CUFEN-EF IBUPROFEN EFFERVESCENT TABLETS 200 MG - summary of medicine characteristics

Cufen-Ef Ibuprofen Effervescent Tablets 200mg

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Ibuprofen BP 200mg/Tab

3 PHARMACEUTICAL FORM

Effervescent tablets

4.1 Therapeutic indications

Ibuprofen is a non-steroidal anti-inflammatory and analgesic drug that is used in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or still's disease), osteoarthritis, anklyosing spondylitis and other non-rheumatoid arthropaties and non-articular rheumatic conditions. It is also indicated in acute periarticular disorders such as bursitis, frozen shoulder, tendinitis, tenosynovitis and low back pain. It may also be used in soft tissue injuries such as sprains and strains. It may be used for the relief of mild to moderate pain such as period pains, dental and postoperative pain and in the relief of migraine.

4.2 Posology and method of administration

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

Dosage

Adults and children over 12 years

The recommended dosage is two to three tablets three times daily. Some patients can be maintained on one or two tablets three times daily. In severe or acute conditions it can be advantageous to increase the dosage until the acute phase is brought under control. The dose should not exceed 4 tablets three times a day.

Children

Daily dose of 20 mg per kg body weight in divided doses. In children weighting less than 30kg the total dosage in 24 hours should not exceed 2 tablets. In juvenile rheumatoid arthritis up to 40mg kg body weight daily in divided doses may be taken.

Elderly

No modification to dosage is required unless renal or hepatic function is impaired in which case caution should be taken.

Directions

The tablets must be dissolved in half a glass of water (100ml). The tablets dissolve more quickly in warm water, or if stirred.

4.3 Contraindications

Cufen-EF Ibuprofen 200 mg should not be given to patients with a history of peptic ulceration, bleeding disorders and cardiovascular disease. Bronchospasm may be precipitated in-patients suffering from or having a previous history of bronchial asthma.

Cufen-EF should not be given to patients in whom aspirin and other non-steroidal anti-inflammatory drugs induce the symptoms of asthma, rhinitis or urticaria.

Each tablet contains 661 mg or 28.8 millimoles of Na+ this should be taken into account when prescribing for patients on a sodium restricted diet.

Severe heart failure (NYHA Class IV)

4.4 Special warnings and precautions for use

Do not exceed the stated dose. Consult your doctor if you are asthmatic, sensitive to Aspirin and receiving regular medical treatment. If symptoms persist, consult your doctor. Do not take if you have a stomach ulcer or other stomach disorders.

Keep out of the reach of children.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400mg/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. < 1200mg daily) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III) 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.

There is a risk of renal impairment in dehydrated adolescents (age range: > 12 years to < 18 years)

Severe skin reactions

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson 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.

Masking of symptoms of underlying infections

Cufen-Ef Ibuprofen Effervescent Tablets 200mg 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 Cufen-Ef Ibuprofen Effervescent Tablets 200mg 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.

4.5 Interaction with other medicinal products and other forms of interaction

Acetylsalicylic acid

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

Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, See section 4.3 Contraindi­cations

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).

Caution should be exercised in-patients receiving coumarin anticoagulants and thiazide diuretics.

4.6 Fertility, pregnancy and lactation

Whilst no teratogenic effects have been demonstrated in animal experiments, the use of this product during pregnancy should, if possible be avoided. Traces of ibuprofen have been detected in breast milk, but no adverse reactions have been reported.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

The most frequent adverse effects are gastro-intestinal disturbances. Peptic ulceration

and gastrointestinal bleeding have been reported.

Other side effects include headache, dizziness, nervousness, skin rash, pruritus,

tinnitus, oedema, depression, drowsiness, insomnia, blurred vision and ocular reactions.

Hyper-sensitivity reactions, abnormalities of liver function, tests impairment of renal

function, agranulocytosis, and thrombocytopenia have occasionally been observed.

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

NSAID treatment.

Clinical studies suggest that use of ibuprofen, particularly at 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).

Skin and subcutaneous tissue disorders:

Not known: Acute generalised exanthematous pustulosis (AGEP)

4.9 Overdose

Symptoms emergency procedures and antidote):

The following symptoms have been reported: headache, vomiting, drowsiness loss of consciousness and hypotension. Gastric lavage, or emisis for children emesis should be considered after careful consideration of the patients condition.

Treatment should then be symptomatic with correction of blood electrolytes.

There is no specific antidote for ibuprofen.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Analgesic/Anti-Inflammatory

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Some pharmacodynamics studies show that when single doses of ibuprofen 400mg was taken within 8 hours before or within 30 minutes after immediate release acetylsalicylic acid dosing (81mg), 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

None stated

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium bicarbonate BP

Sodium carbonate (anhydrous)

Sodium cyclamate 1968 BP

Sodium saccharin BP

Citric acid anhydrous BP

Docusate sodium BP

Polyethylene glycol powder 6000

Povidone BP

Orange mint flavour 611160E

6.2 Incompatibilities

None stated.

6.3 Shelf life

24 months unopened.

6.4 Special precautions for storage

Store in a cool dry place.

6.5 Nature and contents of container

Strip pack using PPFM laminate constructed of 40gsm MGBK paper/12 gsm LDPE / 8ji aluminium foil / 23 gsm LDPE. Strips are packed into a carton containing either: 10, 12, 16, 24, 30, 36, 50, 56, 100 or 112 tablets

6.6 Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

Northumbria Pharma Ltd

Netpark

Thomas Wright Way

Sedgefield

County Durham

TS21 3FD

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 48259/0026