IBUCALM Coated tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Ibuprofen Tablets BP 200mg. Ibucalm 200mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains: Ibuprofen 200mg.
3. Pharmaceutical form
Coated tablet. A pink biconvex round film coated tablet.
4.1. Therapeutic indications
Rheumatic or muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.
4.2. Posology and method of administration
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). For oral administration and short-term use only. Adults, ...
4.3. Contraindications
Hypersensitivity to Ibuprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin ...
4.4. Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below). The elderly are at an increased ...
4.5. Interaction with other medicinal products and other forms of interaction
Ibuprofen should not be used in combination with: <u>Aspirin:</u> Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (See Section ...
4.6. Fertility, pregnancy and lactation
Pregnancy and Lactation Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Ibuprofen in pregnancy should, if possible, be avoided during the first 6 months of pregnancy. ...
4.7. Effects on ability to drive and use machines
None expected at recommended doses and duration of therapy.
4.8. Undesirable effects
Hypersensitivity reactions have been reported and these may consist of: Non-specific allergic reaction and anaphylaxis, Respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm, dyspnoea ...
4.9. Overdose
In children ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half life in overdose 1.5-3 hours. Symptoms Most patients who have ingested clinically ...
5.1. Pharmacodynamic properties
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In human ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ...
5.2. Pharmacokinetic properties
Ibuprofen is rapidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is rapid and complete via the kidneys. Maximum plasma concentrations are reached ...
5.3. Preclinical safety data
There are no clinically relevant preclinical safety data.
6.1. List of excipients
Colloidal anhydrous silica Potato starch Povidone Microcrystalline cellulose Alginic acid Magnesium stearate Sodium lauryl sulphate Sodium starch glycolate Croscarmellose sodium Hypromellose Glycerol ...
6.2. Incompatibilities
None known.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 25ºC. Store in the original package (blisters) to protect from moisture).
6.5. Nature and contents of container
Cartons of 24, 48 or 96 tablets in blister packs of aluminium foil/upvc.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Aspar Pharmaceuticals Ltd, Albany House, Acrewood Way, St Albans, AL4 0JY, United Kingdom
8. Marketing authorization number(s)
PL 08977/0016
9. Date of first authorization / renewal of the authorization
31/08/1989 / 10/11/2005
10. Date of revision of the text
17/06/2021
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