Cyclogest 400mg pessaries

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Progesterone

Saadav alates:

L.D. Collins & Co. Ltd

ATC kood:

G03DA04

INN (Rahvusvaheline Nimetus):

Progesterone

Annus:

400mg

Ravimvorm:

Pessary

Manustamisviis:

Vaginal; Rectal

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 06040102; GTIN: 5012617014412

Infovoldik

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Cyclogest is the registered trademark of
L.D. Collins & Co. Ltd.
WHAT IS IN THIS LEAFLET
1
WHAT CYCLOGEST IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU USE CYCLOGEST
3
HOW TO USE CYCLOGEST
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE CYCLOGEST
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT CYCLOGEST IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU USE CYCLOGEST
DO NOT USE CYCLOGEST IF YOU:
WARNINGS AND PRECAUTIONS
3
HOW TO USE CYCLOGEST
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400mg pessary
PACKAGE LEAFLET: INFORMATION FOR THE USER
• 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. 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, pharmacist or
nurse.
This includes any possible side effects not listed in this leaflet.
See
section 4.
Cyclogest contains progesterone which is a natural, female sex
hormone,
produced in the body.
Cyclogest works by adjusting the hormonal balance within the body for
the
treatment of:
• pre-menstrual syndrome which often affects women during the 7 to
10 days
before their monthly period. The symptoms of pre-menstrual syndrome
include
feelings of tension, irritability, depression, headache, breast
tenderness,
weight gain and bloatedness
• post-natal depression which some women get after their baby has
been born.
• women who need extra progesterone while undergoing treatment in an
Assisted Reproductive Technology (ART) programme.
• are allergic to progesterone or any of the other ingredients of
this medicine
(listed in section 6),
• have unusual vaginal bleeding that has not been evaluated by the
doctor,
• have known or suspected tumour that is hormone sensitive,
• have porphyria disorder

Toote omadused

OBJECT 1
CYCLOGEST 400MG PESSARIES
Summary of Product Characteristics Updated 29-Nov-2019 | L.D. Collins
& Co. Ltd.
•
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
CYCLOGEST 400mg
2. Qualitative and quantitative composition
Each pessary contains 400mg Progesterone PhEur.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Off-white pessaries.
4. Clinical particulars
4.1 Therapeutic indications
Cyclogest is indicated for the
1) Treatment of premenstrual syndrome, including premenstrual tension
and depression.
2) Treatment of puerperal depression.
3) Luteal phase support as part of an Assisted Reproductive Technology
(ART) treatment for women.
4.2 Posology and method of administration
_For the treatment of premenstrual syndrome and puerperal depression:_
200mg daily to 400mg twice a day, by vaginal or rectal insertion. For
premenstrual syndrome commence
treatment on day 14 of menstrual cycle and continue treatment until
onset of menstruation. If symptom