NOTICE
ANSM - Updated on: 06/06/2019
Name of the drug
ELEVIT VITAMIN B9, film-coated tablet
12 vitamins, 7 minerals and trace elements
Framed
Read all of this leaflet carefully before taking this medicine because it contains important information for you.
You should always take this medicine strictly following the information given in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Contact your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects that are not mentioned in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement or if you feel less well.
Keep this medicine out of the reach of children.
What does this booklet contain ?
1. What is ELEVIT VITAMIN B9, film-coated tablet and in which cases is it used?
2. What should I know before taking ELEVIT VITAMIN B9, film-coated tablet?
3. How to take ELEVIT VITAMIN B9, film-coated tablet?
4. What are the possible side effects?
5. How to store ELEVIT VITAMIN B9, film-coated tablet?
6. Contents of the pack and other information .
1. WHAT IS ELEVIT VITAMIN B9, film-coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: ASSOCIATION OF VITAMINS AND MINERAL ELEMENTS (A digestive system and metabolism).
Therapeutic indications :
This medication is indicated for the prevention or correction of disorders related to a deficient or unbalanced diet during pregnancy and lactation.
This medication should not be taken without medical advice.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELEVIT VITAMIN B9, film-coated tablet?
Do not take ELEVIT VITAMIN B9, film-coated tablet:
· if you are allergic to the active substances or to any of the other ingredients of this medicine, mentioned in section 6,
· if you have too much vitamin A and / or D in your body,
· if you have kidney problems
· if you have too much calcium in your blood or urine,
· if you have been told by your doctor that you have any problems with the way your body uses iron or copper.
In case of doubt, it is essential to seek the advice of your doctor or pharmacist.
Warnings and Precautions
Talk to your doctor or pharmacist before taking ELEVIT VITAMIN B9, film-coated tablet.
Do not exceed the recommended dose of one tablet per day.
Excessive amounts of some of the components of this medicine, especially vitamin A, vitamin D, iron and copper, can be harmful to your health.
If you are taking other vitamins and / or minerals or any other treatment or if you are under medical supervision, consult a healthcare professional before taking ELEVIT VITAMIN B9.
Special care should be taken when ELEVIT VITAMIN B9 is taken at the same time as other products, such as food supplements and / or fortified foods / drinks containing vitamin A. Indeed, high doses of vitamin A s 'are harmful to the fetus and may lead to hypervitaminosis A.
ELEVIT VITAMIN B9 should be used with special care when taken at the same time as products such as food supplements and / or fortified foods / beverages containing vitamin D, as high doses of vitamin D may cause hypervitaminosis D.
If you are breast-feeding, but you did not experience a great deal of blood loss during childbirth and have not resumed regular periods, consult your doctor or pharmacist to determine if the amount of iron in ELEVIT VITAMIN B9 is a supplementation solution adapted to your case.
If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.
The presence of vitamin B12 and iron in this medication may mask anemia and delay the diagnosis.
All the needs in mineral salts and vitamins are covered by a balanced and diversified diet with traditional staple foods (fruits, vegetables, meat, eggs, fish, cereals, dairy products).
Your doctor can help you establish a balanced diet that is right for you.
Patients with liver problems may be more sensitive to potential side effects because their body does not properly eliminate the elements in ELEVIT VITAMIN B9. In this case, ELEVIT VITAMIN B9 should only be used under medical supervision.
Patients with urinary stones should use caution when taking vitamin supplements as calcium, ascorbic acid and vitamin D may affect the formation of stones in the urinary system.
ELEVIT VITAMIN B9 contains 0.200 mg of biotin per tablet. If you have a blood test, you should tell your doctor or laboratory staff that you are taking or have recently taken any medicine that contains biotin. This is because biotin can affect the results of some tests. Depending on the test, the results can be falsely high or falsely low. Your doctor may ask you to stop taking ELEVIT VITAMIN B9 before you perform these tests. Other products that you may take, such as multivitamin blends or hair, skin, and nail supplements, may contain biotin and affect lab test results. Please inform your doctor or laboratory staff if you are taking such products .
Children and adolescents
Read section above for warnings and precautions.
ELEVIT VITAMIN B9 can be used in pregnant or breastfeeding adolescents.
Other medicines and ELEVIT VITAMIN B9, film-coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
ELEVIT VITAMIN B9, film-coated tablet with food and drink
Do not take ELEVIT VITAMIN B9 within two hours of eating a meal that contains spinach, rhubarb, or products containing fiber made from whole seeds.
Pregnancy, breastfeeding and fertility
ELEVIT VITAMIN B9 can be used in pregnant and breastfeeding women who are not on a balanced diet. If you are pregnant or breast-feeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not exceed the recommended dose.
Too much vitamin A or vitamin D during pregnancy and breastfeeding can cause growth and development problems for your baby.
If you are breast-feeding, tell your doctor if your baby is also receiving supplements containing vitamin D or calcium.
There are no data on the effect of ELEVIT VITAMIN B9 on fertility .
Driving and using machines
ELEVIT VITAMIN B9 has no or negligible influence on the ability to drive and use machines.
ELEVIT VITAMIN B9, film-coated tablet contains lactose
3. HOW TO TAKE ELEVIT VITAMIN B9, film-coated tablet?
Dosage
The recommended dose is 1 tablet per day.
Administration mode
Oral route.
The tablet should be swallowed with a glass of water, preferably during a meal.
If you have morning sickness, take the tablet at noon or in the evening.
It is recommended that ELEVIT VITAMIN B9 be taken throughout pregnancy and breast-feeding.
Do not exceed the recommended dose
Use in children and adolescents
Pregnant or breastfeeding adolescents:
Read the section above carefully for more details on how to administer ELEVIT VITAMIN B9.
If you take more ELEVIT VITAMIN B9, film-coated tablet than you should:
Consult your doctor or pharmacist immediately if you think you have taken too many ELEVIT VITAMIN B9 tablets or other products containing vitamin A or D and if you suddenly and unexpectedly experience a headache, constipation or diarrhea, if you feel bad or are sick or if you are confused.
If you forget to take ELEVIT VITAMIN B9, film-coated tablet:
Do not take a double dose to make up for the tablet you forgot to take. Just take your next tablet as usual.
If you stop taking ELEVIT VITAMIN B9, film-coated tablet:
If you stop taking ELEVIT VITAMIN B9 you should talk to your doctor or pharmacist to check whether you have enough vitamins and minerals.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Commonly reported side effects (may affect up to 1 in 10 people) are stomach pain, gas, constipation, diarrhea, nausea and vomiting.
In rare cases (may affect up to 1 in 1,000 people) allergic reactions may occur. Symptoms may include swelling of the face, wheezing / difficulty breathing, skin reactions (rash, itching, redness, or skin blisters), or a weak or rapid pulse. If you experience any of these symptoms you should stop taking ELEVIT VITAMIN B9 and consult a doctor.
You may notice a dark color in your stools or your urine is a more yellow color than usual. This is due to the components of ELEVIT VITAMIN B9 and should not be worried about.
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ELEVIT VITAMIN B9, film-coated tablet?
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 carton after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding + 25 ° C.
Store in the original package in order to protect from moisture.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What ELEVIT VITAMIN B9 contains, film-coated tablet
· The active substances are:
Vitamin A ................................................ .................................................. ........................... 4000 IU
As vitamin A palmitate 250
Thiamine hydrochloride (Vitamin B1) ........................................... .................................. 1,600 mg
As thiamine mononitrate
Riboflavin (Vitamin B2) ............................................. .................................................. ..... 1,800 mg
As riboflavin base
Pyridoxine (Vitamin B6) ............................................. .................................................. ...... 2,600 mg
As pyridoxine hydrochloride
Cyanocobalamin (Vitamin B12) ............................................. ..................... 4,000 micrograms
As cyanocobalamin 0.1% WS
Ascorbic acid (Vitamin C) ............................................ ............................................ 100,000 mg
In the form of calcium ascorbate dihydrate .......................................... ...................... (133.10 mg)
Cholecalciferol (Vitamin D3) ............................................. .................................................. ... 500 IU
In the form of a cholecalciferol concentrate, powder form
Alpha-tocopherol (Vitamin E) ........................................... ............................................... 15,000 mg
As alpha-tocopherol acetate
Calcium pantothenate (vitamin B5) ........................................... ................................. 10,000 mg
Biotin (vitamin B8) ............................................. .................................................. ........... 0.200 mg
Folic acid (vitamin B9) ............................................ .................................................. ... 0.800 mg
Nicotinamide (vitamin PP) ............................................. .................................................. 19,000 mg
Calcium................................................. .................................................. ........................ 125,000 mg
In the form of calcium ascorbate dihydrate .......................................... ........................ (12.50 mg)
In the form of calcium pantothenate ............................................ ................................ (0.88 mg)
In the form of calcium hydrogen phosphate ........................................... ................... (111.62 mg)
Iron................................................. .................................................. .................................. 60,000 mg
In the form of ferrous fumarate
Copper................................................. .................................................. ............................... 1,000 mg
In the form of copper sulphate
Manganese ................................................. .................................................. ..................... 1,000 mg
In the form of manganese sulfate
Magnesium................................................. .................................................. ................... 100,000 mg
In the form of magnesium oxide ........................................... ....................................... (69.00 mg)
In the form of magnesium hydrogenphosphate ........................................... .............. (30.38 mg)
In the form of magnesium stearate ............................................ .................................. (0.62 mg)
Phosphorus................................................. .................................................. .................... 125,000 mg
In the form of calcium hydrogen phosphate ........................................... ..................... (86.27 mg)
In the form of magnesium hydrogenphosphate ........................................... .............. (38.73 mg)
Zinc ................................................. .................................................. ................................. 7,500 mg
In the form of zinc sulfate
For a film-coated tablet.
· The other ingredients are:
Core :
Microcrystalline cellulose, sodium carboxymethyl starch, mannitol, povidone K 30, povidone K 90, gelatin, glycerol distearate, magnesium stearate, ethyl cellulose, lactose monohydrate, macrogol 400.
Lamination:
Hypromellose, aqueous dispersion of ethylcellulose, macrogol 6000, talc, titanium dioxide (E171), iron oxide yellow (E172)
What is ELEVIT VITAMIN B9, film-coated tablet and contents of the pack
This drug is in the form of film-coated tablet. Box of 30 or 100.
Not all presentations may be marketed.
Marketing authorization holder
BAYER HEALTHCARE SAS
220 AVENUE DE LA RESEARCH
59120 LOOS
Marketing authorization operator
BAYER HEALTHCARE SAS
33 RUE DE L'INDUSTRIE
74240 GAILLARD
Maker
ROTTENDORF PHARMA GmbH
OSTENFELDER STRASSE 51-61
59320 ENNIGERLOH
GERMANY
Names of the drug in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{month YYYY}.>
Other
Detailed information on this medication is available on the ANSM website (France).