Acondro 0.03mg/3mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Drospirenone; Ethinylestradiol

Disponible depuis:

Viatris UK Healthcare Ltd

Code ATC:

G03AA12

DCI (Dénomination commune internationale):

Drospirenone; Ethinylestradiol

Dosage:

3mg ; 30microgram

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 07030100; GTIN: 5016695005478

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACONDRO 3 MG/0.03 MG FILM-COATED TABLETS
DROSPIRENONE/ETHINYLESTRADIOL
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):

They are one of the most reliable reversible methods of contraception
if used correctly;

They slightly increase the risk of having a blood clot in the veins
and arteries, especially in the
first year or when restarting a combined hormonal contraceptive
following a break of 4 or more
weeks;

Please be alert and see your doctor if you think you may have symptoms
of a blood clot (see
section 2 “Blood clots”).
WHAT IS IN THIS LEAFLET
:
1.
WHAT ACONDRO IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACONDRO

Do not take Acondro

Warnings and precautions

Acondro and venous and arterial blood clots

Acondro and cancer

Bleeding between periods

What to do if no bleeding occurs during the gap week

Other medicines and Acondro

Laboratory tests

Pregnancy and breast-feeding

Driving and using machines

Acondro contains lactose
3.
HOW TO TAKE ACONDRO

When can you start with the first strip

If you take more Acondro than you should

If you forget to take Acondro

What to do in the case of vomiting or severe diarrhoea

Delaying your period: what you need to know
2

Changing the first day of your period: what you need to know

If you want to stop taking Acondro
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE A

Résumé des caractéristiques du produit

OBJECT 1
ACONDRO 0.03 MG/3 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 14-Jul-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Acondro 0.03 mg/3 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg
of drospirenone
Excipient with known effect: Each film-coated tablet contains 62 mg
lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Yellow round film-coated tablets of 5.7 mm diameter.
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception
The decision to prescribe Acondro should take into consideration the
individual woman's current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Acondro
compares with other combined hormonal contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2 Posology and method of administration
Posology
HOW TO TAKE ACONDRO
The tablets must be taken every day at about the same time, if
necessary with a little liquid, in the order
shown on the blister pack. One tablet is to be taken daily for 21
consecutive days. Each subsequent pack
is started after a 7-day tablet-free interval, during which time a
withdrawal bleed usually occurs. This
usually starts on day 2-3 after the last tablet and may not have
finished before the next pack is started.
HOW TO START ACONDRO
• No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman's natural cycle (i.e.
the first day of her menstrual
bleeding).
• Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), vaginal ring,
or transdermal patch)
The woman should start with Acondro preferably on the day after the
last active tablet (the last tablet
containing the active substances) of her previous COC, but at the
latest on the day following the usual
tablet-free or placebo tablet interval of her previous COC. In case a
vaginal ring or transderm