Vitamin d3 meditop

Package leaflet: Information for the patient

Vitamin D MEDITOP 10 000 IU Tablets
cholecalciferol (vit. D)
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Vitamin D 10 000 IU is and what it is used for
2. Important information before taking Vitamin D 10 000 IU
3. How to take Vitamin D 10 000 IU
4. Possible side effects
5. How to store Vitamin D 10 000 IU
6. Contents of the pack and other information

1. What Vitamin D 10 000 IU is and what it is used for

The active substance in Vitamin D 10 000 IU is cholecalciferol (also known as vitamin D).
Cholecalciferol helps the body absorb calcium and supports bone formation, as well as lowering the level of a hormone called parathyroid hormone (PTH), which is important for bone health.
This medicine is indicated for the treatment of initial symptomatic vitamin D deficiency.
Vitamin D deficiency occurs when diet or lifestyle does not provide sufficient vitamin D.

2. Important information before taking Vitamin D 10 000 IU

Do not take Vitamin D 10 000 IU:

• if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6),
• if you have high levels of calcium in your blood or urine,
• if you have kidney stones or calcium deposits in your kidneys,
• if you have severe kidney disorders,
• if you have high levels of vitamin D in your blood (hypervitaminosis D).

Warnings and precautions
Before starting treatment with Vitamin D 10 000 IU, discuss it with your doctor.
Your doctor will decide on treatment, as dosage and duration depend on the condition and your response to therapy.
Your doctor may order laboratory tests to monitor calcium levels in blood and urine, as well as kidney function, and may adjust the dosage and duration of treatment accordingly.
This is particularly important for patients who:

• are elderly and taking medications affecting the heart and kidneys, such as cardiac glycosides (e.g. digoxin) or diuretics (water tablets),
• have high levels of phosphate in the blood (hyperphosphatemia),
• are physically immobilized (have mobility problems),
• have impaired kidney function,
• are at high risk of developing kidney stones.

Inform your doctor if:

• parathyroid hormone levels are unstable (pseudohypoparathyroidism),
• you have sarcoidosis (an immune system disorder affecting the liver, lungs, skin, or lymph nodes).

When taking other medicines containing vitamin D, consider their vitamin D content. Do not take multivitamin products or dietary supplements simultaneously.

Children and adolescents
This medicine must not be used in children and adolescents aged 0 to 17 years.

Vitamin D 10 000 IU and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
It is especially important to inform your doctor if you are taking any of the following:

• Calcium-containing products in high doses – these increase the risk of high blood calcium levels.
• Thiazide diuretics (water tablets) – these reduce calcium excretion in urine; blood calcium levels should be monitored regularly.
• Vitamin D metabolites or analogs (e.g. calcitriol) – their concomitant use may increase the risk of hypercalcemia.
• Corticosteroids (steroids, e.g. prednisolone, dexamethasone) – these may inhibit the action of vitamin D.
• Cholestyramine or colestipol (ion-exchange resins lowering cholesterol) or laxatives (e.g. liquid paraffin) – these reduce vitamin D absorption.
• Orlistat, a medicine used to treat obesity – may reduce vitamin D absorption.
• Magnesium-containing products (e.g. antacids) – must not be taken during vitamin D treatment due to the risk of high blood magnesium levels (hypermagnesemia).
• Cardiac glycosides – medical supervision is required; ECG and blood calcium levels may need monitoring.
• Antiepileptic drugs such as phenobarbital, hydantoin, other barbiturates, or primidone – these may reduce the effectiveness of vitamin D.
• Calcitonin, gallium nitrate, bisphosphonates, or plicamycin – these reduce blood calcium levels.
• Phosphate-containing products in high doses – increase the risk of high blood phosphate levels.
• Aluminium-containing medicines (some antacids), because vitamin D may increase aluminium absorption.
• Antibiotics containing rifampicin – accelerate vitamin D breakdown in the liver and may lead to osteoporosis.
• Isoniazid (an antibiotic used in tuberculosis treatment) – may reduce vitamin D efficacy by inhibiting its metabolic activity.
• Actinomycin, a cytotoxic drug – may reduce vitamin D efficacy by inhibiting its metabolic activation.
• Antifungal imidazole-type medicines – may reduce vitamin D efficacy by inhibiting its metabolic activation.

Pregnancy, breastfeeding and fertility
This high-dose vitamin D medicine is not recommended during pregnancy or breastfeeding; a lower-dose product should be used. If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and using machines
No studies on the effect of this medicine on the ability to drive or operate machinery have been conducted. The effect of cholecalciferol on the ability to drive and operate machinery is unknown.

3. How to take Vitamin D 10 000 IU

Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist. Your doctor decides on treatment, as dosage and duration depend on the severity of the condition and your response to therapy.
The recommended dose is 1–2 tablets per week (equivalent to 10 000–20 000 IU of vitamin D), depending on the severity of the deficiency.
Treatment usually lasts up to one month. After the first month, your doctor may consider reducing the dose.

Special patient groups
Liver function disorders: Routine dose adjustment is not necessary.
Kidney function disorders: Do not use Vitamin D 10 000 IU in patients with severe kidney function impairment.
Vitamin D 10 000 IU tablets may be taken with water, with or without food.

Use in children and adolescents
Vitamin D 10 000 IU must not be used in children and adolescents aged 0 to 17 years.

If you take more than the recommended dose of Vitamin D 10 000 IU
The following symptoms may occur: decreased appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, confusion, increased urination, bone pain, kidney calcification, hypercalciuria, kidney stones, and in severe cases, cardiac arrhythmia.
If you experience any of these symptoms, contact your doctor immediately.

If you forget to take Vitamin D 10 000 IU
Do not take a double dose to make up for a missed tablet. Instead, skip the missed dose and continue taking the tablets as prescribed.

If you stop taking Vitamin D 10 000 IU
Do not stop taking Vitamin D 10 000 IU without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Frequency unknown (frequency cannot be estimated from the available data):
Hypersensitivity reaction, high calcium levels in blood (hypercalcaemia), high calcium levels in urine (hypercalciuria), nausea, diarrhoea, abdominal pain, skin itching, rash and urticaria may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vitamin D3 10 000 IU
Keep the medicine out of the sight and reach of children.
Store below 25 °C.
Keep the container in the outer cardboard package to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Vitamin D 10 000 IU contains

• The active substance is cholecalciferol (vitamin D). Each tablet contains 250 micrograms (10 000 IU) of cholecalciferol (vitamin D).
• The other ingredients are: In the active substance cholecalciferol: dry vitamin D 100 SD/S microcapsules (in powder form), containing modified food starch, sucrose, medium-chain triglycerides, sodium ascorbate and dl-alpha-tocopherol. In the tablet: microcrystalline cellulose 102, low-substituted hydroxypropylcellulose (L-HPC), colloidal anhydrous silica.

What Vitamin D 10 000 IU looks like and contents of the pack
White, round, biconvex tablet smooth on both sides.
10 tablets in opaque white blisters made of PVC/PVDC//Aluminium, in a cardboard box.

Marketing Authorisation Holder
Poland:
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]

Manufacturer
MEDITOP Pharmaceutical Ltd.
Ady Endre u. 1
H-2097 Pilisborosjenő/Pest
Hungary

This medicinal product has been authorised in the Member States of the European Economic Area under the following names:
Czech Republic: Vitamin D Meditop
Germany: Vitamin D MEDITOP 10.000 IE Tabletten
Poland: Vitamin D MEDITOP 10 000 IU Tabletki
Portugal: Colecalciferol MEDITOP
Slovakia: Vitamín D Goodwill 10 000 IU tablety