Carnicor 300 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Carnicor 300 mg/ml oral solution

L-carnitine

Read the entire leaflet carefully before you start taking this medicine, because 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 should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Carnicor 300 mg/ml oral solution is and what it is used for.
2. What you need to know before taking Carnicor 300 mg/ml oral solution.
3. How to take Carnicor 300 mg/ml oral solution.
4. Possible adverse effects.
5. How to store Carnicor 300 mg/ml oral solution.
6. Contents of the pack and other information.

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

Carnicor oral solution contains as its 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 blood ammonia levels) and/or liver toxicity due to valproic acid treatment.
• Preventive treatment in patients being treated with valproic acid who are at high risk of developing liver toxicity.

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

Do not take Carnicor

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Talk to your doctor or pharmacist before taking Carnicor if:

• You have severe kidney problems or are undergoing dialysis
• You have diabetes and are being treated with insulin or oral hypoglycemic agents (medicines used to treat diabetes), because Carnicor may cause a further reduction in blood sugar levels. In such cases, your doctor will ask you to monitor your blood sugar levels frequently.
• You are taking medicines that reduce blood clotting (anticoagulants) (see section 2 “Use of Carnicor with other medicines” and section 4 “Possible side effects”).
• You have a history of seizures.

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

Other medicines and Carnicor

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are taking coumarin drugs (anticoagulant medicines). 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 medicines containing valproic acid, pivalic acid prodrugs, cephalosporins, cisplatin, carboplatin, or ifosfamide, as these may reduce the availability of L-carnitine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant or breastfeeding, you should not take Carnicor unless specifically instructed by your doctor.

Driving and using machines

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

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

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

It may cause dental caries.

This medicine contains 100 mg of sorbitol in each ml of oral solution. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you 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 your doctor (or your child’s doctor) before taking this medicine.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

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

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

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

3. How to Take Carnicor 300 mg/ml Oral Solution

Carnicor oral solution is administered by oral route.

Always follow exactly the instructions for use provided by your doctor or pharmacist. If you have any doubts, please consult your doctor or pharmacist again.

Carnicor oral solution must 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 determined by your doctor according to the patient's age, body weight, and clinical condition.

• Neonates: Initial doses of 50 mg/kg/day, divided into doses every 3 or 4 hours are recommended. This initial dose may be adjusted to 50–100 mg/kg/day depending on individual patient needs. In some cases, the doctor may increase the dose up to 300 mg/kg/day.
• Children and adolescents: The initial dose is 50 mg/kg/day, divided into doses every 3–4 hours. This dose may be adjusted to 50–100 mg/kg/day, always divided into doses every 3 or 4 hours. In some cases, this dose may be increased up to 300 mg/kg/day, with a maximum daily 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 may range from 1,000–3,000 mg/day; however, in more severe cases, higher doses may be required.

Encephalopathy or hepatic toxicity due to valproic acid-induced toxicity: The dose must be adjusted individually 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 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 measured using 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 make up for forgotten doses. Take the next dose as usual.

If you stop taking Carnicor oral solution

Do not interrupt treatment with this medicine without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

These adverse effects are:

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

• nausea, vomiting, diarrhoea, abdominal pain

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

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

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

• Increase in International Normalized Ratio

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

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

#Seizures have been reported in some patients with and without previous history of convulsive activity following administration of L-carnitine orally or intravenously.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

5. Storage of Carnicor 300 mg/ml oral solution

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

No special storage conditions are required.

Expiry

Do not use this medicine after the expiry date stated on the container, following EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the package and other information

Composition of Carnicor 300 mg/ml oral solution:

• The active substance 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, sodium methyl p-hydroxybenzoate (E-219), sodium propyl p-hydroxybenzoate (E-217), cherry flavor (contains ethanol), cherry essence (contains ethanol), and purified water.

Appearance of the product and contents of the container

Carnicor 300 mg/ml oral solution: container with one amber glass bottle containing 40 ml of oral solution; and clinical pack with 20 bottles.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Alfasigma España S.L.

C/ Aribau 195, 4º

08021 Barcelona. Spain

Manufacturer

Pharmaloop, S.L.

Polígono Industrial Azque c/ Bolivia, 15

28806 Alcalá de Henares (Madrid). SPAIN

or

Alfasigma S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome). ITALY

Date of latest revision of the leaflet: April 2021

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/”