Streptomycin sulfate Reig Jofre 1 g powder for injection solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Streptomycin Sulfate Reig Jofre 1 g powder for injectable solution

streptomycin (sulfate)

Package leaflet:

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

1. What Sulfato de estreptomicina Reig Jofre is and what it is used for

Sulfato de estreptomicina Reig Jofre is an antibiotic belonging to the aminoglycoside group, used to treat serious bacterial infections.

Sulfato de estreptomicina Reig Jofre is used in adults and children to treat the following infections:

• Multidrug-resistant tuberculosis (in combination with other antituberculosis medicines)
• Brucellosis (in combination with other antibiotics), also known as Malta fever.
• Plague
• Tularemia, an infection caused by contact with infected animals (mainly rabbits and hares)
• In combination with other antibiotics, to treat endocarditis (inflammation of the inner lining of the heart) caused by bacteria called enterococci.

2. What Sulfato de estreptomicina Reig Jofre is and what it is used for

Do not use Sulfato de estreptomicina Reig Jofre

• If you are allergic to streptomycin, aminoglycosides, or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Sulfato de estreptomicina Reig Jofre if:

• you have a disease affecting nerve and muscle function, such as myasthenia gravis or Parkinson's disease
• you do not urinate regularly
• you are dehydrated
• you are receiving treatment for kidney problems
• you have inner ear deafness
• you are taking other antibiotics
• you are pregnant or breastfeeding

In these cases, you will be given streptomycin only if your doctor considers it essential for treating your illness. Your doctor will be especially careful when adjusting your dose of streptomycin.

Your doctor will be particularly cautious if you have a condition affecting nerve and muscle function, such as Parkinson's disease or myasthenia gravis, or if you are receiving a muscle relaxant during surgery, since streptomycin may have a blocking effect on nerve and muscle function.

Your infection may not respond to streptomycin if it did not respond to other aminoglycoside antibiotics. You may also develop an allergic reaction to streptomycin if you are already allergic to another aminoglycoside.

To reduce the risk of nerve damage to the ear and kidneys, your doctor will be especially careful in evaluating the following:

• Monitoring of hearing, balance, and kidney function before, during, and after treatment.
• Dose adjustment based on the degree of kidney function.
• Monitoring of streptomycin blood levels during treatment if necessary.
• If you already have nerve damage in the ear (impaired hearing or balance function) or if treatment is long-term, additional monitoring of balance and hearing function is required.
• Avoid administering other substances with potential harmful effects on the auditory nerve or kidneys in combination with streptomycin. If this is unavoidable, especially careful monitoring of kidney function is required.
• Body fluid levels and urine output should remain within the normal range.

Interference with laboratory tests:

Streptomycin may cause alterations in blood or urine test values of certain substances such as: blood urea nitrogen, transaminases, alkaline phosphatase, bilirubin, creatinine, lactate dehydrogenase, sodium, potassium, magnesium, and calcium.

Other medicines and Sulfato de estreptomicina Reig Jofre

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

Concomitant or sequential use of Sulfato de estreptomicina with other medicines that may affect the kidneys or nervous system (cisplatin, cyclosporine, neomycin, kanamycin, gentamicin, tobramycin, amikacin, netilmicin, paromomycin, capreomycin, amphotericin B, polymyxin B, colistin, vancomycin) should be avoided.

Sulfato de estreptomicina must not be administered simultaneously or immediately after anesthesia or muscle relaxants.

Aminoglycosides, including streptomycin, may cause ototoxic effects (ear toxicity), which may be enhanced by the administration of drugs such as furosemide, mannitol, and possibly other diuretics.

There is a risk of masking signs of vestibular toxicity (related to balance and spatial orientation) with medications used to treat vertigo.

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription and herbal medicines.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. This medicine should not be used during pregnancy unless absolutely necessary.

Breastfeeding

Inform your doctor if you are breastfeeding. The use of streptomycin sulfate is not recommended during breastfeeding.

Driving and using machines

There are no data on the influence of this medicine on the ability to drive or operate machinery. However, side effects such as allergic reactions, blurred vision, deafness, or vertigo may occur, which could affect your ability to drive or use machines.

3. How to use Streptomycin Sulfate Reig Jofre

Do not ever self-administer this medicine. A qualified healthcare professional, such as a doctor or nurse, will administer it to you by intramuscular injection.

Make sure you drink plenty of fluids while receiving streptomycin sulfate.

Recommended dose in adults:

• Tuberculosis, tularemia, brucellosis, and endocarditis: 15 mg/kg (maximum 1 g) per day, which may be divided into two equal doses every 12 hours.
• Plague: 30 mg/kg (maximum 2 g) per day, divided into two equal doses every 12 hours.

Use in children over 1 month of age and adolescents:

• Tuberculosis, tularemia, brucellosis, and endocarditis: 20–40 mg/kg (maximum 1 g) per day, divided into 2–4 equal doses every 6–12 hours.
• Plague: 30 mg/kg (maximum 1 g) per day, divided into two equal doses every 12 hours.

You will not be given streptomycin sulfate for longer than 2 weeks without your doctor reviewing your treatment.

Patients with kidney problems

If you have kidney problems, your blood levels of streptomycin will be monitored and the dosage adjusted appropriately, either by reducing the dose or by extending the interval between individual doses. Your doctor will adjust the dosing regimen accordingly.

If you receive more Streptomycin Sulfate Reig Jofre than you should

It is highly unlikely that you will be given too much streptomycin sulfate; however, if you think an overdose has occurred, inform your doctor, pharmacist, or nurse immediately. Symptoms of overdose may include deafness, balance disturbances, kidney dysfunction, and/or respiratory paralysis.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the product and the amount administered.

If you miss a dose of Streptomycin Sulfate Reig Jofre

If you believe a dose of streptomycin sulfate has been missed, inform your doctor or nurse immediately.

If you stop treatment with Streptomycin Sulfate Reig Jofre

Your doctor will determine the duration of your treatment with streptomycin sulfate. Do not discontinue treatment without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, Sulfato de estreptomicina Reig Jofre may produce adverse effects, although not everyone experiences them.

Serious adverse effects

Inform your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment: profound deafness, blood in the urine, difficulty breathing, increased or decreased frequency of urination or urine volume, muscle weakness and/or increased thirst.

Other adverse effects

Very common: may affect more than 1 in 10 people

• Increased blood urea levels
• Kidney function disorders: renal failure (reduced function), elevated levels of protein and blood in the urine, renal tubular necrosis (damage to the cells of the kidney tubules)

Common: may affect up to 1 in 10 people

• Deafness, tinnitus (ringing in the ears)
• Balance disturbances

Uncommon: may affect up to 1 in 100 people

• Skin reactions (rash, urticaria)
• Loss of appetite
• Nervous system disorders: dizziness, ataxia (difficulty coordinating movements), headache, somnolence, paresthesia (tingling and numbness sensations), optic neuritis (inflammation of the optic nerve that may cause sudden partial or complete vision loss), nystagmus (involuntary eye movements)
• Nausea, vomiting, stomatitis (inflamed, painful mouth with oral ulcers)
• Blurred vision
• Pain at the injection site

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

• Fever
• Increased liver enzymes
• Blood cell count abnormalities
• Nervous system disorders: neuromuscular blockade (presenting as weakness and fatigue), encephalopathy (impaired brain function), peripheral neuropathy (damage to peripheral nerves causing numbness in the extremities)
• Respiratory depression

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

• Severe allergic reactions (anaphylactic reactions), with signs such as skin rash or itching; chest tightness or difficulty breathing; swelling of the eyelids, face or lips; swelling or redness of the tongue; fever; joint pain; lymph node swelling

Reporting of adverse effects

If you experience any type of adverse effect, consult 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Streptomycin Sulfate Reig Jofre

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Use the reconstituted solution immediately.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, 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

Composition of Streptomycin Sulfate Reig Jofre

• The active substance is streptomycin sulfate. Each vial contains 1 g of streptomycin (as sulfate).
• Excipients: none.

Appearance of the medicinal product and contents of the pack

Vials containing a sterile white or almost white powder.

Pack containing 1 glass vial of 10 ml.

Pack containing 100 glass vials of 10 ml.

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofre, S.A.
Gran Capitán, 10
08970 Sant Joan Despí (Barcelona)
Spain

Date of the most recent revision of this leaflet: April 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended exclusively for physicians or healthcare professionals:

Administration

Streptomycin Sulfate Reig Jofre 1 g is administered by intramuscular route. Dissolve 1 g of streptomycin in 3 ml of water for injectable preparations.

Reconstitution

Reconstitution of the solution must be carried out at the time of administration.

Preparation of solutions for intramuscular injection

Streptomycin Sulfate Reig Jofre 1 g must be dissolved in 3 ml of solvent. Reconstituted solutions have a yellowish color. An increase in color intensity may occur without affecting the potency of the drug. The solution should be examined before injection for the presence of particles or turbidity. If foreign particles are observed, the solution must be discarded.

Streptomycin solution must not be mixed with other drugs due to the risk of precipitation. If necessary, they should be administered in separate solutions.

As a general rule, it is recommended not to mix it with any other product in the same syringe.