Cliovelle 1 mg/0,5 mg Tablett

Country: Żvezja

Lingwa: Svediż

Sors: Läkemedelsverket (Medical Products Agency)

Ingredjent attiv:

estradiolvalerat; noretisteronacetat

Disponibbli minn:

Paranova Läkemedel AB

Kodiċi ATC:

G03FA01

INN (Isem Internazzjonali):

estradiol valerate; norethisterone

Dożaġġ:

1 mg/0,5 mg

Għamla farmaċewtika:

Tablett

Kompożizzjoni:

laktosmonohydrat Hjälpämne; noretisteronacetat 0,5 mg Aktiv substans; estradiolvalerat 1,31 mg Aktiv substans

Klassi:

Apotek

Tip ta 'preskrizzjoni:

Receptbelagt

Żona terapewtika:

Noretisteron och östrogen

L-istatus ta 'awtorizzazzjoni:

Avregistrerad

Data ta 'l-awtorizzazzjoni:

2015-05-13

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLIOVELLE 1 MG/0.5 MG TABLETS
Estradiol/Norethisterone Acetate
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 Cliovelle is and what it is used for
2.
What you need to know before you take Cliovelle
3.
How to take Cliovelle
4.
Possible side effects
5.
How to store Cliovelle
6.
Contents of the pack and other information
1.
WHAT CLIOVELLE IS AND WHAT IT IS USED FOR
Cliovelle is a Hormone Replacement Therapy (HRT). It contains two
types of female hormones, an
oestrogen and a progestogen. Cliovelle is used in postmenopausal women
with at least 1 year since
their last natural period.
Cliovelle is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of oestrogen produced by a woman’s
body drops. This can cause
symptoms such as hot face, neck and chest (“hot flushes”).
Cliovelle alleviates these symptoms after
menopause. You will only be prescribed Cliovelle 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 fractures due to osteoporosis and
other medicines are not suitable for
you, you can use Cliovelle to prevent osteoporosis after menopause.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLIOVELLE
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks which need to be considered when deciding
whether to start taking it, o

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cliovelle 1 mg/0.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains estradiol 1 mg (as estradiol valerate) and
norethisterone acetate 0.5 mg.
Excipient with known effect: lactose 65.78 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round, biconvex tablets, 6 mm in diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone Replacement Therapy (HRT) for estrogen deficiency symptoms in
women more than one
year after menopause.
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).
The experience of treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Cliovelle is a preparation for the continuous combined hormone
replacement treatment of women
with an intact uterus. One tablet is taken daily without interruption,
preferably at the same time of
day.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose
for the shortest duration (see also section 4.4) should be used.
Changing over to a combination product with a higher dose should be
considered if after 3 months the
treatment has not resulted in satisfactory symptom relief.
Method of administration
Oral use.
Women with amenorrhoea not taking HRT or women transferring from
another continuous combined
HRT product can start treatment with Cliovelle on any convenient day.
For women transferring from
sequential preparations the treatment should be started immediately
after withdrawal bleeding has
stopped.
Missed dose
If the patient forgets to take a tablet she can take it within 12
hours of the usual time, otherwise the
forgotten tablet must be discarded. Missed doses can increase the
likelihood of breakthrough bleeding
and spotting.
4.3
CONTRAINDICATIONS
-
Known, past or s