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GYNO-PEVARYL 150 MG VAGINAL PESSARIES - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - GYNO-PEVARYL 150 MG VAGINAL PESSARIES

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 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, torpedoshaped pessaries (vaginal suppositories).

When inserted into the vagina they release

pessaries are and what

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

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 150 pessaries.

Warnings and precautions

Talk to your doctor or pharmacist before using Gyno-Pevaryl 150 pessaries if:

  • You are using other treatment for your vagina.

Talk to your doctor about using another type of contraception while you are using this medicine if:

  • You are using a ‘barrier’ method of contraception. This includes condoms or diaphragms. This is because Gyno-Pevaryl 150 pessaries can damage the rubber and stop them working properly.
  • You are using a spermicidal contraceptive

Other medicines and Gyno-Pevaryl 150 pessaries

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular tell your doctor if you are taking:

  • Medicines to thin the blood

(anticoagulants) such as warfarin or acenocoumarol. Your doctor may check that the anticoagulant is working properly.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You may still be able to use Gyno-Pevaryl 150 pessaries if your doctor thinks you need to.

3

How to use Gyno-Pevaryl 150 pessaries

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Using the pessaries

  • Always wash your hands thoroughly before using this medicine. This is particularly important if you are pregnant

The full course is 3 pessaries

Use one pessary each day, for 3 days Use the pessary just before going to bed. This helps it to stay in place Do not swallow the pessary

turn over

3

How to use Gyno-Pevaryl 150 pessaries (continued)

Inserting the pessary

  • Tear down the groove between two individually wrapped pessaries
  • Remove one pessary from its plastic packet using the easy open tab (figure 1)
  • Lie down with your knees bent and spread apart
  • Push the pessary with your forefinger as far as you can into your vagina (figure 2)

When to stop using Gyno-Pevaryl 150 pessaries

Use the full course of 3 pessaries. Do this, even if the soreness, itching and discharge go away before the end of the course.

If you swallow Gyno-Pevaryl 150 pessaries

If a pessary is eaten or swallowed talk to a doctor or go to the nearest hospital casualty department straight away.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Gyno-Pevaryl 150 pessaries and tell your doctor straight away if you notice the following. You may need urgent medical treatment.

  • Sudden swelling of the face or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction (affects fewer than 1 in 10,000 people)

Other side effects:

Common side effects (affects more than

1 in 100 patients)

  • Itchy skin
  • Burning sensation (skin)

Uncommon side effects (affects fewer than 1 in 100 patients)

  • Rash
  • Burning sensation (around or inside the vagina)

Rare side effects (affects fewer than 1 in 1000 patients)

  • Reddening of your skin

Frequency unknown:

  • Pain, swelling or irritation (around or inside the vagina)
  • Inflammation of the skin (contact dermatitis)
  • Peeling, flaky skin

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

By reporting side effects you can help provide more information on the safety of this medicine.

5

How to store Gyno-Pevaryl 150 pessaries

Keep this medicine out of the sight and reach of children. Store in the original container. Do not store above 30°C. Keep away from heat and sunlight.

Do not use Gyno-Pevaryl 150 pessaries:

  • After the expiry date which is stated on the label. The expiry date refers to the last day of that month
  • If the plastic packet is broken or missing
  • If the pessaries are not white to off-white in colour

Contents of the pack and other information

What Gyno-Pevaryl 150 pessaries contain

The active substance is econazole nitrate.

Each pessary contains 150 mg econazole nitrate.

The other ingredients are Wecobee M and Wecobee FS.

What Gyno-Pevaryl 150 pessaries looks like and contents of the pack

Gyno-Pevaryl 150 pessaries come in a plastic strip containing 3 pessaries. The pessaries are torpedo-shaped and white to off-white in colour.

Marketing Authorisation Holder:

Karo Pharma AB, Box 16184, 103 24 Stockholm, Sweden

Manufacturer:

Lusomedicamenta – Sociedade,

Tecnica Farmaceutica, S.A.,

Estrada Consiglieri Pedroso, 69-B,

Queluz de Baixo, 2730–055 Barcarena,

Portugal

OR

Janssen Pharmaceutica NV, Turnhoutseweg

30, B-2340 Beerse, Belgium

This leaflet was last revised in May 2021.

karo

pharma

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

G GENITO URINARY SYSTEM AND SEX HORMONES

G01 GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS

G01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS

G01AF Imidazole derivatives, gyncological antiinfectives

G01AF05 econazole

Frequently Asked Questions

What is GYNO-PEVARYL 150 mg vaginal pessaries used for?

GYNO-PEVARYL is used to treat vaginal infections caused by fungi, such as yeast infections.

How do I use GYNO-PEVARYL vaginal pessaries?

Insert one pessary deeply into the vagina, preferably at bedtime, for the recommended duration as advised by your healthcare provider.

Can GYNO-PEVARYL be used during menstruation?

It is generally advised to wait until your period is over before using GYNO-PEVARYL for optimal effectiveness.

Is GYNO-PEVARYL safe for pregnant women?

Consult your doctor before using GYNO-PEVARYL if you are pregnant or planning to become pregnant.

What are the common side effects of GYNO-PEVARYL?

Some patients may experience mild irritation, itching, or burning sensations in the vaginal area after use.

Can I use tampons while using GYNO-PEVARYL?

It is recommended to avoid tampons while using GYNO-PEVARYL to ensure proper absorption and effectiveness.

How long does it take for GYNO-PEVARYL to work?

Many patients report improvement in symptoms within a few days of starting treatment, but complete treatment duration should be followed.

What should I do if I forget to use a pessary?

If you forget to insert a pessary, do so as soon as you remember. If it's close to your next dose, skip the missed dose and continue as scheduled.

Can I have sex while using GYNO-PEVARYL?

It's advisable to avoid sexual intercourse until treatment is complete and symptoms have resolved.

Is there a specific time of day it's best to use GYNO-PEVARYL?

Using GYNO-PEVARYL at bedtime is recommended as it allows for maximum absorption and effectiveness overnight.

What should I avoid while using GYNO-PEVARYL?

Avoid douching or using other vaginal products during treatment unless directed by a healthcare professional.

Can I use other medications with GYNO-PEVARYL?

Always consult your doctor before combining any other medications with GYNO-PEVARYL to avoid interactions.

How should I store GYNO-PEVARYL vaginal pessaries?

Store the pessaries in a cool, dry place away from direct sunlight and out of reach of children.

Does GYNO-PEVARYL affect fertility?

There is no evidence that GYNO-PEVARYL affects fertility; however, consult your healthcare provider for personalized advice.

Can men use GYNO-PEVARYL for infections?

GYNO-PEVARYL is specifically designed for use in women. Men should consult a healthcare professional for appropriate treatments.

What if my symptoms don’t improve after using GYNO-PEVARYL?

If symptoms persist after completing treatment, consult your healthcare provider for further evaluation and possible alternative treatments.

Are there any dietary restrictions while using GYNO-PEVARYL?

There are generally no specific dietary restrictions; however, maintaining overall health can support treatment effectiveness.

Does using GYNO-PEVARYL cause any changes in discharge?

Some women may notice changes in discharge during treatment. If you have concerns about unusual changes, contact your doctor.

Where can I buy GYNO-PEVARYL 150 mg vaginal pessaries?

GYNO-PEVARYL can typically be purchased at pharmacies with a prescription or over-the-counter depending on local regulations.

How can I tell if my infection is fungal and requires treatment with GYNO-PEVARYL?

Common signs of a fungal infection include itching, burning, and unusual discharge. Consult a healthcare provider for diagnosis and appropriate treatment recommendations.