SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

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

3    PHARMACEUTICAL FORM

Tablets

4    CLINICAL PARTICULARS

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

Adults:    Initial dose, 2 tablets, taken with a glass of water.

Then 1or 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

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 antihypertensives.

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.

Cardiovascular and cerebrovascular effects:

Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment 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 daily) is associated with an increased risk of myocardial infarction.

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.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and 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.

Abdominal pain, nausea and dyspepsia, constipation, diarrhoea and occasionally peptic ulcer and gastrointestinal haemorrhage.

Rashes, pruritus, urticaria, angiodema, purpura and occasional exfoliate dermatitis and epidermal necrolysis.

Thrombocytopenia and occasionally aplastic anaemia.

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.

Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400 mg daily) and in long-term treatment 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.

5 PHARMACOLOGICAL PROPERTIES

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 inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400 mg was taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81 mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

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.

Peach Pharmaceuticals Travel Pack contains:

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,

rd

11 Boumpoulinas, 3 Floor,

P.C. 1060 Nicosia.

Cyprus

8    MARKETING AUTHORISATION NUMBER(S)

PL 28444/0084

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

02/03/2009

10 DATE OF REVISION OF THE TEXT

17/12/2015