CATAPRES AMPOULES

Adults, including the elderly:

In hypertensive crises 150 to 300 micrograms (1 to 2 ampoules) should be given by slow intravenous injection. This dose may be repeated up to a maximum of 750 micrograms (5 ampoules) in a 24 hour period. Patients undergoing anaesthesia should continue their Catapres/Clonidine Hydrochloride 150 micrograms in 1 ml treatment before, during and after anaesthesia using oral or intravenous administration according to individual circumstances.

Intravenous injection of Catapres/Clonidine Hydrochloride 150 micrograms in 1 ml should be given slowly over 10-15 minutes to avoid a possible transient pressor effect. 9% sodium chloride solution and with 5% Dextrose solution.

Paediatric Population:

There is insufficient evidence for the application of clonidine in children and adolescents younger than 18 years. Therefore the use of clonidine is not recommended in paediatric subjects under 18 years.

Renal insufficiency:

Dosage must be adjusted - according to the individual antihypertensive response which can show high variability in patients with renal insufficiency - according to the degree of renal impairment

Most adverse effects are mild and tend to diminish with continued therapy. Adverse events have been ranked under headings of frequency using the following convention: Very common > 1/10 Common > 1/100, <1/10 Uncommon >1/1000, <1/100 Rare >1/10000, <1/1000 Very rare <1/10000 Not known Cannot be estimated from the available data Endocrine disorders: Gynaecomastia rare Psychiatric disorders: Confusional state not known Delusional perception uncommon Depression common Hallucination uncommon Libido decreased not known Nightmare uncommon Sleep disorder common Nervous system disorders: Dizziness very common Headache common Paraesthesia uncommon Sedation very common Eye disorders: Accommodation disorder not known Lacrimation decreased rare Cardiac disorders: Atrioventricular block rare Bradyarrhythmia not known Sinus bradycardia uncommon Vascular disorders: Orthostatic hypotension very common Raynaud's phenomenon uncommon Respiratory, thoracic and mediastinal disorders: Nasal dryness rare Gastrointestinal disorders: Colonic pseudo-obstruction rare Constipation common Dry mouth very common Nausea common Salivary gland pain common Vomiting common Skin and subcutaneous tissue disorders: Alopecia rare Pruritus uncommon Rash uncommon Urticaria uncommon Reproductive system and breast disorders: Erectile dysfunction common General disorders and administration site conditions: Fatigue common Malaise uncommon Investigations: Blood glucose increased rare Fluid retention and abnormal liver function tests have been reported occasionally.

Two cases of hepatitis have also been reported. 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.

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) or in patients with known hypersensitivity to the active ingredient or other components of the product, and in patients with severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of 2nd or 3rd degree. 4 Special warnings and precautions for use Clonidine should only be used with caution in patients with depression or a history thereof, with Raynaud’s disease or other peripheral vascular occlusive disease.

The product should only be used with caution in patients with cerebrovascular or coronary insufficiency. Catapres/Clonidine Hydrochloride 150 micrograms in 1 ml should be used with caution in patients with mild to moderate bradyarrhythmia such as low sinus rhythm, and with polyneuropathy or constipation.

As with other antihypertensive drugs, treatment with Catapres/Clonidine Hydrochloride 150 micrograms in 1 ml should be monitored particularly carefully in patients with heart failure. In hypertension caused by phaeochromocytoma no therapeutic effect of Catapres/Clonidine Hydrochloride 150 micrograms in 1 ml can be expected.

Clonidine, the active ingredient of Catapres/Clonidine Hydrochloride 150 micrograms in 1 ml, and its metabolites, are extensively excreted in urine. 2 Posology and Method of Administration); careful monitoring is required. Since only a minimal amount of clonidine is removed during routine haemodialysis, there is no need to give supplemental clonidine following dialysis.

Patients who wear contact lenses should be warned that treatment with Catapres/Clonidine Hydrochloride 150 micrograms in 1 ml may cause decreased lacrimation. The use and the safety of clonidine in children and adolescents has little supporting evidence in randomized controlled trials and therefore cannot be recommended for use in this population.

Serious adverse events, including sudden death, have been reported in concomitant use with methylphenidate. The safety of using methylphenidate in combination with clonidine has not been systematically evaluated. Catapres/Clonidine Hydrochloride 150 micrograms in 1 ml Ampoules contain less than 1 mmol sodium (23 mg) per 1 ml ampoule, that is to say essentially ‘sodium-free’.

Catapres/Clonidine Hydrochloride 150 micrograms in 1 ml should not be used in children (please refer to section