CLINDAMYCIN ARISTO 100 mg VAGINAL SUPPOSITORIES

Introduction

Package Leaflet: Information for the User

Clindamicina Aristo 100 mg Vaginal Tablets

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Clindamicina Aristo and what is it used for
2. What you need to know before taking Clindamicina Aristo
3. How to use Clindamicina Aristo
4. Possible side effects
5. Storage of Clindamicina Aristo
6. Package Contents and Additional Information

1. What is Clindamicina Aristo and what is it used for

The name of your medication is Clindamicina Aristo 100 mg vaginal tablets. It is referred to as "Clindamicina" in this package leaflet.

Clindamicina is a semi-solid vaginal tablet (vaginal suppository). When inserted into the vagina, it releases a medication called clindamicina (as phosphate). This medication belongs to a group of medications called "antibiotics".

Clindamicina is indicated for the treatment of a vaginal infection caused by bacteria, known as bacterial vaginosis.

2. What you need to know before taking Clindamicina Aristo

Do not use clindamicina

• if you are allergic to clindamicina, another antibiotic called lincomycin, or any of the other components of this medication (listed in section 6).
• if you have previously had colon inflammation (colitis) when taking antibiotics.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use clindamicina:

• if you have diarrhea or if you frequently experience diarrhea when taking antibiotics.
• if you have a history of inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.

If you experience severe, prolonged, or bloody diarrhea during or after using clindamicina, consult your doctor immediately, as it may be necessary to interrupt treatment. This can be a sign of intestinal inflammation (pseudomembranous colitis) that can occur after antibiotic treatment.

Please consult your doctor if you can take this medication in case of the following:

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

As with all vaginal infections, it is not recommended to have sexual intercourse during treatment with clindamicina. Clindamicina can weaken condoms and diaphragms. Do not rely on condoms or diaphragms as a contraceptive method while using this treatment for the following 72 hours after treatment.

It is not recommended to use other vaginal products, such as tampons or douches (vaginal washes), during treatment with the vaginal tablets.

Girls

Clindamicina should not be used in girls under 16 years old.

Using clindamicina with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

In particular, consult your doctor if you are taking:

• Muscle relaxants, as clindamicina may increase the action of these medications.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Clindamicina is not recommended during the first trimester of pregnancy, as there is insufficient evidence of its safety.

If you are pregnant, you should only use clindamicina after consulting your doctor, who will decide if this treatment is suitable for you.

If you are breastfeeding, your doctor will decide if clindamicina is appropriate for you, as the active ingredient may pass into breast milk.

Although it is unlikely that the infant will ingest a significant amount of the active ingredient through breast milk, if your baby experiences bloody diarrhea or any sign of illness, consult your doctor immediately. You should stop breastfeeding if this occurs.

Driving and Using Machines

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

3. How to use Clindamicina Aristo

Follow the exact instructions for administration of this medication as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Do not use this product if the aluminum wrapper containing the vaginal tablets is torn, open, or not fully sealed.

You should be careful not to heat the tablet, as it may soften or deform.

The recommended dose of this medication is one tablet inserted into the upper part of the vagina at bedtime, for 3 consecutive nights. After insertion, the tablet will melt and disappear.

Insertion:

• Remove the tablet from its aluminum wrapper.
• Lie on your back with your knees touching your chest.
• With the tip of your middle finger, insert the tablet into the vagina as deeply as possible without causing discomfort.

Remember to wash your hands after using the tablets.

If you use more clindamicina than you should

Consult your doctor. Do not use any more tablets until your doctor tells you to.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use clindamicina

If you forget to use a tablet and only a few hours have passed, use it immediately.

If it is almost time for your next tablet, do not use the missed tablet. Wait for the next scheduled dose and use it then.

Continue using your tablets as usual. Do not use a double dose to make up for the missed dose.

If you ingest clindamcina

If you swallow the tablet, contact your doctor. It is unlikely that the tablets will cause you any harm, but your doctor may give you advice on what to do.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Consult your doctor immediately if:

• you experience severe, persistent, or bloody diarrhea (which may be associated with stomach pain or fever). This is a rare side effect that can occur after antibiotic treatment and may be a sign of severe intestinal inflammation or pseudomembranous colitis.
• you experience a severe allergic reaction or skin reactions. These side effects are very rare.

Common (may affect up to 1 in 10 people)

• fungal infections, yeast infection
• headache
• stomach pain, diarrhea, nausea
• itching (in a different area than the application site)
• vaginal candidiasis, vaginal discomfort, vaginal disorder

Uncommon (may affect up to 1 in 100 people)

• vomiting
• rash
• upper stomach or back pain
• fever or chills, general malaise
• urinary pain, blood in the urine, cloudy or foul-smelling urine, increased frequency or urgency of urination
• vaginal infection, vaginal discharge, irregular menstrual periods
• pain (at the application site), itching, localized swelling

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Clindamicina Aristo

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be thrown away through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Clindamicina Aristo

• The active ingredient is clindamicina (as phosphate). Each tablet contains 100 mg of clindamicina (as clindamicina phosphate).

Appearance and Packaging of the Product

Clindamicina is a white to yellowish tablet. It is presented in white PVC-PE strips containing 3 tablets and packaged in cardboard boxes.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

HELP S.A.

Pedini Ioanninon

45500 Ioannina

Greece

Or

QUALIMETRIX S.A.

579 Mesogeion Avenue

Agia Paraskevi

15343 Attiki Athens

Greece

You can request more information about this medication from the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Germany Clindamycin Aristo 100 mg Vaginalzäpfchen

Spain Clindamicina Aristo 100 mg vaginal tablets

Poland Clindavag, 100 mg, globulki

Date of the Last Revision of this Package Leaflet: April 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/