SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Superdrug Migraine Relief 342mg Tablets

Boots Rapid Ibuprofen Lysine 342 mg Tablets

Tesco Migraine Relief 342mg Tablets

Asda Migraine Relief 342mg Tablets

Feminax Express 342 mg Tablets

Wilko Rapid Pain Relief 342 mg Tablets

Superdrug Express Ibuprofen Lysine 342 mg Tablets

Boots Rapid Period Pain Relief 342mg Tablets

Morrisons Express Pain Relief 342 mg Tablets

Galpharm Rapid Ibuprofen Lysine 342 mg Tablets

Superdrug Period Pain Relief 342mg Tablets

Sainsbury’s Healthcare Express Pain Relief 342 mg Tablets

Sainsbury’s Healthcare Migraine Relief 342 mg Tablets

Tesco Rapid Pain Relief 342mg Tablets

Numark Rapid Pain Relief 342mg Tablets

Boots Migraine Pain relief 342mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

200mg Ibuprofen (as Ibuprofen Lysine 342 mg)

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet (tablet).

White, capsule - shaped tablet.

CLINICAL PARTICULARS

4.1 Therapeutic indications

Rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.

4.2    Posology and method of administration

For oral administration and short-term use only.

During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor.

Adults, elderly and adolescents between 12 and 18 years:

The minimum effective dose should be used for the shortest time necessary to relieve symptoms.

If in children and 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.

If in adults the product is required for more than 10 days, or if the symptoms worsen the patient should consult a doctor.

Children and Adolescents between 12 and 18 years: take 1 or 2 tablets with water, up to three times a day as required.

Adults: taken 1 or 2 tablets with water, up to three times a day as required.

Leave at least 4 hours between doses

Do not take more than 6 tablets in any 24 hour period.

Not for use by children under 12 years of age.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

4.3    Contraindications

Hypersensitivity to Ibuprofen or any of the constituents of the product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) associated with aspirin or other non-steroidal anti-inflammatory drugs.

Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Severe hepatic failure, renal failure or heart failure (see Section 4.4 Special warnings and precautions for use).

Severe heart failure (NYHA Class IV)

Last trimester of pregnancy (see Section 4.6 Pregnancy and lactation)

4.4 Special warnings and precautions for use

Respiratory:

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.

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 increased risk of the serious consequences of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

SLE and mixed connective tissue disease:

Systemic lupus erythematosus and mixed connective tissue disease -increased risk of aseptic meningitis (see section 4.8 Undesirable effects).

Other NSAIDs:

The use of Migraine Relief 342 mg Tablets with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).

Renal:

Hypertension and/or cardiac impairment as renal function may deteriorate and/or fluid retention occur.

Renal impairment as renal function may further deteriorate (See section 4.3

Contraindications and Section 4.8 Undesirable effects)

There is a risk of renal impairment in dehydrated adolescents.

Hepatic:

Hepatic dysfunction (See section 4.3 Contraindications and Section 4.8 Undesirable effects)

Impaired female fertility:

There is limited evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.

Gastrointestinal:

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated (see section 4.8)

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with hemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity or bleeding, such as corticosteroids, or anticoagulants such as warfarin or anti-platelet agents such as aspirin (see section 4.5 Interactions).

When gastrointestinal bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Dermatological:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDSs (see section 4.8). Patients appear to be at highest risk for 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. Migraine Relief 342 mg Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Cardiovascular and cerebrovascular effects:

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.

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 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.

The label will include:

Please read the enclosed leaflet before taking this product.

Do not take if you:

•    have (or had two or more episodes of) a stomach ulcer, perforation or bleeding

•    are allergic to ibuprofen or any of the other ingredient of the product, aspirin or other related painkillers

•    are taking other NSAID painkillers, or aspirin, with a daily dose above 75 mg.

Speak to a pharmacist or your doctor before taking this product if you:

•    have or have ever had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

•    are a smoker

•    are pregnant

If symptoms persist or worsen, consult your doctor.

4.5 Interaction with other medicinal products and other forms of interaction Ibuprofen should not be used in combination with:

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, as this may increase the risk of adverse reactions (See section 4.4).

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).

Other NSAIDS including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4).

Ibuprofen should be used with caution in combination with:

Anticoagulants: NSAIDS may enhance the effects of anti-coagulants, such as

warfarin (See section 4.4).

Antihypertensives and diuretics: NSAIDs may diminish the effect of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Corticosteroids:

Increased risk of gastrointestinal ulceration or bleeding (See section 4.4 Special warnings).

Antiplatlet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4)

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and

increase plasma glycoside levels.

Lithium:

There is evidence for potential increases in plasma levels of lithium.

Methotrexate:

There is a potential for an increase in plasma methotrexate.

Ciclosporin: Increased risk of nephrotoxicity.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given

with tacrolimus.

Zidovudine:

There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

4.6 Pregnancy and lactation

Whilst no teratogenic effects have been demonstrated in animal studies, the use of Migraine Relief Caplets should, if possible, be avoided during the first six months of pregnancy.

During the third trimester, Ibuprofen is contraindicated as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and duration of labour increased with an increased bleeding tendency in both mother and child (see Section 4.3 - Contraindications).

In limited studies, Ibuprofen appears in breast milk in very low concentration and is unlikely to affect the breast fed infant adversely.

See Section 4.4 regarding female fertility.

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:

(a)    Non-specific allergic reactions and anaphylaxis

(b)    Respiratory tract reactivity, eg asthma, aggravated asthma, bronchospasm,

dyspnoea

(c)    Various skin reactions, e.g. pruritus, urticaria, angioedema and more

rarely

exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme)

The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Hypersensitivity reactions:

Uncommon: Hypersensitivity reactions with urticaria and pruritus.

Very rare: Severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock).

Exacerbation of asthma and bronchospasm.

Gastrointestinal:

The most commonly-observed adverse events are gastrointestinal in nature.

Uncommon: Abdominal pain, nausea and dyspepsia.

Rare: Diarrhoea, flatulence, constipation and vomiting.

Very rare: Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena,

haematemesis, sometimes fatal, particularly in the elderly. Exacerbation of ulcerative colitis and Crohn’s disease (See section 4.4).

Nervous System:

Uncommon: Headache

Very rare: Aseptic meningitis - single cases have been reported very rarely.

Renal:

Very rare: Acute renal failure, papillary necrosis, especially in long-term use,

associated with increased serum urea and oedema.

Hepatic:

Very rare: Liver disorders.

Haematological:

Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia,

pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.

Skin:

Uncommon: Various skin rashes

Very rare: Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis can occur.

Immune System:

In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (See section 4.4)

Cardiovascular and Cerebrovascular:

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

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).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.’

4.9 Overdose

In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management

Management should be symptomatic and supportive and include the maintainance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5.1 Pharmacodynamic properties

Ibuprofen lysine is the lysine salt of ibuprofen. Ibuprofen is a propionic

derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever.

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).

ATC code: MO1A

5.2 Pharmacokinetic properties

Most pharmacokinetic data obtained following the administration of ibuprofen acid also apply to ibuprofen lysine.

Ibuprofen is rapidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is both rapid and complete via the kidneys.

Peak plasma concentrations occur 1-2 hours after administration of ibuprofen acid. However, ibuprofen is more rapidly absorbed from the gastrointestinal tract following the administration of Migraine Relief 342mg Tablets, with peak plasma concentrations occurring approximately 38 minutes after administration in the fasting state.

The half life of Ibuprofen is about two hours.

In limited studies, Ibuprofen appears in the breast milk in very low concentrations

5.3 Preclinical safety data

No relevant information additional to that contained elsewhere within the SmPC.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Core

Crospovidone

Copovidone

Microcrystalline Cellulose Magnesium Stearate Coat

Opadry II White*

* Contains the constituents; polyvinyl alcohol, titanium dioxide, macrogol and talc.

6.2 Incompatibilities

Not applicable

6.3 Shelflife

36 months

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

A blister pack consisting of white opaque PVC/PVdC blister with aluminium foil. The blisters are packed in cardboard cartons.

Or

A blister pack consisting of white opaque triplex blister with aluminium foil. The blisters are packed in cardboard cartons.

Pack sizes: 8, 12 or 16 tablets

6.6    Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Ltd

Wrafton Braunton Devon EX33 2DL

8    MARKETING AUTHORISATION NUMBER(S)

PL 12063/0071

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16/04/2007

10 DATE OF REVISION OF THE TEXT

22/04/2016