Pirolam intima vag

Package leaflet: Information for the patient

PIROLAM INTIMA Vag, 500 mg, vaginal tablet
Clotrimazolum
Please read all of this leaflet carefully before using this 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.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

Table of contents

1. What Pirolam Intima Vag is and what it is 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 pack and other information

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

The active substance in Pirolam Intima Vag is clotrimazole, which belongs to a group of medicines called
imidazoles. It has broad-spectrum 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 in the treatment of vaginal and vulval (female external genital organs)
infections caused by microorganisms, such as fungi (usually Candida), that are sensitive to clotrimazole.
This medicine is intended for use in adults and adolescents aged 16 years and older.
Vaginal candidiasis (yeast infection) is a common condition in women, caused by a fungus called
Candida. This fungus is normally present on the skin and in the vagina, but under certain conditions
it may become pathogenic.
Vaginal fungal infections occur when the natural balance in the body is disturbed by factors such as:
the use of antibiotics, certain antidiabetic drugs, hormonal contraceptives, vaginal injury, or general
weakening of the body. This leads to an overgrowth of yeast and the development of vaginal infection.
The most common symptoms of vaginal infection include:

• itching in and around the vagina;
• pain and burning sensation, worsened by friction and scratching; additionally, urination may intensify these symptoms due to irritation of tissues;
• vaginal discharge (white, odourless discharge), which usually increases before menstruation.

Vaginal infections may recur. To help prevent recurrence, the following recommendations should be observed:

• gently wash and dry the vaginal area to avoid irritation;
• avoid wearing tight clothing;
• wear cotton underwear, and prefer stockings over tights;
• avoid using perfumed soaps, intimate deodorants, and bath additives;
• change sanitary tampons frequently, as blood-soaked tampons provide an ideal medium for yeast growth.

During sexual intercourse, the delicate tissue may be damaged, worsening the fungal infection.
Transmission of infection to the partner may occur (in men, infection may be asymptomatic, so the
partner may be unaware of being infected), and the partner may also transmit the fungal infection.
In such cases, the partner should also undergo antifungal treatment.
Do not self-medicate with this product if oral antifungal medicines have been ineffective in treating
the current infection.
Please refer to section 2 of this leaflet for information on when you should consult your doctor or
pharmacist before using Pirolam Intima Vag.

2. Important information before using Pirolam Intima Vag

When not to use Pirolam Intima Vag
Do not use Pirolam Intima Vag if the patient is allergic (hypersensitive) to clotrimazole or to any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Pirolam Intima Vag, consult a doctor or
pharmacist:

• if vaginal infection has occurred for the first time,
• vaginal infections during the first trimester of pregnancy,
• if there have been at least 4 episodes of infection within the last year,
• in case of fever of 38°C or higher,
• if the patient experiences lower abdominal pain or back pain,
• in case of foul-smelling vaginal discharge,
• if nausea occurs,
• if there is vaginal bleeding and/or shoulder pain.

Do not use Pirolam Intima Vag during menstruation. Treatment with
this medicine should be completed before the onset of menstrual bleeding.
During treatment with Pirolam Intima Vag, do not use tampons, vaginal douches,
spermicides, or other products intended for vaginal use.
During treatment with Pirolam Intima Vag, sexual intercourse should be avoided, as the infection
may be transmitted to the sexual partner.
The sexual partner should also receive topical treatment simultaneously if symptoms such as itching and inflammation are present, which may indicate a yeast infection.
Treating sexual partners may help prevent recurrent infections.
The effectiveness of latex contraceptives such as condoms and vaginal diaphragms may be reduced.
Pirolam Intima Vag must not be swallowed.

Children and adolescents
Pirolam Intima Vag must not be used in girls under 16 years of age without prior consultation
with a doctor.

Pirolam Intima Vag and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
Inform your doctor if the patient is taking tacrolimus or sirolimus, medicines used to control the immune response after organ transplantation.
It is possible that blood concentrations of certain medicines may increase when used concomitantly with Pirolam Intima Vag. However, this is unlikely when a single 500 mg dose is administered. In case of doubt regarding concomitant use of another medicine with Pirolam Intima Vag, consult a doctor.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Pirolam Intima Vag may be used during pregnancy. During the first 3 months of pregnancy, consult a doctor before using Pirolam Intima Vag. During the last 4–6 weeks of pregnancy, special care should be taken to maintain genital hygiene.

Breastfeeding
Pirolam Intima Vag may be used during breastfeeding. In case of doubt, consult a doctor.

Fertility
No studies have been conducted on the effect of clotrimazole on fertility in humans.

Driving and operating machinery
Pirolam Intima Vag has no effect on the ability to drive or operate machinery.

3. How to use Pirolam Intima Vag

This medicine should always be used exactly as described in the patient information leaflet or as directed by a physician. If in doubt, consult a doctor or pharmacist.

Recommended dose
Adults and adolescents aged 16 years and older

• One vaginal tablet, administered deeply into the vagina, before bedtime. Pirolam Intima Vag is used as a single dose. The vaginal tablet should be placed as deeply into the vagina as possible.

Ensure a moist vaginal environment 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 administered as a single-dose treatment.
If there is no significant improvement after 7 days of administration, consult a doctor to confirm the cause of the infection. If symptoms worsen, contact a doctor.
Treatment may be repeated. However, recurrent infections may indicate another underlying condition causing the symptoms. In case of recurring symptoms, the patient should consult a doctor.
Use in children and adolescents
Pirolam Intima Vag must not be used in girls under 16 years of age without prior consultation with a doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed with the following frequencies:
Common (more frequently than in 1 out of 100 people):

• burning sensation in the vulva and vagina

Uncommon (more frequently than in 1 out of 1,000 people):

• abdominal pain
• itching of the vulva and vagina
• redness of the vulva and vagina
• irritation at the application site

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

• allergic reactions
• swelling
• skin rash
• vaginal bleeding

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

• vaginal desquamation
• discomfort in the vagina
• vaginal pain, nausea, urticaria, vaginal discharge, pain

The use of the medicine should be discontinued if local adverse reactions or
allergic reactions occur (including anaphylactic reaction, angioedema (swelling), low blood pressure,
shortness of breath and/or fainting).
Local adverse reactions may resemble symptoms of the disease. Therefore,
differentiating infection symptoms from drug-induced adverse reactions may be difficult.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Pirolam Intima Vag

Keep this medicine out of the sight and reach of children.
There are no special requirements regarding 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Pirolam Intima Vag contains

• The active substance is clotrimazole.
• Each vaginal tablet contains 500 mg of clotrimazole.
• The other ingredients are: monohydrate lactose, corn starch, potato starch, adipic acid, sodium hydrogen carbonate, 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, double-convex vaginal tablet, elongated in shape, with one end rounded and the other end straightly cut.
Dimensions of the tablet: 24.5 mm (length) x 10.0 mm (width).
Pack: OPA/Aluminium/PVC/Aluminium foil blister containing 1 vaginal tablet.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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