Cyclogest 200mg pessaries

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Progesterone

Available from:

L.D. Collins & Co. Ltd

ATC code:

G03DA04

INN (International Name):

Progesterone

Dosage:

200mg

Pharmaceutical form:

Pessary

Administration route:

Rectal; Vaginal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040102; GTIN: 5012617014429

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
1
2
3
4
5
6
WHAT IS IN THIS LEAFLET WHAT CYCLOGEST IS AND WHAT IT IS USED FOR WHAT YOU NEED TO KNOW BEFORE YOU USE CYCLOGEST HOW TO USE CYCLOGEST POSSIBLE SIDE EFFECTS HOW TO STORE CYCLOGEST CONTENTS OF THE PACK AND OTHER INFORMATION
1
2 WHAT YOU NEED TO KNOW BEFORE YOU USE CYCLOGEST
DO NOT USE Cyclogest if you:
WARNINGS AND PRECAUTIONS
3 HOW TO USE CYCLOGEST
Progesterone
Cyclogest is the registered trademark of
L.D. Collins & Co. Ltd.
PACKAGE LEAFLET: INFORMATION FOR THE USER
200mg pessary
•
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. WHAT CYCLOGEST IS AND WHAT IT IS USED FOR
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.
•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 disorders (a group of inherited or acquired
disorders of certain
enzymes),
•have or have had blood CLOTS in the legs, lungs, eyes or elsewhere
in the body,
•currently have

Summary of Product characteristics

OBJECT 1
CYCLOGEST 200MG PESSARIES
Summary of Product Characteristics Updated 29-Nov-2019 | L.D. Collins
& Co. Ltd.
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1. Name of the medicinal product
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2. Qualitative and quantitative composition
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3. Pharmaceutical form
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4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Pregnancy and lactation
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4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
1. Name of the medicinal product
CYCLOGEST 200mg
2. Qualitative and quantitative composition
Each pessary contains 200mg 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.
4.2 Posology and method of administration
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 symptoms are
present at ovulation commence treatment on day 12.
_Use in special populations: _There is no experience with use of
Cyclogest in patients with impaired liver or
renal functio