Unifen 400 mg Film-Coated Tablets

Unifen belongs to a group of medicines called anti-inflammatory pain killers (also called nonsteroidal anti-inflammatory drugs NSAIDs). The active ingredient, ibuprofen, has pain relieving, fever reducing and anti-inflammatory actions.

Your doctor may prescribe Unifen to treat:

• Rheumatoid arthritis (chronic disease of the system, mainly inflammation of joints)
• Idiopathic juvenile arthritis (Still’s disease) of children
• Ankylosing spondylitis (immobility of a joint due to disease)
• Osteo-arthritis (a non-inflammatory change to a less active form of joints)
• Arthritis due to gout
• Non-articular (non-joint) rheumatism including fibrositis (inflammation with pain and stiffness)
• Non-rheumatic inflammatory conditions such as frozen shoulder (capsulitis), bursitis (inflammation of sac like cavity filled with a liquid in the tissues), tendonitis (inflammation of the tendons), tenosynovitis (inflammation of the membranes of the tendon) and low back pain.
• Relief of mild to moderate pain such as painful menstruation, dental, after prevention of tearing during delivery and pain after childbirth.
• Soft tissue injuries such as sprains and strains.
• Fever.

Do not take Unifen

• if you are hypersensitive (allergic) to ibuprofen or any of the other ingredients of Unifen.
• if you have heart failure.
• if you have stomach ulcer disease or gastro-intestinal bleeding.
• If you have a history of gastro-intestinal bleeding, ulcers or perforation related to previous anti-inflammatory pain killers (NSAIDs).
• If you are sensitive to aspirin or another nonsteroidal anti-inflammatory medicine.
• If you have a history of severe allergic reaction such as anaphylaxis or angioedema (allergic reactions with swelling of the face, lips, tongue, and or throat with difficulty in swallowing or breathing), induced by aspirin or other NSAIDs.
• If you have aspirin-induced nasal protruding growths associated with bronchospasm.
• 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 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 UNIFEN 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 provide before taking UNIFEN:

Take special care with UNIFEN:

• 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 UNIFEN.
• If you are elderly, or suffer from asthma or bronchospasm, bleeding disorders, perforation in the digestive tract, heart disease and in liver or kidney failure.
• If you have a serious skin reaction, after taking UNIFEN.
• UNIFEN should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
• If you have an abnormal accumulation of fluid due to heart disease, cirrhosis (liver disease), volume depletion due to water tablets or kidney problems.
• If you are receiving anti-blood clotters (such as warfarin).
• If you experience blurred or diminished vision, or changes in colour vision.
• If you have a disease of the connective tissue, you may be at risk of developing aseptic meningitis (inflammation of the membranes of the brain).
• Mild reactions such as allergic inflammation of the mucous membrane of the brain or skin rash induced by aspirin or other NSAIDs.
• If you have anaemia.
• If you have ulcers, sores, or white spots in mouth.
• If you have systemic lupus erythematosus (SLE).
• If you are pregnant, do not use UNIFEN at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because this medicine may cause kidney problems in the unborn baby, which can lead to low levels of amniotic fluid that surrounds the baby. This fluid provides a protective cushion and helps the unborn babies’ lungs, digestive system, and muscles to develop. Complications can occur with low levels of this fluid.
• Additionally do not use UNIFEN at 30 weeks or later in pregnancy since it can cause a passage in the baby's heart to close prematurely, possibly leading to heart or lung damage, or even death.
• If you develop a skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells). This is known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). If you are taking UNIFEN for longer than the recommended time or at higher than recommended doses you are at risk of serious harms. These include serious harms to the kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).

Do not share medicines prescribed for you with any other person. Always take Unifen exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Always use the lowest effective dose for the shortest possible duration of treatment.

Adults: The usual dose of Unifen is 600 mg every 6 to 8 hours. Do not take more than 2 400 mg of Unifen per day. To minimize gastrointestinal side-effects or if gastrointestinal disturbances occur, UNIFEN should be given with food or milk.

Children: This formulation is not suitable for children under the age of 12 years.

If you have the impression that the effect of Unifen is too strong or too weak, talk to your doctor or pharmacist.

If you take more Unifen than you should

If you take an overdose, you may experience gastrointestinal effects such as nausea, vomiting and stomach pain. Other symptoms include vomiting, dizziness, convulsion, loss of consciousness and depression of the central nervous system and respiratory system. Treatment is symptomatic and supportive. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take Unifen

If you miss a dose of UNIFEN, take it as soon as you remember unless it is almost time for your next dose. If it is, do not take the missed dose at all. Do not take a double dose to make up for forgotten individual doses.

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

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

• swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• yellowing of the skin and eyes, also called jaundice.

Immune disorders:

Less frequent: Aseptic meningitis (non-infectious inflammation of the membranes covering the brain), anaphylaxis (a severe, potentially life-threatening allergic reaction to something you're allergic to), fever, exacerbation of asthma and bronchospasm

Gastrointestinal system disorders:

Frequent: nausea, vomiting, black stools, vomiting of blood, bleeding from the stomach or bowel, abdominal pain and dizziness.

Less frequent: abdominal discomfort or pain, gastrointestinal 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 reaction to Unifen. 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:

• Frequent side effects:
• Dizziness,
• tinnitus (ringing sound in the ear).
• Less frequent side effects:
• Acute renal failure,
• cystitis (inflammation of the bladder),
• haematuria (blood in urine),
• interstitial nephritis (swelling of the kidney),
• nephrotic syndrome (kidney disorder that causes your body to excrete too much protein in your urine)
• Hepatotoxicity (liver damage),
• abnormalities in liver function tests
• low blood cell count (anaemia, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis)

Frequency unknown:

• Visual impairment,
• changes in visual colour perception,
• toxic amblyopia (lazy eye syndrome)
• Oedema (swelling), hypertension and cardiac failure

These are all serious side effects. You may need medical attention. Tell your doctor if you notice the following:

• Frequent side effects:
• indigestion,
• headache,
• constipation,
• diarrhoea,
• flatulence,
• nervousness,
• drowsiness,
• insomnia,
• depression.

Less frequent side effects:

• abdominal discomfort or pain

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

UNIFEN, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

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 “6.04 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 this UNIFEN.

Unifen 200: Store in well closed containers, below 25 °C, protected from moisture.

Unifen 400: Store in well closed containers, below 25 °C, protected from moisture.

Do not store in bathrooms in order to protect from moisture.

Store all medicines out of reach of children.

Do not use the medicine after the expiry date stated on the container.

Return any unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).