देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Progesterone
Besins Healthcare S.A.
G03DA; G03DA04
Progesterone
100 milligram(s)
Capsule, soft
Product subject to prescription which may be renewed (B)
Pregnen (4) derivatives; progesterone
Not marketed
1988-02-09
PACKAGE LEAFLET: INFORMATION FOR THE USER Utrogestan ® 100mg Soft Capsules progesterone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Utrogestan is and what it is used for 2. Before you take Utrogestan 3. Safety of HRT 4. How to take Utrogestan 5. Possible side effects 6. How to store Utrogestan 7. Further information 1. WHAT UTROGESTAN IS AND WHAT IT IS USED FOR The name of your medicine is Utrogestan 100mg Soft Capsules (called Utrogestan in this leaflet). Utrogestan contains a hormone called progesterone and is to be used with another medicine called oestrogen. The combination of Utrogestan and oestrogen belongs to a group of medicines called hormone replacement therapy (HRT). WHAT UTROGESTAN IS USED FOR Utrogestan is used to reduce the symptoms of the menopause (change of life). It is used only in women who still have a womb (uterus). Utrogestan is used with another hormone called oestrogen. Utrogestan is not a contraceptive. HOW UTROGESTAN WORKS As you get near to the menopause, the amount of the female hormones oestrogen and progesterone in your body goes down. HRT like Utrogestan replaces these hormones and helps reduce the symptoms of the menopause. WHY UTROGESTAN IS TAKEN WITH OESTROGEN If your HRT contains only oestrogen the lining of the womb could build up. This can cause problems. By taking Utrogestan as well, this makes you shed the womb lining. This prevents these problems happening. You might get some bleeding at the end of each month, rather like a period. 2. BEFORE YOU TAKE UTROGESTAN DO NOT TAKE UTROGES पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 18 January 2019 CRN008NZ8 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Utrogestan 100 mg Capsules, Soft 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg progesterone as the active ingredient. Excipient(s) with known effect: contains 1.0mg soya bean lecithin. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Soft capsule (capsules) Oblate, spheroid, white, opaque soft gelatin capsules containing a white paste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As the progesterone component in hormonal replacement therapy for the menopause. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose is 200 mg at bedtime, for 12 days in the last half of each therapeutic cycle (beginning on Day 15 and ending on Day 26). 4.3 CONTRAINDICATIONS Confirmed pregnancy (see Section 4.6); Lactation; Severe disturbances of liver function (including porphyria) or past history as long as liver function tests have not returned to normal, previous or existing liver tumours; Rotor syndrome; Dubin-Johnson syndrome; Severe cardiac disease, Severe renal disease; Jaundice or general pruritus during a previous pregnancy; Active or past deep venous thrombosis; Health Products Regulatory Authority 18 January 2019 CRN008NZ8 Page 2 of 9 Arterial thromboembolic disorders or a past history of these conditions; Sickle cell anaemia; Severe diabetes with vascular changes; Suspected or existing hormone dependent disorders or tumours of the uterus, breast or ovaries; Past history of breast cancer Undiagnosed irregular vaginal bleeding; Disturbances of lipid metabolism; History of herpes gestations; untreated endometrial hyperplasia, Porphyria, otosclerosis with deterioration in previous pregnancies; Endometriosis; Hypersensitivity to soya lecithin and any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For the treatment of post menopaus पूरा दस्तावेज़ पढ़ें