Package leaflet: Information for the user

Elevit film-coated tablets

12 Vitamins, 8 minerals

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Elevit is and what it is used for

2.    What you need to know before you take Elevit

3.    How to take Elevit

4.    Possible side effects

5.    How to store Elevit

6.    Contents of the pack and other information

1.    What Elevit is and what it is used for

Elevit is a film coated tablet containing 12 vitamins and 8 minerals (see section 6).

Vitamins and minerals are essential nutrients. They cannot be produced by the body and you have to get them from your diet.

Elevit is used for prevention of micronutrient, iron and folate deficiencies during pregnancy and lactation due to unbalanced dietary intake.

2.    What you need to know before you take Elevit Do not take Elevit:

•    if you are allergic to any of the ingredients of this medicine (listed 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 problems with how your body uses iron or copper.

Warnings and precautions

Talk to you doctor or pharmacist or nurse before taking Elevit. The recommended dosage of 1 tablet should not be exceeded.

Very high doses of some ingredients, in particular Vitamin A, Vitamin D, iron and copper, can be harmful to health.

If you are taking other vitamins and/or minerals or any other medications or if you are under medical care, please consult a health care professional before taking Elevit.

Elevit must be taken with particular caution together with any other products, including supplements and/or fortified foods/drinks containing Vitamin A since large doses of them are considered harmful to the foetus and may cause hypervitaminosis A.

Elevit 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 hypervitaminosis D.

If you are breast-feeding, but did not suffer great blood loss during birth and have not yet started menstruating, please consult your health care professional to determine if you need the additional iron provided in Elevit.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Elevit.

Patients with liver problems might be more vulnerable to potential harmful effects, since the body does not break down the ingredients in Elevit in a normal way. Therefore, in such cases Elevit 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 have an effect on stone formation in the urinary system.

Children and adolescents

Please read the section above for warnings and precautions.

Elevit can be used in adolescents, who are pregnant or are breast-feeding.

Other medicines and Elevit

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes vitamins and vitamin-fortified foods and drinks.

Take the following medicines at least 2 hours before, or 2 hours after, taking Elevit:

•    tetracyclines and fluoroquinolones (antibiotics),

•    bisphosphonates, such as alendronic acid (for treating bone disorders),

•    penicillamine (for treating rheumatoid arthritis),

•    levothyroxine (thyroxine) (for treating thyroid disorders),

•    antiviral medicines (for treating viral infections, such as Shingles),

•    levodopa (for treating Parkinson’s disease),

•    digoxin / digitoxin (for treating heart problems), and

•    antacids (aluminium, calcium or magnesium containing products).

•    trientine (medicine for treatment Wilson’s disease).

Thiazides (for treating high blood pressure) may increase the level of calcium and decrease the levels of magnesium and zinc in your body. If taking Elevit and thiazides, ask your doctor to test serum calcium and ask if Elevit is sufficient to prevent magnesium and zinc deficiency.

Elevit and food and drink

Do not take Elevit within two hours of eating spinach, rhubarb or fiber-containing whole-grain products.

Pregnancy and breast-feeding

Elevit can be used by pregnant and breastfeeding women whose dietary intake of nutrients is not balanced. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine or any other medicine.

Do not take more than the recommended dose.

Taking too much Vitamin A or Vitamin D can cause problems with your baby’s growth and development while you are pregnant and breast-feeding.

If you are breast-feeding, please tell your doctor if your baby is also having any supplements containing Vitamin D or calcium.

Driving and using machines

Elevit does not affect the ability to drive or operate machines.

Elevit contains sucrose

If you have been told by your doctor that you have.an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Elevit

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet a day.

Take the tablet whole with a glass of water, preferably with a meal (See section “Elevit and food and drink”).

If you have morning sickness, take the tablet at noon or in the evening.

Do not take more than the recommended dose.

Very high doses of some of the ingredients (particularly Vitamin A, Vitamin D, iron or copper) can be harmful to you and your baby.

Use in children and adolescents

Adolescent girls, who are pregnant or are breast-feeding:

Please read the section above for details on how to take Elevit.

If you take more Elevit than you should

Contact your doctor if you think you may have taken too many Elevit tablets or other products containing Vitamin A or D and if you also have a sudden unexpected headache, constipation or diarrhoea, are feeling or being sick or are feeling confused.

If you forget to take Elevit

Do not take a double dose to make up for a forgotten tablet. Just take your next dose as normal.

If you stop taking Elevit

If you stop taking Elevit you may wish to discuss with your doctor or pharmacist whether you are getting enough vitamins and minerals.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people) are stomach-ache, 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, effects on your skin (rash, itching, redness or blisters) or a weak or rapid pulse. If you have any of these symptoms you should stop taking Elevit and consult your doctor.

You may notice a dark colouring of the stool or that your urine is more yellow than normal. This is due to the ingredients in Elevit and is nothing to worry about.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Elevit

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) which is stated on the blister and the carton. 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 and 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 pack and other information What Elevit contains

The active substances are:

Vitamins: Vitamin A Vitamin B1 Vitamin B2

Nicotinamide

Vitamin B5 Vitamin B6

Biotin (Vitamin H)

Vitamin B9 (as folic acid and calcium l-methylfolate)

Vitamin B12 Vitamin C

Vitamin D3 (cholecalciferol) Vitamin E

Minerals and trace elements:

Calcium

Copper

Iodine

Iron

Magnesium

Manganese

Selenium

Zinc

The other ingredients are:

Tablet core:

Calcium carbonate (E 170), Citric acid (E 330), Corn starch, Gelatin, Magnesium stearate, Maltodextrin, Microcrystalline cellulose, Modified food starch,

Mono- and diglycerides of fatty acids (E 471), Povidone K90, Silica (colloidal anhydrous),

Sodium ascorbate, Sodium croscarmellose, Sucrose, Talc (E 553b), Triglycerides medium chain, Trisodium citrate (E 331).

Tablet coat:

Hypromellose, Microcrystalline cellulose, Stearic acid, Titanium dioxide (E 171).

What ELEVIT looks like and contents of the pack

ELEVIT is a white to slightly yellowish oval and biconvex film coated tablet of approximately 17 x 9.5 mm.

ELEVIT is available in pack sizes of 30, 60, 90 or 100 film-coated tablets in PVC/PU/PVDC-aluminium foiled blister. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bayer plc, Consumer Care Division

Bayer House Strawberry Hill, Newbury, RG14 1JA, UK

Manufacturer

Berlimed, C/ Francisco Alonso n° 7, Poligono Industrial Santa Rosa, Alcala de Henares 28806, Madrid, Spain

This medicinal product is authorised in the Member States of the EEA under the following names:

Bulgaria, Romania and United Kingdom:    Elevit

Austria and Hungary:    Elevit Plus

This leaflet was last revised in April 2016