Leaflet: information for the patient

Carnicor 300 mg/ml oral solution

L-carnitine

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Carnicor 300 mg/ml oral solution and what it is used for.

2. What you need to know before starting to take Carnicor 300 mg/ml oral solution.

3. How to take Carnicor 300 mg/ml oral solution.

4. Possible side effects

5. Storage of Carnicor 300 mg/ml oral solution.

6. Contents of the pack and additional informationl.

Carnicor oral solution contains as active substance a type of protein called L-Carnitine.

Carnicor oral solution is indicated in adults and children in the following situations:

• Treatment of primary and secondary L-Carnitine deficiencies
• Treatment of a type of encephalopathy (characterized by elevated ammonia levels in blood) and/or liver toxicity, due to treatment with valproic acid.
• Preventive treatment in patients being treated with valproic acid and at high risk of developing liver toxicity.

Do not take Carnicor

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Carnicor if:

• You have severe kidney problems or are undergoing dialysis
• You are diabetic and being treated with insulin or oral hypoglycemic medications (medications used to treat diabetes), as Carnicor may cause a greater reduction in blood sugar levels. In these cases, your doctor will ask you to perform frequent blood sugar level checks.
• You are taking medications that reduce blood clotting (anticoagulants) (See section 2 “Carnicor use with other medications” and section 4 “Possible side effects”).
• You have a history of seizures.

If you have doubts about any of these aspects, consult your doctor or pharmacist before taking Carnicor.

Other medications and Carnicor

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor if you are taking coumarin-based medications (anticoagulants). Your doctor may need to perform tests to monitor your blood clotting. (See section 2 “Warnings and precautions” and section 4 “Possible side effects”).

Inform your doctor if you are taking medications containing valproic acid, pivoxic acid prodrugs, cephalosporins, cisplatin, carboplatin, and ifosfamide, as they may reduce L-carnitine bioavailability.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant or breastfeeding, do not take Carnicor unless your doctor tells you to.

Driving and operating machinery

The use of Carnicor oral solution does not affect your ability to drive or operate machinery.

Carnicor oral solution contains saccharose, sorbitol (E-420), p-hydroxybenzoate of methyl sodium salt (E-219), p-hydroxybenzoate of propyl sodium salt (E-217), sodium, and ethanol.

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

It may cause tooth decay.

This medication contains 100 mg of sorbitol in each ml of oral solution. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult with your doctor (or your child) before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medication may cause allergic reactions (possibly delayed) because it contains p-hydroxybenzoate of methyl, sodium salt (E-219) and p-hydroxybenzoate of propyl, sodium salt (E-217).

This medication contains less than 23 mg of sodium (1 mmol) per 5 ml of oral solution; it is essentially “sodium-free”.

This medication contains 26.04 mg of alcohol (ethanol) per 5 ml, equivalent to 0.66% (v/v). The amount per dose of 5 ml of this medication is equivalent to less than 1 ml of beer. The small amount of alcohol in this medication does not produce any noticeable effect.

Carnicor oral solution is administered orally.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist again.

Carnicor oral solution should be taken diluted in a glass of water.

The recommended dose is:

Primary and secondary L-Carnitine deficiency due to metabolic disorders: the dose will be established by your doctor based on the patient's age and weight, as well as the pathology situation.

• Newborns: initial doses of 50 mg/kg/day are recommended, divided into doses every 3 or 4 hours. This initial dose can be adjusted to 50-100 mg/kg/day based on each patient's needs. In some cases, the doctor may increase the dose up to 300 mg/kg/day.
• Children and adolescents: the initial dose will be 50 mg/kg/day, divided into doses every 3-4 hours. This dose can be adjusted to 50-100 mg/kg/day, always divided into 3 or 4-hourly doses. In some cases, this dose can be increased up to 300 mg/kg/day, with a maximum dose of 3,000 mg/day.
• Adults: the usual dose is 1,000 mg/day, divided into doses every 3 or 4 hours. This dose can vary from 1,000-3,000 mg/day, although in some more severe cases, higher doses may be required.

Encephalopathy or hepatic toxicity due to toxicity caused by the use of valproic acid: the dose should be adjusted in each case by your doctor. However, the recommended dose is up to 100 mg/kg/day, divided into 3-4 doses (every 6-8 hours)

Treatment for the prevention of hepatotoxicity in patients taking valproic acid: a dose of 50-100 mg/kg/day, divided into 2 or 3 doses, is recommended.

Dosage should be taken with the dosing spoon provided.

One full spoon (3.3 ml) contains 1 g of L-Carnitine.

If you take more Carnicor oral solution than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Carnicor oral solution

Do not take a double dose to compensate for the missed doses. Take the next dose as usual.

If you interrupt treatment with Carnicor oral solution

Do not stop treatment with this medication without consulting your doctor first.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

These adverse effects are:

Frequent adverse effects (may affect up to 1 in 10 people):

• nausea, vomiting, diarrhea, abdominal pain

Less frequent adverse effects (may affect up to 1 in 100 people):

• headache
• hypertension, hypotension
• disturbances of taste(dysgeusia), heartburn, dry mouth
• abnormal body odor
• muscle spasms
• chest pain, abnormal sensation, fever
• increased blood pressure

Rare adverse effects (may affect up to 1 in 10,000 patients):

• Increased International Normalized Ratio (INR)

Adverse effects of unknown frequency (cannot be estimated from available data):

• seizure?, dizziness
• sensation of fluttering or pounding in the chest (palpitations)
• difficulty breathing (dyspnea)
• itching, rash
• muscle twitching

#Some cases of seizures have been reported in patients with and without a history of seizure activity after administration of L-carnitine via oral or intravenous route.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use www.notificaRAM.es

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Expiration Date

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Carnicor 300 mg/ml oral solution:

• The active ingredient is: L-Carnitine inner salt. Each ml of solution contains 300 mg of L-Carnitine inner salt.
• The other components (excipients) are: sucrose, sorbitol (E-420), tartaric acid, p-hydroxybenzoate of methylsodium salt(E-219), p-hydroxybenzoate of propylsodium salt(E-217), cherry flavor (contains ethanol), raspberry flavor (contains ethanol) and purified water.

Appearance of the product and contents of the packaging

Carnicor 300 mg/ml oral solution: packaging with a topaz-colored glass bottle, containing 40 ml of oral solution; and a clinical packaging with 20 bottles.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Alfasigma España S.L.

Avenida Diagonal, 490

08006 Barcelona. SPAIN

Responsible for Manufacturing

Pharmaloop, S.L.

Industrial Park Azque c/ Bolivia, 15

28806 Alcalá de Henares (Madrid). SPAIN

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome). ITALY

Last review date of this leaflet: April 2021

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/”