Relief Capsules are and what they are used for

The name of your medicine is Max Strength Cold & Flu Relief Capsules. These capsules contain a combination of paracetamol (a painkiller), caffeine (a mild stimulant) and phenylephrine hydrochloride (a decongestant).

Max Strength Cold & Flu Relief Capsules 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 Max Strength Cold & Flu Relief Capsules

You should not take Max Strength Cold & Flu Relief Capsules if you:

•    are allergic (hypersensitive) to paracetamol, caffeine, phenylephrine hydrochloride or any of the other ingredients in Max Strength Cold & Flu Relief Capsules (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 very 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.

Talk to your doctor or pharmacist before taking Max Strength Cold & Flu Relief Capsules if you:

•    are elderly

•    suffer from 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 including high blood pressure.

Caution should be exercised when taking paracetamol products prior to (less than 72 hours before) or at the same time as intravenous busulfan.

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 Max Strength Cold & Flu Relief Capsules:

•    general anaesthetics such as halothane

•    general anaesthetics such as halothane and cyclopropane

•    medicines used to treat bacterial infections (e.g. quinolone antibiotics such as enoxacin, pipemidic acid and ciprofloxacin and isoniazid used to treat tuberculosis)

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

•    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)

•    probenecid (used to treat gout)

•    diflunisal (an anti-inflammatory painkiller)

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

•    fluconazole or terbinafine (used to treat fungal infections)

•    clozapine (an antipsychotic used to treat schizophrenia)

•    diuretics such as hydrochlorothiazide

•    ephedrine, a stimulant used in dietary supplements such as Ma Huang

•    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 increases the heart rate)

•    cardiac glycosides (used to treat heart failure)

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•    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)

•    intravenous busulfan (used in chemotherapy to treat cancer).

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 Max Strength Cold & Flu Relief Capsules may cause dizziness. Do not drive or operate machinery if affected.

3. How to take Max Strength Cold & Flu Relief Capsules

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

Adults and children over 12 years

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

•    do not take more than 8 capsules 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 12 years.

If you take more Max Strength Cold & Flu Relief Capsules than you should

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

If you forget to take Max Strength Cold & Flu Relief Capsules

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, Max Strength Cold & Flu Relief Capsules 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 Max Strength Cold & Flu Relief Capsules immediately, and see your doctor or pharmacist:

•    allergic reactions which may be severe such as skin rash, peeling of the skin, itching, swollen red areas of the skin, sometimes with shortness of breath or swelling of the mouth, lips, tongue, throat or face.

•    hallucinations

•    restlessness

•    sleep disturbances.

Side effects that have been reported with Max Strength Cold & Flu Relief Capsules are:

•    anxiety

•    worsening of asthma

•    problems passing water

•    nausea or vomiting

•    increased frequency to urinate

•    piloerection (bristling of hairs on the skin)

•    excitability

•    sleep disturbance or insomnia

•    tremor

•    changes in blood cells

•    lumps (cysts) in the breasts

•    narrowing of blood vessels

•    irritability

•    hallucinations or paranoia

•    restlessness

•    acid reflux

•    muscle weakness

•    very rare cases of serious skin reactions have been reported.

•    rash

•    irregular heart beat

•    palpitations

•    high blood pressure

•    bowel irritation

•    acidosis (increased acid concentration in the blood)

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.

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 Max Strength Cold & Flu Relief Capsules

Keep out of the sight and reach of children.

•    Max Strength Cold & Flu Relief Capsules 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

•    Max Strength Cold & Flu Relief Capsules 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 Max Strength Cold & Flu Relief Capsules contain

The active ingredients are: paracetamol 500mg, caffeine 25mg and phenylephrine hydrochloride 6mg.The other ingredients are: pregelatinised starch, sodium lauryl sulphate, croscarmellose sodium, magnesium stearate, talc, purified water. Empty hard gelatine capsule shell; quinoline yellow (E104), patent blue V (E131), titanium dioxide (E171) and erythrosine (E127).

What Max Strength Cold & Flu Relief Capsules looks like and the contents of the pack

Max Strength Cold & Flu Relief Capsules are hard, red and yellow, gelatine capsules.

Max Strength Cold & Flu Relief Capsules are available on general sale in blister pack sizes of 12 and 16 capsules. 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:

This is a service provided by the Royal National Institute of Blind People.

Leaflet Prepared: July 2015

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