Beduo

Package Leaflet: Information for the User

Beduo, 100 mg + 100 mg, coated tablets

Thiamine hydrochloride + Pyridoxine hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Beduo and what is it used for

Beduo is a combination medicine, belonging to the group of B vitamins. It contains vitamin B and vitamin B.
Beduo is used to treat nervous system diseases caused by a documented deficiency of vitamin B and B.
Note:
A deficiency of vitamin B and B rarely occurs alone. Before starting therapy, it is necessary to check if there is a deficiency of another vitamin.
You should consult a doctor if there is no improvement or worsening of the disease.

2. Important information before taking Beduo

When not to take Beduo

• if you are allergic to thiamine hydrochloride, pyridoxine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Beduo, you should discuss it with your doctor or pharmacist.
In cases of hypersensitivity reactions, such as skin rashes, hives, photosensitivity, anaphylactic reactions (acute hypersensitivity reactions), you should stop taking the medicine.
If necessary, the attending physician will apply appropriate treatment.

Children and adolescents

The safety and efficacy of Beduo in children have not been established.

Beduo and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.
The effect of other medicines on the action of Beduo
Reduced action
Concomitant administration of medicines called pyridoxine antagonists (which inhibit the action of vitamin B) such as hydralazine, isoniazid, cycloserine, D-penicillamine, may increase the need for vitamin B.
Vitamin B is ineffective if taken simultaneously with the cytostatic medicine 5-fluorouracil (used in cancer treatment).
Antacids reduce the absorption of vitamin B.
A deficiency of vitamin B may occur during prolonged treatment with furosemide (used to increase urine production), as it increases the excretion of vitamin B in the urine.
The effect of Beduo on the action of other medicines
Vitamin B in daily doses of 5 mg or more may weaken the action of levodopa (a medicine used to treat Parkinson's disease).

Beduo with food and drink

Alcohol and tea reduce the absorption of vitamin B.
Concomitant consumption of beverages containing sulfites, such as wine, may cause the breakdown of vitamin B, resulting in a lack of its effect.
Drinking alcohol and long-term use of oral contraceptives containing estrogens may lead to a deficiency of vitamin B.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, you should consult your doctor before taking this medicine.
During pregnancy and breastfeeding, the daily requirement for vitamins should be ensured by a balanced diet.
Pregnancy
You should inform your doctor about becoming pregnant. During pregnancy, Beduo may be taken only if the doctor considers it absolutely necessary.
During pregnancy, the recommended daily dose of vitamin B is about 1.4 - 1.6 mg, and vitamin B 2.4 - 2.6 mg. These doses may be increased only in case of a documented deficiency of vitamin B or B, as the safety of using higher doses than recommended has not been confirmed.
Breastfeeding.
During breastfeeding, the recommended daily dose of vitamin B is about 1.4 - 1.6 mg, and vitamin B 2.4 - 2.6 mg. These doses may be increased only in case of a documented deficiency of vitamin B or B, as the safety of using higher doses than recommended has not been confirmed.
Vitamins B and B pass into breast milk.
High doses of vitamin B may inhibit milk production.
You should inform your doctor about breastfeeding. The doctor will decide on the use of Beduo after analyzing the benefits for the mother and the possible risk.

Driving and using machines

No special precautions are necessary.

3. How to take Beduo

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The recommended dose for adults is 1 coated tablet of Beduo per day (corresponding to 100 mg of vitamin B and 100 mg of vitamin B).

Method of administration

Beduo coated tablets should be taken with food or without food, whole (without chewing), with a sufficient amount of liquid, preferably a glass of water (200 ml).

Duration of treatment

After four weeks of treatment, the doctor should decide whether other treatment methods are necessary (see section 2. "Warnings and precautions").

Taking a higher dose of Beduo than recommended

Vitamin B has a wide range of uses.
Long-term use (months or years) of vitamin B in doses above 50 mg per day, as well as short-term use (2 months) in doses above 1 g per day, may lead to the occurrence of neurotoxic symptoms (see section 2. "Warnings and precautions").
The symptom of an overdose of vitamin B is mainly sensory neuropathy, also with ataxia (coordination disorders). Taking very high doses may lead to the occurrence of seizures. In newborns and infants, severe sedation, hypotonia (low blood pressure), and respiratory disorders [dyspnea (shortness of breath), apnea (cessation of breathing)] may occur (see section 2. "Warnings and precautions").
Treatment of overdose
In case of overdose, you should immediately contact a doctor so that appropriate treatment can be started.

Missing a dose of Beduo

Do not take a double dose to make up for a missed dose.
Continue taking the medicine as directed.

Stopping the use of Beduo

This should be agreed with your doctor.
If you have any doubts about the use of the medicine, ask 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 have been observed:
Immune system disorders:
Very rare (may affect up to 1 in 10,000 people): hypersensitivity reactions, such as skin rashes, hives, photosensitivity, anaphylactic reactions (acute hypersensitivity reactions).
Nervous system disorders:
Rare (may affect up to 1 in 1,000 people): peripheral neuropathies (symptoms related to nerves, such as numbness of hands or feet).
Gastrointestinal disorders:
Very rare (may affect up to 1 in 10,000 people): In clinical trials, individual cases of gastrointestinal disorders, such as nausea and other gastrointestinal disorders, have been documented. However, their frequency did not differ significantly from the placebo group. The causal relationship with the use of vitamin B and B has not been fully explained and may depend on the dose.
Overdose of vitamin B (dose above 1 g/day for more than 2 months) causes nerve damage.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Beduo

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

Storage conditions

No special precautions for storage of the medicinal product.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Beduo contains

• The active substances are: thiamine hydrochloride and pyridoxine hydrochloride. One tablet contains 100 mg of thiamine hydrochloride (vitamin B) and 100 mg of pyridoxine hydrochloride (vitamin B).
• The other ingredients are:

Tablet core: microcrystalline cellulose, crospovidone (Type A), hypromellose, talc, magnesium stearate, colloidal anhydrous silica.
Tablet coating: hypromellose, microcrystalline cellulose, stearic acid (Type 50), macrogol stearate (Type I), propylene glycol, calcium carbonate, red iron oxide (E172), yellow iron oxide (E172), macrogol 35000.

What Beduo looks like and contents of the pack

Round, orange, convex coated tablets with a diameter of about 9 mm.
Beduo is available in brown glass bottles (Type III) closed with a PP cap containing a desiccant, with a tamper-evident closure, containing 20, 50 or 100 coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

Date of last revision of the leaflet: