Betaprofen ® Tablets

The active substance is Ibuprofen 200 mg per tablet. Ibuprofen belongs to a group of medicines called Non-steroidal Anti-inflammatory Drugs that work by relieving pain, reducing swelling and fever.

You may have been prescribed BETAPROFEN ® 200 for the treatment of rheumatic & muscular pain and disease mainly affecting the joints with pain and swelling (osteoarthritis).

Do not take BETAPROFEN ® 200:

• If you are hypersensitive (allergic) to Ibuprofen or any of the other ingredients of BETAPROFEN ® 200 (listed in section 6).
• If you have asthma which has symptoms of breathlessness, wheezing, a cough sometimes brought on by exercise, and a feeling of tightness in the chest.
• If you have a disease of the heart and blood vessels.
• If you have or ever had any history of pain and discomfort (indigestion) which is felt between the navel and the breast bone (peptic ulcer).
• If you have or ever had any history of bleeding disorders.
• If you have or ever had any history of kidney disease which has symptoms of little or no urine, drowsiness, nausea, vomiting, breathlessness (renal failure).
• If you are pregnant, do not use BETAPROFEN ® 200 at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because these medicines may cause harm in your unborn baby.

Warnings and precautions

Tell your doctor or health care provider before taking BETAPROFEN ® 200:

Take special care with BETAPROFEN ® 200:

• If you have a history of high blood pressure and/or heart failure.
• If you have a history of peptic ulcers and other stomach or bowel disease.
• If you experience any unusual abdominal symptoms (especially bleeding from the stomach or bowel) during treatment with BETAPROFEN ® 200.
• If you are elderly you will be more prone to side effects, especially bleeding and perforation in the digestive tract, which may be fatal.
• If you have a serious skin reaction, after taking BETAPROFEN ® 200. BETAPROFEN ® 200 should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

Do not share medicines prescribed for you with any other person. Always take BETAPROFEN ® 200 exactly as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

The usual dose for Adults is:

• Acute: 1 200 mg to 2 400 mg per day in divided doses
• Maintenance: 600 mg to 1 200 mg per day in divided doses

The total daily dose should not exceed 2 400 mg per day. To minimize gastrointestinal side-effects or if gastrointestinal disturbances occur, BETAPROFEN ® 200 should be given with food or milk.

BETAPROFEN ® 200 can have side effects. Not all side effects reported for BETAPROFEN ® 200 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BETAPROFEN ® 200, please consult your health care provider for advice.

If any of the following happens, stop taking BETAPROFEN ® 200 and tell your doctor immediately or go to the casualty department at your nearest hospital:

Immune disorders:

Less frequent: Aseptic meningitis (non-infectious inflammation of the membranes covering the brain), angioedema (type of swelling that affects deeper layers in your skin, often around your eyes and lips), anaphylaxis (a severe, potentially life-threatening allergic reaction to something you're allergic to), Fever, rashes, exacerbation of asthma and bronchospasm.

Gastrointestinal system disorders:

Frequent: nausea, vomiting, black stools, vomiting of blood, bleeding from the stomach or bowel, abdominal pain, dizziness and rash. Less frequent: abdominal discomfort or pain, gastro-intestinal ulcers, sometimes with bleeding.

A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells). These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BETAPROFEN ® 200. You may need urgent medical attention or hospitalisation.

Store all medicines out of reach of children. Store in a cool (at or below 25 °C) dry place. Protect from light. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewage systems (e.g. toilets).