APPENDIX

LABELING AND PACKAGE LEAFLET

A. LABELING
INFORMATION ON THE OUTER PACKAGING

CARDBOARD BOX

1. NAME OF THE MEDICINAL PRODUCT

METADOXIL 500 mg tablets

Metadoxine

2. ACTIVE SUBSTANCE(S) AND ITS QUANTITY(S)

Each tablet contains 500 mg of methadoxin.

3. LIST OF AUXILIARY MATERIALS

Microcrystalline cellulose and magnesium stearate.

4. PHARMACEUTICAL FORM AND QUANTITY IN PACKAGING

30 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Use orally.
Before use, read the package leaflet.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT SHOULD BE KEPT OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of sight and reach of children.

7. OTHER SPECIAL WARNING(S) (IF NECESSARY)

8. PERIOD OF ELIGIBILITY

Valid until {mm/yyyy}

9. SPECIAL STORAGE CONDITIONS

Store at a temperature not higher than 30 °C.

Store the blister plates in the outer box to protect the preparation from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS (IF NECESSARY )

11. PARALLEL IMPORTER

Parallel importer: Limedika UAB

12. PARALLEL IMPORT PERMIT NUMBER

Eq. imp. No.: LT/L/15/0281/001

13. SERIAL NUMBER

Series: {number}

14. SALE (ISSUE) PROCEDURE

Non-prescription medicinal product

15. INSTRUCTIONS FOR USE

METADOXIL tablets are used as an adjunctive medicine to relieve the symptoms of chronic alcohol
intoxication and to treat alcohol-induced liver damage. The recommended daily dose is two 500 mg
tablets. If the condition improves within 7 days, it can be used for 2-3 months if necessary.

16. INFORMATION IN BRAILLE

METADOXIL 500 mg

17. OTHER INFORMATION

Manufacturers: Laboratori Baldacci SpA, Italy or Special Product's Line SpA, Italy.
Repackaged by: BĮ UAB "Norfachema"
Repack series

The parallel imported medicinal product differs from the reference medicinal product in terms of
storage conditions: the parallel imported medicinal product must be stored at a temperature not
higher than 30 C ; the reference medicinal product must be stored at a temperature not higher than
25 C.
B. PACKAGE LEAFLET
 Package leaflet: information to the user

METADOXIL 500 mg tablets

Metadoxine

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

- Do not throw this leaflet away as you may need to read it again.
- If you want to know more or consult, contact your pharmacist.
- If symptoms worsen or do not improve within 7 days, consult a doctor.
- If side effects occur (even if they are not listed in this leaflet) , contact your doctor or pharmacist. See
Chapter 4 .

What is this leaflet about?

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. Package contents and other information

1. What METADOXIL is and what it is used for

METADOXIL accelerates the metabolism of alcohol, increases the excretion of alcohol and the toxic
metabolite acetaldehyde in the urine, thus reducing the amount of alcohol in the blood and shortening
its harmful effects on tissues. In the treatment of acute alcohol intoxication, metadoxil has an effective
effect, including alcohol-induced stimulation of motor function. In addition, the medication suppresses
vomiting. In the treatment of chronic alcoholism, there is a statistically significant trend towards the
normalization of liver biochemical test data.

METADOXIL tablets are used as an adjunctive medicine to relieve the symptoms of chronic alcohol
intoxication and to treat alcohol-induced liver damage.

2. What you need to know before taking METADOXIL

METADOXIL should not be used:

- if you are allergic (hypersensitivity) to metadoxine or any auxiliary substance of METADOXIL

tablets;
- if you are breastfeeding a baby.

Warnings and precautions

METADOXIL should be used with caution in patients with Parkinson's disease who are taking
levodopa, as the effect of the latter preparation may be weakened.

Other medicines and METADOXIL

If you are taking or have recently taken any other medicines, or you are not sure , tell your doctor or
pharmacist.
Metadoxyl enhances the decarboxylation of levodopa in the periphery, which reduces its effectiveness.

Pregnancy, lactation and fertility

Before using any medicine, it is necessary to consult a doctor or pharmacist.
As there are insufficient data on the use of METADOXIL in pregnant women, the potential risk to
pregnancy is not known. Methadoxyl can only be used in pregnant women if absolutely necessary. It is
forbidden to take the medicine during breastfeeding, because the medicine reduces the level of the
hormone prolactin in the blood (causes hypoprolactinemia).

Driving and machine control

No studies on the effects on the ability to drive and use machines have been performed, but no such
effects have been observed.

3. How to take METADOXIL

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told
you. If in doubt, ask your doctor or pharmacist.

Dosage and method of administration

For adults

Chronic intoxication with ethyl alcohol, liver damage. The recommended daily dose is two 500 mg
tablets. If the condition improves within 7 days, it can be used for 2-3 months if necessary. With the
doctor's permission, it can be taken even longer, even for 6 months.

For elderly people

Elderly people can be treated with METADOXIL safely, there is no need to change the dose.

Use in children and adolescents

METADOXIL is not recommended for use in children and adolescents, as data on safety and efficacy
are not available.

Patients with liver failure

For liver diseases such as alcoholic liver disease, the recommended dose of METADOXIL can be
used. There is no experience of treating patients with severe liver failure with this medicine. As a
general precaution, such patients are advised not to take this medicine for a long time.

Patients with renal failure

There is no experience with METADOXIL in patients with renal failure. Due to the fact that the drug
is partially excreted from the body through the kidneys, as a general precaution, such patients should
reduce the dose and avoid long-term treatment with this drug.

What to do if you overdose on METADOXIL?

There have been no reports of overdose.

Since the toxic effect of METADOXIL is weak, accidental overdose is unlikely. If you have taken a
lot of METADOXIL tablets at once, contact your doctor immediately, who will decide what necessary
measures should be taken.

If you forget to take METADOXIL

Do not take a double dose to make up for a missed dose

When you stop taking METADOXIL

METADOXIL works as long as it is used. After stopping use, the effects caused by it disappear
quickly.

If you have any further 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.

It should be noted that sometimes adverse reactions can be difficult to distinguish from symptoms
caused by the disease itself. With long-term use of METADOXIL , in rare cases, peripheral
neuropathy may occur, which disappears after some time after the drug is stopped.

The following adverse reactions may occur when using METADOXIL:

Very rare ( affects less than 1 in 10,000 people taking this medicine ): hypersensitivity reactions, nerve
damage (peripheral neuropathy), dizziness and loss of consciousness (disorientation), diarrhea,
vomiting, swelling of the skin or subcutaneous tissue (angioneurotic edema) . skin rash, hives, itching
and decreased appetite.

Tell your doctor or pharmacist if your symptoms get worse or if you notice any side effects not listed
in this leaflet.

Side effect reporting

If you experience side effects, including those not listed in this leaflet, tell your doctor or pharmacist .
You can also report side effects directly by filling out the form on the website www.vvkt.lt , by mail to
the State Medicines Control Service at the Ministry of Health of the Republic of Lithuania, Žirmūnų
str. 139A, LT 09120 Vilnius, tel : 8 800 73568, fax 8 800 20131 or e-mail by mail
NegeidaujamaR@vvkt.lt . By reporting side effects, you can help us get more information about the
safety of this medicine.

5. How to store METADOXIL

Keep this medicine out of the sight and reach of children.

Store at a temperature not higher than 30 °C. Store the blister plates in the outer box to protect the
preparation from light.

Do not use METADOXIL after the expiry date which is stated on the carton and blister after EXP or
EXP . The drug is suitable for use until the last day of the indicated month.

Medicines must not be poured down the drain or thrown away with household waste waste. Ask your
pharmacist how to dispose of unnecessary medicines. These measures will help protect the
environment.

6. Package contents and other information

Composition of METADOXIL

- The active substance is methadoxin. One METADOXIL tablet contains 500 mg of metadoxine.
- Excipients are microcrystalline cellulose and magnesium stearate.

Appearance and content of METADOXIL in the package

METADOXIL tablets are white, round, with the inscription "METADOXIL" on one side and a score
on the other. The score is only intended to break the tablet to make it easier to swallow, but not to
divide it into equal doses.

Package size
Cardboard box containing 30 tablets (3 PVC and aluminum blisters, each containing 10 tablets).

Registrant and manufacturer

Registrant in the exporting country

Laboratori Baldacci SpA

Via S. Michele degli Scalzi 73
PISA
Italy

Manufacturer(s)

Laboratori Baldacci SpA

Via S. Michele degli Scalzi 73
PISA
Italy

or

Special Product's Line SpA

Via Campobello 15
Pomezia (Rome)
Italy

This leaflet was last reviewed on 07/02/2015.

Detailed information about this medicine is available on the website of the State Drug Control Service
under the Ministry of Health of the Republic of Lithuania http://www.vvkt.lt/ .

The parallel imported medicinal product differs from the reference medicinal product in terms of
storage conditions: the parallel imported medicinal product must be stored at a temperature not
higher than 30 C ; the reference medicinal product must be stored at a temperature not higher than
25 C.