LINEZOLID NORMON 600 mg FILM-COATED TABLETS

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

Do not take Linezolid Normon 600 mg

• 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 known as 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 Normon 600 mg passes into breast milk and may affect your 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 this case, inform your doctor, as they 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?
• 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, wheezing)?
• Do you suffer from manic depression, schizoaffective disorder, mental confusion, or other mental problems?
• Are you taking any of the following medications?
• • decongestant or anti-cold medications containing pseudoephedrine or phenylpropanolamine
  • medications for asthma such as salbutamol, terbutaline, fenoterol
  • antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors) such as amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, 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
  • 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 careful with Linezolid Normon 600 mg:

Inform your doctor before taking this medication if:

• 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 a reduction in your field of vision
• loss of sensation in your arms or legs or a feeling of tingling or burning in your arms or legs
• you may experience diarrhea while taking or after taking antibiotics, including Linezolid Normon 600 mg. If the diarrhea becomes severe, lasts a long time, or if you notice that your stools contain blood or mucus, you should stop taking Linezolid Normon 600 mg 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

Other medications and Linezolid Normon 600 mg

There is a risk that Linezolid Normon 600 mg 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 Linezolid Normon 600 mg should notbe taken if you are already taking these medications or have taken them recently (see also section 2, "Do not take Linezolid Normon 600 mg"):

• 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 Normon 600 mg, 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 or anti-cold medications containing pseudoephedrine or phenylpropanolamine
• medications for asthma such as salbutamol, terbutaline, fenoterol
• antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors) such as amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, 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
• medications used to treat moderate or severe pain, such as pethidine
• medications used to treat anxiety disorders such as buspirone
• medications that prevent blood clotting such as warfarin

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

Taking Linezolid Normon 600 mg with food and drinks

• You can take Linezolid Normon 600 mg before, during, or after meals.
• Avoid eating excessive amounts of cheese, yeast extracts, or soybean extracts (such as soy sauce) and alcoholic beverages, especially draft beer and wine. The reason is that this medication may 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 headaches after eating or drinking, inform your doctor or nurse immediately.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 may affect your baby.

Driving and using machines

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

Linezolid Normon contains sodium

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

3. How to take Linezolid Normon 600 mg

Adults

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

If you are on a dialysis program, you should 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 for treatment periods longer than 28 days. Your doctor will decide 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 should monitor your vision.

Use in children and adolescents

Linezolid Normon 600 mg is not normally used in children or adolescents (under 18 years of age).

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 stop taking Linezolid Normon 600 mg

It is essential to continue taking Linezolid Normon 600 mg as indicated by your doctor, unless your doctor tells you to stop the treatment.

If your initial symptoms return when you stop treatment, inform your doctor or pharmacist immediately

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone experiences them.

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

There have been reports of numbness, tingling, or blurred vision 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
• metallic taste
• diarrhea, nausea, or vomiting
• changes in some blood test results, including liver or kidney function tests or blood sugar levels
• unexplained bleeding or bruising, which may be due to changes in the number of certain blood cells that can affect blood clotting or cause anemia
• difficulty sleeping
• increased blood pressure
• anemia (reduced red blood cell count)
• changes in the number of certain blood cells that can affect the ability to fight infections
• skin rash
• itching
• dizziness
• abdominal pain
• constipation
• indigestion
• localized pain
• fever

Uncommon side effects:

• vaginal or genital inflammation in women
• tingling or numbness sensation
• blurred vision
• "ringing" in the ears (tinnitus)
• vein inflammation
• dry, painful mouth, swelling, discomfort, or changes in tongue color
• pain at the injection site or around it
• vein inflammation (including the site where the infusion is administered)
• need to urinate more frequently
• chills
• feeling of fatigue or thirst
• pancreatitis
• increased sweating
• changes in blood proteins, salts, or enzymes that measure liver or kidney function
• seizures
• hyponatremia (low sodium levels in the blood)
• kidney failure
• reduced platelet count
• abdominal swelling
• transient ischemic attacks (temporary disruption of 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 (such as increased heart rate)

Rare side effects:

• reduced field of vision
• change in tooth surface color, which disappears with professional dental cleaning procedures (manual tartrectomy)

Frequency not known:

• serotonin syndrome (symptoms include rapid heart rate, confusion, abnormal sweating, hallucinations, involuntary movements, tremors, and shivering)
• lactic acidosis (symptoms include repeated nausea and vomiting, abdominal pain, rapid breathing)
• severe skin disorders
• sideroblastic anemia (a type of anemia with low red blood cell count)
• 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 package leaflet, consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package 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. Storage of Linezolid Normon 600 mg

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

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be thrown away down the drain or in the trash. Deposit the packaging and any unused medications in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

What Linezolid Normon 600 mg contains

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

The other ingredients are microcrystalline cellulose (E460), corn starch, sodium carboxymethyl starch (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 package contents

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

Linezolid Normon 600 mg tablets are available in boxes of 10, 20, 30, 50, or 60 tablets. Not all pack sizes may be marketed.

This medication 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

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

This leaflet was approved in:September 2015

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