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Princi-B Vitamins B1 and B6 is an over-the-counter medication that combines thiamine nitrate (vitamin B1) and pyridoxine hydrochloride (vitamin B6). It is indicated for adults experiencing temporary fatigue. Read the package insert carefully before use.
Princi-B is a medication that combines two B vitamins. Each film-coated tablet contains 250 mg of thiamine nitrate (vitamin B1) and 50 mg of pyridoxine hydrochloride (vitamin B6).
Princi-B is indicated for temporary fatigue, just like other over-the-counter medications for fatigue. Its official indication describes it as an adjunctive treatment for functional asthenia: fatigue that is not caused by an illness.
It is used to support you through a busy period or a lack of sleep, as part of a short course of treatment.
Dosage
For adults only. The recommended dose is 1 to 3 tablets per day, to be swallowed with a little water. Do not use for more than 4 weeks without consulting a doctor.
Share your feedback on the usage instructions and dosage of Princi-B Vitamins B1 and B6 with our partner “Verified Reviews” after your purchase.
Precautions
Precautions, contraindications, interactions, and side effects are detailed in the medication guide; read it carefully before use.
Active Ingredients
| Active ingredient | Amount per film-coated tablet |
|---|---|
| Thiamine nitrate (vitamin B1) | 250 mg |
| Pyridoxine hydrochloride (vitamin B6) | 50 mg |
Excipient with known effect
Aluminum lac of cochineal red A (E124).
Other excipients
Microcrystalline cellulose, anhydrous colloidal silica, stearic acid, magnesium stearate, hypromellose, titanium dioxide (E171), glycerol, carnauba wax.
Packaging
Box of 30 film-coated tablets in blister packs.
Before taking the first dose, the key question concerns any other ongoing treatments. A vitamin doesn’t sound like a risky medication, and that’s precisely why the contraindication with levodopa can easily go unnoticed in someone being treated for Parkinson’s disease. At the counter, we always check for this before dispensing Princi-B.
Temporary fatigue almost always has an identifiable cause: lack of sleep, overwork, or unusual physical exertion. Princi-B supports you through this period; it does not replace rest or address the underlying cause. Fatigue that persists beyond the intended duration of treatment, or that is accompanied by weight loss, fever, or shortness of breath, is no longer temporary: it’s time to see a doctor rather than simply refill the prescription.
Can I take Princi-B at the same time as a magnesium and vitamin B6 supplement?
The Princi-B package insert does not mention any interactions with dietary supplements, but vitamin B6 intakes add up, and there is a warning regarding high doses of vitamin B6. Before combining Princi-B with a magnesium supplement enriched with B6, a B-vitamin complex, or brewer’s yeast, it is recommended to consult a pharmacist.
Is Princi-B covered by health insurance?
No. Princi-B is an over-the-counter medication that is not covered by health insurance: its price is not regulated, and it is available without a prescription, both in brick-and-mortar pharmacies and online pharmacies. This status does not alter its usage guidelines, which remain as stated in the package insert, nor does it classify it as a vitamin supplement.
Does Princi-B contain lactose or gluten?
No. The excipients in Princi-B contain no lactose, gluten, or sugar. The tablet is therefore suitable for people who are lactose intolerant or who follow a gluten-free diet, subject to the contraindications and warnings specific to the medication.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Last updated: 17/07/2017
Name of the medicinal product
PRINCI B, film-coated tablet
Thiamine nitrate / Pyridoxine hydrochloride
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor, or your pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
Do not use this medication for children.
What is in this leaflet?
1. What is PRINCI B, film-coated tablet and in which cases it is used?
2. What should I know before taking PRINCI B film-coated tablets?
3. How to take PRINCI B, film-coated tablet?
4. What are the possible side effects?
5. How to store PRINCI B, film-coated tablets?
6. Package contents and other information.
1. WHAT IS PRINCI B film-coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: VITAMINS (A Digestive system and metabolism)
This drug is indicated in the states of transient fatigue.
You should talk to your doctor if you do not feel better or feel less well.
2. BEFORE YOU TAKE PRINCI B, film-coated tablet?
Do not take PRINCI B, film-coated tablets:
· if you are allergic (hypersensitive) to thiamine nitrate (vitamin B1) or pyridoxine hydrochloride (vitamin B6) or any of the other ingredients of this medication mentioned in section 6.
· In association with levodopa.
Warnings and Precautions
This medication should not be used for prolonged periods.
Due to the presence of pyridoxine, the association with levodopa, which may reduce the activity of L-Dopa, requires precautions for use (see Other medicines and PRINCI B, film-coated tablet).
This medicine contains an azo dye (E124) and may cause allergic reactions.
Talk to your doctor or pharmacist before taking PRINCI B, film-coated tablets.
children
Not applicable.
Other medicines and PRINCI B, film-coated tablet
This medication is contraindicated in combination with levodopa.
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
PRINCI B, film-coated tablet with food and drink and alcohol
Not applicable.
Pregnancy and breast feeding
It is best not to use this medication during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue this treatment.
If you are breast-feeding, avoid taking this medicine.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
PRINCI B, film-coated tablet contains cochineal red alumina A (E124)
3. HOW TO TAKE PRINCI B, film-coated tablet?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Reserved for adults only.
The recommended dose is 1 to 3 tablets per day.
The tablets should be swallowed with a little water.
Do not use more than 4 weeks without medical advice.
If you take more PRINCI B film-coated tablets than you should
Immediately consult your doctor or pharmacist.
Neurological manifestations of somnolence and / or paresthesia have been reported in high doses and / or in prolonged cures of pyridoxine hydrochloride. These manifestations are reversible upon cessation of treatment. Treatment is symptomatic.
If you forget to take PRINCI B, film-coated tablet
Not applicable.
If you stop taking PRINCI B, film-coated tablet
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Exceptional and reversible neurological manifestations at the end of treatment following high doses and / or prolonged cures.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE PRINCI B, film-coated tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 30 ° C.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What PRINCI B contains, film-coated tablet
· The active substances are:
Thiamine Nitrate ............................................... .................................................. .... 250.00 mg
Pyridoxine hydrochloride ............................................... ............................................ 50.00 mg
For a film-coated tablet
The other components are:
Microcrystalline cellulose, anhydrous colloidal silica, stearic acid, magnesium stearate, hypromellose, cochineal red alumina A (E124), titanium dioxide (E171), glycerol, carnauba wax.
What is PRINCI B, film-coated tablets and contents of the pack
This drug is in the form of film-coated tablet. Box of 30 or 50.
Not all pack sizes may be marketed.
Marketing Authorization Holder
SOCIETY OF STUDIES AND PHARMACEUTICAL RESEARCH (SERP)
5 RUE DU GABIAN
BUILDING TRITON
98000 MONACO
MONACO
Marketing Authorization Operator
SOCIETY OF STUDIES AND PHARMACEUTICAL RESEARCH (SERP)
5 RUE DU GABIAN
BUILDING TRITON
98000 MONACO
MONACO
Maker
SOCIETY OF STUDIES AND PHARMACEUTICAL RESEARCH (SERP)
5 RUE DU GABIAN
BUILDING TRITON
98000 MONACO
MONACO
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
June 2017
Other
Detailed information on this medicine is available on the ANSM website (France).
antiasthenic
vitamins B1 and B6
. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
PRINCI-B: tablet (red); box of 30.
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PRINCI-B: tablet (red); box of 50.
-
Laboratory SERP
| p cp | |
| Thiamine nitrate (vitamin B1) | 250 mg |
| Pyridoxine hydrochloride (vitamin B6) | 50 mg |
Usual dosage:
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