Metocal vitamin D3

Patient Information Leaflet

METOCAL VITAMIN D3 600 mg/400 IU chewable tablets

Calcium carbonate + Colecalciferol
For adults only.
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If your symptoms worsen or do not improve, contact your doctor.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Contact your doctor if you feel unwell or feel worse.

Contents of this leaflet:
1 What METOCAL VITAMIN D3 600 mg/400 IU chewable tablets is and what it is used for
2 What you need to know before taking METOCAL VITAMIN D3 600 mg/400 IU chewable tablets
3 How to take METOCAL VITAMIN D3 600 mg/400 IU chewable tablets
4 Possible side effects
5 How to store METOCAL VITAMIN D3 600 mg/400 IU
6 Contents of the pack and other information

1. What METOCAL VITAMIN D3 600 mg/400 I.U. chewable tablets is and what it is used for

What it is
This medicinal product contains two active substances: Calcium and Vitamin D. Calcium is an important component of bones, and Vitamin D promotes the intestinal absorption of Calcium and its deposition in the bones.

It is used:

• To correct concomitant deficiency states of Vitamin D and Calcium in elderly subjects.
• As a supplement of Vitamin D and Calcium during specific therapies for the treatment of osteoporosis in patients with confirmed deficiency of Calcium and Vitamin D or at high risk.

2. What you need to know before taking METOCAL VITAMIN D3 600mg/400 U.I. chewable tablets

Do not use METOCAL VITAMIN D3 600mg/400 U.I. chewable tablets

• If you are allergic to Calcium, Vitamin D, or any of the other ingredients of this medicine (listed in section 6)
• If you have high levels of calcium in your blood (hypercalcemia) and/or excessive loss of calcium in the urine (hypercalciuria)
• If you have a condition that may lead to hypercalcemia or hypercalciuria (e.g. overactive parathyroid glands, a bone marrow disease (myeloma), or malignant bone tumours (bone metastases))
• If you suffer from renal insufficiency
• If you have kidney stones (calcium lithiasis) or calcium deposits in your kidneys (nephrocalcinosis)
• If you have excessive vitamin D intake (hypervitaminosis D)

Warnings and precautions
Exercise particular caution with METOCAL VITAMIN D3 600 mg/400 U.I. chewable tablets

• If you are undergoing prolonged treatment with METOCAL VITAMIN D3 600 mg/400 U.I. chewable tablets, your blood calcium levels and serum creatinine levels (to assess kidney function) should be monitored regularly. This monitoring is particularly important in elderly patients and in cases of concomitant treatment with cardiac glycosides (e.g. digoxin) and diuretics.

Based on this monitoring, your doctor may decide to reduce or discontinue treatment.

• Before using METOCAL VITAMIN D3 600 mg/400 U.I. chewable tablets, be careful about your intake of vitamin D, calcium, and alkalis such as carbonate from other sources (e.g. dietary supplements or food). Since these products already contain vitamin D and calcium carbonate, additional administration of Metocal Vitamin D3 may lead to Burnett's syndrome. Burnett's syndrome (milk-alkali syndrome) is a disorder of calcium metabolism characterized by elevated blood calcium levels. It may be caused by excessive consumption of milk and/or calcium carbonate from other sources or by abuse of antacids. This may cause the adverse events listed in section 4. Additional administration of Metocal Vitamin D3 should be carried out under strict medical supervision with regular monitoring of calcium levels in the blood (calcemia) and in the urine (calciuria).

Inform your doctor or pharmacist before using METOCAL VITAMIN D3 600mg/400 U.I. chewable tablets:

• If you have had kidney stones.
• If you suffer from a disease of the immune system (sarcoidosis), in which case calcium levels in blood and urine must be monitored.
• If you are immobilized and suffer from reduced bone mass (osteoporosis). This could excessively increase blood calcium levels and cause unwanted effects.
• If you are taking other medicines containing vitamin D or calcium. This could excessively increase blood calcium levels and cause adverse unwanted effects.
• If your kidney function is impaired.

Children and adolescents
Do not give this medicine to children and adolescents, as there are no relevant indications for use in this age group.

Other medicines and METOCAL VITAMIN D3 600mg/400 U.I. chewable tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

In particular:

• Thiazide diuretics (medicines used to treat high blood pressure), as they may increase blood calcium levels.
• Oral steroids, as they may reduce blood calcium levels.
• Orlistat (a medicine used to treat obesity), cholestyramine, laxatives such as liquid paraffin, as they may reduce vitamin D absorption.
• Rifampicin (an antibiotic), phenytoin (a medicine for epilepsy), and barbiturates (medicines that promote sleep), as they may reduce the effect of vitamin D.
• Cardiac glycosides (heart medicines), as they may cause more adverse events if too much calcium is taken.
• Tetracyclines (antibiotics), as they may decrease the amount absorbed. They should be taken at least two hours before, or 4–6 hours after METOCAL VITAMIN D3 600 mg/400 U.I. chewable tablets.
• Thyroid hormones or medicines containing iron, zinc, or strontium, as they may decrease the amount absorbed. They should be taken at least 2 hours before or after METOCAL VITAMIN D3 600 mg/400 U.I. chewable tablets.
• Cancer treatment (estramustine): METOCAL VITAMIN D3 and estramustine should be taken at least two hours apart.
• Bisphosphonates (bone medicines), fluoride, or fluoroquinolones (antibiotics), as they may decrease the amount absorbed. They should be administered at least 3 hours before or after METOCAL VITAMIN D3 600 mg/400 U.I. chewable tablets.

METOCAL VITAMIN D3 600mg/400 U.I. chewable tablets with food and drink
During the two hours before taking METOCAL VITAMIN D3 600 mg/400 U.I. chewable tablets, avoid eating foods containing oxalic acid (e.g. spinach and rhubarb) or phytic acid (e.g. cereals), as they may reduce calcium absorption.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using any medicine.

This medicine may be used during pregnancy; however, the total daily dose of calcium should not exceed 1500 mg and the total daily dose of vitamin D should not exceed 600 U.I. Therefore, the daily dose of METOCAL VITAMIN D3 600 mg/400 U.I. chewable tablets should not exceed one tablet per day. Higher amounts may have a negative effect on the baby.

During breastfeeding, you may use METOCAL VITAMIN D3 600 mg/400 U.I. chewable tablets. Since calcium and vitamin D pass into breast milk, you should first discuss with your doctor whether your baby is already receiving other products containing vitamin D.

The intake of METOCAL VITAMIN D3 600mg/400 U.I. chewable tablets should not have negative effects on fertility.

During pregnancy and breastfeeding, METOCAL VITAMIN D3 600 mg/400 U.I. chewable tablets should be taken two hours apart from meals due to a possible reduction in iron absorption.

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

Excipients
METOCAL VITAMIN D3 600 mg/400 U.I. chewable tablets contain sucrose. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before using this medicine. It may be harmful to teeth.

The following information may be useful if you have diabetes: the amount of digestible carbohydrates in METOCAL VITAMIN D3 600 mg/400 U.I. chewable tablets is 0.47 g per chewable tablet. The daily dose of two chewable tablets corresponds to 0.08 carbohydrate units.

Sodium content
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take METOCAL VITAMINA D3 600 mg/400 U.I. chewable tablets

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.

Dosing
The usual dose is one tablet twice daily for adults and elderly patients (e.g. one in the morning and one in the evening). Pregnant women should take only one tablet per day.
Long-term treatment requires monitoring of calcium levels in blood and urine; this is particularly important if you have a tendency to develop kidney stones.

Method of administration
Chew the tablets and then swallow them with some liquid.
In exceptional cases (e.g. disabled patients), the tablets may be dissolved in the mouth, after consulting your doctor.

Duration of treatment
Your doctor will decide how long you should take METOCAL VITAMINA D3 600 mg/400 U.I. chewable tablets.

If you take more METOCAL VITAMINA D3 600 mg/400 U.I. chewable tablets than you should
If you have taken more METOCAL VITAMINA D3 600 mg/400 U.I. chewable tablets than you should and experience any symptoms of overdose, stop taking METOCAL VITAMINA D3 600 mg/400 U.I. chewable tablets and contact your doctor immediately.
Symptoms of overdose may include loss of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, excessive thirst, increased urge to urinate, bone pain, calcium deposits in the kidneys, kidney stones, and in more severe cases, irregular heartbeat.
In the case of a more severe overdose, cardiac arrest may occur.

If you forget to take METOCAL VITAMINA D3 600 mg/400 U.I. chewable tablets
Do not take a double dose to make up for a forgotten tablet.

If you stop taking METOCAL VITAMINA D3 600 mg/400 U.I. chewable tablets
If you wish to stop or discontinue treatment prematurely, consult your doctor.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone experiences them.
Some rare or very rare side effects could be serious.
Uncommon (may affect up to 1 in 100 people):
Increased calcium levels in the blood (hypercalcaemia) and/or increased calcium excretion in urine (hypercalciuria).
Rare (may affect up to 1 in 1,000 people):
Nausea, abdominal pain, flatulence, bloating, abdominal distension, constipation or diarrhoea;
itching, skin rashes, hives, skin redness and burning sensation.
Very rare (may affect up to 1 in 10,000 people):
Milk-alkali syndrome, usually observed only when excessive amounts of calcium have been ingested (symptoms include frequent need to urinate, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, together with high levels of calcium in the blood and impaired kidney function).
Not known (incidence cannot be estimated from available data):
Severe allergic reactions (hypersensitivity) such as swelling of the face, lips, tongue, throat, vomiting.
If any of the side effects worsen, stop taking the medicine
and contact your doctor immediately.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store METOCAL VITAMIN D3 600 mg/400 I.U. chewable tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Do not store METOCAL VITAMIN D3 600 mg/400 I.U. chewable tablets at temperatures above 25°C.
Do not dispose of medicines 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 METOCAL VITAMINA D3 600 mg/400 U.I. chewable tablets contain
The active substances are: Calcium carbonate 1500 mg
equivalent to elemental Calcium 600 mg
concentrated colecalciferol (powder) 4 mg
equivalent to Vitamin D3 10 μg (400 U.I.)
The excipients are Xylitol,
d-mannitol (E421)
Magnesium stearate
Anhydrous colloidal silica
Pregelatinized corn starch
Butylated hydroxytoluene (E321)
Medium-chain triglycerides
Sucrose
Gelatin
Modified corn starch
Sodium aluminium silicate
Flavours (Tutti frutti 77919-31 Givaudan). See also section 2
"METOCAL VITAMINA D3 600 mg/400 U.I. chewable tablets
contains sucrose" and "Sodium content"

Description of the appearance of METOCAL VITAMINA D3 600 mg/400 U.I. chewable tablets and
pack size
METOCAL VITAMINA D3 600 mg/400 U.I. chewable tablets is a medicine presented as
chewable tablets. The tablets are white, flat, with a break line and the letters C/D printed on the tablet.
METOCAL VITAMINA D3 600 mg/400 U.I. chewable tablets are available in PVC/PVDC/Aluminium blisters, each containing 10 chewable tablets.
Pack sizes of 20, 30, 50, 60, 100 and 300 chewable tablets are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Healthcare Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN, Ireland

Manufacturer
Madaus GmbH
Luetticher Strasse, 5
Troisdorf, Germany

This medicinal product is authorised in the European Economic Area member states under the
following names:
Country Name
Italy METOCAL VITAMINA D3 600 mg/400 U.I.
Ireland Calvidin 600 mg/400 U.I. chewable tablets
Greece Calvidin 600 mg/400 U.I.
Portugal Calcior-D
Germany Calcigen D 600 mg/400 U.I. chewable tablets

This Patient Information Leaflet was last approved on: