Lincocin

Package Leaflet: Information for the User

Lincocin, 300 mg/ml, Solution for Injection and Infusion

Lincomycin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Lincocin and what is it used for
• 2. Important information before using Lincocin
• 3. How to use Lincocin
• 4. Possible side effects
• 5. How to store Lincocin
• 6. Contents of the pack and other information

1. What is Lincocin and what is it used for

Lincocin is an antibiotic belonging to the lincosamide group.
Depending on the susceptibility of bacteria and the concentration of the medicine, Lincocin may act bactericidally or bacteriostatically.
Lincocin is indicated for the treatment of severe infections caused by susceptible anaerobic bacteria, as well as those caused by susceptible streptococci or staphylococci:

• infections of the upper respiratory tract, including tonsillitis, otitis media;
• infections of the lower respiratory tract, including aspiration pneumonia, empyema, and lung abscess;
• skin and soft tissue infections;
• bone and joint infections, including osteomyelitis;
• septicaemia.

Your doctor will prescribe Lincocin if the use of other antibiotics is inappropriate or contraindicated, or if treatment with other antibiotics is ineffective.

2. Important information before using Lincocin

When not to use Lincocin

• If you are allergic to lincomycin, clindamycin, or any of the other ingredients of this medicine (listed in section 6).
• In premature infants or newborns.

Warnings and precautions

Before starting treatment with Lincocin, discuss with your doctor, pharmacist, or nurse if you have any of the following conditions.

• If you are hypersensitive to penicillin. During treatment with Lincocin, you may experience hypersensitivity reactions (e.g., rash, itching, hives, swelling, difficulty breathing). You should then seek medical help immediately (adrenaline, oxygen, and steroids may need to be administered intravenously, and airway management or even intubation may be necessary).
• If you have a history of gastrointestinal disease, especially colitis.
• If you are suspected of having meningitis. Lincomycin does not penetrate the cerebrospinal fluid sufficiently.
• If you have severe kidney or liver impairment, with metabolic disorders. During treatment with high doses of the medicine, your doctor may recommend monitoring lincomycin blood levels. Liver and kidney function should also be monitored in case of prolonged treatment with Lincocin.
• If you are receiving neuromuscular blocking agents (e.g., tubocurarine, pancuronium, vecuronium) concurrently.
• If you have a tendency to allergies.

If you experience any of the following symptoms during treatment with Lincocin, tell your doctor immediately.

• If you develop diarrhoea, especially severe and persistent, during or after treatment, you should consult your doctor. Pseudomembranous colitis (in most cases caused by enterotoxins of Clostridium difficile) should be suspected. This disease, which is a complication of antibiotic therapy, can have a variable course: from mild, watery diarrhoea to a severe, chronic diarrhoea with leukocytosis, severe spastic abdominal pain, and possibly with a mixture of mucus and blood in the stool. In extreme cases, it can be life-threatening, especially in elderly or debilitated patients. Your doctor will recommend immediate discontinuation of the medicine and appropriate treatment (oral metronidazole or, in severe cases, vancomycin). You should not take anti-peristaltic medicines or other constipating medicines. Recurrence of the disease is possible despite appropriate treatment.
• Diarrhoea associated with Clostridium difficile infection, with a course ranging from mild to toxic megacolon and potentially life-threatening, has been reported with the use of almost all antibacterial agents, including Lincocin. Antibacterial therapy alters the normal flora of the colon, leading to overgrowth of C. difficile. In all patients who develop diarrhoea after antibiotic therapy, the presence of C. difficile infection should be considered. Diarrhoea associated with C. difficile has been reported even after more than two months after the administration of antibacterial agents.
• If you experience symptoms of a superinfection - the use of antibiotics may cause overgrowth of non-susceptible microorganisms, especially fungi.

Patients treated with Lincocin have reported severe hypersensitivity reactions, including anaphylactic reactions and severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and erythema multiforme. If you experience an anaphylactic reaction or severe skin reaction, you should discontinue Lincocin and receive appropriate treatment.

Lincocin and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Lincocin may enhance the effect of neuromuscular blocking agents used in general anaesthesia.
Microorganisms resistant to clindamycin are also resistant to Lincocin (cross-resistance).
Lincomycin may affect the results of the alkaline phosphatase test in blood serum, causing them to be elevated.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Lincomycin crosses the placenta.
Benzyl alcohol present in the Lincocin solution, as an excipient, may cross the placenta [see section 2 "Lincocin contains benzyl alcohol (E 1519)"].
There are limited data on the use of Lincocin in pregnancy. Lincocin should only be used during pregnancy if your doctor considers it necessary.
Lincomycin is excreted in human milk. You should not use Lincocin while breastfeeding.
There are no data on the effect of Lincocin on fertility.

Driving and using machines

The effect of Lincocin on the ability to drive and use machines has not been studied.

Lincocin contains benzyl alcohol (E 1519)

Lincocin solution for injection and infusion contains 18.9 mg of benzyl alcohol per vial, which corresponds to 9.45 mg of benzyl alcohol per ml.
Benzyl alcohol may cause allergic reactions.
Do not administer Lincocin to young children (under 3 years) for more than one week without consulting a doctor or pharmacist.
Patients with kidney or liver disease, pregnant or breastfeeding women should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

3. How to use Lincocin

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse.

Intramuscular administration Adults

• 600 mg every 24 hours;
• Severe infections: 600 mg every 12 hours (or more frequently) depending on the severity of the infection symptoms.

Children (over 1 month)

• 10 mg/kg body weight per day in a single injection;
• Severe infections: 10 mg/kg body weight per day every 12 hours or more frequently.

Intravenous administration

Lincomycin should not be administered undiluted by rapid intravenous injection.
The medicine should be administered by infusion lasting at least 60 minutes (see section "Information intended for healthcare professionals only").
Adults

• From 600 mg to 1 g every 8 to 12 hours;
• Severe infections: doses may be increased;
• In life-threatening infections, doses up to 8 g per day may be used.

Children (over 1 month)
Intravenous infusion may be administered at a dose of 10 to 20 mg/kg body weight per day, depending on the severity of the infection symptoms.
The daily dose in children is administered in divided doses.
The medicine should not be administered to premature infants or newborns.

Method of administration

Lincocin can be administered as often as necessary until the maximum daily dose of lincomycin, which is 8 g per day, is reached.
For instructions on dilution, rate of administration, and incompatibilities, see section "Information intended for healthcare professionals only".

Duration of treatment

In streptococcal infections, treatment should be continued for at least 10 days.

Dosage in patients with renal or hepatic impairment

In patients with renal or hepatic impairment, your doctor will consider the possibility of reducing the frequency of Lincocin administration.
If treatment with lincomycin is necessary in patients with severe renal failure, the recommended dose is 25% to 35% of the dose recommended for patients with normal renal function.

Overdose of Lincocin

If you have taken more than the recommended dose of the medicine, seek medical attention immediately.
In case of overdose, symptoms such as abdominal pain, nausea, vomiting, and diarrhoea may occur.
There is no specific antidote. Haemodialysis or peritoneal dialysis is not effective in removing Lincocin from the blood.

Missed dose of Lincocin

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

4. Possible side effects

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

Common side effects (occurring in less than 1 in 10 patients)

• diarrhoea, nausea, vomiting

Uncommon side effects (occurring in less than 1 in 100 patients)

• rash, urticaria
• vaginal infection

Rare side effects (occurring in less than 1 in 1,000 patients)

• pruritus

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

• pseudomembranous colitis, Clostridium difficile infection
• pancytopenia, agranulocytosis, aplastic anaemia, neutropenia, leucopenia, thrombocytopenia
• anaphylactic reactions, angioedema, serum sickness-like reaction
• cardiac arrest and respiratory arrest
• hypotension, thrombophlebitis
• oesophagitis, abdominal discomfort
• jaundice, abnormal liver function tests
• toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, bullous dermatitis, erythema multiforme
• sterile abscess at the injection site, induration at the injection site, pain at the injection site, irritation at the injection site
• a. Rare cases have been reported after too rapid intravenous administration.
• b. After parenteral administration, especially after too rapid administration.
• c. The event has been reported after intravenous administration.
• d. The event has been reported after oral administration.
• e. The events have been reported after intramuscular administration.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides,
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lincocin

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging after "Expiry date (EXP)". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lincocin contains

• The active substance of the medicine is lincomycin in the form of hydrochloride. 1 ml of the solution contains 300 mg of lincomycin.
• The other ingredients of the medicine are: benzyl alcohol (E 1519) [see section 2 "Lincocin contains benzyl alcohol (E 1519)"], water for injections.

What Lincocin looks like and contents of the pack

A glass vial containing 2 ml of solution for injection and infusion (600 mg of lincomycin), sealed with a rubber stopper and an aluminium flip-off cap, in a cardboard box.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium

Manufacturer

Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium

For more information about this medicine, contact your local representative of the marketing authorisation holder:

Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of last revision of the leaflet:

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the URL: https://www.pfizer.pl/ulotka-lincocin-roztwor and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocides http://www.urpl.gov.pl .

Information intended for healthcare professionals only

Dilutions and rate of administration

The basis for calculating the degree of dilution of intravenous doses is a solution of lincomycin that contains 1 g of the product in at least 100 ml of the appropriate solution and is administered intravenously for at least one hour.

Warning

When the rate of intravenous administration or the concentration of lincomycin was higher than recommended, severe respiratory and cardiovascular disorders were observed.

Incompatibilities

Novobiocin, kanamycin, and phenytoin are physically incompatible with lincomycin when administered together.