Patient Information

Linezolid Accordpharma 2 mg/ml Infusion Solution

Linezolid

Read this entire leaflet carefully before you start using 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 and you should not give it to others, even if they have the same symptoms, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

1. What Linezolid Accordpharma is and what it is used for

2. What you need to know before using Linezolid Accordpharma

3. How to use Linezolid Accordpharma

4. Possible side effects

5. Storage of Linezolid Accordpharma

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 is suitable for treating your infection.

Do not use Linezolid Accordpharma if:

- You are allergic (hypersensitive) to linezolid or any of the other components of this medication.

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

- You are breastfeeding. This medication passes into the milk and could affect the baby.

Warnings and precautions

Linezolid may not be suitable for you if you respondyesto any of the following questions. In that case, inform your doctor, as they 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 havehigh blood pressure, regardless of whether you are taking medication for this.

• 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 diarrhea, skin flushing, and shortness of breath)?

• Do you suffer from bipolar disorder, schizophrenia, confusion, or other mental health problems?

• Have you had hyponatremia in the past (low sodium levels in the blood) or used medications that reduce sodium levels in the blood, such as some diuretics (also known as "water pills") like hydrochlorothiazide?

• Do you consume opioids?

• The use of some medications, including antidepressants and opioids, in combination with linezolid, may cause serotonin syndrome, a potentially fatal condition (see section 2 "Other medications and linezolid Accordpharma" and section 4).

• Are you taking any of the following medications?

- Cold remedies containing pseudoephedrine or phenylpropanolamine.

- Medications to treat asthma such as salbutamol, terbutaline, and fenoterol.

- Certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many types of medications of this type, including amitriptyline, citalopram, clomipramine, dosulepina, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, and sertraline.

- Medications used to treat migraines such as sumatriptan or zolmitriptan.

- Medications 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.

- A type of antibiotic called rifampicin.

Be especially careful with Linezolid Accordpharma

Inform your doctor before using this medication if:

- You are elderly

- You bleed easily and bruise easily.

- You have anemia.

- 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:

- Vision problems such as blurred vision, changes in color vision, difficulty seeing clearly, or if you notice that your field of vision is reduced.

- 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, stop taking Linezolid immediately and consult your doctor. In this situation, do not take medications that stop or slow down bowel movements.

- Repeated nausea or vomiting, abdominal pain, or hyperventilation.

- Feeling unwell and experiencing muscle weakness, headache, confusion, and memory loss, which may indicate hyponatremia (low sodium levels in the blood).

Children and adolescents

Linezolid is not usually used to treat children and adolescents (under 18 years old)

Using Linezolid Accordpharma with other medications

There is a risk that Linezolid may sometimes interact with other medications, causing adverse reactions. These interactions may change blood pressure, temperature, or heart rate.

Inform your doctor or pharmacist if you are using, have used recently, or may use any other medication.

Inform your doctor if you are using or have used in the last 2 weeksthe following medications, asyou should notuse linezolid if you are still using them or if you have used them recently (see also section 2 above "Do not use Linezolid Accordpharma").

• Monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid,

selegiline, moclobemide). These medications are used to treat Parkinson's disease.

Also inform your doctor if you are using the following medications. Your doctor may decide to treat you with Linezolid, 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.

• Cold remedies containing pseudoephedrine or phenylpropanolamine.

• Some medications to treat asthma such as salbutamol, terbutaline, and fenoterol.

• Certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many types of medications of this type, including amitriptyline, citalopram, clomipramine, dosulepina, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, and sertraline.

• Medications used to treat migraines such as sumatriptan or zolmitriptan.

• Medications to treat severe allergic reactions such as adrenaline (epinephrine).

• Medications that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine.

• Opioids such as pethidine used to treat moderate or severe pain.

• Medications used to treat anxiety disorders, such as buspirone.

• Medications that prevent blood clotting, such as warfarin.

• A type of antibiotic called rifampicin.

Inform your doctor or pharmacist if you are using or have used recently other medications, even those obtained without a prescription.

Using Linezolid Accordpharma with food and drinks

• 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 barrel beer and wine. The reason is that this medication may react with a substance called tyramine that is naturally present in some foods, causing an increase in your blood pressure.

• If you experience a headache after eating or drinking, inform your doctor or pharmacist immediately.

Pregnancy, breastfeeding, and fertility

The effect of Linezolid on pregnant women is unknown. Therefore, it should not be used during pregnancy, unless your doctor advises you to do so. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not breastfeed while using Linezolid because this medication passes into the milk and could affect your baby.

Driving and operating machinery

Linezolid may cause dizziness or vision 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.

Important information about some of the components of Linezolid Accordpharma

Glucose

This medication contains 13.7 g of glucose per dose. This should be taken into account in patients with diabetes mellitus.

Sodium

This medication contains 114 mg of sodium (main component of table salt/cooking salt) in each unit of volume.This is equivalent to 5.7% of the maximum recommended daily sodium intake for an adult.

Adults

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. Consult your doctor, pharmacist, or nurse if you are unsure

This medicine will be administered to you by a doctor or other healthcare professional through infusion into a vein. The usual dose for adults (18 years or older) is 300 ml (600 mg of linezolid) twice a day administered directly into the bloodstream through a drip over a period of30 to120 minutes.

If you are on dialysis, linezolid will be administered to you 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 medicine have not been established in treatment periods exceeding 28 days. Your doctor will decide on the duration of your treatment.

While using linezolid, your doctor will perform regular blood tests to monitor your blood count.

If you use linezolid for more than 28 days, your doctor will need to monitor your vision.

Use in children and adolescentsThis is not recommended for children or adolescents (under 18 years).

Using more Linezolid than you should

If you think you have been given more linezolid than you should, inform your doctor or nurse.

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 medicine and the amount ingested.

Missing a dose of Linezolid

As this medicine is administered under close supervision, it is very unlikely that a dose will be missed. If you think a dose of the treatment has been missed, inform your doctor or nurse.

Like all medicines, Linezolid may 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:

Severe side effects (frequency in parentheses) of Linezolid are:

- Skin reactions such as red, painful and scaly skin (dermatitis), rash, itching (infrequent) or swelling particularly around the face and neck (infrequent), wheezing and/or difficulty breathing (rare). This may be a sign of an allergic reaction and may require discontinuation of linezolid treatment. Skin reactions such as purple elevated rash due to inflammation of blood vessels (infrequent), red painful and peeling skin (dermatitis) (infrequent), hives (frequent), itching (frequent).

- Vision problems (infrequent), 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 very rare circumstances may lead to complications that can be life-threatening (infrequent).

- Repeated nausea or vomiting, abdominal pain or hyperventilation (rare).

- Cases of seizures or convulsions have been reported in patients taking linezolid. Serotonin syndrome (unknown): If you are taking antidepressants known as SSRIs (selective serotonin reuptake inhibitors) or opioids in addition to Linezolid (see section 2) and notice agitation, confusion, delirium, rigidity, tremors, lack of coordination, seizures, tachycardia, severe respiratory problems and diarrhea (which may indicate serotonin syndrome), inform your doctor

Cases of numbness, tingling or blurred vision have been reported 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 vaginal or oral

- Headache

- Metallic taste in the mouth

- Diarrhea, nausea or vomiting

- Changes in some blood test results, including those that measure proteins, salt or enzymes that measure renal or hepatic function or blood glucose concentration

- Unexplained bleeding or bruising, which may be due to changes in certain blood cells that can affect blood clotting or produce anemia.

- Difficulty falling asleep

- Increased blood pressure

- Anemia (low red blood cell count)

- Change in the number of certain types of blood cells that may affect your ability to fight infections

- Skin rash

- Itching skin

- Dizziness

- Localized or general abdominal pain

- Constipation

- Indigestion

- Localized pain

- Fever

- Reduction in platelet count

Infrequent (may affect up to 1 in 100 people)

- Vaginal or genital inflammation in women

- Numbness or tingling sensations

- Blurred vision

- "Ringing" in the ears (tinnitus)

- Inflammation of the veins

- Swollen, painful, or discolored tongue, mouth or lips

- Dry mouth

- Frequent need to urinate

- Chills

- Feeling tired or thirsty

- Pancreatitis inflammation

- Increased sweating

- Convulsions

- Hyponatremia (low sodium levels in the blood)

- Kidney failure

- Reduction in platelet count

- Abdominal swelling

- Transient ischemic attacks (temporary disruptions to blood flow to the brain causing symptoms such as loss of vision, weakness in legs and arms, slurred speech 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 1000 people)

- Changes in visual field

- Change in the surface color of the teeth, which may be removed with a dental cleaning professional (tartrectomy)

Frequency not known: cannot be estimated from available data

- Serotonin syndrome (symptoms include rapid pulse, confusion, abnormal sweating, hallucinations, involuntary movements, chills and tremors)

- Lactic acidosis (symptoms include repeated nausea and vomiting, abdominal pain, hyperventilation)

- Severe skin disorders

- Sideroblastic anemia (a type of anemia)

- Alopecia (hair loss)

- 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 the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

The hospital staff will ensure that linezolid solution is not used after the use-by date printed on the bag and that it is administered immediately after breaking the seal. They will also visually inspect the solution before use and only use it if it is a transparent solution without particles. Furthermore, they will ensure that the solution is stored in its box and outer bag to protect it from light until it is used properly.

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

Do not use this medication after the expiration date that appears on the bag after “CAD”. The expiration date is the last day of the month indicated

Composition of Linezolid Accordpharma

- The active ingredient is linezolid. Each ml of solution contains 2 mg of linezolid.

- The other components are monohydrate glucose (a type of sugar), sodium citrate (E331), monohydrate citric acid (E330), hydrochloric acid (E507) or sodium hydroxide (E524) and water for injection preparations.

Appearance of the product and contents of the package

Linezolid is a transparent solution that is presented in individual infusion bags containing 300 ml (600 mg Linezolid) of solution.

The bags are supplied in boxes of 10 bags.

Holder of the marketing authorization and responsible for manufacturing

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Responsible for manufacturing

Demo S.A. Pharmaceutical Industry

21st km National Road Athens-Lamia

Krioneri Attiki 145 68, Greece

This medicinal product has been authorized in the Member States of the EU under the following names:

Spain:Linezolid Accordpharma 2 mg/ml solution for infusion

Portugal:Linezolida Accordpharma 2 mg/ml, solution for infusion

Last review date of this leaflet: April 2023

Other sources of information

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

This information is intended solely for healthcare professionals:

Linezolid Accordpharma 2 mg/ml solution for infusion

Linezolid

For more information, please consult the technical data sheet.

Dosage and administration

The treatment with linezolid should only be initiated in a hospital setting and after evaluation by a specialist doctor, such as a microbiologist or an infectious diseases specialist.

Patients who initiate treatment with the parenteral formulation may switch to any of the oral presentations when clinically indicated. In this case, no dose adjustment is required, as the oral bioavailability of linezolid is approximately 100%.

The solution for infusion should be administered over a period of 30 to 120 minutes.

The recommended dose of linezolid should be administered intravenously or orally twice a day.

Recommended duration and dosage for treatment in adults:

The duration of treatment depends on the microorganism, the site of infection, the severity, and the clinical response of the patient.

The recommendations on the duration of treatment listed below reflect those used in clinical trials. For some types of infection, it may be advisable to prescribe shorter treatments, although this has not been evaluated in clinical trials.

The maximum duration of treatment is 28 days. The safety and efficacy of linezolid have not been established when administered for periods exceeding 28 days.

Infections associated with bacteremia do not require an increase in the recommended dose or the duration of treatment. The recommended doses are identical for the solution for infusion, tablets, and oral suspension granules and are as follows:

Children:The safety and efficacy data of linezolid in children and adolescents (<18 years old) are limited.

Older patients:No dose adjustment is required.

Patients with renal insufficiency:No dose adjustment is required.

Patients with severe renal insufficiency (i.e., CLCR <30 mL/min):No dose adjustment is required in these patients. Since the clinical relevance of exposure to high concentrations (up to 10 times) of the two main metabolites of linezolid is unknown, this medication should be used with special caution in patients with severe renal insufficiency and should only be administered if the expected benefit outweighs the potential risk.

Since approximately 30% of the linezolid dose is eliminated during 3 hours of hemodialysis, linezolid should be administered after dialysis in patients who receive this treatment. The main metabolites of linezolid are eliminated in part by hemodialysis, but their concentrations are significantly higher after dialysis than in patients with normal renal function or mild to moderate renal insufficiency. Therefore, linezolid should be used with special caution in patients with severe renal insufficiency undergoing dialysis and only if the expected benefit outweighs the potential risk.

There is currently no experience with the administration of linezolid in patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or alternative treatments for renal insufficiency (other than hemodialysis).

Patients with liver insufficiency:Patients with mild to moderate liver insufficiency (Class A or B in the Child-Pugh scale): No dose adjustment is required.

Patients with mild to moderate liver insufficiency (Class C in the Child-Pugh scale):Since linezolid is metabolized by a non-enzymatic process, it is expected that liver dysfunction will not significantly alter its metabolism, and therefore, no dose adjustment is recommended. However, there are no pharmacokinetic data available, and clinical experience with linezolid in patients with severe liver insufficiency is limited. Linezolid should be used with special caution in patients with severe liver insufficiency and only if the expected benefit outweighs the potential risk.

Special precautions for disposal and other manipulationsFor single use. Check if there are minor leaks by pressing the bag firmly. If there are leaks, it should not be used because it may have lost its sterility. The solution should be visually inspected before use and only solutions that are transparent and free of particles should be used. Do not use these bags in series connections. Dispose of any remaining solution. Do not reuse used bags.

Linezolid solution for infusion is compatible with the following solutions: 5% glucose for intravenous infusion, 0.9% sodium chloride for intravenous infusion, Hartmann's solution for injection preparations (solution for intravenous infusion).

Incompatibilities

This solution should not be added to. If linezolid is administered with other medications simultaneously, each should be administered separately according to its instructions for use. Similarly, if the same intravenous route is used for the sequential infusion of several medications, this should be washed before and after the administration of linezolid with a compatible solution.

It is known that Linezolid solution for infusion is not physically compatible with the following compounds: amphotericin B, chlorpromazine hydrochloride, diazepam, pentamidine isothionate, erythromycin lactobionate, phenytoin sodium, and sulfamethoxazole / trimethoprim. Additionally, it is chemically incompatible with ceftriaxone sodium.

Expiry date

After opening: From a microbiological point of view, the product should be used immediately, unless the opening method prevents the risk of microbial contamination. If not used immediately, the storage times in use and the conditions before use are the responsibility of the user.