PARACETAMOL EXTRA CAPLETS - patient leaflet, side effects, dosage

Patient Information Leaflet for

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 Paracetamol Extra Caplets are and what they are used for

• 2. What you need to know before you take Paracetamol Extra Caplets

• 3. How to take Paracetamol Extra Caplets

• 4. Possible side effects

• 5. How to store Paracetamol Extra Caplets

• 6. Contents of the pack and other information

• 1. What Paracetamol Extra Caplets are and what they are used for

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. what you need to know before you take paracetamol extra caplets

! 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 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

3. how to take paracetamol extra caplets

K DoSa Dosage in adults and children over 16 years: Take one or two caplets every four to six hours when necessary to a maximum of four doses in 24 hours.

Dosage in children 12–15 years: Take one caplet every four to six hours when necessary to a maximum of four doses 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.

• Talk to a doctor at once if you take too much of this medicine, 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.

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.

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

5. how to store paracetamol extra caplets

Keep medicines out of the sight and reach of children.

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. contents of the pack and other information

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.

Manufacturer: Aspar Pharmaceuticals Ltd.,

Capitol Way, Colindale, London NW9 0EQ.

MA Holder and Manufacturer: Aspar pharmaceutical­s Ltd.,

Albany House, Acrewood Way, St Albans, AL4 0JY, United Kingdom.

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 March 2020

PXT/7