PACKAGE LEAFLET: INFORMATION FOR THE USER

Carnitor 1 g Solution for Injection

(levocarnitine)

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 get serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist

-    In this leaflet Carnitor 1 g Solution for Injection will be called Carnitor injection.

In this leaflet:

1.    What Carnitor injection is and what it is used for

2.    Before you are given Carnitor injection

3.    How you will be given Carnitor injection

4.    Possible side effects

5.    How to store Carnitor injection

6.    Further information

1.    What Carnitor injection is and what it is used for

Carnitor injection contains levocarnitine which is a type of protein. It is used to treat primary and secondary carnitine deficiency in adults, children, infants and newborn children. It can also be used to treat secondary carnitine deficiency in haemodialysis patients.

Carnitine deficiency occurs when the body has a shortage of levocarnitine. Carnitor injection makes up for your bodies lack of levocarnitine and helps give your body more energy.

2.    Before you are given Carnitor injection Do not take Carnitor injection:

-    if you are allergic to levocarnitine or any other ingredients in Carnitor injection. These ingredients are listed in section 6 of this leaflet.

If this applies to you, do not take Carnitor injection.

Tell your doctor before you are given Carnitor injection if:

-    you have severe kidney problems or kidney disease and are having dialysis

-    you are diabetic and taking insulin, or any other drug to treat your diabetes.

-    you are taking anticoagulant medicine, such as warfarin, or any other drug to reduce blood clotting

If any of the above applies to you talk to your doctor or pharmacist.

Taking other medicines

Tell your doctor if you are taking anticoagulant medicine, such as warfarin, or any other drug to reduce blood clotting. Your doctor may need to change how often you are tested to see how fast your blood clots.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you may be pregnant or if you become pregnant while having Carnitor injection. Your doctor will decide whether or not you should continue to have your medicine.

If you wish to breastfeed, ask your doctor for advice.

Driving and using machines

You can drive or use machines whilst taking Carnitor injection.

3. How you will be given Carnitor injection How much Carnitor injection will you be given

Your doctor will carefully calculate the amount of Carnitor injection that you should be given and may vary it depending on your response to the treatment. The doctor may take blood and urine samples to check the amount of the drug in your body.

Method of administration

Your doctor will give the injection slowly into your vein (intravenous injection) over a period of 2-3 minutes.

Secondary carnitine deficiency in haemodialysis patients (dialysis of the blood)

A dose of 20 mg per kg of your bodyweight should be given in the same way as above at the end of each dialysis session (assuming three sessions per week). The treatment should last at least three months, which is the time required to restore normal muscle levels of free carnitine. If significant benefit is seen following this first course of treatment ongoing therapy using 1g per day of Carnitor Oral Solution may be used. On the day of dialysis Carnitor Oral Solution should be taken at the end of the dialysis session.

If you are given more Carnitor injection than you should

If you think you have been given too much Carnitor injection tell your doctor.

If you have any further questions about taking this medicine, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Carnitor injection can cause side effects, although not everybody gets them.

Side effects are:

-    Drug-related body odour. Your doctor may reduce your dose to help lessen or stop the odour.

-    For people also taking anticoagulant medicine, such as warfarin, tests may show your blood is taking longer than usual to clot.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist 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 at: 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 Carnitor injection

Keep out of the reach and the sight of children.

Do not use Carnitor injection after the expiry date stated on the sealed glass ampoule. The expiry date refers to the last day of that month.

Store below 25°C and protect from light.

Medicines should not be disposed of via wastewater or in household waste. Return any medicine you no longer need to the pharmacist.

6.    Further information

What Carnitor injection contains

-    The active substance is levocarnitine inner salt. Each Carnitor injection contains 1 g levocarnitine inner salt in each 5 ml sealed glass container (ampoule).

-    The other ingredients are hydrochloric acid 10% and water for injection.

What Carnitor injection looks like and contents of the pack Carnitor injection is a clear, colourless or light straw-coloured liquid. It comes in 5 ml clear sealed glass containers (ampoules). There are 5 ampoules in each pack of Carnitor injection.

Marketing Authorisation Holder:

sigma-tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare, 47 - 00144 Rome, Italy

Manufacturer:

sigma-tau Industrie Farmaceutiche Riunite S.p.A. Pomezia, Italy

This leaflet was last revised in January 2014

Osigma-tau

PACKAGE LEAFLET: INFORMATION FOR THE USER

Carnitor 1 g Solution for Injection

(levocarnitine)

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 get serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist

-    In this leaflet Carnitor 1 g Solution for Injection will be called Carnitor injection.

In this leaflet:

1.    What Carnitor injection is and what it is used for

2.    Before you are given Carnitor injection

3.    How you will be given Carnitor injection

4.    Possible side effects

5.    How to store Carnitor injection

6.    Further information

1.    What Carnitor injection is and what it is used for

Carnitor injection contains levocarnitine which is a type of protein. It is used to treat primary and secondary carnitine deficiency in adults, children, infants and newborn children. It can also be used to treat secondary carnitine deficiency in haemodialysis patients.

Carnitine deficiency occurs when the body has a shortage of levocarnitine. Carnitor injection makes up for your bodies lack of levocarnitine and helps give your body more energy.

2.    Before you are given Carnitor injection Do not take Carnitor injection:

-    if you are allergic to levocarnitine or any other ingredients in Carnitor injection. These ingredients are listed in section 6 of this leaflet.

If this applies to you, do not take Carnitor injection.

Tell your doctor before you are given Carnitor injection if:

-    you have severe kidney problems or kidney disease and are having dialysis

-    you are diabetic and taking insulin, or any other drug to treat your diabetes.

-    you are taking anticoagulant medicine, such as warfarin, or any other drug to reduce blood clotting

If any of the above applies to you talk to your doctor or pharmacist.

Taking other medicines

Tell your doctor if you are taking anticoagulant medicine, such as warfarin, or any other drug to reduce blood clotting. Your doctor may need to change how often you are tested to see how fast your blood clots.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you may be pregnant or if you become pregnant while having Carnitor injection. Your doctor will decide whether or not you should continue to have your medicine.

If you wish to breastfeed, ask your doctor for advice.

Driving and using machines

You can drive or use machines whilst taking Carnitor injection.

3. How you will be given Carnitor injection How much Carnitor injection will you be given

Your doctor will carefully calculate the amount of Carnitor injection that you should be given and may vary it depending on your response to the treatment. The doctor may take blood and urine samples to check the amount of the drug in your body.

Method of administration

Your doctor will give the injection slowly into your vein (intravenous injection) over a period of 2-3 minutes.

Primary carnitine deficiency

The usual recommended dose is 100 mg per kg of your body weight per day. This will be given in 3-4 doses.

Secondary carnitine deficiency in haemodialysis patients (dialysis of the blood)

A dose of 20 mg per kg of your bodyweight should be given in the same way as above at the end of each dialysis session (assuming three sessions per week). The treatment should last at least three months, which is the time required to restore normal muscle levels of free carnitine. If significant benefit is seen following this first course of treatment ongoing therapy using 1g per day of Carnitor Oral Solution may be used. On the day of dialysis Carnitor Oral Solution should be taken at the end of the dialysis session.

If you are given more Carnitor injection than you should

If you think you have been given too much Carnitor injection tell your doctor.

If you have any further questions about taking this medicine, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Carnitor injection can cause side effects, although not everybody gets them.

Side effects are:

-    Drug-related body odour. Your doctor may reduce your dose to help lessen or stop the odour.

-    For people also taking anticoagulant medicine, such as warfarin, tests may show your blood is taking longer than usual to clot.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist 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 at: 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 Carnitor injection

Keep out of the reach and the sight of children.

Do not use Carnitor injection after the expiry date stated on the sealed glass ampoule. The expiry date refers to the last day of that month.

Store below 25°C and protect from light.

Medicines should not be disposed of via wastewater or in household waste. Return any medicine you no longer need to the pharmacist.

6.    Further information

What Carnitor injection contains

-    The active substance is levocarnitine inner salt. Each Carnitor injection contains 1 g levocarnitine inner salt in each 5 ml sealed glass container (ampoule).

-    The other ingredients are hydrochloric acid 10% and water for injection.

What Carnitor injection looks like and contents of the pack Carnitor injection is a clear, colourless or light straw-coloured liquid. It comes in 5 ml clear sealed glass containers (ampoules). There are 5 ampoules in each pack of Carnitor injection.

Marketing Authorisation Holder:

sigma-tau Industrie Farmaceutiche Riunite S.p.A. Viale Shakespeare, 47 - 00144 Rome, Italy

Manufacturer:

sigma-tau Industrie Farmaceutiche Riunite S.p.A. Pomezia, Italy

This leaflet was last revised in January 2014

Osigma-tau