Clindamycin Aristo 100 mg ovules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clindamicina Aristo 100 mg vaginal ovules

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

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

Contents of the leaflet

1. What Clindamicina Aristo is and what it is used for
2. What you need to know before using Clindamicina Aristo
3. How to use Clindamicina Aristo
4. Possible adverse effects
5. How to store Clindamicina Aristo
6. Contents of the pack and other information

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

The name of your medicine is Clindamicina Aristo 100 mg vaginal ovules. It is referred to as "Clindamicina" in this leaflet.

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

Clindamycin is indicated for the treatment of a bacterial infection of the vagina known as bacterial vaginosis.

2. What you need to know before using Clindamicina Aristo

Do not use clindamicine

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use clindamycin:

• if you have diarrhoea or usually develop diarrhoea when taking antibiotics.
• if you have a history of inflammatory bowel disease such as Crohn's disease or ulcerative colitis.

If you develop severe, persistent or bloody diarrhoea during or after treatment with clindamycin, consult your doctor immediately, as you may need to stop treatment. This could be a sign of intestinal inflammation (pseudomembranous colitis) which may occur following antibiotic treatment.

Please consult your doctor if you are unsure whether you can take this medicine if any of the following apply to you:

• if you have kidney or liver problems or disorders of the immune system.
• if you are under 16 or over 65 years of age.

As with all vaginal infections, sexual intercourse is not recommended during treatment with clindamycin. Clindamycin may weaken condoms and diaphragms. Do not rely on condoms or contraceptive diaphragms while using this treatment and for 72 hours after treatment.

The use of other vaginal products such as tampons or douches (vaginal washes) is not recommended during treatment with the vaginal suppositories.

Girls

Clindamycin must not be used in girls under 16 years of age.

Taking clindamycin with other medicines

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

In particular, consult your doctor if you are taking:

• Muscle relaxants, as clindamycin may increase the effect of these medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of clindamycin during the first trimester of pregnancy is not recommended, as there is insufficient evidence regarding its safety.

If you are pregnant, you should only use clindamycin after consulting your doctor, who will decide whether this treatment is appropriate for you.

If you are breast-feeding, your doctor will decide whether clindamycin is suitable for you, as the active substance may pass into breast milk.

Although it is unlikely that the infant will ingest a large amount of active substance through breast milk, if your baby develops bloody diarrhoea or any signs of illness, consult your doctor immediately. You must stop breast-feeding if this occurs.

Driving and using machines

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

3. How to use Clindamicina Aristo

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Do not use this product if the aluminium foil wrapping containing the vaginal ovules is torn, open, or not completely sealed.

Take care to avoid exposing the ovule to heat, as it may soften or become deformed.

The recommended dose of this medicine is one ovule placed high in the vagina at bedtime, for 3 consecutive nights. After insertion, the ovule will melt and disappear.

Insertion:

• Remove the ovule from its aluminium foil wrapper.
• Lie on your back with your knees drawn up towards your chest.
• Using the tip of your middle finger, insert the ovule as far as possible into the vagina without causing discomfort.

Remember to wash your hands after using the ovules.

If you use more clindamycin than you should

Consult your doctor. Do not use any additional ovules until your doctor tells you to do so.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use clindamycin

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

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

Continue using your ovules as normally prescribed. Do not use a double dose to make up for a forgotten dose.

If you swallow clindamycin

If you accidentally swallow or eat the ovule, contact your doctor. The ovules are unlikely to cause you any harm, but your doctor can advise you on what to do.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Consult your doctor immediately if:

• you develop severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is an uncommon adverse effect that may occur after treatment with antibiotics and could be a sign of severe intestinal inflammation or inflammation of the lining of the large intestine (pseudomembranous colitis).
• you experience a severe allergic reaction or skin reactions. These adverse effects are very rare.

Common (may affect up to 1 in 10 people)

• fungal infections, yeast infection
• headache
• stomach pain, diarrhoea, nausea
• itching (in an area different from the application site)
• vaginal candidiasis, vaginal discomfort, vaginal disorder

Uncommon (may affect up to 1 in 100 people)

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clindamicina Aristo

Keep this medicine out of 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 indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be handed over to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clindamicina Aristo

• The active substance is clindamycin (as phosphate). Each vaginal suppository contains 100 mg of
  clindamycin (as clindamycin phosphate).

• The other components are solid semisynthetic glycerides.

Appearance of the product and contents of the container

Clindamicina Aristo is a vaginal suppository of whitish to yellowish colour. It is supplied in white PVC-PE blisters containing 3 suppositories, packed 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850 Torrejón de Ardoz
Madrid, Spain

This medicinal product 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 óvulos
Poland: Clindavag, 100 mg, globulki

Date of the most recent review of this leaflet: April 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/