CLINDAMYCIN NORMON 300 mg/2 ml INJECTABLE SOLUTION

2. What you need to know before you take Clindamicina Normon

Do not take Clindamicina Normon:

If you are allergic to clindamicina, lincomicina, or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• If you have a history of gastrointestinal disease, especially those accompanied by diarrhea. This medicine may worsen the diarrhea, evolving into acute colitis that may require suspension of treatment. Consult your doctor if you experience diarrhea during or after treatment with clindamicina.
• If you have intestinal stasis (constipation).
• If you have severe renal and/or hepatic dysfunction.
• If you receive prolonged therapy with clindamicina, you should undergo periodic check-ups.

Before starting treatment with clindamicina, inform your doctor if you have previously suffered from allergic reactions to medications.

Your doctor should continuously evaluate your condition, as the use of clindamicina phosphate may lead to an excessive growth of non-sensitive organisms.

Acute kidney 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 that causes swelling in your legs, ankles, or feet, shortness of breath, or nausea, you should contact your doctor immediately.

Children and adolescents

Benzyl alcohol has been associated with the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years of age unless indicated by your doctor or pharmacist. For dosage and treatment duration, see section 3. See information on excipients later.

Other medicines and Clindamicina Normon

Taking Clindamicina Normon with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

Clindamicina Normon interacts with the following medications:

• Some muscle relaxants (pancuronium, tubocurarine, suxamethonium) and some inhalation anesthetics (halothane, enflurane, isoflurane, diethyl ether).
• Other antibiotics such as erythromycin and aminoglycosides.
• Warfarin and similar medications, which are used to make blood more fluid and prevent thrombosis. There is a higher likelihood of bleeding when taking medications with warfarin, so your doctor may need to regularly perform blood tests to check your coagulation status.

Pregnancy and breastfeeding

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.

Driving and using machines

There is no evidence of negative effects on the ability to drive vehicles or use hazardous machinery.

Clindamicina Normon contains benzyl alcohol and sodium

This medicine contains 18 mg of benzyl alcohol in each vial.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious side effects, including respiratory problems ("gasping syndrome") in children. DO NOT administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it. This medicine should not be used for more than one week in children under 3 years of age unless indicated by your doctor or pharmacist.

This medicine contains approximately 17.2 mg of sodium (main component of table salt/cooking salt) in each vial. This is equivalent to 0.86% of the maximum recommended daily sodium intake for an adult.

3. How to take Clindamicina Normon

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is administered intravenously or intramuscularly.

Your doctor will decide the appropriate dosage and treatment duration for each type of condition.

Adults:Moderately severe infections: 1.2-1.8 g of clindamicina per day in 3 or 4 equal doses by intravenous or intramuscular route. Severe infections: 2.4-2.7 g of clindamicina per day in 2, 3, or 4 equal doses by intravenous or intramuscular route.

Very severe infections: The doses may be increased, although the maximum recommended dose is 2.7 g of clindamicina per day.

Use in children and adolescents

Children: Your doctor may prescribe the use of this medicine in children in case of strict necessity, despite containing benzyl alcohol as an excipient.

Newborns: 15-20 mg/kg of body weight per day in 3 or 4 equal doses by intravenous or intramuscular route. In premature infants with low weight, lower doses (15 mg/kg of body weight per day) may be sufficient.

Infants and older children: 20-40 mg/kg of body weight per day in 3 or 4 equal doses by intravenous or intramuscular route.

If you take more Clindamicina Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Clindamicina Normon

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

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

The frequencies of adverse reactions are defined as: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), and not known (cannot be estimated from the available data).

Very common: may affect more than 1 in 10 people.

• Gastrointestinal disorders:Diarrhea, which may be accompanied by the presence of blood and mucus in the stool.

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

• Blood disorders:Cases of both decreased and increased blood cell counts, such as white blood cells, as well as decreased platelet counts, have been reported.
• Allergic reactions:The most common is the appearance of skin lesions that can have a varied appearance (e.g., similar to measles) and can sometimes be severe. Redness of the skin may also occur. Other possible adverse reactions include itching, swelling of the face, and difficulty breathing.
• Gastrointestinal disorders:Nausea, vomiting, abdominal pain, flatulence (gas), and unpleasant metallic taste after intravenous administration of high doses.
• Hepatobiliary disorders:Jaundice (yellowing of the skin and mucous membranes) and alterations in liver enzymes (e.g., transaminases).
• Disorders of the skin and mucous membranes:Cases of itching and vaginitis (inflammation of the vagina) have been described, and rarely, cases of skin inflammation with peeling.
• Renal disorders:Some cases of increased urea in the blood, decreased urine production, and/or excess protein in the urine, which indicate renal dysfunction, have been observed.

Fluid retention that causes swelling in the legs, ankles, or feet, shortness of breath, or nausea.

• Cardiovascular disorders:Rarely, cases of cardiopulmonary collapse and hypotension (decreased blood pressure) have occurred after rapid intravenous administration. If you observe any of these reactions or any other reaction not described in this leaflet, consult your doctor or pharmacist.
• Local reactions:Pain, induration (hardening of tissues), and sterile abscess after intramuscular injection, and thrombophlebitis (formation of a blood clot with inflammation of veins) after intravenous infusion.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Clindamicina Normon

Before first opening: Store at a temperature below 25°C.

It is recommended not to store at low temperatures, as crystals may appear, which dissolve when heated with the hands and gently shaken.

After dilution: The diluted vials for intravenous administration remain stable for 24 hours at room temperature (25°C).

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

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

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6. Contents of the pack and further information

Composition of Clindamicina Normon

• The active substance is clindamicina. Each vial contains 300 mg of clindamicina (as phosphate).
• Each ml of diluted solution contains 150 mg of clindamicina (as phosphate).
• The other components are benzyl alcohol, sodium hydroxide, and water for injectable preparations.
• Each vial contains 18 mg of benzyl alcohol and approximately 17.2 mg of sodium.
• Each ml of diluted solution contains 9 mg of benzyl alcohol and approximately 8.6 mg of sodium.

Appearance of the product and pack contents

Clindamicina Normon 300 mg/2 ml is presented as a solution for injection in packs containing 1 vial or 100 vials of 2 ml. The vial contains a clear, colorless, or slightly yellowish solution.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos-Madrid (SPAIN)

Date of the last revision of this leaflet:July 2021.

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

This information is intended only for healthcare professionals

-Intravenous administration

Before intravenous administration as an infusion, the vials of clindamicina should be diluted in a compatible intravenous solution (5% glucose, 0.9% sodium chloride, or Ringer's lactate solution) to a concentration of clindamicina that does not exceed 12 mg/ml. Do not administer as a bolus.

Intermittent infusion

Intravenous intermittent infusion should be performed over at least 10 to 60 minutes. The concentration of clindamicina in the diluent should not exceed 12 mg/ml, and the infusion rate should not exceed 30 mg/minute. The usual infusion rates are as follows: 300 mg of clindamicina in 50 ml of diluent over 10 minutes; 600, 900, and 1,200 mg of clindamicina in 100 ml over 20, 30, and 45 minutes, respectively. It is not recommended to administer more than 1,200 mg in a single infusion of 1 hour.

Clindamicina should not be administered as a bolus.

Initial rapid infusion followed by maintenance infusion

Alternatively, the first dose of clindamicina can be administered as a rapid infusion (10 minutes or more), followed by continuous intravenous infusion as follows: to maintain serum clindamicina levels above 4 μg/ml, rapid infusion of 10 mg/minute over 30 minutes and maintenance infusion of 0.75 mg/minute; to maintain serum clindamicina levels above 5 μg/ml, rapid infusion of 15 mg/minute over 30 minutes and maintenance infusion of 1 mg/minute; to maintain serum clindamicina levels above 6 μg/ml, rapid infusion of 20 mg/minute over 30 minutes and maintenance infusion of 1.25 mg/minute.

-Intramuscular administration

It is not recommended to administer more than 600 mg in a single injection by this route.

Clindamicina phosphate is physically incompatible with ampicillin, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

The validity period once the vial has been diluted is 24 hours at room temperature (25°C).