Prospect: information for the patient

Carnicor 200 mg/ml injectable solution

L-carnitine

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Carnicor 200 mg/ml injectable solution.

3. How to use Carnicor 200 mg/ml injectable solution.

4. Possible adverse effects

5. Storage of Carnicor 200 mg/ml injectable solution.

6. Contents of the package and additional informationl.

Carnicor injectable solution contains as 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 levels of ammonia in the blood) and/or liver toxicity, due to treatment with valproic acid.
• Preventive treatment in patients being treated with valproic acid and presenting a high risk of developing liver toxicity.
• Treatment of secondary L-carnitine deficiencies in patients undergoing long-term hemodialysis treatment.

Do not take Carnicor

• If you are allergic to the active ingredient or to any of the other components of this medication (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 (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 “Using Carnicor with other medications” and section 4 “Possible side effects”).
• You have a history of seizures.

The administration of the solution by intravenous route must be carried out slowly.

If you have any doubts about any of these aspects, consult your doctor or pharmacist before using 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 will need to perform the necessary tests to control your coagulation. (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 the availability of L-carnitine.

Pregnancy, breastfeeding, and fertility

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

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

Driving and operating machinery

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

Carnicor injectable solution is administered via intravenous route.

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

The recommended dose is:

Primary and secondary L-Carnitine deficiency: Your doctor will decide on 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 hepatotoxicity 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 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 solution will be administered via intravenous route slowly over a period of 2-3 minutes.

If you use more Carnicor injectable 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 medication and the amount administered.

If you forgot to use Carnicor injectable solution

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

If you interrupt the treatment with Carnicor injectable solution

Do not interrupt 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 may 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 skin odor
• muscle spasms
• chest pain, abnormal sensation, fever
• increased blood pressure
• reaction at the injection site

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

• Increased International Normalized Ratio

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 tension

#Some cases of seizures have been described in patients with and without a history of seizure activity afteradministration of L-carnitine by 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 of Pharmacovigilance of Medicines 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 Carnicor 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 200 mg/ml injectable solution:

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

Appearance of the product and contents of the packaging

Carnicor 200 mg/ml injectable solution is presented in boxes with 10 amber glass vials, containing each vial 5 ml of injectable solution, and clinical packaging with 100 vials.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Alfasigma España, S.L.

Avda. Diagonal 490 – 08006 Barcelona. SPAIN

Responsible for manufacturing:

Alfasigma, S.p.A.

Via Pontina, Km. 30,400

00071 Pomezia (Rome). ITALY

Last review date of this leaflet: September 2018

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