Carreflor

Package leaflet: Information for the user

CARREFLOR 1 g/10 ml oral solution, 2 g/10 ml oral solution

L-carnitine
Generic medicine
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What CARREFLOR is and what it is used for
2. What you need to know before taking CARREFLOR
3. How to take CARREFLOR
4. Possible side effects
5. How to store CARREFLOR
6. Contents of the pack and other information

1. What CARREFLOR is and what it is used for

The active substance of CARREFLOR is L-carnitine.
Carnitine is a natural constituent of human body cells and plays a fundamental role
in the production and transport of energy.
CARREFLOR is indicated for the treatment of carnitine deficiencies.
Consult your doctor if you do not feel better or feel worse after a short period of treatment.

2. What you need to know before taking CARREFLOR

Do not take CARREFLOR

• 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 CARREFLOR.
Inform your doctor, who will keep you under close monitoring:

• If you have diabetes and are using insulin or oral hypoglycemic agents (medicines taken by mouth that lower blood sugar levels), because CARREFLOR may cause a further reduction in blood sugar. In such cases, your doctor will perform frequent blood sugar checks and may adjust the dose of insulin or oral hypoglycemic agents (see section "How to take CARREFLOR").
• If you have a predisposition to seizures, treatment with L-carnitine may trigger them; if you already suffer from seizures, administration of L-carnitine may increase the frequency and/or severity of seizure episodes.
• If you have severe kidney problems (severe renal insufficiency or end-stage kidney disease) or are undergoing dialysis. In these cases, your doctor will monitor your kidney function during treatment, especially if prolonged (see section "How to take CARREFLOR").
• If you are taking medicines that reduce blood clotting (anticoagulants). In such cases, your doctor will prescribe periodic blood clotting tests (see section "Other medicines and CARREFLOR").

CARREFLOR does not present risks of tolerance (loss of medicine effectiveness over time) or dependence.
Other medicines and CARREFLOR
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Inform your doctor if you are taking medicines that reduce blood clotting (anticoagulants), because an interaction between L-carnitine and coumarin-type drugs cannot be ruled out. Very rare cases of altered blood clotting have been reported in patients receiving concomitant therapy with coumarin drugs (see "Undesirable effects", "Warnings and precautions").
Inform your doctor if you are taking antiepileptic drugs (valproic acid), antibiotics (containing pivalic acid, cephalosporins), or anticancer drugs (cisplatin, carboplatin, and ifosfamide), because they may reduce the amount of CARREFLOR in the blood.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
CARREFLOR may be used during pregnancy if your doctor considers that the benefit to you outweighs the potential risks to the fetus.
Breastfeeding
L-carnitine is a normal component of human breast milk. CARREFLOR may be used during breastfeeding if your doctor considers that the benefit to you outweighs the potential risks to the infant.
Fertility
CARREFLOR has no adverse effects on fertility.
Driving and using machines
CARREFLOR does not affect the ability to drive or operate machinery.
CARREFLOR 1 g/10 ml oral solution contains sodium benzoate, ethanol and sodium
This medicine contains:

• 48 mg of sodium benzoate in each single-dose container of 10 ml solution. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
• 0.00075 mg of alcohol (ethanol) in each 10 ml single-dose container. The small amount of alcohol in this medicine will not produce significant effects.
• less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

CARREFLOR 2 g/10 ml oral solution contains sodium benzoate, sodium and ethanol
This medicine contains:

• 48 mg of sodium benzoate in each 10 ml single-dose container. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
• 0.0015 mg of alcohol (ethanol) in each 10 ml single-dose container. The small amount of alcohol in this medicine will not produce significant effects.
• less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

3. How to take CARREFLOR

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Primary deficiencies and secondary deficiencies due to genetic metabolic diseases
The daily oral dose depends on the patient's age and body weight.
Use in adults and adolescents from 12 years of age
The recommended dose is 2–4 grams per day, according to the severity of the disease and the physician’s judgment.
Use in children
Children from 0 to 2 years of age
The recommended dose is 150 mg per kg of body weight.
Children from 2 to 6 years of age
The recommended dose is 100 mg per kg of body weight.
Children from 6 to 12 years of age
The recommended dose is 75 mg per kg of body weight.
Secondary deficiencies due to hemodialysis
The recommended dose is 2–4 grams per day.
Oral solutions must be taken only after dilution; the single-dose containers should be diluted in a glass of water. Pour the oral solution contained in the single-dose container into a glass of water before drinking it or giving it to your child.
If you have severe kidney problems, oral treatment with CARREFLOR should not be prolonged and high doses should be avoided.
If you are elderly, no special precautions or dosage adjustments are required for CARREFLOR.
If you have diabetes and are using insulin or oral antidiabetic medicines that lower blood sugar levels, CARREFLOR may cause a further reduction in blood glucose. Therefore, your doctor will monitor your blood sugar levels frequently and may adjust the dose of insulin or oral hypoglycemic agents (see section “Warnings and precautions”).
If you take more CARREFLOR than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital. An excessive dose may cause diarrhea.
If you forget to take CARREFLOR
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of CARREFLOR, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop treatment and consult your doctor
immediately, or contact the emergency department of the nearest hospital.

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

• vomiting
• nausea
• diarrhoea
• abdominal pain

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

• headache
• increased or high blood pressure
• low blood pressure
• altered taste
• difficulty digesting
• dry mouth
• fishy odour in urine, breath and sweat*
• sudden and involuntary muscle contractions (muscle spasms)
• chest pain
• feeling strange
• fever

Very rare side effects (affects less than 1 in 10,000 people):

• blood clotting disorders**

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

• seizures***
• dizziness
• irregular heartbeat (palpitations)
• difficulty breathing
• itching
• skin rash
• myasthenia (a disease characterised by muscle weakness) *****
• muscle tension

* This occurs in patients with severe kidney problems or on dialysis, due to accumulation of L-carnitine metabolites in the blood.
** In patients concurrently using medicines that reduce blood clotting (anticoagulants).
*** In patients with or without previous seizure episodes or predisposition.
**** In patients with end-stage renal failure.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store CARREFLOR
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the label after "Exp".
The expiry date refers to the last day of that month.
The expiry date indicated applies to the product in intact packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CARREFLOR contains
The active substance of CARREFLOR is L-carnitine.
The other components are:
Sodium benzoate, Sodium saccharin, Malic acid, Pineapple flavour, Dilute hydrochloric acid, Purified water.
Description of the appearance of CARREFLOR and contents of the pack:
Each pack contains 10 single-dose containers of 10 ml
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome) – Italy
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR) – Italy

Package leaflet: information for the user

CARREFLOR 1 g/5 ml injectable solution for intravenous use, 2 g/5 ml injectable solution for intravenous use

L-carnitine
Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CARREFLOR is and what it is used for

The active substance of CARREFLOR is L-carnitine.
Carnitine is a natural constituent of human body cells and plays a fundamental role
in energy production and transport.
CARREFLOR is used for carnitine deficiencies.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking CARREFLOR

Do not use CARREFLOR

• 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 CARREFLOR.
Inform your doctor, who will monitor you closely:

• If you have diabetes and are using insulin or oral hypoglycemics (medicines taken by mouth that lower blood sugar levels), because CARREFLOR may cause a further reduction in blood sugar. In such cases, your doctor will perform frequent blood sugar level checks and may adjust the dose of insulin or oral hypoglycemics (see section “How to take CARREFLOR”).
• If you are prone to seizures, treatment with CARREFLOR may trigger them; if you already suffer from seizures, administration of CARREFLOR may increase the frequency and/or severity of seizures.
• If you are taking medicines that reduce blood clotting (anticoagulants). In these cases, your doctor will prescribe periodic blood clotting tests (see section “Other medicines and CARREFLOR”).

CARREFLOR does not pose risks of tolerance (loss of effectiveness of the medicine over time) or dependence.

Other medicines and CARREFLOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Inform your doctor if you are taking medicines that reduce blood clotting (anticoagulants), because an interaction between L-carnitine and coumarin-derived drugs cannot be ruled out. Very rare cases of altered blood clotting have been reported in patients receiving concomitant treatment with coumarin-derived drugs (see “Undesirable effects”, “Warnings and precautions”).
Inform your doctor if you are taking antiepileptic drugs (valproic acid), antibiotics (containing pivalic acid, cephalosporins), or anticancer drugs (cisplatin, carboplatin, and ifosfamide), because they may reduce the amount of CARREFLOR in the blood.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.

Pregnancy
CARREFLOR may be used during pregnancy if your doctor considers that the benefit to you outweighs the potential risk to the fetus.

Breastfeeding
L-carnitine is a normal component of breast milk. CARREFLOR may be used during breastfeeding if your doctor considers that the benefit to you outweighs the potential risk to the infant.

Fertility
CARREFLOR has no adverse effects on fertility.

Driving and using machines
CARREFLOR does not affect the ability to drive or operate machinery.

3. How to use CARREFLOR

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Secondary carnitine deficiencies due to haemodialysis
The recommended dose is 2 grams administered slowly intravenously at the end of the dialysis session.
A dosage of 2.5 g may be used in patients who have been undergoing dialysis for more than 1 year.
Intravenous administration should be performed slowly over 2-3 minutes.
If you are elderly, no special precautions or dosage adjustments of CARREFLOR are required.
If you have diabetes and are using insulin or oral antidiabetic medicines, CARREFLOR may cause a further reduction in blood sugar levels. Therefore, your doctor will perform frequent blood sugar checks and may adjust the dose of insulin or oral hypoglycaemic agents (see section “Warnings and precautions”).
If you use more CARREFLOR than you should
In case of accidental ingestion or overdose of CARREFLOR, inform your doctor immediately or go to the nearest hospital. An overdose of CARREFLOR may cause diarrhoea.
If you forget to use CARREFLOR
Do not use a double dose to make up for the missed dose of CARREFLOR.
If you have any doubts about how to use CARREFLOR, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop treatment and consult your doctor
immediately, or contact the nearest hospital emergency department:

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

• vomiting
• nausea
• diarrhoea
• abdominal pain

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

• headache
• increased or high blood pressure
• low blood pressure
• altered taste
• difficulty digesting
• dry mouth
• fishy odour in urine, breath and sweat*
• sudden and involuntary muscle contractions (muscle spasms)
• chest pain
• feeling unwell
• fever
• reaction at injection site

Very rare side effects (may affect up to 1 in 10,000 people)

• disturbances in blood coagulation**

Side effects with unknown frequency (frequency cannot be determined from the available data)

• seizures***
• dizziness
• irregular heartbeat (palpitations)
• difficulty breathing
• itching
• skin rash
• myasthenia (a disease characterised by muscle weakness) ****
• muscle tension

* This occurs in patients with severe kidney problems or on dialysis, due to accumulation of L-carnitine metabolites in the blood.
** In patients taking concomitant medicines that reduce blood coagulation (anticoagulants).
*** In patients with or without previous seizure episodes or who are predisposed.
**** In patients with end-stage kidney failure.

Reporting of side effects:
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store CARREFLOR

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the label after "Exp".
The expiry date refers to the last day of that month.
The stated expiry date refers to the product in its original, unopened packaging, stored correctly.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CARREFLOR contains
The active substance in CARREFLOR is L-carnitine.
The other components are:
Diluted hydrochloric acid
Water for injections

Description of the appearance of CARREFLOR and contents of the pack
Each pack contains 5 dark glass vials of 5 ml each.

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome) - Italy

Manufacturer
Esseti Farmaceutici S.r.l.
Via Campobello, 15
00071 Pomezia (RM) - Italy