Gyno-Pevaryl Once 150mg vaginal pessary

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Econazole nitrate

Available from:

Karo Pharma UK Ltd

ATC code:

G01AF05

INN (International Name):

Econazole nitrate

Dosage:

150mg

Pharmaceutical form:

Pessary

Administration route:

Vaginal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07020200; GTIN: 5012946320208

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
GYNO-PEVARYL
® ONCE 150MG VAGINAL PESSARY
Econazole nitrate
Gyno-Pevaryl is a registered trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Gyno-Pevaryl Once is and what it is used for
2. What you need to know before you use Gyno-Pevaryl Once
3. How to use Gyno-Pevaryl Once
4. Possible side effects
5. How to store Gyno-Pevaryl Once
6. Contents of the pack and other information
1. WHAT GYNO-PEVARYL ONCE IS AND WHAT IT IS USED FOR
The name of your medicine is Gyno-Pevaryl Once 150mg vaginal pessary.
It is
called ‘Gyno-Pevaryl Once’ in this leaflet.
Gyno-Pevaryl Once is a solid, torpedo-shaped pessary (vaginal
suppository).
When inserted into the vagina it releases a medicine called econazole
nitrate.
This belongs to a group of medicines called ‘antifungals’.
Gyno-Pevaryl Once is used for infections of the vagina and the skin
around the
vagina. The infections are caused by fungi and yeasts such as thrush
(_Candida_).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GYNO-PEVARYL ONCE
DO NOT USE GYNO-PEVARYL ONCE IF:

You are allergic to econazole nitrate or any of the other ingredients
of this
medicine (listed in section 6)

You are allergic to any other medicine used to treat thrush or other
fungal
infections

You are under 16 years old
Do not use this medicine if any of the above applies to you. If you
are not sure,
talk to your doctor or pharmacist before using Gyno-Pevaryl Once.
WARNINGS AND PRECAUTIONS
Talk to your doctor or ph

Summary of Product characteristics

OBJECT 1
Gyno-Pevaryl Once 150mg vaginal
pessary
Summary of Product Characteristics Updated 09-Aug-2021 | Karo Pharma
AB
•
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
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5.1 Pharmacodynamic properties
•
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
•
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
Gyno-Pevaryl Once 150mg vaginal pessary
2. Qualitative and quantitative composition
Each pessary contains econazole nitrate 150 mg
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Light beige torpedo shaped pessary
4. Clinical particulars
4.1 Therapeutic indications
Vaginitis due to Candida Albicans and other yeasts
4.2 Posology and method of administration
For vaginal administration.
Adults:
Insert one pessary high into the vagina at night prior to retiring.
Pregnant women should thoroughly wash
their hands before self-administering Gyno-Pevaryl Once pessary.
Children:
Gyno-Pevaryl Once pessary is not indicated for use in children under
the age of 16 years.
Elderly:
No specific dosage recommendations or precautions apply.
4.3 Contraindications
Hypersensitivity to any imidazole prepa