Linezolid Normon 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Linezolid Normon 600 mg film-coated tablets EFG

Linezolid

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Linezolid Normon 600 mg is 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. How to store Linezolid Normon 600 mg
6. Contents of the pack and other information

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

Linezolid is an antibiotic belonging to the oxazolidinone class that works 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 whether Linezolid Normon is suitable for treating your infection.

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 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 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 such cases, 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 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?
• Have you been diagnosed with hyperactive thyroid?
• Do you have a tumour of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumours in the hormonal system, associated with symptoms such as diarrhoea, skin flushing, and wheezing)?
• Do you suffer from manic depression, schizoaffective disorder, confusion, or other mental health problems?
• Are you taking any of the following medicines?
  • Decongestants or cold remedies containing pseudoephedrine or phenylpropanolamine
  • Medicines to treat asthma such as salbutamol, terbutaline, fenoterol
  • Antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors), for example: amitriptilina, citalopram, clomipramine, dosulepina, doxepina, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, 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
  • Medicines used to treat moderate to severe pain, such as meperidine
  • Medicines used to treat anxiety disorders such as buspirone
  • An antibiotic called rifampicin.

Take special care with Linezolid Normon 600 mg:

Inform your doctor before taking this medicine if:

• You bruise easily or bleed easily
• 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 a reduction in your visual field
• Loss of sensation in your arms or legs, or a tingling or burning sensation in your arms or legs
• Diarrhoea may occur while taking or after taking antibiotics, including Linezolid Normon 600 mg. If diarrhoea becomes severe, persists for a long time, or if you notice blood or mucus in your stools, you must stop taking Linezolid Normon 600 mg immediately and consult your doctor. In this situation, you should not take medicines that stop or reduce intestinal movements.
• Nausea or repeated vomiting, abdominal pain, or rapid breathing.

Other medicines and Linezolid Normon 600 mg

There is a risk that Linezolid Normon 600 mg may interact with certain medicines and cause adverse effects such as changes in blood pressure, body temperature, or heart rate.

Inform your doctor if you are taking or have taken within the last 2 weeks the following medicines, as Linezolid Normon 600 mg must not be taken if you are already taking these medicines or have taken them recently (see also section 2, "Do not take Linezolid Normon 600 mg"):

• 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 decide to treat you with Linezolid Normon 600 mg, 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 or cold remedies containing pseudoephedrine or phenylpropanolamine.
• Medicines to treat asthma such as salbutamol, terbutaline, fenoterol.
• Antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors), for example: amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, 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.
• Medicines used to treat moderate to severe pain, such as meperidine.
• Medicines used to treat anxiety disorders such as buspirone.
• Medicines that prevent blood clotting such as warfarin.

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

Taking Linezolid Normon 600 mg with food and drink

• You may take Linezolid Normon 600 mg before, during, or after meals.
• Avoid eating excessive amounts of cheese, yeast extracts, or soybean seed extracts (e.g. soy sauce), and avoid alcoholic beverages, especially draught beer and wine. This is because this medicine can react with a substance called tyramine, which occurs naturally in some foods. This interaction may cause an increase in your blood pressure.
• If you develop a headache 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 are planning to become pregnant, consult your doctor before using this medicine.

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

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

Driving and using machines

Linezolid Normon 600 mg 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.

Linezolid Normon contains sodium

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

3. How to take Linezolid Normon 600 mg

Adults

Always follow exactly the instructions for administration of Linezolid Normon 600 mg given by your doctor. If you have any doubts, consult your doctor or pharmacist. The usual dose is one tablet (600 mg) twice daily (every 12 hours). You should swallow the tablet whole with some water.

If you are on a dialysis regimen, you must take Linezolid Normon 600 mg 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 you are 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 longer than 28 days, your doctor should monitor your vision.

Use in children and adolescents

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

If you take more Linezolid Normon 600 mg than you should

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, indicating the medicine and the amount ingested.

If you forget to take Linezolid Normon 600 mg

Take the missed tablet as soon as you remember. Then take the next 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 Linezolid Normon 600 mg

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

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 or pharmacist.

4. Possible adverse effects

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

Immediately inform your doctor, nurse, or pharmacist if you notice any of the following adverse effects while being treated with Linezolid Normon 600 mg:

• skin reactions such as red, sore, and scaly skin (dermatitis), 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 visual field.
• severe diarrhea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases could lead to complications that may become life-threatening.
• repeated nausea or vomiting, abdominal pain, or rapid breathing.
• seizures or convulsions have been reported in patients treated with Linezolid Normon 600 mg. You should tell your doctor if you experience agitation, confusion, delirium, stiffness, tremor, lack of coordination, or convulsions while also being treated with antidepressants known as SSRIs (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 problems, consult your doctor as soon as possible.

Other reported adverse effects include:

Frequent adverse effects:

• Fungal infections, especially in the vagina or mouth.
• Headache.
• Metallic taste.
• Diarrhea, nausea, or vomiting.
• Abnormal blood test results, including liver function tests, kidney function tests, or blood sugar levels.
• Unexplained bleeding or bruising, possibly due to changes in the number of certain blood cells that may affect blood clotting or cause anemia.
• Difficulty sleeping.
• Increased blood pressure.
• Anemia (reduction in the number of red blood cells).
• Changes in the number of certain blood cells that may affect the ability to fight infections.
• Skin rash.
• Itching of the skin.
• Dizziness.
• Localized or generalized abdominal pain.
• Constipation.
• Indigestion.
• Localized pain.
• Fever.

Uncommon adverse effects:

• Inflammation of the vagina or female genital area.
• Tingling or numbness sensation.
• Blurred vision.
• Ringing in the ears (tinnitus).
• Vein inflammation.
• Dry or sore mouth, swelling, discomfort, color changes of the tongue.
• Pain at the injection site (infusion site) or around it.
• Inflammation of the veins (including at the site where the infusion line is placed).
• Need to urinate more frequently.
• Chills.
• Feeling of fatigue or thirst.
• Pancreatitis.
• Increased sweating.
• Changes in proteins, salts, or enzymes in the blood that measure liver or kidney function.
• Seizures.
• Hyponatremia (low sodium levels in blood).
• Hypoglycemia (low blood sugar levels).
• Kidney failure.
• Reduction in platelet count.
• Abdominal swelling.
• Transient ischemic attacks (temporary disruption of blood flow to the brain causing 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 rate (e.g., increased heart rate).

Rare adverse effects:

• Reduction in visual field.
• Discoloration of tooth surfaces, which resolves with professional dental cleaning procedures (manual tartrectomy).
• Black, hairy appearance of the tongue surface.

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 (low red blood cell count)).
• Alopecia (hair loss).
• Changes in color vision or difficulty seeing details.
• Decrease in blood cell counts.
• Weakness and/or sensory changes.

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

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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Linezolid Normon 600 mg

Keep this medicine out of sight and reach of children.

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.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Linezolid Normon 600 mg contains

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

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

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

Linezolid Normon 600 mg film-coated tablets are white, elongated, biconvex tablets with the imprint "LZN" on one side of the film-coated tablet.

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

This medicinal product 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: 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/

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80368/P_80368.html