APEL 600 mg FILM-COATED TABLETS

2. What you need to know before taking Apel

Do not take Apel:

• if you are allergic to linezolid or any of the other components of this medication (listed in section 6).
• if you are taking or have taken in the last 2 weeks any medication called monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid, selegiline, moclobemide). These medications 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

Consult your doctor, pharmacist, or nurse before starting to use this medication.

Linezolid may not be suitable for you if you answer yesto any of the following questions. In that case, inform your doctor, as they will need to monitor your overall health and blood pressure before and during treatment or may decide that another treatment is better for you. Ask your doctor if you are unsure if any of these categories apply to your case.

• Do you have high blood pressure, whether or not you are taking medication to treat 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 that cause symptoms such as diarrhea, skin flushing, and wheezing)?
• Do you suffer from manic depression, schizoaffective disorder, mental confusion, or other mental problems?
• Do you have a history of hyponatremia (low sodium levels in the blood) or take medications that reduce sodium levels in the blood, such as certain diuretics like hydrochlorothiazide?
• Do you take opioids?

The use of certain medications, including antidepressants and opioids, along with Apel may cause serotonin syndrome, a potentially life-threatening condition (see section 2 "Other medications and Apel" and section 4).

Be careful with Apel:

Inform your doctor before taking this medication if:

• You are an elderly patient.
• You bruise easily and bleed.
• 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 the following appear during treatment:

• vision problems such as blurred vision, changes in color vision, difficulty seeing clearly, or if you notice that your field of vision is reduced.
• loss of sensation in the 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 the diarrhea becomes intense, lasts a long time, or if you notice that your stool contains blood or mucus, you should stop taking this medication immediately and consult your doctor. In this situation, you should not take medications that stop or reduce intestinal movements.
• repeated nausea or vomiting, abdominal pain, or rapid breathing.
• unexplained muscle pain, sensitivity, or weakness, and/or dark urine. These can be signs of a serious disease called rhabdomyolysis (muscle degradation), which can cause kidney damage.
• discomfort and dizziness with muscle weakness, headache, confusion, and memory impairment that may indicate hyponatremia (low sodium levels in the blood).

Taking Apelwithother medications

Occasionally, linezolid may interact with certain medications and produce side effects such as changes in blood pressure, body temperature, or heart rate.

Inform your doctor if you are taking or have taken in the last 2 weeksthe following medications, as you should not take linezolid if you are still taking them or have taken them recently (see also section 2 "Do not take Apel"):

• Monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid, selegiline, moclobemide). These medications are usually used to treat Parkinson's disease.

Also, inform your doctor if you are taking the following medications. Your doctor may decide to treat you with linezolid, but they will need to assess your overall health and blood pressure before and during treatment. In other cases, your doctor may decide that another treatment is better for you.

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

Inform your doctor, pharmacist, or nurse if you are using or have recently used any other medication, even those purchased without a prescription.

Taking Apelwithfood, drinks, and alcohol

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

• Avoid eating excessive amounts of cheese, yeast extracts, or soybean extracts (such as soy sauce) and alcoholic beverages, especially beer and wine. The reason is that linezolid can react with a substance called tyramine that is naturally present in some foods. This interaction can cause an increase in your blood pressure.
• If you start experiencing pulsating headache after eating or drinking, inform your doctor, pharmacist, or nurse immediately.

Pregnancy, breastfeeding, and fertility

The effect of linezolid on 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not breastfeed while taking linezolid because this medication passes into breast milk and could affect your baby.

Driving and using machines

Linezolid can cause dizziness or vision problems. If this happens, do not drive or use machines. Remember that if you are not feeling well, your ability to drive or use machines may be affected.

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

3. How to take Apel

Adults

Always follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is one film-coated tablet (600 mg) twice a day (every 12 hours). You should swallow the film-coated tablet whole with a little water.

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

The normal treatment duration is 10-14 days, but it may be extended up to 28 days. The safety and efficacy of this medication 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 or adolescents (under 18 years).

If you take more Apel than you should

Inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Apel

Take the missed tablet as soon as you remember. Take the next tablet 12 hours later and continue taking the tablets every 12 hours. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Apel

It is essential that you only interrupt your treatment if your doctor advises you to do so. If you interrupt your treatment and the initial symptoms return, inform your doctor or pharmacist immediately.

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

4. Possible side effects

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

Inform your doctor, nurse, or pharmacist immediatelyif you notice any of the following side effects while being treated with linezolid:

The most serious side effects of linezolid (whose frequency is between parentheses) are:

• Severe skin reactions (uncommon), swelling, particularly around the face and neck (uncommon), wheezing, and/or difficulty breathing (rare). This may be a sign of an allergic reaction, and it may be necessary to interrupt treatment with linezolid. Skin reactions such as a purple elevated rash due to inflammation of the blood vessels (rare), red, painful, and scaly skin (dermatitis) (uncommon), skin rash (frequent), itching (frequent).
• vision problems (uncommon) such as blurred vision (uncommon), changes in color perception (unknown), difficulty seeing clearly (unknown), or if you notice that your field of vision is reduced (rare).
• severe diarrhea that contains blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare circumstances may lead to life-threatening complications (uncommon).
• repeated nausea or vomiting, abdominal pain, or rapid breathing (rare).
• seizures or convulsions (uncommon) have been reported in patients treated with linezolid.
• Serotonin syndrome (unknown): you should inform your doctor if you experience agitation, confusion, delirium, rigidity, tremor, incoordination, convulsions, rapid heartbeat, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome), while also being treated with antidepressants called SSRIs and opioids (see section 2).
• Unexplained bleeding or bruising, which may be due to an alteration in the number of certain blood cells that can affect blood clotting or cause anemia (frequent).
• Reduction in the number of blood cells that can affect the ability to fight infections (uncommon). Some signs of infection include: fever (frequent), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• Rhabdomyolysis (uncommon): signs and symptoms include unexplained muscle pain, sensitivity, or weakness, and/or dark urine. These can be signs of a serious disease called rhabdomyolysis (muscle degradation), which can cause kidney damage.
• Pancreatitis (uncommon).
• Convulsions (uncommon).
• Transient ischemic attacks (temporary alteration of blood flow to the brain that causes 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).

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

Other side effects include:

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

• Fungal infections, especially in the vagina or mouth.
• Headache.
• Metallic taste.
• Diarrhea, vomiting, nausea.
• Alteration of some blood test results, including protein, salt, or enzyme tests that measure liver, kidney, or blood sugar function.
• Difficulty sleeping.
• Increased blood pressure.
• Anemia (reduction in the number of red blood cells).
• Dizziness.
• Abdominal pain, localized or generalized.
• Constipation.
• Indigestion.
• Localized pain.
• Reduced platelet count.

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

• Vaginal or genital inflammation in women.
• Feeling of tingling or numbness.
• Swelling, discomfort, color changes of the tongue.
• Dry mouth.
• Need to urinate more frequently.
• Chills.
• Feeling of thirst.
• Increased sweating.
• Hyponatremia (low sodium levels in the blood).
• Kidney failure.
• Abdominal swelling.
• Increased creatinine.
• Stomach pain.
• Changes in heart rhythm (e.g., increased heart rate).
• Decreased blood cell count.
• Weakness and/or sensory changes.

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

The following side effects have also been reported(unknown: frequency cannot be estimated from available data):

• Alopecia (hair loss).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Apel

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away down the drain or in the trash. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Apel

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

Appearance of the Product and Packaging Content

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

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

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Medochemie Ltd

1-10 Constantinoupoleos 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 the last revision of thisleaflet:January 2025

Detailed 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/).