SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
ELEVIT PRONATAL Film coated tablets 2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
in form of Vitamin A concentrate (powder form),
synthetic: Dry Vitamin A palmitate 250 CWS
corresponding to 1.6 mg Thiamine hydrochloride
in form of Rocoat pyridoxine hydrochloride 33 1/3%
in form of powder 0.1% water-soluble : Vitamin B12 0.1% WS
in form of Calcium ascorbate dihydrate
in form of Cholecalciferol concentrate (water-dispersible powder
form) Dry Vitamin D3 type 100 CWS
in form of DL-α-Tocopherol acetate concentrate (powder form):
in form of 133.10 mg calcium ascorbate dihydrate
in form of 10.50 mg calcium pantothenate
in form of 378.89 mg calcium hydrogen phosphate (anhydrous)
in form of 183.00 mg ferrous fumarate
in form of 114.42 mg light magnesium oxide
in form of 217.95 mg magnesium hydrogen phosphate trihydrate
in form of 15.00 mg magnesium stearate
in form of 2.52 mg manganese sulfate (monohydrate)
brought by 183.00 mg ferrous fumarate
in form of 2.51 mg copper sulfate (anhydrous)
in form of 378.89 mg calcium hydrogen phosphate (anhydrous)
in form of 217.95 mg magnesium hydrogen phosphate trihydrate
in form of 20.60 mg zinc sulfate (monohydrate)
1) corresponding to 1080.0
µg of retinol
2) corresponding to 12.5
µg of cholecalciferol
3) corresponding to 15.0 mg of DL-
One ELEVIT PRONATAL tablet contains lactose (45,78mg) and mannitol (58.90mg), see section 4.4.
For a full list of excipients, see section 6.1. 3.
Film coated tablets
Yellow, biconvex, oblong film coated tablets, with a score line.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal dose. 4.
Prevention or correction of disorders due to a vitamin or mineral imbalance or deficiency diet in
preparation for pregnancy and during pregnancy and lactation. 4.2
Posology and method of administration
One tablet daily to be taken as a whole with a glass of water (0.25l) preferably with a meal.
In case of morning sickness, it is recommended that the tablet is taken at noon or in the evening
The recommended period of administration is one month before conception (or when planning a
pregnancy), throughout pregnancy and lactation. 4.3
Hypersensitivity to any of the ingredients Existing hypervitaminosis A and/or D
Contraindication if patient is undergoing treatment with vitamin A or treatment with the synthetic
isomers isotretinoin and etretinate. Beta-carotene is considered as a source of vitamin A
Severe impaired renal function
Iron and/or copper metabolism disorders 4.4
Special warnings and precautions for use
The recommended dosage should not be exceeded. Very high doses of some ingredients, in particular
Vitamin A, Vitamin D, iron and copper, can be harmful to health
Patients receiving other single vitamins or multivitamin preparations, any other medication or those
under medical care should consult a health care professional before taking this product
This preparation must be taken with particular caution together with any other products, including
supplements and/or fortified foods/drinks containing Vitamin A, the synthetic isomers isotretinoin
and etretinate, or beta-carotene, since large doses of the latter mentioned compounds are considered
harmful to the foetus and may cause hypervitaminosis A.
This preparation must be taken with particular caution together with other products, including
supplements and/or fortified foods/drinks containing Vitamin D, since large daily doses may cause
High doses of iron may be noxious.
Folic acid, Vitamin B12 and iron may mask certain forms of anemia.
This preparation does not contain iodine. Adequate iodine supplementation should be provided.
This medicinal product contains lactose (45,78mg/tablet) and mannitol (58.90mg/tablet) as excipients.
Patients with rare heredity problems of galactose intolerance, the Lapp lactase deficiency or glucose-
galactose malabsorption should not take this medicine. Mannitol may have a mild laxative effect. 4.5
Interaction with other medicinal products and other forms of interaction
Concurrent administration of antacids with oral iron preparations may decrease iron absorption. An interval of three hours should be allowed between the administration of antacids and oral iron preparations. Oral administration of iron preparations inhibits absorption of tetracyclines from the gastrointestinal tract and vice versa, leading to decreased serum concentrations of both the antibiotic and iron. If simultaneous administration of the drugs is necessary, patients should receive the tetracycline 2 hours after or 2 hours before oral iron administration.
Interactions with the following other medicinal products were observed: Levodopa, bisphosphonates,
fluoroquinolones, penicillamine, thyroxine, digitalis and thiazide diuretics. 4.6
Pregnancy and lactation
Elevit Pronatal is indicated during pregnancy and lactation, however the recommended dosage should not be exceeded (see section 4.4.). As for every medicinal product, please consult your doctor.
Vitamin A doses of more than 10 000 IU per day have been found to be teratogenic if administered during the first trimester of pregnancy. Thus, this preparation must be taken with particular caution together with other drugs containing vitamin A, the synthetic isomers isotretinoin and etretinate, or beta-carotene, since large doses of the latter mentioned compounds are considered harmful to the
fetus. Chronic overdose of vitamin D might be harmful to the fetus. For pregnant women, the Institute of Medicine (USA) has set the Tolerable Upper Intake Levels (UL) of vitamin D of 50 µg (2000IU) per day, which is considered as safe. Elevit Pronatal contains 500IU/tablet (12.5 µg/tablet). Lactation
Permanent overdose of vitamin D might be harmful to the neonate. Vitamin D and calcium are
excreted into breast milk. This must be taken into consideration if the infant is receiving any
For lactating women the Institute of Medicine (USA) has set the Tolerable Upper Intake Levels (UL)
of vitamin D of 50 µg (2000IU) per day, which is considered as safe. Elevit Pronatal contains
500IU/tablet (12.5 µg/tablet). 4.7
Effects on ability to drive and use machines
Elevit Pronatal has no influence on the ability to drive and use machines. 4.8
In general, this product is well-tolerated. However, in common cases gastrointestinal symptoms (e.g.
constipation, diarrhoea and nausea) may occur, but these generally do not necessitate withdrawal of
In very rare cases (<1/10,000) hypersensitivity reactions including exanthema, asthma, angioderma
and urticaria have been reported.
A slight yellow discoloration of urine may be noticed. This effect is harmless and is due to the
Vitamin B2 contained in the preparation
Elevit Pronatal contains iron, which may lead to a black colouring of the stool. This does not have any
There is no evidence that this product can lead to an overdose when used as recommended (see also
4.4). Most, if not all reports concerning overdoses are associated with concomitant intake of high
dosed single and/or multivitamin preparations.
Acute or long-term overdose can cause hypervitaminosis A and D and hypercalcaemia as well as iron
and copper toxicity.
Uncharacteristic initial symptoms, such as abrupt onset of headache, confusion, and gastrointestinal
disturbances such as constipation, diarrhoea, nausea, and vomiting might be indicative for an acute
overdose. If such symptoms occur, treatment must be stopped and a health care professional
Excessive intake of Vitamin A causes fatigue, irritability, anorexia, gastrointestinal disturbances, skin and hair changes (e.g. erythema and pruritus).
Overdose of Vitamin D leads to hypercalcemia, which shows the following symptoms: Nausea, vomiting, thirst, polydipsia, polyuria and constipation.
High doses of iron cause gastrointestinal irritation and abdominal pain with nausea and vomiting. Other gastrointestinal effects may include constipation and diarrhea.
If symptoms of overdose occur the use of the product must be stopped.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Multivitamins and minerals / trace elements,
ATC code: A 11A A03
Elevit Pronatal is a multivitamin/multimineral preparation containing 12 vitamins in combination with 3 minerals and 4 trace elements especially designed to ensure an adequate micronutrient supply for both the unborn child and the mother-to-be.
Vitamins are essential nutrients. They are indispensable for the normal development and growth of the foetus and the infant, for the metabolism and formation of carbohydrates, energy, lipids, nucleic acids and proteins, as well as for the synthesis of amino acids, collagen and neurotransmitters.
Multivitamins/multimineral preparations are indicated to prevent and correct nutritional micronutrient
deficiencies. Pregnancy and lactation represent periods with increased micronutrient requirements
and, as a consequence, increased risks of micronutrient deficiencies for both the mother and the child.
Especially during pregnancy, micronutrient deficiencies exhibit a more serious health risk, as they
may also impair the normal development of the unborn child. Supplementation with folic acid or folic
acid containing multivitamins is recommended to prevent congenital malformations including neural
tube defects. Neural tube defects develop in the first weeks after conception, a period during which
pregnancy may not have been diagnosed yet, thus supplementation with folic acid is essential at the
stage when pregnancy is being planned. 5.2
Human health and well-being is naturally dependent on the continuous uptake and management of
vitamins and minerals and their absorption, distribution, metabolism and elimination are maintained
by specific physiological mechanisms. The active ingredients of Elevit Pronatal, vitamins, minerals,
and trace elements, are essential micronutrients, which are widely distributed in the human body. The
discrimination between the physiological nutrient concentration in the plasma and its changes after
additional intake of corresponding pharmaceutical preparations is, on the one hand, difficult to assess
and conveys, on the other hand, little or no information on the biological activity of the individual
nutrient in the target tissue. The plasma and tissue levels of micronutrients are homeostatically
regulated and affected by various factors such as diurnal fluctuations, nutritional status, growth, and
pregnancy and lactation. No pharmacokinetic data are available on the active ingredients of Elevit
Pronatal, but the pharmacokinetic properties of the individual components have been extensively
Preclinical safety data
The active ingredients of Elevit Pronatal, vitamins, minerals, and trace elements, are essential
nutrients, which are considered as safe when given at the recommended doses.
No teratogenesis studies have been conducted with Elevit Pronatal in animals. 6.
List of excipients
Macrogol (Type 400)
Sodium starch glycollate
Sodium lauryl sulphate
Macrogol (Type 6000)
Titanium dioxide (E171)
Iron oxide yellow (E172)
Ingredients of the vitamin premixes:
Dry Vitamin A palmitate 250 CWS: Vitamin A palmitate, butylhydroxyanisole, butylhydroxytoluene,
DL-α-Tocopherol, gelatin, sucrose, corn starch.
Rocoat pyridoxine hydrochloride 33 1/3% : Pyridoxine hydrochloride, mono- and diglycerides of
edible fatty acids.
Vitamin B12 0.1% WS : Cyanocobalamin, trisodium citrate, citric acid anhydrous, maltodextrin.
Vitamin D3 powder 100 CWS: Cholecalciferol, DL-α-Tocopherol, partially hydrogenated
soyabeanoil, hydrolysed gelatin, sucrose, corn starch.
Dry Vitamin E 50% type SD: DL-α-Tocopherol acetate, hydrolysed gelatin, silicon dioxide. 6.2
Not applicable. 6.3
2 years 6.4
Special precautions for storage
Do not store above 25°C. Store in the original package. 6.5
Nature and contents of container
PVC/PE/PVDC Alu blisters, with 30 and 100 tablets
Not all pack sizes may be marketed. 6.6
Special precautions for disposal and other handling
MARKETING AUTHORISATION HOLDER
To be completed nationally
Name and address
MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
To be completed nationally 10.
DATE OF REVISION OF THE TEXT
PRE-OPERATIVE INSTRUCTIONS FOR IMPLANT, SINUS AUGMENTATION AND EXTRACTION SURGERY • Please plan ahead: make sure you have all the prescription medications that you will need before and after the surgery. Make ice packs, prepare soft foods, and wear comfortable • Please do not take any aspirin, vitamin E or Ginkgo Biloba 7-10 days prior to surgery. If you need a pain medication, use
04_article Stoffels 18.10.2004 8:58 Page 515 IRRC September 2004 Legal regulation of humanitarian assistance inContradictory images of humanitarian assistance in armed conflictpaint a confusing picture. There are now a great many public and privatehumanitarian organizations operating all over the world. The work that theydo is seen to help save lives and alleviate the suffering of those not