Mybulen Forte 400 mg/10 mg/500 mg Film-Coated Tablets

MYBULEN FORTE belongs to a group of medicines called analgesics (painkillers) and is indicated for the treatment of mild to moderate pain or fever of inflammatory origin for a maximum treatment period of 5 days.

Do not take MYBULEN FORTE if you:

• are hypersensitive (allergic) to the paracetamol, ibuprofen or codeine or any of the other ingredients of MYBULEN FORTE (see What MYBULEN FORTE contains).
• have liver problems.
• have kidney problems.
• have a history of peptic ulcer or stomach (gastrointestinal) perforation, ulceration or bleeding in your stomach or small intestine (duodenum) related to previous use of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) such as MYBULEN FORTE.
• are allergic to aspirin or other NSAIDs.
• have heart failure or heart disease.
• have bleeding and/or ulcers in your digestive tract.
• have diarrhoea resulting from severe inflammation of the inner lining of the colon (pseudomembranous colitis).
• use medicines to prevent your blood from clotting (coumarin anticoagulants) e.g. warfarin (see Other medicines and MYBULEN FORTE).
• are breastfeeding or in your third trimester of pregnancy (see section Pregnancy, breastfeeding and fertility).
• have difficulty breathing or breathing problems, acute asthma, uncontrolled asthma, head injuries or increased pressure inside the skull.
• have ingested large quantities of alcohol (acute alcoholism).
• have painless growths on the inside of your nose (nasal polyps), associated with aspirin-induced bronchospasm (constriction of air passages which causes difficulty breathing, coughing, wheezing, and chest tightness).
• had an operation on the biliary tract.
• are taking a medicine to treat depression called Monoamine Oxidase Inhibitors (MAOIs) or have taken them in the last 2 weeks. MAOIs are medicines such as moclobemide, phenelzine or tranylcypromine.
• during an asthma attack, while you are having difficulty breathing or if you have heart failure secondary to chronic lung disease.
• are under 18 years of age and have had your tonsils or adenoids removed due to obstructive sleep apnoea syndrome (stop and start breathing during sleep).
• know that you metabolise (break down) codeine into morphine very rapidly.
• have chronic constipation.

MYBULEN FORTE should not be given to children younger than 12 years of age.

Warnings and precautions

Take special care with MYBULEN FORTE:

• do not use MYBULEN FORTE longer than 5 days and if your symptoms continue, consult your doctor. If you suffer from kidney or liver disease, you should only use MYBULEN FORTE under the supervision of your doctor.
• do not take more than what your doctor has prescribed and take care not to use other medicines that contain the same ingredients as MYBULEN FORTE. This includes, for example, cold and flu medicines which may contain paracetamol and other anti-inflammatory medicines like diclofenac, celecoxib.
• MYBULEN FORTE may mask the signs of an infection such as fever and inflammation.

Do not share medicines prescribed for you with any other person. Always take MYBULEN FORTE exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. Do not use continuously for more than 5 days without consulting your doctor. Consult your doctor if pain or fever persists or gets worse, if new symptoms occur or if redness and swelling is present, as these could be signs of a serious condition. Consult a doctor if no relief is obtained from the recommended dosage.

The usual dose of MYBULEN FORTE is one tablet three times a day when necessary. The maximum dose is 3 (three) tablets per 24 hours. Not recommended for children under 12 years of age. Care should be taken in adolescents (12 to 18 years) (see Do not take MYBULEN FORTE). Patients suffering from liver and kidney disease should take MYBULEN FORTE under medical supervision.

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

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

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Drug-induced hypersensitivity syndrome (DIHS), Acute Generalised Exanthematous Pustulosis (AGEP) or Fixed Drug Eruption (FDE). These are all very serious side effects. If you have them, you may have had a serious reaction to MYBULEN FORTE. 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:

• changes in the way your heart beats, for example, if you notice it beating faster or slower (palpitations, bradycardia).
• increase in blood pressure (hypertension).
• difficulty in breathing (dyspnoea, comprising asthma, aggravated asthma) or wheezing due to airway spasms (bronchospasm).
• pain in the upper area of the stomach, being and feeling sick (nausea and vomiting) as these may be symptoms of inflammation of the pancreas (pancreatitis).
• less urine than is normal for you.
• black stools (melaena) and/or vomiting blood (haematemesis), which may be signs of bleeding ulcers in your digestive tract.
• pain in the digestive tract directly after eating or for a time period after you have eaten as this may be a sign of an ulcer in your digestive tract.
• impaired vision and/or eye pain.
• impaired hearing.
• yellow pigmentation of skin and eyes, nausea, vomiting, loss of appetite, fever, pain or swelling in the upper right abdomen, fatigue, dark-coloured urine which may be signs of liver problems or hepatotoxicity.
• a stiff neck, headache, nausea, vomiting, fever or disorientation as these may be symptoms of inflammation of the membrane in the brain (aseptic meningitis).
• shortness of breath, fatigue, swollen legs and rapid heartbeat as these could be signs of heart failure, a heart attack or stroke.
• dull pain in the middle to upper right area of the stomach (biliary spasm).
• prolonged use can lead to addiction and tolerance which means you no longer respond to a medicine in the way you did at first.
• breathing difficulty, wheezing, and dry coughs that appear to shake the entire body. Chills, sweating, aching, discomfort and/or fatigue as these are symptoms of alveolitis.
• ringing or buzzing sounds in ears (tinnitus), dizziness/loss of balance, change in hearing as these are signs of ototoxicity which can lead to sensorineural hearing loss.
• kidney disease which affects the ability of the kidney to remove acids properly from your blood into your urine (renal tubular acidosis). This may also cause you to feel light headed or have weakness of your muscles.
• very low levels of potassium in your blood (hypokalaemia).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• Abnormal blood laboratory results such as reduction in blood platelets (which increases bleeding or bruising), white blood cells (which makes infections more likely) and red blood cells (which may cause weakness or breathlessness),
• unable to pass stool (constipation), nausea, vomiting, flatulence (gas), dyspepsia (heartburn), loose, watery stool (diarrhoea), stomach-ache,
• tiredness (fatigue),
• drowsiness,
• dizziness,
• nervousness,
• inability to sleep (insomnia), low mood (depression),
• headache.

Less frequent side effects:

• Inflammation of the skin (dermatitis),
• runny nose (rhinitis),
• itching, red bumps (urticaria); itching (pruritus), small purple coloured spots caused by bleeding into the skin (purpura), increased sensitivity of skin to sun (photosensitivity reaction),
• confusion, restlessness, changes of mood, unrealistic feeling of well-being (euphoria); feeling of unease such as worry or fear (anxiety),
• feeling of pins-and-needles (paraesthesia),
• somnolence (sleepiness),
• blurred or double vision, miosis (decrease in pupil size), other ocular (eye) reactions, hearing/visual impairment,
• tinnitus (ringing sound in the ear), vertigo (internal or external spinning sensation),
• cough suppression,
• dry mouth,
• sweating, facial flushing, lowered body temperature (hypothermia),
• inability to urinate.

Side effects with an unknown frequency:

• Increase in severity of colitis (inflammation of the colon) and Crohn’s disease (inflammation of the digestive tract),
• difficulty swallowing (dysphagia), food getting stuck in the oesophagus after swallowing (impaction), chest pain that is often centrally located and does not respond to antacids, backflow of undigested food (regurgitation) as these are symptoms of Pulmonary eosinophilia,
• you have blood in your urine as this is a sign of haematuria,
• fluid retention,
• light-headedness,
• irritability,
• headache, nausea, vomiting, confusion, dizziness, feeling weak or tired, loss of appetite and increased heartbeat due to high acid levels in the body (metabolic acidosis or pyroglutamic aciduria).

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, pharmacist or nurse. 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. Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088. By reporting side effects, you can help provide more information on the safety of MYBULEN FORTE.

Store all medicines out of reach of children. Store at or below 25 °C. Do not store in a bathroom. Do not use after the expiry date stated on the label.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).