Motifine 75 mg Capsules

MOTIFINE belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieves pain and inflammation. MOTIFINE is used for the emergency treatment of acute gout attacks.

Do not take MOTIFINE:

• If you are hypersensitive (allergic) to diclofenac or any of the other ingredients of MOTIFINE (listed in section 6).
• If you are hypersensitive to other anti-inflammatory medication including aspirin.
• If you have severe liver or kidney impairment.
• If you are pregnant or breastfeeding your baby (see “Pregnancy and breastfeeding”).
• If you have heart failure (when the heart is incapable to supply sufficient blood flow to meet the body's needs), established ischaemic heart disease (reduced blood supply to your heart) and/or stroke and peripheral arterial disease (narrowing of the arteries resulting in reduced blood flow to the limbs).
• If you suffer from a gastric or intestinal ulcer.
• If you have a history of gastrointestinal bleeding or perforation (PUBs) related to previous anti-inflammatory medicine use.
• If you suffer from porphyria.
• Children under the age of 12 years.

Warnings and precautions:

Side effects may be minimised by using the lowest effective dose for the shortest duration necessary. Talk to your doctor before taking MOTIFINE if you are also taking other non-steroidal anti-inflammatory drugs (NSAIDs), as MOTIFINE should not be used at the same time as other NSAIDs. Your doctor should be informed if you suffer from any of the following conditions:

• High blood pressure or any other heart disease.
• Any gastrointestinal disease (e.g., ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia).
• If you suffer from or have a history of bronchial asthma; hay fever or other allergies, polyps in your nose, difficulty breathing (COPD), long term respiratory infections.
• SLE (Systemic Lupus Erythematosus), an inflammation of the connective tissue.
• Blood clotting problems.
• A condition called hepatic porphyria.

MOTIFINE should be discontinued immediately at the first appearance of skin rash, fever, mucosal lesions and any other sign of allergic reaction or hypersensitivity. These may be signs of a very serious condition called drug rash with eosinophilia and systemic symptoms (DRESS) (see section “Possible side effects”). You should also contact your doctor immediately. If you suffer from impaired kidney function, heart impairment, liver dysfunction, if you are taking diuretics (water tablets), or are elderly, you are at risk of kidney failure. Your renal function should be regulatory monitored while on MOTIFINE treatment.

Do not share medicines prescribed for you with any other person. Always take MOTIFINE exactly described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. You should use the lowest effective dose for the shortest possible duration of treatment. The capsules should be swallowed whole with a liberal quantity of liquid.

Adults

One capsule daily. Dose may be increased to two capsules daily, if necessary, with a maximum daily dose of 150 mg. The first dose should be taken in the morning with breakfast and the second if required 8 - 12 hours later. The maximum treatment period of 3 days should not be exceeded.

If you have the impression that the effect of MOTIFINE is too strong or too weak, tell your doctor or pharmacist.

If you take more MOTIFINE than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison centre. Symptoms of an overdose can include: headache, nausea (feeling sick), vomiting, abdominal pain, stomach or intestinal bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, ringing in the ears, fainting, or occasionally convulsions (seizures, uncontrolled fits).

If you forget to take MOTIFINE: Do not take a double dose to make up for the forgotten individual doses. Continue to take the next capsule at the usual time. If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

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

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

• Fainting; fast or irregular heartbeat; fast or irregular breathing; large hive-like swellings; mouth, lips or tongue swelling; puffiness of swelling of the eyelids or around the eyes; wheezing or tightness in the chest.
• Blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).
• Drug rash with eosinophilia and systemic symptoms (DRESS), which include symptoms such as fever, skin rash, swelling of your lymph nodes and/ or face, kidney and liver injury. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MOTIFINE. 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:

• Sudden and crushing chest pain (signs of myocardial infarction, heart attack or Kounis syndrome).
• Heart disorders, including heart attack or breathlessness, difficulty breathing when lying down, or swelling of the feet or legs (signs of heart failure), especially if you have been taking a higher dose (150 mg per day) for a long period of time.
• Fast or irregular heartbeat (palpitations).
• Sudden weakness or numbness in the face, arm or leg especially on one side of the body, sudden loss or disturbance of vision; sudden difficulty in speaking or ability to understand speech; sudden migraine-like headaches which happen for the first time, with or without disturbed vision. These symptoms can be an early sign of a stroke.
• High blood pressure (hypertension), low blood pressure, symptoms of which may include faintness, giddiness or light headedness (hypotension).
• Lower gut disorders (including inflammation of the colon or worsening of ulcerative colitis or Crohn’s disease).
• Inflammation of the pancreas (pancreatitis).
• Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick) as you may be experiencing ischemic colitis.
• Diarrhoea containing blood or rectal bleeding (haemorrhagic diarrhoea).
• Any sign of ulcers or bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit (haematemesis) or black, tarry faeces (melaena), vomiting of blood.
• Liver disorders (yellowing of the skin or eyes).
• Kidney problems (water retention, problems urinating i.e., passing water) presence of blood or protein in the urine, an unexpected change in the amount of urine produced and/or its appearance.
• Breathelessness, coughing and a tightness across the chest (asthma).
• Inflammation of the lung (pneumonitis).
• Inflammation of blood vessels (vasculitis).
• Inflammation of the lining of the brain with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation (meningitis).
• Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with MOTIFINE and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain.
• If you notice that you are bruising more easily than usual or have frequent sore throats or infections. 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

• Flatulence, constipation, inflammation of the lining of the stomach.
• Headache, dizziness, vertigo, nervousness.

Less frequent side effects

• Disturbance of taste, vision, hearing or sensation.
• Anxiety, confusion, depression or trembling.
• Hair loss (temporary).
• Blood disorders (your blood may not clot easily, or bruises may appear).
• Increased sensitivity to sunlight (i.e., burn more easily or exposure to light causes itching.
• If you have hallucinations (seeing or hearing something that does not exist).

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 “Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications:

https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of MOTIFINE.

• Store at or below 25 °C. Protect from moisture
• The capsules should be stored in the blister strips until required for use
• KEEP ALL MEDICINES OUT OF REACH OF CHILDREN
• Do not use the capsules after the expiry date printed on the container
• Return all unused medicine to your pharmacist
• Do not dispose of unused medicine in drains and sewerage systems (e.g., toilets)