Lincocin

Package leaflet: Information for the patient

LINCOCIN 500 mg hard capsules

Lincomycin
Please read all of this leaflet carefully before 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 their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 contains the active substance lincomycin hydrochloride, which belongs to a group of medicines known as "systemic antibacterial agents – lincosamides" that slow down or block the growth of bacteria.
This medicine is indicated for the treatment of serious infections caused by certain types of bacteria (staphylococci, pneumococci, streptococci) that cannot be treated with other antibiotics.
In particular, Lincocin should be reserved for patients who are allergic to penicillin or in cases where the physician considers penicillin unsuitable for use.
Before starting treatment with Lincocin, the physician must carefully evaluate, based on the nature of the infection, the possibility of using less toxic medicines, in order to avoid the occurrence of severe intestinal inflammation (colitis) (see section "Possible side effects").
During treatment, laboratory tests (sensitivity tests) should be performed, as Lincocin may lose effectiveness over time.
If necessary, this medicine may be taken together with other antibiotics.

2. What you should know before taking Lincocin

Do not take Lincocin if

• you are allergic to lincomycin hydrochloride, to other similar products (clindamycin), or to any of the other ingredients of this medicine (listed in section 6);
• you have a mild infection or an infection caused by a virus (viral infections).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lincocin.
If you develop very severe skin reactions, contact your doctor immediately.
The use of this medicine is not recommended if you:

• experience diarrhoea during treatment with Lincocin, as it may progress to inflammation of the intestine (colitis), which can even be fatal (see also section 4 “Possible side effects”). Like other antibiotics, Lincocin may alter the normal bacterial flora of the intestine and may lead to excessive growth of a bacterium called Clostridium difficile, causing diarrhoea. In less severe cases, these symptoms resolve after discontinuation of Lincocin treatment. Your doctor will determine the most appropriate therapy based on the severity of symptoms and will monitor you regularly, as Clostridium difficile-associated diarrhoea may occur even up to 2 months after stopping this medicine;

• suffer from stomach or intestinal diseases;

• have a hereditary tendency to develop severe allergic reactions (anaphylactic reactions);

• have liver disease, except when absolutely necessary;

• have kidney problems;

• are being treated with erythromycin, another antibiotic used to treat bacterial infections (see section “Other medicines and Lincocin”);

• have an infection of the membranes surrounding the brain, called meningitis, as Lincocin is not effective in this case.

Inform your doctor if you think any of the following conditions apply to you:

• you are being treated with other medicines that relax muscles (medicines with neuromuscular blocking properties), as Lincocin should be administered with caution in such cases (see section “Other medicines and Lincocin”);
• you have previously suffered from asthma or other allergic reactions;
• you are taking medicines that reduce the natural movement of the intestine ( antiperistaltic medicines ), such as opioids and diphenoxylate with atropine, as these may worsen possible intestinal side effects of Lincocin;
• you are debilitated, as you may be more susceptible to possible intestinal side effects of this medicine;
• you are an elderly person (see section “Elderly patients”).

During treatment, this medicine may become less effective and may promote the development of more severe infections (superinfections). In such cases, your doctor will prescribe appropriate therapy.
If you have a fungal infection (moniliasis), your doctor will prescribe, in addition to Lincocin, a specific medicine to treat the moniliasis infection (antimoniliasis treatment).
Laboratory tests
During prolonged treatment with Lincocin, your doctor will perform regular blood tests and monitor liver and kidney function.
Elderly patients
If you are elderly, your doctor will monitor you regularly during treatment with Lincocin, as you may be more susceptible to possible intestinal side effects of this medicine, such as diarrhoea.
Other medicines and Lincocin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking the following medicines:

• neuromuscular blocking agents (medicines used to relax muscles, especially before surgery);
• erythromycin and clindamycin (antibiotics used to treat bacterial infections).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Lincocin if you are pregnant or breastfeeding.
Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive or operate machinery.
Lincocin contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Lincocin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially ‘sodium-free’.

3. How to take Lincocin

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

• severe infections: 1 capsule of 500 mg every 8 hours;
• very severe infections: 1 capsule of 500 mg every 6 hours.

It is recommended not to ingest anything except water for 1–2 hours both before and after taking Lincocin.

Use in patients with severe kidney problems
If you have severe kidney problems (severely impaired renal function), your doctor will prescribe lower doses of this medicine than those normally recommended.

If you take more Lincocin than you should
Cases of overdose are not known.
If you think you have taken more Lincocin than you should, stop treatment immediately and contact your doctor or the nearest hospital without delay.

If you forget to take Lincocin
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose. If you think you have missed more than one dose, consult your doctor.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur:
Common (may affect up to 1 in 10 people):

• diarrhoea, nausea, vomiting

Uncommon (may affect up to 1 in 100 people):

• vaginal infection
• skin rash, urticaria

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

• pruritus (itching)

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

• persistent diarrhoea, which may be a symptom of a serious inflammation of the colon (see section “Warnings and precautions”);
• reduction in the number of white blood cells in the blood (neutropenia, leucopenia, agranulocytosis), development of red-brown skin spots due to a decrease in platelets (thrombocytopenic purpura), reduction in the number of red blood cells (aplastic anaemia), or reduction in all blood components (pancytopenia);
• allergic reactions such as swelling of the face, lips and tongue (angioedema), very severe allergic reactions (serum sickness and anaphylactic reactions);
• inflammation of the oesophagus (oesophagitis), abdominal discomfort;
• yellowing of the skin, mucous membranes and eyes due to liver problems, and abnormal results in some liver function tests;
• very serious skin reactions:
• sudden onset of severe rash, blisters or skin peeling, possibly accompanied by high fever or joint pain (toxic epidermal necrolysis (TEN))
• rash characterized by the rapid appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow fluid) (acute generalised exanthematous pustulosis (AGEP))
• widespread rash with blisters and peeling of large areas of skin, particularly around the mouth, nose, eyes or genitals (Stevens-Johnson syndrome (SJS))
• rash, which may include blisters, appearing as small target-like lesions (dark centres surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
• irritation and inflammation of the skin (exfoliative dermatitis, bullous dermatitis).

Other side effects:

• inflammation of the tongue (glossitis) or of the mouth mucosa (stomatitis), inflammation of the intestine (enterocolitis), anal itching;
• kidney disorders (renal dysfunction) characterized by increased levels of nitrogen in the blood (azotemia), reduced urine output (oliguria) and/or presence of protein in the urine (proteinuria);
• dizziness and ringing sounds in the ears (tinnitus).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lincocin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lincocin contains
The active substance is lincomycin (as lincomycin hydrochloride).
Each capsule contains 544.81 mg of lincomycin hydrochloride (equivalent to 500 mg of lincomycin base).
The other ingredients are: talc, magnesium stearate, lactose monohydrate.
The hard capsule shell is composed of gelatin, titanium dioxide, indigotine (E132), iron oxide (E172).

Description of the appearance of Lincocin and the contents of the pack
Lincocin 500 mg hard capsules are available in PVC/aluminum blisters, pack containing 12 capsules.

Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

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

Package leaflet: Information for the user

LINCOCIN 300 mg injectable solution, 600 mg injectable solution

Lincomycin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, the doctor treating your child, pharmacist, or nurse.
• This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, the doctor treating your child, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Lincocin is and what it is used for
2. What you need to know before Lincocin is administered
3. How to administer 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 contains the active substance lincomycin hydrochloride, which belongs to a group of medicines called "systemic antibacterial agents – lincosamides" that slow down or block the growth of bacteria.
This medicine is indicated for the treatment of serious infections caused by certain types of bacteria (staphylococci, pneumococci, streptococci) that cannot be treated with other antibiotics.
In particular, Lincocin should be reserved for patients who are allergic to penicillin or in cases where the doctor considers penicillin to be unsuitable.
Before starting treatment with Lincocin, the doctor should carefully evaluate, based on the nature of the infection, whether less toxic medicines could be used instead, in order to avoid the possible occurrence of severe intestinal inflammation (colitis) (see section "Possible side effects").
During treatment, laboratory tests (sensitivity tests) should be performed, as Lincocin may lose effectiveness over time.
If necessary, this medicine may be administered concomitantly with other antibiotics.

2. What you need to know before Lincocin is administered

Do not administer Lincocin if

• you or your child:
• are allergic to lincomycin hydrochloride, to other similar products (clindamycin), or to any of the other ingredients of this medicine (listed in section 6);
• have a mild infection or an infection caused by a virus (viral infections).
• your child:
• was born prematurely, is a newborn, or is under 2 years of age (see section “Children”).

Warnings and precautions
Consult your doctor, pharmacist, or nurse before Lincocin is administered to you or your child.
If you or your child develop severe skin reactions, contact your doctor immediately.
This medicine is not recommended if you or your child:

• experience diarrhoea during treatment with Lincocin, as it may progress to inflammation of the intestine (colitis), even fatal (see also section 4 “Possible side effects”). Like other antibiotics, Lincocin may alter the normal bacterial flora of the intestine and may lead to overgrowth of a bacterium called Clostridium difficile, which causes diarrhoea. In mild cases, these symptoms resolve after stopping Lincocin treatment. Your doctor will determine the most appropriate therapy based on the severity of symptoms and will monitor you regularly, as Clostridium difficile-associated diarrhoea may occur up to 2 months after discontinuation of this medicine;
• have stomach or intestinal diseases;
• have a hereditary tendency to develop severe allergic reactions (anaphylactic reactions);
• have liver disease, except when strictly necessary;
• have kidney problems;
• are being treated with erythromycin, another antibiotic used to treat bacterial infections (see section “Other medicines and Lincocin”);
• have an infection of the membranes surrounding the brain, called meningitis, as Lincocin is not effective in this case.

Inform your doctor or your child’s doctor if you think any of the following conditions apply to you or your child:

• you are being treated with other medicines that relax muscles (medicines with neuromuscular blocking properties), as Lincocin should be administered with caution in such cases (see section “Other medicines and Lincocin”);
• you have previously suffered from asthma or other allergic reactions;
• you are taking medicines that reduce the natural movement of the intestine ( antiperistaltic medicines ), such as opioids and diphenoxylate with atropine, as these may worsen possible intestinal side effects of Lincocin;
• you are debilitated, as you may be more susceptible to possible intestinal side effects of this medicine;
• if you are elderly (see section “Elderly”).

During treatment, this medicine may lose effectiveness and promote the development of more severe infections (superinfections). In such cases, your doctor will prescribe appropriate therapy.
If you or your child have a fungal infection (moniliasis), your doctor will prescribe, along with Lincocin, a specific medicine to treat the moniliasis infection (antimoniliasis treatment).
Laboratory tests
During prolonged treatment with Lincocin, your doctor or your child’s doctor will perform regular blood tests and monitor liver and kidney function.
Children
This medicine must not be administered to newborns or children under 2 years of age (see section “Do not administer Lincocin if”). Benzyl alcohol, one of the components of this medicine, may cause serious, even fatal, adverse reactions in children and newborns, such as a condition known as “gasping syndrome”, characterized by reduced brain function, deterioration of the nervous system, lactic acid accumulation in the body, breathing difficulties, heart problems, and blood abnormalities.
Elderly
If you are elderly, your doctor will monitor you regularly during treatment with Lincocin, as you may be more susceptible to possible intestinal side effects of this medicine, such as diarrhoea.
Other medicines and Lincocin
Inform your doctor, your child’s doctor, pharmacist, or nurse if you or your child are taking, have recently taken, or might take any other medicine.
Inform your doctor if you or your child are taking the following medicines:

• neuromuscular blocking agents (medicines used to relax muscles, especially before surgery);
• erythromycin and clindamycin (antibiotics used to treat bacterial infections).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before this medicine is administered.
Lincocin will not be administered if you are pregnant or breastfeeding.
Driving and operating machinery
There are no data available to determine the effect of this medicine on the ability to drive or operate machinery.
Lincocin contains benzyl alcohol
This medicine contains 9.45 mg/ml of benzyl alcohol and therefore must not be given to premature infants or newborns. It may cause toxic and allergic reactions in children up to 3 years of age.

3. How to administer Lincocin

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

This medicine can be administered by injection into a muscle (intramuscular route) or by slow injection into a vein (intravenous route). In the latter case, Lincocin will always be administered to you or your child by a doctor or nurse.

Administration via a muscle (intramuscular route)

Adults
The recommended dose is:

• Severe infections: 1 vial of 2 ml (600 mg) every 24 hours;
• Very severe infections: 1 vial of 2 ml (600 mg) every 12 hours or more frequently.

Children (over 2 years of age)
The recommended dose is:

• Severe infections: 10 mg per kilogram of body weight per day;
• Very severe infections: 10 mg per kilogram of body weight every 12 hours or more frequently.

Administration via a vein (intravenous route)

Adults
The recommended dose is 1 vial of 2 ml (600 mg) every 8–12 hours. If the infection is very severe, your doctor may decide to increase the dose.

Children (over 2 years of age)
The recommended dose is 10–20 mg per kilogram of body weight per day, divided into 2–3 infusions every 12–8 hours.

If you or your child has an infection caused by a type of bacterium called beta-haemolytic Streptococcus, treatment should be continued for at least 10 days to reduce the risk of autoimmune diseases that may affect the heart or kidneys (rheumatic disease or glomerulonephritis).

Use in patients with severe kidney problems
If you or your child have severe kidney problems (severely impaired renal function), your doctor will prescribe lower doses of this medicine than those normally recommended.

If more Lincocin is administered than prescribed
Cases of overdose are not known.
If you think you have administered more Lincocin than you should to your child, stop treatment immediately and contact your doctor or go to the nearest hospital.

If you forget to use Lincocin
Do not use a double dose to make up for a forgotten dose. If you think you have missed more than one dose, consult your doctor or your child’s doctor.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Common (may affect up to 1 in 10 people):

• diarrhoea, nausea, vomiting

Uncommon (may affect up to 1 in 100 people):

• vaginal infection
• skin rash, urticaria

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

• pruritus (itching)

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

• persistent diarrhoea, which may be a symptom of a serious inflammation of the colon (see section “Warnings and precautions”);
• reduction in the number of white blood cells in the blood (neutropenia, leucopenia, agranulocytosis), development of red-brown skin spots due to reduced platelet count (thrombocytopenic purpura), reduction in the number of red blood cells (aplastic anaemia), or reduction in all blood components (pancytopenia);
• allergic reactions such as swelling of the face, lips and tongue (angioedema), very severe allergic reactions (serum sickness and anaphylactic reactions);
• cardiopulmonary arrest following too rapid intravenous infusion;
• drop in blood pressure (hypotension), especially if the medicine is administered too quickly;
• inflammation of the veins (thrombophlebitis) following infusion of the medicine into a vein;
• abdominal discomfort;
• yellowing of the skin, mucous membranes and eyes due to liver problems, and abnormal results in some liver function tests;
• very severe skin reactions:
• sudden onset of a severe rash, blisters or skin peeling, possibly accompanied by high fever or joint pain (toxic epidermal necrolysis (TEN))
• rash characterised by the rapid appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow fluid) (acute generalised exanthematous pustulosis (AGEP))
• widespread rash with blisters and peeling of large areas of skin, particularly around the mouth, nose, eyes or genitals (Stevens-Johnson syndrome (SJS))
• skin rash, which may present with blisters and appears as small targets (dark centres surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
• irritation and inflammation of the skin (exfoliative dermatitis, bullous dermatitis);
• local irritation, pain, hardening of the skin and accumulation of non-pus material within tissues (sterile abscess) at the site of intramuscular injection.

Other side effects:

• inflammation of the tongue (glossitis) or of the mucous membrane of the mouth (stomatitis), inflammation of the intestine (enterocolitis), itching near the anus (anal pruritus);
• kidney disorders (renal dysfunction) characterised by increased levels of nitrogen in the blood (azotemia), reduced urine output (oliguria) and/or presence of protein in the urine (proteinuria);
• dizziness and perception of ringing sounds in the ears (tinnitus).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lincocin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lincocin contains
The active substance is lincomycin (as lincomycin hydrochloride).
Each 1 ml vial contains 326.88 mg of lincomycin hydrochloride (equivalent to 300 mg of lincomycin base).
Each 2 ml vial contains 653.77 mg of lincomycin hydrochloride (equivalent to 600 mg of lincomycin base).
The other components are: benzyl alcohol, water for injections.

Description of the appearance of Lincocin and contents of the pack
Lincocin 300 mg injectable solution is available in a carton containing 1 glass vial of 1 ml with a break-off neck.
Lincocin 600 mg injectable solution is available in a carton containing 1 type I glass vial of 2 ml with a closure made of bromobutyl rubber.

Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Italy

Manufacturer
Lincocin 300 mg injectable solution
Valdepharm
Parc Industriel d’Incarville
27106 Val de Reuil, Cedex
France

Lincocin 600 mg injectable solution
Pfizer Manufacturing Belgium N.V.
Rijksweg 12
B-2870 Puurs
Belgium

The following information is intended exclusively for doctors or healthcare professionals

LINCOCIN 300 mg injectable solution
LINCOCIN 600 mg injectable solution
Lincomycin
Route of administration
LINCOCIN injectable solution must be diluted to a concentration not exceeding 600 mg/100 ml (see the section below entitled "Compatibility") and administered by slow intravenous infusion over a period of not less than 1 hour. Severe cardiopulmonary reactions have occurred when this drug has been administered at concentrations and infusion rates higher than those recommended.
Compatibility
Lincomycin is physically compatible for 24 hours at room temperature, unless otherwise indicated, with:

• Infusion solutions: dextrose in water, 5% and 10% solutions; dextrose in saline, 5% and 10% solutions; Ringer's solution; sodium lactate 1/6 molar; Travert 10%-Electrolyte N. 1; dextran in saline 6% weight/volume.
• Vitamins in infusion solutions: vitamin B complex; vitamin B complex with ascorbic acid.
• Antibiotics in infusion solutions: sodium penicillin G (satisfactory for 4 hours); cephalothin; cephaloridine; tetracycline HCl; colistimethate (satisfactory for 4 hours); ampicillin; methicillin; chloramphenicol; polymyxin B sulfate.

It should be emphasized that compatibility and incompatibility determinations are based solely on physical observations and not on chemical analyses. Adequate clinical evaluation of the safety and efficacy of these combinations has not been performed.
Incompatibility
Lincomycin is physically incompatible with novobiocin and kanamycin.