Compral ® Pain Tablets

COMPRAL ® PAIN TABLETS belongs to a group of medicines called analgesic combinations, used to relieve pain. COMPRAL ® PAIN TABLETS is used for the relief of pain of mild to moderate intensity and is also indicated in a wide variety of febrile conditions (related to fever).

Do not take COMPRAL ® PAIN TABLETS :

• if you have or ever had a problem of your blood not clotting properly, have severe liver function problems or if you are taking medicines to reduce blood clotting.
• if you are hypersensitive (allergic) to aspirin or other NSAIDs, paracetamol, caffeine or to any of the other ingredients of COMPRAL ® PAIN TABLETS. (listed in section 6).
• if you have a history of asthma, bronchospasm (sudden constrictions of the muscles of the passage ways by which air passes through the nose to the air sacs of the lungs), angioedema (painless swelling of the tissue layer under the skin), rhinitis (irritation and inflammation of the mucous membranes inside the nose), urticaria (hives), when you take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs-class of medicines which aspirin belongs to).
• if you have or ever had a stomach ulcer, damage or bleeding of the stomach related to previous use of aspirin and other NSAIDs (class of medicines which aspirin belongs to) including COMPRAL ® PAIN TABLETS.
• if you have severe kidney damage, liver impairment or heart failure.
• if you have or ever had gout.
• if you are pregnant, do not use NSAIDs at 30 weeks or later in your pregnancy because these medicines may cause problems in your unborn baby.
• If you have a history of intestine rupture, open wounds or bleeding related to NSAIDS, including COMPRAL ® PAIN TABLETS.
• If your child is under the age of 18 years (see Warnings and precautions).

Warning and precautions

COMPRAL ® PAIN TABLETS contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose even if the person may not be showing or experiencing any symptoms, the nearest doctor, hospital or Poison Centre must be contacted immediately.

Do not share medicines prescribed for you with any other person.

Always take COMPRAL ® PAIN TABLETS exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure.

DO NOT EXCEED THE RECOMMENDED DOSE.

Not for use in children and adolescents under 18 years of age.

Use the lowest effective dose for the shortest possible duration of treatment.

Adults: 1 to 2 tablets, 4 hourly. Not more than 4 doses in 24 hours. This means not more than 8 tablets in 24 hours.

If you take more COMPRAL ® PAIN TABLETS than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Paracetamol You will require specialised treatment as soon as possible. A delay in starting treatment may mean that antidote (medicine to counteract the overdose) is given too late to be effective. Usually, liver damage can only be confirmed after the time for effective treatment has passed.

COMPRAL ® PAIN TABLETS can have side effects. Not all side effects reported for COMPRAL ® PAIN TABLETS are included in this leaflet. Should your general health worsen or if you experience untoward effects while taking COMPRAL ® PAIN TABLETS, please consult your healthcare care provider for advice.

If any of the following happen, stop taking COMPRAL ® PAIN TABLETS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Fever, skin rash, swelling of the lymph nodes and/or swelling of the face (also known as DRESS). The rash may be red or itchy with swelling but sometimes may be more serious and accompanied by fever and ulcers or abscesses.
• Blisters on your skin or inside your mouth, nose, vagina, or bottom.
• The appearance of a rash or sunburn when you have been outside (even on a cloudy day).
• Other allergic reactions such as itching, or wheezing, coughing or difficulty breathing, or swelling of the lips and tongue.
• You experienced any bleeding from your stomach (symptoms can include blood in your stools or vomit).
• You experienced an increase in the number of nosebleeds or bruising.
• You experienced ringing in your ears or temporary hearing loss.
• You experienced any water retention.
• When used in children, changes in behaviour, nausea and vomiting occur (it could be early signs of Reye’s syndrome).
• Serious skin reactions such as swelling, itching, red severe rash especially those covering your whole body (appearing as allergic wheals), (see section 2).

These are very serious side effects. If you have them, you may have had a serious reaction to COMPRAL ® PAIN TABLETS. You may need urgent medical attention or hospitalisation.

Store all medicines out of reach of children.

Store at or below 25 °C in a well closed container. Exposure to air should be kept to a minimum.

Do not store in a bathroom.

Do not use after the expiry date stated on the polypaper, blister or tracer pack or carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).