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Paracetamol Extra Strength Pain Relief Tablets

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Document: leaflet ALDI_PL 29831-0166 change

PACKAGE LEAFLET: INFORMATION FOR THE USER Health Essentials Pain Relief Extra 500mg/65mg Tablets

Paracetamol and Caffeine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

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

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.


-    You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet:

1.    What Health Essentials Pain Relief Extra Tablets are and what they are used for

2.    What you need to know before you take Health Essentials Pain Relief Extra Tablets

3.    How to take Health Essentials Pain Relief Extra Tablets

4.    Possible side effects

5.    How to store Health Essentials Pain Relief Extra Tablets

6.    Contents of the pack and other information

1. WHAT HEALTH ESSENTIALS PAIN RELIEF EXTRA TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Health Essentials Pain Relief Extra Tablets. These tablets contain a combination of paracetamol (a painkiller) and caffeine (a mild stimulant).

Health Essentials Pain Relief Extra Tablets are used to relieve mild to moderate pain including, toothache, period pains, and pains associated with the joints and muscles.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HEALTH ESSENTIALS PAIN RELIEF EXTRA TABLETS

Do not take Health Essentials Pain Relief Extra Tablets if you:

•    are allergic to paracetamol, caffeine or any of the other ingredients of this medicine (listed in section 6)

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Health Essentials Pain Relief Extra Tablets if you:

•    suffer from kidney disease

•    suffer from liver disease, particularly if caused by alcohol

•    suffer from alcoholism

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

Caution should be exercised when taking paracetamol 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.

Other medicines and Health Essentials Pain Relief Extra Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following medicines can affect or be affected by Health Essentials Pain Relief Extra Tablets:

•    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, primodone)

•    medicines used to treat depression (e.g. fluvoxamine)

•    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)

•    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)

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

Pregnancy and breast-feeding

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

Driving and using machines

Health Essentials Pain Relief Extra Tablets do not affect your ability to drive or operate machinery.

3. HOW TO TAKE HEALTH ESSENTIALS PAIN RELIEF EXTRA TABLETS

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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Swallow tablets whole with a glass of water.

Adults and children over 12 years

•    1 to 2 tablets every 4 hours as required

•    do not take more than 8 tablets 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. Children under 12 years

•    do not give to children under 12 years unless your doctor tells you to.

If you take more Health Essentials Pain Relief Extra Tablets 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 Health Essentials Pain Relief Extra Tablets

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 a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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 this medicine 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.


Side effects that have been reported with Health Essentials Pain Relief Extra Tablets are:

• rash    • worsening of asthma    • tremor

• anxiety    • sleep disturbance    • changes in blood cells

•    very rare cases of serious skin    •    palpitations    •    irregular heartbeat

reactions have been reported    •    feeling or being sick    •    acid reflux

•    bowel irritation    •    irritability    •    restlessness

•    increased frequency to urinate    •    insomnia    •    lumps (cysts) in    the breasts

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 HEALTH ESSENTIALS PAIN RELIEF EXTRA TABLETS

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

•    Store in a dry place below 25°C

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

•    Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Health Essentials Pain Relief Extra Tablets contain

The active ingredients are: paracetamol 500mg and caffeine 65mg.

The other ingredients are: potato starch, pregelatinised maize starch, povidone, magnesium stearate, purified talc, croscarmellose sodium, stearic acid and water.

What Health Essentials Pain Relief Extra Tablets look like and the contents of the pack

Health Essentials Pain Relief Extra Tablets are capsule shaped tablets.

Health Essentials Pain Relief Extra Tablets are available on general sale in blister pack sizes of 8, 10, 12 and 16 tablets. Not all pack sizes may be marketed.

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

Health Essentials Pain Relief Extra 500mg/65mg Tablets

29831/0166

This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in 07/2015

GSL


£WOCKHARDT


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