Vitamin D3 Meditop

Leaflet attached to the packaging: patient information

Vitamin D MEDITOP 10,000 IU Tablets

Cholecalciferol (vit. D)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Vitamin D 10,000 IU and what is it 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. Package contents and other information

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

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

2. Important information before taking Vitamin D3 10,000 IU

When not to take Vitamin D 10,000 IU:

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

Warnings and precautions

Before starting treatment with Vitamin D 10,000 IU, discuss it with your doctor. The doctor decides on the treatment, as the dosage and duration of treatment depend on the disease and the patient's response to treatment. The doctor may order laboratory tests to determine blood and urine calcium levels and kidney function and adjust the dosage and treatment duration accordingly. This is especially important for patients who:

• are elderly and also take medications that affect the heart and kidneys, such as digitalis glycosides (e.g., digoxin) or diuretics,

have high blood phosphate levels (hyperphosphatemia),

• are physically limited (have mobility problems),
• have kidney function disorders,
• are at high risk of forming kidney stones.

The patient should inform their doctor:

• if parathyroid hormone levels are not even (pseudohypoparathyroidism),
• if the patient has "sarcoidosis" (an immune system disorder that affects the liver, lungs, skin, or lymph nodes).

When taking other medicines containing vitamin D, the vitamin D content in them should be considered. Do not take multivitamin products or dietary supplements at the same time.

Children and adolescents

This medicine must not be used in children and adolescents from 0 to 17 years old.

Vitamin D 10,000 IU and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. It is especially important to tell your doctor if you are taking any of the following medicines:

• Products containing high-dose calcium - they increase the risk of high blood calcium levels.
• Thiazide diuretics (diuretics) reduce calcium excretion in the urine - blood calcium levels should be regularly checked.
• Vitamin D metabolites or analogs (e.g., calcitriol), as their concurrent use may increase the risk of high blood calcium levels.
• Corticosteroids ("steroids", such as prednisolone, dexamethasone) may inhibit the action of vitamin D.
• Cholestyramine or colestipol (ion exchange resins that lower cholesterol levels) or laxatives (e.g., paraffin oil) - they reduce vitamin D absorption.
• Orlistat, a medicine used to treat obesity - it may decrease vitamin D absorption.
• Products containing magnesium (such as antacids) - they should not be taken during treatment with vitamin D due to the risk of high blood magnesium levels (hypermagnesemia).
• Cardiac glycosides - the patient should be under medical supervision, and ECG and blood calcium levels may need to be monitored.
• Antiepileptic drugs such as phenobarbital, hydantoin, and other barbiturates or primidone - they may reduce the effect of vitamin D.
• Calcitonin, gallium nitrate, bisphosphonates, or plicamycin - they reduce blood calcium levels.
• Products containing high-dose phosphorus - they increase the risk of high blood phosphate levels.
• Medicines containing aluminum (some antacids), as vitamin D may increase aluminum absorption.
• Antibiotics containing rifampicin - they accelerate the breakdown of vitamin D in the liver and may lead to osteoporosis.
• Isoniazid (an antibiotic used to treat tuberculosis) - it may reduce the effectiveness of vitamin D due to the inhibition of its activity during vitamin D metabolism.
• Actinomycin, a cytotoxic medicine - it may reduce the effectiveness of vitamin D due to the inhibition of its metabolic activation.
• Antifungal medicines of the imidazole type - they may reduce the effectiveness of vitamin D due to the inhibition of its metabolic activation.

Pregnancy, breastfeeding, and fertility

During pregnancy and breastfeeding, this medicine containing a high dose of vitamin D is not recommended, and a product with a lower dose should be used. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. The effect of cholecalciferol on the ability to drive and use machines is not known.

3. How to take Vitamin D3 10,000 IU

This medicine should always be taken according to the doctor's or pharmacist's instructions. If you have any doubts, consult your doctor or pharmacist. The doctor decides on the treatment, as the dosage and duration of treatment depend on the severity of the disease and the patient's response to treatment. 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 disorder. The treatment period is usually limited to one month. After the first month, the doctor may consider reducing the dose. Special patient groups: Liver function disorders: No routine dose adjustment is necessary. Kidney function disorders: Do not take Vitamin D 10,000 IU if you have severe kidney function disorders. Vitamin D 10,000 IU tablets can be taken with a sufficient amount of water, regardless of meals.

Use in children and adolescents

Vitamin D 10,000 IU must not be used in children and adolescents from 0 to 17 years old.

Taking 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 the patient experiences any of these symptoms, they should immediately inform their doctor.

Missing a dose of Vitamin D 10,000 IU

Do not take a double dose to make up for a missed tablet. Instead, skip the missed tablet and continue taking the tablets according to the dosage.

Stopping treatment with Vitamin D 10,000 IU

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Frequency not known (frequency cannot be estimated from the available data) Hypersensitivity reaction, high blood calcium levels (hypercalcemia), high urine calcium levels (hypercalciuria), nausea, diarrhea, abdominal pain, skin itching, rash, and hives may occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vitamin D3 10,000 IU

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Keep the container in the outer carton 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 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. Package contents 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).
• 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), anhydrous colloidal silica.

What Vitamin D 10,000 IU looks like and what the package contains

White, round, biconvex, and smooth tablet. 10 tablets in non-transparent, white blisters with PVC/PVDC//Aluminum and a carton box

Marketing authorization 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: biofarm@biofarm.pl

Manufacturer

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

This medicine has been authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Vitamin D Meditop

Germany: Vitamin D MEDITOP 10,000 IU Tablets

Poland: Vitamin D MEDITOP 10,000 IU Tablets

Portugal: Colecalciferol MEDITOP

Slovakia: Vitamin D Goodwill 10,000 IU tablets

Date of last revision of the leaflet