Calimix

Package leaflet: Information for the patient

Calimix 50 micrograms/dose Nasal Spray, suspension

mometasone furoate
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 using 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 Calimix is and what it is 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 that some athletes abuse and take 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 blocked or runny nose.

What is Calimix Nasal Spray used for?
Allergic rhinitis and perennial rhinitis
Calimix is indicated for use in adults and children aged 3 years and older for the treatment of symptoms of seasonal allergic rhinitis (also known as hay fever) or perennial rhinitis.
Hay fever, which occurs during certain times of the year, is an allergic reaction caused by inhaling tree, grass, and weed pollens, as well as moulds and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be triggered by sensitivity to a variety of allergens, including house dust mites, animal fur (or dander), feathers, and certain foods. Calimix reduces nasal swelling and irritation, thereby relieving sneezing, itching, and blocked 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 older.
Nasal polyps are small growths on the nasal mucosa and usually affect both nostrils. Calimix reduces nasal inflammation, leading to a gradual shrinkage of the polyps, thereby relieving the sensation of nasal obstruction that can affect breathing through the nose.

2. What you should know before using Calimix

Do not use Calimix:

• if you are allergic to mometasone furoate or to 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 must wait until the infection has resolved before starting to use the nasal spray.
• if you have recently undergone nasal surgery or have suffered a nasal injury. You must not use the nasal spray until the nasal condition has healed.

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

• if you have or have had tuberculosis
• if you have any other type of infection
• if you have a perforation of the nasal septum
• if you are taking other corticosteroids, either by mouth or by injection
• if you have cystic fibrosis. While using Calimix, talk to your doctor:
• if your immune system is not working properly (if you have difficulty fighting infections) and if you have been in contact with someone who has 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 in your nose or throat. When corticosteroid nasal sprays are used at high doses for prolonged periods, adverse effects due to systemic absorption of the medicine may occur.

If you experience eye itching or irritation, your doctor may prescribe additional treatments to be used together with Calimix.
Talk to your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
When corticosteroid nasal sprays are used at high doses for prolonged periods, they may cause certain adverse effects, such as slowed growth in children.
Regular monitoring of children's height is recommended during prolonged treatment with nasal corticosteroids, and you should inform your doctor if you notice any changes.

Other medicines and Calimix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking other corticosteroid medicines for allergy treatment, either by mouth or by injection, your doctor may advise you to stop that treatment when you start using Calimix.
When stopping treatment with oral or injectable corticosteroids, some people may experience adverse effects such as joint or muscle pain, weakness, and depression. You may also feel as though you are developing other allergies, such as itching, tearing, or red, itchy skin rashes.
Consult your doctor if you notice 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 certain HIV treatments: ritonavir, cobicistat).

Pregnancy, breastfeeding and fertility
Information on the use of mometasone furoate during pregnancy is limited or lacking.
It is not known whether mometasone furoate is excreted in breast milk.
Calimix must not be used during pregnancy or breastfeeding.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or 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 operate machinery.

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

3. How to use Calimix

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not take higher doses, more frequently, or for longer than prescribed by your doctor.

Treatment of hay fever and perennial rhinitis

Use in adults and children above 12 years of age
The recommended dose is two sprays in each nostril once daily.
In some patients, Calimix begins to relieve symptoms within 12 hours of the first dose; however, the full benefit of treatment may not be evident during the first two days. Therefore, it is necessary to continue using it regularly to achieve the full therapeutic effect.

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

Use in children aged 3 to 11 years
The recommended dose is one spray in each nostril once daily.
If you or your child suffer from severe hay fever, your doctor may recommend starting treatment with mometasone furoate before the onset of pollen season: this will help prevent the development of hay fever symptoms. After the pollen season ends, hay fever symptoms should improve and treatment may no longer be necessary.

Nasal polyps
Use in adults above 18 years of age
The recommended initial dose is two sprays in each nostril once daily.

• If symptoms are not controlled after 5 or 6 weeks, the dose may be increased to two sprays in each nostril twice daily. When symptoms are under control, your doctor will ask you to reduce the dose.
• If you observe no improvement in symptoms after 5 or 6 weeks of twice-daily administration, you must contact your doctor to discuss alternative treatments instead of Calimix.

Preparing the nasal spray for use
Calimix is equipped with a dust cap that protects the atomizer and keeps it clean. Remember to remove it before using the spray and replace it after use.
If you are using the spray for the first time, you must "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 atomizer, and your thumb under the base of the bottle. Do not pierce the nasal applicator.
3. Point the atomizer away from yourself and press with your fingers to actuate the spray 10 times until a fine mist appears. If you have not used the spray for 14 days or more, you must "re-prime" the bottle by actuating the spray twice until a fine mist is produced.

How long will the nasal spray last?
With two sprays in each nostril once daily, 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 atomizer into the other, as illustrated (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
4. Begin to inhale gently or slowly through your nose and, during inhalation, administer one spray into the nostril by pressing ONCE with your fingers.
5. Exhale through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if needed.
6. Remove the atomizer from the nostril and exhale through your mouth.

7. Repeat steps 3 to 6 for the other nostril (Figure 3). After using the spray, clean the atomizer thoroughly with a clean tissue or cloth and replace 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 atomizer.
• Wash the atomizer and dust cap with warm water, then rinse under running water.
• Do not attempt to unblock the nasal applicator by inserting a pin or any other sharp object, as this may damage the nasal applicator and prevent you from receiving the correct dose of medicine.
• Allow the dust cap and atomizer to dry in a warm place.
• Reattach the atomizer to the bottle and replace the dust cap.
• After cleaning, the spray must be re-primed with 2 sprays before first use.

If you use more Calimix than you should
Inform your doctor if you have accidentally used more than prescribed.
In rare cases, prolonged use or high doses of steroids may affect levels of certain hormones. In children, this effect may impact growth and development.

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

If you stop using Calimix
In some patients, Calimix begins to relieve symptoms 12 hours after the first dose; however, the full benefit of treatment may not be apparent before two days. It is very important that you use the nasal spray regularly. Do not stop treatment, even if you feel better, until your doctor tells you to do so.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
Immediate hypersensitivity (allergic) reactions may occur with the use of this medicine. These reactions can be severe. You must stop using Calimix Nasal Spray and seek immediate medical assistance if any of the following symptoms occur:

• swelling of the face, tongue or pharynx
• difficulty in swallowing
• urticaria
• shortness of breath or breathing difficulties.

When corticosteroid nasal sprays are used at high doses for prolonged periods, adverse effects due to systemic absorption of the medicine may occur.

Other adverse reactions
Some people may experience the following after using Calimix or other corticosteroid nasal sprays:
Common adverse reactions (may affect up to 1 in 10 people)

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

Not known (frequency cannot be estimated from the 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 in breathing and/or breathlessness
• blurred vision.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, 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 stated on the vial and the carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Do not freeze.
The vial should be used within 2 months after first opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Calimix contains

• The active substance 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 components are microcrystalline cellulose and sodium carmellose, 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, white to off-white 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 Venezia (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 European Economic Area countries under the following names:
Italy Calimix 50 micrograms/dose nasal spray, suspension