Clotidal Max

Package Leaflet: Information for the Patient

Clotidal MAX, 500 mg, vaginal tablet
Clotrimazole

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no significant improvement after 7 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Clotidal MAX and what is it used for
• 2. Important information before using Clotidal MAX
• 3. How to use Clotidal MAX
• 4. Possible side effects
• 5. How to store Clotidal MAX
• 6. Package contents and other information

1. What is Clotidal MAX and what is it used for

The active substance of Clotidal MAX 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.
Clotidal MAX is used to treat vaginal and vulvar infections (infections of the female external genital organs) caused by microorganisms, such as fungi (usually Candida), that are sensitive to clotrimazole.
The 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.
Vaginal fungal infections occur when the natural balance in the body is disrupted by factors such as the use of antibiotics, anti-diabetic medications, contraceptives, vaginal injuries, and general weakening of the body. This leads to an increase in the amount of yeast and the development of a vaginal infection.
The most common symptoms of vaginal infection are:

• itching in the vagina and around it;
• pain and burning, worsening with friction and scratching; urine can also exacerbate these symptoms by irritating the tissues;
• discharge (white, odorless vaginal discharge), which usually worsens before menstruation.

Vaginal infections can recur. To prevent this, several rules should be followed:

• wash and dry the genital area gently to avoid irritation;
• avoid wearing tight clothing;
• wear cotton underwear and prefer stockings to tights;
• avoid using perfumed soaps and deodorants for intimate hygiene and bath products;
• change tampons frequently, 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 sexual partner. The contraceptive effectiveness of latex contraceptives, such as condoms and diaphragms, may be reduced.
Clotidal MAX should not be swallowed.

2. Important information before using Clotidal MAX

When not to use Clotidal MAX

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 Clotidal MAX, the patient should discuss it with their doctor or pharmacist:

• if the vaginal infection occurs for the first time, if there have been at least 4 cases of infection in the last year,
• in the case of a vaginal infection during the first trimester of pregnancy,
• in the case of a fever above 38°C,
• if the patient experiences lower abdominal pain, back pain,
• in the case of foul-smelling discharge,
• in the case of nausea,
• if there is vaginal bleeding and (or) arm pain.

During the use of Clotidal MAX, the patient should not use tampons, douching, spermicides, or other vaginal products.
During the use of Clotidal MAX, the patient should avoid sexual intercourse, as the infection can be transmitted to the sexual partner.
The effectiveness of latex contraceptives, such as condoms and diaphragms, may be reduced.
Clotidal MAX should not be swallowed.

Children and adolescents

Clotidal MAX should not be used in girls under 16 years of age without consulting a doctor.

Clotidal MAX and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor if they are taking tacrolimus or sirolimus, medicines used to control the immune response after organ transplantation.
It is possible that the concentration of certain medicines in the patient's blood may increase if they are used at the same time as Clotidal MAX. However, this is unlikely in the case of a single 500 mg dose. If there are any doubts about using another medicine with Clotidal MAX, the patient should consult their doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Clotidal MAX can be used during pregnancy. However, during the first 3 months of pregnancy, the patient should consult their doctor before using Clotidal MAX.
Breastfeeding
Clotidal MAX can be used during breastfeeding. If there are any doubts, the patient should consult their doctor.

Driving and using machines

Clotidal MAX does not affect the ability to drive and use machines.

3. How to use Clotidal MAX

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If there are any doubts, the patient should consult their 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.

The patient should 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.
Clotidal MAX should not be used during menstruation. The use of this medicine should be stopped before the start of menstrual bleeding.
The sexual partner should also undergo antifungal treatment at the same time.

Duration of treatment

Clotidal MAX is used for the treatment of vaginal infections in a single dose.
If there is no significant improvement after 7 daysof using the medicine, the patient should consult their doctorto confirm the cause of the infection. If the symptoms worsen, the patient should contact their doctor.

Use in children and adolescents

Clotidal MAX should not be used in girls under 16 years of age without consulting a doctor.
If there are any further doubts about using this medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Clotidal MAX 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):

• burning

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

• abdominal pain
• itching
• redness of the skin and (or) irritation

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

• allergic reactions
• swelling
• skin rash
• vaginal bleeding

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

• exfoliation in the genital area
• discomfort
• pelvic pain

The patient should stop using the medicine if they experience local side effects or allergic reactions.
Local side effects may be similar to the symptoms of the disease. Therefore, it may be difficult to distinguish between the symptoms of the infection and the side effects caused by the medicine.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Clotidal MAX

The medicine should be stored out of sight and reach of children. There are no special recommendations for the storage temperature of the medicinal product.
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 given month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Clotidal MAX contains

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

What Clotidal MAX looks like and what the package contains

Clotidal MAX, 500 mg, is a white, convex-concave, elongated vaginal tablet with one rounded and one straight cut side. The tablet measures: 24.5 mm (length) x 10.0 mm (width).
Packaging: a blister pack containing 1 vaginal tablet.

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer

Mako Pharma Sp. z o. o.
ul. Władysława Reymonta 2
05-092 Dziekanów Leśny
Poland
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warsaw
tel.: +48 (22) 543 60 00

Date of the last revision of the leaflet: January 2025