Prospect: information for the user

Clindamicina Qualigen 300 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, 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 effects, consult your doctor,even if they are not listed in this prospect. See section 4.

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

2.What you need to knowbefore starting to take Clindamicina Qualigen

3.How to take Clindamicina Qualigen

4.Possible adverse effects

1. Storage of Clindamicina Qualigen

6. Contents of the pack 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 (infection of the paranasal sinuses), in children over 1 month and under 18 years.

Do not use Clindamicina hard capsules

• If you are allergic to clindamicina, lincomicina or any of the other ingredients of this medicine (listed in section 6).
• If in the past you have suffered from colitis associated with the use of antibiotics

Warnings and precautions

• Allergic reactions (including anaphylactic reaction and shock) may occur during treatment, in which case, treatment with Clindamicina should be interrupted and appropriate treatment should be initiated.
• Symptoms suggesting antibiotic-associated colitis (diarrhea) may occur during or after treatment with this medicine. If this is the case, 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 paralysis in the muscle, such as pancuronio, tubocurarina), inform your doctor, as clindamicina may potentiate the action of these medicines.
• If treatment with Clindamicina is long, you should have blood tests and tests to evaluate your blood count and liver and kidney function 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.

Children and adolescents

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

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 Clindamicina 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:

• Anticoagulant (antagonist of vitamin K) as they should prescribe frequent blood coagulation tests.
• Neuromuscular blocking agent (such as pancuronio, tubocurarina), as its effect may be potentiated with the use of this medicine.
• Oral typhus vaccine as this is inactivated with the concomitant administration of antibacterial agents; Clindamicina should not be administered in the 3 days before or after vaccination.

Taking Clindamicina hard capsules with food and drinks

The capsules can be taken with food, as the ingestion of food does not modify the absorption of Clindamicina. 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.

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

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

Breastfeeding

Clindamicina is excreted in breast milk after oral or intravenous administration. Due to the potential for severe adverse reactions in the infant, the use of clindamicina is contraindicated during breastfeeding.

Driving and operating machinery

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

Clindamicina hard capsules contain lactose

If your doctor has indicated 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 sensitivity of the microorganism. Your doctor will indicate the treatment schedule to follow.

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 clindamicin 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 clindamicin 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 capsules should be taken whole, which should be taken into account when administering the medication.

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 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 should be applied, including corticosteroids, adrenaline, and antihistamines.

If you forgot to take Clindamicina

In case of forgotten 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 Clindamicina as indicated by your doctor.

If you interrupt the treatment with Clindamicina

If you abandon the treatment with Clindamicina 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 medications, Clindamicina may have adverse 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 adverse effects occurrence during clinical trials was:

Frequent: may affect up to 1 in 10 people

• abdominal pain, diarrhea, pseudomembranous colitis.
• liver function test abnormalities.

Rare: may affect up to 1 in 100 people

• nausea, vomiting.
• reddish rash on the skin with small bumps (maculopapular eruption), red, elevated, and itchy skin lesions (urticaria).

Unknown frequency (cannot be estimated from available data)

• vaginal infection.
• decreased white blood cells (agranulocytosis, leucopenia, neutropenia), decreased platelets (thrombocytopenia), increased eosinophils.
• allergic reaction (anaphylactoid reaction), drug reaction with increased eosinophils and generalized symptoms (DRESS syndrome).
• alteration of taste.
• esophageal ulcer, esophagitis.
• yellow discoloration of skin and mucous membranes (jaundice).
• severe skin reactions: toxic epidermal necrolysis, Stevens-Johnson syndrome, multiform erythema, vesicular dermatitis, exfoliative dermatitis, pruritus.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: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.

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

Do not use this medication after the expiration date that appears on the box. The expiration date is the last day of the month indicated.

Medications 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 at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition

The active principle is clindamicina (as hydrochloride). Each capsule contains 300 mg of clindamicina (in the form of hydrochloride).

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

Appearance of the product and contents of the packaging

Hard white opaque capsules, size 0, and engraved with “CLIN 300”.

Alu / PVC blister in a cardboard box with 24 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Holsten Pharma GmbH

Hahnstrasse31-35,

Frankfurt/Main

Hessen - 60528

Germany

Last review date of this leaflet: July 2021

The 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/.