Lincomycin

Patient Information Leaflet

Lincocin, 500 mg capsules
Lincomycinum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

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

Leaflet Contents

1. What Lincocin is and what it is used for
2. What you need to know before taking Lincocin
3. How to take Lincocin
4. Possible side effects
5. How to store Lincocin
6. Contents of the pack and other information

1. What Lincocin is and what it is used for

Lincocin is an antibiotic belonging to the lincosamide group.
Depending on bacterial sensitivity and drug concentration, Lincocin may exert bactericidal or bacteriostatic effects.
Lincocin is indicated for the treatment of serious infections caused by sensitive anaerobic bacteria, as well as infections caused by sensitive streptococci or staphylococci:

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

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

2. Important information before using Lincocin

When not to use Lincocin

• If the patient is allergic to lincomycin, clindamycin, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Lincocin, discuss with your doctor, pharmacist, or
nurse if any of the following situations apply to the patient.

• If the patient is hypersensitive to penicillin. Hypersensitivity reactions (e.g. rash, itching, skin eruption, swelling, shortness of breath) may occur during treatment with Lincocin. In such case, seek immediate medical help (adrenaline, oxygen, and intravenous corticosteroids may be required, and possibly airway management or even intubation).
• If the patient has previously suffered from gastrointestinal disorders, particularly colitis.
• If meningitis is suspected. Lincomycin does not adequately penetrate into the cerebrospinal fluid.
• If the patient has severe impairment of kidney and/or liver function associated with metabolic disturbances. During high-dose therapy, the doctor may recommend monitoring of lincomycin blood levels. Kidney and liver function should also be monitored during prolonged treatment with Lincocin.
• If the patient is concurrently receiving neuromuscular blocking agents (muscle relaxants used in general anaesthesia), such as tubocurarine, pancuronium, vecuronium.
• If the patient has a tendency towards allergies.

If any of the following symptoms occur during treatment with Lincocin, the patient should
immediately inform the doctor.

• If diarrhoea develops during treatment or within several weeks after its completion, especially if it is severe and persistent, the patient should seek immediate medical advice. Pseudomembranous colitis should be suspected (in most cases caused by enterotoxins of Clostridium difficile bacteria). This condition, a complication of antibiotic therapy, may vary in severity: from mild, watery diarrhoea to a severe, chronic diarrhoea associated with leukocytosis, intense spasmodic abdominal pain, and possibly mucus and blood in the stool. In extreme cases, it may be life-threatening, particularly in elderly or debilitated patients. The doctor will recommend immediate discontinuation of the drug, and after confirming the diagnosis of pseudomembranous colitis, appropriate treatment will be initiated (oral metronidazole is administered, and in severe cases – vancomycin). Drugs that inhibit intestinal peristalsis or other constipating agents should not be used. Relapses of the disease may occur despite appropriate treatment.
• Diarrhoea associated with Clostridium difficile infection, ranging from mild to fatal colitis, has been reported with nearly all antibacterial agents, including Lincocin. Antibiotic treatment alters the normal colonic flora, leading to overgrowth of C. difficile. Pseudomembranous colitis should be considered in any patient who develops diarrhoea after antibiotic use. Diarrhoea associated with C. difficile has been reported even more than two months after administration of antibacterial agents.
• If signs of superinfection are observed – antibiotic use may lead to overgrowth of resistant microorganisms, particularly yeasts.

Severe hypersensitivity reactions, including anaphylactic reactions, and serious skin adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis, and erythema multiforme, have been reported in patients treated with Lincocin. If an anaphylactic reaction or severe skin reactions occur, treatment with Lincocin must be discontinued and appropriate therapy initiated.

Lincocin and other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 laboratory test results of serum alkaline phosphatase activity, causing falsely elevated values.
Medicines containing kaolin and pectin inhibit the absorption of orally administered Lincocin; therefore, these medicines should be taken at least 2 hours before or 3 to 4 hours after Lincocin.

Lincocin with food and drink
To ensure optimal absorption, it is recommended not to take food 1–2 hours before and after administration of Lincocin.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Lincomycin crosses the placenta.
There are only limited data on the use of Lincocin during pregnancy. Lincocin may be used during pregnancy only if the doctor considers it necessary.
Lincomycin is excreted in human milk. Lincocin should not be used during 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 or operate machinery has not been studied.

Lincocin contains lactose monohydrate and sodium

Lactose
The medicine contains 605 mg of lactose monohydrate per capsule.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Lincocin

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor, pharmacist, or nurse.
Recommended dosage of Lincocin
Adults

• 500 mg three times daily (every 8 hours).
• Severe infections: 500 mg four times daily (every 6 hours).

Children (over 1 month of age)
Lincocin capsules are not recommended for use in children due to the inability to precisely
adjust the dosage.
Dosage in patients with impaired kidney or liver function
In patients with impaired kidney or liver function, the doctor may consider reducing the frequency
of Lincocin administration.
If treatment with lincomycin is necessary in patients with severe renal impairment, the appropriate
dose is 25% to 35% of the dose recommended for patients with normal kidney function.
Duration of treatment
The medicine should be administered for as long as directed by your doctor. In infections caused by
beta-hemolytic streptococci, treatment should last at least 10 days.
If you feel that the effect of Lincocin is too strong or too weak, consult your doctor again.
Taking more Lincocin than recommended
If you take more than the recommended dose, seek medical advice immediately.
In case of overdose, gastrointestinal symptoms may occur, such as: abdominal pain, nausea,
vomiting, diarrhea.
Overdose may be treated by inducing vomiting or gastric lavage. There is no specific antidote.
Hemodialysis or peritoneal dialysis are not effective in removing Lincocin from plasma.
Missed dose of Lincocin
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.

Common (may occur in up to 1 in 10 people)

• Diarrhea, nausea, vomiting

Uncommon (may occur in up to 1 in 100 people)

• Rash, urticaria
• Vaginal infection

Rare (may occur in up to 1 in 1,000 people)

• Itching

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

• Pseudomembranous colitis, infection with Clostridium difficile bacteria
• Pancytopenia (deficiency of major types of blood cells), agranulocytosis, aplastic anemia, neutropenia (reduced number of phagocytic granulocytes), leukopenia (reduced number of white blood cells), thrombocytopenic purpura
• Anaphylactic reactions, angioedema, serum sickness syndrome
• Circulatory and respiratory arrest
• Hypotension, thrombophlebitis
• Esophagitis, abdominal discomfort
• Jaundice, abnormal liver function test results
• Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, bullous dermatitis, exfoliative dermatitis, erythema multiforme
• Sterile abscess at infusion site, induration at injection site, pain at injection site, irritation at injection site

a. Rare cases reported after too rapid intravenous administration.
b. After parenteral administration, especially if administered too rapidly.
c. Event reported after intravenous administration.
d. Event reported after oral administration.
e. Events reported after intramuscular administration.

Reporting of adverse reactions

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the Marketing Authorization Holder or its representative.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lincocin

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

6. Contents of the pack and other information

What Lincocin contains

• The active substance is lincomycin hydrochloride. Each capsule contains 500 mg of lincomycin.
• The other ingredients are: magnesium stearate, talc, monohydrate lactose (see section 2 "Lincocin contains monohydrate lactose and sodium"); gelatin capsule: titanium dioxide (E171), indigo carmine FD&C Blue No. 2 (E132) (see section 2 "Lincocin contains monohydrate lactose and sodium"), gelatin.

What Lincocin looks like and contents of the pack
The capsules are blue-dark blue with the white imprint "P&U 500" on both sides.
The pack contains 12 capsules (2 blisters with 6 capsules each).

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer
Pfizer Italia s.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP)
Italy

For further information, please contact the local representative of the Marketing Authorisation Holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

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