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PACKAGE LEAFLET: INFORMATION FOR THE USER Paracetamol Extra Strength Pain Relief Tablets

Paracetamol and Caffeine

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 Paracetamol Extra Strength Pain Relief Tablets 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 Paracetamol Extra Strength Pain Relief Tablets are and what they are used for

2. Before you take Paracetamol Extra Strength Pain Relief Tablets

3. How to take Paracetamol Extra Strength Pain Relief Tablets

4. Possible side effects

5. How to store Paracetamol Extra Strength Pain Relief Tablets

6. Further information.

1. What Paracetamol Extra Strength Pain Relief Tablets are and what they are used for

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

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

2. Before you take Paracetamol Extra Strength Pain Relief Tablets

You should not take Paracetamol Extra Strength Pain Relief Tablets if you:

• are allergic (hypersensitive) to paracetamol, caffeine or any of the other ingredients in Paracetamol Extra Strength Pain Relief Tablets (see section 6, Further information)

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

Talk to your doctor or pharmacist before taking Paracetamol Extra Strength Pain Relief 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.

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 Paracetamol Extra Strength Pain Relief 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 are breast-feeding you should only take this medicine if your doctor has specifically recommended it.

Driving and using machinery

Paracetamol Extra Strength Pain Relief Tablets do not affect your ability to drive or operate machinery.

3. How to take Paracetamol Extra Strength Pain Relief Tablets

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

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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 Paracetamol Extra Strength Pain Relief 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 Paracetamol Extra Strength Pain Relief 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 the one missed.

4. Possible side effects

Like all medicines, Paracetamol Extra Strength Pain Relief Tablets 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 Paracetamol Extra Strength Pain Relief Tablets are:

• rash

• tremor

• sleep disturbance

• very rare cases of serious skin reactions have been reported

• feeling or being sick

• bowel irritation

• restlessness

• insomnia

• worsening of asthma

• anxiety

• changes in blood cells

• palpitations

• irregular heartbeat

• acid reflux

• irritability

• increased frequency to urinate

• 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 Paracetamol Extra Strength Pain Relief Tablets

Keep out of the sight and reach of children.

• Paracetamol Extra Strength Pain Relief Tablets 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

• Paracetamol Extra Strength Pain Relief Tablets 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 Paracetamol Extra Strength Pain Relief 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 Paracetamol Extra Strength Pain Relief Tablets look like and the contents of the pack

Paracetamol Extra Strength Pain Relief Tablets are capsule shaped tablets.

Paracetamol Extra Strength Pain Relief Tablets are available on general sale in blister pack sizes of 8, 10, 12 and 16 tablets.

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
Paracetamol Extra Strength Pain Relief Tablets	29831/0166

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

Leaflet Prepared: February 2015

GSL