DALACIN 300 mg HARD CAPSULES

2. What you need to know before you take Dalacin hard capsules

Do not take Dalacin hard capsules

• If you are allergic to clindamycin, lincomycin, or any of the other ingredients of this medicine (listed in section 6).
• If you have ever had 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 suggesting antibiotic-associated colitis (diarrhea) may appear. If this is the case, treatment should be suspended and your doctor will prescribe the most suitable treatment.
• If you have an inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, inform your doctor so that he 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 enhance the effect of these medicines.
• If treatment with Dalacin is prolonged, you should have regular blood tests and checks to assess your blood count and liver and kidney function.
• Acute kidney problems may occur. Inform your doctor about any medication you are currently taking and if you have any kidney problems. If you experience decreased urine production, fluid retention that causes swelling of the 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 always 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.

Using Dalacin hard capsules with other medicines

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

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

• Warfarin and similar medicines, which are used to make the blood more fluid and prevent blood clots. There is a greater risk of bleeding when taking medicines with warfarin, so your doctor may need to regularly check your blood coagulation.
• Neuromuscular blocking agents (such as pancuronium, tubocurarine), as their effect may be enhanced by the use of this medicine.
• Oral typhoid vaccine, as it is inactivated by the concomitant administration of antibacterial agents; Dalacin should not be administered in the 3 days prior to or after vaccination.
• Medicines that enhance or inhibit the function of the 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 food intake 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking 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 anomalies. There are no sufficient and well-controlled studies with pregnant women during the first trimester of pregnancy.

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

Breastfeeding

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

Driving and using machines

The influence of this medicine on the ability to drive or use machines is negligible or nonexistent.

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.

3. How to take Dalacin hard capsules

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor. If you are unsure, consult your doctor or pharmacist.

This medicine is administered orally.

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

Adults

The recommended dose in adults is 600 to 1800 mg per day, divided into 2, 3, or 4 equal doses, depending on the severity, location of the infection, and sensitivity of the microorganism. Your doctor will indicate the regimen to follow.

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

The usual dosage for acute pharyngitis and certain pneumonias is 300 mg, 2 times a day for 10 days.

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

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

Toxoplasmic encephalitis in patients with HIV infection: 600-1200 mg of clindamycin every 6 hours intravenously or orally for 2 weeks.

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

Use in elderly patients

No dose adjustment is necessary in elderly patients with normal liver and kidney function.

Use in patients with renal insufficiency

No dose adjustment is necessary in patients with renal insufficiency.

Use in patients with hepatic insufficiency

No dose adjustment is necessary in patients with hepatic 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 dose of clindamycin is calculated based on total body weight, regardless of obesity. This medicine is indicated only in children who can swallow capsules. The capsules should be taken whole, which should be taken into account when administering the medicine, as it may not be suitable for providing the exact dose needed for treatment in children.

Method of administration

Dalacin hard capsules should be taken 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 Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

Information for the healthcare professional

In case of overdose, peritoneal dialysis or hemodialysis is not effective in eliminating the medicine. Gastric lavage may be performed. Treatment with activated charcoal and implementation of adequate symptomatic treatment is recommended.

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

If you forget to take Dalacin

In case of a missed dose, use the medicine as soon as possible and continue with the 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 make up for the missed dose. Continue using Dalacin as indicated by your doctor.

If you stop taking Dalacin

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

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

4. Possible side effects

Like all medicines, Dalacin can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience:

• Fluid retention that causes swelling in the legs, ankles, or feet, difficulty breathing, or nausea.

The frequency of adverse reactions during clinical trials was:

Common: may affect up to 1 in 10 people

• Pseudomembranous colitis.
• Diarrhea, abdominal pain.
• Abnormal liver function tests.

Uncommon: may affect up to 1 in 100 people

• Vomiting, nausea.
• Reddish skin rash with small grains (macules or papules), skin lesions that are red, elevated, and itchy (urticaria).

Frequency not known (cannot be estimated from the available data)

• Clostridioides difficile-associated colitis, vaginal infection.
• Decreased white blood cell count (agranulocytosis, neutropenia, leucopenia), decreased platelet count (thrombocytopenia), increased white blood cell count (eosinophilia).
• Allergic reactions (anaphylactic shock), allergic reaction (anaphylactoid and anaphylactic reaction), hypersensitivity.
• Alteration of taste (dysgeusia).
• Esophageal ulcers*, esophageal inflammation*.
• Yellowing of the skin and mucous membranes (jaundice).
• Skin reactions that can be severe: a skin and mucous membrane disease that causes massive exfoliation and systemic toxicity (toxic epidermal necrolysis), a skin disease that causes blisters and painful ulcers on the skin and mucous membranes (Stevens-Johnson syndrome), a drug reaction with increased white blood cell count and generalized symptoms (DRESS syndrome), red lesions on the skin, angioedema (swelling under the skin), skin eruptions with blisters and peeling (exfoliative dermatitis, bullous dermatitis), blisters on the mucous membranes (erythema multiforme), itching, generalized skin eruption of variable form, extension, and distribution (morbilliform eruption).

*Adverse effects that are more likely to occur if Dalacin hard capsules are taken in a lying position and/or with little water.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dalacin hard capsules

Store below 30°C.

Keep in the original packaging.

Keep out of the sight and reach of children.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Further information

Composition

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

Appearance and packaging

It is presented as hard capsules of lavender color, engraved with "CLIN 300" on the body and the Pfizer logo on the cap, packaged in blisters. Each pack contains 24 or 500 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pfizer, S.L.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja.

28108, Alcobendas (Madrid). Spain.

Manufacturer

Fareva Amboise.

Zone Industrielle, 29 route des Industries.

37530, Pocé-sur-Cisse. France.

Date of the last revision of this leaflet: September 2024

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