VITAMIN D3 FARMASIERRA 50,000 IU TABLETS
How to use VITAMIN D3 FARMASIERRA 50,000 IU TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Vitamin D33Farmasierra 50,000 IU Tablets
Colecalciferol (Vitamin D3)
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
- Keep this package leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
Contents of the Package Leaflet:
- What is Vitamin D3 Farmasierra and what is it used for
- What you need to know before taking Vitamin D3 Farmasierra
- How to take Vitamin D3 Farmasierra
- Possible side effects
- Storage of Vitamin D3 Farmasierra
- Package Contents and Additional Information
1. What is Vitamin D3 Farmasierra and what is it used for
This medication contains Vitamin D3, which regulates calcium absorption and metabolism, as well as calcium incorporation into bone tissue.
Vitamin D3 Farmasierra is indicated for the initial treatment of clinically relevant Vitamin D deficiency in adults.
2. What you need to know before taking Vitamin D3 Farmasierra
Do not take Vitamin D3Farmasierra
- if you are allergic to colecalciferol (Vitamin D3) or any of the other components of this medication (listed in section 6)
- if you have hypercalcemia (elevated calcium levels in the blood) or hypercalciuria (elevated calcium levels in the urine).
- if you have hypervitaminosis D (elevated Vitamin D levels in the blood).
- if you have kidney stones.
- if you have severe kidney impairment (serious kidney problems)
If you have any of the above conditions, consult your doctor or pharmacist before taking this medication.
Warnings and Precautions
Consult your doctor or pharmacist before starting to take Vitamin D3:
- if you have sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints).
- if you have kidney problems or have had kidney stones.
- if you have pseudohipoparathyroidism, a rare condition in which the body does not respond properly to parathyroid hormone produced by the body
- when using other medications that contain Vitamin D simultaneously.
Taking Vitamin D3Farmasierra with Food and Drinks
Take Vitamin D3 preferably with meals.
Children and Adolescents
This medication is not suitable for use in children and adolescents under 18 years of age.
Other Medications and Vitamin D3Farmasierra
Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication, especially:
- Thiazide diuretics (to treat high blood pressure).
- Cardiac glycosides (to treat heart conditions), e.g., digoxin.
- Glucocorticoids (to treat inflammation).
- Colestyramine or hydrochloride colestipol (used to treat high cholesterol).
- Laxatives containing mineral oil.
- Orlistat (weight loss)
- Magnesium (contained in some antacids)
- Phenytoin or barbiturates (used to treat epilepsy).
- Medications for the treatment of excess calcium (calcitonin, etidronate, gallium nitrate, pamidronate, or plicamycin)
- Rifampicin (antibiotic)
- Isoniazid (tuberculosis medication)
- Actinomycin (chemotherapy)
- Imidazole (antifungal)
Pregnancy, Breastfeeding, and Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
Vitamin D3 should only be used during pregnancy if the Vitamin D deficiency has been clinically diagnosed. During pregnancy, the daily intake of Vitamin D should not exceed 400 IU.
Vitamin D3 can be used during breastfeeding. Vitamin D3 passes into breast milk. This should be taken into consideration when administering additional Vitamin D to the infant.
There are no data on the effects of Vitamin D3 on fertility. However, it is not expected that normal levels of Vitamin D will have adverse effects on fertility.
Driving and Using Machines
Vitamin D3 has no known effects on the ability to drive or use machines.
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3. How to Take Vitamin D3 Farmasierra
Follow the administration instructions for Vitamin D3 Farmasierra exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.
The dose should be individualized based on the degree of Vitamin D supplementation needed. Medical supervision is necessary, as dosage requirements may vary depending on the patient's response.
The patient's dietary habits should be carefully evaluated, and the Vitamin D content of certain foods should be taken into account.
The tablets can be taken whole with water or crushed. You should take this medication preferably with a large meal so that your body can absorb the Vitamin D3.
Use in Adults
Recommended dose:
25,000 IU once a week. After the first month, the dose may be reduced.
High doses may be considered under medical supervision: 50,000 IU/week (single dose) for 6-8 weeks;
This initial treatment may be followed by maintenance therapy, as indicated by your doctor.
Alternatively, national dosage recommendations for the treatment of Vitamin D deficiency can be followed.
Use in Children
Vitamin D3 Farmasierra is not intended for use in children and adolescents under 18 years of age.
If You Take More Vitamin D3Farmasierra Than You Should
If you have taken more of this medication than prescribed, or if a child has accidentally taken this medication, contact your doctor or emergency services to assess the risk.
An excess of Vitamin D causes an alteration of the calcium cycle in the body. The following symptoms may be experienced: weakness, fatigue, headache, nausea, vomiting, diarrhea, excessive urination, calcium in the urine, dry mouth, nocturia, proteinuria, intense thirst, loss of appetite, dizziness.
In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562.04.20, indicating the medication and the amount used. It is recommended to bring the packaging and package leaflet of the medication to the healthcare professional.
If You Forget to Take Vitamin D3Farmasierra
Do not take a double dose to make up for forgotten doses.
Take the forgotten dose as soon as possible; then return to your regular dosing schedule.
If it is almost time for the next dose, do not take the forgotten dose, just take the next dose normally.
If You Interrupt Treatment with Vitamin D3Farmasierra
If you have any further questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medications, Vitamin D3 can cause side effects, although not everyone will experience them. If you think any of the side effects you are experiencing is serious, or if you notice any side effects not mentioned in this package leaflet, tell your doctor or pharmacist.
You should stop taking Vitamin D3 immediately and consult your doctor if you experience symptoms of severe allergic reactions, such as:
- Swelling of the face, lips, tongue, or throat
- Difficulty swallowing
- Hives and difficulty breathing.
Uncommon side effects(occur in less than 1 in 100 patients): Hypercalcemia (elevated calcium levels in the blood) and hypercalciuria (elevated calcium levels in the urine).
Rare side effects(occur in less than 1 in 1,000 patients): Itching, skin rash, and hives.
Reporting Side Effects
If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es.
By reporting side effects, you can help provide more information on the safety of this medication.
5. Storage of Vitamin D3 Farmasierra
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date stated on the carton and blister pack after the abbreviation CAD. The expiration date is the last day of the month indicated.
Store the tablets in their original packaging to protect them from light.
Keep the bottle tightly closed to protect it from moisture.
Do not store above 25°C.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.
6. Package Contents and Additional Information
Composition of Vitamin D3Farmasierra
The active ingredient is colecalciferol 1250 micrograms, equivalent to 50,000 IU of Vitamin D3.
The other ingredients are refined palm oil, hydrogenated palm oil, butylhydroxytoluene E321, isomaltose, colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
Appearance of Vitamin D3Farmasierra and Package Contents
Vitamin D3 Farmasierra - oblong tablets of white-yellowish color with an aesthetic score line on one side. The score line serves only to facilitate fractionation and swallowing, but not to divide into equal doses.
It is presented in PVC/PVDC/PE-Al blisters containing 4 tablets and packaged in a cardboard box.
Not all presentations may be marketed.
Marketing Authorization Holder
Farmasierra Laboratorios SL
Ctra de Irún km 26,200
28709 San Sebastián de los Reyes
Madrid
Spain
Manufacturer
Farmasierra Manufacturing SL
Ctra de Irún km 26,200
28709 San Sebastián de los Reyes
Madrid Spain
Date of the Last Revision of this Package Leaflet: June2022
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)
- Country of registration
- Average pharmacy price18.73 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to VITAMIN D3 FARMASIERRA 50,000 IU TABLETSDosage form: CAPSULE, 25,000 IUActive substance: colecalciferolManufacturer: Laboratorios Alter S.A.Prescription requiredDosage form: CAPSULE, 50,000 IUActive substance: colecalciferolManufacturer: Laboratorios Alter S.A.Prescription requiredDosage form: CAPSULE, 50,000 IUActive substance: colecalciferolManufacturer: Consilient Health LimitedPrescription required
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