Clindamycin Qualigen 300 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Clindamicin Qualigen 300 mg hard capsules EFG

Read the entire leaflet carefully before you start taking 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.

  • If you experience any adverse reactions, consult your doctor, even if these are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Clindamicin Qualigen is and what it is used for

2. What you need to know before taking Clindamicin Qualigen

3. How to take Clindamicin Qualigen

4. Possible side effects

   1. Storage of Clindamicin Qualigen

5. Package contents and additional information

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

This medicine belongs to a group of antibiotics known as lincosamides.

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

It is important that you follow your doctor's instructions regarding dosage, frequency, and duration of treatment.

Do not keep or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the sink or in household waste.

It is used to treat bacterial infections in various parts of the body in adults.

Additionally, this medicine is used for the treatment of acute sinusitis (infection of the paranasal sinuses) in children older than 1 month and under 18 years of age.

2. What you need to know before starting to take Clindamicina Qualigen

Do not use Clindamicina hard capsules

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

Warnings and precautions

• Allergic-type reactions (including anaphylactic reaction and shock) may occur during treatment. If this happens, you must stop treatment with Clindamicina and start appropriate treatment immediately.
• Symptoms suggesting antibiotic-associated colitis (diarrhea) may appear during or after treatment with this medicine. In such cases, treatment must be discontinued and your doctor will prescribe the most appropriate treatment.
• If you have an inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, inform your doctor so they can confirm whether you should use this medicine.
• Prolonged use of this medicine may lead to overgrowth of other microorganisms, particularly fungi.
• If you are being treated with neuromuscular blocking agents (used to induce muscle paralysis, such as pancuronium, tubocurarine), inform your doctor, as clindamycin may enhance the effects of these medicines.
• If treatment with Clindamicina is prolonged, periodic blood tests and assessments of blood counts, as well as liver and kidney function, should be performed.
• Acute kidney problems may occur. Inform your doctor about any medicines you are currently taking and if you have any kidney problems. If you experience reduced urine output, fluid retention causing swelling of the legs, ankles or feet, shortness of breath, or nausea, contact your doctor immediately.

Children and adolescents

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

The recommended dose for children over 1 month of age is 8 to 25 mg/kg/day divided into 3 or 4 equal doses; see section 3 for further details.

Taking Clindamicina hard capsules with other medicines

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

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

• Vitamin K antagonists (anticoagulants), as frequent blood coagulation tests must be prescribed.
• Neuromuscular blocking agents (such as pancuronium, tubocurarine), since their effects may be enhanced when used concomitantly with this medicine.
• Oral typhoid vaccine, as it becomes inactivated when administered concomitantly with antibacterial agents; Clindamicina should not be administered within 3 days before or after vaccination.

Taking Clindamicina hard capsules with food and drinks

The capsules may be taken with food, as food intake does not alter the absorption of clindamycin. It is recommended to take the capsules with a large glass of water to minimize the risk of 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 using this medicine.

Clindamycin crosses the placental barrier in humans. In clinical studies in 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 insufficient and well-controlled studies in pregnant women during the first trimester of pregnancy.

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

Breastfeeding

Clindamycin is excreted in human milk following oral or intravenous administration. Due to the potential for serious adverse reactions in the nursing infant, the use of clindamycin is contraindicated during breastfeeding.

Driving and operating machinery

The effect of this medicine on the ability to drive or operate machinery is negligible or none.

Clindamicina hard capsules contain lactose

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

3. How to take Clindamicina Qualigen

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor. If in doubt, consult your doctor or pharmacist.

This medicine is administered orally.

Your doctor will determine the most appropriate dose and duration of treatment for you, based on 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, site of infection, and microbial sensitivity. Your doctor will indicate the appropriate regimen to follow.

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

The usual dosage for acute pharyngotonsillitis and certain pneumonias is 300 mg twice daily for 10 days.

Pelvic inflammatory disease: after intravenous treatment administered by a healthcare professional, 450–600 mg of clindamycin every 6 hours orally, to complete a total treatment duration of 10–14 days (combined intravenous and oral therapy).

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

Toxoplasmic encephalitis in patients with HIV infection: 600–1,200 mg of clindamycin every 6 hours administered intravenously or orally for 2 weeks.

After this period, 300–600 mg every 6 hours orally for 8–10 weeks. The treatment is given in combination with pyrimethamine (25–75 mg/day orally) and folinic acid (10–20 mg/day), with higher doses of pyrimethamine.

Use in elderly patients

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

Use in patients with renal impairment

No dose adjustment is required in patients with renal impairment.

Use in patients with hepatic impairment

No dose adjustment is required in patients with hepatic impairment.

Use in children

The recommended dose in children over 1 month of age is 8 to 25 mg/kg/day divided into 3 or 4 equal doses. The capsules must be taken whole, which should be taken into account when administering the medicine.

If you take more Clindamicina 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 amount ingested.

Information for healthcare professionals

In case of overdose, peritoneal dialysis or hemodialysis are not effective in removing the drug. Gastric lavage may be performed. Administration of activated charcoal and appropriate symptomatic treatment are recommended.

If an allergic-type reaction occurs, standard emergency treatment should be applied, including corticosteroids, epinephrine, and antihistamines.

If you forget to take Clindamicina

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if it is almost time for the next dose, it is better to skip the missed dose and wait for the next scheduled dose. Do not take a double dose to make up for the missed dose. Continue using Clindamicina as directed by your doctor.

If you stop treatment with Clindamicina

If you discontinue treatment with Clindamicina before the time recommended by your doctor, symptoms may worsen or reappear.

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

4. Possible adverse effects

Like all medicines, Clindamycin may cause adverse effects, although not everyone experiences them.

Immediately inform your doctor if you experience:

• fluid retention causing swelling in the legs, ankles or feet, difficulty breathing or nausea

The frequency of occurrence of adverse effects during clinical trials was:

Common: may affect up to 1 in 10 people

• Abdominal pain, diarrhoea, pseudomembranous colitis.
• Abnormal liver function tests.

Uncommon: may affect up to 1 in 100 people

• Nausea, vomiting.
• Reddish skin rash with small spots (macules or papules) (maculopapular eruption), red raised itchy skin lesions (urticaria).

Frequency not known (cannot be estimated from available data)

• Vaginal infection.
• Decrease in white blood cells (agranulocytosis, leucopenia, neutropenia), decrease in platelets (thrombocytopenia), increase in a type of white blood cells (eosinophilia).
• Allergic reaction (anaphylactoid reaction), drug reaction with increased white blood cells (eosinophilia) and widespread symptoms (multiorgan involvement) (DRESS syndrome).
• Altered sense of taste.
• Oesophageal ulcer, oesophagitis.
• Yellowing of the skin and mucous membranes (jaundice).
• Skin adverse reactions which in some cases may be severe: skin and mucous membrane disease causing massive exfoliation and systemic toxicity (toxic epidermal necrolysis), skin disease causing blisters and painful sores on the skin and mucous membranes (Stevens-Johnson syndrome), red skin lesions and blisters on mucous membranes (erythema multiforme), skin eruptions with blisters and peeling (exfoliative dermatitis, vesicular dermatitis), itching.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

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

5. Storage of Clindamicin Qualigen

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

Store below 30°C. Keep in the original packaging to protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition

The active substance is clindamycin (as hydrochloride). Each capsule contains 300 mg of clindamycin (as hydrochloride).

The other components are: capsule contents (monohydrate lactose, corn starch, magnesium stearate and talc) and capsule components (titanium dioxide (E171), gelatin, and printing ink (shellac, black iron oxide (E-172), propylene glycol (E1520) and ammonium hydroxide (E527)).

Appearance of the product and contents of the container

White to opaque white hard capsules, size 0, marked with “CLIN 300”.

Alu/PVC blister pack in a cardboard box containing 24 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Holsten Pharma GmbH

Hahnstrasse 31-35,

Frankfurt/Main

Hessen - 60528

Germany

Date of the most recent revision of this leaflet: July 2021

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/ .