Patient leaflet - Carnitor 1 g chewable tablets / Levocarnitine 1 g chewable tablets
1. WHAT CARNITOR CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR
Carnitor chewable tablets contain levocarnitine which is a type of protein. They are used to treat primary and secondary carnitine deficiency in adults and children over 12 years of age.
Carnitine deficiency occurs when the body has a shortage of levocarnitine. Carnitor chewable tablets make up for your bodies lack of levocarnitine and help give your body more energy.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARNITOR CHEWABLE TABLETS
Do not take Carnitor chewable tablets:
- if you are allergic to levocarnitine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Tell your doctor or pharmacist before taking Carnitor chewable tablets 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 on a diet to reduce calorie intake
- you have an intolerance to some sugars
- you are taking anticoagulant medicine, such as warfarin, or any other drug to reduce blood clotting
If any of the above apply to you, talk to your doctor or pharmacist.
Other medicines and Carnitor chewable tablets
Tell your doctor if you are taking anticoagulant medicine, such as warfarin, or any other drug to reduce blood clotting.
Tell your doctor if you are taking, have taken or might take any other medicines, including those obtained without a prescription.
Pregnancy, breast-feeding and fertility
Pregnancy
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 taking this medicine.
Breast-feeding
Levocarnitine is a normal component of breast milk. If you wish to breast-feed, ask your doctor for advice if the benefit for you is greater than the potential risks for the baby.
Fertility
Levocarnitine has no safety issues on fertility.
Driving and using machines
You can drive or use machines whilst taking Carnitor chewable tablets.
Carnitor chewable tablets contain sucrose
If you have been told by the doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This product contains 1,8 g of sucrose per dose. This should be taken into account in patients if you suffer of diabetes mellitus. May be harmful to the teeth.
3. HOW TO TAKE CARNITOR CHEWABLE TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
How many Carnitor chewable tablets should you take
Your doctor will carefully calculate the number of chewable tablets you should take and may change it depending on your response to treatment.
Your doctor may take blood and urine samples to check the amount of the drug in your body.
Method of administration
Carnitor chewable tablets are for oral use. They should be chewed, not swallowed whole.
Primary and secondary Carnitine deficiency
The usual dose of Carnitor chewable tablets is 200 mg per kg of your body weight per day. This should be taken over 2-4 doses. Higher doses of up to 400 mg per kg of your body weight per day may be necessary. Your doctor will tell you exactly how many chewable tablets to take and when to take them.
Maintenance therapy for haemodialysis patients
If significant clinical benefit was gained by a first course of Carnitor injection, then ongoing therapy of one Carnitor chewable tablet per day may be taken. On the day of dialysis, the chewable tablet should be taken at the end of the session.
If you have serious kidney problems, treatment with Carnitor chewable tablets should not be prolonged and at high doses.
If you are elderly you do not need special precautions or modifications to Carnitor dosage.
If you take more Carnitor chewable tablets than you should
An excessive dose of Carnitor chewable tablets can cause diarrhoea. If you take too many Carnitor chewable tablets, contact your doctor or immediately go to the nearest hospital casualty department.
If you forget to take Carnitor chewable tablets
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 chewable tablets
Do not stop taking this medicine without first talking to your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):
- Mild stomach upsets such as stomach cramps and vomiting, diarrhoea, or you may feel or be sick for a short time.
Uncommon side effects (may affect up to 1 in 100 people):
- Drug-related body and/or skin odour (your doctor may reduce your dose to help lessen or stop the odour), headache, increased/high blood pressure or low blood pressure, altered taste, sudden and involuntary muscle contraction (muscle spasms), feeling abnormal, fever.
Very rare side effects (may affect up to 1 in 10,000 people):
- International Normalised Ratio increased; for people also taking an anticoagulant medicine, such as warfarin, tests may show your blood is taking longer than usual to clot
.
Not known side effects (frequency cannot be estimated from the available data):
Convulsions*, itching, rash on the skin, muscle rigidity.
* In patients with prior convulsive episodes or underling predisposing conditions to convulsions.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE CARNITOR CHEWABLE TABLETS
- Keep out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton after Exp. The expiry date refers to the last day of that month.
3077
27.07.20[5]
- If your medicines show any signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
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 Carnitor chewable tablets contain
- The active substance is levocarnitine.
- Each tablet contains 1 g of levocarnitine.
- The other ingredients are mint flavour, liquorice flavour, sucrose and magnesium stearate.
What Carnitor chewable tablets look like and contents of the pack
Carnitor chewable tablets are white, round, chewable tablets, approximately 2.2 cm wide. They come in blisters containing two chewable tablets.
The medicine comes in packs of 10 chewable tablets.
Manufacturer and product licence holder
Carnitor chewable tablets are manufactured by Alfasigma S.p.A, Via Pontina Km 30, 400 - 00071 Pomezia, Italy.
Procured from within the EU by product licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref) 27.07.20[5]
Carnitor is a trademark of Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
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PL 20636/3077