Package Insert: Information for the Patient

Dalacin 300 mg Hard Capsules

Clindamicina

Read this entire package insert carefully before starting to use this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given 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.

1.What Dalacin hard capsules are and for what they are used

2.What you need to know before starting to use Dalacin hard capsules

3.How to use Dalacin hard capsules

4.Possible adverse effects

5.Storage of Dalacin hard capsules

6.Contents of the package and additional information

This medication belongs to a group of antibiotics called lincosamides.

It is used for the treatment of infections caused by bacteria in different parts of the body, in adults.

This medication is also used for the treatment of acute sinusitis (paranasal sinus infection),in children over 1 month and under 18 years old.

Do not use Dalacin hard capsules

• If you are allergic to clindamycin, lincomycin or any of the other ingredients of this medicine (listed in section 6).
• If in the past you have suffered from antibiotic-associated colitis

Warnings and precautions

• During treatment, allergic reactions or severe skin reactions may occur, in which case, treatment with Dalacin should be discontinued and appropriate treatment initiated.
• During treatment with this medicine or after it, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If so, treatment should be suspended and your doctor will put you on the treatment they consider most appropriate.
• If you have an inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, inform your doctor so that they can confirm whether you should use this medicine.
• Prolonged administration of this medicine may cause the growth of other microorganisms, especially fungi.
• If you are being treated with neuromuscular blockers (used to produce muscle paralysis, such as pancuronium, tubocurarine), inform your doctor, as clindamycin may potentiate the action of these medicines.
• If treatment with Dalacin is long, you should have blood tests and tests to evaluate your blood count and liver and kidney function performed periodically.
• Acute renal disorders may occur. Inform your doctor of any medication you are currently taking and if you have any kidney problems. If you experience decreased urine production, fluid retention causing swelling of legs, ankles or feet, shortness of breath or nausea, you should contact your doctor immediately.
• Due to the risk of esophageal inflammation (esophagitis) and esophageal ulcers, it is essential to take Dalacin capsules as indicated in section 3.

Children and adolescents

This medicine is not suitable for children who are unable to swallow the capsules whole.

The recommended dose in children over 1 month is 8 to 25 mg/kg/day divided into 3 or 4 equal doses, see section 3 for more information.

Use of Dalacin hard capsules with other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

You should inform your doctor if you are receiving any of the following medicines:

• Warfarin and other similar medicines, used to make the blood more fluid and prevent clots. There is a greater likelihood of bleeding when taking medicines with warfarin, so your doctor may need to perform regular blood tests to check your coagulation status.
• Neuromuscular blocking agent (such as pancuronium, tubocurarine), as its effect may be potentiated with the use of this medicine.
• Oral typhoid vaccine, as this is inactivated by the concurrent administration of antibacterial agents; Dalacin should not be administered in the 3 days before or after vaccination.
• Medicines that potentiate or inhibit the function of CYP3A4 and CYP3A5 isoenzymes, as their effect may increase or decrease the efficacy of this medicine (such as rifampicin).

Taking Dalacin hard capsules with food and drinks

The capsules can be taken with food, as the ingestion of food does not modify the absorption of Dalacin. It is recommended to take the capsules with a large glass of water to avoid possible esophageal irritation.

Pregnancy, breastfeeding and fertility

Pregnancy

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

Clindamycin crosses the placental barrier in humans. In clinical studies with pregnant women, systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are not enough controlled studies with pregnant women during the first trimester of pregnancy.

Therefore, clindamycin should not be used during pregnancy unless strictly necessary.

Breastfeeding

Clindamycin is excreted in breast milk after oral or intravenous administration. Due to the potential severe adverse reactions in the infant, such as diarrhea, blood in stool or rash, the use of clindamycin during breastfeeding is contraindicated.

Driving and operating machinery

The influence of this medicine on the ability to drive or operate machinery is negligible or insignificant.

Dalacin hard capsules contain lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

This medication is administered orally.

Your doctor will establish the most suitable dose and treatment duration for you, according to your condition and response to treatment.

Adults

The recommended dose in adults is 600 to 1,800 mg per day, divided into 2, 3, or 4 equal doses depending on the severity, location of the infection, and microorganism sensitivity. Your doctor will indicate the treatment schedule.

The treatment duration should be determined based on the type of infection and response, and should be as short as possible, generally 7 to 14 days.

The usual dosage in acute pharyngoamigdalitis and certain pneumonias is 300 mg, twice a day for 10 days.

Pelvic inflammatory disease: after intravenous treatment administered by a healthcare professional, 450-600 mg of clindamicin every 6 hours orally until completing 10-14 days (complete treatment (intravenous and oral administration).

Pneumonia in patients with HIV infection: 300-450 mg of clindamicina every 6 hours orally for 21 days. The treatment is performed in combination therapy with primaquine (15-30 mg/day orally).

Toxoplasma encephalitis in patients with HIV infection:600-1,200 mg of clindamicina every 6 hours orally or intravenously for 2 weeks.

After this period, 300-600 mg every 6 hours orally for 8-10 weeks is administered. The treatment is performed in combination therapy with pyrimethamine (25-75 mg/day orally) and folic acid (10-20 mg/day) with the highest doses of pyrimethamine.

Use in elderly patients

No dose adjustment is required in elderly patients with normal liver and renal function.

Use in patients with renal insufficiency

No dose adjustment is required in patients with renal insufficiency.

Use in patients with liver insufficiency

No dose adjustment is required in patients with liver insufficiency.

Use in children

The recommended dose in children over 1 month is 8 to 25 mg/kg/day divided into 3 or 4 equal doses. The clindamicina dose is calculated based on total body weight, regardless of obesity. This medication is indicated only in children who can swallow capsules. Capsules should be taken whole, which should be taken into account when administering the medication as it may not be suitable to provide the exact dose required for treatment in children.

Form of Administration

Dalacin hard capsules should be swallowed whole with a large glass of water and at least 30 minutes before lying down to avoid possible esophageal irritation.

If you take more Dalacin hard capsules than you should

In case of overdose, you may experience nausea, vomiting, diarrhea, or allergic reactions.

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

Information for the healthcare professional

In case of overdose, peritoneal dialysis or hemodialysis are not effective for eliminating the medication. Gastric lavage may be performed. Activated charcoal treatment and appropriate symptomatic treatment are recommended.

In case of an allergic reaction, standard emergency treatment including corticosteroids, adrenaline, and antihistamines should be applied.

If you forgot to take Dalacin

In case of missed dose, use the medication as soon as possible and continue treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one. Do not take a double dose to compensate for the missed dose. Continue using Dalacin as indicated by your doctor.

If you interrupt treatment with Dalacin

If you stop treatment with Dalacin before what your doctor has recommended, symptoms may worsen or reappear.

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

Like all medicines, Dalacin can have side effects, although not everyone will experience them.

Inform your doctor immediately if you experience:

• Fluid retention causing swelling in legs, ankles, or feet, difficulty breathing, or nausea.

The frequency of side effects observed in clinical trials was:

Frequent: may affect up to 1 in 10 people

• Pseudomembranous colitis.
• Diarrhea, abdominal pain.
• Abnormal liver function test results.

Rare: may affect up to 1 in 100 people

• Vomiting, nausea.
• Red rash on the skin with small bumps (maculopapular rash), red, raised, and itchy skin lesions (urticaria).

Unknown frequency (cannot be estimated from available data)

• Colitis caused by Clostridioides difficile, vaginal infection.
• Decreased white blood cells (agranulocytosis, neutropenia, leucopenia), decreased platelets (thrombocytopenia), increased eosinophils.
• Allergic reactions (anaphylactic shock), allergic reaction (anaphylactoid and anaphylactic reactions), hypersensitivity.
• Disrupted sense of taste (dysgeusia).
• Esophageal ulcer*, esophagitis*.
• Yellowing of skin and mucous membranes (jaundice).
• Severe skin reactions: toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), angioedema, dermatitis exfoliativa, dermatitis bullosa, erythema multiforme, pruritus, generalized morbilliform rash.

*Side effects that are more likely to occur if Dalacin hard capsules are taken lying down and/or with little water.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store below 30°C.

Store in the original packaging.

Keep out of sight and reach of children.

Do not use this medicine after the expiry date shown on the packaging..The expiry date is the last day of the month indicated.

Do not dispose of medicines through the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition

• The active ingredient is clindamicina. Each capsule contains 300 mg of clindamicina (as hydrochloride).
• The other components are: capsule content (lactose monohydrate, cornstarch, talc, and magnesium stearate) and capsule components (gelatin, erythrosine [E127], indigo carmine, indigotin [E132], and titanium dioxide [E171]).

Product Appearance and Packaging Content

It is presented as lavender-colored hard capsules with “CLIN 300” engraved on the body and the Pfizer logo on the cap, packaged in blisters. Each package contains 24 or 500 hard capsules.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization

Pfizer, S.L.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja.

28108, Alcobendas (Madrid). Spain.

Responsible for Manufacturing

Fareva Amboise.

Zone Industrielle, 29 route des Industries.

37530, Pocé-sur-Cisse. France.

Last Review Date of this Leaflet: September 2024

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