PACKAGE LEAFLET: INFORMATION FOR THE USER

TONACAL D 600 mg + 400 IU chewable tablets

Calcium + colecalciferol
Please read this leaflet carefully before 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, pharmacist, or nurse.
This medicine is intended for use in adult patients only. This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Tonacal D is and what it is used for
What you need to know before taking Tonacal D
How to take Tonacal D
Possible side effects
How to store Tonacal D
Contents of the pack and other information

1. WHAT TONACAL D IS AND WHAT IT IS USED FOR

Tonacal D chewable tablets contain two active substances, calcium carbonate and colecalciferol (vitamin D), which are normally obtained through diet; in addition, vitamin D is produced in the skin following exposure to sunlight.
Tonacal D chewable tablets may be prescribed by a doctor for the treatment and prevention of vitamin D and calcium deficiency.
Tonacal D is used:

to correct calcium and vitamin D deficiency in the elderly;
in combination with osteoporosis treatment when calcium and vitamin D levels are too low or when there is a high risk of them becoming too low.

2. BEFORE TAKING TONACAL D

Do not take Tonacal D

if you are allergic to calcium, vitamin D, or any of the excipients of Tonacal D (especially soybean oil);
if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria);
if you have severe kidney problems;
if you have kidney stones;
if you have high levels of vitamin D in your blood (hypervitaminosis D).

Warnings and precautions

if you have had kidney stones or other kidney problems (your doctor will carefully monitor treatment with Tonacal D if your kidneys are not functioning properly, to prevent blood calcium levels from becoming too high);
if you are immobilized in bed for a prolonged period (months) and suffer from osteoporosis (bone fragility), as you may develop elevated calcium levels in the blood;
if you are taking other medicines containing calcium or vitamin D, your doctor or pharmacist will advise you accordingly;
if you have sarcoidosis, your doctor will advise you accordingly.

Other medicines and Tonacal D
Do not take Tonacal D without informing your doctor or pharmacist if you are taking:

any other medicine containing vitamin D;
the following heart medications: digitalis or other cardiac glycosides;
tetracycline-type antibiotics or fluoroquinolones; it is recommended to wait at least 3 hours after taking these before taking Tonacal D chewable tablets;
thiazide diuretics;
if you are using other medicines for bone diseases, such as bisphosphonates or sodium fluoride, it is recommended to wait at least 3 hours after taking them before taking Tonacal D chewable tablets;
phenytoin (a medicine for epilepsy) and barbiturates (medicines used for epilepsy or to promote sleep), as they reduce the effect of vitamin D;
rifampicin, as it reduces the effectiveness of vitamin D3;
orlistat (a medicine for the treatment of obesity), cholestyramine, laxatives such as liquid paraffin, as they may reduce the absorption of vitamin D;
estramustine (a medicine used in chemotherapy), thyroid hormones, or medicines containing iron, zinc, or strontium ranelate, as their absorption may be reduced. These medicines should be taken at least 2 hours before or after Tonacal D3.

Tonacal D with food and drinks
This medicine may interact with certain foods, such as those containing oxalic acid (e.g. spinach, rhubarb, sorrel, cocoa, tea, etc.), phosphate (e.g. ham, sauces, processed cheese, etc.), or phytic acid (e.g. legumes, whole grains, chocolate, etc.). Therefore, it is recommended to take Tonacal D at least 2 hours before or after a meal containing these foods.

Pregnancy and breastfeeding
Tonacal D chewable tablets should be used during pregnancy and breastfeeding only if recommended by your doctor.

Important information about certain excipients in Tonacal D
The product contains: sorbitol (E 420), aspartame (E 951), lactose, hydrogenated soybean oil, sucrose.
The product contains aspartame, which is a source of phenylalanine. Phenylalanine may be harmful for patients with phenylketonuria.
The product contains lactose, sucrose, and sorbitol; therefore, if your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking Tonacal D.
The product contains soybean oil; therefore, if you are allergic to peanuts or soy, do not take this medicine.

3. HOW TO TAKE TONACAL D

Always take Tonacal D exactly as directed by your doctor. If you have any doubts, consult your doctor.
The usual dose for adults and elderly patients is one chewable tablet twice daily (for example, one in the morning and one in the evening), preferably taken after meals.
The tablets should be chewed or allowed to dissolve in the mouth; they must not be swallowed whole.
If you take more Tonacal D than you should
Contact your doctor. If you are unable to do so, go immediately to the nearest emergency room, taking with you any remaining tablets and the pack.
If you forget to take Tonacal D
Take the tablet as soon as possible. Afterwards, take your next dose at the usual time. However, if it is almost time for your next dose, do not take the missed dose and continue your treatment as usual. Never take a double dose to make up for a forgotten dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Tonacal D may cause adverse reactions, although not everyone experiences them.
The following adverse reactions are uncommon (occurring in 1–10 out of 1,000 patients):

hypercalcemia (excessively high levels of calcium in the blood) – symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, excessive thirst, increased need to urinate, muscle weakness, drowsiness, and confusion;
hypercalciuria (excessively high levels of calcium in the urine).

The following adverse reactions are rare (occurring in 1–10 out of 10,000 patients):

nausea;
stomach pain;
constipation;
diarrhoea;
flatulence;
pruritus;
rash;
urticaria.

The frequency of the following adverse reactions is unknown (cannot be estimated from the available data):

Severe allergic reactions (hypersensitivity), such as, for example, swelling of the face, lips, or tongue.

Special populations
Patients with renal impairment: there is a potential risk of hyperphosphatemia, nephrolithiasis, and nephrocalcinosis.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TONACAL D

Do not store above 30°C.
Keep the medicine in the original container to protect it from moisture.
Keep this medicine out of the sight and reach of children.
Do not use Tonacal D after the expiry date stated on the packaging after the abbreviation “Exp.”.
The expiry date refers to the last day of the month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Tonacal D contains

Each tablet contains the active substances calcium carbonate (1500 mg, equivalent to 600 mg of calcium) and colecalciferol (Vitamin D) (400 IU, equivalent to 0.01 mg).
The excipients are: sorbitol (E 420), maltodextrins, sodium croscarmellose (E 468), aspartame (E 951), sodium saccharin (E 954), monohydrate lactose, anise flavour, mint flavour, molasses flavour, magnesium stearate, DL-α-tocopherol (E 307), hydrogenated soybean oil, gelatin, sucrose, corn starch.

Description of the appearance of Tonacal D and packaging contents
The tablets are circular in shape with bevelled edges, white or almost white in colour, with the inscription "D" on one side only.
Bottle containing 60 chewable tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
S.F. Group Srl – Via Tiburtina, 1143 – 00156 Rome, Italy
Responsible manufacturer for batch release:
Italfarmaco S.p.A. - Viale Fulvio Testi, 330 – 20126 Milan, Italy

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