Microsoft word - caltrate plus proposed combined pil clean.doc

Product Name: CALTRATE® PLUS (Complementary Medicine)
HCR: Pfizer Laboratories (Pty) Ltd
Dosage form: Film-coated and chewable tablets

PROPOSED PATIENT INFORMATION LEAFLET
This leaflet tells you about CALTRATE® PLUS.
Read the contents of this leaflet carefully before you start using CALTRATE® PLUS,
because it contains important information for you.
CALTRATE® PLUS is available without a doctor’s prescription. Nevertheless you still need to
take CALTRATE® PLUS carefully to get the best results from it.
Keep this leaflet. You may need to read it again. Ask your doctor, pharmacist or other
healthcare professional if you need more information or advice.
NAME OF THIS PRODUCT
CALTRATE® PLUS film-coated tablets
CALTRATE® PLUS chewables

WHAT CALTRATE® PLUS CONTAINS:

CALTRATE® PLUS is a calcium supplement, formulated with essential bone friendly minerals
to help prevent osteoporosis. The active substances are as follows:
CALTRATE® PLUS film coated tablets
Active ingredient
Each tablet contains
% NRV for person 4
years and over **

CALTRATE® PLUS Chewables
Active ingredient
Each tablet contains
% NRV for person
4 years and over **
*1500 mg calcium carbonate = 600 mg elemental calcium. ** According to the nutrient reference value. Regulations published 1 March 2010 *** NRV not established
Product Name: CALTRATE® PLUS (Complementary Medicine)
HCR: Pfizer Laboratories (Pty) Ltd
Dosage form: Film-coated and chewable tablets
Nutritional
Per film-coated
Per chewable
information
*Value shows glucose, lactose and sucrose.
Each chewable tablet contains 1,9 g dextrose (sugar). Not suitable for diabetics.
Potential allergens. No known allergens
Minerals added to CALTRATE® PLUS film-coated tablets as: Calcium carbonate, cupric
sulphate, magnesium carbonate, magnesium oxide, manganese sulphate and zinc oxide.
Minerals added to CALTRATE® PLUS chewables as: Calcium carbonate, cupric oxide,
magnesium oxide, manganese sulphate, sodium borate and zinc oxide.
The inactive ingredients for CALTRATE® PLUS film-coated tablets are: microcrystalline
cellulose, magnesium stearate, croscarmellose sodium, opadry pink, hydroxypropyl
methylcellulose, hypromellose, polysorbate, titanium dioxide, triacetin, maize starch, DL-alpha
tocopherol, medium chain triglycerides, sucrose, modified food starch, silicon dioxide and
sodium ascorbate.
The inactive ingredients for CALTRATE® PLUS chewables are: dextrose (1,9 g per tablet),
magnesium stearate, adipic acid (Adipure), maltodextrin, cellulose, mineral oil, hydroxypropyl
methylcellulose, stearic acid, crospovidone, gelatin (bovine), sucrose, corn starch, vegetable
oil, DL-alpha-tocopherol, modified food starch, flavourants (cherry/fruit punch/orange) and
colourants (red/purple/blue/yellow)
WHAT CALTRATE® PLUS IS USED FOR:

CALTRATE® PLUS is a supplement containing calcium, vitamin D and minerals.
There is an increased demand for calcium during teenage growth, pregnancy, lactation and
from the peri-menopausal period onwards and patients may not receive adequate calcium in
their diets.
Vitamin D assists the body to utilise calcium. Zinc, copper & manganese help certain body
enzymes and regulators to function properly to form the structure for bone strength. Studies
suggest that magnesium may improve bone mineral density. Boron may enhance calcium
absorption.
Healthy bone is made of 2/3 calcium and 1/3 collagen. Collagen provides a soft framework,
and calcium adds strength and hardens the framework. This combination makes the bone
strong and flexible, and can help to absorb impact.

Product Name: CALTRATE® PLUS (Complementary Medicine)
HCR: Pfizer Laboratories (Pty) Ltd
Dosage form: Film-coated and chewable tablets

Calcium supplements are used as part of the prevention and treatment of osteoporosis, a
disease where bone mass and density is decreased putting the bones at risk for fractures.
Osteoporosis mostly affects middle-aged and older persons, especially those with a family
history of fragile bones. Regular exercise and a healthy diet, that includes calcium, builds and
maintains good bone health and may reduce the risk of osteoporosis later in life. Recent data
has shown postmenopausal women can benefit from greater calcium intake. While adequate
calcium intake is important, daily intakes above 2000 mg are not likely to provide any
additional benefit.
BEFORE YOU TAKE CALTRATE® PLUS:

Do not take CALTRATE® PLUS:
If you are allergic (hypersensitive) to the active ingredients or any of the excipients. If you have greater than normal amounts of calcium in the blood or urine (possibly caused by an overactive parathyroid gland, Vitamin D overdosage or certain types of tumours). If you have kidney problems or a history of kidney stones. If you have sarcoidosis (inflammatory disease of the lymph nodes and other organs) or milk-alkali syndrome (caused by excessive intake of milk and antacids). If you are diabetic, take the film coated tablets and not the chewable tablets.
Take special care with CALTRATE® PLUS:
If are suffering from dehydration, diarrhoea, or an electrolyte imbalance If you have chronic stomach or intestinal problems. Allow a three hour interval between taking CALTRATE® PLUS and some antibiotics
(oral tetracyclines and fluoroquinolones), fluoride and bisphosphonates (medicines
used to treat high calcium levels in the blood)
Avoid taking high doses of Vitamin D or Vitamin A while taking CALTRATE® PLUS.

Taking CALTRATE® PLUS with food and drink:
CALTRATE® PLUS must be taken one to one and half hours after meals with a full glass of
water or juice. The chewable tablet should be chewed completely before swallowing with a full
glass of water or juice.
Do not take CALTRATE® PLUS within one to two hours of eating large amounts of fibre-
containing foods such as bran, whole-grain cereals or breads.

Pregnancy and Breastfeeding:
CALTRATE® PLUS may be taken at the recommended doses in pregnancy and
breastfeeding (see section, ‘How to take CALTRATE PLUS’).
Taking other medicines with CALTRATE® PLUS:
You can take CALTRATE® PLUS with your daily multivitamin. Consult your healthcare
professional for advice if your multivitamin contains high quantities of calcium or vitamin D. If
you are taking other medicines on a regular basis, including complementary or traditional
medicines, the use of CALTRATE® PLUS with these medicines may cause undesirable
interactions. Please consult your healthcare professional for advice.

Product Name: CALTRATE® PLUS (Complementary Medicine)
HCR: Pfizer Laboratories (Pty) Ltd
Dosage form: Film-coated and chewable tablets
Tell your doctor or pharmacist if you are taking any of the following medicines: Thiazide diuretics (medicines to increase excretion of water), as they may increase the amount of calcium in your body Digitalis glycosides or calcium channel blockers (heart medicines), as they may cause more side effects if you take too much calcium. Antibiotics (tetracyclines or fluoroquinolones) should be taken 2 hours before, or 4 – 6 hours after Caltrate Plus, as the amount if antibiotic absorbed may be reduced. Medicines to treat high blood calcium levels e.g. bisphosphonates, cellulose sodium phosphate, potassium and sodium phosphates should be taken at least 3 hours before or after Caltrate Plus as the amount absorded may be reduced. Calcitonin (medicine used to treat high bone turnover such as Paget’s disease of the bone) Corticosteroids e.g. cortisone, prednisone containing medicines as they may reduce the amount of calcium in your blood. Other medicines containing calcium, magnesium, Vitamin A or Vitamin D containing supplements / medicines as this may increase the level of calcium in your blood.
HOW TO TAKE CALTRATE® PLUS:
Always take CALTRATE® PLUS exactly as instructed. You should check with your health
care professional if you are unsure.
The usual dose is one CALTRATE® PLUS film-coated tablet or chew tablet per day, unless
your doctor prescribes a different dose.
CALTRATE® PLUS tablets must be taken 1 to 1½ hours after meals with a full glass of water
or juice. The chewable tablets should be chewed completely before swallowing with a full
glass of water or juice.
Do not take the tablets within 1 to 2 hours of eating large amounts of high fibre foods such as
bran and whole-grain cereals or breads.
CALTRATE® PLUS film-coated tablets are suitable for use in diabetics and patients with
lactose intolerance.
CALTRATE® PLUS chewable tablets contains 1,9 g of Dextrose, as well as other sugars,
therefore should be avoided by diabetics.
Do not exceed the recommended dose.
If you have the impression that the effect of CALTRATE® PLUS is too strong or too weak, talk
to your doctor or pharmacist.
If you take more CALTRATE® PLUS than you should:
In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek
help at the nearest hospital or poison control centre.
Early signs of overdose include: severe constipation; dry mouth; continuing headache;
increased thirst; irritability; loss of appetite; mental depression; metallic taste; unusual
tiredness or weakness.
Late signs of overdose include: confusion, drowsiness, high blood pressure, increased
sensitivity of eyes or skin to light, irregular, fast or slow heartbeat, nausea and vomiting,
unusually large amount of urine or increased frequency of urination.

Product Name: CALTRATE® PLUS (Complementary Medicine)
HCR: Pfizer Laboratories (Pty) Ltd
Dosage form: Film-coated and chewable tablets

If you forget to take CALTRATE® PLUS:
Take the missed dose as soon as possible and then go back to your regular dosing schedule.
Do not take a double dose to make up for forgotten individual doses.
POSSIBLE SIDE EFFECTS:
CALTRATE® PLUS can have side effects.
Frequent:
Metallic taste, constipation, nausea and vomiting, diarrhoea. Stomach cramps, increased thirst, raised calcium levels in the blood, alkalosis, and kidney stones, Milk-alkali syndrome, difficult or painful urination, frequent urge to urinate, drowsiness. Belching, muscle weakness, increased calcium levels in the urine
Note not all side effects reported for this medicine are included in this leaflet. Should your
general health worsen while taking this medicine, please consult your healthcare professional
for advice.
STORING AND DISPOSING OF CALTRATE® PLUS:
Keep out of the reach and sight of children.
Store CALTRATE® PLUS film coated tablets at or below 25 °C.
Store CALTRATE® PLUS chew tablets at or below 25 °C.
Store in the original container and keep the container tightly closed to protect from moisture.
Do not store in the bathroom.
Do not use after the expiry date stated on the label.
Do not dispose of unused CALTRATE® PLUS in drains or sewerage systems (e.g. toilets).
Return all unused CALTRATE® PLUS to your pharmacist.
PRESENTATION OF CALTRATE® PLUS:

CALTRATE® PLUS film-coated tablets are packed in white plastic bottles with a white plastic
flat top screw cap in counts of 30, 60 or 90 tablets into a carton.
The container is sealed with a tamper-evident foil for your safety.
Do not use if the foil is broken.
CALTRATE® PLUS chewable tablets are packed in white plastic bottles with a white plastic
flat top screw cap in counts of 60 tablets into a carton.
The container is sealed with a tamper-evident foil for your safety.
Do not use if the foil is broken.

Product Name: CALTRATE® PLUS (Complementary Medicine)
HCR: Pfizer Laboratories (Pty) Ltd
Dosage form: Film-coated and chewable tablets

IDENTIFICATION OF CALTRATE® PLUS:

CALTRATE® PLUS film-coated tablets are oval shaped light pink tablets engraved on one
side with a “+” on the left side and “P4” on the right side of the bisect and “CALTRATE” on the
other side.
CALTRATE® PLUS chewable tablets have 3 assorted flavours.
Fruit punch: Purple round tablet, engraved on one side with “600” above the score and “C4” below the score and “CALTRATE PLUS” on the other side. Orange: Orange round tablet, engraved on one side with “600” above the score and “C4” below the score and “CALTRATE PLUS” on the other side. Cherry: Pink round tablet, engraved on one side with “600” above the score and “C4” below the score and “CALTRATE PLUS” on the other side.
NAME AND ADDRESS OF REGISTRATION HOLDER:

Pfizer Laboratories (Pty) Ltd
Co. Reg. No.: 1954/000781/07
85 Bute Lane,
Sandton 2196,
South Africa
Tel: 0860 Pfizer (734 937)
DATE OF PUBLICATION:

May 2013

Source: http://www.caltrate.co.za/files/Caltrate%20Plus%20proposed%20combined%20PIL.pdf