Patient leaflet: Information for the user

Clotidal MAX, 500 mg, vaginal tablet
Clotrimazolum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as advised by
your doctor or pharmacist.

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

Contents of the leaflet

What Clotidal MAX is and what it is used for
Important information before using Clotidal MAX
How to use Clotidal MAX
Possible side effects
How to store Clotidal MAX
Contents of the pack and other information

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

The active substance in Clotidal MAX is clotrimazole, which belongs to a group of medicines called
imidazoles. It has a broad antifungal spectrum, 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 vulval infections (female external genital organs) 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 can become pathogenic.
Vaginal fungal infections occur when the body's natural balance is disrupted by factors such as: use of antibiotics, antidiabetic drugs, contraceptive agents, vaginal injury, or general weakening of the body. This leads to an overgrowth of yeast and development of vaginal infection.
The most common symptoms of vaginal infection are:

itching in and around the vagina;
pain and burning, which worsen due to friction and scratching; additionally, urination may intensify these symptoms due to tissue irritation;
vaginal discharge (white, odorless discharge from the vagina), which usually increases before menstruation.

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

wash and dry the genital area gently 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 a blood-soaked tampon provides an ideal medium for yeast growth.

During sexual intercourse, delicate tissues may be damaged, worsening the fungal infection.
There is also a risk of infecting the partner (in men, infection may be asymptomatic, so the partner may be unaware of being infected), as well as the possibility of the partner transmitting a fungal infection. In such cases, the partner should also undergo antifungal treatment.
Do not self-medicate with this product if oral antifungal medicines have previously been ineffective in treating the current infection.
Please refer to section 2 of this leaflet for information on when to speak with your doctor or pharmacist before using Clotidal MAX.

2. Important information before using Clotidal MAX

When not to use Clotidal MAX
If the patient has an allergy (hypersensitivity) to clotrimazole or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting to use Clotidal MAX, discuss this with a doctor or pharmacist:

if vaginal infection occurs for the first time, or if there have been at least 4 episodes of infection within the past year,
in case of vaginal infection during the first trimester of pregnancy,
if body temperature is 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 vaginal bleeding and/or shoulder pain is present.

During treatment with Clotidal MAX, do not use tampons, vaginal douches, spermicides, or other vaginal products.
While using Clotidal MAX, avoid sexual intercourse, as the infection may be transmitted to the sexual partner.
The effectiveness of latex contraceptive methods, such as condoms and diaphragms, may be reduced.
Do not swallow Clotidal MAX.
Children and adolescents
Do not use Clotidal MAX in girls under 16 years of age without consulting a doctor.
Clotidal MAX and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking tacrolimus or sirolimus, medicines used to control the immune response after organ transplantation.
The blood concentration of certain medicines may increase when used concomitantly with Clotidal MAX. However, this is unlikely after a single 500 mg dose. If in doubt about using another medicine together with Clotidal MAX, consult a doctor.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Clotidal MAX may be used during pregnancy. However, during the first three months of pregnancy, consult a doctor before using Clotidal MAX.
Breastfeeding
Clotidal MAX may be used during breastfeeding. In case of doubt, consult a doctor.
Driving and operating machinery
Clotidal MAX does not affect the ability to drive or operate machinery.

3. How to use Clotidal MAX

This medicine should always be used exactly as described in the patient leaflet or as directed by
your doctor. If in doubt, consult your doctor or pharmacist.
Recommended dose
Adults and adolescents aged 16 years and older

One vaginal tablet, administered deeply into the vagina, before bedtime. Clotidal MAX is administered as a single dose. The vaginal tablet should be inserted 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 be expelled from the vagina.
Do not use Clotidal MAX during menstruation. Discontinue use prior to the onset of menstrual bleeding.
The sexual partner should also receive antifungal treatment simultaneously.
Duration of treatment
Clotidal MAX is used as a single-dose treatment.
If there is no significant improvement within 7 days after administration, you should consult your
doctor to confirm the cause of the infection. If symptoms worsen, contact your doctor.
Use in children and adolescents
Do not use Clotidal MAX in girls under 16 years of age without consulting 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 everybody gets them.
The following adverse reactions have been observed with the following frequency:
Common (more frequent than in 1 out of 100 people):

burning

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

abdominal pain
itching
skin redness and (or) irritation

Rare (more frequent 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):

peeling in the genital area
discomfort
pelvic pain

The medicine should be discontinued if local adverse reactions or allergic reactions occur.
Local adverse reactions may resemble symptoms of the disease. Therefore, distinguishing between symptoms of infection and adverse reactions caused by the medicine 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 of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Clotidal MAX

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

6. Contents of the pack and other information

What Clotidal MAX contains

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

What Clotidal MAX looks like and contents of the pack
Clotidal MAX 500 mg is a white, elongated, double convex vaginal tablet, rounded on one end and straight-cut on the other. Dimensions of the tablet: 24.5 mm (length) x 10.0 mm (width).
Pack: OPA/Aluminium/PVC/Aluminium blister pack containing 1 vaginal tablet.
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
Ziębicka Street 40
50-507 Wrocław
Poland
Manufacturer
Mako Pharma Sp. z o.o.
Władysława Reymonta Street 2
05-092 Dziekanów Leśny
Poland
For further information, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
Poleczki Street 35, 02-822 Warsaw
Tel.: +48 (22) 543 60 00