PARACETAMOL EXTRA STRENGTH PAIN RELIEF TABLETS, SUPERDRUG PARACETAMOL PLUS PAIN RELIEF TABLETS, HEALTH ESSENTIALS PAIN RELIEF EXTRA 500 MG / 65 MG TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take paracetamol extra strength pain relief tablets

Do not take Paracetamol Extra Strength Pain Relief Tablets if you:

• are allergic (hypersensitive) 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 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.

Other medicines and Paracetamol Extra Strength Pain Relief 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 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, breast-feeding and fertility

If necessary, Paracetamol Extra Strength Pain Relief Tablets can be used during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should use the lowest possible dose that reduces your pain and /or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.

Driving and using machines

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 take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Swallow tablets whole with a glass of water.

Adults and children 16 years and over:

• 1 to 2 tablets every 4 – 6 hours.
• 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 12 – 15 years:

• One tablet every 4 – 6 hours when necessary to a maximum of 4 doses in 24 hours.

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. Do not take a double dose to make up for a forgotten dose.

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 Paracetamol Extra Strength Pain Relief Tablets are:

• 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: or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 this medicine 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.
• Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

6. contents of the pack and other informationwhat paracetamol extra strength pain relief tablets containthe 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 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. 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:

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

This leaflet was last revised in 07/2019.

[GSL]

^WOCKHARDT