RINOCLENIL 50 MCG Spray do nosa, zawiesina

Treść ulotki

1. RINOCLENIL 50 micrograms nasal spray, suspension
   1. What is RINOCLENIL and what is it used for
   2. What you need to know before you take RINOCLENIL
   3. How to take RINOCLENIL
   4. Possible side effects
   5. How to store RINOCLENIL
   6. Contents of the pack and other information
2. RINOCLENIL 100 micrograms nasal spray, suspension
   1. What is RINOCLENIL and what is it used for
   2. What you need to know before taking RINOCLENIL
   3. How to take RINOCLENIL
   4. Possible side effects
   5. How to store RINOCLENIL
   6. Contents of the pack and other information

RINOCLENIL 50 micrograms nasal spray, suspension

Beclometasone dipropionate

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What is RINOCLENIL and what is it used for

RINOCLENIL is a medicine that contains beclometasone dipropionate, an active ingredient
belonging to the group of corticosteroids that reduces swelling and inflammation of the airways.
RINOCLENIL is used to treat or prevent inflammation of the nose (rhinitis) due to allergies
(both seasonal and perennial) or vasomotor disorders, which can cause: sneezing, runny nose, itching and a feeling of nasal obstruction, decreased sense of smell.

2. What you need to know before you take RINOCLENIL

Do not take RINOCLENIL if:

• you are allergic (hypersensitive) to beclometasone dipropionate or any of the other ingredients of this medicine (listed in section 6) or to other medicines containing cortisone;
• you have tuberculosis or a viral infection located in the nose (local);

RINOCLENIL is not suitable for children under 6 years of age.

Warnings and precautions
Talk to your doctor before taking RINOCLENIL if:

• you are taking corticosteroids as side effects may occur due to the drug passing into the bloodstream;
• you have inflammation of the nose or nasal cavities (sinuses) due to microorganisms;
• you have ulcers in the nose;
• you have had trauma or surgery to the nose.

Contact your doctor if you experience blurred vision or other visual disturbances.

Pay particular attention if

• you are switching from treatment with corticosteroids for systemic therapy (e.g. tablets) to treatment with RINOCLENIL; this is particularly important if you have impaired adrenal function;
• you notice a worsening of symptoms or tearing, itching or redness of the eyes, due to severe allergy.

IN ALL THESE CASES CONSULT YOUR DOCTOR WHO MAY PRESCRIBE SUITABLE THERAPY.

Children and adolescents
In children using RINOCLENIL, height should be measured regularly as long-term treatment with nasal corticosteroids may lead to a slowing of growth. If this occurs, consult your doctor as the therapy may need to be adjusted.

Other medicines and RINOCLENIL
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is particularly important if you are using systemic (e.g. tablets) or nasal medicines containing cortisone, as this may increase the risk of impaired adrenal function (adrenal suppression).
Some medicines can increase the effects of RINOCLENIL and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
RINOCLENIL does not impair the ability to drive or operate machinery.

RINOCLENIL contains35.1 micrograms of benzalkonium chloride per dose, which may cause irritation or swelling inside the nose, especially if used for a long period.
Caution for athletes: the product contains substances prohibited for doping. Taking it differently from the therapeutic indications, dosage regimen and route of administration specified is prohibited.

3. How to take RINOCLENIL

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and children over 6 years
The recommended dose is 2 sprays (= 100 mcg of active substance) in each nostril, 2 times a day. Once symptoms improve, you can reduce the number of sprays.
In some cases, your doctor may also advise you to perform 1 spray (= 50 mcg of active substance) in each nostril, 3-4 times a day.
The maximum dose, in adults, should not exceed 8 sprays (400 micrograms) per day.
Do not use RINOCLENIL for more than one month, unless otherwise indicated by your doctor.
Children under 6 years:
Do not administer to children under 6 years of age.

Method of administration
Take RINOCLENIL nasally, carefully clean your nose before administration to ensure successful delivery.
Before use, read the following instructions carefully, which indicate what to do and what to pay attention to.
A positive outcome of the treatment depends on correct use of the nasal spray.

INSTRUCTIONS FOR USE OF YOUR NASAL SPRAY
Opening the package
When you open the box, the applicator is closed with the protective cap and the safety ring.
If you are using RINOCLENIL for the first time, it is advisable to remove the protective cap, the safety ring and operate the dosing pump several times to activate the nebulization mechanism.

Taking a dose of RINOCLENIL
Before each administration: shake vigorouslythe bottle.
Figure 1 Perform a thorough cleaning of the nose.
Figure 2 Remove the protective cap.
Figure 3 Remove the safety ring laterally, which blocks the pump.
Figure 4 Hold the bottle between your fingers. To activate the nebulization mechanism, operate the dosing pump several times until you obtain a visible spray.
Figure 5 Place the nasal applicator on one nostril, closing the other nostril with a finger.
Inhale and press the base of the nasal applicator simultaneously. In this way, a single, precisely dosed dose of active substance is delivered. Repeat the same operation on the other nostril.
Figure 6 After use, replace the protective cap and the safety ring.

In case of blockage of the applicator, wash it carefully with lukewarm water, without intervening on the hole with sharp objects.

If you take more RINOCLENIL than you should
If you accidentally take excessive doses of RINOCLENIL, the risk of side effects is increased. In such cases, inform your doctor immediately, as appropriate measures may be necessary.

If you forget to take RINOCLENIL
Continue regularly with the therapy, without doubling the next dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
risk of side effects.
If you use RINOCLENIL, especially in high doses and/or for prolonged periods of time, you may notice:
burning sensation, irritation (possible sensitization phenomena), dryness of the nose;
nasal bleeding (epistaxis), perforation of the nasal septum, increased eye pressure with possible worsening of vision (glaucoma), blurred vision (frequency not
known);
adrenal suppression (with symptoms such as loss of appetite, hypotension, abdominal pain,
weight loss, fatigue, headache, nausea, vomiting), weakening of the bones (osteoporosis),
stomach or duodenal ulcer (peptic).
IF YOU SHOULD NOTICE ANY OF THE ABOVE EFFECTS, STOP TAKING RINOCLENIL AND
CONSULT YOUR DOCTOR IMMEDIATELY.
In children and adolescents taking intranasal corticosteroids, delayed
growth has also been reported (frequency not known).

Reporting of side effects
If you experience any side effect, 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 www.aifa.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 RINOCLENIL

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is reported on the pack after the words
EXP. The expiry date refers to the last day of that month. This date applies to the
product in intact packaging, correctly stored.
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 RINOCLENIL contains
The active ingredient is: beclometasone dipropionate.
Each container contains: 11.55 mg of beclometasone dipropionate (each spray contains 50
micrograms).
The other ingredients are: polysorbate 20, microcrystalline cellulose and sodium carboxymethylcellulose,
benzalkonium chloride, phenylethyl alcohol, dextrose (glucose) monohydrate, purified water.

Description of the appearance of RINOCLENIL and contents of the pack
This medicine is a suspension, available in a 30 ml bottle equipped with a dosing pump and
nasal applicator.
RINOCLENIL is sufficient for at least 200 sprays of 50 micrograms of beclometasone.

Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A. – Via Palermo, 26/A – Parma.

Manufacturer
Manufacturer responsible for batch release
ZETA Farmaceutici S.p.A. via Galvani, 10 36066 Sandrigo (VI)

Alternative manufacturer responsible for batch release
Chiesi Farmaceutici S.p.A. – Parma Plant, Via S. Leonardo, 96.

RINOCLENIL 100 micrograms nasal spray, suspension

Beclometasone dipropionate

Read this leaflet carefully before you start to take this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want any further information or advice, ask your pharmacist.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse after a short period of treatment.

Contents of this leaflet:

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

1. What is RINOCLENIL and what is it used for

RINOCLENIL is a medicine that contains beclometasone dipropionate, an active ingredient
belonging to the group of corticosteroids that reduces swelling and inflammation of the airways.
RINOCLENIL is used to treat or prevent inflammation of the nose (rhinitis) due to allergies
(both seasonal and perennial) or vasomotor disorders, which can cause: sneezing, runny nose, itching and a feeling of nasal obstruction, decreased sense of smell.

2. What you need to know before taking RINOCLENIL

Do not take RINOCLENIL if:

• you are allergic (hypersensitive) to beclometasone dipropionate or any of the other ingredients of this medicine (listed in section 6) or to other medicines containing cortisone;
• you have tuberculosis or a viral infection, located in the nose (local);

RINOCLENIL is not suitable for children under 6 years of age.

Warnings and precautions
Talk to your doctor before taking RINOCLENIL if:

• you are undergoing therapy with corticosteroids as undesirable effects may occur due to the passage of the drug into the bloodstream;
• you have inflammation of the nose or nasal cavities as a whole (paranasal sinuses) due to microorganisms;
• you have ulcers in the nose;
• you have had trauma or surgery to the nose.

Contact your doctor if you experience blurred vision or other visual disturbances.

Pay particular attention if

• you are switching from treatment with corticosteroids for systemic therapy (e.g. tablets) to therapy with RINOCLENIL; this is particularly important if you have impaired adrenal function;
• you notice a worsening of symptoms or tearing, itching or redness of the eyes, due to severe allergy.

IN ALL THESE CASES CONSULT YOUR DOCTOR WHO MAY PRESCRIBE APPROPRIATE THERAPY.

Children and adolescents
In children using RINOCLENIL, height should be measured regularly as long-term treatment with nasal corticosteroids may lead to a slowing of growth. If this occurs, consult your doctor as it may be necessary to modify the therapy.

Other medicines and RINOCLENIL
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
This is particularly important if you are using systemic medicines (e.g. tablets) or nasal medicines containing cortisone, as this may increase the risk of impaired adrenal function (adrenal suppression).
Some medicines can increase the effects of RINOCLENIL and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and 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 taking this medicine

Driving and operating machinery
RINOCLENIL does not impair the ability to drive or operate machinery.

RINOCLENIL contains35.1 micrograms of benzalkonium chloride per delivery which may cause irritation or swelling inside the nose, especially if used for a long period.
Attention for those who engage in sports: the product contains substances prohibited for doping. Taking it differently from the therapeutic indications, dosage regimen and route of administration is prohibited.

3. How to take RINOCLENIL

Take this medicine following exactly what is reported in this leaflet or the instructions of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.

Adults and children over 6 years
The recommended dose is 2 sprays (= 200 mcg of active substance) in each nostril, 1 time a day.
In children, if deemed appropriate, the doctor may also advise you to perform 1 spray (= 100 mcg of active substance) in each nostril, 2 times a day.
Do not use RINOCLENIL for more than one month, unless otherwise indicated by your doctor.
Children under 6 years:
Do not administer to children under 6 years of age.

Method of administration
Take RINOCLENIL nasally, carefully clean your nose before administration to ensure the successful delivery.
Before use, read carefully the following instructions, which indicate what to do and what to pay attention to.
Positive treatment outcome depends on the correct use of the nasal spray.

INSTRUCTIONS FOR USE OF YOUR NASAL SPRAY
Opening the package
When you open the box, the applicator is closed with the protective cap and the protective ring.
If you use RINOCLENIL for the first time, it is advisable to remove the protective cap, the protective ring and operate the dosing pump several times to activate the nebulization mechanism.

Taking a dose of RINOCLENIL
Before each administration: shake vigorouslythe bottle.
Figure 1 Perform a thorough cleaning of the nose.
Figure 2 Remove the protective cap.
Figure 3 Remove the protective ring that blocks the pump laterally.
Figure 4 Hold the bottle between your fingers. To activate the nebulization mechanism, operate the dosing pump several times until a visible spray is obtained.
Figure 5 Place the nasal applicator on one nostril, closing the other nostril with a finger.
Inhale and press the base of the nasal applicator simultaneously. In this way, a single dose accurately dosed of active substance is delivered. Repeat the same operation on the other nostril.
Figure 6 After use, replace the protective cap and the protective ring.

In case of occlusion of the applicator, wash it carefully with warm water, without intervening on the hole with sharp objects.

If you take more RINOCLENIL than you should
If you accidentally take excessive doses of RINOCLENIL, the risk of having undesirable effects is increased. In such cases, inform your doctor immediately, as appropriate measures may be necessary.

If you forget to take RINOCLENIL
Continue regularly with the therapy, without doubling the next dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them and the
risk of side effects.
If you use RINOCLENIL, especially in high doses and/or for prolonged periods of time, you may notice:
a burning sensation, irritation (possible sensitization phenomena), dryness of the nose;
nosebleeds (epistaxis), perforation of the nasal septum, increased eye pressure with possible worsening of vision (glaucoma), blurred vision (frequency not
known);
adrenal suppression (with symptoms such as loss of appetite, hypotension, abdominal pain,
weight loss, fatigue, headache, nausea, vomiting), weakening of the bones (osteoporosis),
stomach or duodenal ulcer (peptic).
IF YOU EXPERIENCE ANY OF THE ABOVE EFFECTS, STOP TAKING RINOCLENIL AND
CONSULT YOUR DOCTOR IMMEDIATELY.
In children and adolescents who take intranasal corticosteroids, delayed
growth has also been reported (frequency not known).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.aifa.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 RINOCLENIL

Keep this medicine out of sight and reach of children.
No special storage precautions are required.
Do not use this medicine after the expiry date which is stated on the pack after the words
EXP. The expiry date refers to the last day of that month. This refers to the product in intact packaging, correctly stored.
Do not dispose of any medicine in waste water 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 RINOCLENIL contains
The active ingredient is: beclometasone dipropionate.
Each container contains: 23.1 mg of beclometasone dipropionate (each spray contains 100
micrograms).
The other ingredients are: polysorbate 20, microcrystalline cellulose and sodium carboxymethylcellulose,
benzalkonium chloride, phenylethyl alcohol, glucose (dextrose) monohydrate, purified water.

Description of the appearance of RINOCLENIL and contents of the pack
This medicine is a suspension, available in a 30 ml bottle equipped with a dosing pump and
nasal applicator.
RINOCLENIL is sufficient for at least 200 sprays of 100 micrograms of beclometasone.

Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A. – Via Palermo, 26/A – Parma.

Manufacturer
Manufacturer responsible for batch release
ZETA Farmaceutici S.p.A. via Galvani, 10 36066 Sandrigo (VI)

Alternative manufacturers responsible for batch release
Chiesi Farmaceutici S.p.A. – Parma Manufacturing Plant, Via S. Leonardo, 96