Package Leaflet: Information for the User

Linezolid Normon 600 mg Film-Coated Tablets EFG

Linezolid

Read this leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Linezolid Normon 600 mg and what it is used for

2. What you need to know before taking Linezolid Normon 600 mg

3. How to take Linezolid Normon 600 mg

4. Possible side effects

5. Storage of Linezolid Normon 600 mg

6. Contents of the pack and additional information

Linezolid 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 tissue infections. Your doctor will have decided if Linezolid Normon is suitable for treating your infection.

Do not take Linezolid Normon 600 mg

• If you are allergic to linezolid or any of the other components of this medication (including those 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, for example, phenelzine, isocarboxazid, selegiline, moclobemide). These medications are usually used to treat depression or Parkinson's disease.
• If you are breastfeeding. Linezolid Normon 600 mg passes into breast milk and could affect the baby.

Warnings and precautions

Linezolid Normon 600 mg may not be suitable for you if you answer yes to any of the following questions. In that case, inform your doctor, as he/she 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 whether any of these categories apply to your case.

• Do you have high blood pressure?
• 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 present with symptoms of diarrhea, skin flushing, wheezing)?
• Do you suffer from manic depression, schizoaffective disorder, confusion, or other mental health problems?
• Are you taking any of the following medications?
• • Decongestants or antihistamines that contain pseudoephedrine or phenylpropanolamine
  • Asthma medications such as salbutamol, terbutaline, fenoterol
  • Tricyclic antidepressants or SSRIs (selective serotonin reuptake inhibitors) such as, for example: amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline
  • Migraine medications such as sumatriptan or zolmitriptan
  • Medications used to treat severe allergic reactions such as adrenaline (epinephrine)
  • Medications that increase blood pressure such as noradrenaline (norepinephrine), dopamine, and dobutamine
  • Medications used to treat moderate or severe pain, such as pethidine
  • Medications used to treat anxiety disorders such as buspirone
  • An antibiotic called rifampicin.

Be especially careful with Linezolid Normon 600 mg:

Inform your doctor before taking this medication if:

• You have a history of bleeding easily or bruising 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:

• Visual problems such as blurred vision, changes in color vision, difficulty seeing clearly, or if you notice a reduction in your field of vision
• Loss of sensation in your arms or legs or a feeling of numbness or tingling in your arms or legs
• Dyspepsia may occur while taking or after taking antibiotics, including Linezolid Normon 600 mg. If diarrhea becomes intense, lasts a long time, or if you notice that your stools contain blood or mucus, stop taking Linezolid Normon 600 mg immediately and consult your doctor. In this situation, do not take medications that stop or reduce bowel movements.
• Recurring nausea or vomiting, abdominal pain, or rapid breathing.

Other medications and Linezolid Normon 600 mg

There is a risk that Linezolid Normon 600 mg may interact with certain medications 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 weeksthe following medications, as Linezolid Normon 600 mgshould notbe taken if you are already taking these medications or have taken them recently (see also in section 2, "Do not take Linezolid Normon 600 mg"):

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

Inform your doctor also if you are taking the following medications. Your doctor may decide to treat you with Linezolid Normon 600 mg, but 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.

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

Taking Linezolid Normon 600 mg with food and drinks

Pregnancy, breastfeeding, and fertility

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

The effect of Linezolid Normon 600 mg on pregnant women is unknown. Therefore, pregnant women should not use Linezolid Normon 600 mg, unless advised by their doctor.

You should not breastfeed while taking Linezolid Normon 600 mg as it passes into breast milk and could affect your baby.

Driving and operating machinery

Linezolid Normon 600 mg may cause dizziness or visual problems. If this happens, do not drive or operate machinery. Remember that if you do not feel well, you may be affected in your ability to drive or operate machinery.

Linezolid Normon contains sodium

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

Adults

Always follow exactly the administration instructions for Linezolid Normon 600 mg as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist. The usual dose is one tablet (600 mg) twice a day (every 12 hours). Swallow the tablet whole with a little water.

If you are on dialysis, take Linezolid Normon 600 mg after each session.

The usual 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 Normon 600 mg, your doctor will perform periodic blood tests to monitor your blood count.

If you take Linezolid Normon 600 mg for more than 28 days, your doctor will monitor your vision.

Use in children and adolescents

Linezolid Normon 600 mg is not usually used in children or adolescents (under 18 years old).

If you take more Linezolid Normon 600 mg than you should

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 Linezolid Normon 600 mg

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 Linezolid Normon 600 mg

It is essential to continue taking Linezolid Normon 600 mg as instructed, unless your doctor tells you to stop.

If your initial symptoms return after interrupting treatment, inform your doctor or pharmacist immediately.

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

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

Inform your doctor, nurse or pharmacistimmediately if you notice any of the following side effects while taking Linezolid Normon 600 mg:

• 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 treatment with Linezolid Normon 600 mg may need to be discontinued.mg.
• vision problems such as blurred vision, changes in color perception, difficulty seeing clearly or if you notice a reduction in your visual field.
• severe diarrhea that contains blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases may lead to complications that can be life-threatening.
• repeated nausea or vomiting, abdominal pain or rapid breathing.
• cases of seizures or convulsions have been reported in patients taking Linezolid Normon 600 mg. Inform your doctor if you experience agitation, confusion, delirium, stiffness, tremor, ataxia and convulsions while also taking antidepressants called ISRSs (see section 2).

Cases of numbness, tingling or blurred vision have been reported in patients who have taken Linezolid Normon 600 mg for more than 28 days. If you experience vision difficulties, consult your doctor as soon as possible.

Other reported side effects include:

Common side effects:

• Fungal infections, especially in the vagina or mouth.
• Headache.
• Metalllic taste.
• Diarrhea, nausea or vomiting.
• 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).
• Change in the number of certain blood cells that can affect the ability to fight infections.
• Skin rash.
• Itching skin.
• Dizziness.
• Abdominal pain localized or generalized.
• Constipation.
• Indigestion.
• Localized pain.
• Fever.

Uncommon side effects::

• Vaginal or genital area inflammation in women.
• Numbness or tingling sensation.
• Blurred vision.
• “Tinnitus” (ringing in the ears).
• Vein inflammation.
• Dry or painful mouth, swelling, discomfort, changes in tongue color.
• Pain at the injection site (route) or around it.
• Vein inflammation (including the location where the infusion route is placed).
• Urination frequency.
• 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.
• Platelet reduction.
• Abdominal swelling.
• Transient ischemic attacks. (temporary alteration in blood flow to the brain that causes short-term symptoms such as vision loss, weakness in arms and legs, difficulty speaking and loss of consciousness).
• Skin inflammation.
• Increased creatinine.
• Stomach pain.
• Changes in heart rhythm (e.g. increased heart rate).

Rare side effects:

• Reduced visual field.
• Change in tooth surface color, which disappears with professional dental cleaning procedures (manual tartrectomy).

Frequency not known:

• Serotonin syndrome (symptoms that include rapid heart rate, confusion, abnormal sweating, hallucinations, involuntary movements, tremors and chills).
• Lactic acidosis (symptoms include repeated 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.
• Decreased blood cell count.
• Weakness and/or sensory changes.

If any of the side effects become severe or if you notice any side effect not listed in this leaflet, consult your doctor or pharmacist.

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 not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging afterCad. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment..

What Linezolid Normon 600 mg contains

The active ingredient is linezolid. Each tablet contains 600 mg of linezolid.

The other components are microcrystalline cellulose (E460), cornstarch, carboxymethylstarch sodium (type A) (derived from potato starch), hydroxypropylcellulose (E463), colloidal silicon dioxide, and magnesium stearate (E572). The coating film contains hypromellose (E464), titanium dioxide (E171), macrogol 6000, and talc.

What Linezolid Normon 600 mg looks like and contents of the packaging

Linezolid Normon 600 mg film-coated tablets are white, elongated, biconvex, and have the imprint LZN on one face of the film-coated tablet.

Linezolid Normon 600 mg tablets are available in boxes of 10, 20, 30, 50, or 60 tablets.They may not be commercially available in all packaging sizes.

This medicine is authorized in the member states of the European Economic Area under the following names:

Spain: Linezolid Normon 600 mg film-coated tablets EFG

Portugal: Linezolida Normon

Germany: Linezolid Normon 600 mg Filmtabletten

Holder of the marketing authorization and responsible manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This leaflet has been approved in:September 2015

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/