Calcial D 600 mg/400 IU chewable tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Calcial D 600 mg/400 IU chewable tablets
calcium / colecalciferol (vitamin D3)
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse reactions, talk to your doctor or pharmacist, even if the adverse reactions are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Calcial D is and what it is used for
- What you need to know before taking Calcial D
- How to take Calcial D
- Possible side effects
- How to store Calcial D
- Contents of the pack and other information
1. What Calcial D is and what it is used for
Calcial D is a calcium and vitamin D supplement.
Calcial D is indicated for the treatment of calcium and vitamin D deficiency states. It may also be used as a supplement in the treatment of osteoporosis in patients with evident calcium and vitamin D deficiency or at high risk of developing such deficiency.
2. What you need to know before taking Calcial D
Do not take Calcial D:
- If you are allergic to calcium carbonate, vitamin D3, or any of the other ingredients of this medicine (listed in section 6).
- If you have kidney stones.
- If you have severe renal insufficiency.
- If you have high levels of calcium in your blood or urine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Calcial D.
If you suffer from any of the following conditions, remember to always inform your doctor before taking this medicine:
- If you are taking other products containing vitamin D, you must inform your doctor, as you should stop taking them.
- If you have sarcoidosis (a granulomatous disease affecting various organs, including the skin, which may be associated with elevated blood calcium levels).
- If you have renal insufficiency or a tendency to form kidney stones.
- If you have any heart disease.
Consult your doctor, even if any of the above circumstances occurred in the past.
Children
The safety and efficacy of Calcial D have not been established in children, so its use is not recommended in this age group.
Other medicines and Calcial D
Taking Calcial D with other medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Calcial D may interact with the following medicines:
- Cardiac glycosides, such as digoxin.
- The following antibiotics: tetracyclines, penicillin, neomycin, chloramphenicol.
- Certain diuretics: loop diuretics (furosemide, ethacrynic acid) and thiazide diuretics (hydrochlorothiazide).
- Antacids containing aluminium salts.
- Thyroid hormones.
- Cholestyramine.
- Corticosteroids.
- Mineral oils.
- Phenytoin.
- Barbiturates.
- Bisphosphonates.
- Sodium fluoride.
Taking Calcial D with food, drinks and alcohol
If you take Calcial D chewable tablets together with foods containing oxalates (cabbage, spinach, chocolate), phosphates (red meat), or phytic acid (wholemeal bread, cereals), interactions may occur; therefore, it is recommended not to take Calcial D with meals.
During treatment with Calcial D, you should not consume foods that may be "fortified" with vitamin D.
Pregnancy, breast-feeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Talk to your doctor or pharmacist before taking any medicine.
Your doctor will assess whether treatment is appropriate for you.
The use of Calcial D is not recommended during pregnancy or breast-feeding.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Calcial D contains aspartame. This medicine contains 5 mg of aspartame per dose unit. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
Calcial D contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
Calcial D contains sorbitol. This medicine contains 600 mg of sorbitol per dose unit. Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with an intolerance to certain sugars, or with hereditary fructose intolerance (HFI), a rare genetic disorder in which fructose cannot be broken down, you (or your child) should consult your doctor before taking this medicine.
3. How to take Calcial D
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Adults and elderly patients
The recommended dose is 1 to 2 tablets per day.
Your doctor will determine the duration of your treatment with Calcial D. Do not stop treatment earlier, as the desired effect will not be achieved.
Method of administration:
Calcial D chewable tablets are for oral use. Chew the Calcial D tablets, and then drink a little water if desired.
Alternatively, 1 or 2 tablets may be dispersed in half a glass of water and immediately ingested.
If you feel that the effect of Calcial D is too strong or too weak, inform your doctor or pharmacist.
If you take more Calcial D than you should
If you have taken more Calcial D than you should, consult your doctor or pharmacist immediately.
In case of overdose, you may experience thirst, nausea, vomiting, dehydration, increased frequency of urination, and constipation.
In case of overdose or accidental ingestion, contact the Toxicology Information Service: Telephone 91 562 04 20.
If you forget to take Calcial D
Do not take a double dose to make up for missed doses.
If you forget to take a dose, take the next dose as soon as possible and continue as before.
If you stop taking Calcial D
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been observed:
Rare (may affect up to 1 in 1,000 people): constipation, flatulence, nausea, abdominal pain, and diarrhoea.
With prolonged administration at high doses, elevated levels of calcium in blood and urine may occur, with symptoms such as loss of appetite, vomiting, nausea, headache, weakness, apathy, and drowsiness. Other more severe symptoms include thirst, dehydration, increased frequency of urination, abdominal pain, and irregular heartbeat.
If you notice any other reaction not described in this leaflet, consult your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines, www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Calcial D
Do not store above 25°C. Keep in the original container.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, after CAD. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Calcial D
- The active substances are calcium (carbonate) and colecalciferol (vitamin D3). Each chewable tablet contains 600 mg of calcium and 400 IU of colecalciferol.
- The other components are: sodium saccharin, sorbitol (E-420), pregelatinized corn starch, magnesium stearate (E-572), sodium croscarmellose, aspartame (E-951), anhydrous lactose, anise flavour, mint flavour and milk flavour.
Appearance of the product and contents of the pack
Calcial D are white chewable tablets with an anise-mint flavour.
They are supplied in polyethylene bottles containing 60 chewable tablets.
Marketing Authorization Holder and Manufacturer
ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.
C/ Sagitario, 14
03006 Alicante (Spain)
Date of the most recent revision of this leaflet: 11/2020
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es