LINCOCIN 500 mg HARD CAPSULES

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

Do not take Lincocin:

• If you are allergic to the active ingredient (lincomycin), clindamycin, or any of the other components of this medication (listed in section 6).
• If you have meningitis.
• If you have had antibiotic-associated colitis in the past.
• During breastfeeding.

Warnings and precautions

• During treatment, allergic reactions (including anaphylactic reaction, shock) may occur. There have also been reports of severe skin reactions, which can be life-threatening, associated with lincomycin treatment, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).

Both SJS and TEN can initially appear as red, target-like patches or circular patches, often with central blisters on the torso. Additionally, ulcers may occur in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe eruptions are often preceded by fever or flu-like symptoms. The eruptions can progress to widespread skin peeling and potentially fatal complications.

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

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

• During or after treatment with this medication, symptoms suggesting antibiotic-associated colitis (diarrhea) may occur. If this happens, you should interrupt treatment with Lincocin and inform your doctor, who will provide the appropriate treatment.
• 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 medication.
• Prolonged administration of lincomycin may cause the growth of other microorganisms, especially fungi.
• If you are being treated with neuromuscular blockers (used to produce muscle paralysis, such as pancuronium, tubocurarine), inform your doctor, as lincomycin may enhance the action of these medications.
• During prolonged treatments, periodic blood tests and liver and kidney function tests should be performed. It should be used with caution in patients with renal and hepatic insufficiency.
• If you are going to undergo any diagnostic tests, as it may interfere with plasma levels of alkaline phosphatase.

Children and adolescents

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

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

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

Other medications and Lincocin hard capsules

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Inform your doctor if you are taking any of the following medications:

• Neuromuscular blockers (such as pancuronium, tubocurarine) since lincomycin may enhance the action of these medications.
• Kaolin-pectin, as it decreases the gastrointestinal absorption of lincomycin. If kaolin is administered, there should be an interval of at least 2 hours before the use of lincomycin.

Taking Lincocin hard capsules with food, drinks, and alcohol

To achieve optimal absorption, it is recommended not to ingest any food or drink during a period of 1 to 2 hours before or after the administration of lincomycin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Lincomycin crosses the placental barrier in humans. There are no sufficient and well-controlled studies in pregnant women.

Therefore, this medication should not be used during pregnancy unless it is strictly necessary.

Breastfeeding

Lincomycin is excreted in breast milk after oral or intravenous administration. Due to the potential serious adverse reactions in the infant, the use of lincomycin is contraindicated during breastfeeding.

Fertility

There are no data available on the effect of lincomycin on fertility in humans.

Driving and using machines

No studies have been conducted on the ability to drive and use machines.

Lincocin hard capsules contain lactose and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Lincocin hard capsules

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the most suitable dose and treatment duration for you, according to your condition and response to treatment.

This medication is administered orally.

Adults

The recommended dose is 500 mg (1 capsule) every 6 or 8 hours, depending on the severity, location of the infection, and sensitivity of the microorganism. Your doctor will indicate the schedule to follow.

The treatment duration should be determined based on the type of infection and response and should be as short as possible, usually 7 to 14 days. In infections caused by beta-hemolytic streptococci, treatment should be maintained for at least 10 days.

Use in patients with renal insufficiency

In patients with mild or moderate renal insufficiency, it should be used with caution, considering the possibility of reducing the administration frequency.

In patients with severe renal insufficiency, the suitable dose is 25-30% of the recommended dose for patients with normal renal function.

Use in patients with hepatic insufficiency

In these patients, the possibility of reducing the administration frequency should be considered.

Use in children and adolescents

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

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

The capsules should be taken whole, which should be taken into account when administering the medication. This medication 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 medication is not suitable for the treatment of children under 12 years.

Children under 1 month

The safety and efficacy in children under 1 month 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 diarrhea.

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 medication and the amount ingested.

If you forget to take Lincocin hard capsules

In case of forgetting a dose, use the medication as soon as possible, continuing with the treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one. Do not take a double dose to make up for the missed doses.

If you stop treatment with Lincocin hard capsules

If you stop treatment with this medication before your doctor recommends, the symptoms may worsen or reappear.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Frequent: 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, and 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, leucopenia), red blood cells, and platelets (pancytopenia), aplastic anemia (the bone marrow does not produce enough new blood cells), destruction of platelets (thrombocytopenic purpura).
• Allergic skin reactions of anaphylactic type, skin swelling (angioedema), serum sickness.
• Esophageal inflammation, abdominal discomfort, pseudomembranous colitis, ulcerative colitis (Clostridium difficilecolitis).
• Yellowing of the skin and mucous membranes (jaundice), changes in liver function tests.
• Skin diseases that can be severe: peeling of large areas of skin (toxic epidermal necrolysis), which causes painful blisters and ulcers on the skin and mucous membranes (Stevens-Johnson syndrome), a skin rash characterized by the rapid appearance of red spots with small white or yellow-filled blisters (acute generalized exanthematous pustulosis). See section 2
• Blisters on the skin (bullous dermatitis), skin rashes with blisters and peeling (exfoliative dermatitis), red lesions on the skin and blisters on the mucous membranes (erythema multiforme).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lincocin hard capsules

Store below 25°C.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown away down the drain or in the trash. Place the packaging and any unused medications in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Lincocin hard capsules

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

Appearance of the product and package contents

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

Each package 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 last revision of thisleaflet:November 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.