CARNITENE "1 G/10 ML ORAL SOLUTION" 10 SINGLE-DOSE CONTAINERS"

Name
Carnitene 1 g/10 ml oral solution
Carnitene 1.5 g/5 ml oral solution
Carnitene 1 g chewable tablets
L-carnitine


What is it and what is it for?
Carnitene contains the active ingredient L-carnitine. Carnitine is a natural constituent of human cells and plays a key role in energy production and transportation.

Carnitene is indicated for the treatment of carnitine deficiencies.

Talk to your doctor if you do not feel better or if you feel worse after a short time of treatment.


What you need to know before taking the medicine
Do not take Carnitene
• if you are allergic to L-carnitine or any of the other ingredients of this medicine (listed in section 6).


Warnings and precautions
Talk to your doctor or pharmacist before taking Carnitene.

Inform your doctor, who will monitor you closely:
• if you have diabetes and are taking insulin or oral hypoglycaemics (medicines taken by mouth that lower blood sugar levels) because Carnitene may cause a further reduction in blood sugar. In these cases, your doctor will monitor your blood sugar levels frequently and may adjust the dose of your insulin or oral hypoglycaemics (see section “How to take Carnitene”).
• if you have a predisposition for convulsions, treatment with L-carnitine may trigger them; if you already suffer from convulsions, the administration of L-carnitine may increase the number and/or severity of convulsive seizures
• if you have severe kidney problems (severe kidney failure or end-stage renal disease) or if you are on dialysis. In these cases, your doctor will monitor your kidney function during treatment, particularly if it is prolonged (see section “How to take Carnitene”)
• if you are using medicines that reduce blood clotting (anticoagulants). In these cases your doctor will prescribe periodic blood clotting tests (see section “Other medicines and Carnitene”)

Carnitene does not present any risk of habituation (loss of effectiveness of the medicine over time) or dependence.


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)
• vomit
• nausea
• diarrhea
• abdominal pain

Uncommon side effects (may affect up to 1 in 100 people)
• heachache
• increased or high blood pressure
• low blood pressure
• alteration of taste
• difficulty digesting
• dry mouth
• fishy odor in urine, breath, and sweat*
• sudden, involuntary muscle contraction (muscle spasms)
• chest pain
• feeling strange
• fever

Very rare side effects (may affect up to 1 in 10,000 people)
• blood clotting disorders**

Side effects with unknown frequency (frequency cannot be estimated from the available data)
• convulsions***
• dizziness
• irregular heartbeat (palpitations)
• difficulty breathing
• itching
• skin rash
• myasthenia (disease characterized by muscle weakness)****
• muscle tension

* This occurs in patients with severe kidney problems or on dialysis, due to the accumulation of L-carnitine metabolites in the blood.
** In patients who are taking medicines that reduce blood clotting (anticoagulants) at the same time
*** In patients with or without previous convulsive episodes or predisposed
**** In patients with end-stage renal failure.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.