Land: New Zealand
Sprog: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Clonidine hydrochloride 25ug
Teva Pharma (New Zealand) Limited
Clonidine hydrochloride 25 µg
25 mcg
Tablet
Active: Clonidine hydrochloride 25ug Excipient: Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Pregelatinised maize starch Purified talc Sodium starch glycolate
Blister pack, PVC/Al, 112 tablets
Prescription
Prescription
PCAS Finland Oy
The prophylactic management of migraine or recurrent vascular headaches in adult patients. The management of vasomotor conditions commonly associated with the menopause and characterised by flushing.
Package - Contents - Shelf Life: Blister pack, PVC/Al - 112 tablets - 36 months from date of manufacture stored at or below 25°C
2012-07-12
CONSUMER MEDICINE INFORMATION CLONIDINE (TEVA) Clonidine hydrochloride 25 microgram tablets WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Clonidine (Teva). This leaflet answers some common questions about Clonidine (Teva). It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.medsafe.govt.nz. Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Clonidine (Teva) against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT CLONIDINE (TEVA) IS USED FOR Clonidine (Teva) contains a medicine called clonidine. This belongs to a group of medicines called vasodilators. Vasodilators widen the blood vessels and this helps the blood to flow more easily. Clonidine (Teva) tablets are used to prevent migraine attacks and similar types of headache. It is also used to prevent hot flushes that may occur in women during the menopause (change of life). Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Clonidine (Teva) is available only with a doctor's prescription. Clonidine (Teva) is not addictive. BEFORE YOU TAKE CLONIDINE (TEVA) Clonidine (Teva) is not suitable for everyone. _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE CLONIDINE (TEVA) IF YOU: • you are allergic to any medicine containing clonidine or any of the ingredients listed at the end of this leaflet • you have certain heart problems, such as irregular/slow heartbeat • you are already taking other medicines that contain clonidine. DO NOT TAKE IT AFTER THE EXPIRY DATE (‘EXP.’ AS PER CARTON AND BLISTER PRINTED ON THE PACK. If you take it after the expiry date has passed, it may not work Læs hele dokumentet
Version 1.0 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME CLONIDINE (Teva) 25 microgram tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains clonidine hydrochloride 25 micrograms. Excipient with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to off-white circular tablet, engraved with ‘CD 25’ on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The prophylactic management of migraine or recurrent vascular headaches in adult patients. The management of vasomotor conditions commonly associated with menopause and characterised by flushing. 4.2 DOSE AND METHOD OF ADMINISTRATION Dose _Adults (including elderly patients) _ Therapy should be started with one tablet twice daily (morning and evening). If there is no relief after two weeks the dosage can be gradually increased to 3 tablets twice daily. Duration of treatment will depend on the frequency and severity of attacks. It may take 2 - 4 weeks until Clonidine (Teva) is fully effective. Note: Clonidine (Teva) is not suitable for clearing acute migraine headaches. Special populations _Renal impairment _ Clonidine should be used with caution in patients with renal insufficiency. Careful monitoring of blood pressure is required. Paediatric population The safety and efficacy of clonidine in children and adolescents have not been established. 4.3 CONTRAINDICATIONS Clonidine (Teva) should not be used 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 blocks of 2nd or 3rd degree. In case of rare hereditary conditions that may be incompatible with an excipient of the product (see section 4.4 Special warnings and precautions for use) the use of the product is contraindicated. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE At doses higher than those recommended above, clonidine is an effective antihypertensive agent. Caution should be observed Læs hele dokumentet