Norinyl-1 tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Norethisterone; Mestranol

Beschikbaar vanaf:

Pfizer Ltd

ATC-code:

G03FA01

INN (Algemene Internationale Benaming):

Norethisterone; Mestranol

Dosering:

1mg ; 50microgram

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 07030100; GTIN: 5012882007706

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE USER
NORINYL-1
® 1 MILLIGRAM (MG)/50 MICROGRAMS (ΜG) TABLETS
norethisterone/mestranol
Important things that you SHOULD know about your medicine:
•
Norinyl-1 is an oral contraceptive medicine for use by women.
•
This medicine has been prescribed for you. Do not pass it on to
others.
•
You should take Norinyl-1 regularly as instructed by your doctor or
nurse, in order for it to
be effective. When taken as instructed, it is a very effective
contraceptive. See Section 3
“What if I forget to take a tablet?”
•
Most people do not have serious problems when taking Norinyl-1 but
side effects can occur
- see Section 4 for details. If any of the side effects get serious,
or if you notice any side
effects not listed in this leaflet, please tell your doctor, nurse or
pharmacist.
•
Taking some other medicines may stop Norinyl-1 from working properly.
See Section 2
for details. Check with your doctor, nurse or pharmacist before taking
any other medicines
while you are taking Norinyl-1.
Please read the rest of this leaflet. It includes other important
information on the safe and
effective use of this medicine that might be especially important to
you. If you have any further
questions, ask your doctor, nurse or pharmacist.
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 Norinyl-1 is and what it is used for
2.
What you need to know before you take Norinyl-1
3.
How to take Norinyl-1
4.
Possible side effects
5.
How to store Norinyl-1
6.
Cont

Productkenmerken

OBJECT 1
NORINYL-1 TABLETS
Summary of Product Characteristics Updated 24-Dec-2019 | Pfizer
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 Fertility, 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
Norinyl-1
2. Qualitative and quantitative composition
Each tablet contains 1 milligram norethisterone and 50 micrograms
mestranol.
Excipient(s) with known effect
Each tablet contains 41.47 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White, flat, circular, bevel-edged tablet inscribed 'SEARLE' on one
side and '1' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Norinyl-1 is indicated for oral contraception.
4.2 Posology and method of administration
Posology
The dosage of Norinyl-1 for the initial cycle of therapy is 1 tablet
taken at the same time each day from the
first day of the menstrual cycle. For subsequent cycles, no tablets
are taken for 7 days, then a new course is
started of 1 tablet daily for the next 21 days. This sequence of 21
da