Patient leaflet - IBUPROFEN 200 MG TABLETS, LIBROFEM 200 MG TABLETS
3. how to take librofem tablets
Always take Librofem Tablets exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with water during or after meals.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
The usual dose is:
Adults and children over 12 years:
The starting dose is 2 tablets, taken with a glass of water then 1–2 tablets every four hours. Do not take more than six tablets in any 24 hour period. The risk of side effects is greater in the elderly, so your doctor will give you the lowest dose possible, and take special care of you.
Children below 12 years: Not recommended.
Librofem Tablets are for short term use only. Take the lowest dose for the shortest time necessary to relieve your symptoms. Continuous use should not exceed 48 hours.
If in adolescents (between 12 and 18 years) this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Ibuprofen may be associated with a small increase risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you take more Librofem Tablets than you should
If you have taken more Librofem Tablets than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.
The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.
If you forget to take Librofem Tablets
If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten tablet.
4. possible side effects
Like all medicines, Librofem Tablets can cause side effects, although not everybody gets them.
- If any of the following happens, stop taking Librofem Tablets and tell your doctor immediately or go to the nearest hospital emergency department: Rare allergic (hypersensitive) reactions such as difficulty of breathing, wheezing or dizziness
- Skin reactions including paling of skin, rash, itching, hives, blisters, blood spots, swelling of the skin with wheals and, less often, blistering skin diseases which may appear like a burn, or as a red/purple rash, or a scaly skin.
- Asthma attacks (condition that affects the airways of the lungs causing breathing difficulties) or worsening of asthma Sensitivity to light
- Stomach ulcers, bleeding, or holes in the stomach or intestine, High blood pressure, Fluid retention (particularly in the elderly), vomiting a substance that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools. The risk may be higher for people who are older in age.
Common (occurring in less than 1 in 10 patients)
- Nausea, Vomiting
- Gastro-intestinal:
- Diarrhoea, Gas or Bloating, Constipation, Pain in abdomen or Upset stomach
- Worsening of ulcers in the lining of the rectum and colon
- Worsening of inflammation of the digestive system
- Inflammation or irritation of the lining of the stomach
- Indigestion
- Effects on heart:
- Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke
- Hypertension
Uncommon (occurring in less than 1 in 100 patients)
- Effects on Kidney: Inflammation of kidney tissue, kidneys disorder causing them to leak large amounts of protein from the blood into the urine, kidney failure, appearance of blood in the urine.
- Effects on Liver: Abnormal liver function tests, swelling of the liver that makes it stop working well (hepatitis) and yellowing of skin and the whites of your eyes (jaundice)
- Effects on Nervous system and special senses:
- Visual problems
- Inflammation of eye nerve
- Headache
- Feeling of burning, itching, prickling or tingling in the skin
- Aseptic Inflammation of the lining of the brain (With symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation) especially in patients with diseases like lupus erythromatous (a condition in which immune system attacks healthy cells and tissues of many parts of the body), mixed connective tissue disease (overlap disease)
- Nervousness, Depression, Confusion, Hallucinations
- Ringing in the ears
- Light-headedness (loss of balance)
- Feeling of general discomfort or uneasiness
- Sleeplessness
- Excessive Tiredness
- Drowsiness
- Effects on blood:
- Low platelet count
- Effected blood cell counts
- Failure of the bone marrow to produce sufficient blood cells for the circulation (Aplastic anaemia)
- Abnormal breakdown of red blood cells
Not known
A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Librofem if you develop these symptoms and seek medical attention immediately. See also section 2.
Drug reaction with eosinophilia and systemic symptoms
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).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. how to store librofem tablets
Keep out of the reach and sight of children.
Do not store the tablets above 25°C. Keep them in the original pack.
Do not take these tablets after the expiry date shown on the pack.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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6. FURTHER INFORMATION
What Librofem Tablets look like and contents of the pack:
Librofem 200mg Tablets are pink, round, biconvex, film-coated tablets and packed in blister packs of 12, 24, 48 & 96 Tablets.
Marketing Authorisation Holder and Manufacturer:
Activase Pharmaceuticals Limited, 11 Boumpoulinas, 3rd Floor, 1060 Nicosia, Cyprus
PL 28444/0087
This leaflet was last revised in November 2020
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