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MIACALCIC 200 I.U. NASAL SPRAY SOLUTION

Active substance(s): CALCITONIN (SALMON)

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Package leaflet: Information for the user

Miacalcic®
200 IU nasal spray, solution
Calcitonin (salmon, synthetic)
Read all of this leaflet carefully before you start using
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.
What is in this leaflet:
1. What Miacalcic nasal spray is and what it is used for
2. What you need to know before you use Miacalcic
nasal spray
3. How to use Miacalcic nasal spray
4. Possible side effects
5. How to store Miacalcic nasal spray
6. Contents of the pack and other information

1. What Miacalcic nasal spray is and what it is
used for
Miacalcic nasal spray contains the active substance
calcitonin (salmon, synthetic).
Calcitonin is a hormone that occurs naturally in the body of

both humans and animals. It regulates the level of calcium
in the blood. Calcitonin is used to reverse bone loss and may
also help in bone formation.
Miacalcic nasal spray is used to treat osteoporosis (thin and
weak bones) in women after the menopause to reduce the
risk of spinal fractures.

2. What you need to know before you use
Miacalcic nasal spray
Do not use Miacalcic nasal spray
– if you are allergic to calcitonin (salmon, synthetic) or any of
the other ingredients of this medicine (listed in section 6);
– if you have a very low calcium level in your blood
(hypocalcaemia).
Warning and precautions
Before treatment with Miacalcic nasal spray tell your doctor
if you suspect you may be allergic to calcitonin (salmon,
synthetic). Your doctor will perform a skin test before you
start using Miacalcic nasal spray.
If you have a sore nose, do not start using Miacalcic nasal
spray. Tell your doctor who will examine your nose before you
start using Miacalcic nasal spray.

particularly important to tell your doctor if you are taking
a medicine containing lithium, as the dose of lithium may
need to be changed.
Pregnancy and breast-feeding
Miacalcic nasal spray should not be used in pregnant or
breast-feeding women.
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 any medicine.
Driving and using machines
Miacalcic nasal spray may cause tiredness, dizziness and
disturbed vision which could affect your reactions. If this
happens to you, do not drive or use any machines.
Miacalcic nasal spray contains benzalkonium chloride
Miacalcic nasal spray contains benzalkonium chloride, which
can cause swelling of the inside of your nose, especially with
longterm use. If you notice any nasal congestion, contact
your doctor. Your doctor may decide to prescribe another
treatment for you.

3. How to take Miacalcic nasal spray
Children and adolescents (age under 18 years)
Use of Miacalcic is not recommended in patients under
18 years of age.
Older people
Miacalcic nasal spray can be used by older patients without
any special requirements.
Other medicines and Miacalcic nasal spray
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. It is

Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
This medicine is for nasal use only.
Your pharmacist has stored Miacalcic nasal spray in a
refrigerator. Before you start using it, you should let the
spray reach room temperature. You should store Miacalcic
nasal spray at room temperature.
The usual dose is one spray puff (200 IU) daily. It is
recommended that you administer Miacalcic nasal spray to
alternating nostrils.
It is recommended that you also take an adequate amount of

calcium and vitamin D whilst using Miacalcic nasal spray.
Ask your doctor for advice.
Before the nasal spray is used for the first time, the pump
must be primed as described below in the “Instructions for
use of Miacalcic nasal spray”. The instructions should be
followed carefully.

6. Dip tube: The tube inside the spray bottle that draws up
the medicine when you press the pump.
7. Bottle: Contains enough medicine for at least 14 metered
doses.

Instructions for use of Miacalcic nasal spray
Please read the instructions carefully so that you know how
to use your nasal spray. These instructions tell you about:
A. The different parts of your nasal spray.
B. How to prepare a new nasal spray for use.
C. Using the nasal spray.
D. Checking the counter

• NEVER shake the nasal spray bottle as this could cause
air bubbles which may affect your dose.

B. Preparing a new nasal spray bottle for use:

The dose counter window of a new
nasal spray bottle is in the position
marked in the picture.
• First, remove the protective cap.

Always follow your doctor’s instructions regarding
dose carefully.
A. The different parts of the spray bottle
1. Protective cap: Keeps the nozzle
clean and protects the jet. Always
replace the protective cap after
you have used the nasal spray.
2. Jet: The tiny hole from which the
medicine sprays out.
3. Nozzle: The part you insert into
your nostril.
4. Pump: The part you press down
to operate the spray.
5. Counter: The dose counter
window on a new nasal spray
shows , as shown in the
picture. The display will change
as you use the pump (see below).

• Hold the nasal spray upright in
one or two hands and press down
firmly on the pump 3 times.
This primes the new spray by
clearing the air out of the dip tube.
You will only need to do this once
when you start a new spray.
Do not worry if a little medicine
sprays out; this is normal.

As you press the pump,
watch the changes in the
dose counter window:
to

to

to

• When the green is showing
in the dose counter window,
your new nasal spray is
ready to use.
• Follow the instructions for
“Using your spray”.

C. Using your nasal spray
• After removing the protective cap,
bend your head forward slightly and
insert the nozzle into one of your
nostrils. Try to hold the nasal spray
upright, as shown in the picture.
• Press the pump firmly only once.
• Remove the nasal spray from
your nose and breathe in deeply
through your nostril to help keep
the medicine in your nose.
• If your doctor has told you to take two puffs at a time,
repeat this procedure in your other nostril.
• After use, clean the nozzle with a dry tissue and replace
the protective cap.

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D. Checking the counter
Every time you use the nasal spray the number in the dose
counter window will change. The number displayed tells you
how many puffs you have already taken. The Nasal Spray is
guaranteed to deliver 14 metered doses. You may be able to
obtain 2 additional doses.

4. Possible side effects

When the dose counter window turns
red and displays the number (16),
as shown in this picture you have
taken 16 spray puffs and the spray
is finished. You may notice that a
little liquid is left in the nasal spray
bottle, but this is normal.

Some side effects could be serious:
– Increased heartbeat, nettle rash (hives), difficulty
breathing, swelling of the tongue and throat, tightness
in your chest, a sudden fall in blood pressure or shock.
These may be signs of a severe allergic reaction
(anaphylaxis) and are very rare.
– Swelling of your face, limbs or entire body (uncommon).
If you experience any of these, contact a
doctor immediately.

If the spray mechanism becomes blocked, this may be fixed
by pressing the pump forcefully; do not attempt to unblock it
using a sharp pointed object as this may cause damage.
If you think your nasal spray is not working properly, return
it to your supplier. Never try to fix the nasal spray yourself or
take it apart, as this may affect your dose.
If you use more Miacalcic nasal spray than you should
If you have accidentally taken too much Miacalcic nasal
spray, tell your doctor immediately. You may require
medical attention.
If you forget to use Miacalcic nasal spray
If you forget to use your nasal spray, take the spray as soon
as you remember unless it is less than 4 hours before the next
dose. If so, wait and take your next dose at the usual time.
Do not take a double dose to make up for a forgotten one.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects,
although not everybody gets them. The most frequently
observed side effects are those affecting the nose such as
sore nose and runny or stuffy nose. These are generally mild
and rarely require the treatment to be stopped.

Other side effects:
Very Common side effects (may affect more than 1 in
10 people):
– Sore nose, runny or stuffy nose (rhinitis), swelling,
redness and damage to the inside of the nose, sneezing,
dry nose, nasal allergies, irritated nose, unpleasant smell.
Common side effects (may affect up to 1 in 10 people):
– diarrhoea, stomach pain, feeling sick,
– tiredness,
– pain in bone or joints,
– dizziness,
– headache,
– changes in the way things taste,
– sudden waves of redness of the face and/or neck (flush),
– nose bleed,

– feeling of pressure or pain in nose, cheeks and behind
eyes (inflammation of the sinuses), nasal inflammation
and damage,
– sore throat and discomfort when swallowing (pharyngitis).
Uncommon side effects (may affect up to 1 in 100 people):
– high blood pressure (hypertension),
– flu-like symptoms,
– disturbed vision,
– allergic reactions,
– cough,
– being sick,
– itching.
Rare side effects (may affect up to 1 in 1,000 people):
– Skin rash.
Not known (frequency cannot be estimated from the
available data):
Trembling
In rare cases the effectiveness of Miacalcic may be reduced.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

5. How to store Miacalcic nasal spray
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the package after EXP. The expiry date refers to the last
day of that month.
Store in a refrigerator (2°C–8°C). Do not freeze.
Once opened, the nasal spray must be kept at room
temperature (not above 25°C).
The nasal spray must be used within 1 month after opening.

Keep the bottle upright at all times to reduce the risk of air
bubbles getting into the dip tube.
Do not shake the bottle.
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.

6. Contents of the pack and other information
What Miacalcic nasal spray contains
– The active substance is calcitonin (salmon, synthetic).
Each 2 ml bottle of Miacalcic nasal spray contains at
least 14 metered doses of 200 IU. One IU (International
Unit) corresponds to 0.167 micrograms of calcitonin
(salmon, synthetic).
– The other ingredients are benzalkonium chloride
(as a preservative), sodium chloride, hydrochloric acid
and water.

Miacalcic nasal spray is released onto the market by
Novartis Pharmaceuticals UK Ltd, Wimblehurst Road,
Horsham, West Sussex RH12 5AB, United Kingdom.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria
Calcitonin “Novartis”
Belgium
Miacalcic
Ireland
Miacalcic
This leaflet was last revised in April 2012.
If you would like any more information, or would like
the leaflet in a different format, please contact Medical
Information at Novartis Pharmaceuticals UK Ltd,
tel. 01276 698370.
Miacalcic is a registered trade mark

What Miacalcic nasal spray looks like and contents of
the pack
Miacalcic 200 IU is a nasal spray, solution (nasal spray).
Miacalcic 200 IU nasal spray is available in packs of one or
three bottle(s) of 2 ml.
Not all strengths and pack sizes may be marketed in
your country.
Marketing Authorisation Holder and Manufacturer
Novartis Pharmaceuticals UK Ltd, trading as
Sandoz Pharmaceuticals, Frimley Business Park, Frimley,
Camberley, Surrey GU16 7SR, England.

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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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