Natemiille

Package leaflet: Information for the patient

NATEMILLE 600 mg/1000 IU orodispersible tablets

calcium / colecalciferol
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

1. What NATEMILLE is and what it is used for
2. What you need to know before taking NATEMILLE
3. How to take NATEMILLE
4. Possible side effects
5. How to store NATEMILLE
6. Contents of the pack and other information

1. What NATEMILLE is and what it is used for

NATEMILLE is used for the prevention and treatment of calcium and vitamin D deficiency
in the elderly, and as an additional treatment in the management of osteoporosis in patients at risk
of calcium and vitamin D deficiency, when dietary supplementation with 600 mg/day of calcium and 1000 IU/day of vitamin D is considered appropriate.
NATEMILLE contains calcium and vitamin D, both of which are important components for bone formation. Vitamin D regulates the absorption and metabolism of calcium, as well as the deposition of calcium in bone tissue.
Consult your doctor or pharmacist if you have any further questions and always follow their instructions.
Contact your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before taking NATEMILLE

Do not take NATEMILLE

• if you are allergic (hypersensitive) to calcium, vitamin D, or to 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 suffer from renal failure;
• if you are allergic to peanuts or soya;

Warnings and precautions
Talk to your doctor or pharmacist before taking NATEMILLE

• if you suffer from sarcoidosis (a specific connective tissue disorder affecting the lungs, skin, and joints);
• if you are taking other medicines containing vitamin D or calcium;
• if you have reduced kidney function or a high tendency to develop kidney stones;
• if you are bedridden due to osteoporosis;

Other medicines and NATEMILLE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The effect of this treatment may be influenced if this medicine is taken simultaneously with certain drugs used for:

• hypertension (thiazide diuretics);
• heart disorders (cardiac glycosides such as digoxin);
• hypercholesterolemia (cholestyramine);
• constipation (laxatives such as paraffin oil);
• epilepsy (phenytoin or barbiturates);
• inflammatory conditions/immunosuppression (corticosteroids);
• obesity (orlistat).

Ensure your doctor is aware if you are taking any of the medicines listed above. A dose adjustment may be necessary.
If you are taking a medicine for:

• osteoporosis (bisphosphonates), you must take this medicine at least one hour before taking NATEMILLE.

If you are taking medicines for:

• infections (quinolones), you must take these medicines two hours before or six hours after taking NATEMILLE.

If you are taking a medicine for:

• infections (tetracyclines), you must take these medicines two hours before or four to six hours after taking NATEMILLE.

If you are taking a medicine for:

• dental caries (sodium fluoride)
• anaemia (iron), you must take these medicines at least three hours before taking NATEMILLE.

If you are taking medicines for:

• hypothyroidism (levothyroxine), you must take these medicines at least four hours apart from taking NATEMILLE.

NATEMILLE with food, drinks and alcohol
Calcium absorption may be inhibited by foods containing oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains).
You should wait at least two hours before taking NATEMILLE after consuming foods high in oxalic acid or phytic acid.

Pregnancy and breastfeeding and fertility
During pregnancy, the daily intake of calcium and vitamin D should not exceed 1500 mg of calcium and 600 IU of vitamin D, respectively.
Therefore, NATEMILLE is not recommended during pregnancy.
NATEMILLE may be used during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account if additional vitamin D is being administered to the infant.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
No effects on the ability to drive or use machinery are known.

NATEMILLE contains aspartame.
Aspartame is a source of phenylalanine. Phenylalanine may be dangerous for patients with phenylketonuria.

NATEMILLE contains lactose and sucrose.
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

NATEMILLE contains soya oil.
If you are allergic to peanuts or soya, do not take this medicine.

3. How to take NATEMILLE

Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, you should consult your doctor or pharmacist.
The dosage is individually determined for you by your doctor.
The recommended dose is one tablet per day.
The tablets may be sucked and must not be swallowed whole.
The tablets should preferably be taken after meals.
The amount of calcium in NATEMILLE is lower than the recommended daily intake.
Therefore, NATEMILLE should primarily be used in patients who require vitamin D supplementation but who obtain between 500 mg and 1000 mg of calcium per day through their diet. The amount of dietary calcium intake must be assessed by the doctor.
NATEMILLE is not indicated for children and adolescents.
If you take more NATEMILLE than you should
If you take more NATEMILLE than you should, contact your doctor or pharmacist immediately.
Some symptoms of NATEMILLE overdose include: loss of appetite, thirst, abnormally increased urinary excretion, nausea, vomiting, and constipation.
If you forget to take NATEMILLE
Take the tablet as soon as possible. Then, take the next dose at the usual time. However, if it is almost time for the next dose, do not take the missed dose and continue as normal.
Never take two doses at the same time.
If you have further doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking NATEMILLE and contact your doctor immediately if symptoms of a severe allergic reaction occur, such as:

• swelling of the face, lips, tongue or throat
• difficulty swallowing
• hives and difficulty breathing

Uncommon (may affect up to 1 in 100 people): hypercalcemia (high levels of calcium in the blood) and/or hypercalciuria (high levels of calcium in the urine).
Rare (may affect up to 1 in 1,000 people): constipation, flatulence, nausea, abdominal pain, itching, skin rash, urticaria.
Not known (frequency cannot be estimated from the available data): severe allergic reactions.

Special populations
Patients with renal impairment: there is a potential risk of hyperphosphatemia, nephrolithiasis, and nephrocalcinosis.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NATEMILLE

• Keep this medicine out of the sight and reach of children.
• Keep the packaging closed. Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
• Store in the original packaging to protect from light.
• Keep the container tightly closed to protect the product from moisture.
• The product is valid for 60 days after first opening of the bottle.
• Do not use this medicine if you notice any visible signs of deterioration.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NATEMILLE contains

• The active substances are: calcium carbonate 1500 mg, equivalent to 600 mg of calcium, and colecalciferol (vitamin D3) 1000 IU, equivalent to 0.025 mg.
• The other excipients are: maltodextrins, aspartame (E 951), low-substituted hydroxypropylcellulose (E 463), monohydrate lactose, anhydrous citric acid (E 330), orange flavour, stearic acid, DL-α-tocopherol (E 307), partially hydrogenated soybean oil, gelatin, sucrose, corn starch.

Description of the appearance of NATEMILLE and contents of the pack

White or almost white, round orodispersible tablets with bevelled edges.
Container for tablets containing 30 or 60 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
ITALFARMACO S.p.A. – Viale F. Testi, 330 – 20126 Milano.
Tel. +39 02 64431
Fax. +39 02 644346
e-mail: [email protected]

Responsible manufacturer for batch release
ITALFARMACO S.p.A. – Viale F. Testi, 330 – 20126 Milano.

This medicinal product is authorised in the European Economic Area Member States under the following names:
Italy: Natemille 600mg/1,000UI orodispersible tablets
Spain: Osmille D 600 mg/1,000 IU bucodispersable tablets

This leaflet was last approved on: