TOBRAMICIN NORMON 100 mg/2 ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Tobramycin Normon 100 mg/2 ml Solution for Injection EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Contents of the pack:

1. What Tobramycin Normon is and what it is used for
2. Before you use Tobramycin Normon
3. How to use Tobramycin Normon
4. Possible side effects
5. Storage of Tobramycin Normon
6. Contents of the pack and other information

1. What Tobramycin Normon is and what it is used for

Tobramycin is an antibiotic that belongs to the group of aminoglycosides (used to combat bacterial infections).

Tobramycin Normon can be used to treat:

• Treatment of central nervous system infections such as meningitis, septicemia, and neonatal sepsis.
• Treatment of gastrointestinal infections such as peritonitis.
• Treatment of complicated and recurrent urinary tract infections such as pyelonephritis and cystitis.
• Treatment of lower respiratory tract infections such as pneumonia, bronchopneumonia, and acute bronchitis, including patients with cystic fibrosis.
• Treatments of skin, bone, and soft tissue infections such as burns.

2. Before you use Tobramycin Normon

Tobramycin should not be injected intrathecally (in the spinal column) under any circumstances.

Do not use Tobramycin Normon

• If you are allergic to tobramycin, other aminoglycoside antibiotics, or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are taking potent diuretics (pills to urinate) such as furosemide or ethacrynic acid.

If any of these cases apply to you, inform your doctor before using this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Tobramycin Normon

• If you or members of your maternal family have a disease caused by a mitochondrial mutation (a genetic disease) or hearing loss due to antibiotics, it is recommended that you inform your doctor or pharmacist before taking this medication. Certain mitochondrial mutations can increase your risk of hearing loss with this product. Your doctor may recommend genetic tests before administering tobramycin.
• If you have severe muscle disorders, such as myasthenia gravis (a disease in which muscles weaken and fatigue easily) or Parkinson's disease (a brain disease that affects mobility).
• If you have kidney problems.
• If you have severe burns.
• If you have endocarditis (inflammation inside the heart).
• If you have neutropenia (low white blood cell count).
• If you are an elderly person.
• If you are dehydrated.

Similarly, special care is required if this medication is to be administered to babies or infants under 6 weeks of age, or if you have received a large-volume blood transfusion or have cystic fibrosis.

Using Tobramycin Normon with other medications

Special care is required if you are going to take/use other medications, as they may interact with Tobramycin Normon, for example:

• Aminoglycosides (e.g., amikacin, streptomycin, neomycin, kanamycin, gentamicin, paromomycin).
• Amphotericin B (a medication used to treat fungal infections), clindamycin, and vancomycin, immunosuppressive agents, and cytotoxic agents (such as cyclosporine, cisplatin) increase the risk of renal toxicity. Also, the use of cephalosporins (such as cephalothin), acetylsalicylic acid, and methoxyflurane may increase the risk of kidney toxicity.
• Magnesium salts, medications to treat myasthenia gravis, pancuronium, and tubocurarine, some inhaled anesthetics, massive blood transfusions of citrated blood, as it may increase neuromuscular blockade.
• Certain potent diuretics, such as ethacrynic acid and furosemide, increase ototoxicity.
• Medications used as general anesthetics, as they may increase respiratory depression.
• Medications used as muscle relaxants during general anesthesia.
• Antihistamines, buclizine, cyclizine, loxapine, meclozine, phenothiazines, thioanthine, or trimethobenzamide.
• Neostigmine and pyridostigmine (medications used to treat muscle weakness).
• Indomethacin, as it may decrease the elimination of the antibiotic, increasing the risk of toxicity.
• Beta-lactam antibiotics, as there is a mutual inactivation of the effects of both tobramycin and beta-lactams.
• Malathion.
• Other medications (e.g., warfarin and phenindione).

Tell your doctor or nurse if you are using, have recently used, or might use any other medication.

Pregnancy, breastfeeding, and fertility

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.

There may be a risk of congenital defects if this medication is used during pregnancy, and some children whose mothers took a similar medication (streptomycin) were born deaf. It will only be used if the potential benefits clearly outweigh the risks.

Driving and using machines

Do not drive or use machines if you experience any adverse reaction (e.g., dizziness or drowsiness), which may reduce your ability to do so.

Tobramycin Normon contains sodium and sodium metabisulfite

Tobramycin Normon may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite (E-223).

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

3. How to use Tobramycin Normon

This medication is administered by injection (using a syringe) intramuscularly or intravenously, or by infusion (drip) in a vein.

It is administered as an infusion and must be diluted before use. It is infused over a period of 20 to 60 minutes.

Dose

Your doctor will determine the most suitable dose of tobramycin for you and how often it should be administered.

The dose will depend on your state of health, your weight, the severity of the infection, your age, and the functioning of your kidneys. Your doctor will inform you about kidney function using urine and blood samples.

Treatment usually lasts between 7 and 10 days. If you take tobramycin for more than 10 days or exceed the recommended dose, you may experience more severe side effects, including dangerous breathing difficulties, which may also occur if you do not drink enough liquid, have impaired renal function, or are taking other medications that may affect your hearing.

Your doctor will take blood samples periodically to ensure you are receiving the correct dose.

Patients with normal kidney function:

• Adult use: the recommended dose in adults is 3 mg/kg per day in three equal doses every 8 hours.

In cases of very severe infections, up to 5 mg/kg per day may be administered in 3 or 4 equal doses. Your doctor may decrease this dose when deemed convenient.

• Use in children: the recommended dose is 6 to 7.5 mg/kg per day in 3 or 4 doses.
• Use in premature or newborn infants under one week: a dose of up to a maximum of 4 mg/kg per day every 12 hours is recommended.

The usual duration of treatment is 7 to 10 days, although sometimes a longer treatment is necessary. In these cases, renal, auditory, and vestibular functions (balance) should be monitored, as the likelihood of toxicity increases when the treatment duration exceeds 10 days.

Patients with altered kidney function:if you have any kidney function impairment, inform your doctor, as a dose adjustment will be necessary.

Use in the elderly:they may require lower maintenance doses than younger patients.

Obese patients:your doctor will adjust the dose based on your body weight.

Patients with burns and patients with severe infections:they may require higher doses or more frequent administrations.

If you use more Tobramycin Normon than you should

In case of overdose or accidental administration, consult your doctor or pharmacist immediately or call the Toxicology Information Service (Tel. 91 562 04 20), indicating the product and the amount administered.

Information for the doctor:in case of overdose or toxic reactions, treatment should be symptomatic. Hemodialysis or peritoneal dialysis helps to eliminate aminoglycosides from the blood in patients with renal dysfunction, but not in patients with normal renal function. Respiratory and renal functions should be monitored. When two or more aminoglycosides are administered simultaneously, neuromuscular blockade may occur, leading to skeletal muscle weakness and prolonged respiratory depression or paralysis. Anticholinesterases or calcium salts can be used to help reverse the blockade. Mechanical respiratory assistance may also be necessary.

If you forget to use Tobramycin Normon

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

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

If you experience any of the following symptoms, inform your doctor immediately:

• Severe allergic reaction: you may experience a sudden rash with itching (urticaria), swelling of the hands, feet, ankles, face, lips, mouth, or throat (which can cause difficulty swallowing or breathing), and you may feel like you are going to faint.
• Hearing loss.
• Ringing, buzzing, or roaring in the ears.
• Dizziness.
• Vertigo (feeling that you or your surroundings are spinning).

These side effects are serious. You may need urgent medical attention.

If you experience any of the following symptoms, inform your doctor as soon as possible:

Frequent: may affect up to 1 in 10 people

• Pain or reaction at the injection site.
• Swelling, redness, and sensitivity along a vein.
• Change in white blood cell levels.
• Changes in urinary function, urinating more than usual.

Uncommon: may affect up to 1 in 100 people

• Increased white blood cell levels.
• Headache.
• Cough.
• Hoarseness or difficulty speaking.
• Sore throat.
• Difficulty breathing.
• Noisy breathing.
• Nausea and vomiting.
• Rash or development of colored spots.
• Itching.

Rare: may affect up to 1 in 1,000 people

• Confusion and disorientation.
• Increased amount of sputum or coughing up blood.
• Diarrhea.
• Fever.
• Feeling of tiredness or drowsiness.
• Palpitations.
• Blurred vision.
• Paresthesia in arms or legs, "tingling".
• Anemia (decrease in red blood cells that can pale the skin).
• Decrease in white blood cells (which can make you more prone to infections).
• Decrease in blood platelet count, which increases the risk of bleeding or bruising.

Very rare: may affect up to 1 in 10,000 people

• Seizures or muscle spasms.
• Loss of strength.

Frequency not known: cannot be estimated from the available data

• Oral or genital fungal infections.
• Near-unconscious state.

Tobramycin Normon may cause kidney damage (damage can range from mild kidney failure to acute kidney failure). Your doctor may perform blood tests to monitor this.

Tobramycin Normon may cause changes in blood cells. Your doctor may perform blood tests to check the number of cells and electrolyte levels in the blood, which may decrease.

Also, your doctor will check if you experience hearing problems. Hearing loss is usually irreversible.

Some patients who have received a tobramycin injection in the eye have experienced severe vision problems. This is not a recommended use for this medication.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tobramycin Normon

Keep this medication out of sight and reach of children.

No special storage conditions are required. Occasionally, the solution may have a pale yellow color that does not indicate any alteration in the potency of the medication.

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.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, 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 other information

Composition of Tobramycin Normon

• The active ingredient is tobramycin. Each vial contains 100 mg of tobramycin (sulfate).
• The excipients are: sodium metabisulfite (E-223), phenol, disodium edetate, sulfuric acid (E-513), and water for injectable preparations.

Appearance of the product and contents of the pack

Tobramycin Normon 100 mg/2 ml is a colorless or slightly yellowish, transparent, clear solution for injection, containing 100 mg of tobramycin per 2 ml of solution. It is presented in a pack containing 1 glass vial. Each vial contains 2 ml of solution.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Other presentations

Tobramycin Normon 50 mg/2 ml solution for injection EFG

Date of the last revision of this leaflet:October 2023

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/

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This information is intended only for healthcare professionals:

Intravenous administration:Dilute with 0.9% sodium chloride or 5% dextrose. The normal amount of diluent is 50 to 100 ml for the adult dose. In the dose for children, the volume of diluent should be proportionally smaller than for adults. The diluted solution is usually administered directly over a period of 20 to 60 minutes. Administration periods of less than 20 minutes are not recommended to avoid exceeding serum levels of 10 µg/ml.

Extemporaneous mixtures of beta-lactam antibiotics and aminoglycosides may result in mutual inactivation. Tobramycin is incompatible with amphotericin B, sodium cephalothin, sodium nitrofurantoin, sodium sulfadiazine, and tetracyclines. Similarly, incompatibilities should be checked in case any other medication is added to the solution. Handle under usual asepsis conditions for intravenous infusion solutions.