Prospecto:Information for the User

Apel 600 mg Film-Coated Tablets

linezolid

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor,pharmacistor nurse.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

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

1.What is Apel and how is it used

2.What you need to knowbeforestarting totake Apel

3.How to take Apel

4.Possible adverse effects

5Storage of Apel

6.Contents of the package and additional information

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

It is used for the treatment of pneumonia and certain skin or subcutaneous infections..Your doctor will have decided if Apel is suitable for treating your infection.

Do not take Apel:

- if you are allergic to linezolid or any of the other ingredients in this medicine (listed in section 6).

- if you are taking or have taken in the last 2 weeks any medicine called monoamine oxidase inhibitors (MAOIs such as phenelzine, isocarboxazid, selegiline, moclobemide). These medicines are usually used to treat depression or Parkinson's disease.

- if you are breastfeeding. Linezolid passes into the milk and could affect the baby.

Warnings and precautions

Consult 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 that case, tell your doctor, as he/she will need to monitor your general 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 whether any of these categories apply to your case.

• Do you have high blood pressure, whether or not you are taking medicines to treat it?
• Have you been diagnosed with hyperthyroidism?
• Do you have a tumour of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumours in the hormonal system that present with symptoms of diarrhoea, skin flushing, wheezing)?
• Do you have manic depression, schizoaffective disorder, confusion or other mental health problems?
• Are you taking any of the following medicines?

• decongestants for colds or flu that contain pseudoephedrine or phenylpropanolamine
• asthma medicines such as salbutamol, terbutaline, fenoterol
• tricyclic antidepressants or SSRI (selective serotonin reuptake inhibitors) such as 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 severe allergic reactions such as adrenaline (epinephrine)
• medicines that increase blood pressure such as noradrenaline (norepinephrine), dopamine and dobutamine
• medicines used to treat moderate or severe pain such as pethidine
• medicines used to treat anxiety disorders such as buspirone
• a type of antibiotic called rifampicin

Be especially careful with Apel:

Inform your doctor before taking this medicine if:

• You bruise easily and bleed a lot.
• You have anaemia (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 diarrhoea.

Inform your doctor immediately if during treatment you experience:

• vision problems such as blurred vision, changes in colour vision, difficulty seeing clearly or if you notice that your field of vision is reduced.
• numbness or tingling in your arms or legs.
• diarrhoea while taking or after taking antibiotics, including linezolid. If the diarrhoea becomes severe, lasts a long time, or if you notice that your stools contain blood or mucus, stop taking this medicine immediately and consult your doctor. In this situation, do not take medicines that stop or slow down bowel movements.
• repeated nausea or vomiting, abdominal pain or rapid breathing.

Taking Apel with other medicines

Linezolid may interact with certain medicines and produce adverse 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 weeks the following medicines, as you should not take linezolid if you are still taking them or if you have taken them recently (see also section 2 above “Do not take Apel”):

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

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

• decongestants for colds that contain pseudoephedrine or phenylpropanolamine.
• some medicines for asthma such as salbutamol, terbutaline, fenoterol.
• some antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many types of these medicines, 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 severe allergic reactions such as adrenaline (epinephrine).
• medicines that increase blood pressure such as noradrenaline (norepinephrine), dopamine and dobutamine.
• medicines used to treat moderate or severe pain such as pethidine.
• medicines used to treat anxiety disorders such as buspirone.
• medicines that prevent blood clotting such as warfarin.

Inform your doctor, pharmacist or nurse if you are using or have used recently any other medicine, including those bought without a prescription.

Taking Apel with food, drink and alcohol

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

• Avoid eating large amounts of cheese, yeast extracts or soybean extracts (such as soy sauce) and alcoholic drinks, especially draught beer and wine. The reason is that linezolid may react with a substance called tyramine that is naturally present in some foods. This interaction may 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, or 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 because this medicine passes into the milk and could affect your baby.

Driving and using machines

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

This medicine contains less than 23 mg of sodium (1mmol) per dose; this is, essentially “sodium-free”.

Adults

Always follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

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

If you are on dialysis, 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 in treatment periods exceeding 28 days. Your doctor will decide on 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 will 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

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

If you forgot 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 instructs you to do so. If your initial symptoms return after interrupting your treatment, inform your doctor or pharmacist immediately.

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

Like all medicines, this medicine 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 taking linezolid:

• Skin reactions such as red, painful and scaly skin (dermatitis), skin rash, itching or swelling, particularly around the face and neck. This may be a sign of an allergic reaction and may require discontinuation of linezolid treatment.
• Visual problems such as blurred vision, changes in color perception, difficulty seeing clearly or if you notice a reduction in your visual field.
• Severe diarrhea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases may lead to complications that can be life-threatening.
• Recurring nausea or vomiting, abdominal pain or rapid breathing.
• There have been reports of seizures or convulsions in patients taking linezolid. Inform your doctor if you experience agitation, confusion, delirium, stiffness, tremors, clumsiness and convulsions while also taking antidepressants called ISRSs (see section 2).

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.
• Metalllic taste.
• Diarrhea, vomiting, nausea.
• Alteration of some blood test results, including liver, kidney function tests or blood sugar levels.
• Unexplained bleeding or bruising, which may be due to a change in the number of certain blood cells that can affect blood clotting or cause anemia.
• Difficulty sleeping.
• Increased blood pressure.
• Anemia (reduction in the number of red blood cells).
• Reduction in the number of white blood cells that can affect the ability to fight infections.
• Skin rash.
• Itching.
• Dizziness.
• Abdominal pain localized or generalized.
• Constipation.
• Indigestion.
• Localized pain.
• Fever.

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

• Vaginal or genital area inflammation in women.
• Numbness or tingling.
• Blurred vision.
• “Tinnitus” (ringing in the ears).
• Vein inflammation (only IV).
• Dry or painful mouth, swelling, discomfort, changes in tongue color.
• Increased need to urinate.
• Chills.
• Sensation of fatigue or thirst.
• Pancreatitis inflammation.
• Increased sweating.
• Alteration in blood proteins, salts or enzymes that measure liver or kidney function.
• Seizures.
• Hyponatremia (low sodium levels in blood).
• Renal failure.
• Reduction in platelet count.
• Abdominal swelling.
• Transient ischemic attacks (temporary alteration in blood flow to the brain causing short-term symptoms such as vision loss, weakness in arms and legs, difficulty speaking and loss of consciousness).
• Pain at the injection site.
• Skin inflammation.
• Increased creatinine.
• Stomach pain.
• Changes in heart rhythm (e.g. increased heart rate).

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

• Reduced visual field.
• Change in tooth enamel color, which disappears with professional dental cleaning procedures.

Also, the following side effects have been reported(unknown: the frequency cannot be estimated from available data):

• Serotonin syndrome (symptoms include rapid heart rate, confusion, abnormal sweating, hallucinations, involuntary movements, tremors and chills).
• Lactic acidosis (symptoms include recurring nausea and vomiting, abdominal pain, rapid breathing).
• Severe skin disorders.
• Sideroblastic anemia (a type of anemia (low red blood cell count).
• Alopecia (hair loss).
• Changes in color vision or difficulty seeing details.
• Reduction in blood cell count.
• Weakness and/or sensory changes.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

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

Keepthis medicationout of the sight and reach of children.

This medication does not require special storage conditions.

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

Medicines should not be thrown down the drain or in the trash. Dispose of the packaging and unused medications at thePharmacy Take-Backpoint. By doing so, you will help protect the environment.

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), hydroxypropyl cellulose (E 463), cornstarch, carboxymethyl sodium (type A) (derived from potato starch) and magnesium stearate (E 572). The coating contains: hypromellose (E 464), macrogol 400, titanium dioxide (E 171).

Appearance of the product and contents of the packaging

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 sizes of packaging may be commercially available.

Marketing Authorization Holder

Medochemie Ltd

1-10 Constantinoupoleos street

3011 Limassol,

Cyprus

Responsible for Manufacturing

Medochemie Ltd, Factory AZ

2 Michael Erakleous Street,

Agios Athanassios Industrial Area,

Agios Athanassios, Limassol, 4101

Cyprus

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044Madrid

SPAIN

Last review date of thisleaflet:September 2018

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