Indivina 2mg/5mg tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Medroxyprogesterone acetate; Estradiol valerate

Pieejams no:

Orion Pharma (UK) Ltd

ATĶ kods:

G03AA17

SNN (starptautisko nepatentēto nosaukumu):

Medroxyprogesterone acetate; Estradiol valerate

Deva:

5mg ; 2mg

Zāļu forma:

Oral tablet

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 06040101; GTIN: 6432100005281

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
INDIVINA 1 MG/2.5 MG TABLETS
INDIVINA 1 MG/5 MG TABLETS
INDIVINA 2 MG/5 MG TABLETS
Estradiol/Medroxyprogesterone
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 Indivina is and what it is used for
2.
What you need to know before you take Indivina
3.
How to take Indivina
4.
Possible side effects
5.
How to store Indivina
6.
Contents of the pack and other information
1.
WHAT INDIVINA IS AND WHAT IT IS USED FOR
Indivina is a Hormone Replacement Therapy (HRT). It contains two types
of female hormones, an
oestrogen and progestogen. Indivina is used in menopausal women with
at least three years since their last
natural period.
Indivina 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"). Indivina
alleviates these symptoms after
menopause. You will only be prescribed Indivina 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 Indivina to prevent osteoporosis after menopause.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDIVINA
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks which need to be considered

Produkta apraksts

OBJECT 1
INDIVINA 2 MG/5 MG TABLETS
Summary of Product Characteristics Updated 20-May-2016 | Orion Pharma
(UK) Limited
1. Name of the medicinal product
Indivina 2 mg/5 mg tablets
2. Qualitative and quantitative composition
One Indivina 2 mg/5 mg tablet contains:
Estradiol valerate
Medroxyprogesterone acetate
Excipient with known effect: Lactose
monohydrate
2 mg
5 mg
79.5 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
White, round, bevelled-edge, diameter 7 mm, flat tablets with a code
on one side with, 2+5.
4. Clinical particulars
4.1 Therapeutic indications
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in
women with an intact uterus
more than three years 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
sections 4.4 and 5.1)
The experience of treating women older than 65 years is limited.
4.2 Posology and method of administration
Indivina is a continuous combined HRT regimen in which estrogen and
progestagen are given every day
without interruption.
Posology
One tablet each day orally without a tablet-free interval. Tablet
should be taken approximately at the same
time of the day.
Treatment is recommended to be initiated with Indivina 1 mg/2.5 mg
tablet. Depending on the clinical
response to treatment, the dosage can then be adjusted to individual
needs.
Medroxyprogesterone acetate (MPA) 2.5 mg is usually sufficient to
prevent breakthrough bleeding. If
breakthrough bleeding occurs and persists, and endometrial abnormality
has been ruled out, the dose can
be increased to 5 mg (Indivina 1mg/5 mg tablet).
If 1 mg of estradiol valerate (E
2
V) is not sufficient to alleviate estrogen deficiency symptoms, the
dose
can be increased to 2 mg (Indivina 2 mg/5 mg tablet).
In women with amenorrhea and not taking HRT or women who switch from
another continuous
combined HRT product, treatment