Страна: Израел
Език: английски
Източник: Ministry of Health
CLONIDINE HYDROCHLORIDE
RAFA LABORATORIES LTD
N02CX02
TABLETS
CLONIDINE HYDROCHLORIDE 25 MCG
PER OS
Required
RAFA LABORATORIES LTD, JERUSALEM
CLONIDINE
CLONIDINE
Prophylaxis of migraine and recurrent vascular headache, but not acute attacks.Treatment of menopausal flushing.
2014-11-30
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor's prescription only ® Clonnirit Active ingredient: Each tablet contains: 25 mcg Clonidine hydrochloride. For the list of the additional ingredients, see section 6. See also 'Important information about some of the medicine's ingredients' in section 2. Read the entire leaflet carefully before using this medicine. This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or pharmacist. This medicine has been prescribed for treating your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. What is the medicine intended for? The medicine is intended for preventing migraine attacks and recurring headaches, that are not acute, due to narrowing or dilation of blood vessels. In addition, the medicine is intended for the treatment of flushing for women in menopause. Therapeutic group: Anti-migraine medicines 2. Before using the medicine Do not use the medicine if: • You are sensitive (allergic) to the active ingredient or to any of the additional ingredients the medicine contains (for a list of the additional ingredients, see section 6). • You suffer from a slow heartbeat caused by a heart disease called ‘sick sinus syndrome’ or from severe heart problems. Special warnings regarding the use of the medicine: • Use of the medicine may cause dryness in the eyes; this may constitute a problem for patients wearing contact lenses. • If you are about to undergo surgery (including dental) or any procedure requiring anesthesia, inform the doctor and the anesthesiologist of taking this medicine. • If you are sensitive to any food or medicine, inform your doctor before taking this medicine. Before starting the treatment with Clonnirit tell the doctor if: • You suffer or have suffered in the past from Raynaud’s disease - a problem with blood circulatio Прочетете целия документ
1 Clonnirit -DL-July 2023-02 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Clonnirit ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains clonidine hydrochloride 25 micrograms. Excipients: Each tablet contains approximately 18 mg lactose. For full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Tablets Small round pale blue tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of migraine and recurrent vascular headache, but not acute attacks. Treatment of menopausal flushing. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS:_ Initially 2 tablets twice daily. If after two weeks there has been no remission, increase to 3 tablets twice daily. The duration of treatment depends upon the severity of the condition. If symptoms continue to occur the patient should be informed that it may take 2-4 weeks until Clonnirit is fully effective. _ELDERLY:_ No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported. _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. _PATIENTS WITH RENAL IMPAIRMENT_ Clonnirit should be used with caution in patients with renal insufficiency. Careful monitoring of blood pressure is required. Method of administration Per Os 4.3 CONTRAINDICATIONS Clonnirit should not be used in patients with severe bradyarrhythmia resulting from either sick-sinus syndrome or AV block of 2nd or 3rd degree, or in patients with hypersensitivity to the active substance, clonidine, or to any of the excipients listed in section 6.1. 2 In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to section 4.4 Special warnings and precautions for use) the use of this product is contraindicat Прочетете целия документ