40 mg / ml injection solution
gentamicin

1. What Gensumycin is and what it is used for

Gensumycin contains gentamicin sulfate which is an antibiotic.

Gensumycin is used to treat serious infections of the lungs, urinary tract, intestines, or inflammation of the heart ( endocarditis ) in children and adults.

2. What you need to know before you use Gensumycin

Do not use Gensumycin

  • if you are allergic to gentamicin sulphate or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to other aminoglycoside antibiotics

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Gensumycin.

Gensumycin can be harmful to the kidneys and hearing and you are therefore closely monitored during treatment. Among other things, the doctor will monitor kidney function, cerebral nerve function and take blood samples.

Your doctor will be especially careful and monitor you if:

  • you have impaired kidney function, are older or have too little fluid in you (are dehydrated)
  • you have muscle weakness
  • you have diarrhea

Tell your doctor or pharmacist if you have severe diarrhea.

Other medicines and Gensumycin

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

Gensumycin should not be combined with the following drugs:

  • Furosemide (diuretic)

Several drugs can also affect or be affected by treatment with Gensumycin. It concerns:

  • ciclosporin (medicines that inhibit immune reactions)
  • indomethacin (anti-inflammatory drug)

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is a risk that the fetus is affected. Do not use Gensumycin during pregnancy except on certain prescriptions from the doctor.

The ingredient in Gensumycin is excreted in human milk in such quantities that there is a risk that the baby may be affected.

Driving and using machines

During treatment with Gensumycin, side effects such as dizziness and balance disorders may occur. This should be taken into account when sharper attention is required, e.g. while driving. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Gensumycin

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor who adapts it for you.

If you use more Gensumycin than you should 

For large amounts of this drug, e.g. make you feel dizzy, affect hearing, get cramps.

In the event of an overdose, your doctor will take appropriate action.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people ): Ear effects with nausea, dizziness, and balance disorders. Hearing loss. Eczema, itching. Protein in the urine (can be measured in urine samples). The increased amount of creatinine and urea in the blood.

Uncommon (may affect up to 1 in 100 people): Changes in blood type: altered white blood cell type ( eosinophilia ), increased platelet count ( platelets ). Hives. Increased levels of liver enzymes in the blood.

Rare (may affect up to 1 in 1,000 people): Changes in the blood picture: anemia ( anemia ), very low platelet count ( thrombocytopenia ) and decreased white blood cell count (leucopenia). Headache. Low blood pressure.

Very rare (may affect up to 1 in 10,000 people): Acute renal failure, high levels of phosphate and amino acids in the urine (so-called Fanconi-like syndrome, associated with high doses given over a long period of time).

Has been reported (occurs in an unknown number of users): Decreased sensation and/or tingling/numbness in the arms and/or legs ( peripheral neuropathy ). Permanent hearing loss, deafness.

Infection of other gentamicin-resistant bacteria. Diarrhea with or without blood and/or stomach cramps. Severe allergic reaction in the skin and mucous membranes together with blisters and redness of the skin which in very severe cases can affect internal organs and can be life-threatening ( Stevens-Johnson syndrome, toxic epidermal necrosis ).

Allergic reactions (including severe allergic reactions such as anaphylaxis ), which may include:

  • Itchy, lumpy rash (hives) or hives ( urticaria )
  • Swelling of hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing
  • Fainting, dizziness, fainting (low blood pressure )

If you suspect that you have had a severe allergic reaction, contact your healthcare provider immediately.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Gensumycin

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

This medicine does not require any special storage instructions.

Prepared solutions are for single use only and should be used within 12 hours.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is gentamicin sulphate. 1 ml solution for injection contains: gentamicin sulphate equivalent to 40 mg gentamicin.
  • The other ingredients (excipients) are sodium chloride, sulfuric acid / sodium hydroxide (for pH adjustment) and water for injections.

What the medicine looks like and contents of the pack

Clear, to slightly opalescent/colorless to light yellow solution. Vial 5×2 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Sanofi AB

Box 30052

104 25 Stockholm

Manufacturer:

Famar Health Care Services

Madrid SAU

Spain

Muhammad Nadeem

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