Gyno-Pevaryl 150mg vaginal pessaries

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Econazole nitrate

Available from:

Karo Healthcare 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: 5012946320017

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Gyno-Pevaryl
®
150mg vaginal pessaries
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 150 pessaries are and what they are used for
2. What you need to know before you use Gyno-Pevaryl 150 pessaries
3. How to use Gyno-Pevaryl 150 pessaries
4. Possible side effects
5. How to store Gyno-Pevaryl 150 pessaries
6. Contents of the pack and other information
1. What Gyno-Pevaryl 150 pessaries are and what they are used
for
The name of your medicine is Gyno-Pevaryl 150mg vaginal pessaries.
They are
called ‘Gyno-Pevaryl 150 pessaries' in this leaflet. This pack
contains 3
pessaries.
Gyno-Pevaryl 150 pessaries are solid, torpedo-shaped pessaries
(vaginal
suppositories). When inserted into the vagina they release a medicine
called
econazole nitrate. This belongs to a group of medicines called
‘antifungals’.
Gyno-Pevaryl 150 pessaries are 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 150
pessaries
Do not use Gyno-Pevaryl 150 pessaries 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
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Do not use this medicine if any of the above applies to you. If

Summary of Product characteristics

OBJECT 1
Gyno-Pevaryl 150 mg Vaginal
Pessaries
Summary of Product Characteristics Updated 06-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
•
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
GYNO-PEVARYL™ 150 mg Vaginal Pessaries
2. Qualitative and quantitative composition
Vaginal pessaries each containing 150 mg econazole nitrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
White to off-white torpedo-shaped pessaries.
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:
One pessary should be inserted high into the vagina each evening for
three consecutive days. Pregnant
women should thoroughly wash their hands before self-administering
Gyno-Pevaryl 150 mg vaginal
pessaries.
Children:
Gyno-Pevaryl 150 mg vaginal pessaries are not indicated for use in
children under the age of 16 years.
Elderly:
No specific dosage recommendations or precaut