TOTELLE 1/0.125 Milligram Coated Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

ESTRADIOL HEMIHYDRATE, TRIMEGESTONE

Dostupné z:

Pfizer Healthcare Ireland

ATC kód:

G03FA16

INN (Medzinárodný Name):

ESTRADIOL HEMIHYDRATE, TRIMEGESTONE

Dávkovanie:

1/0.125 Milligram

Forma lieku:

Coated Tablets

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Progestogens and estrogens, fixed combinations

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2011-07-22

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER 

TOTELLE 1 MG/0.125 MG COATED TABLET  

_ _Estradiol/trimegestone
_ _

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, pharmacist or nurse. 
- 
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,
pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET 

1. 
What Totelle is and what it is used for 
2. 
What you need to know before you take Totelle 
3. 
How to take Totelle 
4. 
Possible side effects 
5. 
How to store Totelle 
6. 
Contents of the pack and other information 

1. 
WHAT TOTELLE IS AND WHAT IT IS USED FOR 

Totelle is a Hormone Replacement Therapy (HRT). It contains two
types of female hormones, an oestrogen 
and a progestogen. Totelle is used in
postmenopausal women with at least 1 year since their last natural 
period.  

Totelle is used for:  

RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE  
During the menopause, the amount of the oestrogen produced
by a woman’s body drops. This can cause 
symptoms such as hot face, neck and chest ("hot flushes"). Totelle  alleviates
these symptoms after 
menopause. You
will only be prescribed Totelle if your symptoms seriously hinder your daily life.  

PREVENTION OF OSTEOPOROSIS  
After the menopause some women may develop
fragile bones (osteoporosis). You should discuss all 
available options with your doctor.  
If you are at an increased risk of fra

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Totelle 1 mg/ 0.125 mg coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 1.03 mg estradiol hemihydrate
corresponding to 1.00 mg estradiol and 0.125 mg
trimegestone.
Excipients with known effects: Lactose monohydrate and sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
Blue, round, biconvex, coated tablet printed with “1/0.125”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women
more than 1 year postmenopause.
Prevention of osteoporosis in postmenopausal women at high risk of
future fractures who are
intolerant of, or contraindicated for, other medicinal products
approved for the prevention of
osteoporosis. (See also section 4.4).
HRT should not be initiated or continued to prevent cardiovascular
disease or dementia.
The benefits and risks of HRT must always be carefully weighed,
including consideration of the emergence of risks
as therapy continues (see section 4.4). Oestrogens with or without
progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with
treatment goals and risks for the individual woman.
When prescribing solely for the prevention of postmenopausal
osteoporosis, therapy should only be considered for
women at significant risk of osteoporosis and for whom non-oestrogen
medications are not considered to be
appropriate.
The experience treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment is a continuous combined regimen. One combined estradiol/
trimegestone tablet is taken daily without
interruption.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose for the shortest
duration should be used (see also section 4.4). Patients should be
re-evaluated periodically to determine if treatment for
symptoms is still necessar