LINEZOLID KERN PHARMA 600 mg FILM-COATED TABLETS

2. What you need to know before you take Linezolid Kern Pharma

Do not take this medicine if:

• You are allergic to linezolid or any of the other ingredients of this medicine (listed in section 6).
• You are taking or have taken in the last 2 weeks certain medications called monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid, selegiline, moclobemide). These medications are usually used to treat depression or Parkinson's disease.
• You are breastfeeding. The reason is that this medication passes into breast milk and may affect the baby.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with linezolid.

This medication may not be suitable for you if you answer yesto any of the following questions. In that case, inform 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 not sure if any of these categories apply to your case.

• Do you have high blood pressure, whether or not you are taking medications 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, schizophrenic disorder, mental confusion, or other mental problems?

Be careful with Linezolid Kern Pharma

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 immediatelyif any of the following occur 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.
• Numbness or tingling in your arms or legs or a sensation of burning or tingling in your arms or legs.
• Diarrhea may occur while taking or after taking antibiotics, including linezolid. If diarrhea becomes severe, lasts a long time, or if you notice that your stools contain blood or mucus, you should stop taking Linezolid immediately and consult your doctor. In this situation, do not take medications that stop or reduce intestinal movements.
• Repeated nausea or vomiting, abdominal pain, or rapid breathing.

Using Linezolid Kern Pharma with other medications

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

Inform your doctor or pharmacist if you are taking or have recently taken any other medication.

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

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

Also, inform your doctor if you are taking the following medications. 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.

• Cold remedies that contain pseudoephedrine or phenylpropanolamine.
• Certain medications for 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 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.
• Medications that prevent blood clotting such as warfarin.
• An antibiotic called rifampicin.

Taking Linezolid Kern Pharma with food, 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 draft beer and wine. The reason is that this medication 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 headaches 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 this medication 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 Kern Pharma because this medication passes into breast milk and may 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 are not feeling well, your ability to drive or use machines may be affected.

Linezolid Kern Pharma 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 Kern Pharma

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Adults

The recommended dose is one film-coated tablet (600 mg of linezolid) 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 this medication, 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 of age).

If you take more Linezolid Kern Pharma 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 Kern Pharma

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 Kern Pharma

It is important that you only stop your treatment if your doctor tells you to.

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, pharmacist.

4. Possible side effects

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

Tell your doctor, nurse, or pharmacist immediatelyif you notice any of the following side effects while taking this medication:

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

• Severe skin reactions (unknown), swelling, particularly around the face and neck (unknown), wheezing, and/or difficulty breathing (unknown). This may be a sign of an allergic reaction and may require discontinuation of linezolid treatment.
• Skin reactions such as red, painful, and scaly skin (dermatitis) (uncommon), skin rash (common), itching (common).
• Vision problems such as blurred vision (uncommon), changes in color perception (unknown), difficulty seeing details (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 (rare).
• Repeated nausea or vomiting, abdominal pain, or rapid breathing (unknown).
• Seizures or convulsions (uncommon) have been reported in patients treated with this medication. You should inform your doctor if you experience agitation, confusion, delirium, stiffness, tremor, discoordination, and convulsions while also being treated with antidepressants called SSRIs (see section 2) (unknown).
• Bleeding or unexplained bruising, which may be due to an alteration in the number of certain blood cells that can affect blood clotting or cause anemia (common).
• Reduction in the number of blood cells that can affect the ability to fight infections (common). Some signs of infection include fever (common), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• Pancreatitis (inflammation of the pancreas) (uncommon).
• Seizures (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:

Common side effects(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 liver, kidney, or blood sugar tests.
• Difficulty sleeping.
• Increased blood pressure.
• Anemia (reduction in the number of red blood cells).
• Dizziness.
• Abdominal pain, localized or generalized.
• Constipation.
• Indigestion.
• Localized pain.

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

• Vaginal or genital inflammation in women.
• Feeling of tingling or numbness.
• Vein inflammation (only IV).
• Swelling, discomfort, color changes of the tongue.
• Need to urinate more frequently.
• Chills.
• Feeling of thirst.
• Increased sweating.
• Alteration in proteins, salts, or enzymes in the blood that measure liver or kidney function.
• Hyponatremia (low sodium levels in the blood).
• Kidney failure.
• Reduction in the number of platelets.
• Abdominal swelling.
• Pain at the injection site.
• Increased creatinine.
• Stomach pain.
• Changes in heart rhythm (e.g., increased heart rate).

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

• Change in tooth color, which disappears with professional dental cleaning procedures.

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

• Alopecia (hair loss).
• Decrease in blood cell count.
• Weakness and/or sensory changes.

Reporting of side effects

If you experience any side effects, 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 Medication Surveillance System for Human Use https://ww.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Linezolid Kern Pharma

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

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging or blister after “EXP”. The expiration date is the last day of the month indicated. This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Linezolid Kern Pharma

• The active ingredient is linezolid. Each film-coated tablet contains 600 mg of linezolid.
• The other ingredients are: cornstarch, microcrystalline cellulose 101 (E460i), hydroxypropylcellulose (E463), microcrystalline cellulose 102 (E460i), sodium carboxymethyl starch (type A) (from potato), and magnesium stearate. The coating contains: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 400 (E1521), and talc (E553b).

Appearance of the product and pack contents

Linezolid Kern Pharma 600 mg film-coated tablets EFG are oval-shaped, white, and scored on one side. The score line is to facilitate breaking and ease swallowing but not to divide into equal doses.

The film-coated tablets of linezolid are presented in PVC/Aluminum blisters. Each pack contains a total of 10 film-coated tablets (only for hospital use).

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this leaflet:September 2019

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/