Simbactin

Package Leaflet: Information for the User

Symbactin, 100 mg, Vaginal Tablets

Clindamycin

Read the Package Leaflet Carefully Before Using the Medicinal Product

• Keep this package 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. 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 inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Symbactin and What is it Used For
• 2. Important Information Before Using Symbactin
• 3. How to Use Symbactin
• 4. Possible Side Effects
• 5. How to Store Symbactin
• 6. Contents of the Package and Other Information

1. What is Symbactin and What is it Used For

This medicinal product is called Symbactin, 100 mg, vaginal tablets, and will be referred to as Symbactin throughout this leaflet.
Symbactin is a semi-solid vaginal tablet for vaginal use. After insertion into the vagina, it releases a substance called clindamycin phosphate. Clindamycin belongs to a group of medicines called antibiotics.
Symbactin is used to treat bacterial vaginal infections, also known as bacterial vaginosis.

2. Important Information Before Using Symbactin

When Not to Use Symbactin:

• if you are allergic to clindamycin, another antibiotic - lincomycin, or any of the other ingredients of this medicinal product (listed in section 6);
• if you have ever had inflammation of the colon after using antibiotics.

Warnings and Precautions

Before using Symbactin, discuss with your doctor or pharmacist:

• if you have diarrhea or if you usually experience diarrhea after using antibiotics;
• if you have ever had inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.

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If you experience severe, prolonged, or bloody diarrhea during or after treatment with Symbactin, you should consult your doctor immediately, as treatment may need to be discontinued. This could be a sign of intestinal inflammation (pseudomembranous colitis), a complication of antibiotic treatment.
Before using Symbactin, consult your doctor if:

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

Symbactin should not be used in children and adolescents under 16 years old.
As with all vaginal infections, it is not recommended to have sexual intercourse during treatment with Symbactin. Symbactin can reduce the effectiveness of condoms and diaphragms, so do not rely on them during treatment and for the next 72 hours after completing treatment.
It is not recommended to use vaginal products such as vaginal tampons and douches during treatment with Symbactin.

Symbactin and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. In particular, inform your doctor about:

• muscle relaxants, as Symbactin may enhance their effects.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicinal product.
Symbactin should not be used during the first three months of pregnancy, as there is not enough data on the safety of its use during this period.
Symbactin may only be used during pregnancy if your doctor decides that it is necessary for you.
Since the active substance of Symbactin may pass into breast milk, your doctor will decide whether you can use this medicinal product while breast-feeding.
It is unlikely that the baby will receive a significant amount of the active substance through breast milk. However, if the baby experiences bloody diarrhea or other symptoms, consult your doctor immediately. In such cases, breast-feeding should be discontinued.

Driving and Using Machines

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

3. How to Use Symbactin

Always use this medicinal product exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
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Do not use this medicinal product if the blisters containing the vaginal tablets are torn, open, or not fully closed.
Do not store the vaginal tablets at high temperatures, as heat may soften and deform them.
The recommended dose is one vaginal tablet, which should be inserted deep into the vagina, in the evening before bedtime, for 3 consecutive days. After application, the vaginal tablet will dissolve and disintegrate completely.

Insertion of the Vaginal Tablet:

• remove the vaginal tablet from the blister;
• lie on your back with your knees bent towards your chest;
• insert the vaginal tablet into the vagina with the tip of your middle finger as far as possible without causing discomfort.

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

Overdose of Symbactin

If you have taken more than the recommended dose, consult your doctor immediately.
Do not use more vaginal tablets than recommended, unless your doctor tells you to.

Missed Dose of Symbactin

If you miss a dose and it is only a few hours late, use the medicinal product as soon as possible.
If it is almost time for the next dose, skip the missed dose and use the next dose at the usual time.
Make sure to use the vaginal tablets at the same time every day.
Do not use a double dose to make up for a missed dose.

Accidental Ingestion of Symbactin

If you swallow a vaginal tablet, consult your doctor. This is not a health risk, but your doctor will advise you on what to do in this situation.
If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.

4. Possible Side Effects

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

• severe, prolonged, or bloody diarrhea (which may be accompanied by abdominal pain or fever). This is an uncommon side effect that may occur after antibiotic treatment and may be a sign of serious intestinal inflammation or colitis (pseudomembranous colitis);
• a severe allergic reaction or skin reactions. These are very rare side effects.

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

• fungal infections, thrush;
• headache;
• abdominal pain, diarrhea, nausea;

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• itching (in areas 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, feeling unwell (lack of energy);
• painful urination, blood in urine, cloudy or foul-smelling urine, increased frequency of urination or sudden urge 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 inform your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
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 medicinal product.

5. How to Store Symbactin

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month.
Store in a temperature below
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 Package and Other Information

What Symbactin Contains

• The active substance is clindamycin phosphate. Each vaginal tablet contains 100 mg of clindamycin as clindamycin phosphate.
• The other ingredient is: solid fat.

What Symbactin Looks Like and Contents of the Package

Symbactin is a white to yellowish vaginal tablet. The vaginal tablets are packed in white, soft PVC/PE blisters. The carton contains 3 vaginal tablets.

Marketing Authorization Holder and Manufacturer

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Marketing Authorization Holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Manufacturer

HELP S.A., Pedini Ioanninon, 45500 Ioannina, Greece
QUALIMETRIX S.A., 579 Mesogeion Avenue, 15343 Agia Paraskevi, Athens, Greece
Date of Last Revision of the Package Leaflet:June 2025
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