Genticin Injectable
102657/LF/158/04
Package leaflet: Information for the patient
31039131
Read all of this leaflet carefully before you are given 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 or nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Genticin Injectable is and what it is used for
2. What you need to know before you are given Genticin Injectable
3. How you will be given Genticin Injectable
4. Possible side effects
5. How to store Genticin Injectable
6. Contents of the pack and other information
1. WHAT GENTICIN INJECTABLE IS AND WHAT IT IS USED FOR
The name of your medicine is Genticin Injectable.
Genticin Injectable contains the active ingredient gentamicin which belongs to a group of medicines called antibiotics.
Genticin Injectable is used in adults and children to treat bacterial infections such as severe chest infections, urinary tract infections and septicaemia.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GENTICIN INJECTABLE
You should not be given Genticin Injectable:
• if you are allergic to gentamicin or a similar medicine containing an aminoglycoside antibiotic or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from myasthenia gravis, a disease causing muscle weakness.
Warnings and precautions
Talk to your doctor or nurse before being given Genticin Injectable:
• if you have any problems with your kidneys, liver or hearing
• if you have any infections or a fever
• if you have low blood pressure or low blood volume
• if you are considered to be significantly overweight
• if you have Parkinson’s disease or any other disease causing muscle weakness
• if you are pregnant or think you may be pregnant.
If any of these apply to you or if you are not sure, tell your doctor.
Monitoring during treatment
Your doctor may want to send you for blood tests from time to time to check the levels of gentamicin in your blood. This is because your doctor may need to keep a careful eye on you during your treatment to prevent damage to your ears. If you are over 65 years of age or the patient is under 1 year of age, they may also monitor your hearing, your balance and how your kidneys and liver are working.
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AMDIPHARM
Other medicines and Genticin Injectable
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
This is especially important if you are taking:
• Antibiotics such as penicillin, ticarcillin, clindamycin, lincomycin, cephalosporins, vancomycin or other aminoglycoside antibiotics
• Ciclosporin (used to stop the body rejecting bone marrow or organ transplants)
• Cisplatin and fludarabine (chemotherapy drugs)
• Amphotericin (used to treat fungal infections)
• Furosemide (frusemide), and piretanide (used to treat heart problems)
• Muscle relaxants
• Medicines used to treat myasthenia gravis such as neostigmine and pyridostigmine
• Indomethacin (an anti-inflammatory)
• Biphosphonates (used to treat osteoporosis).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.
Pregnancy
Genticin Injectable is not recommended for use in pregnancy unless considered appropriate by your doctor.
Breast-feeding
Use of Genticin Injectable whilst breastfeeding is not recommended if you are suffering from kidney problems.
Driving and using machines
This medicine should not affect your ability to drive or use machines.
3. HOW YOU WILL BE GIVEN GENTICIN INJECTABLE
This medicine will be given to you by a doctor or nurse as an injection into a muscle or vein. It can also be given as a drip (infusion). Your doctor will work out the dose which is suitable for you. The recommended dose in adults with normal kidney function is
3 - 6 mg/kg of body weight per day as one (preferred) up to two single doses. Your doctor may increase the dose or frequency of doses, based on your condition.
Use in children and adolescents
The recommended dose in children aged 1 year and above and adolescents with normal renal function is 3 - 6 mg/kg of body weight per day as one (preferred) up to two single doses.
Use in infants after the first month of life
The daily dose in infants after the first month of life is 4.5 - 7.5 mg/kg of body weight per day as one (preferred) up to two single doses.
Use in newborns
The daily dose in newborns is
4 - 7 mg/kg of body weight per day.
Due to the longer half-life, newborns are given the required daily dose in one single dose.
Use in elderly
The dose for the elderly will be adjusted accordingly.
Use in patients with kidney problems
The dose for patients with kidney problems will be adjusted accordingly.
If you are given more Genticin Injectable than you should
Overdosing is unlikely. If it does happen the doctor will treat any symptoms that follow.
Symptoms of overdose include dizziness, a feeling of spinning and hearing loss.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice:
• itching or skin rashes
• swelling of the face, lips or throat
• difficulty in breathing or wheeziness; tell your doctor immediately.
These may be signs of an allergic reaction.
Tell your doctor or nurse immediately if you experience:
• Problems with your kidney function
• Difficulty in breathing following surgery
• Muscle weakness.
Other side effects include: Uncommon (may affect up to 1 in 100 people):
• Feeling or being sick
• Sore mouth
• Problems with your liver
• Blood disorders.
Rare (may affect up to 1 in 1,000 people):
• Diarrhoea
• Stomach pain
• Electrolyte disturbances (changes in the levels of salts in the blood).
Very rare (may affect up to 1 in 10,000 people):
• Problems with your brain
• Fits, confusion, hallucinations, tiredness and depression.
Not known (frequency cannot be estimated from the available data):
• Symptoms of increased urination, swelling in legs, ankles, breathlessness, loss of appetite, sleeping difficulty. These could be a sign of kidney failure
• Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
• Symptoms of bruising, discolouration of skin, small red spots. These could be a sign of purpura
• Problems with your ears that causes a loss of balance
• Hearing loss, which is usually reversible.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE GENTICIN INJECTABLE
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after Expiry Date. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Genticin Injectable contains
- The active substance is gentamicin sulphate. Each 2 ml ampoule contains gentamicin sulphate (equivalent to 80 mg gentamicin base).
- The other ingredients are water for injection and sulphuric acid.
What Genticin Injectable looks like and the content of the pack
Genticin Injectable is a colourless to pale yellow liquid.
It is available in 2 ml clear glass ampoules in boxes of 10 x 2 ml ampoules.
Marketing Authorisation Holder and Manufacturer
Amdipharm UK Limited Capital House,
85 King William Street,
London EC4N 7BL, UK
Manufacturer
Famar S.A.,
Agiou Dimitriou 63,
Alimos Attiki,
17456,
Greece
Genticin is the registered trade mark of Amdipharm Mercury International Limited.
This leaflet was last revised in October 2016
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