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CALCICHEW FORTE CHEWABLE TABLETS

Active substance(s): CALCIUM CARBONATE / CALCIUM CARBONATE / CALCIUM CARBONATE

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1. Colour:

Calcichew*Forte
1000 mg
60 tablets
6168967
QI000007046
6169052-01
6083707-06
170 x 60
200 ml
UK
5022690031442
513
100%

Black

MOCK-UP

2. Colour PMS: 373

1. proof:

• Braille

24.01.2017

• Size/Die cut:

Graphic:

Thomas W. Hansen

OS:

Mac OS X

Software:

Adobe CC 2014

E-mail:
thomas-westervoll.hansen@takeda.com

forte
5

Each tablet contains 2500mg calcium carbonate
(equivalent to 1 gram calcium). Also includes
isomalt (E953).
Please read the patient information leaflet for
further information.
For oral administration.
Adults, elderly and children: 1 tablet to
be chewed or sucked daily or as
directed by your doctor.
Keep out of the reach and sight
of children.
P
Do not store above 30ºC.
Keep the container tightly closed to
protect from moisture. PL 16189/0024
Takeda UK Ltd. Woobur Green,
BUCKS, HP10 0DF, UK
*Registered Trademark

equivalent to 1g calcium

60 Chewable Tablets

Peel here but do not remove

calcichew
calcium carbonate
chewable
tablets
equivalent to 1g calcium

60 Chewable Tablets

PATIENT INFORMATION LEAFLET

CALCICHEW* FORTE 1000 MG
CHEWABLE TABLETS
calcium carbonate

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must talk to a doctor if you do not feel better or if you feel worse after
two weeks.
- If you get any of the side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Calcichew Forte is and what it is used for

6169052-01

022690 031442

EXP

calcichew
chewable
tablets

calcium carbonate

forte

Use in children
The recommended dose for children is one tablet daily.

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

The tablets can be chewed or sucked.

4. POSSIBLE SIDE-EFFECTS

If you take more than you should

Like all medicines, this medicine can cause side effects, although not everybody
gets them.

If you have taken more Calcichew Forte than you should,talk to your
doctor or pharmacist immediately.
If you accidentally take more Calcichew Forte than you should, you
may have an increase in your blood calcium levels. Symptoms of this
are: excessive thirst, nausea, vomiting, constipation, abdominal pain,
muscle weakness, tiredness, mental disturbances, lack of appetite,
bone pain, having to pass more water than usual, kidney problems
and, in severe cases, irregular heartbeat.
Very rarely in addition: irritability, continuing headache,
lightheadedness, muscle spasms, twitches and tingling sensation.
If you forget to take Calcichew Forte Chewable Tablets
Do not take a double dose to make up for a forgotten tablet.

2. What you need to know before you take Calcichew Forte
3. How to take Calcichew Forte
4. Possible side-effects
5. How to store Calcichew Forte
6. Contents of the pack and other information
1. WHAT CALCICHEW FORTE IS AND WHAT IT IS USED FOR
Calcichew Forte 1000 mg Chewable Tablets are orange flavoured chewable
tablets containing the active ingredient calcium.Calcium is found in the diet and
is an important substance in bone formation.
Calcichew Forte is used to treat and prevent calcium deficiency which may
occur if your diet or lifestyle does not provide enough, or when body
requirements are increased. This medicine may also be prescribed or
recommended for certain bone conditions, for example osteoporosis, or during
pregnancy. It may also be given to patients receiving renal dialysis to remove
the phosphate from the blood that cannot be removed by dialysis.

Stop taking your medicine and see a doctor immediately if you experience
any of the following side effects. These side effects may be a sign of milk-alkali
syndrome (also called Burnett’s Syndrome) that is reported to occur very rarely
(affects less than 1 in 10,000 people):
• Frequent urge to urinate
• Headache
• Loss of appetite, nausea or vomiting
• Unusual tiredness or weakness, along with elevated levels of calcium in the
blood and kidney impairment.
Side effects may include:
Uncommon side effects (may affect up to 1 in 100 people):
• excessive amounts of calcium in your blood (hypercalcaemia) or in your
urine (hypercalcuria) may occur with large doses

Rare side effects (may affect up to 1 in 1,000 people):
• nausea
• diarrhoea
• stomach ache
• wind (flatulence)
• constipation
• heartburn (dyspepsia)
Very rare side effects (may affect up to 1 in 10,000 people):
• rash
• hives
• itching
If you are taking Calcichew Forte Chewable Tablets because you are having
kidney dialysis, tell your doctor if you notice any white deposits on your skin.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of this medicine.
5. HOW TO STORE CALCICHEW FORTE

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW FORTE

Your serum calcium or phosphate levels, or urinary

Do not take Calcichew Forte if you:
• are allergic (hypersensitive) to calcium or any of the other ingredients of this
medicine (listed in section 6)

calcium excretion must be monitored if you have any of



have a condition that causes excess amounts of calcium in your blood or
urine (hypercalcaemia or hypercalciuria)



have kidney stones.

Warnings and precautions
Talk to your doctor or pharmacist before taking Calcichew Forte:


if you have osteoporosis (brittle bones) as a result of being immobile



if you are on long term treatment, especially if you are taking medicines for a
heart disorder (cardiac glycosides), or diuretics (used in the treatment of
high blood pressure or oedema)



if you have signs of impaired kidney function or a high tendency to kidney
stone (calculus) formation



if you have cancer or any other conditions that may have affected your bones.

the following conditions.


kidney problems



you are on long-term treatment with Calcichew



you are already taking additional doses of calcium

If you have increased calcium levels in the blood or
develop signs of kidney problems, the dose of Calcichew

The tablets are round, white, uncoated convex and orange flavoured; they may
have small specks.
The tablets are packed in white, plastic bottles of 60 tablets.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Manufacturer
Takeda AS, Drammensveien 852, N-1385 Asker, Norway..
This leaflet was last revised in December 2016.

What Calcichew Forte Chewable Tablets contain
The active ingredients in each tablet is:
• 2500 mg calcium carbonate (equivalent to 1000mg calcium)
The other ingredients are: xylitol (E967), povidone, isomalt (E953), fatty acid
mono- and di-glycerides, magnesium stearate, orange flavour, sucralose (E955)
(see also end of Section 2 “Calcichew Forte contains isomalt”).
What Calcichew Forte look like and contents of
the pack



thiazide diuretics (water tablets); your serum calcium levels should be
monitored regularly.



cardiac glycosides (heart medicines); you should be monitored by
electrocardiogram (ECG) and your serum calcium levels measured.



tetracycline antibiotics; these should be taken at least two hours before,
or four to six hours afterwards. Calcium carbonate may interfere with the
absorption of tetracycline preparations if taken at the same time.



levothyroxine (hormone used to treat thyroid deficiency); these should be
taken at least four hours before, or afterwards.



quinolone antibiotics (ciprofloxacin, lomefloxacin, norfloxacin,
sparfloxacin): the effect of these medicines may be reduced if taken at the
same time as calcium. Take quinolone antibiotics two hours before or six
hours after taking Calcichew 500 mg

Forte should be reduced or the treatment discontinued.
Other medicines and Calcichew Forte
Tell your doctor or pharmacist if you are taking or have
recently taken or might take any other medicines.
In particular, the following medicines may interact with
Calcichew Forte tablets:

Keep this medicine out of the sight and reach of children. Store in the original
package to protect from moisture. Do not store above 30˚C.
Do not use this medicine after the expiry date which is stated on the label after
EXP. The expiry date refers to the last day of that month.
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 to protect the environment.



bisphosphonates; should be taken at least one hour before Calcichew
500 mg.



Calcium salts may decrease the absorption of iron, zinc and strontium
ranelate. Consequently iron, zinc or strontium ranelate preparations should
be taken at least two hours before or after Calcichew 500 mg

Marketing Authorisation Holder
Takeda UK Ltd. Building 3, Glory Park, Glory Park Avenue, Wooburn Green,
BUCKS, HP10 0DF,
United Kingdom

Additional Information
Calcichew Forte contains calcium designed to keep bones healthy. Calcium is
an essential component of bones.
Requirements for calcium increase with age and, although many people obtain
enough calcium from their diet, some people may require a supplement in order
that their body has all the calcium it needs to maintain healthy bones.
People with diets and lifestyles that mean they will obtain less than the
recommended intake of calcium are at risk of weakened bones. Prolonged lack

Taking Calcichew Forte with food and drink
For treatment of calcium deficiency or use as an additional osteoporosis
therapy, Calcichew Forte can be taken with or without food and drink.
For use as a phosphate binder, Calcichew Forte should be taken just before,
during or just after each meal.
Pregnancy, breastfeeding 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
Calcichew Forte.
During pregnancy the daily intake should not exceed 2500 mg calcium
(including food and supplementation). If you are pregnant, you may use
Calcichew 500 mg in case of a calcium deficiency.
Calcichew Forte can be used during breastfeeding. Calcium passes into breast
milk.
Driving and using machines
Calcichew Forte has no known influence on the ability to drive or use machines.

of adequate calcium intake can lead to the development of osteoporosis, a
condition where bones become weak to a level that minimal trauma (for
example, a fall) can result in a fracture, most typically at the hip, spine or wrist.
Calcichew Forte has been designed to give people, whose intake of calcium is
low, a boost to the recommended amounts.
Maintaining healthy bones and helping to avoid osteoporosis is an important
issue for many people. There are many ways that people can help themselves:
regular exercise, a balanced diet with an adequate intake of calcium and, for
some people, advice on how to prevent falls which may lead to fracture.
The National Osteoporosis Society (NOS) is a national charity dedicated to
improving the diagnosis, prevention and treatment of osteoporosis. The NOS
offers support to people with osteoporosis and raises awareness of the
importance of healthy bones.
If you are concerned about osteoporosis, please contact the National
Osteoporosis Society, Camerton, Bath BA2 0PJ.
Tel: 01761 471 771, Fax: 01761 471 104 or email: info@nos.org.uk.
*Registered Trademark

Calcichew Forte contains isomalt
Calcichew Forte contains isomalt (E953): if you have been
told by your doctor that you have an intolerance to some
sugars, talk to your doctor before taking this medicine. May
be harmful to teeth.
3. HOW TO TAKE CALCICHEW FORTE
Always take 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:
For use as an additional osteoporosis therapy: One tablet daily.
For calcium deficiency: One tablet daily.
As a phosphate binder (for kidney failure patients on dialysis): Your doctor
will decide how many Calcichew Forte Chewable Tablets you need. The label
the pharmacist puts on your medicine will tell you exactly how many tablets to
take.

6169052-01

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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