IBUPROFEN 200 MG TABLETS, LIBROFEM 200 MG TABLETS - summary of medicine characteristics

Librofem tablets

Ibuprofen 200mg tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient: Ibuprofen BP 200 mg

For a full list of excipients, see section 6.1

Tablets

4.1 Therapeutic indications

The relief of symptoms of dysmenorrhoea (period pain), headache, migraine, muscular pain, backache and feverishness.

Route of administration:

Oral, swallowed with a drink of water.

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. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).

Adults:                        I­nitial dose, 2 tablets, taken with a glass

of water. Then 1 or 2 tablets every four hours.

Do not exceed 6 tablets in 24 hours.

Children under 12 years:     Not suitable.

Elderly:                      N­ot suitable.

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.

For GSL Ibuprofen: continuous use should not exceed 48 hours.

4.3 Contraindications

Hypersensitivity to any of the constituents.

Hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs including provocation or exacerbation of asthma, rhinitis or urticaria.

Current or previous peptic ulceration.

Severe heart failure (NYHA Class IV).

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). Particular caution is needed in the elderly who are at risk of serious consequences of adverse reactions. Caution must be exercised in patients receiving oral anti-coagulants, diuretics or anti-hypertensives.

Caution is also required in patients with renal, cardiac or hepatic impairment since renal function may deteriorate. Renal function should be monitored in such patients.

There is a risk of renal impairment in dehydrated adolescents.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Severe skin reactions:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, StevensJohnson syndrome, and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDSs (see section 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. Ibuprofen should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.

Cardiovascular and cerebrovascular effects:

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. < 1200 mg/day) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA IIIII), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.

Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.

Masking of symptoms of underlying infections:

‘Librofem/Ibu­profen’ can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When ‘Librofem /Ibuprofen’ is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.

Tablets contain sucrose, lactose and sodium:

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per 200 mg, that is to say essentially ‘sodium-free’.

Label warnings:

Do not take if you have had, or are suffering from stomach ulcers, or if you are taking aspirin or any other pain relieving medication.

Do not take if you are allergic to ibuprofen, any other ingredients of the tablets, aspirin or any other pain killer.

Consult your doctor before taking Librofem if you are asthmatic, pregnant, elderly or receiving any regular medication.

Do not exceed the maximum dose.

Keep out of the reach of children.

If symptoms persist, discontinue use and consult your doctor or pharmacist.

4.5 Interaction with other medicinal products and other forms of interaction Concurrent aspirin or other NSAIDs may result in an increased evidence of adverse reactions. NSAIDs may diminish the effect of anti-hypertensives or diuretics, may interfere with the action of cardiac glycosides, and may enhance the effects of oral anti-coagulants.

Acetylsalicylic acid

Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

4.6 Fertility, Pregnancy and lactation

Whilst no teratogenic effects have been demonstrated in animal experiments, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed and duration of labour increased. Ibuprofen appears in breast milk in very low concentrations and is unlikely to affect the breast-fed infant adversely.

4.7 Effects on ability to drive and use machines None stated.

4.8 Undesirable effects

Gastro-intestinal and skin disorders are most frequently reported.

Gastro-intestinal: Abdominal pain, nausea and dyspepsia, constipation,

diarrhoea and occasionally peptic ulcer and gastro-intestinal haemorrhage.

Skin:              R­ashes, pruritus, urticaria, angiodema, purpura and

occasional exfoliate dermatitis and epidermal necrolysis.

Haematological: Thrombocytopenia and occasionally aplastic anaemia.

Renal:               ­Haematuria, interstitial nephritis, renal papillary necrosis,

and renal failure have occasionally been reported.

Respiratory:      Bronchospasm may be precipitated in patients suffering

from or with a previous history of bronchial asthma or allergic disease.

Hepatic:               ­Abnormal liver function tests, jaundice, hepatitis and

occasionally hepatic failure and hepatic necrosis.

Headache, tinnitus, dizziness and vertigo, visual disturbances, depression, confusion, hallucinations and generalised allergic reactions including anaphylaxis have been reported.

Oedema, hypertension and cardiac failure, have been reported in association with NSAID treatment.

Skin and subcutaneous tissue disorders:

Not known: Acute generalised exanthematous pustulosis (AGEP).

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

Photosensitivity reactions

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

4.9 Overdose

Symptoms include headache, vomiting, drowsiness and hypotension. Gastric lavage and correction of severe electrolyte abnormalities should be considered.

In serious poisoning metabolic acidosis may occur.

5.1. Pharmacodynamic properties

Ibuprofen is a phenylpropionic acid derivative which has analgesic, antiinflammatory and anti-pyretic actions and has been shown to be effective in the relief of dysmenorrhoea.

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg were taken within 8 h before or within 30 min after immediate release acetylsalicylic acid dosing (81 mg), a decreased effect of acetylsalicylic acid on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).

5.2 Pharmacokinetic properties

Ibuprofen is absorbed from the gastro-intestinal tract and peak plasma concentrations occur about 1 to 2 hours after ingestion. Ibuprofen is extensively bound to plasma proteins and has a half life of about 2 hours. It is rapidly excreted in the urine mainly as metabolites and their conjugates. About 1% is excreted in urine as unchanged ibuprofen and about 14% as conjugated ibuprofen.

5.3 Preclinical safety data None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Core

Aerosil 200 standard

Lactose

Povidone K25

Sodium starch glycollate

Maize starch

Magnesium stearate

Stearic acid

Coat

Hydroxypropyl methylcellulose

Polysorbate

Purified talc special

Red iron oxide

Titanium dioxide

Polyethylene glycol

Sucrose

Solvents

Purified water

Industrial methylated spirit

6.2 Incompatibilities

None stated.

6.3 Shelf life

60 months.

6.4 Special precautions for storage

Protect from heat and humidity.

6.5 Nature and contents of container

PVC blister pack.

Pack sizes: 12, 24, 48 & 96 tablets.

1 x Richmond Antiseptic Cream 50g (Cetrimide 0.5%w/w) PL 11382/0040

(Eastern Pharmaceuticals)

6 x Loperamide Hydrochloride 2mg Capsules PL 11311/0151 (Tillomed Laboratories)

6 x Rehydration Treatment Blackcurrant Flavour Sachets PL 17047/0006 (Peach Pharmaceuticals)

12 x Ibuprofen 200mg Tablets PL 11382/0032 (Eastern Pharmaceuticals)

6.6 Special precautions for disposal

Medicines should be kept out of the reach of children.

7 MARKETING AUTHORISATION HOLDER

Activase Pharmaceuticals Limited,

11 Boumpoulinas, 3rd Floor,

P.C. 1060

Nicosia.

Cyprus

8 MARKETING AUTHORISATION NUMBER(S)

PL 28444/0087

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

02/03/2009