Marvelon tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Desogestrel; Ethinylestradiol

Dostopno od:

Organon Pharma (UK) Ltd

Koda artikla:

G03AA09

INN (mednarodno ime):

Desogestrel; Ethinylestradiol

Odmerek:

150microgram ; 30microgram

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 07030100; GTIN: 5013257000513

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
MARVELON®
desogestrel (150 micrograms)
ethinyl estradiol (30 micrograms)
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”).
•
Some women should not take the Pill because of current medical
problems or illnesses.
Please read this leaflet to make sure Marvelon is right for you.
•
To prevent pregnancy it is important to take Marvelon as instructed
and to start each pack
on time. Please make sure that you understand what to do if you miss a
pill or if you think
you are pregnant.
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 or need more advice, ask your
doctor, family planning
nurse 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, family planning
nurse or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT MARVELON IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MARVELON
3.
HOW TO TAKE MARVELON
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MARVELON
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT MARVELON IS AND WHAT IT IS USED FOR
Marvelon is a combined oral contraceptive pill (‘the Pill’).
YOU TAKE IT TO PREVENT PREGNANCY.
This low-dose contraceptive contains two types of female sex hormones,
oestro

Lastnosti izdelka

OBJECT 1
MARVELON TABLETS
Summary of Product Characteristics Updated 25-Apr-2022 | Organon
Pharma (UK) Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Marvelon®
2. Qualitative and quantitative composition
Desogestrel B.P.
150 micrograms
Ethinylestradiol Ph.Eur
30 micrograms
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets.
Tablets are round, biconvex and 6 mm in diameter. They are coded on
one side TR5 and on the reverse
side Organon*.
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception.
The decision to prescribe Marvelon should take into consideration the
individual woman's current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Marvelon
compares with other CHCs (see sections 4.3 and 4.4).
4.2 Posology and method of administration
4.2.1 HOW TO TAKE MARVELON
Tablets must be taken in the order directed on the package every day
at about the