Package Insert: Information for the User

Dalacin 100mg suppositories

Clindamicina

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

The name of your medication is Dalacin 100 mg suppositories. It is referred to as “Dalacin” in this leaflet.

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

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

Do not use Dalacin:

• if you are allergic to clindamycin, another antibiotic called lincomycin, or to 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 Dalacin:

• 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 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 medication in the following cases:

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

This medication should not be used in girls under 16 years old.

As with all vaginal infections, it is not recommended to maintain sexual relations during treatment with Dalacin. Dalacin can weaken condoms and diaphragms. Do not rely on condoms or diaphragms while using this treatment for the next 72 hours after treatment.

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

Use of Dalacin with other medications

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

Particularly, consult your doctor if you are taking:

• muscle relaxants, as Dalacin may increase the effect of these medications.

Pregnancy, breastfeeding, and fertility

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

This medication is not recommended during the first trimester of pregnancy, as there is not enough evidence of its safety.

If you are pregnant, your doctor 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 infant will ingest a significant amount of active ingredient through breast milk, if your baby experiences diarrhea with blood or any sign 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 ifthe aluminum foilthat containsthe vaginal capsulesis torn,openor not completely sealed.

You should be careful so that the capsule does not heat up, as it could soften or deform.

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

Insertion:

?Remove the capsule from its aluminum foil packaging.

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

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

Remember to wash your hands after using the capsules.

If you use more Dalacin than you should

Consult your doctor. Do not use any additional capsules 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 Dalacin

If you forgot to use a capsule 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 capsules normally

If you ingest Dalacin

If you swallow or ingest the capsule, contact your doctor. It is unlikely that the capsules will cause any harm, but your doctor may provide guidance 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 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 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 feeling of illness
• painful urination, blood in urine, cloudy or foul-smelling urine, increased urination frequency or urgency
• vaginal infection, vaginal discharge, irregular menstruation
• pain (at the application site), 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 25?°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 Dalacin

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

The other components are semi-synthetic solid glycerides

Appearance of the product and contents of the packaging

Dalacin is a white to off-white capsule. It is presented in

aluminum strips containing 3 capsules 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

Responsible for manufacturing:

Pfizer Service Company BV

Hoge Wei 10, Zaventem

B-1930

Belgium

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet 12/2022

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