Clindavag

Package Leaflet: Information for the Patient

Clindavag, 100 mg, Vaginal Tablets

Clindamycin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Clindavag and what is it used for

The name of this medicine is Clindavag, 100 mg, vaginal tablets. The medicine in this leaflet is called Clindavag.
Clindavag is a semi-solid vaginal tablet that is inserted into the vagina. After insertion, the medicine called clindamycin phosphate is released.
Clindavag belongs to a group of medicines called antibiotics.
Clindavag is used to treat bacterial vaginal infections, also known as bacterial vaginosis.

2. Important information before using Clindavag

When not to use Clindavag

• If you are allergic to clindamycin, another antibiotic - lincomycin, or any of the other ingredients of this medicine (listed in section 6).
• If you have ever had colitis after taking antibiotics.

Warnings and precautions

Before starting to use Clindavag, discuss it with your doctor.

• If you have diarrhea or usually get diarrhea when taking antibiotics.
• If you have ever had an inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.

If you experience severe, prolonged, or bloody diarrhea after using or after using Clindavag, you should immediately consult your doctor, as it may be necessary to discontinue treatment. These symptoms may indicate colitis (pseudomembranous colitis), which can occur after antibiotic treatment.
You should discuss the use of this medicine with your doctor if:

• You have kidney, liver, or immune system problems.
• You are under 16 or over 65 years old.

As with all vaginal infections, it is not recommended to have sexual intercourse while using Clindavag. Clindavag may weaken the effectiveness of condoms and diaphragms. You should not rely on the effectiveness of condoms or diaphragms if you use them within 72 hours after treatment.
It is not recommended to use other vaginal products, such as tampons or douches, while being treated with vaginal tablets.

Children

Clindavag should not be used in children under 16 years old.

Clindavag and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about the medicines you plan to take.
In particular, tell your doctor if you are taking:

• Muscle relaxants, as Clindavag may increase the effect of such medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Clindavag should not be used during the first three months of pregnancy, as there is limited data on its safety during this period.
If you are pregnant, Clindavag should only be used after careful discussion with your doctor, who will decide whether the treatment is suitable for you.
If you are breastfeeding, your doctor will decide whether Clindavag is suitable for you, as the active substance may pass into breast milk.
Although it is unlikely that a breastfed baby will take a significant amount of the active substance from the milk it drinks, if the baby experiences bloody diarrhea or any signs of illness, you should immediately tell your doctor. In such cases, you should stop breastfeeding.

Driving and using machines

It is unlikely that the medicine will affect your ability to drive or use machines.

3. How to use Clindavag

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Do not use the medicine if the blister with the vaginal tablet is torn, open, or not fully closed.
Make sure the vaginal tablet does not get too hot, as heat can cause the tablet to soften and become deformed.
The recommended dose is one vaginal tablet, which should be inserted deep into the vagina, every evening, at bedtime, for 3 consecutive days. After application, the tablet will dissolve and disappear.

Inserting the vaginal tablet:

• Remove the vaginal tablet from the blister.
• Lie on your back with your knees bent towards your chest.
• Using the tip of your middle finger, insert the vaginal tablet into the vagina as far as it will go without causing discomfort.

Always wash your hands before and after inserting the vaginal tablet.

Using more Clindavag than prescribed

If you have taken more than the prescribed dose, contact your doctor immediately.
Do not use more vaginal tablets than prescribed without consulting your doctor.

Missing a dose of Clindavag

If it has been a few hours since you missed a dose, use the medicine as soon as you remember. If it is almost time for the next dose, skip the missed dose.
Take the next dose at the usual time.
Make sure to use the vaginal tablets at the same time every day.
Do not take a double dose to make up for a missed dose.

If you swallow Clindavag

If the vaginal tablet has been swallowed, contact your doctor. It is unlikely that the tablet will cause any harm, but your doctor will advise you what to do in such cases.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clindavag can cause side effects, although not everybody gets them.
Tell your doctor immediately if:

• You develop severe, persistent, or bloody diarrhea (which may be associated with abdominal pain or fever). This is an uncommon side effect that can occur after antibiotic treatment and may be a sign of serious colitis or pseudomembranous colitis.
• You experience severe allergic reactions or skin reactions. These are very rare side effects.

Common (may affect up to 1 in 10 people):

• fungal infections, yeast infections
• headache
• abdominal pain, diarrhea, nausea (feeling sick)
• itching (in a place other than the application site)
• vaginal thrush, discomfort in the vagina, vaginal disturbances.

Uncommon (may affect up to 1 in 100 people):

• vomiting
• rash
• upper abdominal pain or back pain
• fever or chills, nausea (feeling unwell)
• pain when urinating, blood in the urine, cloudy or foul-smelling urine, increased frequency of urination or sudden need to urinate
• vaginal infection, vaginal discharge, irregular menstrual bleeding
• pain (at the application site), itching, local swelling.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. You can also report side effects 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
You can also report side effects 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 Clindavag

Keep this medicine out of the sight and reach of children.
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.
Store in a temperature below 30°C.
Medicines should 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 Clindavag contains

• The active substance is clindamycin phosphate. Each vaginal tablet contains clindamycin phosphate equivalent to 100 mg of clindamycin.
• The other ingredients are: solid fat.

What Clindavag looks like and contents of the pack

Clindavag is a white to yellowish vaginal tablet. 3 vaginal tablets in a white PVC/PE blister pack, packed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw

Manufacturer

HELP S.A.
Pedini Ioanninon
45500 Ioannina
Greece
QUALIMERIX S.A.
579 Mesogeion Avenue
15343 Agia Paraskevi Athens
Greece
Date of last revision of the leaflet:June 2024

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://urpl.gov.pl