Cliovellan 1 mg/0,5 mg Tablett

Country: Sweden

Bahasa: Sweden

Sumber: Läkemedelsverket (Medical Products Agency)

Bahan aktif:

estradiolvalerat; noretisteronacetat

Boleh didapati daripada:

Dr. Kade Pharmazeutische Fabrik GmbH

Kod ATC:

G03FA01

INN (Nama Antarabangsa):

estradiol valerate; norethisterone

Dos:

1 mg/0,5 mg

Borang farmaseutikal:

Tablett

Komposisi:

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

Kelas:

Apotek

Jenis preskripsi:

Receptbelagt

Kawasan terapeutik:

Noretisteron och östrogen

Ringkasan produk:

Förpacknings: Blister, 28 tabletter (PP); Blister, 30 tabletter (PP); Blister, 84 tabletter (PP); Blister, 90 tabletter (PP); Blister, 28 tabletter (plast/Al); Blister, 30 tabletter (plast/Al); Blister, 84 tabletter (plast/Al); Blister, 90 tabletter (plast/Al)

Status kebenaran:

Godkänd

Tarikh kebenaran:

2006-02-03

Risalah maklumat

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cliovellan 1 mg/0.5 mg tablets
Estradiol/Norethisterone Acetate
READ ALL 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 THE LEAFLET
1.
What Cliovellan is and what it is used for
2.
What you need to know before you take Cliovellan
3.
How to take Cliovellan
4.
Possible side effects
5.
How to store Cliovellan
6.
Contents of the pack and other information
1.
WHAT CLIOVELLAN IS AND WHAT IT IS USED FOR
Cliovellan is a Hormone Replacement Therapy (HRT). It contains two
types of female hormones,
an estrogen and a progestogen.
Cliovellan is used in postmenopausal women with at least 1 year since
their last natural period.
Cliovellan is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of estrogen produced by a woman’s
body drops. This can
cause symptoms such as hot face, neck and chest (“hot flushes”).
Cliovellan alleviates these
symptoms after menopause. You will only be prescribed Cliovellan 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 Cliovellan to prevent osteoporosis after
menopause.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLIOVELLAN
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks which need to be considered when deciding
whether to st

Ciri produk

Produktinformationen för Cliovellan 1mg/0,5 mg tablett, MTnr 20837,
gäller vid det
tillfälle då läkemedlet godkändes. Informationen kommer inte att
uppdateras eftersom
läkemedlet inte marknadsförs i Sverige. Av samma anledning finns
inte någon svensk
produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där
Sverige är referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på
dokumentet, beror det på att läkemedlet i Sverige är godkänt under
ett annat namn.
S U M M A R Y O F P R O D U C T C H A R A C T E R I S T I C S
1.
NAME OF THE MEDICINAL PRODUCT
Cliovellan 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: lactose 65.78 mg.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets
White, round, flat 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.
The experience of treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cliovellan 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.
Women with amenorrhoea not taking HRT or women transferring from
another co