Pirolam Intima Vag

Leaflet attached to the packaging: patient information

PIROLAM INTIMA Vag, 500 mg, vaginal tablet

Clotrimazole

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Please keep this leaflet, you may need to read it again.
• If you need advice or further information, please ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Pirolam Intima Vag and what is it used for
• 2. Important information before using Pirolam Intima Vag
• 3. How to use Pirolam Intima Vag
• 4. Possible side effects
• 5. How to store Pirolam Intima Vag
• 6. Contents of the packaging and other information

1. What is Pirolam Intima Vag and what is it used for

The active substance of Pirolam Intima Vag is clotrimazole, which belongs to a group of medicines called imidazoles. It has a broad spectrum of antifungal activity, meaning it destroys fungi and inhibits their growth. It is effective against microorganisms such as dermatophytes, yeasts, and molds.

Pirolam Intima Vag is used to treat vaginal and vulvar infections (female external genital organs) caused by microorganisms, such as fungi (usually Candida), sensitive to clotrimazole.

This medicine is intended for use in adults and adolescents from 16 years of age.

Vaginal yeast infection (candidiasis) is a recurring infection in women caused by a fungus called Candida. This fungus occurs on the skin and in the vagina and can become pathogenic in certain cases.

Fungal infections of the vagina occur when the natural balance in the body is disrupted by factors such as the use of antibiotics, certain antidiabetic medications, contraceptives, vaginal injuries, and general weakening of the body. This leads to an increase in the amount of yeast and the development of vaginal infection.

The most common symptoms of vaginal infection are:

• itching in the vagina and around it;
• pain and burning, worsening due to friction and scratching; additionally, urine can exacerbate these symptoms due to tissue irritation;
• discharge (white, odorless discharge from the vagina), which usually worsens before menstruation.

Vaginal infections can recur. To prevent this, you should follow a few rules:

• wash and dry the genital area gently to avoid irritation;
• avoid wearing tight clothing;
• wear cotton underwear, and instead of tights, wear stockings;
• avoid using perfumed soaps and deodorants for intimate hygiene and bath products;
• frequently change tampons, as a blood-soaked tampon is an ideal medium for yeast growth.

During sexual intercourse, the delicate tissue may be damaged, and the yeast infection may worsen; the infection can also be transmitted to the partner (sometimes in men, the infection is asymptomatic, so the partner may not know about their illness); the partner may also become infected with yeast. In such a case, the partner should also undergo antifungal treatment.

Do not use this medicine if other oral antifungal medications were ineffective during the treatment of the current infection.

Please read the information in section 2 of the leaflet about when to consult a doctor or pharmacist before using Pirolam Intima Vag.

2. Important information before using Pirolam Intima Vag

When not to use Pirolam Intima Vag

If the patient is allergic (hypersensitive) to clotrimazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Pirolam Intima Vag, you should discuss it with your doctor or pharmacist:

• if this is the first time you have had a vaginal infection,
• vaginal infections during the first trimester of pregnancy
• if you have had at least 4 cases of vaginal infections in the last year,
• if you have a fever of 38°C or higher,
• if you experience lower abdominal pain, back pain,
• if you have foul-smelling discharge,
• if you experience nausea,
• if you have vaginal bleeding and (or) arm pain.

Do not use Pirolam Intima Vag during menstruation. You should stop using this medicine before the start of menstrual bleeding.

During the use of Pirolam Intima Vag, you should not use tampons, douching, spermicides, or other vaginal products.

During the use of Pirolam Intima Vag, you should avoid sexual intercourse, as the infection can be transmitted to your sexual partner.

Your sexual partner should also undergo local antifungal treatment if they experience symptoms such as itching and inflammation, which may indicate a yeast infection.

Treating sexual partners can help prevent reinfection.

The contraceptive effectiveness of latex contraceptives, such as condoms and diaphragms, may be reduced.

Do not swallow Pirolam Intima Vag.

Children and adolescents

Pirolam Intima Vag should not be used in girls under 16 years of age without consulting a doctor.

Pirolam Intima Vag and other medicines

Please tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Please tell your doctor if you are taking tacrolimusor sirolimus, medicines used to control the immune response after organ transplantation.

It is possible that the concentration of certain medicines in your blood may increase if they are used at the same time as Pirolam Intima Vag. However, this is unlikely in the case of a single 500 mg dose. If you have any doubts about using another medicine with Pirolam Intima Vag, please consult your doctor.

Pregnancy and breastfeeding

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

Pregnancy

Pirolam Intima Vag may be used during pregnancy. During the first 3 months of pregnancy, before using Pirolam Intima Vag, you should consult your doctor. In the last 4-6 weeks of pregnancy, you should particularly carefully maintain genital hygiene.

Breastfeeding

Pirolam Intima Vag may be used during breastfeeding. If you have any doubts, please consult your doctor.

Fertility

No studies have been conducted on the effect of clotrimazole on human fertility.

Driving and using machines

Pirolam Intima Vag does not affect the ability to drive and use machines.

3. How to use Pirolam Intima Vag

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

Recommended dose

Adults and adolescents from 16 years of age

• One vaginal tablet, deeply inserted into the vagina, before bedtime. The medicine is used in a single dose. The vaginal tablet should be inserted as deeply as possible into the vagina.

Please ensure a moist environment in the vagina so that the tablet dissolves completely. Otherwise, undissolved parts of the tablet may slip out of the vagina.

Duration of treatment

Pirolam Intima Vag is used for the treatment in a single dose.

If after 7 days there is no significant improvement, you should consult your doctor to confirm the cause of the infection. If your symptoms worsen, you should contact your doctor.

Treatment may be repeated. However, recurring infections may indicate another disease causing the symptoms. If you experience recurring symptoms, you should consult your doctor.

Use in children and adolescents

Pirolam Intima Vag should not be used in girls under 16 years of age without consulting a doctor.

If you have any further doubts about using this medicine, please ask your doctor.

4. Possible side effects

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

Side effects have been observed with the following frequency:

Common (more than 1 in 100 people):

• vulvar and vaginal burning sensation

Uncommon (more than 1 in 1,000 people):

• abdominal pain
• vulvar and vaginal itching
• vulvar and vaginal redness
• irritation at the application site

Rare (more than 1 in 10,000 people):

• allergic reactions
• edema
• skin rash
• vaginal bleeding

Frequency not known (cannot be estimated from the available data):

• vaginal shedding
• feeling of discomfort in the vagina
• vaginal pain, nausea, hives, discharge, pain

Please stop using the medicine if you experience local side effects or allergic reactions (including anaphylactic reaction, angioedema, low blood pressure, shortness of breath, and (or) fainting).

Local side effects may be similar to the symptoms of the disease. Therefore, distinguishing between the symptoms of the infection and the side effects caused by the medicine may be difficult.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

tel.: +48 22 49 21 301

fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

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

5. How to store Pirolam Intima Vag

Keep this medicine out of the sight and reach of children.

There are no special precautions for storage temperature.

Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Pirolam Intima Vag contains

• The active substance is clotrimazole.
• Each vaginal tablet contains 500 mg of clotrimazole.
• The other excipients are: lactose monohydrate, corn starch, potato starch, adipic acid, sodium bicarbonate, magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate.

What Pirolam Intima Vag looks like and contents of the pack

Pirolam Intima Vag 500 mg is a white, oblong, biconvex vaginal tablet with one side rounded and the other side flat.

Tablet dimensions: 24.5 mm (length) x 10.0 mm (width).

Packaging: a blister pack containing 1 vaginal tablet.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Mako Pharma Sp. z o.o.

ul. Władysława Reymonta 2

05-092 Dziekanów Leśny

Date of last revision of the leaflet:January 2025