Benoxam
PolandTable of Contents
Package leaflet: Information for the patient
Benoxam, 300 mg, tablets
Benfotiamine
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any doubts, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet
- What Benoxam is and what it is used for
- Important information before taking Benoxam
- How to take Benoxam
- Possible side effects
- How to store Benoxam
- Contents of the pack and other information
1. What Benoxam is and what it is used for
Benoxam contains benfotiamine (vitamin B1).
Indications:
- Treatment of confirmed vitamin B1 deficiency;
- Prevention of vitamin B1 deficiency in patients at risk, when vitamin B1 cannot be effectively supplemented by diet;
- Treatment of neuropathies caused by vitamin B1 deficiency.
Vitamin B1 deficiency requiring supplementation may occur in the following conditions:
chronic alcoholism (alcoholic cardiomyopathy, Wernicke's encephalopathy, Korsakoff's syndrome); diabetes; long-term parenteral nutrition; malabsorption (malabsorption syndrome, bariatric surgery); hemodialysis; systemic infections; impaired nutritional status (due to dietary deficiency, malnutrition, prolonged fasting or starvation, or advanced age); increased demand (e.g. pregnancy and breastfeeding).
2. Important information before taking Benoxam
When not to take Benoxam
If the patient is allergic to benfotiamine, thiamine (vitamin B_), or any of the other
components of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Benoxam, consult your doctor or pharmacist.
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age due to insufficient data.
Benoxam with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Thiamine is inactivated by 5-fluorouracil (the active substance in medicines used to treat cancer).
Benoxam with food, drink and alcohol
No special precautions are required.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
The recommended daily intake of vitamin B_ during pregnancy is 1.4 to 1.6 mg. The safety of higher daily doses has not been documented. Benoxam may be used during pregnancy only if a vitamin B_ deficiency has been diagnosed and the doctor considers treatment necessary.
Breastfeeding
The recommended daily intake of vitamin B_ during breastfeeding is 1.4 to 1.6 mg. The safety of higher daily doses has not been documented. Benoxam may be used during breastfeeding only if a vitamin B_ deficiency has been diagnosed and the doctor considers treatment necessary. Vitamin B_ passes into breast milk.
Effect on fertility
There are no available data on the effect of Benoxam on fertility.
Driving and operating machinery
Benoxam has no influence on the ability to drive or operate machinery.
3. How to take Benoxam
Always take this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
The following dosage recommendations apply only if your doctor has not advised otherwise. Always follow the prescribed instructions, as failure to do so may result in the medicine not achieving the expected effect.
Dosage
Adults
Treatment of confirmed vitamin B_ deficiency:
Unless otherwise prescribed by the doctor, 1 tablet (300 mg benfotiamine) of Benoxam per day.
Prevention of vitamin B_ deficiency:
The usual dose is ½ tablet (150 mg benfotiamine) of Benoxam per day.
Treatment of neuropathies caused by vitamin B_ deficiency:
The usual dose is ½ tablet (150 mg benfotiamine) of Benoxam per day.
Use in children and adolescents
Benoxam is indicated for use only in adults. The efficacy and safety of Benoxam have not been established in children and adolescents under 18 years of age.
Elderly patients
Dose adjustment is not necessary in elderly patients.
Patients with renal impairment
Dose adjustment is not necessary in patients with impaired kidney function.
Patients with hepatic impairment
The safety and efficacy of Benoxam have not been demonstrated in patients with impaired liver function. Benoxam should not be used in patients with hepatic impairment.
Method and route of administration
Swallow the tablet with a glass of water. Tablets may be taken at any time of day. The tablet may be divided into two equal doses.
Duration of treatment
The duration of Benoxam treatment depends on the response to therapy. Benoxam should initially be taken for at least 3 weeks. Subsequently, maintenance treatment will depend on the response, and the dose may range from 150 to 300 mg benfotiamine, i.e., from ½ to 1 tablet of Benoxam. If there is no response or an insufficient response to treatment for vitamin B_ deficiency, the treatment regimen should be re-evaluated.
Inform your doctor or pharmacist if the effect of Benoxam is too weak or too strong.
Overdose of Benoxam
If an overdose of Benoxam is taken, medical intervention is usually not required. However, if any concerning symptoms occur after taking an overdose, consult your doctor.
Missed dose of Benoxam
Do not take a double dose to make up for a missed dose. Take Benoxam as usual at the scheduled time, and try to remember to take it regularly.
Stopping Benoxam
If treatment is discontinued, its effectiveness may be reduced or completely lost. If adverse effects occur, consult your doctor for advice on continuing treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, Benoxam may cause adverse reactions, although not everyone experiences them.
Adverse reactions reported during the use of Benoxam:
Very rare adverse reactions, which may occur in less than 1 in 10,000 patients:
- Hypersensitivity reactions (allergy) such as rash, urticaria.
- In clinical studies on benfotiamine, isolated cases of gastrointestinal disturbances such as nausea have been reported.
If any of the above adverse reactions worsen, or if any other adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.
5. How to store the medicine Benoxam
Store below 30°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the pack and other information
What Benoxam contains
- The active substance is benfotiamine. One tablet contains 300 mg of benfotiamine.
- Other ingredients are: Calcium hydrogen phosphate, Potato starch, Talc, Low-substituted hydroxypropyl cellulose, Microcrystalline cellulose (type 102), Glyceryl dibehenate, Colloidal anhydrous silica.
What Benoxam looks like and contents of the pack
White or almost white capsule-shaped tablets with a division line on both sides.
PVC/PVDC/Aluminium blisters in a cardboard box.
Pack sizes: 10, 20, 30 and 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
tel.: +48 81 463 48 82
[logo Solinea]
Manufacturers:
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom
Mako Pharma Sp. z o.o.
ul. Władysława Reymonta 2
05-092 Dziekanów Leśny