Document: leaflet MAH GENERIC_PL 08977-0025 change

• leaflet MAH GENERIC_PL 08977-0024
• leaflet MAH GENERIC_PL 08977-0025

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Patient Information Leaflet for PARACETAMOL EXTRA CAPLETS Paracetamol and Caffeine

Read this leaflet carefully before taking these caplets. It does not contain all the information about your medicine that you may need to know, so please ask your doctor or pharmacist if you have any questions. This leaflet only applies to Paracetamol Extra Caplets.

? Paracetamol Extra Caplets contain paracetamol and caffeine and are used for the relief of headache, migraine, backache, fever, dental pain, period pain, the symptoms of cold and flu, sciatica and rheumatic and muscular aches and pains.

2. Check before you take

Do not take these caplets if you:

Are allergic to Paracetamol, or any of the other ingredients listed in section 6 (See section 4 - Possible Side Effects)

Have a peptic ulcer or have had one in the past Are pregnant Take special care and tell your doctor if you:

Suffer from liver or kidney problems Have heart disease or high blood pressure Suffer from G6PD deficiency Suffer from alcohol dependency Are pregnant or breast feeding Are on a low sodium diet Tell your doctor or pharmacist if you are already taking any of the following medicines: Blood thinning medicines such as Warfarin

Metoclopramide, and Domperidone (for sickness and digestive disorders) Colestyramine (to help control cholesterol levels)

Andrenocorticoids, anabolic steroids, androgens or ACTH Oral tetracyclines (a type of antibiotic)

Any drugs that affect the liver Any other anti inflammatory drugs e.g. aspirin Antidepressants e.g. barbiturates, amitryptiline

Dosage in adults, the elderly and children over 12 years:

Take one to two caplets every four hours.

Do not take more than a total of 8 caplets in 24 hours.

Swallow the caplets whole with a drink of water. Do not chew.

When taking this medicine, it is important to remember the following:

■    Do not give these caplets to children under 12 years of age unless told to by your doctor Do not exceed the stated dose

Do not drink alcohol or take other Paracetamol containing products whilst taking this medicine.

■    Do not take excessive amounts of caffeine containing beverages.

■    If symptoms persist for more than 3 days consult your doctor.

If you take more Paracetamol Extra Caplets than you should.

■    Seek medical attention IMMEDIATELY if you accidentally take too many caplets, even if you feel well, because of the risk of delayed serious liver damage. Take the container and any remaining tablets with you. Symptoms of overdose include nausea, diarrhoea, vomiting, and abdominal pain.

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If you forget to take Paracetamol Extra Caplets.

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

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

4. Possible side effects

Paracetamol Extra Caplets can cause side effects but not everybody gets them.

If you experience any of the following symptoms below after taking this medicine go to the nearest hospital IMMEDIATELY.

serious side effects

■    Pancreatitis or Hepatitis (symptoms include abdominal pain, tiredness, fever, nausea, yellowing of skin or eyes)

■    Skin rashes and itching

■    Difficulty breathing Swollen face

■    Unusual bruising or bleeding, throat and mouth ulcers or bleeding gums accompanied by tiredness and flu like symptoms

Other side effects

Pain in the lower back and groin Restlessness and excitement Blood disorders including aneamia Changes in your urine Stomach ulcers Nausea and vomiting Insomnia Headache

Irritability and anxiety Rapid or irregular heartbeat If you experience any of these or any other side effects and they get serious, contact your doctor or pharmacist.

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. Storing your medicine

Keep your medicine in a safe place where children cannot see or reach it.

Do not store above 25°C. Store in the original packaging to protect from light and moisture. Do not use this medicine after the expiry date printed on the packaging.

6. More about your medicine

The active ingredients in Paracetamol Extra Caplets are Paracetamol 500mg and Caffeine Anhydrous 65mg. They are tablets with embossed ‘ap and x’ on one face on either side of a break line. The other ingredients are starch, povidone K-30, povidone K90, croscarmellose sodium, talc, stearic acid and magnesium stearate.

The Product Licence Holder and Manufacturer is Aspar Pharmaceuticals Ltd, Capitol Way, Colindale, London NW9 0EQ.

PL 08977/0025 & PL 08977/0024

Paracetamol Extra Caplets are sold in blister packs of 8, 16, 24, 28 and 32.

Not all pack sizes may be marketed.    Text Revised January 2014