Betagesic 200 mg Film-Coated Tablets

BETAGESIC contains ibuprofen which belongs to a group of medicines referred to as non - steroidal anti - inflammatory medicines (NSAIDs). BETAGESIC is used for the relief of :

• Headaches from musculo - skeletal origin,
• Muscular aches and pain (originating from muscle and bone e.g., backache),
• Feverishness,
• Menstrual pain,
• Dental pain.

Do not take BETAGESIC

• If you are allergic to ibuprofen or any of the other ingredients of BETAGESIC tablets (listed in section 6).
• If you have heart failure.
• If you have bleeding disorder.
• If you have a heart problem.
• If you have peptic ulceration or a history of such ulceration.
• If you have history of gastric perforation or bleeding after having taken a different NSAID including BETAGESIC.
• Active or history of recurrent ulcer, haemorrhage, or perforations.
• If you are sensitive to aspirin.
• Severe kidney or liver problems.
• If you are pregnant, do not use BETAGESIC from 30 weeks of pregnancy onwards because it may cause kidney and heart problems in your unborn baby.

Warnings and precautions

Special care should be taken with BETAGESIC:

• If you are pregnant or planning to become pregnant consult your healthcare provider before taking BETAGESIC. Taking NSAIDs between 20 to 30 weeks of pregnancy may harm your unborn baby. If you are prescribed NSAIDs by your healthcare provider when you are between 20 and 30 weeks of your pregnancy your healthcare provider may need to monitor the amount of fluid in your womb around your baby.
• If gastrointestinal bleeding or ulceration occurs while taking BETAGESIC, stop taking BETAGESIC.
• If you are prescribed NSAIDs by your health care provider when you are between 20 and 30 weeks of your pregnancy, limit BETAGESIC use to the lowest effective dose and shortest duration possible.
• If you develop a fever, skin rash, swelling of the lymph nodes and/or swelling of the face. This is known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Discontinue treatment if these symptoms develop.
• If you have mild to moderate impaired (damaged) renal (kidney) function.
• Liver dysfunction.
• If you are receiving blood thinning medicines.
• If you have bleeding disorder.
• Do not take BETAGESIC with another type of NSAID.
• If you have history of hypertension (high blood pressure) and/or heart problems due to risk of fluid retention, oedema (swelling caused by fluid build in the body tissues), and heart failure.
• If you have significant risk factors for heart problems such as hypertension (high blood pressure), hyperlipidaemia, diabetes mellitus and smoking, take caution. You should be treated with diclofenac after careful consideration.
• if you are asthmatic or suffer from allergies. If you are suffering from asthma, consult with your doctor before taking BETAGESIC.
• If you are an elderly or you are giving BETAGESIC to an elderly person, due to increased risk of adverse reactions especially gastrointestinal perforation, ulceration, and bleeding.
• If you suffer from ulcers or you have history of ulcers.
• If you have history of gastrointestinal diseases (e.g., ulcerative colitis, [inflammation of the large intestine], Crohn’s disease [an inflammatory disease affecting the gut], hiatus hernia [when part of your stomach moves up into your chest], gastro - oesophageal reflux disease [disease where stomach acid rises up into the oesophagus] and angiodysplasia [abnormality with the blood vessels in the gastrointestinal tract]), BETAGESIC can worsen the conditions.
• If you have history of gastrointestinal toxicity or you are giving BETAGESIC to an elderly person with history of gastrointestinal toxicity. Report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the first stages of treatment.
• If you have an infection since the symptoms such as fever and inflammation may be masked. Consult a doctor if symptoms persist or worsen.
• If you have systemic lupus erythematosus as BETAGESIC may cause meningitis or heart attack or stroke.
• If you develop serious skin reactions including exfoliative dermatitis (severe inflammation of the skin surface), Stevens - Johnson syndrome and toxic epidermal necrolysis (life threatening skin disorder causing rash, skin peeling and sores on the mucous membranes) and acute generalised exanthematous pustulosis (AGEP), a drug eruption characterised by superficial small skin lesions containing pus. Stop taking BETAGESIC at the first appearance of any sign of hypersensitivity.

Children and adolescents

Do not give BETAGESIC to children under the age of 12 years.

Other medicines and BETAGESIC

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicine.) Caution is advised if you take BETAGESIC together with any of the following medicines:

Do not share medicines prescribed for you with any other person. Always take BETAGESIC exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Adults and children 12 years of age and older

The recommended initial dose is 2 tablets orally with water, then if necessary, 1 or 2 tablets every four hours. Do not take more than 6 tablets in 24 hours. Not to be given to children under 12 years of age. Use the lowest effective dose for the shortest duration of time necessary to relieve your symptoms. If your symptoms continue for more than 7 days, consult your doctor.

If you take more BETAGESIC than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. The most likely symptoms of overdosage are stomach pain and nausea.

If you forget to take BETAGESIC

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

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

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

• Anaphylaxis indicated by swelling of mouth, throat and face or limbs and the inability to breathe;
• Asthma of worsening of your asthma;
• Allergic reaction such as rash, hives or itchy skin, low blood pressure (feeling faint);
• DRESS syndrome a life - threatening reaction which may resemble a flu - like infection or fever, skin rash, swelling of the lymph nodes and/or swelling of the face abnormal heartbeat.
• Severe skin reactions. These are all very serious side effects. If you have them, you may have had a serious reaction to BETAGESIC. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following.

• Vomiting blood;
• Painful ulcers in your stomach and mouth;
• Bleeding in the gut;
• Liver disease (indicated by tummy pain and yellowing of the eyes and skin).

Tell your doctor if you notice any of the following:

• Less frequent side effects
• Agranulocytosis (severe low white blood cells),
• Anaemia, neutropenia, eosinophilia, thrombocytopenia (Blood disorders);
• Hypersensitivity reactions consisting of urticaria (rash) and pruritis (itchy skin);
• Severe hypersensitivity reactions including facial, tongue and throat swelling, dyspnoea (difficulty breathing), tachycardia (increased heart rate /rapid heartbeat), and hypotension (anaphylaxis [sudden, severe allergic reaction], angioedema [rapid swelling under the skin], or severe shock);
• Headache and aseptic meningitis (inflammation of the membranes that surround the brain and spinal cord);
• Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia (indigestion), abdominal pain;
• Peptic ulcers, perforation, or gastrointestinal bleeding, melaena (dark black tarry stools), haematemesis (vomiting blood), ulcerative stomatitis (inflammation of the mucous membrane lining of the mouth);
• Hepatotoxicity (liver damage caused by medication) and abnormalities in liver function tests;
• Skin rash, bullous reactions (fluid filled blisters), Stevens - Johnson Syndrome (serious disorder of the skin and mucous membranes), toxic epidermal necrolysis (severe skin reaction);
• Cystitis (inflammation of the bladder), haematuria (blood in urine), acute renal failure, interstitial nephritis (inflammation of the kidney), nephrotic syndrome (a condition where your kidneys leak too much protein into your urine).

Frequency unknown:

• Oedema (fluid build - up in the body tissues);
• Hypertension (high blood pressure);
• Heart failure;
• Provocation of bronchospasm (cause contraction of airways) in patients with asthma;
• Drug reaction with eosinophilia and systemic symptoms (DRESS)
• Acute generalised exanthematous pustulosis (AGEP), a drug eruption characterised by superficial small epidermal lesions containing pus (rare skin reactions);
• Photosensitivity reaction;
• Nervousness;
• Depression;
• Insomnia (difficulty sleeping);
• Drowsiness;
• Headache;
• Dizziness;
• Blurred vision and other visual field defects (blurred eyesight and other eyesight problems);
• Tinnitus (Ringing in the ear);
• Gastritis (inflammation of the stomach wall);
• Worsening of colitis and Crohn’s disease (chronic disease that cause inflammation and irritation of the digestive tract);
• Impairment of renal function.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety x SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of BETAGESIC. May also report to Adcock Ingram Limited using the following email: [email protected]

Store all medicine out of reach of children. Store at or below 25 ºC. Do not use after expiry date stated on the label. Return all unused medicine to your pharmacist.