Prefetal tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

beta carotene, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D3, vitamin E, folic acid, biotin, nicotinamide, chromium (chromium chloride), copper (copper sulfate), iron (ferrous fumarate), iodine (potassium iodide), molybdenum (sodium molybdate dihydrate), selenium (sodium selenite), zinc (zinc oxide), magnesium, calcium

Available from:

Soho Flordis International Switzerland SA

ATC code:

A11AA03

INN (International Name):

beta carotene, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D3, vitamin E, folic acid, biotin, nicotinamide, chromium (chromium chloride), copper (copper sulfate), iron (ferrous fumarate), iodine (potassium iodide), molybdenum (sodium molybdate dihydrate), selenium (sodium selenite), zinc (zinc oxide), magnesium, calcium

Dosage:

2mg+ 1,4mg+ 1,4mg+ 1,9mg+ 2,6mcg+ 85mg+ 200IU (5mcg)+ 15mg+ 600mcg+ 30mcg+ 18mg+ 30mcg+ 1mg+ 27mg+ 200mcg+ 50mcg+ 60mcg+ 11mg+ 53mg+ 150mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30) in glass bottle

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2021-07-21

Patient Information leaflet

CAREFULLY READ THIS PACKAGE INSERT
It contains important information. You have received this drug either
with a doctor’s prescription for your personal use or
by the pharmacist without a medical prescription. So, in order to
obtain the greatest benefit from this medication, you
should take it as described in this package insert or as advised by
your physician or your pharmacist. Keep this package
insert as you may wish to read it again or refer to it later on.
PREFETAL, FILM COATED TABLETS
β-carotene, Thiamine nitrate, Riboflavin, Pyridoxine hydrochloride,
Cyanocobalamin, Ascorbic acid,
Cholecalciferol, DL-alpha-Tocopheryl acetate, Folic acid, Biotin,
Nicotinamide, Chromium(3+) chloride
hexahydrate, Copper sulphate anhydrous, Iron(2+) fumarate, Potassium
iodide, Sodium molybdate dihydrate,
Sodium selenite, Zinc oxide, Magnesium oxide, Calcium hydrogen
phosphate anhydrous, Calcium hydrogen
phosphate dihydrate
COMPOSITION WITH THE LIST OF EXCIPIENTS
Each tablet contains:
ACTIVE INGREDIENTS
DOSAGE PER FILM-COATED TABLET
Beta-carotene
2 mg
Vitamin B
1
(thiamine nitrate)
1.4 mg
Vitamin B2 (riboflavin)
1.4 mg
Vitamin B
6
(pyridoxine hydrochloride)
1.9 mg
Vitamin B12 (cyanocobalamin)
2.6 mcg
Vitamin C (ascorbic acid)
85 mg
Vitamin D3 (cholecalciferol)
200 IU
Vitamin E (d,l-alpha-tocopherol acetate)
15 mg
Folic acid
600 mcg
Biotin (vitamin H)
30 mcg
Nicotinamide (niacin, vitamin PP)
18 mg
Chromium (as chromium chloride)
30 mcg
Copper (as copper sulphate, anhydrous)
1 mg
Iron (as ferrous fumarate)
27 mg
Iodine (as potassium iodide)
200 mcg
Molybdenum (as sodium molybdate dihydrate)
50 mcg
Selenium (as sodium selenite)
60 mcg
Zinc (as zinc oxide)
11 mg
Magnesium (as magnesium oxide heavy and magnesium stearate)
53 mg
Calcium (as calcium hydrogen phosphate anhydrous and calcium hydrogen
phosphate dihydrate)
150 mg
EXCIPIENTS:
Povidone; Cellulose, microcrystalline; Silicon dioxide, colloidal
anhydrous; Croscarmellose sodium; Magnesium stearate; Hypromellose;
Triethyl
citrate; Talc; Titanium dioxide (E171); Red iron oxide

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1. NAME OF THE MEDICINAL PRODUCT
PREFETAL, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: (Formulation No.10070)
ACTIVE INGREDIENTS
DOSAGE PER FILM-
COATED TABLET
Beta-carotene (from beta-carotene 20% preparation)
2 mg
Vitamin B
1
(thiamine nitrate) (from thiamine nitrate 33% preparation)
1.4 mg
Vitamin B2 (riboflavin)
1.4 mg
Vitamin B
6
(pyridoxine hydrochloride)
1.9 mg
Vitamin B12 (from cyanocobalamin 0.1% trituration)
2.6 mcg
Vitamin C (ascorbic acid)
85 mg
Vitamin D3 (cholecalciferol preparation)
200 IU
Vitamin E (d,l-alpha-tocopherol acetate 50% preparation)
15 mg
Folic acid
600 mcg
Biotin (vitamin H) (from biotin 1% preparation)
30 mcg
Nicotinamide (niacin, vitamin PP)
18 mg
Chromium (as chromium chloride)
30 mcg
Copper (as copper sulphate, anhydrous)
1 mg
Iron (as ferrous fumarate)
27 mg
Iodine (as potassium iodide)
200 mcg
Molybdenum (as sodium molybdate dihydrate)
50 mcg
Selenium (as sodium selenite)
60 mcg
Zinc (as zinc oxide)
11 mg
Magnesium (as magnesium oxide heavy and magnesium stearate)
53 mg
Calcium (as calcium hydrogen phosphate anhydrous and calcium
hydrogen phosphate dihydrate)
150 mg
Excipients:
Povidone; Cellulose, microcrystalline; Silicon dioxide, colloidal
anhydrous; Croscarmellose sodium; Magnesium stearate;
Hypromellose; Triethyl citrate; Talc; Titanium dioxide (E171); Red
iron oxide (E172).
Excipients contained in substances preparations:
Lactose monohydrate; Gelatin (fish origin); Sucrose; Glucose syrup;
Maize starch; all-rac-alpha-Tocopherol (E307); Mannitol
(E421); Mono and diglycerides of edible fatty acids (E471);
Triglycerides medium-chain; Maltodextrin; Acacia (E414); Sodium
ascorbate; Modified food starch.
3. PHARMACEUTICAL FORM
Film coated tablets for oral use.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PREFETAL is a multi-vitamin/multi-mineral supplementation product,
indicated for women of child-
bearing age that are intending to become pregnant, are already
pregnant or are lactating. It