Lincocin 500 mg capsulas duras

Prospecto:information for the user

Lincocin 500 mg hard capsules

lincomycin

Read this prospectus carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctoror pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this prospectus. See section 4.

1.What is Lincocin and what is it used for

2.What you need to knowbeforestarting totake Lincocin

3.How to take Lincocin

4.Possible adverse effects

5Storage of Lincocin

6.Contents of the package and additional information

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

It is used in adults to treat infections caused by bacteria in different parts of the body.

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

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 a history of antibiotic-associated colitis.
• During breastfeeding.

Warnings and precautions

• During treatment, allergic reactions (including anaphylactic shock) may occur.Severe skin reactions, which can be life-threatening, have also been reported, including Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and acute generalized pustular psoriasis (PEGA), associated with lincomycin treatment.

Both SSJ and NET may initially appear as red spots similar to a bull's-eye or circular spots 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.

PEGA appears as a generalized scaly rash of red color, with bumps under the skin and blisters, accompanied by fever. Common location: primarily located in skin folds, trunk, and upper limbs.

If you experience a severe rash or other skin symptoms, stop taking this medication and inform your doctor or seek medical attention immediately.

• During or after treatment with this medication, symptoms may occur that suggest antibiotic-associated colitis (diarrhea). If this occurs, discontinue treatment with Lincocin and inform your doctor, who will initiate appropriate treatment.
• If you have or have had an inflammatory gastrointestinal disease, such as Crohn's disease or ulcerative colitis, inform your doctor to confirm whether you should use this medication.
• Prolonged administration of lincomycin may lead to 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 potentiate the action of these medications.
• During prolonged treatment, periodic blood tests and liver, kidney, and blood cell function tests should be performed. Use with caution in patients with renal and hepatic insufficiency.
• If you are to undergo diagnostic testing, as it may interfere with plasma levels of alkaline phosphatase.

Children and adolescents

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

The recommended dose in adolescents 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. Do not exceed a dose of 500 mg per dose (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 taken recently, 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) as lincomycin may potentiate the action of these medications.
• Calcium carbonate and pectin as it may decrease the gastrointestinal absorption of lincomycin. If calcium carbonate 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 for a period of 1 to 2 hours before or after the administration of lincomycin.

Pregnancy,breastfeeding, and fertility

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

Pregnancy

Lincomycin crosses the placental barrier in humans.No sufficient and well-controlled studies have been conducted in pregnant women.

Therefore, this medication should not be used during pregnancy except if strictly necessary.

Breastfeeding

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

Fertility

No data are available on the effect of lincomycin on fertility when administered to humans.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery.

Lincocin hard capsules contain lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

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

Your doctor will establish 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 treatment schedule.

The treatment duration 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-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 appropriate dose is 25% to 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. Do not exceed 500 mg per dose.

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 1 month to 12 years old

The use of this medication is not suitable for the treatment of children under 12 years old.

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 Toxicological Information Service at 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Lincocin hard capsules

In case of forgotten dose, use the medication as soon as possible and continue 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 compensate for the missed doses.

If you interrupt the treatment with Lincocin hard capsules

If you abandon the treatment with this medication before what your doctor has recommended, the symptoms may worsen or reappear.

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

Like all medications, this medication may cause adverse effects, although not everyone will experience them.

Frequent: may affect up to 1 in 10 people

• Diarrhea, nausea, vomiting.

Infrequent: may affect up to 1 in 100 people

• Vaginal infection.
• Skin rash; red, elevated, and itchy skin lesions (urticaria).

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

• Itching (pruritus).

Unknown frequency (cannot be estimated from available data)

• Decreased white blood cells (agranulocytosis, neutropenia, leucopenia), red blood cells, and platelets (pancytopenia), aplastic anemia (bone marrow does not produce enough new blood cells), platelet destruction (thrombocytopenic purpura).
• Allergic skin reactions of anaphylactic type, skin swelling (angioedema), serum disease.
• Esophageal inflammation, abdominal discomfort, pseudomembranous colitis, ulcerative colitis (colitis caused by Clostridium difficile).
• Yellow discoloration of the skin and mucous membranes (jaundice), liver function test abnormalities.
• Severe skin diseases: widespread skin peeling (toxic epidermal necrolysis), causing painful blisters and sores on the skin and mucous membranes (Stevens-Johnson syndrome), a skin rash characterized by the rapid appearance of red skin areas dotted with small white/yellow pustules or blisters filled with a white/yellow liquid (acute generalized pustular psoriasis). See section 2
• Blisters on the skin (bullous dermatitis), skin eruptions with blisters and peeling (exfoliative dermatitis), red skin lesions and blisters on the mucous membranes (erythema multiforme).

Reporting 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 prospectus. You can also report them directly through the Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Store below 25°C.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthepackageafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lincocin hard capsules

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

Appearance of the product and contents of the packaging

Hard capsules size 0, 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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas - Madrid

Spain

Responsible for manufacturing

Pfizer Italia S.r.L

Località Marino del Tronto

63100 Ascoli Piceno (AP)

Italy

Last review date of thisleaflet:November 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.