Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Cidomycin is and what it is used for
2. Before you take Cidomycin
3. How to take Cidomycin
4. Possible side effects
5. How to store Cidomycin
6. Further information

Do not have this medicine if:

• You have Myasthenia Gravis. This is a disease that causes muscle weakness.
• You are allergic (hypersensitive) to gentamicin, any other antibiotics or to any of the other ingredients of this medicine (see Section 6: Further Information).
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat and tongue.

Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Cidomycin.

Take special care with Cidomycin

Check with your doctor or pharmacist before having this medicine if:

• You are pregnant, might become pregnant, or think you may be pregnant.
• You are breast-feeding (see 'Pregnancy and breast-feeding' section below)
• You have any muscle weakness problem
• You are extremely overweight
• You have kidney problems, are over 65 years of age or the patient is less than 1 year old. This is because your doctor will need to keep a careful eye on you during your treatment, to prevent damage to your ears. He may check your hearing, your balance, how your kidneys are working and the amount of gentamicin in your blood.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before having Cidomycin.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Cidomycin can affect the way some other medicines work. Also some medicines can affect the way Cidomycin works.

In particular, tell your doctor if you are taking any of the following:

• Medicines to thin the blood such as warfarin
• Water tablets or injections (diuretics) such as furosemide or etacrynic acid
• Amphotericin B (used to treat fungal infections)
• Cephalosporin antibiotics such as cephaloridine
• Ciclosporin (used in organ transplants or for severe skin problems)
• Neostigmine or pyridostigmine (used to treat Myasthenia Gravis)
• Muscle relaxants - sometimes used during operations which need an anaesthesic
• Indometacin (used to treat pain or swelling)
• Bisphosphonates (used to treat osteoporosis)
• Cisplatin (used to treat some cancers)
• Botulinum toxin - used to lower the activity of overactive muscles. This is also sometimes used in cosmetic procedures.

These medicines may increase certain side effects (see Section 4: Possible side effects).

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Cidomycin should not normally be used during pregnancy.

If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.

Important information about some of the ingredients of Cidomycin

Cidomycin contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These may cause allergic reactions which may not happen straight away). The signs are extreme difficulty in breathing with wheezing and tightness in your chest (this is called 'bronchospasm').

Cidomycin contains very little sodium. It contains less than 1 mmol sodium (23 mg) per ampoule or vial.

Having this medicine

Your doctor will decide how much to give you, depending on your weight. The correct dose also depends on the type of infection and any other illnesses you may have. Blood samples will be taken by your doctor or nurse to check the dose is right for you.

Adults:

• The usual daily dose in adults is 3-5mg for each kg of body weight
• This is split into doses given every 6-8 hours
• This dose may be increased or decreased by your doctor depending on your illness

Children (aged 1 year and above):

• The usual daily dose is 3-6mg for each kg of body weight
• This is given either as 1 single dose (preferred) or split into 2 separate doses

Babies (aged 4 weeks to 1 year):

• The usual daily dose is 4.5-7.5 mg for each kg of body weight
• This is given either as 1 single dose (preferred) or split into 2 separate doses

Premature babies or new born babies (up to 4 weeks)

• The usual daily dose is 4.5-7mg for each kg of body weight
• This is given in 1 single dose

If you have more Cidomycin than you should

It is most unlikely that you will be given too much medicine by the doctor or nurse. Your doctor or nurse will be checking your progress and checking the medicine that you are given. Ask if you are not sure why you are getting a dose of medicine.

If you forget to have Cidomycin

Your doctor or nurse have instructions about when to give you your medicine. It is most unlikely that you will not be given the medicine as it has been prescribed. If you think that you may have missed a dose then talk to your nurse or doctor.

If you stop having Cidomycin

It is important that the course of treatment your doctor has prescribed is finished. You may start to feel better but it is important to continue your treatment until the doctor advises. If you stop, your infection may get worse again.

Tell your doctor or nurse as soon as possible if any of the following side effects happen:

Ear problems: these may happen because Cidomycin can sometimes damage the ear, especially if your kidneys do not work very well. The side effects are:

• Difficulty keeping your balance
• Feeling dizzy
• Poor hearing.

Kidney problems: if you notice anything unusual when you pass water, such as:

• If you see any sign of blood in your water (urine)
• If you find you are passing less water than is normal for you.

Nerve or muscle problems:

• If you have unusual difficulty in moving which has not happened before
• If you have a feeling of weakness or unusual tiredness
• If you have any breathing difficulties that have not happened before

If you are not sure if you have any of the above, talk to your doctor or nurse as soon as possible.

Tell your doctor or nurse if any of the following side effects gets serious or last longer than a few days. Also tell them if you notice any side effects not listed in this leaflet

• Allergic (also called hypersensitivity) reactions, such as nettle rash or difficulty breathing
• Headache
• Feeling tired
• Purplish or reddish-brown skin colouring
• Mouth ulcers
• Feeling or being sick (nausea or vomiting)
• Rash
• Bloody diarrhoea
• Fits or convulsions
• Feeling confused
• Depression
• Strange visions or sounds (hallucination) and memory loss

What Cidomycin contains

• The active substance is gentamicin sulphate equivalent to 80mg of gentamicin.
• The other ingredients are sulphuric acid and sodium hydroxide, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate and water for injections.

What Cidomycin looks like and content of the pack

The medicine is a clear, colourless solution for injection in 2ml ampoules or vials.

Cidomycin is available in packs of 5 ampoules and packs of 5 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer