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Indicated in the treatment of conditions of deficiency of vitamin B6, such as those due to increased requirements or not eating enough
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1. What is Benadon 300 mg tablets and what it is used
Benadon tablet contains vitamin B6 Pyridoxine that is, a water soluble vitamin involved in many processes in the human metabolism.
It is indicated in the treatment of conditions of deficiency of vitamin B6, such as those due to increased requirements or insufficient intake in adults and adolescents over 14 years old.
2. What you need to know before you start taking Benadon 300 mg tablets
Do not take Benadon if:
- if you are allergic to the active substance or any of the other ingredients (listed in section 6)
- if you are being treated with levodopa (a medicine used in Parkinson's disease).
- patient is pregnant or breastfeeding.
- patient are kids under 14 years old
- if patient have kidney disease or liver disease (renal and / or liver failure).
Warnings and Precautions
Consult your doctor or pharmacist before you start taking Benadon tablets.
You do not take a higher dose than recommended or for a longer period of time than recommended. The treatment duration should not exceed two weeks. If your doctor has prescribed Benadon tablets, dosage and duration shall be prescribed by your doctor. With continued administration and high doses of pyridoxine (vitamin B6) and when vitamin B6 is not taken as recommended, side effects of serious neurological (tingling, reduced sensitivity, changes in form may occur walking, etc.), (see section 4). There have been cases of dependence and abstinence for a month by taking doses of vitamin B6 even lower than containing this medicine. You should avoid sun exposure because pyridoxine can cause photosensitivity.
Interference with laboratory tests If you are having any diagnostic test (including blood, urine, skin tests using allergen, etc. ...) inform the doctor that you are taking this medication because it can alter the results.
Children and adolescents
Children and adolescents under 14 years old should not take this medicine.
Benadon with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are using any of the following medications it may be necessary to change the dose of any of them or discontinue treatment, since the effects of these medicines can be modified by Benadon tablets:
-Altretamina (A medicine used to treat cancer) - Levodopa (medicine to treat Parkinson's disease) -Fenobarbital, phenytoin (medicines for epilepsy) -Amiodarona (heart).
Several medicines interfere with pyridoxine (vitamin B6) and can reduce levels of this vitamin, including: -Antibiótico for tuberculosis: isoniazid, cycloserine, ethionamide - Hydralazine (for hypertension) -Penicilamina (for rheumatic diseases)-oral contraceptives -Inmunosupresores, such as corticosteroids, cyclosporine and azathioprine (used in organ transplantation) - Cyclophosphamide (for cancer).
Benadon with food, drink and alcohol
Excessive alcohol intake reduces the absorption of vitamins.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, contact your doctor or pharmacist before taking this medicine. This medicine is contraindicated in pregnancy and lactation due to high doses of vitamin B6, which exceeds the Recommended Daily Dose, which could affect the development of the fetus or infant.
Driving and using machines
There have been no effects on the ability to drive and use machines. However, this medicine may cause drowsiness in a few patients, which should not drive and / or operate machinery during treatment.
3. How to take Benadon 300 mg tablets
Follow exactly the instructions of medicine administration in this leaflet or as your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 14 years old:
We recommend taking half a tablet (150 mg pyridoxine) per day. In the opinion of a doctor, it could indicate taking one tablet (300 mg pyridoxine) per day.
Patients with renal or hepatic impairment:
Benadon tablets are contraindicated in patients with renal or hepatic impairment.
Orally. The tablet can be split in half and divide into equal doses. The tablets should not be chewed and should be swallowed with sufficient amount of water. In general, treatment should not exceed two weeks, although your doctor may recommend the administration for more than 15 days. If symptoms do not improve after 7 days of treatment, consult your doctor.
If you take more tablets than you should Benadon
If you take more tablets than recommended Benadon in the prospectus or what your doctor has prescribed may suffer nervous disorders such alterations or reduced sensitivity, tingling, numbness in hands and feet, unsteady gait, etc. In case of overdose depending on the dose among other effects you may experience nausea, vomiting; also: sensitization to sunlight (photosensitivity) with skin lesions such as redness, blistering; headache, drowsiness, lethargy, difficulty breathing.
In children, accidental ingestion of very high doses can also produce deep sedation and weakness.
In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist call the poison control center, phone: +34 91 562 04 20, indicating the medicine and the amount taken (or go to a medical center).
If you forget to take tablets Benadon
Do not take a double dose to make up the missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Benadon tablets can cause side effects, although not everybody gets them.
Related adverse effects are based on spontaneous reporting.
May occur in prolonged treatments and more frequently with high doses, a disorder characterized, among other symptoms, reduced sensitivity, tingling in the arms and legs (paresthesia), impaired gait, numbness in feet and hands, etc .; These symptoms usually disappear when discontinued. It may happen that 200 mg of pyridoxine per day for 30 days approximately produce a withdrawal syndrome and pyridoxine dependent.
gastrointestinal disturbances such as nausea, abdominal pain (with high doses), vomiting and loss of appetite may also occur; adverse effects on the skin as photosensitivity, with skin lesions such as blisters, blisters, redness, rash or itching; rarely, a condition characterized by nodules and grains with pus on the face and neck; adverse nervous system effects such as lethargy, drowsiness (in sensitive individuals), insomnia, memory impairment may also appear (with high doses).
If you experience side effects, consult your doctor or pharmacist even if it comes to possible side effects not listed in this leaflet.
5. Conservation Benadon 300 mg tablets
Keep this medicine out of the sight and reach of children.
It does not require any special storage conditions.
6. Contents of the pack and other information
Composition of Benadon 300 mg film-coated tablets
The active substance is pyridoxine hydrochloride (vitamin B6), 300 mg
The other ingredients (excipients) are: talc, magnesium stearate (vegetable), povidone K-90, macrogol 6000, methacrylic acid copolymer (1: 1), sodium carboxymethyl cellulose and purified water.
Looks like and contents of the pack
This medicine comes in the form of coated, round, white film, scored tablets. The compressed can be divided into equal halves. It is available in PVC-aluminum blister packs Each pack contains 20 film-coated tablets.
Authorization holder responsible for marketing and manufacturing
Holder of the marketing authorization
Bayer Hispania, S.L. Av. Baix Llobregat, 3-5 08970 Sant Joan Despi, Barcelona
Responsible for manufacturing
GP Grenzach Produktions GmbH Emil-Barell Strasse 7 78839
BAYER SANTE FAMILIALE 33 Rue d l'Industrie
(Gaillard) - 74240
Source: Spanish Agency for Medicines and Health Products