Package Insert: Information for the Patient

Clindamicina Normon 600 mg/4 ml Injectable Solution EFG

Clindamicina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

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

This medication belongs to a group of antibiotics called lincosamides.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.

It is essential to follow the instructions regarding dosage, administration, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have leftover antibiotics after completing treatment, return them to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

Clindamicina is an antibiotic indicated for the treatment of severe localized infections in the lower respiratory tract, skin and soft tissues, abdomen, bones and joints, blood, and genitourinary tract.

Additionally, clindamicina, in combination with other medications, is effective in treating the following infections:

- Toxoplasma encephalitis in patients with HIV infection.

- Pneumonia caused by Pneumocystis carinii in patients with HIV infection.

Do not take Clindamicina Normon:

If you are allergic to clindamicin, lincomycin or any of the other components of this medication (listed in section 6).

Warnings and precautions

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

- If you have a history of gastrointestinal disease, especially those accompanied by diarrhea. This medication may worsen the diarrheal condition, evolving into acute colitis that may require suspension of treatment. Consult your doctor if you experience diarrhea during or after treatment with clindamicin.

- If you suffer from intestinal stasis (constipation).

- If you have severe renal and/or hepatic dysfunction.

- If you receive prolonged therapy with clindamicin, you should undergo periodic examinations.

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

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

Acute renal disturbances 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 must contact your doctor immediately.

Children and adolescents

Benzyl alcohol has been associated with the risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children.

Do not administer this medication to your newborn (up to 4 weeks of age) unless your doctor recommends it.

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

Other medications and Clindamicina Normon

Taking Clindamicina Normon with other medications. Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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 other similar medications, used to make blood more fluid and prevent clots. There is a higher risk of bleeding when taking medications with warfarin, so your doctor may need to perform regular blood tests to check your coagulation status.

Pregnancy and breastfeeding

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

Driving and operating machinery

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

Clindamicina Normon contains benzyl alcohol and sodium.

This medication contains 36 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 may accumulate in your body and cause adverse effects (metabolic acidosis).

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

Benzyl alcohol has been associated with the risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children. Do not administer this medication to your newborn (up to 4 weeks of age) unless your doctor recommends it. This medication should not be used for more than one week in children under 3 years of age unless your doctor or pharmacist advises it.

This medication contains approximately 34.6 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 1.73% of the recommended daily maximum sodium intake for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is administered via intravenous or intramuscular route.

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

Adults:Moderately severe infections: 1.2-1.8 g of clindamicin per day in 3 or 4 equal doses via intravenous or intramuscular route. Severe infections: 2.4-2.7 g of clindamicin per day in 2, 3, or 4 equal doses via intravenous or intramuscular route. Very severe infections: Doses may be increased, although the maximum recommended dose is 2.7 g of clindamicin per day.

Use in children and adolescents

Children:Your doctor may prescribe the use of this medication 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 via intravenous or intramuscular route. In premature infants with low birth weight, lower doses (15 mg/kg of body weight per day) may be sufficient.

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

If you use more Clindamicina Normon than you should

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

If you forgot to takeClindamicina Normon

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 unknown frequency (cannot be estimated from available data).

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

• Gastrointestinal alterations:Diarrhea, possibly accompanied by the presence of blood and mucus in stools

Unknown frequency (cannot be estimated from available data)

• Blood disorders:Cases of both decreased and increased levels of certain blood cells, such as white blood cells, as well as decreased platelets, have been reported.
• Allergic reactions:The most common is the appearance of skin lesions that can have a varied appearance (for example, similar to measles) and, on occasion, can be severe. Redness of the skin may also occur. Other possible adverse reactions are itching, facial swelling, and difficulty breathing.
• Gastrointestinal alterations:Nausea, vomiting, abdominal pain, flatulence (gas), and a metallic, unpleasant taste after intravenous administration of high doses.
• Hepatobiliary alterations:Jaundice (yellowing of the skin and mucous membranes) and alterations of liver enzymes (for example, transaminases).
• Skin and mucous membrane alterations:Cases of itching and vaginitis (vaginal inflammation) and, rarely, cases of skin inflammation with peeling have been described.

Renal alterations:Some cases of increased urea in the blood, decreased urine output, and/or excessive protein in the urine, indicating renal dysfunction, have been observed.

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

• Cardiovascular alterations:Rarely, some cases of cardiopulmonary collapse and hypotension (low blood pressure) have occurred after too rapid intravenous administration. If any of these reactions or any other reaction not described in this leaflet are observed, consult a 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 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 can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://wwwnotificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Before the 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 warmed with the hands and gently agitated.

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

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

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

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Clindamicina Normon

• The active ingredient is clindamicina. Each vial contains 600 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 36 mg of benzyl alcohol and approximately 34.6 mg of sodium.
• Each ml of diluted solution contains 4.5 mg of benzyl alcohol and approximately 4.3 mg of sodium.

Appearance of the product and contents of the package

Clindamicina Normon 600 mg/4 ml is presented as an injectable solution in containers with 1 vial or 100 vials of 4 ml. The vial contains a transparent, colorless, or slightly yellowish solution.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this prospectus:July 2021

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

This information is intended solely for healthcare professionals

-Intravenous administration

Before its intravenous administration in the form of perfusion, the vials of clindamicina must be diluted in a compatible intravenous solution (5% glucose, 0.9% sodium chloride, or Ringer lactate solution) to a clindamicina concentration that does not exceed 12 mg/ml. Do not administer in a bolus.

Intermittent perfusion

Intravenous perfusion should be performed in at least 10 to 60 minutes. The clindamicina concentration in the diluent should not exceed 12 mg/ml, and the perfusion percentage should not exceed 30 mg/minute. The usual perfusion percentages are as follows: 300 mg of clindamicina in 50 ml of diluent for 10 minutes; 600, 900, and 1,200 mg of clindamicina in 100 ml for 20, 30, and 45 minutes, respectively. Do not recommend administering more than 1,200 mg in a single infusion of 1 hour.

Clindamicina should not be administered in a bolus.

Initial and unique rapid perfusion followed by maintenance perfusion

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

-Intramuscular administration

Do not recommend administering more than 600 mg in a single injection by this route.

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

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