Nchi: Uswidi
Lugha: Kiswidi
Chanzo: Läkemedelsverket (Medical Products Agency)
hydroklortiazid; ramipril
Ebb Medical AB
C09BA05
hydrochlorothiazide; ramipril
5 mg/25 mg
Tablett
ramipril 5 mg Aktiv substans; hydroklortiazid 25 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 100 tabletter
Avregistrerad
2017-09-13
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RAMIPRIL/HYDROKLORTIAZID HEXAL 2.5 MG/12.5 MG TABLETS RAMIPRIL/HYDROKLORTIAZID HEXAL 5 MG/25 MG TABLETS ramipril and hydrochlorothiazide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What [nationally completed name] is and what it is used for 2. What you need to know before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] is a combination of two medicines called ramipril and hydrochlorothiazide. RAMIPRIL belongs to a group of medicines called “ACE inhibitors” (Angiotensin Converting Enzyme inhibitors). It works by: • Decreasing your body’s production of substances that raise your blood pressure • Making your blood vessels relax and widen • Making it easier for your heart to pump blood around your body. HYDROCHLOROTHIAZIDE belongs to a group of medicines called “thiazide diuretics” or water tablets. It works by increasing the amount of water (urine) you produce. This lowers your blood pressure. [Nationally completed name] is used to treat high blood pressure. The two active substances work together to lower your blood pressure. They are used together when treatment with just one did not work. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [nationally completed name] : • Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ramipril/Hydroklortiazid HEXAL 2.5 mg/12.5 mg tablets Ramipril/Hydroklortiazid HEXAL 5 mg/25 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg of ramipril and 12.5mg of hydrochlorothiazide. Each tablet contains 5 mg of ramipril and 25 mg of hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. [Nationally approved name] 2.5 mg/12.5 mg _: _ White, oblong, biplane with facet, both sides with breaking notch. Embossment one-sided 'R 15' The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. [Nationally approved name] 5 mg/25 mg: White, oblong, biplane with facet, both sides with breaking notch. Embossment one-sided 'R 30' The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension. This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology It is recommended that [nationally completed name] is taken once daily, at the same time of the day, usually in the morning. [Nationally completed name] can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2). [Nationally completed name] has to be swallowed with liquid. It must not be chewed or crushed. Adults The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control. The administration of the fixed combination of Ramipril and hydrochlorothiazide is usually recommended after dose titration with one of the individual components. [Nationally completed name] should be started at the lowest available dose. If necessary, the dose can be progressively increased to achieve target blood pressure; the maximum permitted d Soma hati kamili