Apel 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Apel 600 mg film-coated tablets EFG

linezolid

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

1. What Apel is and what it is used for

2. What you need to know before taking Apel

3. How to take Apel

4. Possible side effects

5. Storage of Apel

6. Contents of the pack and other information

1. What Apel is and what it is used for

Apel is an antibiotic belonging to the oxazolidinone group that works by preventing the growth of certain bacteria (germs) that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dosage, frequency, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of down the drain or in household waste.

It is used to treat pneumonia and certain skin or deep skin infections. Your doctor will have decided whether Apel is suitable for treating your infection.

2. What you need to know before taking Apel

Do not take Apel:

• if you are allergic to linezolid or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking or have taken within the last 2 weeks any medicines known as monoamine oxidase inhibitors (MAOIs), such as phenelzine, isocarboxazide, selegiline, or moclobemida. These medicines are usually used to treat depression or Parkinson's disease.
• if you are breastfeeding. Linezolid passes into breast milk and could affect your baby.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use this medicine.

Linezolid may not be suitable for you if you answer yes to any of the following questions. In such cases, inform your doctor, as they may need to monitor your general health and blood pressure before and during treatment, or may decide that another treatment is more appropriate for you. Ask your doctor if you are unsure whether any of these categories apply to you.

• Do you have high blood pressure, whether or not you are taking medication for it?
• Have you been diagnosed with hyperthyroidism?
• Do you have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumors in the hormonal system, associated with symptoms such as diarrhea, skin flushing, and wheezing)?
• Do you suffer from manic depression, schizoaffective disorder, confusion, or other mental health problems?
• Do you have a history of hyponatremia (low sodium levels in the blood), or are you taking medicines that reduce sodium levels in the blood, such as certain diuretics like hydrochlorothiazide?
• Are you taking opioids?

Using certain medicines, including antidepressants and opioids, together with Apel may lead to serotonin syndrome, a potentially life-threatening condition (see section 2 “Other medicines and Apel” and section 4).

Take special care with Apel:

Inform your doctor before taking this medicine if:

• You are elderly.
• You bruise easily or bleed easily.
• You have anemia (low red blood cell count).
• You are prone to infections.
• You have a history of seizures.
• You have liver or kidney problems, especially if you are on dialysis.
• You have diarrhea.

Inform your doctor immediately if, during treatment, you experience any of the following:

• Vision problems such as blurred vision, changes in color vision, difficulty seeing clearly, or a reduction in your field of vision.
• Loss of sensation in your arms or legs, or a tingling or burning sensation in your arms or legs.
• Diarrhea may occur while taking or after taking antibiotics, including linezolid. If diarrhea becomes severe, persists for a long time, or if you notice blood or mucus in your stools, stop taking this medicine immediately and consult your doctor. In this situation, do not take medicines that stop or reduce intestinal movements.
• Repeated nausea or vomiting, abdominal pain, or rapid breathing.
• Unexplained muscle pain, tenderness, or weakness, and/or dark urine. These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.
• Malaise and dizziness with muscle weakness, headache, confusion, and memory impairment, which may indicate hyponatremia (low sodium levels in the blood).

Taking Apel with other medicines

Linezolid may sometimes interact with certain medicines, causing adverse effects such as changes in blood pressure, body temperature, or heart rate.

Tell your doctor if you are taking or have taken any of the following medicines in the past 2 weeks, as you should not take linezolid if you are still taking them or have recently taken them (see also section 2 above “Do not take Apel”):

• Monoamine oxidase inhibitors (MAOIs), such as phenelzine, isocarboxazide, selegiline, or moclobemida. These medicines are commonly used to treat Parkinson's disease.

Also inform your doctor if you are taking any of the following medicines. Your doctor may still decide to treat you with linezolid, but will need to assess your general condition and blood pressure before and during treatment. In other cases, your doctor may decide that another treatment is more suitable for you.

• Decongestants for colds containing pseudoephedrine or phenylpropanolamine.
• Certain asthma medications such as salbutamol, terbutaline, or fenoterol.
• Certain antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many medicines in this group, including amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, or sertraline.
• Medicines used to treat migraines such as sumatriptan or zolmitriptan.
• Medicines used to treat sudden severe allergic reactions such as adrenaline (epinephrine).
• Medicines that increase blood pressure such as noradrenaline (norepinephrine), dopamine, and dobutamine.
• Opioids, for example, pethidine, used to treat moderate or severe pain.
• Medicines used to treat anxiety disorders such as buspirone.
• Medicines that prevent blood clotting such as warfarin.
• An antibiotic called rifampicin.

Tell your doctor, pharmacist, or nurse if you are currently using or have recently used any other medicines, including those obtained without a prescription.

Taking Apel with food, drinks, and alcohol

• You may take linezolid before, during, or after meals.

• Avoid eating large amounts of cheese, yeast extracts, or soybean extracts (e.g., soy sauce), and avoid alcoholic beverages, especially draught beer and wine. This is because linezolid can react with a substance called tyramine, naturally present in some foods. This interaction may cause a rise in your blood pressure.

• If you develop a pulsating headache after eating or drinking, inform your doctor, pharmacist, or nurse immediately.

Pregnancy, breastfeeding, and fertility

The effect of linezolid in pregnant women is unknown. Therefore, pregnant women should not use linezolid unless advised by their doctor. 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.

You should not breastfeed while taking linezolid, as this medicine passes into breast milk and could affect your baby.

Driving and using machines

Linezolid may cause dizziness or vision problems. If this occurs, do not drive or operate machinery. Remember that if you do not feel well, your ability to drive or use machines may be impaired.

This medicine contains less than 23 mg of sodium (1 mmol) per dose unit; hence, it is essentially "sodium-free".

3. How to take Apel

Adults

Always follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

The recommended dose is one film-coated tablet (600 mg) twice daily (every 12 hours). Swallow the film-coated tablet whole with some water.

If you are on a dialysis program, you should take linezolid after each dialysis session.

The usual duration of treatment is 10–14 days, but may be extended up to 28 days. The safety and efficacy of this medicine have not been established for treatment periods longer than 28 days. Your doctor will decide the duration of your treatment.

While taking linezolid, your doctor will perform periodic blood tests to monitor your blood count.

If you take linezolid for more than 28 days, your doctor should monitor your vision.

Use in children and adolescents

Linezolid is not normally used in children and adolescents (under 18 years of age).

If you take more Apel than you should

Inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Apel

Take the missed tablet as soon as you remember. Then take the next film-coated tablet 12 hours after the missed dose, and continue taking the tablets every 12 hours. Do not take a double dose to make up for the forgotten dose.

If you stop taking Apel

It is important that you only stop your treatment if instructed by your doctor. If your initial symptoms return after stopping treatment, inform your doctor or pharmacist immediately.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tell your doctor, nurse or pharmacist immediately if you notice any of the following adverse effects while being treated with linezolid:

The most serious adverse effects of linezolid (with frequency in parentheses) are:

• Severe skin reactions (uncommon), swelling particularly around the face and neck (uncommon), wheezing and/or difficulty breathing (rare). These may be signs of an allergic reaction and treatment with linezolid may need to be stopped. Skin reactions such as raised purple rash due to inflammation of blood vessels (rare), red, sore and scaly skin (dermatitis) (uncommon), skin rash (common), itching (common).
• Vision problems (uncommon), such as blurred vision (uncommon), changes in color perception (frequency not known), difficulty seeing clearly (frequency not known), or if you notice a reduction in your field of vision (rare).
• Severe diarrhoea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases could lead to complications that may become life-threatening (uncommon).
• repeated nausea or vomiting, abdominal pain or rapid breathing (rare).
• epileptic seizures or convulsions (uncommon) have been reported in patients treated with linezolid.
• Serotonin syndrome (frequency not known): you should inform your doctor if you experience agitation, confusion, delirium, rigidity, tremor, lack of coordination, convulsions, rapid heartbeat, severe breathing problems and diarrhoea (suggestive of serotonin syndrome), especially if you are also being treated with antidepressants called SSRIs and opioids (see section 2).
• Unexplained bleeding or bruising, which may be due to changes in the number of certain blood cells that can affect blood clotting or cause anaemia (common).
• Reduction in the number of blood cells that can affect the ability to fight infections (uncommon). Some signs of infection include: fever (common), sore throat (uncommon), mouth ulcers (uncommon), and tiredness (uncommon).
• Rhabdomyolysis (uncommon): Signs and symptoms include unexplained muscle pain, tenderness or weakness, and/or dark urine. These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.
• Inflammation of the pancreas (uncommon).
• Seizures (uncommon).
• Transient ischaemic attacks (temporary disruption of blood flow to the brain causing short-term symptoms such as loss of vision, weakness in arms and legs, difficulty speaking and loss of consciousness) (uncommon).
• Ringing in the ears (tinnitus) (uncommon).

Cases of numbness, tingling or blurred vision have been reported in patients who have taken linezolid for more than 28 days. If you experience any vision problems, consult your doctor as soon as possible.

Other adverse effects include:

Common (may affect up to 1 in 10 people):

• Fungal infections, especially in the vagina or mouth.
• Headache.
• Metallic taste.
• Diarrhoea, vomiting, nausea.
• Changes in certain blood test results, including tests for proteins, salts or enzymes measuring liver, kidney function or blood sugar levels.
• Difficulty sleeping.
• Increased blood pressure.
• Anaemia (reduction in the number of red blood cells).
• Dizziness.
• Localised or general abdominal pain.
• Constipation.
• Indigestion.
• Localised pain.
• Reduction in platelet count.

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

• Inflammation of the vagina or female genital area.

• Tingling or numbness sensation.

• Swelling, discomfort, changes in tongue color.

• Dry mouth.

• Need to urinate more frequently.

• Chills.

• Thirst sensation.

• Increased sweating.

• Hyponatremia (low sodium levels in blood).

• Hypoglycaemia (low blood sugar levels).

• Kidney failure.

• Abdominal swelling.

• Increased creatinine.

• Stomach pain.

• Changes in heart rate (e.g. increased heartbeat).

• Decrease in blood cell count.

• Weakness and/or sensory changes.

• Rare (may affect up to 1 in 1,000 people): Change in tooth surface color, which disappears with professional dental cleaning procedures.

• Change in tongue surface color to black, with a hairy appearance.

The following adverse effects have also been reported (frequency not known: frequency cannot be estimated from available data):

• Alopecia (hair loss).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Apel

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Sigre Point in your pharmacy. This helps protect the environment.

6. Contents of the pack and other information

Composition of Apel

• The active substance is linezolid. Each film-coated tablet contains 600 mg of linezolid.
• The other components are: microcrystalline cellulose (E 460), hydroxypropylcellulose (E 463), maize starch, sodium carboxymethylstarch (type A) (derived from potato starch), and magnesium stearate (E 572). The coating film contains: hypromellose (E 464), macrogol 400, titanium dioxide (E 171).

Appearance of the product and pack contents

The film-coated tablets are white, oval-shaped, biconvex, flat on both sides, with dimensions of 18 x 9 mm.

The pack contains opaque PVC/PVDC-Alu blisters with 10, 14, 20, 24, 30, 50, 60 or 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Medochemie Ltd

1-10 Konstantinoupoleos Street

3011 Limassol,

Cyprus

Manufacturer

Medochemie Ltd, Factory AZ

2 Michael Erakleous Street,

Agios Athanassios Industrial Area,

Agios Athanassios, Limassol, 4101

Cyprus

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

Date of latest revision of this leaflet: March 2026

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