NOTICE
ANSM - Last updated: 01/06/2017
Name of the medicinal product
CALCIUM ARROW 500 mg, sucked tablet
Calcium
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is CALCIUM ARROW 500 mg, tablet to suck and in which cases it is used?
2. What should I know before taking CALCIUM ARROW 500 mg, tablet to suck?
3. How to take CALCIUM ARROW 500 mg, tablet to suck?
4. What are the possible side effects?
5. How to store CALCIUM ARROW 500 mg, tablet to suck?
6. Package contents and other information.
1. WHAT IS CALCIUM ARROW 500 mg, sucked tablet AND WHAT IT IS USED FOR?
CALCIUM / ELEMENT MINERAL
(A: digestive system and metabolism)
This medicine contains calcium. It is indicated :
· in case of calcium deficiency following an increase in needs (growth, pregnancy, breastfeeding);
· in supportive treatment of bone decalcifications in the elderly, or after menopause, corticosteroids, prolonged immobilization after resumption of mobility.
2. BEFORE YOU TAKE CALCIUM ARROW 500 mg, tablet to suck?
Never take CALCIUM ARROW 500 mg, tablet to be sucked in the following cases:
· antecedent of allergy to one of the constituents,
· hypercalcemia (abnormally high levels of calcium in the blood),
· hypercalciuria (exaggerated elimination of calcium in the urine),
· calcium lithiasis (renal calculus),
· tissue calcifications,
· prolonged immobilisation accompanied by hypercalcemia and / or hypercalciuria: calcium should be administered only at the resumption of mobility,
· phenylketonuria (hereditary disease due to enzymatic deficiency), due to the presence of aspartame.
Warnings and Precautions
Talk to your doctor or pharmacist before taking CALCIUM ARROW 500 mg, tablet to suck .
Use this medicine with caution in case of prolonged treatment or renal insufficiency: it is necessary to have the calcium level in the urine and in the blood.
Excessive calcium intake can be dangerous. DO NOT USE THIS MEDICINE WITHOUT MEDICAL ADVICE.
Due to the presence of lactose, this medication should not be used in patients with galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency (rare metabolic diseases).
Due to the presence of sorbitol, this medication should not be used in cases of intolerance to fructose (hereditary metabolic disease).
Children and Youth
Reserved for children over 6 years of age.
Other medicines and CALCIUM ARROW 500 mg, sucked tablet
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including digitalis, cyclines, bisphosphonates, estramustine, iron salts, and thiazide diuretics, even if they are of a non-prescription drug.
CALCIUM ARROW 500 mg, tablet to suck with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
In case of deficiency, your doctor may prescribe this medication during pregnancy or lactation.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
CALCIUM ARROW 500 mg, sucking tablet contains lactose monohydrate, aspartame, and sorbitol.
3. HOW TO TAKE CALCIUM ARROW 500 mg, sucked tablet?
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.
Adults: 2 to 3 tablets to suck per day.
Child from 6 to 10 years: 1 tablet to suck per day.
Child over 10 years: 2 tablets to suck per day.
Administration mode
Oral use.
The tablets are to be sucked.
If you take more than CALCIUM ARROW 500 mg, tablet to suck you should not have
Immediately consult your doctor or pharmacist.
If you forget to take CALCIUM ARROW 500 mg, tablet to suck
Do not take a double dose to make up for a missed dose.
If you stop taking CALCIUM ARROW 500 mg, tablet to suck
Not applicable.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Digestive disorders such as constipation, flatulence, nausea.
· In case of prolonged treatment at high doses: risk of modification of the calcium level in blood or urine.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE CALCIUM ARROW 500 mg, sucked tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the vial after EXP. The expiry date refers to the last day of that month.
No special storage conditions.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What CALCIUM ARROW 500 mg contains, sucked tablet
· The active substance is:
Calcium element ................................................ .................................................. ..... 500.00 mg
In the form of calcium carbonate ............................................ ............................ 1250.00 mg
For a tablet to suck.
· The other ingredients are: xylitol, povidone K 30, lactose monohydrate, aspartame, levomenthol, mint flavor, talc, magnesium stearate.
What is CALCIUM ARROW 500 mg, tablet to suck and contents of the pack
This medication is in the form of a tablet to be sucked. Box of 60.
Marketing Authorization Holder
ARROW GENERICS
26 AVENUE TONY GARNIER
69007 LYON
Marketing Authorization Operator
ARROW GENERICS
26 AVENUE TONY GARNIER
69007 LYON
Maker
MACORS LABORATORIES
ZI PLAINE DES ISLES
RUE DES CAILLOTTES
89000 AUXERRE
or
GALIEN LPS
98 RUE BELLOCIER
89100 SENS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).