CARNICOR 100 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Carnicor 100 mg/ml Oral Solution

L-Carnitine

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Carnicor 100 mg/ml Oral Solution and what is it used for.
2. What you need to know before you take Carnicor 100 mg/ml Oral Solution.
3. How to take Carnicor 100 mg/ml Oral Solution.
4. Possible side effects
5. Storage of Carnicor 100 mg/ml Oral Solution.
6. Contents of the pack and further information.

1. What is Carnicor 100 mg/ml Oral Solution and what is it used for

Carnicor Oral Solution contains the active substance 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 high levels of ammonia in the blood) 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 you take Carnicor 100 mg/ml Oral Solution

Do not take Carnicor

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

Warnings and Precautions

Talk to your doctor before taking Carnicor if:

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

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

Other Medicines and Carnicor

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Tell your doctor if you are taking coumarin medications (anticoagulants). Your doctor may need to perform tests to check your blood clotting. (See section 2 "Warnings and Precautions" and section 4 "Possible side effects").

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

Pregnancy, Breastfeeding, and Fertility

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

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

Driving and Using Machines

Taking Carnicor Oral Solution does not affect your ability to drive or use machines.

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

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

It may cause tooth decay.

This medicine contains 90 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 some 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 before taking this medicine.

Sorbitol may cause gastrointestinal upset and have a mild laxative effect.

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

This medicine contains less than 23 mg of sodium (1 mmol) per 10 ml vial; it is essentially "sodium-free".

This medicine contains 9.31 mg of alcohol (ethanol) in each 10 ml vial, equivalent to 0.12% (v/v).

The amount of this medicine per vial is equivalent to less than 1 ml of beer. The small amount of alcohol in this medicine does not produce any noticeable effect.

3. How to Take Carnicor 100 mg/ml Oral Solution

Carnicor Oral Solution is administered orally.

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. If you have any 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, weight, and pathology.

• Newborns: initial doses of 50 mg/kg/day divided into doses every 3 or 4 hours are recommended. This initial dose can be adjusted to 50-100 mg/kg/day based on the needs of each patient. 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 doses every 3 or 4 hours. 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 may vary from 1,000-3,000 mg/day, although in more severe cases, higher doses may be required.

Encephalopathy or liver toxicity due to valproic acid toxicity: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.

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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 stop taking this medicine without consulting your doctor first.

If you have any further questions on 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.

These side effects are:

Common side effects (may affect up to 1 in 10 people):

• nausea, vomiting, diarrhea, abdominal pain

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

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

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

• Increased International Normalized Ratio

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

• seizure?
• dizziness
• palpitations (feeling of a rapid or forceful heartbeat)
• difficulty breathing (dyspnea)
• itching, rash
• muscle stiffness

Some cases of seizures have been reported in patients with a history of seizure activity after oral or intravenous administration of L-carnitine.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website www.notificaRAM.es

5. Storage of Carnicor 100 mg/ml Oral Solution

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

No special storage conditions are required.

Expiry Date

Do not use this medicine after the expiry date which is stated on the packaging, after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Angileptol Mint Flavor

Each tablet contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other ingredients (excipients) are: sorbitol (E420), potassium acesulfame (E950), magnesium stearate, and mint flavor

Appearance of the Product and Contents of the Pack

Angileptol are lozenges, white, round, and with the Greek letter σ on one side.

They are presented in packs containing 15 and 30 lozenges.

Other Presentations

Angileptol Mint-Eucalyptus Flavor

Angileptol Honey-Lemon Flavor

Marketing Authorization Holder

Alfasigma Spain S.L.

C/ Aribau 195, 4th floor

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 the Last Revision of this Package Leaflet:September 2021

Other Sources of Information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es