Patient leaflet - CARNITOR 1 G ORAL SOLUTION
1. what carnitor solution is and what it is used for
Carnitor solution contains levocarnitine which is a type of protein. lt is used to treat primary and secondary carnitine deficiency in adults and children over 12 years of age.
Carnitinedeficient occurs when thebody has a shortage of levocarnitine. Carnitor solution makes up for your bodies lack of levocarnitine and helps give your body more energy.
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2. Before you take Carnitor solution
Do not take Carnitor solution:
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– If you are allergic to levocarnitine or any of the other ingredients of this medicine (listed in section 6).
If this applies to you, do not take Carnitor solution.
Warnings and precautions
Talk to your doctor before taking Carnitor solution if:
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– you have severe kidney problems or kidney disease and are having dialysis
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– you are diabetic and taking insulin, or any other drug to treat your diabetes
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– 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.
Other medicines and Carnitor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any 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.
Carnitor solution with food and drink
Not applicable.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may be pregnant orif you become pregnant whiletaking Carnitor solution. Your doctor will decide whether or not you should continue to take 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 solution.
Carnitor solution contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 1 ml of oral solution, that is to say essentially „sodium-free“.
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3. Howtota k eCarnitorsoluti on ,. ,
Always take thls medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
How much Carnitor solution should you take Your doctor will carefully calculate the amount of Carnit°rsolution that you should take and may va-y rt depending on yourresponse to the treatment.Your doctor may takeblood and urine samples to check the amount of the drug in your body.
M ethodofadministration.....
Carni.tor solution.is for oraluse.«canbe ,drunk directly or diluted further with water or fruit juices.
P rimary and s econdar y Carnitine de fici ency ,
The usual dose of Carnitor solution is 200 mg per kg of your body weight per day. This should be taken over24 doses.Higher doses of up to 400 mg per kg ofyour body weight per day may be necessary.
Your doctor will tell you exactly how much to take and when to take it.
Maintenance therapy for haemodialysis patients
If significant benefit was gained by a first course of Carnitor injection,then ongoing therapy of 1 g per day of Carnitor solution may be taken. On the day of dialysis, Carnitor solution should be taken at the end of the session.
If you take more Carnitor solution than you should
If you take too much Carnitor solution, contact your doctor or immediately go to the nearest hospital casualty department.
If you forget to take Carnitor solution
Do not take a double dose to make up for the forgotten dose. Simply continue with the next dose as planned.
If you stop taking Carnitor solution
Do not stop taking this medicine without first talkingtoyourdoctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, Carnitor solution can cause side effects, although not everybody gets them. Side effects are:
– Mild stomach upsets such as stomach cramps and diarrhoea, or you may feel or be sick for a shorttime.
– For people also taking anticoagulant medicine, such a warfarin, tests may show your blood is taking longer than usual to clot.
– Drug-related body odour. Your doctor may reduce your dose to help lessen or stop the odour.
Reporting of side effects
If you get any side effects, talkto 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: yellowcard or search for MHRA Yellow Card in the Google Play orAppleApp Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store carnitor solution
Keepoutof_thesightand.reachofchildren. , Do not use Carnitor after the expiry date stated on the bottle. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original container in order to protect from light. Medicines should not be thrown away in waste water or household waste. Return any medicine you no longer need to your pharmacist.
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6. Further information
What Carnitor solution looks like and contents of the pack g
Carnitor solution is a clear, colourless or light straw- g coloured liquid. lt comes inlOml amber glass bottles cj with fully removable plastic caps. £
Manufacturer:
Alfasigma S.pA., Via Pontina km 3O,4OO,
OOO71 Pomezia(Rome), Italy
Procured from within the E U by the Product
Licence holder:
Shakespeare Pharma Ltd.,1BHarrison Court, Hilton Business Park, Hilton, DE65 5UR,UK
Repackaged by:
Alliance Healthcare s.r.o., 1O8 OO Praha 1O – Malesice
Czech Republic
Carnitor 1 g Oral Solution
PL 40593/0035 | POM |
This leaflet was last revised on 25th May 2O21.
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CarnitorV is a registeredTrademark.qfAlfasigma. S.pA., Via Ragazzi del '99, n. 5,4O133 Bologna, Italy