Summary of medicine characteristics - LAGAP MIGRAINE RELIEF TABLETS
1 NAME OF THE MEDICINAL PRODUCT
Lagap Migraine Relief Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
| mg | |
| Aspirin | 500.0 |
| Cyclizine Hydrochloride | 25.0 |
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For relief of migraine pain and alleviation of associated nausea and headache.
4.2 Posology and method of administration
Tablets must be dissolved in water prior to oral administration.
| Adults | Two tablets at onset of, or first sign of | |
| 4.3 Contraindi | symptoms. Two further tablets may be taken after four hours if required. Maximum in 24 hours, 8 tablets. | |
| cations As with | Elderly persons: | As adults. |
| other aspirin containing products, Femigraine | Children: | Do not give to children under 12 years, and avoid up to and including 15 years of age if feverish. |
is contraindicated in patients with active peptic ulceration or a history of peptic ulceration, haemophilia, or who are hypersensitive to aspirin.
4.4 Special warnings and precautions for use
If symptoms persist consult your doctor. Keep out of the reach of children. There is a possible association between aspirin and Reye's Syndrome when administered to children with a fever. Reye’s syndrome is a very rare disease which affects the brain and liver, and can be fatal. For this reason aspirin should not be given to children under 12 years and should be avoided up to and including 15 years of age if feverish.
4.5 Interaction with other medicinal products and other forms of interaction
Aspirin may enhance the effects of anticoagulants and may inhibit the action of uricosuric agents. Action of cyclizine may be potentiated by alcohol or other centrally acting sedatives.
4.6 Pregnancy and lactation
i) Cyclizine: current knowledge indicates that there are teratogenic problems in animals but not in humans. It is best avoided in pregnancy unless there is medical evidence to the contrary.
ii) There is epidemiological evidence of the safety of aspirin in pregnancy but it may prolong labour and contribute to maternal and neonatal bleeding and so is best avoided during the third trimester.
Aspirin is excreted into breast milk at low concentrations and breast feeding is contraindicated at high doses because of the theoretical risk of affecting clotting mechanisms in the infant.
iii) Femigraine is best avoided during pregnancy except where there is no alternative.
4.7 Effects on ability to drive and use machines
May cause drowsiness and blurred vision in a small number of patients.
4.8 Undesirable effects
Occasional fixed drug eruption, hypersensitivity hepatitis, and rarely, anaphylaxis may occur with use of cyclizine. Aspirin may precipitate bronchospasm and induce asthmatic attack or other hypersensitivity reactions in susceptible subjects, it may induce gastro-intestinal haemorrhage.
4.9 Overdose
4.9 OverdoseSymptoms of overdose include drowsiness, dizziness, convulsions, respiratory depression and tinnitus. Rarely, agitation, ataxia and hallucinations may occur. Treatment comprises gastric lavage, forced alkaline diuresis and supportive measures. Restoration of acid-base balance may be necessary. Convulsions can be controlled with diazepam injections.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Aspirin is an antipyretic, anti-inflammatory analgesic agent. For relief of mild to moderate pain and reduction of fever in upper respiratory tract infections, and painful or febrile disorders such as influenza, neuralgia, rheumatic pain, dysmenorrhoea and migraine.
Aspirin inhibits prostaglandin synthesis, so that the prostaglandin induced sensitivity of peripheral nerve endings to kinins and other inflammation and pain mediators is eliminated. It inhibits platelet aggregation by blocking thromboxane A2 synthesis in the platelets.
Cyclizine is an anti-emetic/anti-nauseant used widely for prevention or treatment of sickness.
5.2 Pharmacokinetic properties
Aspirin is rapidly absorbed from the gastro-intestinal tract after oral administration and is rapidly distributed throughout the whole body. It is hydrolysed to its active primary metabolite salicylic acid and completely excreted in the urine, principally as glucuronic acid and glycine conjugates of salicylic acid, but also as salicylic acid itself. Salicylates are extensively bound to plasma proteins. Maximum plasma concentrations are reached after 10–40 minutes (acetyl salicylic acid) and 0.3–2 hours (total salicylate). The elimination half-life of acetyl salicylic acid is dose dependant typically 4 hours after a 1g dose.
Cyclizine is extensively metabolised to form norcyclizine 1–1.8mg of which is excreted in the urine in four days after a 50mg dose. Peak blood concentrations following a single oral dose of 50mg has been reported to be 0.069 ^g/ml in 2 hours. Plasma concentrations (of norcyclizine) were in the range 0.004–0.022 ^g/ml following oral doses of 50mg thrice daily to four subjects.
5.3 Preclinical safety data
5.3 Preclinical safety dataNot applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Mannitol
Polyvinylpyrrolidone
Malic Acid
Sodium Dioctyl Sulphosuccinate
Sodium Bicarbonate
Citric Acid (Anhydrous)
Dextrates (Anhydrous)
Sodium Carbonate (Anhydrous)
Saccharin Sodium
Lemon Permaseal
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
6.5 Nature and contents of containerPolythene coated foil ‚Strip Packs‘.
Foil strips of 4 or 6 tablets in a cardboard carton.
Pack sizes: 4, 12, 16, 18, 24.
6.6 Special precautions for disposal
No special precautions necessary.
7 MARKETING AUTHORISATION HOLDER
Cullen & Davison Ltd.
Killenaule Road
Fethard
Co. Tipperary
Ireland
8 MARKETING AUTHORISATION NUMBER(S)
PL 08977/0036
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
05/11/2000