Carnicor 200 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Carnicor 200 mg/ml injection solution

L-carnitine

Read the entire leaflet carefully before you start using 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Carnicor 200 mg/ml injection solution is and what it is used for.
2. What you need to know before using Carnicor 200 mg/ml injection solution.
3. How to use Carnicor 200 mg/ml injection solution.
4. Possible side effects.
5. How to store Carnicor 200 mg/ml injection solution.
6. Contents of the pack and other information.

1. What Carnicor 200 mg/ml injectable solution is and what it is used for

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

Carnicor injectable 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 receiving 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 using Carnicor 200 mg/ml injection solution

Do not take Carnicor

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

Warnings and precautions

Talk to your doctor before starting to use Carnicor if:

• You have 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 frequently monitor your blood sugar levels.
• 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.

The intravenous administration of the solution must be performed slowly.

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

Other medicines and Carnicor

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

Tell your doctor if you are taking coumarin drugs (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”).

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.

Do not use Carnicor during pregnancy or breastfeeding unless specifically instructed by your doctor.

Driving and using machines

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

3. How to Use Carnicor 200 mg/ml Injection Solution

Carnicor injection solution is administered intravenously.

Always follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If you have any doubts, please consult your doctor or pharmacist again.

The recommended dose is:

Primary and secondary L-Carnitine deficiency: Your doctor will determine the most appropriate dose based on your individual condition. 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 hepatic toxicity due to toxicity caused by valproic acid: 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 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 your condition every 3 months to adjust the dose if necessary.

Carnicor injection solution should be administered by slow intravenous injection over a period of 2–3 minutes.

If you use more Carnicor injection 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 medicine and the amount administered.

If you forget to use Carnicor injection solution

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

If you stop using Carnicor injection solution

Do not stop 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, diarrhea, abdominal pain

Uncommon adverse 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
• injection site reaction

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

• Increased International Normalized Ratio (INR)

Adverse effects with 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 tightness

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

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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

Do not use Carnicor after the expiry date stated on the packaging, after 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 empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Carnicor 200 mg/ml injectable solution:

• The active substance is: L-Carnitine inner salt. Each ml of solution contains 200 mg of L-Carnitine inner salt.
• The other components (excipients) are: sterile, pyrogen-free distilled water and diluted hydrochloric acid.

Appearance of the product and contents of the container

Carnicor 200 mg/ml injectable solution is supplied in boxes containing 10 amber glass ampoules, each containing 5 ml of injectable solution, and clinical pack containing 100 ampoules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Alfasigma España, S.L.
C/ Aribau 195, 4º
08021 Barcelona. Spain

Manufacturer:

Alfasigma, S.p.A.
Via Pontina, Km. 30,400
00071 Pomezia (Rome). ITALY

Date of the most recent review of this summary: September 2018

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