Active ingredients: Vitamins, Minerals
ELEVIT film-coated tablets - 12 vitamins 7 minerals and trace elements
Indications Why is Elevit used? What is it for?
Elevit belongs to the category of multivitamins and minerals / trace elements.
Elevit is used for the prevention or correction of disorders due to vitamin or mineral imbalance or deficiency or dietary deficiencies during pregnancy and breastfeeding.
Vitamins, minerals and trace elements are essential nutrients. They cannot be produced by the body and therefore must be consumed in the diet. These substances are essential for daily vital functions (eg breathing, digestion, energy generation, brain and nervous system function, reproduction, growth) and for the at the same time they are part of numerous tissues and organs.
Pregnant and breastfeeding women need far more vitamins, minerals and trace elements than non-pregnant women. In particular, a pregnant woman must provide nourishment not only for her own body but also for that of her baby.
With a balanced diet without the consumption of nicotine and alcohol, pregnant and breastfeeding women normally have sufficient quantities of vitamins, minerals and trace elements. Despite everything, deficiencies can occur in pregnancy and breastfeeding. Frequent vomiting during the early stages of pregnancy could be due to a deficiency of essential nutrients.
Consequences of deficiencies can include anemia and fatigue for the mother and growth retardation and changes in the baby's skin and mucous membranes.
Elevit contains all the essential nutrients required during pregnancy and breastfeeding. This prevents the occurrence of deficiencies in the mother and baby. Folic acid helps prevent baby malformations.
Contraindications When Elevit should not be used
Do not take Elevit, if it is / ha
- allergic to any of the other ingredients of this medicine (listed in section 6),
- too high blood levels of vitamin A and / or D,
- being treated with Vitamin A or the similar chemicals isotretinoin and etretinate. Beta-carotene is considered a source of Vitamin A,
- severely reduced kidney function,
- increased blood calcium levels or severely increased "calcium elimination in the urine,"
- metabolic disorders of iron and / or copper.
Precautions for use What you need to know before taking Elevit
Talk to your doctor, pharmacist or nurse before taking Elevit if you are / have:
- urinary stones: Calcium, ascorbic acid and vitamin D can have an effect on stone formation.
- being treated with other vitamin products.
Very high doses of some Elevit ingredients especially Vitamin A, Vitamin D, Iron and Copper can be harmful.
Patients using other vitamin preparations or who are under medical treatment should consult their doctor or pharmacist before taking Elevit.
Particular caution is required with any other products, including supplements and / or fortified foods / drinks, containing vitamin A, beta-carotene or vitamin D. Please note: Elevit should not be used if you have too high levels of vitamin A or D or, when using vitamin A supplements. See section "Do not take Elevit".
Elevit does not contain iodine. Adequate iodine supplementation must be provided.
Interactions Which drugs or foods can modify the effect of Elevit
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially those listed below.
The following medicines can affect or be affected by Elevit. Where necessary, they should be used at least 2 hours before or after taking Elevit.
- levodopa: a medicine to treat Parkinson's disease
- medicines to treat low bone density whose active ingredient names end in "dronate"
- thyroxine, levothyroxine: medicines to treat the reduced functioning of the thyroid gland
- digitalis: a medicine to treat heart disease
- medicines to treat bacterial infections whose active substance names end in "oxacin" or "cyclin"
- penicillamine: a medicine to treat rheumatic joint inflammation and heavy metal poisoning
- medicines to increase urine output called thiazides used for example to reduce high blood pressure
- antacids: medicines that neutralize or bind stomach acid
- trientine: a medicine to treat copper buildup in tissues called Wilson's disease
- medicines to treat viral infections
Medicines that lower blood lipid levels, cholestyramine and colestipol, may decrease the absorption of lipophilic vitamins. Tell your doctor if it is necessary to use these medicines during pregnancy and breastfeeding. Consideration should be given to administering these medicines. Elevit is sufficient to prevent vitamin A, D and E deficiencies in the mother and fetus / baby.
Elevit with food and drink
Oxalic acid, contained in spinach and rhubarb, and phytic acid, contained in whole grains, can reduce the absorption of calcium. Avoid taking Elevit within two hours of consuming large amounts of these foods.
Warnings It is important to know that:
Pregnancy and breastfeeding
Elevit is specifically formulated for pregnant and breastfeeding women. However the recommended dosage should not be exceeded.
Doses of vitamin A in excess of 10,000 international units (IU) per day can cause deformities in the fetus if administered during the first three months of pregnancy. Therefore, please consider the information in the "Warnings and Precautions" section.
Prolonged overdose of vitamin D can be harmful to the fetus and newborn babies. The vitamins and minerals contained in the medicine are secreted into breast milk. This must be taken into consideration if the infant is receiving any of these supplements.
The daily dose of Vitamin D considered safe for pregnant and breastfeeding women is 4,000 IU. . Elevit contains 500 IU per tablet.
Driving and using machines
Elevit has no effect on the ability to drive and use machines.
Elevit contains lactose and soybean oil
If you have been told by your doctor that you have an "intolerance to some sugars, contact your doctor before taking Elevit.
If you are allergic to peanuts or soy, do not use this medicine.
Dosage and method of use How to use Elevit: Dosage
Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist or nurse. If you are unsure, consult your doctor, pharmacist or nurse.
The recommended dose is one tablet a day to be swallowed whole with a glass of water preferably with meals.
If you feel sick in the morning, take the tablet at noon or in the evening.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Duration of treatment
Start taking Elevit one month before conception (or when planning a pregnancy). Continue throughout the pregnancy and until the end of breastfeeding.
Use in adolescents
Elevit can be used in adolescents who are planning to become pregnant, pregnant or breastfeeding. The dosage is the same as that applies to adult women.
Patients with kidney disease
Elevit must not be used in patients with severe renal impairment see section 2, "Do not take Elevit".
Patients with liver disease
Elevit should be administered under medical supervision in patients with impaired liver function.
Senior citizens
Elevit is indicated in women of childbearing age. There is no relevant use in the elderly population.
If you forget to take Elevit
Do not take a double dose to make up for a forgotten dose.
Continue with the recommended dose of one tablet a day. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Overdose What to do if you have taken an overdose of Elevit
An overdose can cause an increase in blood levels of vitamins A and D, calcium, iron and copper.
Nonspecific initial symptoms are:
- sudden headache
- confusion, fatigue, irritability
- nausea, vomiting, abdominal pain, constipation, diarrhea, loss of appetite
- redness of the skin, itching
- thirst, including excessive thirst, passing more urine than normal
Stop treatment and consult your doctor if these symptoms occur.
The daily intake of high doses of Vitamin A and Vitamin D can be harmful to the fetus. See section 2 "Pregnancy and breastfeeding".
Side Effects What are the side effects of Elevit
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can occur with the following frequencies:
Common may affect up to 1 in 10 people
- abdominal pain, flatulence, constipation, diarrhea
- nausea, vomiting
Rare, these may affect up to 1 in 1,000 people
- allergic reactions with symptoms such as
- swelling of the face, wheezing / difficulty in breathing
- effects on the skin: rash, itching, redness, blistering
- weak or rapid heartbeat.
Stop taking Elevit immediately and consult your doctor if you experience symptoms of an allergic reaction.
Frequency not known, in agreement with available data
- increased excretion of calcium in the urine
- headache, dizziness, insomnia, nervousness
Elevit contains iron which can make stool black, but this phenomenon has no clinical relevance. A slight yellow coloring of the urine may be observed. This effect is not harmful and is due to the Vitamin B2 present in the formulation.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/ it / responsible. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25 ° C. Store in the original package to protect from light.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What Elevit contains
The active ingredients in a film-coated tablet are:
- 12 vitamins:
- vitamin A: 3600 IU
- vitamin B1: 1.55 mg
- vitamin B2: 1.8 mg
- vitamin B6: 2.6 mg
- vitamin B12: 4.0 µg
- vitamin C: 100.0 mg
- vitamin D3: 500 IU
- vitamin E: 15 IU
- calcium pantothenate: 10.0 mg
- biotin: 0.2 mg
- folic acid: 0.8 mg
- nicotinamide: 19.0 mg
- 7 minerals and trace elements:
- iron: 60.0 mg
- calcium: 125.0 mg
- copper: 1.0 mg
- magnesium: 100.0 mg
- manganese: 1.0 mg
- phosphorus: 125.0 mg
- zinc: 7.5 mg
The other ingredients are: lactose, mannitol, macrogol 400, glycerol distearate, gelatin, microcrystalline cellulose, ethylcellulose, sodium starch glycolate, magnesium stearate, povidone K90, povidone K30. hypromellose, aqueous dispersion of ethylcellulose (ethylcellulose, sodium lauryl sulfate, cetyl alcohol), macrogol 6000, talc, titanium dioxide (E171), yellow iron oxide (E172).
Description of what Elevit looks like and contents of the package
ELEVIT comes in the form of yellow, biconvex, oblong film-coated tablets with a score line.
The contents of the pack are 30 or 100 tablets.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ELEVIT TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains:
Vitamin A (Retinol) 3600 I.U. 1)
• in the form of concentrated synthetic Vitamin A powder,
Vitamin A palmitate dry 250 CWS
Vitamin B1 (Thiamine nitrate) 1.55 mg
- corresponding to 1.6 mg of Thiamine hydrochloride
Vitamin B2 (Riboflavin) 1.8 mg
Vitamin B6 (Pyridoxine hydrochloride) 2.6 mg
- in the form of Rocoat pyridoxine hydrochloride 33 and 1/3%
Vitamin B12 (Cyanocobalamin) 4.0 mcg
- in the form of 0.1% water-soluble powder: Vitamin B12 0.1% WS
Vitamin C (Ascorbic Acid) 100.0 mg
- in the form of Calcium ascorbate dihydrate
Vitamin D3 (Cholecalciferol) 500 I.U. 2)
- in the form of concentrated cholecalciferol (in dispersible powder
in water) Vitamin D3 type 100 CWS dry
Vitamin E (to tocopheryl acetate) 15 I.U. 3)
• in the form of to- Concentrated tocopheryl acetate (powder):
• Vitamin E 50% type CWS / S dry
Calcium pantothenate 10.0 mg
Biotin 0.2 mg
Nicotinamide 19.0 mg
Folic acid 0.8 mg
Calcium 125.0 mg
- in the form of 133.10 mg of calcium ascorbate dihydrate
- in the form of 10.50 mg of calcium pantothenate
- in the form of 378.89 mg of anhydrous dibasic calcium phosphate
Iron 60.0 mg
- in the form of 183.00 mg of ferrous fumarate
Magnesium 100.0 mg
- in the form of 114.42 mg of light magnesium oxide
- in the form of 217.95 mg of magnesium hydrogen phosphate trihydrate
- in the form of 15.00 mg of magnesium stearate
Manganese 1.0 mg
- in the form of 2.52 mg of manganese sulphate monohydrate
• determined by 183.00 mg of ferrous fumarate
Copper 1.0 mg
- in the form of 2.51 mg of anhydrous copper sulphate
Phosphorus 125.0 mg
- in the form of 378.89 mg of anhydrous dibasic calcium phosphate
- in the form of 217.95 mg of magnesium hydrogen phosphate trihydrate
Zinc 7.5 mg
- in the form of 20.60 mg of zinc sulphate monohydrate
1) corresponding to 1080.0 mcg of retinol
2) corresponding to 12.5 mcg of cholecalciferol
3) corresponding to 15.0 mg of a-tocopheryl acetate
Excipients:
One ELEVIT tablet contains lactose (45.78mg) and soybean oil: see section 4.4.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Film-coated tablet
Yellow, biconvex, oblong film-coated tablets, scored.
The score line on the tablet is only to make it easier to break the tablet for easier swallowing and not to divide into equal doses.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Prevention or correction of disorders due to vitamin or mineral imbalance or deficiency or dietary deficiencies during pregnancy and breastfeeding.
04.2 Posology and method of administration
Dosage
One tablet a day to be taken whole with a glass of water (0.25 l), preferably with meals.
In case of morning sickness, it is recommended to take the tablet at noon or in the evening.
The recommended duration of treatment is one month before conception (or when pregnancy is planned), throughout the course of pregnancy and breastfeeding.
Special populations:
Pediatric population: Elevit can be used in adolescents who are planning to become pregnant, pregnant or breastfeeding. The dosage is the same as that applied to adult women.
Patients with renal impairment: Elevit is contraindicated in patients with severe renal impairment (see section 4.3)
Patients with hepatic impairment: Elevit should be administered with caution under medical supervision in patients with hepatic impairment
Elderly patients: Elevit is indicated in women of childbearing age. There is no relevant use of Elevit in older women.
Method of administration
For oral use.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Active hypervitaminosis A or D.
Concomitant therapy with vitamin A or with the synthetic isomers isotretinoin and etretinate. Beta-carotene is considered a source of Vitamin A supplementation.
Severe impairment of renal function.
Hypercalcemia.
Severe hypercalciuria.
Metabolic disorders of iron and / or copper.
04.4 Special warnings and appropriate precautions for use
Do not exceed the recommended dose.
Very high dosages of some components, in particular Vitamin A, Vitamin D, iron and copper can be harmful to health.
Patients taking other mono- or multivitamin preparations or any other medicines or who are under medical treatment should consult a doctor before taking this medicine.
This medicine should be taken with particular caution together with any other products, including supplements and / or fortified foods / drinks, containing Vitamin A, or beta-carotene as high doses of these compounds can harm the fetus and cause hypervitaminosis A.
This medicine should be taken with particular caution with any other product, including supplements and / or fortified foods / drinks, containing Vitamin D as high daily doses of this compound can cause hypervitaminosis D.
Patients with nephrolithiasis or urolithiasis should exercise caution when using vitamin supplements as calcium, ascorbic acid and vitamin D can affect stone formation.
This medicine does not contain iodine. Adequate iodine supplementation should be provided.
This medicinal product contains lactose (45.78 mg / tablet) as an excipient.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains soybean oil. Patients who are allergic to peanuts or soy should not use this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Medicines that contain calcium, magnesium, iron, copper or zinc may interact with antacids, gastric acid suppressant drugs, antibiotics (tetracyclines, fluoroquinolones), levodopa, bisphosphonates, penicillamine, thyroxine (levothyroxine), trientine, digitalis, antiviral and diuretic agents thiazides when administered orally, thus reducing the bioavailability of the drug and / or minerals contained in Elevit.
If concomitant use is necessary, the administration of the two products must be separated by at least 2 hours.
Cholestyramine and colestipol can decrease the absorption of lipophilic vitamins.
If the use of these medicinal products is necessary during pregnancy and lactation, consideration should be given to whether the administration of Elevit is sufficient to prevent vitamin A, D and E deficiencies in the mother and fetus / child.
Drug-Food Interactions: given that oxalic acid (contained in spinach and rhubarb) and phytic acid (contained in whole grains) can inhibit calcium absorption, it is not recommended to take this product within two hours of taking. of foods that contain concentrations of oxalic acid or phytic acid.
04.6 Pregnancy and breastfeeding
Elevit is indicated during pregnancy and lactation, however it is recommended not to exceed the recommended dosage (see section 4. 9). As with any medicine, consult your doctor.
During pregnancy and breastfeeding, the daily intake should not exceed 2500 mg of calcium, 4000 IU (100 mcg) of vitamin D and 3000 mcg (10000 IU) of Vitamin A. The intake of foods rich in Vitamin A ( eg liver or liver products) and / or vitamin D and the intake of fortified foods and drinks, which may contain high levels of these vitamins, must be taken into consideration.
Pregnancy
Vitamin A doses above 10,000 IU / day could be teratogenic if administered during the first trimester of pregnancy. Elevit contains 3600 IU / tablet or 1080 mcg / tablet of vitamin A. Therefore, this medicine should be taken with special caution together with any other products, including supplements and / or fortified foods / drinks containing Vitamin A or beta-carotene. Concomitant treatment with vitamin A or the synthetic isomers isotretinoin and etretinate is contraindicated (see section 4.3). A chronic overdose of vitamin D can be harmful to the fetus.
The Institute of Medicine (USA) has set the maximum acceptable level of Vitamin D intake (UL) at 100 mcg (4000 IU) per day for pregnant women; this dose is considered safe.
Elevit contains 500 IU per tablet (12.5 mcg / tablet) of Vitamin D.
An overdose of vitamin D should be avoided as permanent hypercalcemia can lead to retardation of physical and mental development, supravalvular and aortic stenosis and retinopathy in the child. In animals, an overdose of vitamin D during pregnancy has shown teratogenic effects. There is no evidence that vitamin D at recommended doses is teratogenic in humans.
Feeding time
Prolonged overdose of vitamin D can be harmful to the newborn.
The vitamins and minerals in this medicine are secreted into breast milk. This must be taken into consideration if the infant is receiving any of these supplements.
The Institute of Medicine (USA) has set the maximum acceptable level of Vitamin D intake (UL) at 100 mcg (4000 IU) per day for breastfeeding women; this dose is considered safe.
Elevit contains 500 IU per tablet (12.5mcg / tablet) of Vitamin D.
Fertility
There are no data on the effect of the medicine on fertility.
04.7 Effects on ability to drive and use machines
Elevit does not affect the ability to drive or use machines
04.8 Undesirable effects
The following adverse reactions were identified from the marketing of Elevit.
In common cases, gastrointestinal disorders may occur, but generally these do not require discontinuation of treatment.
In rare cases this medicine can cause allergic reactions.
If an allergic reaction occurs, treatment should be discontinued and a doctor or pharmacist consulted.
The undesirable effects are divided into frequency categories as follows: very common (1/10), common (1/100,
In a placebo-controlled clinical study in 2,471 pregnant women taking Elevit (one tablet daily for 1 month to 6 months), the percentage of subjects reporting side effects was as follows: constipation (1.8%) , diarrhea (1.4%) and rash (0.08%).
The percentage of subjects reporting these undesirable effects in the placebo group was not statistically different.
A slight discoloration of the urine may be observed. This effect is not "harmful and" due to the Vitamin B2 present in the formulation.
Elevit contains iron which can make stool black, but this phenomenon has no clinical relevance.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
There is no evidence that this medicinal product could lead to overdose when used correctly (see also section 4.4).
Most, if not all, reports of vitamin and mineral overdose are associated with a concomitant intake of high doses of mono- or multivitamin preparations.
Acute or prolonged overdose can cause hypervitaminosis A and D and hypercalcemia as well as iron and copper intoxication.
Nonspecific initial symptoms, such as sudden headache, confusion, nausea, vomiting, abdominal pain, constipation, diarrhea, fatigue, irritability, anorexia, erythema, pruritus, thirst, polydipsia or polyuria may indicate acute overdose.
If such symptoms occur, discontinue treatment and consult a physician. In the event of symptoms of overdose, use of the medicinal product should be discontinued.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: multivitamins and minerals / trace elements.
ATC code: A 11A A03.
Elevit is a multivitamin / polimineral preparation that contains 12 vitamins in association with 3 minerals and 4 trace elements, specially designed to ensure an adequate supply of micronutrients to both the fetus and the future mother.
Vitamins are essential nutrients, indispensable for the normal development and growth of the fetus and newborn, 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.
Multivitamin / polimineral preparations are indicated for the prevention and correction of nutritional deficiencies of micronutrients. Pregnancy and breastfeeding are periods in which there is an increase in the need for micronutrients and, consequently, a greater risk of micronutrient deficiency for both the mother and the baby. During pregnancy, in particular, the deficiency of micronutrients entails an even more serious health risk, as it can also compromise the normal development of the fetus.
Supplementation with folic acid or a multivitamin containing folic acid is recommended to prevent birth defects including neural tube defects.
Neural tube defects can develop during the first few weeks after conception, a period during which pregnancy may not yet have been diagnosed; supplementation with folic acid is therefore essential during the phase in which pregnancy is planned.
05.2 Pharmacokinetic properties
Health and well-being are naturally dependent on the continuous intake and management of vitamins and minerals, the absorption, distribution, metabolism and elimination of which are maintained by specific physiological mechanisms.
The active ingredients contained in Elevit, vitamins, minerals and trace elements, are essential micronutrients widely distributed in the human body.
The differentiating factor between the physiological plasma concentration of nutrients and its variation consequent to the supplementary intake of the corresponding pharmacological preparations, on the one hand it is difficult to evaluate and express and on the other hand the information available on the biological activity of the single nutrients in the target tissue. they are few or nonexistent.
The levels of micronutrients present in plasma and tissues are homeostatically regulated and influenced by various factors such as diurnal fluctuations, nutritional status, growth, pregnancy and lactation. No pharmacokinetic data are available on the active substances of Elevit, but the pharmacokinetic properties of the individual components are well documented.
05.3 Preclinical safety data
Elevit's active ingredients, vitamins, minerals and trace elements are essential nutrients that are considered safe when administered at recommended doses.
No teratogenicity studies have been conducted with Elevit in animals.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Core of the tablet:
Lactose monohydrate
Mannitol
Macrogol 400
Glycerol distearate
Jelly
Microcrystalline cellulose
Ethylcellulose
Sodium starch glycolate
Magnesium stearate
Povidone K90
Povidone K30
Tablet coating:
Hypromellose
Ethylcellulose
Cetyl alcohol
Sodium lauryl sulfate
Macrogol 6000
Talc
Titanium dioxide (E171)
Yellow iron oxide (E172)
Components of vitamin premixes:
-Vitamin A palmitate dry 250 CWS: Vitamin A palmitate, butylhydroxyanisole, butylhydroxytoluene, DL -? - tocopherol, gelatin, sucrose, corn starch.
-Rocoat pyridoxine hydrochloride 33 and 1/3%: Pyridoxine hydrochloride, mono- and diglycerides of edible fatty acids.
-Vitamin B12 0.1% WS: Cyanocobalamin, trisodium citrate, anhydrous citric acid,
maltodextrin.
- Vitamin D3 powder 100 CWS: Cholecalciferol, DL-a-tocopherol, partially hydrogenated soybean oil, hydrolyzed gelatin, sucrose, corn starch.
-Vitamin E 50% type CWS / S dry: all-rac-a-tocopheryl acetate, modified food starch, maltodextrin, silicon dioxide.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Do not store above 25 ° C.
Store in the original package to protect from light.
06.5 Nature of the immediate packaging and contents of the package
PVC / PE / PVDC / Aluminum blisters of 30 and 100 tablets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Bayer S.p.A Viale Certosa 130, Milan
08.0 MARKETING AUTHORIZATION NUMBER
30 film-coated tablets AIC 037072016
100 film-coated tablets AIC 037072028
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
9/11/2006
Renewal 17.04.2007
10.0 DATE OF REVISION OF THE TEXT
- AIFA determination of: 05/2015
