STREPTOMYCIN SULFATE REIG JOFRE 1 g POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User.

Streptomycin Reig Jofre 1 g powder for injectable solution

streptomycin (sulfate)

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What Streptomycin Reig Jofre is and what it is used for

Streptomycin Reig Jofre is an antibiotic belonging to the aminoglycoside group, used to treat serious infections caused by bacteria.

Streptomycin Reig Jofre is used in adults and children to treat the following infections:

• Multidrug-resistant tuberculosis (in combination with other antitubercular medications)
• 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 you need to know before you start taking Streptomycin 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 you start using Streptomycin Reig Jofre if:

• you have a disease that affects 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 receive streptomycin only if your doctor considers it essential for the treatment of your disease. Your doctor will be especially careful when adjusting your streptomycin dose correctly.

Your doctor will be especially careful if you have a disease that affects nerve and muscle function, such as Parkinson's disease or myasthenia gravis, or if you receive a muscle relaxant during an operation, since streptomycin can have a blocking effect on nerve and muscle function.

It is possible that your infection will not respond to streptomycin if you did not respond to other aminoglycoside antibiotics. It is also possible that you will develop an allergic reaction to streptomycin if you are already allergic to another aminoglycoside.

To reduce the risk of nerve and kidney damage, your doctor will be especially careful when evaluating the following:

• Monitoring of hearing, balance, and kidney function before, during, and after treatment.
• Dose adjustment according to the degree of kidney function.
• Monitoring of streptomycin levels in the blood during treatment if necessary.
• If you already have nerve damage in the ear (hearing loss or balance problems) or if treatment is long-term, additional monitoring of balance and hearing function is required.
• Avoiding the administration of other substances with potential harmful effects on the auditory nerve or kidneys in combination with streptomycin. If this is unavoidable, close monitoring of kidney function is required.
• The level of body fluids and urine production should be within the normal range.

Interference with analytical tests:

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

Other medicines and Streptomycin Reig Jofre

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

The simultaneous or sequential use of Streptomycin Reig Jofre with other medicines that may affect the kidneys or the nervous system (cisplatin, cyclosporin, neomycin, kanamycin, gentamicin, tobramycin, amikacin, netilmicin, paromomycin, capreomycin, amphotericin B, polymyxin B, colistin, vancomycin) should be avoided.

It should not be administered simultaneously or immediately after anesthesia or muscle relaxants.

Aminoglycosides, including streptomycin, may cause toxic effects on the ear, which can be potentiated by the administration of medications such as furosemide, mannitol, and possibly other diuretics.

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

Tell your doctor or pharmacist if you are using or have recently used 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 are planning to have a baby, ask your doctor for advice before taking this medicine. This medicine should not be used during pregnancy unless it is absolutely necessary.

Breastfeeding

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

Driving and using machines

There is no data on the influence of this medicine on the ability to drive and use machines. However, effects such as allergic reactions, blurred vision, deafness, or vertigo may occur, which can affect the ability to drive and use machines.

3. How to use Streptomycin Reig Jofre

This medicine will never be administered by yourself. A qualified person, such as a doctor or nurse, will administer it to you by intramuscular route.

Make sure to drink plenty of fluids while receiving streptomycin.

The recommended dose in adults is:

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

Use in children over 1 month and adolescents:

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

You will not be given Streptomycin Reig Jofre for more than 2 weeks without your doctor reviewing your treatment.

Patients with kidney problems

If you have kidney problems, you will be monitored to adjust the streptomycin levels in your blood correctly, either by reducing the dose or increasing the time between individual doses. Your doctor will adjust the dosage regimen in this case.

If you receive more Streptomycin Reig Jofre than you should

It is very unlikely that you will be given too much Streptomycin Reig Jofre, but if you think you have been given too much, tell your doctor, pharmacist, or nurse immediately. Symptoms may include deafness, balance problems, kidney problems, and/or respiratory paralysis.

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

If you forget to use Streptomycin Reig Jofre

If you think you have missed a dose of Streptomycin Reig Jofre, inform your doctor or nurse immediately.

If you stop using Streptomycin Reig Jofre

Your doctor will tell you how long to use Streptomycin Reig Jofre. Do not stop using this medicine without talking to your doctor first.

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

4. Possible side effects

Like all medicines, Streptomycin Reig Jofre can cause side effects, although not everybody gets them.

Serious side effects

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

Other side effects

Very common:may affect more than 1 in 10 people

• Increased urea values in the blood
• Kidney problems: renal failure (decreased function), high levels of proteins 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, ringing in the ears
• Balance problems

Uncommon:may affect up to 1 in 100 people

• Skin problems (rash, hives)
• Decreased appetite
• Nervous system problems: dizziness, ataxia (difficulty coordinating movements), headache, drowsiness, paresthesia (tingling sensation), optic neuritis (inflammation of the optic nerve that can cause sudden partial or complete vision loss), nystagmus (uncontrolled eye movement).
• Nausea, vomiting, stomatitis (inflamed mouth, painful and with mouth ulcers).
• Blurred vision
• Pain at the injection site

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

• Fever
• Increased liver enzymes
• Changes in blood cell count
• Nervous system problems: neuromuscular blockade (presents with weakness and fatigue), encephalopathy (brain malfunction), peripheral neuropathy (damage to peripheral nerves that presents with numbness in the limbs).
• 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; swelling of the lymph nodes.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Streptomycin Reig Jofre

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month shown.

No special storage conditions are required. Use the reconstituted solution immediately.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

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

Appearance and packaging

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

Reig Jofre Laboratory, S.A. Gran Capitán, 10

08970 Sant Joan Despí (Barcelona) Spain

Date of last revision of this leaflet:April 2025.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es

This information is intended only for healthcare professionals:

Administration

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

Reconstitution

The reconstitution of the solution should be performed at the time of administration.

Preparation of solutions for intramuscular injection

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

The streptomycin solution should not be mixed with other medicines due to the risk of precipitation. If necessary, they should be administered in separate solutions.

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