Becozyme is indicated to prevent deficiencies in B vitamins in case of exclusive parenteral nutrition. Dosage: 1 to 2 ampoules per day, by IM, IV or IV infusion route.

Overdose is not expected at the recommended dosages, especially since all the cases reported were associated with the concomitant intake of mono or poly-vitamin preparations at high doses. Symptoms of overdose may be confusion, gastrointestinal upset (such as constipation, diarrhea, nausea and vomiting). If these symptoms appear, discontinue treatment and consult a doctor.

Warnings and Precaution

• Do not exceed the recommended dosage.
• Consult your doctor before taking this medicine if you are already taking vitamin preparations or if you are already taking any other treatment.
• The risk of an allergic reaction is increased with repeated I.M. or I.V. injections. Therefore, oral administration should be preferred whenever possible.
• If you have kidney problems, consult your doctor before taking BECOZYME ampoule.
• If a biological examination is planned, inform your doctor because taking BECOZYME ampoule could affect the results.
• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• This drug is contraindicated in combination with levodopa.
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medication, under normal conditions of use, can be used during pregnancy and lactation.
• There are no data demonstrating an effect of BECOZYME ampoule on fertility.
• Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
• If you have further questions about the use of this medicine, ask for more information

Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects have been reported with an unknown frequency (cannot be estimated from the available data):

• Digestive disorders: abdominal pain, nausea, vomiting, constipation and diarrhea.
• Allergic manifestations: asthma, moderate reactions affecting the skin, the respiratory tract, the gastrointestinal tract, and / or the cardiovascular system. Symptoms may include rashes, hives (rash similar to that caused by the stinging nettle), facial edema (sudden swelling), pruritus, wheezing, erythema, cardio-respiratory distress, and severe reactions including anaphylactic shock. In the event of an allergic type episode, treatment should be stopped immediately and a healthcare professional should be consulted.
• Headache
• Slight coloration of the urine
• Moderate reaction at the injection site

Reporting of side effects: If you get 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 side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers – Website: www.ansm.sante.fr .By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE BECOZYME?

• Keep this medication out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiration date refers to the last day of that month.
• After opening: do not store above 25 ° C.
• Do not throw away any medicine via wastewater or household waste. Ask your pharmacist to throw away any medicines you no longer use. These measures will help protect the environment.

Becozyme composition

Each 2 ml ampoule of solution for injection contains :

Active ingredients :

• 10 mg Vitamin B1 (thiamine hydrochloride) .
• 5.47 mg Vitamin B2 (riboflavin sodium phosphate) .
• 40 mg Vitamin PP (nicotinamide).
• 4 mg Vitamin B6 (pyridoxine hydrochloride).
• 4 mg Vitamin B5 (dexpanthenol) .

Excipients : phenol, concentrated hydrochloric acid, water for injections.

What presentations exist?

• Pack of twelve 2 ml ampoules.
• Pack of six 2 ml ampoules (hospital presentation only).

Which pharmaco-therapeutic class does Becozyme belong to?

Vitamins (A : Digestive systetRand Metabolism).

Who is the exploitant?

• Bayer Sante Familiale – 33, rue de l’Industrie – 74240 Gaillard – France.
• Manufacturer: Cenexi – 52, rue Marcel et Jacques Gaucher -94122 Fontenay-sous-Bois Cedex – France.

What is Becozyme used for?

This medicine is to be used to prevent B vitamins deficiency, during exclusive parenteral nutrition.

When must Becozyme not be used?

This medicine MUST NOT BE USED :

• when there is a history of allergy to one of its constituents.
• in combination with levodopa.

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