Linezolid Hikma 2 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Linezolid Hikma 2 mg/ml solution for infusion EFG

Read all of this 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, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Linezolid Hikma is and what it is used for
2. What you need to know before using Linezolid Hikma
3. How to use Linezolid Hikma
4. Possible side effects
5. How to store Linezolid Hikma
6. Contents of the pack and other information

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

Linezolid is an antibiotic belonging to the oxazolidinone group that works by preventing the growth of certain bacteria (germs) that cause infections. It is used to treat pneumonia and certain skin or subcutaneous tissue infections. Your doctor will decide whether Linezolid is appropriate for treating your infection.

2. What you need to know before using Linezolid Hikma

Do not use Linezolid Hikma:

• if you are allergic to linezolid or to 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, for example, phenelzine, isocarboxazid, selegiline, moclobemide). These medicines may be used to treat depression or Parkinson's disease.
• if you are breastfeeding. Linezolid passes into breast milk and could affect the baby.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Linezolid.

Linezolid 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 better for you.

Ask your doctor if you are unsure whether any of these categories apply to you.

• Do you have high blood pressure, whether or not you are taking medication for it?
• 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, presenting symptoms such as diarrhoea, skin flushing, wheezing)?
• Do you suffer from bipolar disorder, schizophrenia, mental confusion, or other mental health problems?
• Are you taking opioids?

The use of certain medicines, including antidepressants and opioids, together with Linezolid may cause serotonin syndrome, a potentially life-threatening condition (see section 2 “Use of Linezolid Hikma with other medicines” and section 4).

Take special care with Linezolid Hikma

Inform your doctor before using 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 if you notice a reduction in your visual field.
• Loss of sensation in 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. If diarrhoea becomes severe, persists for a long time, or if you notice blood or mucus in your stools, you must stop taking Linezolid 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.

Use of Linezolid Hikma with other medicines

Sometimes, Linezolid can interact with certain medicines and cause adverse effects such as changes in blood pressure, body temperature, or heart rate.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Tell your doctor if you are taking or have taken within the last 2 weeks the following medicines, as you must not use Linezolid if you are still taking them or have taken them recently (see also the section 2 above “Do not use Linezolid Hikma”).

• monoamine oxidase inhibitors (MAOIs, such as phenelzine, isocarboxazid, selegiline, moclobemide). These medicines may be used to treat depression or Parkinson's disease.

Also inform your doctor if you are taking the following medicines. Your doctor may decide to treat you with Linezolid, 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 better for you.

• Cold decongestants containing pseudoephedrine or phenylpropanolamine.
• Certain medicines for treating asthma such as salbutamol, terbutaline, fenoterol.
• Certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many medicines in this group, including amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline, or certain medicines used to treat opioid dependence such as buprenorphine. These medicines may interact with linezolid and you may experience symptoms such as rhythmic and involuntary muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, excessive reflexes, increased muscle tone, body temperature above 38°C. Contact your doctor if you experience these symptoms.
• 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, opioids such as meperidine.
• Medicines used to treat anxiety disorders, such as buspirone.
• Medicines that prevent blood clotting, such as warfarin.
• An antibiotic called rifampicin.

Use of Linezolid Hikma with food, drinks, and alcohol

• You may take Linezolid before, during, or after meals.
• Avoid eating large amounts of cheese, yeast extracts, or soybean extracts (e.g. soy sauce), and avoid alcoholic beverages, especially draught beer and wine. This is because this medicine may 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 throbbing headache after eating or drinking, inform your doctor, pharmacist, or nurse immediately.

Pregnancy, breastfeeding, and fertility

The effect of Linezolid in pregnant women is unknown. Therefore, pregnant women should not use this medicine 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 medicine.

You must not breastfeed while being treated with Linezolid, as this medicine passes into breast milk and could affect your baby.

Driving and using machines

Linezolid may cause dizziness or vision problems. If this happens, do not drive or operate machinery. Remember that if you do not feel well, your ability to drive or operate machinery may be impaired.

Linezolid Hikma contains Glucose

This medicine contains 45.7 mg/ml (13.7 g/300 ml) of glucose. Patients with diabetes mellitus should take this into account.

Linezolid Hikma contains Sodium

This medicine contains 114 mg of sodium (the main component of cooking/table salt) per bag. This corresponds to 5.7% of the maximum daily recommended intake of sodium for an adult.

3. How to use Linezolid Hikma

Adults

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

This medicine will be administered by a doctor or other healthcare professional via an infusion drip (intravenous infusion into a vein). The recommended dose for adults (18 years and older) is 300 ml (600 mg of linezolid) twice daily, administered directly into the bloodstream (intravenously) via an infusion drip over a period of 30 to 120 minutes.

If you are on a dialysis programme, Linezolid will be administered after each dialysis session.

A treatment course usually lasts 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 receiving Linezolid, your doctor will perform periodic blood tests to monitor your blood count.

If you are treated with Linezolid for more than 28 days, your doctor should monitor your vision.

Use in children and adolescents

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

If you use more Linezolid Hikma than you should

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

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount received.

If you forget to use Linezolid Hikma

As this medicine is administered under close supervision, it is very unlikely that a dose will be missed. If you think a dose of your treatment has been forgotten, inform your doctor or nurse. Do not take a double dose to make up for missed doses.

4. Possible adverse effects

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

Tell your doctor, nurse or pharmacist immediately if you notice any of the following adverse effects while being treated with Linezolid:

The serious adverse effects (with frequency in parentheses) of Linezolid are:

• Severe skin reactions (uncommon), swelling, particularly around the face and neck (uncommon), wheezing and/or difficulty breathing (rare). These may be signs of an allergic reaction and may require discontinuation of treatment with Linezolid. Skin reactions such as raised purpuric lesions due to inflammation of blood vessels (rare), painful, red and scaly skin (dermatitis) (uncommon), skin rash (common), itching (common).
• Vision problems (uncommon) such as blurred vision, changes in color perception (frequency not known), difficulty seeing fine detail (frequency not known), or if you notice a reduction in your visual field (rare).
• Severe diarrhoea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases could lead to complications that may become life-threatening (uncommon).
• Repeated nausea or vomiting, abdominal pain or rapid breathing (rare).
• Seizures or convulsions (uncommon) have been reported in patients receiving this medicine.
• Serotonin syndrome (frequency not known): Inform your doctor if you experience agitation, confusion, delirium, rigidity, tremor, lack of coordination, convulsions, rapid heartbeat, severe breathing problems and diarrhoea (suggestive of serotonin syndrome) while also taking antidepressants known as SSRIs or opioids (see section 2).
• Unexplained bleeding or bruising, which may be due to changes in the number of certain blood cells that can affect blood clotting or cause anaemia (common).
• Changes in the number of blood cells that may affect the ability to fight infections (uncommon). Some signs of infection include: fever (common), sore throat (uncommon), mouth ulcers (uncommon) and fatigue (uncommon).
• Inflammation of the pancreas (uncommon).
• Convulsions (uncommon).
• Transient ischaemic attacks (temporary disruption of blood flow to the brain causing 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).

Cases of numbness, tingling or blurred vision have been reported in patients who have taken this medicine for more than 28 days. If you experience vision problems, consult your doctor as soon as possible.

Other adverse effects include:

Common (may affect up to 1 in 10 patients):

• Fungal infections, especially vaginal thrush or oral thrush.
• Headache.
• Metallic taste.
• Diarrhoea, vomiting, nausea.
• Changes in certain blood test results, including tests for proteins, salts or enzymes measuring liver, kidney function or blood sugar levels.
• Difficulty sleeping.
• Increased blood pressure.
• Anaemia (reduction in the number of red blood cells).
• Dizziness.
• Localised or generalised abdominal pain.
• Constipation.
• Indigestion.
• Localised pain.
• Decreased platelet count.

Uncommon (may affect up to 1 in 100 patients):

• Inflammation of the vagina or female genital area.
• Tingling or numbness sensations.
• Swelling, discomfort, changes in tongue color.
• Dry mouth.
• Pain at the infusion site or around it.
• Inflammation of veins (including at the site where the infusion is administered).
• Need to urinate more frequently.
• Chills.
• Feeling thirsty.
• Increased sweating.
• Hyponatremia (low sodium levels in blood).
• Hypoglycemia (low blood sugar levels).
• Kidney failure.
• Abdominal swelling.
• Pain at injection site.
• Increased creatinine.
• Stomach pain.
• Changes in heart rate (e.g., increased rate).
• Low blood count.
• Weakness and/or sensory changes.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Change in the color of the tooth surface, which disappears with professional dental cleaning procedures.
• Change in tongue surface color to black, with a hairy appearance.

The following adverse effects have also been reported (frequency not known: cannot be estimated from available data):

• Alopecia (hair loss).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Linezolid Hikma

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

Store in the original packaging until use to protect from light. Do not use this medicine after the expiry date stated on the container, bag, and sachet, after EXP. The expiry date refers to the last day of the month indicated.

Hospital staff will ensure that Linezolid Hikma infusion solution is not used beyond the expiry 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 use it only if it is a clear, particle-free solution. Additionally, they will ensure that the solution is properly stored in its carton and aluminium wrapper to protect it from light and keep it out of the sight and reach of children until use.

After opening:

From a microbiological standpoint, unless the opening method excludes the risk of microbial contamination, the product should be used immediately. Otherwise, the user is responsible for the storage times and conditions during use.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Linezolid Hikma

• The active substance is linezolid. Each ml of solution contains 2 mg of linezolid. Each 300 ml perfusion bag contains 600 mg of linezolid.
• The other components are monohydrate glucose, sodium citrate, anhydrous citric acid, hydrochloric acid or sodium hydroxide for pH adjustment, and water for injectable preparations. See section 2 “Linezolid contains glucose and sodium”.

Appearance of the product and contents of the pack

Linezolid Hikma is a clear solution supplied in individual perfusion bags containing 300 ml of solution. The bags are packed in packs of 10 bags.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença

2705-906 Terrugem SNT

Portugal

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Austria Linezolid Hikma 2 mg/ml Infusionslösung

Germany Linezolid Hikma 2 mg/ml Infusionslösung

Spain Linezolid Hikma 2 mg/ml solution for perfusion EFG

France LINEZOLIDE HIKMA 2 mg/mL, solution for perfusion

Italy Linezolid Hikma

Portugal Linezolid Hikma

Date of latest review of this leaflet: March 2026

Other sources of information

Detailed and up-to-date 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/

This information is intended for healthcare professionals only:

Linezolid Hikma 2 mg/ml solution for perfusion EFG

IMPORTANT: Consult the Summary of Product Characteristics before prescribing.

Dosage and method of administration

Treatment with linezolid should only be initiated in a hospital setting and after evaluation by a specialist physician, such as a microbiologist or an infectious disease specialist.

Patients starting treatment with the parenteral formulation may be switched to any of the oral formulations when clinically indicated. In such cases, no dose adjustment is required, as the oral bioavailability of linezolid is approximately 100%.

The perfusion solution must be administered over a period of 30 to 120 minutes.

The recommended dose of linezolid should be administered intravenously twice daily.

Recommended duration and dosage for treatment in adults:

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

The treatment duration recommendations indicated below reflect those used in clinical trials. For certain types of infection, shorter treatment courses may be appropriate, 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.

For infections associated with concomitant bacteremia, there is no need to increase the recommended dose or duration of treatment.

The recommended dosage for the perfusion solution is as follows:

Infections	Dosage	Duration of treatment
Hospital-acquired pneumonia	600 mg twice daily	10-14 consecutive days
Community-acquired pneumonia
Complicated skin and soft tissue infections

Pediatric population: There are insufficient data on the pharmacokinetics, safety, and efficacy of linezolid in children and adolescents (< 18 years of age) to establish dosage recommendations. Therefore, until more data become available, the use of linezolid is not recommended in this age group.

Elderly patients: Dose adjustment is not required.

Renal impairment: Dose adjustment is not required.

Severe renal impairment (i.e., CrCl < 30 mL/min): Dose adjustment is not required in these patients. However, since the clinical relevance of exposure to high concentrations (up to 10 times) of the two main metabolites of linezolid in these patients is unknown, this medicinal product should be used with special caution in patients with severe renal impairment and administered only if the expected benefit outweighs the potential risk.

As approximately 30% of a dose of linezolid is removed during 3 hours of hemodialysis, Linezolid Hikma should be administered after dialysis in patients undergoing this treatment. The main metabolites of linezolid are partially removed by hemodialysis, but their concentrations are considerably higher after dialysis than those observed in patients with normal renal function or mild to moderate renal impairment. Therefore, linezolid should be used with special caution in patients with severe renal impairment undergoing dialysis and only administered if the expected benefit outweighs the potential risk.

To date, there is no experience with the administration of linezolid in patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or other alternative treatments for renal impairment (different from hemodialysis).

Hepatic impairment: Patients with mild to moderate hepatic impairment (Child-Pugh Class A or B): Dose adjustment is not required.

Severe hepatic impairment (Child-Pugh Class C): Since linezolid is metabolized via a non-enzymatic process, impaired liver function is not expected to significantly alter its metabolism, and therefore dose adjustment is not recommended. However, sufficient clinical data are lacking, and linezolid should be used in these patients only if the expected benefit outweighs the theoretical risk.

Overdose

No specific antidote is known. Cases of overdose have not been reported. However, the following information may be useful: supportive treatment is recommended together with maintenance of glomerular filtration. Approximately 30% of a dose of linezolid is removed during 3 hours of hemodialysis, but there are no available data on the elimination of linezolid by peritoneal dialysis or hemoperfusion.

Instructions for use and handling

For single use only. Remove the overwrap only when ready to use, then check for minor leaks by squeezing the bag firmly. If leaks are present, the bag must not be used, as sterility may have been compromised. The solution should be inspected visually before use, and only clear solutions free of particles should be used. Do not use these bags in series connections. Discard any unused solution. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Do not reconnect partially used bags.

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

Incompatibilities

No additives should be added to this solution. If linezolid is administered simultaneously with other drugs, each should be administered separately according to its instructions for use. Similarly, if the same intravenous line is used for sequential infusion of multiple drugs, the line must be flushed before and after administration of linezolid with a compatible infusion solution.

Linezolid Hikma infusion solution is known to be physically incompatible with the following compounds: amphotericin B, chlorpromazine hydrochloride, diazepam, pentamidine isethionate, erythromycin lactobionate, sodium phenytoin, and sulfamethoxazole/trimethoprim. In addition, it is chemically incompatible with ceftriaxone sodium.

Expiry date

Before opening: 24 months.

After opening: From a microbiological standpoint, unless the method of opening excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the duration and conditions of in-use storage are the responsibility of the user.

Special precautions for storage

Store in the original packaging (overwrap and carton) until ready for use to protect from light.