Sign in with your myHealthbox account

Forgot your password? or

UTROGESTAN 100 MG SOFT CAPSULES

Information leaflet

                                                               Irish Medicines Board




                                              IRISH MEDICINES BOARD ACTS 1995 AND 2006

                    MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007

                                                                (S.I. No.540 of 2007)




 PA1341/001/001
 Case No: 2078342

 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to

 Besins Healthcare

 Rue Vilain XIIII, no 19, 1000 Brussels, Belgium

 an authorisation, subject to the provisions of the said Regulations, in respect of the product

 Utrogestan 100 mg soft capsules

 The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
 may be specified in the said Regulations as listed on the reverse of this document.

 This authorisation, unless previously revoked, shall continue in force from 24/03/2010.

 Signed on behalf of the Irish Medicines Board this




 ________________

 A person authorised in that behalf by the said Board.




______________________________________________________________________________________________________________________
Date Printed 20/04/2010                               CRN 2078342                                         page number: 1
                                                   Irish Medicines Board




                                                        Part II
                               Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Utrogestan 100 mg soft capsules

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each capsule contains 100 mg progesterone as the active ingredient.

 Excipients: Contains 1.0mg Soya bean lecithin and 149mg Arachis Oil.
 For a 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;
    Arterial thromboembolic disorders or a past history of these conditions;
    Sickle cell anaemia;




______________________________________________________________________________________________________________________
Date Printed 20/04/2010                               CRN 2078342                                         page number: 2
                                                    Irish Medicines Board




    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 arachis (peanut oil), soya lecithin and any of the ingredients.

 4.4 Special warnings and precautions for use

 For the treatment of post menopausal symptoms, HRT should only be initiated for symptoms that adversely affect
 quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT
 should only be continued as long as the benefit outweighs the risk.

 Utrogestan 100mg Capsules are intended to be co-prescribed with an oestrogen product as HRT. The prescribing
 information for the co-prescribed oestrogen product should be referred to for information about the overall risks of
 HRT.

 Before starting treatment pregnancy must be excluded. Prior to treatment, a thorough personal and family general
 medical history should be taken. Patients should have a physical examination with special emphasis on the body
 weight, blood pressure, heart, breasts, pelvic organs with an endometrial assessment if indicated, the legs and skin.
 Follow-up examinations are recommended at least six-monthly during treatment.

 Conditions which need supervision

 Special supervision is needed in patients presenting the conditions below or having conditions that are known to
 aggravate during previous hormone treatment or pregnancy, as these conditions may re-occur or be aggravated under
 treatment with Utrogestan. These conditions are:
       Multiple sclerosis,

       Epilepsy,

       Diabetes mellitus with or without vascular involvement,

       Benign breast disease,

       Risk factors for oestrogen-dependent tumours, e.g. 1st degree heredity for breast cancer
       Liver disorders

       Hypertension,

       Cardiac, hepatic or renal dysfunction,

       Migraine,

       Asthma,

       Chorea minor,




______________________________________________________________________________________________________________________
Date Printed 20/04/2010                               CRN 2078342                                         page number: 3
comments powered by Disqus

Alerts


There are no recent safety alerts related to this product.