Leaflet: information for the user

Clindamicina Aristo 100 mg suppositories

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

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

2. What you need to know before starting to use Clindamicina Aristo

3. How to use Clindamicina Aristo

4. Possible side effects

5. Storage of Clindamicina Aristo

6. Contents of the pack and additional information

The name of your medicine is Clindamicina Aristo 100 mg vaginal suppositories. It is referred to as “Clindamicina” in this leaflet.

Clindamicina is a semi-solid vaginal suppository. When inserted into the vagina, it releases a medicine called clindamycin (as phosphate). This medicine belongs to a group of drugs called “antibiotics”.

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

No use clindamicina

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use clindamicina:

• If you have diarrhea or if you habitually have 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 taking clindamicina, consult your doctor immediately, as it may be necessary to discontinue treatment. This can be a sign of intestinal inflammation (pseudomembranous colitis) that can occur after antibiotic treatment.

Please consult your doctor if the following applies to you:

• If you have kidney, liver, or immune system problems.
• If you are under 16 years or over 65 years of age.

As with all vaginal infections, it is not recommended to have sex during clindamicina treatment. 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 vaginal douches during clindamicina treatment with the suppositories.

Girls

Clindamicina should not be used in girls under 16 years of age.

Use of clindamicina with other medications

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

Particularly, 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 or breastfeeding, think you may be pregnant, or plan to become 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, your doctor will decide if clindamicina treatment is suitable for you.

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

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

Driving and operating machinery

This medication is unlikely to affect your ability to drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Do not use this product if the aluminum foil packaging containing the vaginal suppositories is torn, open, or not completely sealed.

You should be careful so that the suppository does not get warm, as it could soften or deform.

The recommended dose of this medication is one suppository placed in the upper part of the vagina at bedtime, for 3 consecutive nights. After insertion, the suppository will dissolve and disappear.

Insertion:

• Remove the suppository from its aluminum foil packaging.
• Lie on your back with your knees bent and your chest touching your thighs.
• Using the tip of your middle finger, insert the suppository into the vagina as deeply as possible without causing discomfort.

Remember to wash your hands after using the suppositories.

If you use more clindamicina than you should

Consult your doctor. Do not use any additional suppositories until your doctor tells you to.

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

If you forgot to use clindamicina

If you forgot to use a suppository and only a few hours have passed, use it immediately.

If there is little time left before your next scheduled application, do not use it then. Wait for the next application and use it then.

Continue using your suppositories normally. Do not use a double dose to compensate for the missed dose.

If you ingest clindamicina

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

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

Like all medications, this medication may produce adverse effects, although not all people 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 adverse effect that may occur after antibiotic treatment and may be a sign of severe intestinal inflammation or inflammation of the large intestine lining (pseudomembranous colitis).
• you experience a severe allergic reaction or skin reactions. These adverse effects are very rare.

Frequent (may affect up to 1 in 10 people)

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

Rare (may affect up to 1 in 100 people)

• vomiting
• hives
• upper stomach or back pain
• fever or chills, general discomfort
• painful urination, blood in urine, cloudy or foul-smelling urine, increased urination frequency or urgency
• vaginal infection, vaginal discharge, irregular menstruation
• local pain, itching, localized swelling

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Store below 30 C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Clindamicina Aristo

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

clindamicina (as clindamicina phosphate).

• The other components are solid semisynthetic glycerides

Appearance of the product and content of the container

Clindamicina is a white to yellowish capsule. It is presented in white strips of

PVC-PEcontaining 3 capsules and packaged in cardboard boxes.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible for manufacturing

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 by contacting the local representative of the holder of the marketing authorization:

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 with the following names:

GermanyClindamycin Aristo 100 mg Vaginalzäpfchen

SpainClindamicina Aristo 100 mg capsules

PolandClindavag, 100 mg, globulki

Last review date of this prospectus: April 2020

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/