Lincocin

Leaflet attached to the packaging: information for the user

Lincocin, 500 mg, capsules

Lincomycin

Read the leaflet carefully before taking 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 any not listed in this leaflet, please 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 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 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 pharyngitis and 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 other antibiotics are not suitable or contraindicated, or if treatment with other antibiotics is ineffective.

2. Important information before taking Lincocin

When not to take Lincocin

• If you are 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 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, urticaria, angioedema, dyspnoea). You should then seek medical help immediately (adrenaline, oxygen, and intravenous steroids may be necessary, as well as securing the airway or even intubation).
• 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 renal and/or hepatic impairment with metabolic disorders. During treatment with high doses of Lincocin, your doctor may recommend monitoring the concentration of lincomycin in the blood. Liver and kidney function should also be monitored in the case of long-term use of Lincocin.
• If you are taking drugs that block neuromuscular junctions (muscle relaxants used in general anaesthesia, such as tubocurarine, pancuronium, vecuronium).
• If you have a tendency to allergies.

If you experience any of the following symptoms while taking Lincocin, tell your doctor immediately.

• If you develop diarrhoea, especially severe and persistent, during or after treatment, you should contact your doctor immediately. 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 syndrome with severe, chronic diarrhoea, leukocytosis, severe spastic abdominal pain, and possibly with the presence of mucus and blood in the stool. In extreme cases, it can be life-threatening, especially in elderly or weakened individuals. Your doctor will recommend immediate discontinuation of Lincocin and appropriate treatment (oral metronidazole or, in severe cases, vancomycin). You should not take anti-peristaltic drugs or other anti-diarrheal medications. Recurrences of the disease are possible despite appropriate treatment.
• Diarrhoea associated with Clostridium difficile infection, with a course from mild to toxic megacolon and potentially fatal, has been reported with the use of almost all antibacterial agents, including Lincocin. Antibiotic therapy alters the normal intestinal flora, 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 notice symptoms of a superinfection - the use of antibiotics may cause overgrowth of non-susceptible microorganisms, especially fungi.

Patients taking 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.
Drugs containing kaolin and pectin may reduce the absorption of orally administered Lincocin, so these drugs should be taken at least 2 hours before or 3 to 4 hours after Lincocin.

Lincocin with food and drink

To ensure optimal absorption of the medicine, it is recommended that you do not take food for 1-2 hours before and after taking Lincocin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Lincomycin crosses the placenta.
There are only 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 take 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 lactose and sodium

Lactose

The medicine contains 605 mg of lactose monohydrate per capsule.
If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means that the medicine is considered "sodium-free".

3. How to take Lincocin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

Usual dose of Lincocin

Adults

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

Children (over 1 month of age)
The capsule form is not recommended for children due to the inability to precisely dose.
Dosing in patients with renal or hepatic impairment
Your doctor will consider reducing the frequency of Lincocin administration in patients with renal or hepatic impairment.
If a patient with severe renal impairment requires treatment with lincomycin, the appropriate dose is 25-35% of the recommended dose for patients with normal renal function.

Duration of treatment

Take the medicine for as long as your doctor recommends. In streptococcal infections, treatment should last at least 10 days.
If you feel that the effect of Lincocin is too strong or too weak, you should consult your doctor.

Taking more Lincocin than recommended

If you take more Lincocin than recommended, contact your doctor immediately.
Overdose of Lincocin may cause gastrointestinal symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.
Overdose can be treated by inducing vomiting or gastric lavage. There is no specific antidote. Haemodialysis or peritoneal dialysis is not effective in removing Lincocin from the blood.

Missing a 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(may affect up to 1 in 10 people)

• diarrhoea, nausea, vomiting

Uncommon(may affect up to 1 in 100 people)

• rash, urticaria
• vaginal infection

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

• pruritus

Frequency not known(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, respiratory arrest
• hypotension, thrombophlebitis
• oesophagitis, abdominal distress
• jaundice, abnormal liver function tests
• toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, 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. Events have been reported after intramuscular administration.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please 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
Jerozolimskie Avenue 181C
02-222 Warsaw
Tel.: +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 authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lincocin

Store in a temperature 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 "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 is lincomycin in the form of hydrochloride. Each capsule contains 500 mg of lincomycin.
• The other ingredients are: magnesium stearate, talc, lactose monohydrate (see section 2 "Lincocin contains lactose and sodium"); capsule shell:titanium dioxide (E171), indigo carmine FD&C Blue 2 (E132) (see section 2 "Lincocin contains lactose and sodium"), gelatin.

What Lincocin looks like and contents of the pack

The capsules are blue-purple with a white inscription "P&U 500" on both sides.
The pack contains 12 capsules (2 blisters of 6 capsules).

Marketing authorization holder

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

Manufacturer

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

For more information, contact your local representative of the marketing authorization holder:

Pfizer Polska Sp. z o.o.
tel. 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://pfi.sr/ulotka-lincocinkapsulki and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocides http://www.urpl.gov.pl.