Package Insert: Information for the User

Osmille D 600 mg/1,000 IU chewable tablets

calcium carbonate/vitamin D3

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert.See section 4.

Osmille D is used to prevent and treat calcium or vitamin D deficiency3in elderly individuals and as an additional treatment inosteoporosis in patients at risk of vitamin D or calcium deficiency, when a dietary supplement of 600 mg/day of calcium and 1,000 UI/day of vitamin D3is appropriate.

Osmille D contains calcium and vitamin D3, both important components in bone formation. Vitamin D3regulates calcium absorption and metabolism as well as calcium incorporation into bone tissue.

Ask your doctor or pharmacist if you have any doubts and always follow their instructions.

You should consult a doctor if you worsen or do not improve after several days.

Do not take Osmille D

• If you are allergic to calcium, vitamin D, or any of the other components of this medication (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 kidney failure.
• If you are allergic to soy or peanuts.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Osmille D.

• If you have sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints).
• If you are taking other medications that contain vitamin D or calcium.
• If your kidneys do not function well or you have a tendency to form kidney stones.
• If you are bedridden due to osteoporosis.

Other medications and Osmille D

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The effect of treatment may be affected if this medication is taken simultaneously with other medications 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 that your doctor knows if you are taking any of the medications listed above. Your dose may need to be adjusted.

If you take simultaneously a medication for

• Osteoporosis (bisphosphonates)

You should take it at least one hour before taking Osmille D.

If you take simultaneously medications for

• Infections (quinolones)

You should take them two hours before or six hours after taking Osmille D.

If you take simultaneously medications for

• Infections (tetracyclines)

You should take them two hours before or six hours after taking Osmille D.

If you take simultaneously medications for

• Dental caries (sodium fluoride)
• Anemia (iron)

You should take these medications at least three hours before taking Osmille D.

If you take simultaneously medications for

• Hypothyroidism (levotiroxine)

You should separate the taking of Osmille D by at least four hours.

Taking Osmille D with food, drinks, and alcohol

The absorption of calcium may be inhibited by foods containing oxalic acid (present in spinach and rhubarb) or phytic acid (present in whole grains). You should wait at least two hours before taking Osmille D if you have taken foods with high oxalic acid or phytic acid content.

Pregnancy, breastfeeding, and fertility

During pregnancy, the daily intake should not exceed 1,500 mg of calcium and 600 IU of vitamin D. Therefore, it is not recommended to take Osmille D during pregnancy.

Osmille D can be taken during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when additional vitamin D is provided to the infant.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

No effects have been observed on the ability to drive and operate machinery.

Osmille D contains aspartame

This medication contains 8.67 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Osmille D contains lactose and sucrose

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication. It may harm your teeth

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The dose is established by your doctor on an individual basis.

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 be taken preferably after meals.

The amount of calcium in Osmille D is less than the usual daily recommended intake. Osmille D is therefore recommended for patients who need an additional intake of vitamin D, but with a daily intake of 500-1,000 mg of calcium. The recommended calcium dose for you should be established by your doctor.

Use in children and adolescents

Osmille D is not indicated for children and adolescents.

If you take moreOsmille Dthan you should

If you have taken more Osmille D than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of an Osmille D overdose may include loss of appetite, thirst, abnormal emission of large amounts of urine, nausea, vomiting, and constipation.

If you forgot to take Osmille D

Take it as soon as you remember. Then, take the next dose as usual. However, if it is already time for your next dose, omit the missed dose and continue as usual. Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

You should stop taking Osmille D and immediately inform your doctor if you experience severe allergic reaction symptoms such as:

• Swelling of the face, lips, tongue, or throat
• Difficulty swallowing
• Hives and difficulty breathing.

Less common 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, diarrhea, pruritus, rash, and urticaria.

Adverse effects of unknown frequency (frequency cannot be estimated with available data):severe allergic reactions.

Other special populations

Patients with renal insufficiency may have a potential risk of hyperphosphatemia, nephrolithiasis, and nephrocalcinosis.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children

Keep the container perfectly closed.

Do not use this medication after the expiration date that appears on the container, after CAD. The expiration date is the last day of the month indicated.

Store in the original container to protect it from light. Keep the container perfectly closed to protect it from moisture.

The expiration is 60 days after its first opening

Do not use this medication if you observe any visible sign of deterioration.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Osmille D

• The active principles 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 UI of colecalciferol equivalent to 0.025 mg.
• The other components are: maltodextrin, aspartame (E951), low-substitution hydroxypropylcellulose (E463), lactose monohydrate, anhydrous citric acid (E330), orange aroma, stearic acid, All-rac-α-tocopherol (E307), partially hydrogenated soybean oil, gelatin, sucrose, cornstarch, silicon dioxide.

Appearance of the product and content of the packaging

Osmille D is presented in the form of white or almost white, circular, bisected, buccal dispersible tablets.

Bottles of 30 or 60 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

ITALFARMACO, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Phone: 91 657 23 23

Responsible for manufacturing

ITALFARMACO, S.p.A.

Viale Fulvio Testi 330

20126 Milan

Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder

Laboratorios EFFIK S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Phone: 91 358 52 73

This medication is authorized in the member states of the European Economic Area with the following names

SpainOsmille D 600 mg/1,000 UI buccal dispersible tablets

ItalyNatemille 600 mg/1,000 UI orodispersible tablets

Date of the last review of this prospectus:January 2022

The updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).