CARNICOR 200 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Carnicor 200 mg/ml Solution for Injection

L-Carnitine

Read this package leaflet carefully before you start using 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 200 mg/ml Solution for Injection and what is it used for.
2. What you need to know before you start using Carnicor 200 mg/ml Solution for Injection.
3. How to use Carnicor 200 mg/ml Solution for Injection.
4. Possible side effects
5. Storage of Carnicor 200 mg/ml Solution for Injection.
6. Contents of the pack and further information.

1. What is Carnicor 200 mg/ml Solution for Injection and what is it used for

Carnicor Solution for Injection contains the active substance L-Carnitine, a type of protein.

Carnicor Solution for Injection 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.
• Treatment of secondary L-Carnitine deficiencies in patients undergoing long-term hemodialysis.

2. What you need to know before you start using Carnicor 200 mg/ml Solution for Injection

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

Consult your doctor before starting to use Carnicor if:

• You have kidney problems or are undergoing dialysis
• You are diabetic and are being treated with insulin or oral hypoglycemic agents (medicines used to treat diabetes), as 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.

The administration of the solution by intravenous route should be done slowly.

If you have any doubts about any of these aspects, consult your doctor or pharmacist before using 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-type medicines (anticoagulant medicines). Your doctor will need to perform the necessary tests to monitor your blood clotting. (See section 2 "Warnings and precautions" and section 4 "Possible side effects").

Tell your doctor if you are taking medicines 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 use Carnicor unless your doctor advises you to.

Driving and Using Machines

Using Carnicor Solution for Injection does not affect your ability to drive or use machines.

3. How to Take Carnicor 200 mg/ml Solution for Injection

Carnicor Solution for Injection is administered by intravenous route.

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.

The recommended dose is:

Primary and secondary L-Carnitine deficiency:Your doctor will decide the most suitable dose based on your situation. The usual dose is 100 mg/kg/day divided into 3-4 doses (every 6-8 hours). Your doctor may decide to increase this dose up to a maximum of 300 mg/kg/day.

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)

Preventive treatment for liver toxicity in patients taking valproic acid:a dose of 50-100 mg/kg/day divided into 3-4 doses is recommended.

Secondary L-Carnitine deficiency during hemodialysis treatment:The recommended dose is 10-20 mg/kg at the end of each dialysis session. Your doctor will evaluate the situation every 3 months to adjust the dose.

Carnicor injectable will be administered by slow intravenous route over a period of 2-3 minutes.

If you use more Carnicor Solution for Injection 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 administered.

If you forget to use Carnicor Solution for Injection

Do not use a double dose to make up for forgotten doses. Take the next dose as usual.

If you stop using Carnicor Solution for Injection

Do not stop using this medicine without consulting your doctor first.

If you have any other 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.

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
• reaction at the injection site

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 fluttering or pounding in the chest)
• difficulty breathing (dyspnea)
• itching, rash
• muscle stiffness

There have been reports of seizures in patients with and without a history of seizure activity after administration of L-Carnitine by oral or intravenous route.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) 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 Carnicor after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This 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 and Packaging of the Product

Angileptol are sucking tablets, white, round, and with the Greek letter σ on one face.

They are available in packs of 15 and 30 sucking tablets.

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 Last Revision of this Package Leaflet:September 2021

Other Sources of Information

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