Folepar B12

PACKAGE LEAFLET

FOLEPAR B12 Syrup

12 g vials
ORAL USE
COMPOSITION
After adding and dissolving the vitamins contained in the plastic cap,
each vial contains:
Active substances:
Folic acid 6 mg
Nicotinamide 24 mg
Thiamine hydrochloride 12 mg
Cyanocobalamin 6 mcg
Excipients:
Mannitol, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Natural orange flavour,
Natural lemon flavour, Caramel (E150), Ethyl alcohol, Glycerin, Sucrose, Purified water.
PHARMACEUTICAL FORM AND CONTENT
Syrup – 10 vials of 12 g with a separating cap containing the vitamins.
THERAPEUTIC CATEGORY
Combinations of vitamins.
MARKETING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE
ABC Farmaceutici S.p.A
Via Cantone Moretti, 29 Località San Bernardo 10015 Ivrea (TO)
THERAPEUTIC INDICATIONS
Macrocytic anaemias (pernicious and pernicious-like), as an adjunct in hepatic and gastrointestinal insufficiencies.
CONTRAINDICATIONS
Known hypersensitivity to one or more of the components.
See also information provided under "Special warnings".
PRECAUTIONS FOR USE
No particular precautions are required for this medicinal product. However, refer to the information provided under "Special warnings".
INTERACTIONS
No clinically significant interactions are known.
SPECIAL WARNINGS
Due to the presence of sucrose (4.44 g/12 g of syrup), FOLEPAR B12 is contraindicated in hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or in sucrase-isomaltase deficiency. The product contains ethyl alcohol (1.2 g/12 g of syrup) and may therefore be harmful in patients with liver disease, alcoholism, epilepsy, brain disorders, in pregnant women and children. Ethanol may alter or enhance the effect of other medicinal products.
For athletes: this preparation contains ethyl alcohol and may lead to a positive result in anti-doping tests.
The product contains glycerin, which in high doses may cause headache, gastrointestinal disturbances and diarrhoea.
Due to the presence of methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, the medicinal product may cause allergic reactions (such as delayed urticaria); rarely, immediate reactions with urticaria and bronchospasm may occur.
This product can be taken safely by patients with celiac disease.
Pregnancy and breastfeeding
This product is indicated also during pregnancy and breastfeeding. However, it should be noted that the product contains ethyl alcohol.
Effects on ability to drive and use machines
Folepar B12 has no effect on the ability to drive or use machinery.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Oral vials:

• Adults: 2 vials daily, before meals.
• Children: 1 vial daily (divided into two halves), before meals.

Instructions for use

The vitamins, isolated as dry hydrodispersible powder in the reservoir cap, are dissolved at the time of use as follows:

1. Remove the outer protective cap.
2. Press firmly on the cutting cap to release the vitamins into the syrup.
3. Shake for a few minutes until complete dissolution is achieved.

OVERDOSAGE
No symptoms related to overdose have been reported.
UNDESIRABLE EFFECTS
Due to its folic acid content, this medicinal product may cause a severe allergic reaction (anaphylactic reaction) with frequency "not known".
Following the instructions provided in this leaflet reduces the risk of adverse effects.
It is important to inform your doctor or pharmacist of any adverse effect occurring, even if not described in this leaflet.
EXPIRY DATE AND STORAGE
See the expiry date stated on the packaging.
The expiry date refers to the product stored in its original, undamaged packaging.
Warning: do not use the medicinal product after the expiry date stated on the packaging.
REVISION OF THE PACKAGE LEAFLET BY AIFA
KEEP THIS MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN