Metadoxil

Package leaflet: Information for the patient

METADOXIL 500 mg tablets, 500 mg/15 ml oral solution

Metadoxil
Please 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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What METADOXIL is and what it is used for

METADOXIL contains the active substance metadoxine, which is used in alcohol intoxication.
This medicinal product acts by reducing blood alcohol levels (alcoholemia) and facilitating its elimination
through urine.
This medicine is indicated for the long-standing condition caused by habitual and prolonged use of alcoholic beverages (chronic alcoholism).
In cases of acute alcohol intoxication (acute alcoholism), METADOXIL 300 mg/5 ml injectable solution is indicated.

2. What you need to know before taking METADOXIL

Do not take METADOXIL

• if you are allergic to metadoxine or to any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking METADOXIL.
Take this medicine with caution and inform your doctor if you have Parkinson's disease and are being treated with levodopa, as metadoxine may reduce its effects (see section “Other medicines and METADOXIL”).
Children and adolescents
This medicine is not recommended for children and adolescents.
Other medicines and METADOXIL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking levodopa, used for the treatment of Parkinson's disease, as metadoxine may reduce its effects.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
METADOXIL is not recommended during pregnancy, except in cases of absolute necessity and under direct medical supervision.
Do not take METADOXIL if you are breastfeeding, because metadoxine reduces blood levels of a hormone called prolactin (hypoprolactinemic action) (see section “Do not take METADOXIL”).
Driving and using machines
METADOXIL does not impair the ability to drive or operate machinery.
METADOXIL 500 mg / 15 ml oral solution contains sucrose and methyl parahydroxybenzoate
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine. In particular, each bottle contains 7.5 g of sucrose. This should be taken into account in patients with diabetes mellitus. It may be harmful to teeth.
METADOXIL 500 mg / 15 ml oral solution contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to take METADOXIL

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
METADOXIL 500 mg tablets
The recommended dose is 2 tablets daily taken by mouth (oral route) for the treatment
of chronic conditions.
METADOXIL 500 mg/15 ml oral solution
The recommended dose is 2 vials daily taken by mouth (oral route) for the treatment
of chronic conditions.
If you take more METADOXIL than you should
Cases of overdose with this medicine are not known.
In case of accidental ingestion of an excessive dose of METADOXIL, inform your doctor immediately or go to the nearest hospital.
If you forget to take METADOXIL
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Very rare (may affect up to 1 in 10,000 people)

• allergic reactions (hypersensitivity);
• numbness, tingling, sensitivity, and weakness in the arms and legs (peripheral neuropathy). These symptoms occur especially if you take the medicine for a long time and tend to disappear after stopping treatment;
• dizziness, disorientation;
• diarrhoea, vomiting;
• swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing and breathing (angioedema), skin irritation (rash, urticaria), itching;
• reduced appetite.

In some cases, it may be difficult to distinguish side effects from symptoms of the underlying disease.
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 www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store METADOXIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store below 30°C and protect from light.
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 METADOXIL contains
METADOXIL 500 mg tablets

• The active substance is metadoxine. Each tablet contains 500 mg of metadoxine.
• The other components are: microcrystalline cellulose, magnesium stearate.

METADOXIL 500 mg/15 ml oral solution

• The active substance is metadoxine. Each 15 ml vial contains 500 mg of metadoxine.
• The other components are: sucrose, sorbic acid, edetate disodium, methyl p-hydroxybenzoate, tangerine flavour, purified water.

Description of the appearance of METADOXIL and contents of the pack
METADOXIL 500 mg tablets
Box containing 30 tablets.
METADOXIL 500 mg/15 ml oral solution
Box containing 10 vials of 15 ml each.
Marketing Authorization Holder and Manufacturer
Laboratori Baldacci S.p.A. – Via S. Michele degli Scalzi 73 – 56124 Pisa – Italy

Package leaflet: information for the user

METADOXIL 300 mg/5 ml injectable solution

Metadoxine
Please read this leaflet carefully before using 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What METADOXIL is and what it is used for

METADOXIL contains the active substance metadoxine, which is used in alcohol intoxication.
This medicinal product acts by reducing blood alcohol levels (alcoholemia) and facilitating
alcohol elimination through urine.
This medicine is indicated in cases of acute alcohol intoxication (acute ethanolism) and in the long-standing condition caused by habitual and prolonged use of alcoholic beverages (chronic ethanolism).

2. What you need to know before using METADOXIL

Do not use METADOXIL

• if you are allergic to metadoxine or to any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding (see the section "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before using METADOXIL.
Use this medicine with caution and inform your doctor if you have Parkinson's disease and are
being treated with levodopa, as metadoxine may reduce its effects (see section "Other medicines and METADOXIL").
Children and adolescents
The use of METADOXIL is not recommended in children and adolescents.
Other medicines and METADOXIL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Use this medicine with caution and inform your doctor if you are taking levodopa, used for the treatment of Parkinson's disease, as metadoxine may reduce its effects.
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 using this medicine.
The use of METADOXIL is not recommended during pregnancy, except in cases of absolute necessity and under direct medical supervision.
Do not use METADOXIL if you are breastfeeding, because metadoxine reduces blood levels of a hormone called prolactin (hypoprolactinemic effect) (see section "Do not use METADOXIL").
Driving and using machines
METADOXIL has no effect on the ability to drive or operate machinery.
METADOXIL contains sodium metabisulfite and methyl parahydroxybenzoate
This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.
METADOXIL contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions) and, exceptionally, bronchospasm.

3. How to use METADOXIL

Use this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine must be administered by injection into a muscle (intramuscular route) or into a vein (intravenous route).
Treatment of acute alcohol intoxication
The recommended dose is 1-2 vials administered intramuscularly or intravenously.
Treatment of chronic alcohol intoxication
The recommended dose is 1 vial per day administered intramuscularly or intravenously.
If you use more METADOXIL than you should
Cases of overdose with this medicine are not known.
In case of accidental ingestion/overdose of METADOXIL, contact your doctor immediately or go to the nearest hospital.
If you forget to use METADOXIL
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Very rare (may affect up to 1 in 10,000 people)

• allergic reactions (hypersensitivity);
• numbness, tingling, sensitivity, and weakness in the arms and legs (peripheral neuropathy). These symptoms occur especially if you take the medicine for a long time and tend to disappear after stopping treatment;
• dizziness, disorientation;
• diarrhoea, vomiting;
• swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing and breathing (angioedema), skin irritations (rash, urticaria), itching;
• loss of appetite.

In some cases, it may be difficult to distinguish side effects from the symptoms of the underlying disease.
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 through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store METADOXIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after “EXP.”.
The expiry date refers to the last day of that month.
Store below 30°C and protect from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What METADOXIL contains

• The active substance is metadoxine. Each vial (5 ml) contains 300 mg of metadoxine.
• The other components are: sodium metabisulfite, edetate disodium, methyl p-hydroxybenzoate, water for injections.

Description of the appearance of METADOXIL and package contents
Pack containing 10 vials of 5 ml.
Marketing Authorization Holder
Laboratori Baldacci S.p.A. – Via S. Michele degli Scalzi 73 – 56124 Pisa – Italy
Manufacturer
Doppel Farmaceutici S.r.l. – Via Volturno, 48 – Quinto de' Stampi, Rozzano (MI) – Italy