Nasometin control
Poland
Table of Contents
Before using the medicine, carefully read the package leaflet and educational materials.
These are available in pharmacies.
Detailed and up-to-date information about this medicine is available by scanning the QR code
with a smartphone (see also section 6 of the leaflet).
Package leaflet: Information for the user
Nasometin Control, 50 micrograms/dose, nasal spray, suspension
Mometasoni furoas
For use in adults only
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
- Keep this leaflet for future reference.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 14 days, or if you feel worse, contact your doctor.
Leaflet contents:
- What Nasometin Control is and what it is used for
- Important information before using Nasometin Control
- How to use Nasometin Control
- Possible side effects
- How to store Nasometin Control
- Contents of the pack and other information
1. What Nasometin Control is and what it is used for
What is Nasometin Control?
Nasometin Control contains the active substance mometasone furoate, a medicine belonging to the group of corticosteroids. Mometasone furoate delivered as a nasal spray helps reduce inflammation (swelling and irritation of the nasal mucosa).
What is Nasometin Control used for?
Nasometin Control is used to treat symptoms of diagnosed seasonal allergic rhinitis (also known as hay fever) in adults aged 18 years and older.
Hay fever, which occurs several times a year, is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, as well as moulds and fungal spores. Nasometin Control reduces swelling and irritation of the nasal mucosa, thereby relieving sneezing, itching, nasal congestion, or runny nose caused by hay fever.
If there is no improvement after 14 days, or if you feel worse, contact your doctor.
2. Important information before using Nasometin Control
When not to use Nasometin Control
if the patient is allergic to mometasone furoate or any of the other ingredients
of this medicine (listed in section 6).
if the patient has an untreated nasal mucosal infection. Using Nasometin Control
during such an infection (e.g. herpes) may worsen the course of the disease. The use of
nasal spray should be delayed until the infection has resolved.
if the patient has recently undergone nasal surgery or nasal trauma. The nasal spray must not
be used until nasal wounds have healed.
Warnings and precautions
Before starting Nasometin Control, consult a doctor or pharmacist if the patient:
has had or currently has tuberculosis;
has any other infection;
is receiving other corticosteroids (orally or by injection);
has cystic fibrosis.
While using Nasometin Control, consult a doctor or pharmacist if:
the patient's immune system is not functioning properly (the patient has difficulty fighting
infections), and the patient has been in contact with someone who has measles or chickenpox. Contact with such individuals should be avoided;
the patient has an infection in the nose or throat;
the patient has used the medicine for 3 months without consulting a doctor;
the patient experiences persistent irritation of the nose or throat.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
Prolonged use of high doses of corticosteroids in nasal spray may lead to systemic adverse effects due to absorption of the drug into the body.
If the patient experiences itching or eye irritation, the doctor may recommend using additional medications besides Nasometin Control.
Children and adolescents
Nasometin Control must not be used in children and adolescents under 18 years of age.
Nasometin Control and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use, including over-the-counter medicines.
Some medicines may increase the effect of Nasometin Control. The doctor may wish to monitor closely patients taking such medicines (including certain HIV treatments: ritonavir, cobicistat).
If the patient is being treated for allergies with other corticosteroids taken orally or by injection, the doctor may recommend discontinuing them when starting Nasometin Control.
In some patients, after stopping oral or injectable corticosteroids, certain adverse effects may occur, such as joint or muscle pain, weakness, and depression. Other allergic symptoms may also appear, such as itching, watery eyes, or red, itchy skin rashes. If any of these symptoms occur, contact a doctor.
Pregnancy and breastfeeding
There is no or very limited information available on the use of Nasometin Control in pregnant women.
It is not known whether mometasone furoate passes into human breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
The effect of Nasometin Control on the ability to drive or operate machinery is unknown.
Nasometin Control contains benzalkonium chloride
Nasometin Control contains benzalkonium chloride, which may cause irritation or swelling of the nasal mucosa, especially if the medicine is used for a prolonged period.
3. How to use Nasometin Control
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose in adults aged 18 years and older is two sprays of the aerosol into each nostril once daily.
After improvement is achieved, the dose may be reduced to one spray into each nostril once daily. If symptoms worsen, the dose should be increased again to two sprays into each nostril once daily.
In some patients, Nasometin Control provides symptom relief within 12 hours after the first dose, although full therapeutic benefits may not be evident until after two days of treatment.
If there is no improvement or if improvement is insufficient after a maximum of 14 days of treatment, medical advice must be sought.
Nasometin Control should not be used for longer than 3 months without consulting a doctor.
Children and adolescents
Nasometin Control should not be used in children and adolescents under 18 years of age.
Preparing the medicine for use
Nasometin Control has a protective cap that covers the nozzle and prevents contamination. Remember to remove it before using the aerosol and replace it after use.
Shake the bottle vigorously before each use.
Do not pierce the applicator (the opening in the nozzle) with a pin or any other sharp object.
Before first use:
Before the first use of the aerosol, prime the pump by pressing down on the bottle 10 times until a fine mist is produced.
- Shake the bottle vigorously.
- Remove the plastic protective cap.
- Place your index and middle fingers on either side of the pump, and your thumb under the bottle (Figure 1). Do not pierce the applicator.
- Pointing the nozzle away from yourself, press down with your fingers 10 times until a fine mist is produced (Figure 1).
Figure 1
If the medicine has not been used for 14 days or longer, re-prime the pump by spraying twice until a fine mist is produced.
How to use the nasal aerosol
- Shake the bottle vigorously and remove the protective cap (Figure 2).
Figure 2
- Gently blow your nose to clear the nasal passages.
- Close one nostril with your index finger. Tilt your head slightly forward. Place the pump between your index and middle fingers, supporting the bottle from underneath with your thumb. Hold the bottle upright and insert the nozzle vertically into the other nostril. It is important not to spray Nasometin Control directly onto the nasal septum, which separates the two nostrils (Figure 3).
Figure 3
- Press the pump once with your fingers to release a fine mist into the nostril, while simultaneously inhaling gently and slowly through the nose (Figure 4).
Figure 4
WARNING! Holding the bottle in an upright position is very important, as incorrect spraying may cause damage to the nasal septum (Figure 5).
Figure 5
- Breathe out through your mouth. Then repeat step 4 to administer a second spray into the same nostril (if the recommended dose requires it).
- Remove the nozzle from the nostril and breathe out through your mouth. Repeat steps 3 to 6 to administer the aerosol into the other nostril.
After using the aerosol, gently wipe the nozzle with a clean tissue or cloth and replace the protective cap.
Cleaning
Regular cleaning of the nozzle is important to ensure proper functioning.
Remove the protective cap and gently pull off the nozzle.
Wash the nozzle and cap with warm water, then rinse thoroughly under running water.
Do not attempt to unblock the applicator by inserting a pin or any other sharp object into the opening, as this may damage the applicator and result in incorrect dosing.
Leave the cap and nozzle in a warm place to dry completely.
Reattach the nozzle to the bottle, then replace the protective cap.
After cleaning, re-prime the pump by spraying twice.
Use of a higher than recommended dose of Nasometin Control
This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor. Using a lower or higher dose than recommended may worsen symptoms.
If you accidentally use more than the recommended dose, consult your doctor.
Rarely, prolonged or high-dose use of steroids may adversely affect the function of certain hormones.
Missed dose of Nasometin Control
If you forget to use the nasal aerosol at your usual time, use it as soon as you remember, then continue treatment as directed.
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Immediate hypersensitivity (allergic) reactions, including severe ones, may occur after using this medicine.
If any of the symptoms listed below occur in the patient, stop using Nasometin Control and seek immediate medical help:
- swelling of the face, tongue or throat
- difficulty swallowing
- hives
- wheezing or difficulty breathing.
Long-term use of high doses of corticosteroids in nasal aerosol may lead to systemic adverse effects due to absorption of the drug into the body.
Other adverse reactions
Frequent adverse reactions (may affect fewer than 1 in 10 people):
- headache
- sneezing
- nosebleeds
- nasal pain
- ulceration of the nasal mucosa
- respiratory tract infection.
Adverse reactions occurring with unknown frequency (frequency cannot be estimated from available data):
- increased intraocular pressure (glaucoma) and (or) cataract causing visual disturbances
- blurred vision
- nasal septum perforation
- taste and smell disturbances
- difficulty breathing and (or) wheezing.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Nasometin Control
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the cardboard
box after EXP. The expiry date refers to the last day of the stated month.
Do not freeze.
Before using the first dose, shake the bottle vigorously and spray the medicine 10 times (until
a uniform aerosol is obtained). If the pump has not been used for 14 days or longer,
its function should be checked before the next use by spraying the medicine twice, until
a uniform aerosol is obtained.
The shelf life after first opening the bottle is 2 months.
Do not unscrew the pump or dispenser.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.
6. Contents of the pack and other information
What Nasometin Control contains
- The active substance is mometasone furoate. Each spray contains 50 micrograms of mometasone furoate (as mometasone furoate monohydrate). The total mass of the suspension in one spray is 100 mg.
- Other ingredients are: microcrystalline cellulose, sodium carmellose, glycerol, citric acid monohydrate, sodium citrate, polysorbate 80, benzalkonium chloride, water for injections.
What Nasometin Control looks like and contents of the pack
Nasometin Control is a white, homogeneous nasal spray suspension, packed in white bottles with a spray pump and a blue protective cap.
1 bottle contains 10 g of nasal spray suspension (corresponding to 60 metered doses).
1 bottle contains 17 g of nasal spray suspension (corresponding to 120 metered doses).
1 bottle containing 18 g of nasal spray suspension (corresponding to 140 metered doses).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Mometasonfuroat – 1 A Pharma Heuschnupfenspray 50 Mikrogramm/Sprühstoß Nasenspray, Suspension
Bulgaria MomaNose 50 micrograms/actuation, nasal spray, suspension
Czech Republic Momanose
Denmark Mommox
Estonia Nasometin
Croatia Momanose 50 mikrograma sprej za nos, suspenzija
Hungary Momepax Control 50 mikrogramm/adag szuszpenziós orrspray
Ireland Rhinex Relief 50 micrograms/actuation nasal spray, suspension
Italy Mometasone Sandoz BV
Lithuania Nasometin 50 mikrogramų/dozėje nosies purškalas (suspensija)
Latvia Nasometin 50 mikrogrami/izsmidzinājumā deguna aresols, suspensija
Poland Nasometin Control
Romania Rinamet 50 micrograme/doză, spray nazal, suspensie
Slovenia Mommox RINO 50 mikrogramov/vpih pršilo za nos, suspenzija
Slovakia Nasometin 0,05 mg/dávka
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Detailed and up-to-date information on this medicinal product is available by scanning with a smartphone the QR code located below in the leaflet and on the outer packaging. The same information is also available at the website:
https://www.sandoz.pl/sites/www.sandoz.pl/files/Nasometin%20Control_0.pdf
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