PACKAGE LEAFLET: INFORMATION FOR THE USER

CADTRE “1000 mg + 880 U.I. effervescent granules”

30 effervescent granules sachets
Calcium carbonate and vitamin D3
Please read carefully this leaflet before taking this medicine because 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 you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist (See section 4).
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms.

Contents of this leaflet:

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

1. What CADTRE is and what it is used for

CADTRE contains the active substances Calcium carbonate and Vitamin D3. Calcium is an important component of bones, and Vitamin D3 promotes the intestinal absorption of Calcium and its deposition in bones.

It is used:

To correct concurrent deficiency states of Vitamin D3 and Calcium in elderly subjects
As a supplement of Vitamin D3 and Calcium during specific treatments for osteoporosis in subjects with confirmed deficiency or at high risk of Calcium and Vitamin D3 deficiency

2. What you need to know before taking CADTRE

Do not use CADTRE if:

you are allergic to Calcium, Vitamin D3, or any of the other ingredients of this medicine (listed in section 6);
you have diseases and/or conditions that may lead to high levels of calcium in the urine (hypercalciuria) or in the blood (hypercalcemia);
you are experiencing prolonged immobilization, especially if associated with elevated levels of calcium in the urine and/or blood (hypercalciuria and/or hypercalcemia);
you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
you have a medical condition causing accumulation of the amino acid phenylalanine (phenylketonuria);
you have kidney stones (calcium lithiasis);
your kidneys are no longer able to function properly (renal insufficiency).

Warnings and precautions
Talk to your doctor or pharmacist before taking CADTRE:

if you have impaired kidney function or are prone to forming kidney stones. Your treatment should be closely monitored if your kidneys are not working properly to ensure adequate calcium levels in your blood;
if you suffer from an inflammatory disease of unknown origin characterized by granuloma formation in various organs (sarcoidosis);
if you are an immobilized patient with osteoporosis;
if you are taking calcium and alkalis from other sources (food, fortified foods, or other medicinal products).
If you are undergoing long-term treatment, your doctor may periodically check your blood calcium levels and request a urine sample to monitor kidney function by measuring serum creatinine levels. Based on the results, your doctor may reduce the dosage or decide to discontinue treatment.

Children and adolescents
CADTRE is not intended for use in children.

Other medicines and CADTRE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Consult your doctor if you are taking any of the following medicines:

heart medications such as digoxin or other cardiac glycosides;
drugs used to treat bone disorders such as bisphosphonates or sodium fluoride;
drugs used to increase urine production (thiazide diuretics);
drugs used to treat epilepsy such as phenytoin or barbiturates;
glucocorticosteroids;
tetracycline antibiotics (tetracyclines);
other medicines containing vitamin D or calcium;
other medicines containing basic (alkaline) substances such as carbonate, since concomitant use with CADTRE may cause episodes of milk-alkali syndrome.
Calcium salts may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, iron, zinc, or strontium ranelate preparations should be taken at least two hours before or after CADTRE.

CADTRE with food, drinks and alcohol
This medicine may interact with certain foods containing oxalic acid (e.g. spinach and rhubarb), phosphates (e.g. bran), or phytic acid (e.g. whole grains), as these may reduce the absorption of calcium contained in CADTRE.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Due to its high vitamin D content, this dosage is not recommended during pregnancy and breastfeeding. In pregnant women, excessive intake of calcium and vitamin D must be avoided, as persistent hypercalcemia is associated with adverse effects on fetal development.

CADTRE may be used during breastfeeding, but your doctor must be informed, as calcium and vitamin D pass into breast milk. This should be taken into account when administering vitamin D supplements to the infant.

Driving and using machines
CADTRE is not expected to affect your ability to drive or operate machinery.

CADTRE contains sodium and aspartame
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. it is essentially "sodium-free".
This medicine contains 40 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation because the body cannot properly eliminate it.

3. How to take CADTRE

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults
Pour the contents of the sachet into a glass, add a generous amount of water, stir and drink immediately
after the effervescence has finished. The recommended dose is one sachet daily, preferably taken
after meals.
Your doctor or pharmacist will tell you how many sachets to take each day.
If you take more CADTRE than you should
If you take an excessive dose of this medicine, the following symptoms may occur: nausea, vomiting,
intense thirst, increased frequency of urination, constipation. If any of these adverse effects occur,
contact your doctor immediately and take the necessary precautionary measures.
If you forget to take CADTRE
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, CADTRE can cause side effects, although not everyone experiences them.
You may experience an allergic reaction. If you develop skin rashes, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue, you must stop taking this medicine immediately and seek urgent medical attention.
Uncommon (may affect up to 1 in 100 people)

High calcium levels in the blood (hypercalcaemia). Symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, extreme thirst, need to urinate more often, muscle weakness, drowsiness, and confusion;
Increased calcium levels in urine (hypercalciuria).
Rare (may affect up to 1 in 1,000 people)
Constipation, flatulence, nausea, abdominal pain, diarrhoea;
Itching, skin rash, and urticaria.
Not known (frequency cannot be estimated from the available data)
Milk-alkali syndrome, associated with high calcium levels in the blood (hypercalcaemia), elevated blood pH (alkalosis), and reduced or impaired kidney function (renal failure).
Increased phosphate levels in the blood (hyperphosphataemia), kidney stones (nephrolithiasis), kidney damage due to accumulation of calcium salts (nephrocalcinosis). This may occur in individuals with kidney problems.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You may also report side effects directly through the national reporting system at the following website: 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 CADTRE

Keep this medicine out of the reach and sight of children.
Do not use CADTRE after the expiry date which is stated on the packaging after "exp".
The expiry date refers to the last day of that month.
Store below 25°C and keep in the original packaging to protect the medicine from moisture.
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. Contents of the pack and other information

What CADTRE contains
Each sachet contains
Active substances: Calcium carbonate 2500 mg (equivalent to 1000 mg of calcium) - Colecalciferol (Vita-
min D3) 880 IU
Other components: citric acid, aspartame, sodium saccharin, orange flavour, maltode-
xtrin, orange yellow S.
Description of the appearance of CADTRE and contents of the pack
Effervescent granules. Carton containing 30 sachets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEW RESEARCH srl
Via Tiburtina n° 1143
00156 Rome
Manufacturer
LA.FA.RE. S.r.l.
Via Sac. Benedetto Cozzolino 77
80056 Ercolano - Naples