CALIMIX 50 MICROGRAMS Назальный спрей, суспензия

Содержание инструкции

1. Calimix 50 micrograms/spray Nasal Spray, suspension
   1. What is Calimix and what is it used for
   2. What you need to know before using Calimix
   3. How to use Calimix
   4. Possible side effects
   5. How to store Calimix
   6. Contents of the pack and other information

Calimix 50 micrograms/spray Nasal Spray, suspension

mometasone furoate
Generic medicine

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Calimix is and what it is used for
• 2. What you need to know before you use Calimix
• 3. How to use Calimix
• 4. Possible side effects
• 5. How to store Calimix
• 6. Contents of the pack and other information

1. What is Calimix and what is it used for

What is Calimix?
Calimix contains mometasone furoate, which belongs to a group of medicines called corticosteroids.
Mometasone furoate should not be confused with the "anabolic" steroids abused by some athletes and
taken in the form of tablets or injections. When mometasone furoate is sprayed into the nose, it can
help relieve inflammation (swelling and irritation of the nose), sneezing, itching and a stuffy or runny nose.

What is Calimix Nasal Spray used for?
Seasonal allergic rhinitis and perennial rhinitis
Calimix is indicated for use in adults and children aged 3 years and over for the treatment of
symptoms of seasonal allergic rhinitis (also called hay fever) or perennial rhinitis.
Hay fever, which occurs at certain times of the year, is an allergic reaction caused by
inhaling pollen from trees, grasses, weeds, and also molds and fungal spores. Perennial rhinitis is
present all year round and symptoms may be caused by sensitivity to a variety of elements, including
house dust mites, animal dander (or flakes), feathers and certain foods. Calimix reduces
nasal swelling and irritation, thereby relieving sneezing, itching and conditions of a stuffy or runny nose, caused by hay fever or perennial rhinitis.
Nasal polyps
Calimix is indicated for the treatment of nasal polyps in adults aged 18 years and over.
Nasal polyps are small growths on the nasal mucosa and usually affect both nostrils.
Calimix reduces inflammation of the nose, causing a gradual shrinking of the polyps, thereby relieving
the feeling of nasal obstruction that can affect breathing through the nose.

2. What you need to know before using Calimix

Do not use Calimix:

• if you are allergic to mometasone furoate or any of the other ingredients of this medicine (listed in section 6).
• if you have an untreated nasal infection. Using Calimix during an untreated nasal infection, such as herpes, may worsen the infection. You should wait for the infection to resolve before starting to use the nasal spray.
• if you have recently had nasal surgery or have suffered a nasal trauma. You should not use the nasal spray until the nasal problem has resolved.

Warnings and precautions
Talk to your doctor or pharmacist before using Calimix:

• if you suffer from or have suffered from tuberculosis
• if you suffer from any other type of infection
• if you have a perforation of the nasal septum
• if you are taking other corticosteroids, either orally or by injection
• if you suffer from cystic fibrosis. While using Calimix, consult your doctor:
• if your immune system is not functioning properly (if you have difficulty fighting infections) and if you have been in contact with a person suffering from measles or chickenpox. Avoid contact with people who have these infections.
• if you have an infection in your nose or throat.
• if you have been using this medicine for several months or longer.
• if you have persistent irritation of the nose or throat. When nasal sprays based on corticosteroids are used at high doses for prolonged periods, undesirable effects due to the absorption of the medicine into the body may occur.

In case of eye itching or irritation, your doctor may prescribe other treatments to use together with
Calimix.
Consult your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
If used at high doses for prolonged periods, nasal sprays based on corticosteroids can cause
some undesirable effects, such as a slowing of growth in children.
It is recommended to regularly check the height of children undergoing prolonged treatment with
nasal corticosteroids and to inform the doctor if any changes are noticed.

Other medicines and Calimix
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you are taking other corticosteroid medicines to treat allergies, either orally or by injection, your
doctor may advise you to stop this treatment when you start using Calimix.
When stopping treatment with oral or injectable corticosteroids, some people may experience
undesirable effects, such as joint or muscle pain, weakness and depression. You may also
seem to develop other allergies, such as itching, tearing or red and itchy patches on the skin.
Consult your doctor if you notice the appearance of any of these effects.
Some medicines can increase the effects of Calimix and your doctor may want to monitor you closely if you are taking these medicines (including some drugs for the treatment of HIV:
ritonavir, cobicistat).

Pregnancy, breastfeeding and fertility
Information on the use of mometasone furoate during pregnancy is scarce or absent.
It is not known whether mometasone furoate is released into breast milk.
Calimix should not be used during pregnancy or breastfeeding.
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Calimix does not affect the ability to drive or use machines.

Calimix contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per spray, which can cause irritation
and swelling inside the nose, especially if used for long periods.

3. How to use Calimix

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist. Do not take higher or more frequent doses or for longer than prescribed by your doctor.

Treatment of hay fever and perennial rhinitis
Use in adults and children over 12 years of age
The recommended dose is two sprays in each nostril once a day.
In some patients Calimix starts to relieve symptoms within 12 hours of the first dose; however, complete
benefit from treatment may not be seen for the first two days. Therefore, it is necessary to continue to
use it regularly to achieve the full benefit of treatment.

• Once your symptoms are under control, your doctor may advise you to reduce the dose to one spray a day in each nostril.
• If you do not experience any improvement, consult your doctor, who may prescribe you to increase the dose; the maximum daily dose is four sprays in each nostril once a day.

Use in children aged between 3 and 11 years
The recommended dose is one spray in each nostril once a day.
If you, or your child, suffer from severe hay fever, your doctor may advise you to start using
mometasone furoate before the start of the pollen season: this will help to prevent the onset of
hay fever symptoms. At the end of the pollen season, the symptoms of hay fever should
improve and treatment may no longer be necessary.

Nasal polyps
Use in adults over 18 years of age
The recommended starting dose is two sprays in each nostril once a day.

• If after 5 or 6 weeks your symptoms are not under control, the dose may be increased to two sprays in each nostril twice a day. When your symptoms are under control, your doctor will ask you to reduce the dose.
• If you do not observe any improvement in symptoms after 5 or 6 weeks of administration twice a day, you should contact your doctor to discuss the application of other treatments as a substitute for Calimix.

Preparing the nasal spray for use
Calimix is equipped with a dust cap that protects the spray nozzle and keeps it clean. Remember to
remove it before using the spray and reposition it after use.
If you are using the spray for the first time, you will need to “prime” the bottle by actuating the spray 10 times until you see
a fine mist:

• 1. Gently shake the bottle.
• 2. Place your index and middle fingers on either side of the nozzle, your thumb under the base of the bottle. Do notpuncture the nasal applicator.
• 3. Point the nozzle away from yourself and press down with your fingers to actuate the spray 10 times until you obtain a light mist. If you have not used the spray for 14 days or more, you will need to “reprime” the bottle by actuating the spray 2 times until a fine mist is produced. How long will the nasal spray lastApplying two sprays in each nostril once a day, the product should provide sufficient doses for 35 days (for the bottle containing 140 metered sprays).

How to use the nasal spray

• 1. Gently shake the bottle and remove the dust cap. (Figure 1)
• 2. Gently blow your nose.

• 3. Close one nostril and insert the nozzle into the other, as illustrated (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
• 4. Start to inhale gently or slowly through your nose and, while inhaling, administer one spray into your nose by pressing down with your fingers ONCE.
• 5. Exhale through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if necessary.
• 6. Withdraw the nozzle from the nostril and exhale through your mouth.

• 7. Repeat steps 3 to 6 for the other nostril (Figure 3). After using the spray, carefully wipe the nozzle with a tissue or clean cloth and reposition the dust cap.

How to clean the nasal spray

• It is important to clean the nasal spray regularly, otherwise it may not work properly.
• Remove the dust cap and gently pull off the nozzle.
• Wash the nozzle and dust cap with warm water, then rinse with running water.
• Do not attempt to unblock the nasal applicator by inserting a pin or other sharp object,as this will damage the nasal applicator and will not allow you to have thecorrect dose of the medicine.
• Leave the dust cap and nozzle to dry in a warm place.
• Reposition the nozzle onto the bottle and put the dust cap back on.
• The spray needs to be re-primed with 2 sprays at the first use after cleaning.

If you use more Calimix than you should
Inform your doctor if you have accidentally used more than you should.
In rare cases, prolonged or high-dose use of steroids can affect levels of some hormones. In children
this effect can affect growth and development.

If you forget to use Calimix
If you forget to use the nasal spray at the correct time, use it as soon as you remember, then continue as usual. Do not use a double dose to make up for a missed dose.

If you stop treatment with Calimix
In some patients Calimix starts to relieve symptoms 12 hours after the first dose; however, the full
benefit of treatment may not be seen before two days. It is very important that you use the spray
nasally regularly. Do not stop treatment, even if you feel better, until your doctor tells you to.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
With the use of this medicine, immediate hypersensitivity (allergic) reactions may occur. These
reactions can be serious. You must stop using Calimix Spray Nasale and seek immediate
medical assistance if symptoms such as:

• swelling of the face, tongue or pharynx
• difficulty swallowing
• urticaria (hives)
• shortness of breath or difficulty breathing. When nasal sprays based on corticosteroids are used at high doses for prolonged periods, side effects due to absorption of the medicine into the body may occur.

Other side effects
Some people, after using Calimix or other nasal sprays based on corticosteroids, may experience:

Common side effects(may affect up to 1 in 10 people)

• headache
• sneezing and irritation/burning sensation in the nose
• nosebleeds [occurred very commonly (may affect more than 1 in 10 people) in people with nasal polyps treated with two sprays of Calimix in each nostril twice a day]
• nasal or throat pain
• ulcers in the nose
• respiratory tract infections.

Not known(frequency cannot be estimated based on available data)

• increased pressure inside the eye (glaucoma) and/or cataracts causing visual disturbances
• damage to the nasal septum separating the nostrils
• alterations in taste or smell
• difficulty breathing and/or shortness of breath
• blurred vision.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at: http://www.agenziafarmaco.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store Calimix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the packaging after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions. Do not freeze.
The bottle must be used within 2 months of first opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Calimix contains

• The active ingredient is mometasone furoate. Each spray (0.1 ml) delivers 50 micrograms of mometasone furoate (as monohydrate). The total weight of one spray is 100 mg.
• The other ingredients are microcrystalline cellulose and sodium carboxymethylcellulose, glycerol, disodium citrate dihydrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride solution (see section 2) and water for injections.

Description of the appearance of Calimix and contents of the pack
Calimix is an opaque suspension from white to whitish in colour.
Calimix is a nasal spray, suspension.
Each bottle contains 140 sprays.

Marketing Authorisation Holder and Manufacturer
Laboratorio Chimico Deca Dr. Capuani Srl
Via Giotto 1
30172 Venice (VE)

Manufacturer
Teva Czech Industries s.r.o.
Ostravská 29, č.p. 305
747 70 Opava–Komárov
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Italy Calimix 50 micrograms/actuation nasal spray, suspension