Bencium 500 mg/800 IE Tuggtablett

Šalis: Švedija

kalba: švedų

Šaltinis: Läkemedelsverket (Medical Products Agency)

Veiklioji medžiaga:

kalciumkarbonat; kolekalciferol

Prieinama:

Consilient Health Limited

ATC kodas:

A12AX

INN (Tarptautinis Pavadinimas):

calcium carbonate; cholecalciferol

Dozė:

500 mg/800 IE

Vaisto forma:

Tuggtablett

Sudėtis:

sackaros Hjälpämne; kolekalciferol 800 IE Aktiv substans; aspartam Hjälpämne; sorbitol Hjälpämne; kalciumkarbonat 1250 mg Aktiv substans; xylitol Hjälpämne; isomalt Hjälpämne

Recepto tipas:

Receptbelagt

Produkto santrauka:

Förpacknings: Burk, 25 tabletter; Burk, 30 tabletter; Burk, 90 (3 x 30) tabletter; Burk, 100 (4 x 25) tabletter

Autorizacija statusas:

Godkänd

Leidimo data:

2019-05-21

Pakuotės lapelis

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENCIUM 500 MG / 800 IU CHEWABLE TABLETS
calcium / colecalciferol (vitamin D
3
)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
- 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 Bencium is and what it is used for
2. What you need to know before you take Bencium
3. How to take Bencium
4. Possible side effects
5. How to store Bencium
6. Contents of the pack and other information
1. WHAT BENCIUM IS AND WHAT IT IS USED FOR
Bencium is a calcium-vitamin D
3
-supplement.
It is used
- to prevent and treat deficiency of calcium and vitamin D in the
elderly.
-
for vitamin D and calcium supplementation as, supportive treatment of
osteoporosis (brittle bones) for
patients who are at risk of vitamin D and calcium deficiency.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENCIUM
DO NOT TAKE BENCIUM
- if you are allergic to calcium, vitamin D or any of the other
ingredients of this medicine (listed in section
6)
- if you have high levels of calcium in your blood (hypercalcaemia)
- if you have high levels of calcium in your urine (hypercalciuria)
- if you suffer from overactive parathyroid glands
(hyperparathyroidism)
- if you suffer from bone marrow cancer (myeloma)
- if you suffer from cancer that has affected your bones (bone
metastases)
-
if you have restriction in movement of the limbs (prolonged
immobilisation) accompanied with
hypercalcaemia and / or hypercalciuria
- if you have kidney stones (nephrolithiasis)
- if you have calcium deposits in your kidneys (nephrocalcinosis)
- if you suffer from an excessive suppl

Prekės savybės

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Bencium 500 mg / 800 IU chewable tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
Calcium carbonate equivalent to 500 mg calcium.
Colecalciferol concentrate (powder form) equivalent to 800 IU (20
micrograms) colecalciferol (vitamin D
3
).
Excipients with known effect:
Each chewable tablet contains 0.5 mg of aspartame (E951), 52 mg of
sorbitol (E420), 185 mg of isomalt
(E953), 1.5 mg of sucrose and 0.01 mg benzyl alcohol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Chewable tablet.
White, round, orange flavoured tablet with a diameter of 18 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bencium is indicated:
- for the prevention and treatment of vitamin D and calcium deficiency
in the elderly
-
as vitamin D and calcium supplement as an adjunct to specific
osteoporosis treatment of patients who
are at risk of vitamin D and calcium deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly_
1 chewable tablet daily (corresponding to 500 mg of calcium and 800 IU
of vitamin D
3
).
For patients receiving treatment for human immunodeficiency virus
(HIV) with HIV integrase inhibitor drugs
(e.g., raltegravir, dolutegravir, elvitegravir), the SmPC of the
particular HIV integrase inhibitor should be
consulted for adequate recommendations regarding coadministration with
calcium (i.e., Bencium) (see section
4.5).
_Paediatric population_
Bencium tablets are not intended for use in children or adolescents.
_Dosage in hepatic impairment_
No dose adjustment is required.
_Dosage in renal impairment_
2
Bencium should be used with caution in patients with impairment of
renal function (see section 4.4). Bencium
should not be used in patients with severe renal impairment (see
section 4.3).
3
Method of administration
Oral use.
Bencium can be taken at any time, with or without food. The chewable
tablets should be chewed and
swallowed.
Attention should be given to a sufficien