Lincocin 500 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lincocin 500 mg hard capsules

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 pass it on to others, even if they have the same symptoms as you, because it may harm them.

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

Contents of the 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 adverse effects

5. Storage of Lincocin

6. Contents of the pack and other information

1. What Lincocin hard capsules are and what they are used for

Lincocin is an antibiotic that belongs to the group of lincosamides.

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

In adolescents aged 12 years and older, it is used for the treatment of acute sinusitis (infection in the paranasal sinuses).

2. What you need to know before taking Lincocin hard capsules

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.

Warnings and precautions

• Allergic-type reactions (including anaphylactic reaction, shock) may occur during treatment. Serious 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, on the trunk. Additionally, ulcers may develop in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe rashes are often preceded by fever or flu-like symptoms. The rashes may progress to widespread skin peeling and potentially fatal complications.

AGEP presents as a widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. The most common locations are skin folds, trunk, and upper limbs.

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

• Symptoms suggesting antibiotic-associated colitis (diarrhea) may occur during or after treatment with this medicine. If this occurs, you must stop treatment with Lincocin and contact 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 drugs.
• 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 levels of alkaline phosphatase.

Children and adolescents

This medicine is not suitable for children under 12 years of age who are unable to swallow the capsules whole.

The recommended dose in adolescents aged 12 years and older is 30 to 60 mg/kg per day divided into 3 or 4 equal doses, depending on the severity of the infection. The dose per administration should not exceed 500 mg (see section 3).

The safety and efficacy in infants under 1 month of age have not been established. No data are available.

Other medicines and Lincocin hard capsules

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 taking lincomycin.

Taking Lincocin hard capsules with food, drinks, and alcohol

To achieve optimal absorption, it is recommended not to consume any food or drink within 1 to 2 hours before or after administration of 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.

Breastfeeding

Lincomycin is excreted in breast milk following oral or intravenous administration. Due to the potential for serious adverse reactions in the breastfed 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 hard capsules contain lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule; therefore, it is essentially "sodium-free".

3. How to take Lincocin hard capsules

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the most appropriate dose and duration of treatment for you, depending on your condition and your response to treatment.

This medicine is administered orally.

Adults

The recommended dose is 500 mg (1 capsule) every 6 or 8 hours, depending on the severity, site of infection, and microorganism sensitivity. Your doctor will advise you on the appropriate regimen.

The duration of treatment should be determined based on the type of infection and 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.

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

The recommended dose for adolescents aged 12 years and older is 30 mg/kg/day divided into 3 or 4 equal doses.

In cases of more severe infections, the dose may be increased depending on severity, up to 60 mg/kg/day divided into 3 or 4 equal doses. The dose per administration should not exceed 500 mg.

The capsules must be taken whole, which should be taken into account when administering the medicine. This medicine is not suitable for adolescents who are unable to swallow the capsules whole.

Children from 1 month to 12 years of age

The use of this medicine is not suitable for the treatment of children under 12 years of age.

Children under 1 month of age

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

If you take more Lincocin hard capsules than you should

In case of overdose, you may experience pain, nausea, vomiting, and diarrhoea.

In case of overdose or accidental ingestion, consult 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 hard capsules

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if the next dose is due soon, it is better not to take the missed dose and wait for the next scheduled dose. Do not take a double dose to make up for a missed dose.

If you stop treatment with Lincocin hard capsules

If you discontinue treatment with this medicine before your doctor has advised, 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 experiences 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 (bone marrow fails to produce enough new blood cells), destruction of platelets (thrombocytopenic purpura).
• Anaphylactic-type skin allergic reactions, swelling of the skin (angioedema), serum sickness.
• Inflammation of the esophagus, 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 with small pustules or blisters filled with white/yellow fluid (acute generalized exanthematous pustulosis). See section 2.
• Blisters on the skin (bullous dermatitis), skin eruptions with blisters and peeling (exfoliative dermatitis), red skin lesions and blisters on mucous membranes (erythema multiforme).

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

5. Storage of Lincocin hard capsules

Store below 25°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 refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lincocin hard capsules

• The active substance is lincomycin. Each hard capsule contains 500 mg of lincomycin (as hydrochloride).
• The other components are: capsule contents (monohydrate lactose, talc, magnesium stearate), capsule components (gelatin, indigo carmine (E-132), titanium dioxide (E-171)).

Appearance of the product and contents of the pack

Size 0 capsules filled with white powder, with an opaque light blue body marked P&U 500 and a dark blue opaque cap marked P&U, packed in blisters.

Each pack contains 24 capsules.

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 Italia S.r.L

Località Marino del Tronto

63100 Ascoli Piceno (AP)

Italy

Date of the most recent revision of the leaflet: November 2021

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