Riliscal

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

RILISCAL 600 mg / 2.000 IU orodispersible tablets

calcium / colecalciferol
Please read all of 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 has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What RILISCAL is and what it is used for

RILISCAL is used to treat calcium and vitamin D deficiency in adults.
RILISCAL contains calcium and vitamin D3, both of which are important components for bone formation.
Vitamin D3 regulates the absorption and metabolism of calcium and the incorporation of calcium into bone tissue.
Consult your doctor or pharmacist if you have 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 RILISCAL

Do not take RILISCAL

• if you are allergic to calcium, vitamin D, or 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 (increased levels of vitamin D in the blood)
• if you have kidney stones
• if you suffer from renal insufficiency
• if you are pregnant
• if you are allergic to soy or peanuts

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

• if you suffer from sarcoidosis (a specific connective tissue disorder affecting 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 form kidney stones
• if you are immobilized with osteoporosis

Children and adolescents
RILISCAL orodispersible tablets are not intended for use in children and adolescents.

Other medicines and RILISCAL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be influenced if this medicine is taken at the same time as certain other medicines used for:

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

Make sure 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 it at least three hours before taking RILISCAL

If you are taking certain medicines for:

• infection (quinolones), you must take these medicines two hours before or six hours after taking RILISCAL

If you are taking certain medicines for:

• infection (tetracyclines), you must take these medicines two hours before or four to six hours after taking RILISCAL

If you are taking certain medicines for:

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

If you are taking medicines for:

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

RILISCAL 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 RILISCAL after consuming foods high in oxalic or phytic acid.

Pregnancy, breastfeeding and fertility
RILISCAL must not be used during pregnancy.
RILISCAL may be used during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when additional vitamin D is given to the infant. Such supplementation does not replace the administration of vitamin D in newborns.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
RILISCAL has no known effects on the ability to drive vehicles or operate machinery.

RILISCAL contains aspartame
This medicine contains 8.67 mg of aspartame in each orodispersible tablet.
Aspartame is a source of phenylalanine. Phenylalanine may be harmful for people with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

RILISCAL contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

RILISCAL contains soybean oil
If you are allergic to peanuts or soy, do not take this medicine.

3. How to take RILISCAL

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, you must consult your doctor or pharmacist.
The dosage will be 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 RILISCAL is lower than the recommended daily intake.
Therefore, RILISCAL should primarily be used in patients who require vitamin D supplementation but whose dietary calcium intake ranges between 500 mg and 1000 mg per day.
The amount of calcium taken in the diet should be assessed by the doctor.
Use in children and adolescents
RILISCAL is not indicated in children and adolescents.
If you take more RILISCAL than you should
If you take more RILISCAL than you should, contact your doctor or pharmacist immediately.
Some symptoms of RILISCAL overdose are: loss of appetite, thirst, abnormally increased urinary secretion, nausea, vomiting, and constipation.
If you forget to take RILISCAL
Take the tablet as soon as possible. Afterwards, 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 usual.
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 everyone gets them.
You must stop taking RILISCAL 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 breathing difficulties

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

Other special population
Patients with renal impairment may have a potential risk of hyperphosphatemia, nephrolithiasis, and nephrocalcinosis.

Reporting of side effects
If you experience any side effect, 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 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 RILISCAL

• 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 shelf life of the product after first opening the bottle is 30 days.
• 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What RILISCAL contains

• The active substances are: calcium carbonate 1500 mg, equivalent to 600 mg of calcium, and colecalciferol (vitamin D3) 2,000 IU, equivalent to 0.050 mg.

• The other components are: maltodextrins, aspartame (E 951), low-substituted hydroxypropylcellulose (E 463), lactose monohydrate, anhydrous citric acid (E 330), orange flavour (containing flavouring preparations, natural flavouring substances, maltodextrin and dextrin), stearic acid, DL-α-tocopherol (E 307), partially hydrogenated soybean oil, gelatin, sucrose, corn starch.

Description of the appearance of RILISCAL and contents of the pack
RILISCAL is an orodispersible tablet, white to almost white, rounded in shape with bevelled edges. Packaged in a bottle containing 30 tablets.
Multipacks contain 60 tablets (2 packs of 30) orodispersible tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
EFFIK ITALIA S.p.A. – Via dei Lavoratori, 54 – 20092 Cinisello Balsamo (MI)
Tel. +39 02 66049189
Fax. +39 02 61770358
www.effikitalia.it

Manufacturer
ITALFARMACO S.p.A. – Viale F. Testi, 330 – 20126 Milano.

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Riliscal 600 mg/2,000 IU orodispersible tablets
Spain: Cadelius D 600 mg/2,000 IU buccodispersible tablets
France: Cadelius 600 mg/2,000 IU orodispersible tablets
Portugal: Riliscal 600 mg + 2,000 IU orodispersible tablets
Greece: CADELIUS 600 mg + 2,000 I.U. δισκία διασπειρόμενα στο στόμα

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