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DIDRONEL PMO TABLETS

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Didronel PMO
®

(etidronate disodium,
calcium carbonate)

VERY IMPORTANT INFORMATION
Read before taking the tablets
Keep this booklet for future reference

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Read all of this leaflet carefully before you start
taking this medicine.
- Keep this leaflet. You may need to read it again.
-  you have any further questions, ask your doctor or
If
pharmacist.
- 
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
-  any of the side effects gets serious, or if you notice any
If
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:

LIVRET DIDRONELPMOAatheonrancepouroinallieucRECTOVERSOP

1. What Didronel PMO is and what it is used for .................................. 5
2. Before you take Didronel PMO ........................................................................ 7
3. How to take Didronel PMO ................................................................................ 10
4. Possible side effects ................................................................................................ 12
5. How to store Didronel PMO .............................................................................. 14
6. Further information .................................................................................................... 15

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1.  HAT DIDRONEL PMO IS AND WHAT IT IS USED
W
FOR
Didronel PMO is a non-hormonal therapy used to treat existing
osteoporosis (a condition where bone mass decreases
and bone brittleness increases) and to prevent bone loss in
postmenopausal women who are at risk of getting osteoporosis.
It is also used to prevent and treat osteoporosis that has been
caused by use of corticosteroid treatment.
Whilst osteoporosis can affect any bone, the spine, wrist and
hip are the most common bones that break. As well as broken
bones, people with osteoporosis may have back pain, develop a
curved back and lose height.
Didronel PMO works directly on your bones to increase bone
density which may reduce the risk of fractures.
Didronel PMO consists of two different types of tablets:
D
•  idronel 400mg Tablets, which contain the active ingredient
etidronate disodium. These help stop the destructive process
that weakens your bones when you have osteoporosis.

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•  acit 500mg Effervescent Tablets, which contain calcium
C
carbonate as the active ingredient (when dispersed in water
provide 500mg of elemental calcium in the form of calcium
citrate). These provide the calcium that your body may need
to harden new bone.

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2. BEFORE YOU TAKE DIDRONEL PMO
DO NOT take Didronel PMO if you:
•  ave an allergy (hypersensitivity) to etidronate disodium or
h
any of the other ingredients of Didronel PMO (see Section 6
on “What Didronel PMO contains”)
• f you are under dental treatment or will undergo dental
I
surgery, tell your dentist that you are being treated with
Didronel PMO.
•  ave a high concentration of calcium in your blood
h
(hypercalcaemia) or urine (hypercalciuria)
• have severe kidney impairment
• have osteomalacia (a disease in which the bones soften)
• are pregnant, think you might be pregnant or are breast-feeding.
Children must NOT be given Didronel PMO.
Patients with an intolerance to fructose (sugar found in many
foods) should not take the medicine.
Take special care with Didronel PMO
Consult your doctor before taking this medicine if you have:
• impaired kidney function or kidney stones, now or in the past
•  owel problems such as enterocolitis (inflammation of the
b
large and small intestine)

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•  ain, swelling or numbness of the jaw or a ‘heavy jaw feeling’
p
,
or loosening of a tooth (if you are undergoing dental surgery,
tell your dentist that you are being treated with Didronel).
•  he diagnostic utility of bone-imaging agents may be impaired
T
by current or recent etidronate use.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any
other medicines, including those obtained without a prescription.
The following should NOT be taken two hours before or after
taking a Didronel tablet:
• vitamins with mineral supplements, such as iron
• calcium supplements
• laxatives containing magnesium
• antacids containing calcium or aluminium.
Your doctor also needs to know if you are taking the anticoagulant
‘warfarin’ before Didronel PMO is prescribed.
Seek medical advice before taking the Cacit tablets if you are taking:
• vitamin D
• heart medicines such as digoxin and other cardiac glycosides
• tetracycline antibiotics.

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Pregnancy and breast-feeding
It is important not to become pregnant whilst taking Didronel
PMO, so adequate contraceptive measures need to be taken
where necessary. It is not known if etidronate disodium (the
active ingredient in the white tablet) passes into breast milk. This
medicine should therefore not be taken during breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Didronel PMO is not expected to affect your ability to drive or
operate machinery.
Important information about some of the ingredients of
Didronel PMO
Sunset yellow FCF (colouring E110) - this may cause allergic
reactions, including asthma. Allergy is more common in those
people who are allergic to aspirin.
Sorbitol - if you know you have an intolerance to some sugars,
contact your doctor before taking this medicine.

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3. HOW TO TAKE DIDRONEL PMO
Step I) Didronel tablets
Swallow one white Didronel tablet with plain water (NOT with
milk or other drinks) each day for 14 days on an empty stomach.
Dairy products and other foods containing calcium can stop
your Didronel PMO from being absorbed properly. You should
not eat or drink anything but water for at least two hours before
and two hours after taking the tablet (i.e. take the tablet in the
middle of a 4-hour fast).
Step II) Cacit tablets
Once you have finished taking the Didronel tablets for 14
consecutive days, take one Cacit tablet each day for the next 76
days – with or without food. These tablets need to be dissolved
in water or milky drinks and the solution consumed immediately
after the fizzing has stopped.
One treatment pack contains all these tablets and will last for 90 days.
Do NOT take a Didronel tablet and a Cacit tablet on the same
day; the therapy is in two steps and should be followed as
directed above. It will take some time for this medicine to have

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a full effect on your bones. Stay on the therapy for as long
as your doctor has prescribed it for you. Do not forget to get
a prescription for another pack of Didronel PMO from your
doctor’s surgery when this one is nearly finished.
Didronel PMO therapy is not recommended for children.
If you take more Didronel PMO than you should
Do not exceed the recommended dose.
If you take more than one Didronel tablet in one day, inform your
doctor immediately or go to your nearest Accident & Emergency
Department (take the box with you if possible).
If you take more than one Cacit tablet in a day, check with your
doctor before continuing treatment.
If you forget to take Didronel PMO
If you forget to take either a Didronel or Cacit tablet, skip that
dose completely and continue on the next day as usual. Do NOT
take a double dose to make up for the one you have forgotten.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Didronel PMO can cause side effects,
although not everybody gets them.
You may suffer an allergic reaction, symptoms of which may
include skin rash, itching, swelling of the face and tongue as
well as difficulty breathing. If this happens to you, stop taking
the medicine immediately and seek urgent medical help.
Common side effects:
• nausea (feeling sick)
• diarrhoea
• constipation or wind
• indigestion, stomach pain or irritation
• vomiting.
Uncommon side effects:
•  ypersensitivity including fluid retention in the skin (angioedema)
h
Rare side effects:
• sensory disturbances (paresthesia)
• worsening of asthma for those who suffer from it
• confusion
• burning of the tongue

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• hair loss
•  lood cell count abnormalities which will be seen in the
B
results of the blood tests
•  ed blotches which may include red spots on the skin
r
(erythema multiforme)
• headache
• ingling sensation (“pins and needles”) typically in the arms or
t
legs
• joint problems such as arthritis or joint pain
• mild leg cramps.
Very rare side effects:
•  steonecrosis of the jaw (see section 2 “Take special care
O
with Didronel PMO”).
A few people with stomach ulcers may notice that these get
worse with Didronel treatment.
If you are unable to overcome an infection or experience a sore
throat, fever and bruising, contact your doctor as you may need
a blood test.
Unusual fracture of the thigh bone particularly in patients on
long-term treatment for osteoporosis may occur rarely. Contact

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your doctor if you experience pain, weakness or discomfort in
your thigh, hip or groin as this may be an early indication of a
possible fracture of the thigh bone.
If any of the side effects gets serious, or if your notice any
side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE DIDRONEL PMO
Keep out of the reach and sight of children.
Store the product in a dry place, below 30°C.
The stopper on the tube of the Cacit tablets should be carefully
replaced after use.
Do not use Didronel PMO after the expiry date which is stated
on the label after ‘Exp’ The expiry date refers to the last day of
.
that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

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6. FURTHER INFORMATION
What Didronel PMO contains
•  idronel tablet – the active substance is etidronate disodium
D
400mg and other ingredients are pregelatinised starch (nonwheat starch), magnesium stearate and microcrystalline
cellulose.
•  acit tablet – the active substance is calcium carbonate
C
500mg and other ingredients are citric acid, sodium
saccharin, sodium cyclamate, sunset yellow (E110) and
orange flavouring (containing Sorbitol E420). See section 2
on “Important information about some of the ingredients of
Didronel PMO”
.
What Didronel PMO looks like and contents of the pack
The product consists of two different types of tablets: 14 white
Didronel tablets packaged in a blister pack and 76 round,
and flat white/pink speckled Cacit 500mg effervescent tablets
packaged in four plastic tubes.

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Marketing Authorisation Holder
Warner Chilcott UK Limited
Old Belfast Road
Millbrook, Larne
County Antrim
BT40 2SH
United Kingdom.
Manufacturer
Warner Chilcott France
Parc d’activité de la Grande Brèche
5 rue Désir Prévost
91070 Bondoufle
France.

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Didronel® is a registered Trademark
Marketing Authorisation Number: PL 10947/0019
The leaflet was last revised in February 2011

PL Number:


POM

LIVRET DIDRONELPMOAatheonrancepouroinallieucRECTOVERSOPG

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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