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CAFERGOT TABLETS 1MG

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Cafergot tablets 1mg

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Ergotamine tartrate PhEur 1.0mg and caffeine PhEur 100mg.

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PHARMACEUTICAL FORM White, round, sugar coated tablets

4. 4.1.

CLINICAL PARTICULARS Therapeutic Indications Acute attacks of migraine and migraine variants unresponsive to simple analgesics.

4.2

Posology and method of administration Adults: There is considerable inter-individual variation in the sensitivity of patients to ergotamine. Care should therefore be exercised in selecting the optimum therapeutic dose for an individual patient, which will not give rise to unwanted effects, either acutely or chronically. The maximum recommended dosages should not be exceeded and ergotamine treatment should not be administered at intervals of less than 4 days. For maximum efficacy, the optimal dose (in the preferred presentation) should be administered immediately prodromal symptoms are experienced. One or two tablets taken at the first warning of an attack are normally sufficient to obtain migraine relief. Some individuals may require higher dosages which should never exceed 4 tablets (4mg ergotamine) in 24 hours. It is essential to use the minimum effective dose.

The maximum recommended weekly dose of 8 tablets (8mg ergotamine) should not be exceeded. Children under 12 years: Not recommended. Elderly: Whilst there is no evidence to suggest that the elderly require different dosages of Cafergot, the contraindications of this drug are common in the elderly, eg. coronary heart disease, renal impairment, hepatic impairment and severe hypertension. Caution should therefore be exercised when prescribing for this age group. 4.3 Contraindications Known hypersensitivity to ergot alkaloids, caffeine, or any other components of the formulation. Patients with impaired peripheral circulation, obliterative vascular disease, coronary heart disease, inadequately controlled hypertension, septic conditions or shock. Impaired hepatic or renal function, temporal arteritis and patients with hemiplegic or basilar migraine are also contraindicated. Pregnancy or nursing mothers. Concomitant treatment with macrolide antibiotics, HIV-protease or reversetranscriptase inhibitors, azole antifungals (see 4.5 Interactions with other medicinal products and other forms of interaction). Concomitant treatment with vasoconstrictive agents (including ergot alkaloids, sumatriptan and other 5HT1-receptor agonists (see 4.5 Interactions with other medicinal products and other forms of interaction). 4.4 Special warnings and precautions for use Cafergot is only indicated for the treatment of acute migraine attacks and not for prevention. Continued daily use of Cafergot or use in excess of the recommended doses must be avoided since this may cause vasospasm. Owing to its vasoconstrictor properties, ergotamine may cause myocardial ischaemia or, in rare cases, infarction, even in patients with no known history of coronary heart disease. Patients who are being treated with Cafergot should be informed of the maximum doses allowed and of the first symptoms of over dosage: hypoaesthesia, paraesthesia ( eg numbness, tingling) in the fingers and toes, non-migraine-related nausea and vomiting, and symptoms of myocardial ischaemia (e.g. precordial pain). If symptoms such as tingling in the fingers or

toes occur, the drug should be discontinued at once and the physician consulted. If contrary to recommendations ergotamine-containing drugs are used excessively over years, they may induce fibrotic changes, in particular of the pleura and retroperitoneum. There have also been rare reports of fibrotic changes of the cardiac valves. The occurrence of drug-induced headaches has been reported during prolonged and uninterrupted treatment with Cafergot. 4.5 Interaction with other medicinal products and other forms of interaction Ergotism (increased peripheral vasoconstriction) Several drugs increase the risk of ergotism (vasoconstriction, convulsions, other CNS and GI effects) and concomitant use of the following with Cafergot should be avoided (see section 4.3): Antibacterials Macrolides (eg erythromycin, azithromycin, clarithromycin, spiramycin) or telithromycin quinupristin/dalfopristin tetracycline Antifungals lmidazoles (eg ketaconazole, miconazole) Triazoles (eg itraconazole, posaconazole, voriconazole) Antivirals (eg amprenavir, indinavir, nelfinavir, ritonavir, saquinavir. atazinavir, efavirenz) 5HT1 agonists Avoid Cafergot for 6 hours after almotriptan, rizatriptan, sumatriptan or zolmitriptan. Avoid almotriptan, rizatriptan, sumatriptan or zolmitriptan for 24 hours after Cafergot. Avoid Cafergot for 24 hours after eletriptan or frovatriptan. Avoid eletriptan or frovatriptan for 24 hours after Cafergot. Cimetidine Sympathomimetic agents Beta-blockers Other vasoconstrictors - excessive nicotine may enhance vasoconstriction Other Anaesthetics Halothane reduces the effect of ergometrine on the parturient uterus

Antidepressants Reboxetine - possible increase in hypertension in association with ergot

4.6

Pregnancy and lactation Ergotamine-containing products are contraindicated in pregnancy due to oxytocic and vasoconstrictor effects on the placenta and umbilical cord. Ergotamine is excreted in breast milk and may cause symptoms of vomiting, diarrhoea, weak pulse and unstable blood pressure in infants. Thus, Cafergot are contraindicated in nursing mothers.

4.7

Effects on ability to drive and use machines Dizziness and feelings of anxiety (trembling, sweating etc) have been reported with Cafergot. If a patient is affected they should not drive, operate machinery or take part in activities where these reactions may put themselves or others at risk

4.8

Undesirable effects The caffeine component of Cafergot may give rise to unwanted stimulant effects. Side effects of Cafergot are related in the main to the ergotamine component. The most common of all side-effects are nausea and vomiting. Depending on the dose of ergotamine, signs and symptoms of vasoconstriction may occur. Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (greater than or equal to 1 in 10); common (less than or equal to 1 in 100, less than 1 in 10); uncommon (greater than or equal to 1 in 1,000, less than 1 in 100); rare (greater than or less than 1 in 10,000, less than 1 in 1,000) very rare ( less than 1 in 10,000), including isolated reports. Table 1 Immune system disorders Rare: Hypersensitivity reactions Nervous system disorders Common: Dizziness Uncommon: Paraesthesia (e.g. tingling), hypoaesthesia (e.g numbness) Ear and labyrinth disorders

Rare:

Vertigo

Cardiac disorders Uncommon: Cyanosis Rare: Bradycardia, tachycardia Very rare: Myocardial ischaemia, myocardial infarction Vascular disorders Uncommon: Peripheral vasoconstriction Rare: Increase in blood pressure Very rare: Gangrene Respiratory, thoracic and mediastinal disorders Rare: Dyspnoea Gastrointestinal disorders Common: Nausea and vomiting (not migraine related), abdominal pain Uncommon: Diarrhoea Skin and subcutaneous tissue disorders Uncommon: Pain in extremities Rare: Myalgia General disorders and administration site conditions Uncommon: Weakness in extremities Investigations Rare: Absence of pulse Injury, poisoning and procedural complications Rare: Ergotism

1. Hypersensitivity reactions such as skin rash, face oedema, urticaria and dyspnoea. 2. Ergotism is defined as an intense arterial vasoconstriction, producing signs and symptoms of vascular ischemia of the extremities and other tissues (such as renal or cerebral vasospasm). Rare cases of intestinal ischaemia have been associated with chronic use and overuse of ergotamine-containing preparations. Rarely, headache may be provoked either by chronic overdosage or by rapid withdrawal of the product. Excessive use of ergotamine-containing products for prolonged periods may result in fibrotic changes, in particular of the pleura and retroperitoneum. Rare cases of fibrosis of cardiac valves have also been reported. The occurrence of drug induced headaches has been reported during prolonged and uninterrupted treatment with Cafergot (see 4.4 Special Warnings and Precautions).

4.9.

Overdose Symptoms: Nausea, vomiting, drowsiness, confusion, tachycardia, dizziness, respiratory depression, hypotension, convulsion, shock, coma and symptoms and complications of ergotism. Ergotism is defined as an intense arterial vasoconstriction, producing signs and symptoms of vascular ischemia of the extremities such as tingling, numbness and pain in the extremities, cyanosis, absence of pulse and if the condition is allowed to progress untreated, gangrene may result. Furthermore ergotism can also involve signs and symptoms of vascular ischemia of other tissues such as renal or cerebral vasospasm. Most cases of ergotism are associated with chronic intoxication and/or overdose. Treatment: should be directed to the elimination of ingested material by aspiration and gastric lavage. Treatment should be symptomatic. In the event of severe vasospastic reactions, i.v. administration of a peripheral vasodilator such as nitroprusside, phentolamine or dihydralazine, local application of warmth to the affected area and nursing care to prevent tissue damage are recommended. In the event of coronary constriction, appropriate treatment such as nitroglycerin should be initiated.

5. 5.1.

PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties Ergotamine is a highly vasoactive ergot alkaloid having characteristically complex pharmacological actions. It is a partial tryptaminic agonist in certain blood vessels and both a partial agonist and antagonist of -adrenergic receptors of blood vessels. Although its exact mode of action in migraine is not known, its therapeutic effects have been attributed to its ability to cause vasoconstriction, thereby eliminating the painful dilation/pulsation of branches of the external carotid artery.

5.2.

Pharmacokinetic Properties There is great interindividual variation in the absorption of ergotamine in patients and volunteers. Bioavailability is of the order of 5% or less by oral or rectal administration. After im or iv administration, plasma concentrations decay in a bi-exponential fashion. The elimination half life is 2 to 2.5 hours and clearance is about 0.68L/h/kg. Metabolism occurs in the liver. The major

enzyme involved in the metabolism of ergotamine is Cytochrome P450 (CYP) 3A4. The primary route of excretion is biliary.

5.3

Preclinical safety data There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.

6. 6.1.

PHARMACEUTICAL PARTICULARS List of Excipients Tartaric acid, gelatin, stearic acid, lactose, starch, talc, gum acacia, sugar, and carnauba wax.

6.2.

Incompatibilities None.

6.3

Shelf life 2 years.

6.4.

Special Precautions for Storage None.

6.5

Nature and contents of container Cartons of 30 tablets in opaque aluminium/PVdC blister packs.

6.6.

Instructions for Use, Handling and Disposal None.

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MARKETING AUTHORISATION HOLDER
Alliance Pharmaceuticals Ltd Avonbridge House Bath Road Chippenham Wiltshire SN15 2BB

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MARKETING AUTHORISATION NUMBER(S) PL: 16853/0004

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/05/03

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DATE OF REVISION OF THE TEXT
30/03/2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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