Benexol (Vitamin B) 50 Tablets

The BENEXOL B12 film-coated tablet is taken through the mouth.

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Active Ingredient

250 mg Vitamin B (Thiamine hydrochloride. IH2O), 250 mg vitamin B6 (Pyridoxine hydrochloride), 1 mg Vitamin B12

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Please read this INSTRUCTIONS carefully before you start using this medicine because it contains important information for you.

Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is BENEXOL B12 and what is it used for?

2. Things to consider before using

3. BENEXOL B 12 How to use BENEXOL B12?

4. What are the possible side effects?

5. store BENEXOL B12

BENEXOL B12 How to use ?

Instructions for proper use and dose / frequency of application

Use a film-coated tablet per day, unless your doctor has recommended it separately.

The product is usually prescribed for one to several weeks. In some cases, the doctor may extend the duration of treatment for a few months.

Method and method of

Elderly use

Different age groups:

Use in children Use in

elderly

Geriatric population: No

administration specific dosage recommendation is given.

Special Use Conditions

Kidney and Liver Failure: Do

not use in patients with renal or hepatic impairment.

If you have an impression that BENEXOL B12 is too strong or too weak, talk to your doctor or pharmacist.

If you use more BENEXOL B12 than you should use that

There is no evidence this product may cause an overdose if used as recommended.

Symptoms occurring in the event of an overdose are as follows; As a result of nerve damage, loss of sensation and lack of coordination in movements, nausea, headache, numbness, drowsiness, blood increases in AST (enzyme test used in the diagnosis of heart and liver diseases) and decrease in blood folic acid concentrations. If the treatment is stopped, the effects disappear.

Talk to a doctor or pharmacist if you have used more than you should use from BENEXOL B12.

If you have forgotten to use BENEXOL B12

Do not take a double dose to compensate for the missed doses.

Effects when treatment with BENEXOL B12 is terminated effects

There are no known.

4. What are the possible side effects?

Like all medicines, BENEXOL B12 may have side effects in people who are sensitive to the ingredients.

Evaluation of undesirable effects is based on the following frequencies:

Very common (> 1/10); common (> 1/100 to <1/10); uncommon (> 1 / 1,000 to <1/100); infrequently (> 1 / 10,000 to <1 / 1,000); very rare (<1 / 10,000), unknown (cannot be estimated from the available data)

If it is one of the following, stop using BENEXOL B12 and IMMEDIATELY tell your doctor or contact the emergency department of the hospital nearest you:

Allergic reactions;

•filled with water (hives)

Rashes• Rashes

• Swelling of the face

and rashes• Difficulty in breathing with the wheezing • Swelling of the

skin

These are all very serious side effects that are unknown. If you have one of these, you have a serious allergy to BENEXOL B12. You may need urgent medical attention or hospitalization.

If you notice any of the following, report it immediately to your doctor or contact the emergency department of the hospital nearest you:

• Increase Liver, heart, muscle tissue, kidney, or brain

in aspartate aminotransferase (Aspartate aminotransferase (ASP-SGOT) after a tissue damage in the. increase)

• reduction in blood folate levels (as alcoholism, pregnancy, anemia, cancers such as cell

division rate is high cases or dietary event of failure to sufficiently with a B vitamin soluble folate decrease the level of blood serum)

all are often unknown serious side effects. Emergency medical intervention may be required.

If you notice any of the following, tell your doctor:

• Diarrhea

• Indigestion

• Nausea

• Abdominal pain

•abnormal urine that

Stench forThese are the mild side effects of BENEXOL B12are unknown.

2.BENEXOL B12 before using

DO NOT USE BENEXOL B12 in the following cases

;

• If you are allergic to any of the ingredients in the medicine

• If you are pregnant or breastfeeding

• If you are under 12 years of age

• If you already have liver or kidney failure

BENEXOL USE CAREFULLY B12 of the following cases:

if;

• If you are a patient with Parkinson's disease who is treated with levodopa alone, daily B vitamins should not be used on several times the dose of 2 mg.

• If you have Leber (a decrease in hereditary optic nerve volume),If you have

•severe megaloblastic anemia (a type of anemia that develops as a result of vitamin B12 and / or folic acid deficiency), a

decrease in the concentration of Vitamin B12 or an abnormal decrease in the concentration with the maximum dose intake can occur within 3 months. If irreversible treatment is taken for longer periods, it may cause irreversible neurological (nervous system related) damage.

Folate deficiency; not shown, but the appropriate result of the treatment may not be observed.

Due to the high dose of pyridoxine hydrochloride (vitamin B6), recommended dosage and treatment time should not be exceeded. Because, if not taken as recommended, severe neurotoxicity (unwanted side effects in the nervous system) may occur.

Please consult with your doctor if these adaptations are true for you, even at any time in the past.

Use of BENEXOL B12 with food and drink

Alcohol intake for more than two weeks may reduce the absorption of this vitamin from the digestive tract.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

It should it contains high-dose vitamin B6 which exceeds the recommended Daily Dietary Intake

not be used during pregnancy because. Women with childbearing potential must apply effective birth control during the treatment. Bl, B6 and / or B12 vitamins have no effect on hormonal contraception methods. However, there are no studies on other control methods.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

It should not be used during breastfeeding because it contains high-dose vitamin B6 exceeding inden the recommended daily intake “.

Use of drive and use machines

tools and machinery No influence on the ability to has been observed.

Important information on some excipients contained in BENEXOL B12

This medicinal product contains less than 1 mmol (23 mg) of sodium per dose. No warning is required due to the dose.

When

used in combination with other drugs, the effect of BENEXOL B12 or the other drug used may vary. Please tell your doctor if you are using the following medicines:

• BI vitamin may cause false positive results in the determination of uro-proteinogen using the Ehrlich reagent.

• High doses of B vitamin may inhibit the spectrophotometric determination of theophylline concentrations in the blood.

5. Storage of

BENEXOL B12 Keep BENEXOL B12 out of the reach of children and in its container.

Store at room temperature below 25 ° C. Protect from moisture.

Use in accordance with expiration dates.

Do not use BENEXOL B12 after the expiration date in the packaging.