Osmille D 600 mg/1000 IU orodispersible tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Osmille D 600 mg/1.000 IU orodispersible tablets
calcium carbonate/colecalciferol
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Osmille D is and what it is used for
- What you need to know before taking Osmille D
- How to take Osmille D
- Possible adverse effects
- How to store Osmille D
- Contents of the pack and other information
1. What Osmille D is and what it is used for
Osmille D is used to prevent and treat calcium or vitamin D3 deficiency in elderly individuals and as an additional treatment in osteoporosis in patients at risk of vitamin D or calcium deficiency, when a dietary supplement of 600 mg/day of calcium and 1,000 IU/day of vitamin D3 is appropriate.
Osmille D contains calcium and vitamin D3, both of which are important components in bone formation. Vitamin D3 regulates the absorption and metabolism of calcium as well as the deposition of calcium into bone tissue.
If you have any doubts, consult your doctor or pharmacist and always follow their instructions.
Consult a doctor if your condition worsens or does not improve after several days.
2. What you need to know before taking Osmille D
Do not take Osmille D
- If you are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6).
- If you have hypercalcemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in the urine).
- If you have hypervitaminosis D (high levels of vitamin D in the blood).
- If you have kidney stones.
- If you have renal failure.
- If you are allergic to soy or peanuts.
Warnings and precautions
Talk to your doctor or pharmacist before taking Osmille D
- if you have sarcoidosis (a specific type of connective tissue disease affecting the lungs, skin, and joints).
- if you are taking other medicines containing vitamin D or calcium.
- if your kidneys do not function properly or if you are prone to developing kidney stones.
- if you are immobilized due to osteoporosis.
Other medicines and Osmille D
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The effect of treatment may be affected if this medicine is taken simultaneously with other medicines for:
- high blood pressure (thiazide diuretics)
- heart problems (cardiac glycosides such as digoxin)
- high cholesterol (cholestyramine)
- constipation (laxatives such as liquid paraffin)
- epilepsy (phenytoins or barbiturates)
- inflammatory diseases/immunosuppression (corticosteroids)
- obesity (orlistat)
Please ensure your doctor knows if you are taking any of the medicines listed above. Your dose may need to be adjusted.
If you are taking a medicine for
- osteoporosis (bisphosphonates)
you should take it at least one hour before taking Osmille D.
If you are taking medicines for
- infections (quinolones)
you should take them two hours before or six hours after taking Osmille D.
If you are taking medicines for
- infections (tetracyclines)
you should take them two hours before or six hours after taking Osmille D.
If you are taking medicines for
- dental caries (sodium fluoride)
- anaemia (iron)
you should take these medicines at least three hours before taking Osmille D.
If you are taking medicines for
- hypothyroidism (levothyroxine)
you should separate the administration of Osmille D by at least four hours.
Taking Osmille D with food, drinks and alcohol
Calcium absorption may be inhibited by foods containing oxalic acid (found in spinach and rhubarb) or phytic acid (found in whole grains). You should wait at least two hours after consuming foods high in oxalic acid or phytic acid before taking Osmille D.
Pregnancy, breastfeeding and fertility
During pregnancy, daily intake should not exceed 1,500 mg of calcium and 600 IU of vitamin D. Therefore, taking Osmille D during pregnancy is not recommended.
Osmille D may be taken during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when additional vitamin D is administered to the infant.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Osmille D contains aspartame
This medicine contains 8.67 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
Osmille D contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may harm the teeth.
3. How to take Osmille D
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The dose is individually determined by your physician.
The recommended dose is 1 tablet per day.
The tablets must be dissolved in the mouth. They must not be swallowed whole.
The tablets should preferably be taken after meals.
The amount of calcium in Osmille D is lower than the daily intake usually recommended. Therefore, Osmille D is recommended for patients who require additional vitamin D, but who have a daily intake of 500–1,000 mg of calcium. The calcium dose recommended for you should be determined by your doctor.
Use in children and adolescents
Osmille D is not indicated in children and adolescents.
If you take more Osmille D than you should
If you have taken more Osmille D than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
Symptoms of an Osmille D overdose may include loss of appetite, thirst, abnormally large amounts of urine, nausea, vomiting, and constipation.
If you forget to take Osmille D
Take it as soon as you remember. Then take your next dose as usual. However, if it is already time for your next dose, skip the missed dose and continue as normal. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
You must stop taking Osmille D and inform your doctor immediately if you experience symptoms of serious allergic reactions such as:
- Swelling of the face, lips, tongue or throat
- Difficulty swallowing
- Hives and difficulty breathing.
Uncommon adverse effects (may affect up to 1 in 100 people): hypercalcemia (elevated calcium levels in serum) and/or hypercalciuria (elevated calcium levels in urine).
Rare adverse effects (may affect up to 1 in 1,000 people): constipation, flatulence, nausea, abdominal pain, diarrhoea, pruritus, rash and urticaria.
Adverse effects with unknown frequency (frequency cannot be estimated from the available data): serious allergic reactions.
Other special populations
Patients with renal impairment may have a potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Osmille D Storage
Keep this medicine out of the sight and reach of children.
Keep the container tightly closed.
Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect it from light. Keep the container tightly closed to protect it from moisture.
The shelf life is 60 days after first opening.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Osmille D
- The active substances are calcium carbonate and colecalciferol (vitamin D3). Each tablet contains 1,500 mg of calcium carbonate, equivalent to 600 mg of calcium, and 1,000 IU of colecalciferol, equivalent to 0.025 mg.
- The other components are: maltodextrin, aspartame (E951), low-substituted hydroxypropylcellulose (E463), lactose monohydrate, anhydrous citric acid (E330), orange flavor, stearic acid, all-rac-α-tocopherol (E307), partially hydrogenated soybean oil, gelatin, sucrose, corn starch, silicon dioxide.
Appearance of the product and contents of the container
Osmille D is presented as white or almost white, round, bevelled orodispersible tablets.
Bottles containing 30 or 60 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
ITALFARMACO, S.A.
C/ San Rafael, 3
28108 Alcobendas, Madrid
Spain
Tel.: 91 657 23 23
Manufacturer
ITALFARMACO, S.p.A.
Viale Fulvio Testi 330
20126 Milan
Italy
Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder
Laboratorios EFFIK S.A.
C/ San Rafael, 3
28108 Alcobendas, Madrid
Spain
Tel: 91 358 52 73
This medicinal product is authorized in the Member States of the European Economic Area under the following names
Spain: Osmille D 600 mg/1,000 IU orodispersible tablets
Italy: Natemille 600 mg/1,000 IU orodispersible tablets
Date of the most recent review of this leaflet: January 2022
Up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).