DALACIN 100 mg VAGINAL SUPPOSITORIES

Introduction

Leaflet: information for the user

Dalacin 100mg vaginal ovules

Clindamycin

Read the entire leaflet carefully before starting to take the medicine, as 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 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 leaflet. See section 4.

Contents of the leaflet:

1. What is Dalacin and what is it used for
2. What you need to know before using Dalacin
3. How to use Dalacin
4. Possible side effects
5. Storage of Dalacin

1. Package contents and additional information

1. What is Dalacin and what is it used for

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

Dalacin 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 called "antibiotics".

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.

It is essential that you follow the instructions regarding dosage, administration, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

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

2. What you need to know before using Dalacin

Do not use Dalacin:

• if you are allergic to clindamycin, another antibiotic called lincomycin, or any of the other components of this medicine (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 Dalacin:

• if you have diarrhea or if you frequently 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 using Dalacin, 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 medicine in case of the following:

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

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

As with all vaginal infections, it is not recommended to have sexual intercourse during treatment with Dalacin. Dalacin 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.

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

Using Dalacin with other medicines

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

In particular, consult your doctor if you are taking:

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of Dalacin is not recommended during the first trimester of pregnancy, as there is not enough evidence of its safety.

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

If you are breastfeeding, your doctor will decide if Dalacin is suitable for you, as the active ingredient may pass into breast milk. Although it is unlikely that the baby will ingest a significant amount of the active ingredient through breast milk, if your baby has diarrhea with blood 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 medicine will affect your ability to drive or use machines.

3. How to use Dalacin

Follow your doctor's instructions for administering this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

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

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

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

Insertion:

? Remove the ovule from its aluminum wrapper.

? Lie on your back with your knees touching your chest.

? With the tip of your middle finger, insert the ovule into the vagina as deeply as possible without causing discomfort.

Remember to wash your hands after using the ovules.

If you use more Dalacin than you should

Consult your doctor. Do not use any more ovules 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 medicine and the amount ingested.

If you forget to use Dalacin

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 ovule application, do not use it then. Wait for the next application and use it then.

Continue using your ovules normally

If you ingest Dalacin

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Consult your doctor immediately if:

• you have 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 inflammation of the lining of the large intestine (pseudomembranous colitis).
• you have 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 place other than the application site)
• vaginal candidiasis, vaginal discomfort, vaginal disorder

Uncommon (may affect up to 1 in 100 people)

• vomiting
• rash
• pain in the upper stomach or back
• fever or chills, general malaise
• painful urination, 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 leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dalacin

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

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

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Dalacin composition

• The active ingredient is clindamycin (as phosphate). Each ovule contains 100 mg of clindamycin (as clindamycin phosphate).

The other ingredients are semi-synthetic solid glycerides

Appearance of the product and package contents

Dalacin is a white or off-white ovule. It is presented in aluminum strips containing 3 ovules and is packaged in cardboard boxes.

Marketing authorization holder:

Holder:

Pfizer, S.L.

Avda. de Europa 20-B.

Parque Empresarial La Moraleja.

28108 (Alcobendas), Madrid

Manufacturer:

Pfizer Service Company BV

Hoge Wei 10, Zaventem

B-1930

Belgium

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet 12/2022

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