Prospecto:Information for the User

Lincocin 600 mg injectable solution

Lincomycin

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

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

-This medicine has been prescribedonlyto you, and you should 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 or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Lincocin injectable solution and for what it is used

2.What you need to knowbeforestarting touse Lincocin injectable solution

3.How to use Lincocin injectable solution

4.Possible adverse effects

5Storage of Lincocin injectable solution

6. Contents of the package and additional information

Lincocin is an antibiotic that belongs to the group of lincosamides.

It is used in adults to treat infections caused by bacteria in different parts of the body.

In children over 1 month of age, it is used to treat acute exacerbation of chronic bacterial sinusitis (infection in the paranasal sinuses).

Do not take Lincocin:

• If you are allergic to the active ingredient (lincomycin), clindamycin, or any of the other components of this medication (listed in section 6).
• If you have meningitis.
• If you have had a history of antibiotic-associated colitis.
• During breastfeeding.
• In newborns under one month of age.

Warnings and precautions

• During treatment, allergic reactions (including anaphylactic shock) may occur. Severe skin reactions, which can be life-threatening, have also been reported, including Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and acute generalized pustular psoriasis (PEGA).

Both SSJ and NET may initially appear as red spots similar to a bull's-eye or circular spots with central blisters on the torso. Additionally, ulcers may occur in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe eruptions are often preceded by fever or flu-like symptoms. The eruptions may progress to widespread skin peeling and potentially fatal complications.

PEGA appears as a generalized scaly red rash with bumps under the skin and blisters, accompanied by fever. Common locations: primarily in skin folds, the trunk, and upper limbs.

If you experience a severe rash or any of these skin symptoms, stop taking this medication and inform your doctor or seek immediate medical attention.

• During or after treatment with this medication, symptoms may occur that suggest antibiotic-associated colitis (diarrhea). If this occurs, discontinue treatment with Lincocin and inform your doctor, who will initiate the appropriate treatment.
• If you have or have had an inflammatory gastrointestinal disease, such as Crohn's disease or ulcerative colitis, inform your doctor before using this medication.
• Prolonged administration of lincomycin may lead to the growth of other microorganisms, particularly fungi.
• If you are taking neuromuscular blockers (used to induce muscle paralysis, such as pancuronium or tubocurarine), inform your doctor, as lincomycin may potentiate the action of these medications.
• During prolonged treatment, periodic blood tests and liver, kidney, and blood function tests should be performed. Use with caution in patients with renal and hepatic insufficiency.
• If you are scheduled for a diagnostic test, as it may interfere with plasma levels of alkaline phosphatase.

Children and adolescents

This medication is not suitable for neonates under one month of age.

Other medications and Lincocin

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

Inform your doctor if you are taking any of the following medications:

• Neuromuscular blockers (such as pancuronium or tubocurarine), as lincomycin may potentiate the action of these medications.
• Calcium carbonate-pectin, as it may decrease the gastrointestinal absorption of lincomycin. If calcium carbonate is administered, there should be an interval of at least 2 hours before using lincomycin.

Pregnancy,breastfeedingand fertility

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

Pregnancy

Lincomycin crosses the placental barrier in humans.No sufficient and well-controlled studies have been conducted in pregnant women.

Therefore, this medication should not be used during pregnancy except in cases where it is strictly necessary.

This medication contains benzyl alcohol, which may cross the placenta (see section 3).

Breastfeeding

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

Fertility

No data are available on the effect of lincomycin on fertility when administered to humans.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery.

Lincocin injectable solution contains benzyl alcohol

This medication contains 18.9 mg of benzyl alcohol in each vial, equivalent to 9.45 mg/ml.

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 a 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.

Follow exactly the administration instructions of this medication as indicated by your pharmacist or nurse.This medication should be administered exactly as directed by your pharmacist or nurse.In case of doubt, ask your doctor, pharmacist, or nurse.

The duration of treatment should be determined based on the type of infection and response, and should be as short as possible, generally 7 to 14 days.In infections caused by beta-hemolytic streptococci, treatment should be maintained for at least 10 days.

This medication will be administered to you by a doctor or other healthcare professional through an intramuscular bolus injection or through infusion (by perfusion within a vein)

Adults

Administration by intramuscular injection:

The recommended dose is 600 mg every 24 hours. In case of severe infections, the dose may be increased to 600 mg every 12 hours.

Infusion by intravenous perfusion:

Lincocin should be diluted in 5% glucose,5% glucose with 0.9% sodium chlorideor Ringer's solution and administered for a period of not less than 1 hour. Severe cardiopulmonary reactions have been reported after administration of the drug at concentrations and rates higher than those recommended.

The recommended dose is 600 mg to 1 g every 8 – 12 hours. Depending on the severity of the infection, the dose may be increased up to a maximum recommended dose of 8 g of lincomycin. For more information on dilution and infusion rates, see the information for healthcare professionals at the end of this leaflet.

Use in patients with renal insufficiency

In patients with mild or moderate renal insufficiency, it should be used with caution, considering the possibility of reducing the frequency of administration.

In patients with severe renal insufficiency, the appropriate dose is 25% to 30% of the recommended dose for patients with normal renal function.

Use in patients with hepatic insufficiency

In these patients, the possibility of reducing the frequency of administration should be considered.

Use in children and adolescents

Children from 1 month to 12 years of age and adolescents

Administration by intramuscular injection:

The recommended dose is 10 mg/kg/day in a single intramuscular injection. In case of severe infections, the dose may be increased to 10 mg/kg/day every 12 hours.

Infusion by intravenous perfusion:

The recommended dose is 10 to 20 mg/kg/day divided into administrations every 8 – 12 hours, depending on the severity of the infection (for more information on dilution and infusion rates, see the information for healthcare professionals at the end of this leaflet).

Children under 1 month

The safety and efficacy in children under 1 month have not been established. There are no available data.

If you take more Lincocin injectable solution than you should

If you think you may have been given more Lincocin than you should, inform your doctor or nurse.

Haemodialysis and peritoneal dialysis do not effectively remove lincomycin from the blood.

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.

If you forget to take Lincocin injectable solution

Since this medication is administered under supervision, it is very unlikely that a dose will be forgotten. If you think you may have forgotten to administer a dose of treatment, inform your doctor or nurse. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Lincocin injectable solution

If you abandon treatment with this medication before what your doctor has recommended, symptoms may worsen or reappear.

If you have any other doubts about the use of thismedication, ask your doctor,orpharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent: can affect up to 1 in 10 people

• Diarrhea, nausea, vomiting.

Less frequent: can affect up to 1 in 100 people

• Vaginal infection.
• Skin rash, red, elevated, and itchy skin lesions (urticaria).

Rare: can affect up to 1 in 1,000 people

• Itching (pruritus).

Unknown frequency (cannot be estimated from available data)

• Decreased white blood cells (agranulocytosis, neutropenia, leucopenia), red blood cells, and platelets (pancytopenia), aplastic anemia (bone marrow does not produce enough new blood cells), platelet destruction (thrombocytopenic purpura).
• Allergic skin reactions of anaphylactic type, skin swelling (angioedema), serum disease.
• Cardiorespiratory arrest.
• Decreased blood pressure, formation of clots that can obstruct one or more veins (only after administration as intravenous infusion).
• Abdominal discomfort, pseudomembranous colitis, ulcerative colitis (colitis caused by Clostridium difficile).
• Yellow discoloration of the skin and mucous membranes (jaundice), liver function test abnormalities.
• Dermatological diseases that in some cases can be severe: large areas of skin peeling (toxic epidermal necrolysis), causing painful blisters and sores on the skin and mucous membranes (Stevens-Johnson syndrome), a skin rash characterized by the rapid appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow liquid) (acute generalized pustular psoriasis) (see section 2).
• Blisters on the skin (bullous dermatitis), skin eruptions with blisters and peeling (exfoliative dermatitis), red skin lesions and blisters on mucous membranes (erythema multiforme).
• Injection site abscess, pain and/or irritation at the injection site after intramuscular injection.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special conservation conditions.

After dilution of the medication: this medication should be administered immediately; however, diluted solutions should be kept below 30°C.

Maintainthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthepackageafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines that you do not need at the SIGREpoint of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. By doing so, you will help protect the environment.

Composition of Lincocin injectable solution

• The active ingredient is lincomycin. Each vial contains 600 mg of lincomycin (as hydrochloride).
• The other components are: benzyl alcohol (E1519) and water for injection preparations.

Appearance of the product and contents of the packaging

Clear glass vial, type I, 2 ml capacity with a bromobutyl rubber stopper and an aluminum cap with a polipropylene flip-off tab.

Each package contains 1 vial.

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

Pfizer Manufacturing Belgium N.V.

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium.

Last review date of thisleaflet:06/2023

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/.

Information for healthcare professionals:

Dilution and infusion rates of Lincocin injectable solution.

These doses may be repeated as required based on the severity of the infection, up to the maximum daily dose of 8 grams of lincomycin.