CALCIGRAN FORTE 500MG EXTRA D N60

ATC code: A12AX 

Active substances: Calcium, Colecalciferolum

Vendor, principal: Nycomed Sefa As. 

 Prescription drug (℞) 

CALCIGRAN FORTE RED 500MG/+1000RÜ N60

Package leaflet: Information for the user Calcigran Forte Red 500 mg / 1,000 IU chewable tablets

calcium/cholecalciferol (vitamin D3)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Calcigran Forte Red is and what it is used for

Calcigran Forte Red are chewable tablets that contain calcium and vitamin D3, both of which are important substances in the formation of bones.
Calcigran Forte Red is used to prevent and treat calcium and vitamin D deficiency, as well as for the specific treatment of osteoporosis (loss of bone density).

2. What you need to know before you use Calcigran Forte RedDo not take Calcigran Forte Red 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 severe kidney disease ;
-   if you have kidney stones ;
-   if you have high vitamin D levels in the blood
-   if you have high levels of calcium in the blood or urine.

Warnings and precautions

Talk to your doctor or pharmacist before using Calcigran Forte Red.
-   if you use the medicine for a long time, especially if you are using diuretics (used to treat high blood pressure and swelling) or cardiac glycosides (used to treat cardiac disorders) at the same time;
-   if you have impaired renal function;
-   if you have sarcoidosis (immune system disorders which may cause vitamin D levels to rise in your body);
-   if you have osteoporosis and you are also immobile;
-   if you are taking other preparations that contain vitamin D. Additional consumption of calcium and vitamin D must be carried out under a doctor’s supervision.

Children and adolescents

Calcigran Forte Red chewable tablets are not intended for use in children or adolescents.

Other medicines and Calcigran Forte Red

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are also taking tetracycline (antibiotic), you should take it at least 2 hours before or 4-6 hours after taking Calcigran Forte Red. Calcium carbonate may hinder the absorption of medicines, which contain tetracycline, taken at the same time.
Medicines that contain bisphosphonates (used to treat osteoporosis) should be taken at least 1 hour before taking Calcigran Forte Red.
Calcium may decrease the effect of levothyroxine (used to treat thyroid deficiency). Therefore, levothyroxine should be taken at least 4 hours before or 4 hours after taking Calcigran Forte Red.
The effect of quinolone antibiotics may be reduced if these are taken at the same time as calcium. Take quinolone antibiotics at least 2 hours before or 6 hours after taking Calcigran Forte Red.
Calcium salts may reduce the absorption of iron, zinc and strontium ranelate. Therefore, preparations containing iron, zinc or strontium ranelate should be taken at least 2 hours before or after taking Calcigran Forte Red.
Treatment with orlistat (an anti-obesity medicine) may reduce the absorption of fat-soluble vitamins (e.g. vitamin D3).
Other medicines that may affect or be affected by Calcigran Forte Red are:
-   thiazide diuretics (used to treat hypertension or swelling);
-   cardiac glycosides (used to treat heart diseases).
If you are taking any of the listed medicines, ask your doctor for specific instructions about using this medicine.

Calcigran Forte Red with food and drink

Calcigran Forte Redmay be taken with or without food and drink.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Calcigran Forte Red may be used during pregnancy if you have calcium or vitamin D deficiency. You must not take more than 2,500 mg of calcium and 4,000 IU of vitamin D daily during pregnancy, as overdosing may harm your unborn baby.
Calcigran Forte Red tablets may be used during breast-feeding. Calcium and vitamin D are excreted into breast milk, which must be considered if additional vitamin D is given to the infant.

Driving and using machines

Calcigran Forte Red has no known effect on the ability to drive and operate machinery.

Calcigran Forte Red contains aspartame, sorbitol and sucrose

Calcigran Forte Red contains aspartame (E951), source of phenylalanine. It may be harmful for patients with phenylketonuria.
Calcigran Forte Red contains sorbitol (E420) and sucrose. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to use Calcigran Forte Red

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Dosage:
The recommended dose is one tablet once a day. The tablets may be chewed or sucked.

Use in children and adolescents

Calcigran Forte Red is not intended for use in children and adolescents.

If you take more Calcigran Forte Red than you should

If you have taken more Calcigran Forte Red than prescribed, talk to your doctor or pharmacist immediately.

If you forget to take Calcigran Forte Red

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions have occurred with unknown incidence (it cannot be estimated based on available data). If you get the following symptoms, talk to your doctor immediately: swelling of the face, tongue, lips (angioedema) or throat (laryngeal oedema).
Uncommon side effects (may affect up to 1 user in 100)
Large doses can raise the calcium levels in the blood or urine (hypercalcaemia or hypercalciuria).
Rare side effects (may affect up to 1 user in 1,000)
Constipation, dyspepsia (indigestion), flatulence, nausea, stomach pain and diarrhoea.
Very rare side effects (may affect up to 1 user in 10,000)
Itching, rash and hives. Milk-alkali syndrome (also referred to as the Burnett’s syndrome and usually expressed only after administering a large dose of calcium), the symptoms of which include a frequent need to urinate, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, an increase in the calcium levels in the blood, and renal impairment.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Calcigran Forte Red

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the package. The expiry date refers to the last day of that month.
Do not store at a temperature higher than 30 °C. Store in the original package, protected from light. Keep the bottle tightly sealed to protect it from moisture.
After the initial opening of the bottle, use the medicine within 60 days.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Calcigran Forte Red contains

-   The active substances in a single tablet are:
-   1,250 mg of calcium carbonate (corresponding to 500 mg of calcium),
-   1,000 IU (25 micrograms) of cholecalciferol (vitamin D3).
-   The other ingredients are sorbitol (E420), povidone, flavouring (strawberry and water melon), maize maltodextrin, glyceryl triacetate (E1518), citric acid esters of mono- and diglycerides of fatty acids, magnesium stearate, aspartame (E951), all-rac-alpha-tocopheryl, sucrose, modified maize starch, medium chain triglycerides, sodium ascorbate and colloidal anhydrous silica.

What Calcigran Forte Red looks like and contents of the pack

Calcigran Forte Red are white and round chewable tablets with a diameter of 16 mm. The pills may have tiny spots.
Pack sizes:
HDPE jar with an HDPE screw cap: 30, 60, 90, 100, and 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation
Holder:
Takeda Pharma AS Jaama 55B 63308 Pölva Estonia
Manufacturers:
Takeda AS Drammensveien 852,
NO-1383 Asker Norway
or
Takeda Pharma AS Jaama 55B 63308 Pölva Estonia

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium:
Czech Republic: Estonia:
Finland: Lithuania: Luxembourg: The Netherlands: Slovakia:
Spain:
Sweden:

Steovit D3 aardbei/watermeloen 500 mg/1000 I.E. kauwtabletten Calcichew D3 Jahoda 500 mg/ 1000 IU žvykaci tablety Calcigran Forte Red
Calcichew D3 Opti mansikka-meloni 500 mg/25 mikrog Calcigran Forte 500 mg/1000 TV kramtomosios tabletes Steovit D3 fraise/pasteque 500mg/1000UI comprimes a croquer Calci-Chew D3 500 mg/1000 I.E. aardbei/watermeloen kauwtabletten Calcichew D3 Jahoda-Melon 500mg/1000IU žuvacie tablet Mastical D 500 mg/1000 UI comprimidos masticables sabor fresa Calcichew-D3 Melon 500 mg/1000 IE tuggtabletter

This leaflet was last revised in January 2017