Lincocin 600 mg injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lincocin 600 mg injection solution

Lincomycin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

2. What you need to know before using Lincocin injection solution

3. How to use Lincocin injection solution

4. Possible side effects

5. Storage of Lincocin injection solution

6. Contents of the pack and other information

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

Lincocin is an antibiotic belonging to the lincosamide group.

It is used in adults for the treatment of bacterial infections in different parts of the body.

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

2. What you need to know before using Lincocin injectable solution

Do not take Lincocin:

• If you are allergic to the active substance (lincomycin), clindamycin, or any of the other ingredients of this medicine (listed in section 6).
• If you have meningitis.
• If you have previously had antibiotic-associated colitis.
• During breastfeeding.
• In newborn infants under one month of age.

Warnings and precautions

• Allergic-type reactions (including anaphylactic reaction, shock) may occur during treatment. Cases of severe skin reactions, which may be life-threatening, have also been reported with lincomycin treatment, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).

Both SJS and TEN may initially appear as reddish, target-like spots or circular lesions, often with central blisters, typically on the trunk. Additionally, ulcers may develop in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These serious rashes are often preceded by fever or flu-like symptoms. The rashes may progress to widespread skin peeling and potentially life-threatening complications.

AGEP presents as a widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Most commonly affected areas: skin folds, trunk, and upper limbs.

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

• Symptoms suggesting antibiotic-associated colitis (diarrhea) may occur during or after treatment with this medicine. If this occurs, discontinue treatment with Lincocin and inform your doctor, who will initiate appropriate therapy.
• If you have or have had an inflammatory gastrointestinal disease such as Crohn's disease or ulcerative colitis, discuss this with your doctor to confirm whether you should use this medicine.
• Prolonged administration of lincomycin 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 lincomycin may enhance the effects of these medicines.
• During prolonged treatment, periodic blood tests and assessments of liver and kidney function, as well as blood counts, should be performed. Use with caution in patients with renal or hepatic impairment.
• Inform your doctor if you are scheduled for any diagnostic tests, as this medicine may interfere with plasma alkaline phosphatase levels.

Children and adolescents

This medicine is not suitable for neonates under 1 month of age.

Other medicines and Lincocin

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

Tell your doctor if you are taking any of the following medicines:

• Neuromuscular blocking agents (such as pancuronium, tubocurarine), as lincomycin may enhance the effects of these medicines.
• Kaolin-pectin, as it reduces gastrointestinal absorption of lincomycin. If kaolin is administered, there should be an interval of at least 2 hours before administering lincomycin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Lincomycin crosses the placental barrier in humans. There are insufficient and well-controlled studies in pregnant women.

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

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

Breastfeeding

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

Fertility

There are no data on the effect of lincomycin on fertility when administered in humans.

Driving and using machines

No studies on the ability to drive and use machines have been conducted.

Lincocin injectable solution contains benzyl alcohol

This medicine contains 18.9 mg of benzyl alcohol per 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 the body and cause adverse effects (metabolic acidosis).

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

Do not administer this medicine to your newborn (up to 4 weeks of age) unless specifically advised by your doctor.

This medicine should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.

3. How to use Lincocin injectable solution

Follow exactly the instructions for administration of this medicine given by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

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

This medicine will be administered by a doctor or other healthcare professional as an intramuscular bolus injection or by infusion (into a vein).

Adults

Intramuscular administration:

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

Intravenous infusion:

Lincocin must be diluted in 5% glucose, 5% glucose with 0.9% sodium chloride, or Ringer's solution and administered over a period of not less than 1 hour. Serious cardio-pulmonary reactions have occurred after administration of the drug at concentrations and infusion rates higher than 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 further information on dilution and infusion rates, see the information for healthcare professionals at the end of this leaflet.

Use in patients with renal impairment

In patients with mild or moderate renal impairment, caution should be exercised, considering the possibility of reducing the frequency of administration.

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

Use in patients with hepatic impairment

In these patients, consideration should be given to reducing the frequency of administration.

Use in children and adolescents

Children from 1 month to 12 years of age and adolescents

Intramuscular administration:

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

Intravenous infusion:

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

Children under 1 month of age

Safety and efficacy in children under 1 month of age have not been established. No data are available.

If you take more Lincocin injectable solution than you should

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

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

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

If you forget to take Lincocin injectable solution

Since this medicine is administered under supervision, it is very unlikely that a dose will be forgotten. If you think a dose of your treatment has been missed, inform your doctor or nurse. Do not take a double dose to make up for missed doses.

If you stop treatment with Lincocin injectable solution

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

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

4. Possible adverse effects

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

Common: may affect up to 1 in 10 people

• Diarrhea, nausea, vomiting.

Uncommon: may affect up to 1 in 100 people

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

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

• Itching (pruritus).

Frequency not known (cannot be estimated from available data)

• Decrease in white blood cells (agranulocytosis, neutropenia, leukopenia), red blood cells and platelets (pancytopenia), aplastic anemia (the bone marrow does not produce enough new blood cells), destruction of platelets (thrombocytopenic purpura).
• Allergic skin reactions of anaphylactic type, skin swelling (angioedema), serum sickness.
• Respiratory and cardiac arrest.
• Decreased blood pressure, formation of blood clots that may block one or more veins (only after intravenous infusion administration).
• Abdominal discomfort, pseudomembranous colitis, ulcerative colitis (Clostridium difficile colitis).
• Yellowing of the skin and mucous membranes (jaundice), abnormalities in liver function tests.
• Skin disorders, which in some cases may be severe: peeling of large areas of skin (toxic epidermal necrolysis), causing blisters and painful 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 fluid) (acute generalized exanthematous pustulosis) (see section 2).
• Skin blisters (bullous dermatitis), skin eruptions with blistering and peeling (exfoliative dermatitis), red skin lesions and blisters on mucous membranes (erythema multiforme).
• Abscess at injection site, pain and/or irritation at injection site following intramuscular injection.

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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lincocin injectable solution

This medicine does not require any special storage conditions.

After dilution: this medicine should be administered immediately; however, diluted solutions should be kept below 30°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. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lincocin injectable solution

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

Appearance of the product and contents of the pack

Type I colorless glass vial with a capacity of 2 ml, fitted with a bromobutyl rubber stopper and an aluminium "flip-off" cap made of polypropylene.

Each pack 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

Date of the most recent review of this leaflet: 06/2023

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

Information for healthcare professionals:

Dilution and infusion rates for Lincocin injectable solution.

These doses may be repeated as frequently as required according to the severity of the infection, up to the recommended maximum daily dose limit of 8 grams of lincomycin.