MENOGRAINE Film-coated tablet Ref.[115281] Active ingredients: Clonidine

Methylphenidate

Serious adverse events, including sudden death, have been reported in concomitant use with methylphenidate. The safety of using methylphenidate in combination with MENOGRAINE has not been systematically evaluated.

Depression

MENOGRAINE should not be used in patients with a previous history of depressive illness, since further depressive episodes have been reported in such patients.

MENOGRAINE should be used with caution in patients with cerebrovascular disease, heart disease including myocardial infarction, coronary insufficiency, heart failure, renal impairment, occlusive peripheral vascular disorder such as Raynaud’s disease, polyneuropathy and constipation.

Dysrhythmia

Depending on the dose given, clonidine as contained in MENOGRAINE, can cause bradycardia. In patients with pre-existing cardiac conduction abnormalities, dysrhythmia have been observed after high doses of clonidine, as contained in MENOGRAINE.

Withdrawal

Withdrawal of MENOGRAINE therapy should be gradual as sudden discontinuation may cause rebound hypertension, sometimes severe. Caution should therefore be observed where antihypertensive medicines are being used, as potentiation of the hypotensive effect may occur. Provided the recommended MENOGRAINE dosage regimen is followed, no difficulty with hypotension should arise during the routine management of patients with migraine. Patients should be instructed not to discontinue therapy without consulting their healthcare provider. Following sudden discontinuation of MENOGRAINE after prolonged treatment with high doses, agitation, restlessness, palpitations, rapid rise in blood pressure, nervousness, tremor, headache or nausea have been reported. When discontinuing therapy with MENOGRAINE, the medical practitioner should reduce the dose gradually over 2 to 4 days.

Symptoms of increased catecholamine release such as agitation, sweating, tachycardia, headache, and nausea may also occur. Beta-blockers can exacerbate the rebound hypertension and if MENOGRAINE is being given concurrently with a beta-blocking medicine, MENOGRAINE should not be discontinued until several days after the withdrawal of the beta-blocker.

Patients should be warned of the risk of missing a dose or stopping the medicine without consulting their doctor and should carry a reserve supply of MENOGRAINE tablets.

Anaesthesia

Although hypotension may occur during anaesthesia in patients treated with clonidine, as contained in MENOGRAINE, clonidine should not be withdrawn, indeed, if necessary, it should be given intravenously during the operation to avoid the risk of rebound hypertension. Intravenous injection of clonidine should be given slowly to avoid a possible transient pressor effect especially in patients already receiving other antihypertensive medicines such as guanethidine or reserpine.

Contact lenses

Patients who wear contact lenses should be warned that treatment with clonidine, as contained in MENOGRAINE, may cause decreased lacrimation.

Paediatric population

The use and the safety of MENOGRAINE in children and adolescents under 18 years have insufficient evidence in randomized controlled trials and therefore cannot be recommended for use in this population.

Excipients

MENOGRAINE contains lactose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take MENOGRAINE.

Antidepressants, vasodilators, diuretics and antihypertensive medicines

The hypotensive effect may be antagonized by tricyclic antidepressants and enhanced by vasodilators, diuretics or other antihypertensive medicines.

Orthostatic hypotension may be provoked or aggravated by concomitant administration of tricyclic antidepressants or neuroleptics with alpha-receptor blocking properties. It may be necessary to adjust the dosage of MENOGRAINE, if these medicines are administered concurrently.

Beta-blockers and cardiac glycosides

Beta-blockers can cause severe rebound hypertension.

Concomitant use of beta-blockers and/or cardiac glycosides can cause bradycardia or dysrhythmia (AV-block) in isolated cases.

It cannot be ruled out that concomitant administration of a beta-receptor blocker will cause or potentiate peripheral vascular disorders.

If during combined treatment with a beta-blocker there is need to interrupt or discontinue antihypertensive therapy, the beta-blocker must always be discontinued slowly first (reducing the dose gradually to avoid sympathetic hyperactivity) and then the clonidine, which should also be reduced gradually over several days if previously given in high doses.

CNS depressants

Central nervous system depressants can cause enhanced sedation.

Although there is no experience from clinical trials, the effect of tranquillisers, hypnotics or alcohol could theoretically be potentiated by clonidine, as contained in MENOGRAINE.

Mirtazapine

Substances with alpha₂-receptor blocking properties, such as mirtazapine, may abolish the alpha₂-receptor mediated effects of clonidine, as contained in MENOGRAINE in a dose-dependent manner.

Safety in pregnancy and lactation has not been established. Use with caution in pregnancy and lactation.

Pregnancy

There is limited amount of data from the use of clonidine, as contained in MENOGRAINE, in pregnant women. As with all medicines, clonidine, as contained in MENOGRAINE, should not be used in pregnancy, especially the first trimester.

In animal studies involving doses higher than the equivalent maximum therapeutic dose in man, effects on foetal development were only seen in one species. Foetal malformations did not occur.

Careful monitoring of mother and child is recommended.

Clonidine, as contained in MENOGRAINE, passes the placental barrier and may lower the heart rate of the foetus. Postpartum, a transient rise in blood pressure in the new-born cannot be excluded.

There is no adequate experience regarding the long-term effects of prenatal exposure.

Breastfeeding

Clonidine, as contained in MENOGRAINE, is excreted in human milk. However, there is insufficient information on the effect on new-borns. The use of clonidine is therefore not recommended during breast feeding.

Fertility

No clinical studies on the effect on human fertility have been conducted with clonidine. Non-clinical studies with clonidine, as contained in MENOGRAINE indicate no direct or indirect harmful effects with respect to the fertility index.

MENOGRAINE has a moderate influence.

MENOGRAINE may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant medicines. Patients should be warned not to take charge of vehicles or machinery or perform potentially hazardous tasks where loss of concentration may lead to accidents.

a) Summary of the safety profile

Drowsiness, dry mouth, dizziness, and headache commonly occur during the initial stages of therapy with MENOGRAINE.

Most adverse effects are mild and tend to diminish with continued therapy.

b) Tabulated list of adverse reactions

c) Description of selected adverse reactions

Metabolism and nutrition disorders

Fluid retention may occur and is usually transient but may be responsible for a reduction in the hypotensive effect during continued treatment.

Investigations

Large doses have been associated with initial increases in blood pressure and transient hyperglycaemia, although these do not persist during continued therapy.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org. za/Publications/Index/8

Not applicable.