Albothil

Leaflet attached to the packaging: patient information

Albothyl, 90 mg, vaginal tablets

Policresulen

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 the patient leaflet 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 possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 9 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Albothyl and what is it used for

Policresulen in the medicine acts selectively on proteins of necrotic and diseased tissues.
It does not affect healthy tissues. The acidic reaction of the medicine (low pH) destroys bacteria.
Albothyl is used for local treatment of bacterial vaginitis.
Albothyl is not indicated for use in women under 18 years of age or during menopause,
due to lack of experience with the use of the medicine in these age groups.

2. Important information before using Albothyl

When not to use Albothyl

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• During menstruation.

Warnings and precautions

Before starting to use Albothyl, the patient should discuss it with their doctor or pharmacist.

• The vaginal tablets should not be swallowed, as policresulen may cause esophageal ulcers. In case of accidental swallowing of Albothyl, the patient should drink a large amount of water and immediately contact their doctor to avoid ulcers of the mouth, throat, and esophagus.
• Albothyl strongly stimulates the healing process. There is no reason to worry if necrotic tissue separates (even in large quantities) from diseased areas. This is a sign of the therapeutic effect of the medicine.
• Due to the risk of irritating action, during the use of the medicine, the patient should avoid using traditional soaps for intimate hygiene.
• During the use of Albothyl and for 7 days after its completion, the patient should not have sexual intercourse.
• The patient should protect their eyes from contact with the medicine. If the medicine comes into contact with the eyes, they should be rinsed immediately with water; it may be necessary to consult an ophthalmologist.
• Albothyl does not prevent HIV infections or other sexually transmitted diseases, such as gonorrhea or syphilis.
• If the medicine stains fabric or skin, the stained area should be rinsed immediately with water to prevent it from drying.
• Spots visible on the surface of the vaginal tablets result from the natural appearance of the tablet base and do not affect the efficacy and safety of the medicine.

Albothyl and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use.
The medicine is intended for local use. Since the risk of interaction with other medicines cannot be excluded, the patient should avoid using other vaginal medicines during treatment with Albothyl.

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.
The medicine can be used during pregnancy only with strictly defined indications (after prescription by a doctor) and after considering the risk resulting from the treatment for the mother and child.
There are no data on the penetration of the medicine into breast milk in nursing mothers.
Animal studies have not shown any effect on fertility disorders.

Driving and using machines

Albothyl does not affect the ability to drive and use machines.

3. How to use Albothyl

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Recommended dose
Depending on the severity of symptoms, 1 vaginal tablet per day or every other day. The vaginal tablets should be used at night.
The vaginal tablets should be used until the symptoms disappear, but no longer than for 9 days. If the symptoms do not disappear within this time or if the symptoms recur shortly after the end of treatment, the patient should consult their doctor.
Method of administration

For vaginal use.

To facilitate administration, the vaginal tablet can be moistened with water and then inserted deep into the vagina. Before inserting the vaginal tablet, the patient should lie on their back. Using sanitary pads allows avoiding staining of underwear and bedding.
If Albothyl is administered to the patient in a doctor's office, to keep the medicine in the correct position, a tampon should be used, which should be removed within 1 to 2 hours of inserting the vaginal tablet.

Using a higher dose of Albothyl than recommended

No symptoms of overdose have been observed.

Missing a dose of Albothyl

If it is almost time for the next scheduled dose, the patient should take it at the appropriate time.
The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are listed according to their frequency.
Very common(occurring in more than 1 in 10 patients):

• vaginal dryness.

Common(occurring in less than 1 in 10 patients):

• discharge of mucous membrane fragments.

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

• vaginal and vulvar candidiasis, vaginal and vulvar itching, vaginal discharge, feeling of vaginal and vulvar discomfort, vaginal and vulvar dryness, feeling of a foreign body;
• systemic allergic reactions;
• urticaria.

If serious local irritation symptoms occur, the patient should stop using the medicine and consult their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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 181 C, 02-222 Warsaw
Phone: +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 allow more information to be collected on the safety of the medicine.

5. How to store Albothyl

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the specified 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 needed. This will help protect the environment.

6. Contents of the packaging and other information

What Albothyl contains

• The active substance of the medicine is policresulen. 1 vaginal tablet contains 90 mg of policresulen.
• The other ingredients are: macrogol 4000, macrogol 1500, edetic acid.

What Albothyl looks like and what the pack contains

Albothyl is a vaginal tablet with a color ranging from creamy to reddish-brown.
The carton contains 6 vaginal tablets in 1 blister pack and a bag with polyethylene finger covers.

Marketing authorization holder

Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orifarm Healthcare Sp. z o.o.
ul. Przyokopowa 31
01-208 Warsaw
Poland
[email protected]

Manufacturer

Takeda GmbH
Byk-Gulden-Strasse 2
D-78467 Konstanz
Germany
Date of last revision of the leaflet:07/2023