Rinoclenil

Package leaflet: Information for the patient

RINOCLENIL 50 micrograms nasal spray, suspension

Beclometasone dipropionate
Please read this entire leaflet carefully before using this medicine, as it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement, 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 using RINOCLENIL
3. How to use RINOCLENIL
4. Possible side effects
5. How to store RINOCLENIL
6. Contents of the pack and other information

1. What RINOCLENIL is and what it is used for

RINOCLENIL is a medicine containing beclometasone dipropionate, an active substance belonging to the corticosteroid group, which reduces swelling and inflammation of the airways.
RINOCLENIL is used to treat or prevent nasal inflammation (rhinitis) caused by allergies (both seasonal and perennial) or by vasomotor disorders, which may cause: sneezing, runny nose, itching, nasal congestion, and reduced sense of smell.

2. What you should know before taking RINOCLENIL

Do not take RINOCLENIL if:

• you are allergic (hypersensitive) to beclomethasone dipropionate or to 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 affecting the nose (localized).

RINOCLENIL is not suitable for children under 6 years of age.
Warnings and precautions
Talk to your doctor before taking RINOCLENIL if:

• you are being treated with corticosteroids, as undesirable effects due to the passage of the drug into the bloodstream may occur;
• you have inflammation of the nose or nasal cavities including the paranasal sinuses caused by microorganisms;
• you have nasal ulcers;
• you have recently had trauma or surgery to the nose.

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

• you are switching from treatment with systemic corticosteroids (e.g. tablets) to treatment with RINOCLENIL; this is particularly important if you have adrenal gland function impairment;
• you notice 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 AN APPROPRIATE TREATMENT.
Children and adolescents
In children using RINOCLENIL, height should be monitored regularly, as long-term treatment with nasal corticosteroids may cause slowed growth. In such cases, consult your doctor, as therapy adjustment may be necessary.
Other medicines and RINOCLENIL
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is particularly important if you are using systemic (e.g. tablets) or nasal medications containing cortisone, as this may increase the risk of adrenal function impairment (adrenal suppression).
Some medicines may increase the effects of RINOCLENIL, and your doctor may wish to closely monitor you if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
RINOCLENIL does not affect the ability to drive vehicles or operate machinery.
RINOCLENIL contains 35.1 micrograms of benzalkonium chloride per spray dose, which may cause irritation or swelling inside the nose, especially if used for prolonged periods.
Attention for athletes: The product contains substances prohibited for doping. Any use differing from the therapeutic indications, dosage regimen, or route of administration specified is forbidden.

3. How to take RINOCLENIL

Take this medicine exactly as stated 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 of age
The recommended dose is 2 sprays (= 100 mcg of active substance) in each nostril, twice daily. Once symptoms have improved, the number of sprays may be reduced.
In some cases, your doctor may instruct you to use 1 spray (= 50 mcg of active substance) in each nostril, 3–4 times daily.
The maximum daily dose for adults should not exceed 8 sprays (400 micrograms).
Do not use RINOCLENIL for longer than one month unless otherwise directed by your doctor.

Children under 6 years of age
Do not administer to children under 6 years of age.

Method of administration
Use RINOCLENIL by nasal administration. Clean your nose thoroughly before administration to ensure proper delivery.

Before use, carefully read the following instructions, which explain what to do and what to pay attention to.
Successful treatment depends on correct use of the nasal spray.

INSTRUCTIONS FOR USING YOUR NASAL SPRAY

Opening the package
When you open the box, the dispenser is closed with the protective cap and the safety ring.
If you are using RINOCLENIL for the first time, remove the protective cap, the safety ring, and then prime the pump by actuating it several times to activate the spray mechanism.

Taking a dose of RINOCLENIL
Before each administration: shake the bottle vigorously.
Figure 1: Clean your nose carefully.
Figure 2: Remove the protective cap.
Figure 3: Remove the safety ring laterally to release the pump.
Figure 4: Hold the bottle between your fingers. To activate the spray mechanism, press the pump several times until a visible spray is produced.
Figure 5: Place the nasal nozzle into one nostril, closing the other nostril with a finger. Inhale and simultaneously press the base of the nasal nozzle. This delivers a single, precisely measured dose of the active substance. Repeat the same procedure in the other nostril.
Figure 6: After use, replace the protective cap and the safety ring.

If the dispenser becomes blocked, clean it thoroughly with lukewarm water. Do not use sharp objects to clear the nozzle.

If you take more RINOCLENIL than you should
If you accidentally take an excessive dose of RINOCLENIL, the risk of experiencing adverse effects increases. In such cases, contact your doctor immediately, as appropriate measures may be necessary.

If you forget to take RINOCLENIL
Continue your treatment as usual. Do not double the next dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Following the instructions in this leaflet reduces the risk of side effects.

If you use RINOCLENIL, especially at high doses and/or for prolonged periods, you may experience:

• nasal burning sensation, irritation (possible sensitisation reactions), dryness of the nose;
• nosebleeds (epistaxis), nasal septum perforation, 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), bone weakening (osteoporosis), stomach or duodenal (peptic) ulcer.

IF YOU EXPERIENCE ANY OF THE ABOVE EFFECTS, STOP USING RINOCLENIL AND CONTACT YOUR DOCTOR IMMEDIATELY.

In children and adolescents taking intranasal corticosteroids, growth retardation has also been reported (frequency not known).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via 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 special storage conditions.
Do not use this medicine after the expiry date stated on the carton after the word EXP. The expiry date refers to the last day of that month. This date applies to the product in its original, undamaged packaging and stored correctly.
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 RINOCLENIL contains
The active substance is: beclometasone dipropionate.
Each container contains: 11.55 mg of beclometasone dipropionate (each spray delivers 50 micrograms).
The other components 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 metering pump and nasal applicator.
RINOCLENIL provides at least 200 sprays of 50 micrograms of beclometasone.

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

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

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

Patient information leaflet

RINOCLENIL 100 micrograms nasal spray, suspension

Beclometasone dipropionate
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement 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 using RINOCLENIL
3. How to use RINOCLENIL
4. Possible side effects
5. How to store RINOCLENIL
6. Contents of the pack and other information

1. What RINOCLENIL is and what it is used for

RINOCLENIL is a medicine containing beclometasone dipropionate, an active substance belonging to the corticosteroid group that reduces swelling and inflammation of the airways.
RINOCLENIL is used to treat or prevent nasal inflammation (rhinitis) caused by allergies (both seasonal and perennial) or vasomotor disturbances, which may cause: sneezing, runny nose, itching, nasal congestion, and reduced 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 to 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 affecting the nose (localized);

RINOCLENIL is not suitable for children under 6 years of age.
Warnings and precautions
Talk to your doctor before taking RINOCLENIL if:

• you are being treated with corticosteroids, as undesirable effects due to the passage of the drug into the bloodstream may occur;
• you have inflammation of the nose or nasal cavities in general (paranasal sinuses) caused by microorganisms;
• you have nasal ulcers;
• you have had trauma or surgery to the nose.

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

• you are switching from treatment with systemic corticosteroids (e.g. tablets) to treatment with RINOCLENIL; this is particularly important if you have adrenal gland function impairment;
• you notice 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 AN APPROPRIATE TREATMENT.
Children and adolescents
In children using RINOCLENIL, regular height monitoring is necessary, as long-term treatment with nasal corticosteroids may cause slowed growth. In such a case, consult your doctor, as it may be necessary to adjust the treatment.
Other medicines and RINOCLENIL
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
This is particularly important if you are using systemic (e.g. tablets) or nasal medications containing cortisone, as this may increase the risk of adrenal function impairment (adrenal suppression).
Some medicines may increase the effects of RINOCLENIL, and your doctor may decide to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
RINOCLENIL does not affect the ability to drive vehicles or operate machinery.
RINOCLENIL contains 35.1 micrograms of benzalkonium chloride per spray, which may cause irritation or swelling inside the nose, especially if used for a prolonged period.
Caution for athletes: The product contains substances prohibited in doping. Any use differing from the therapeutic indications, dosage regimen, or route of administration specified is forbidden.

3. How to take RINOCLENIL

Take this medicine exactly as stated 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 of age
The recommended dose is 2 sprays (= 200 mcg of active substance) in each nostril, once daily.
In children, if considered appropriate, your doctor may instruct you to administer 1 spray (= 100 mcg of active substance) in each nostril, twice daily.
Do not use RINOCLENIL for longer than one month unless otherwise directed by your doctor.
Children under 6 years of age:
Do not administer to children under 6 years of age.
Method of administration
RINOCLENIL is for nasal use. Before administration, carefully clear the nose to ensure proper delivery.
Before use, read the following instructions carefully, as they indicate what to do and what to pay attention to.
Successful treatment outcome depends on correct use of the nasal spray.
INSTRUCTIONS FOR USING YOUR NASAL SPRAY
Opening the package
When you open the box, the dispenser is closed with the protective cap and the safety ring.
If you are using RINOCLENIL for the first time, remove the protective cap and the safety ring, then prime the pump by actuating it several times to activate the spray mechanism.
Taking a dose of RINOCLENIL
Before each administration: shake the bottle vigorously.
Figure 1 Carefully clear the nose.
Figure 2 Remove the protective cap.
Figure 3 Remove the safety ring laterally to unblock the pump.
Figure 4 Hold the bottle between your fingers. To activate the spray mechanism, press the pump several times until a visible spray is produced.
Figure 5 Place the nasal applicator into one nostril, closing the other nostril with a finger. Inhale and press the base of the nasal applicator simultaneously. This delivers a single, precisely measured dose of the active substance. Repeat the same procedure in the other nostril.
Figure 6 After use, replace the protective cap and safety ring.

If the dispenser becomes blocked, clean it thoroughly with lukewarm water. Do not use sharp objects to clear the nozzle.
If you take more RINOCLENIL than you should
If you accidentally take an excessive dose of RINOCLENIL, the risk of experiencing adverse effects increases. In such cases, contact your doctor immediately, as appropriate measures may be necessary.
If you forget to take RINOCLENIL
Continue your treatment as usual. Do not double the next dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Following the instructions in this leaflet reduces the risk of side effects.

If you use RINOCLENIL, especially at high doses and/or for prolonged periods, you may experience:

• nasal burning sensation, irritation (possible sensitisation reactions), nasal dryness;
• nosebleeds (epistaxis), nasal septum perforation, 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), bone weakening (osteoporosis), peptic ulcer of the stomach or duodenum.

IF YOU EXPERIENCE ANY OF THE ABOVE EFFECTS, STOP USING RINOCLENIL AND CONTACT YOUR DOCTOR IMMEDIATELY.

In children and adolescents taking intranasal corticosteroids, growth retardation has also been reported (frequency not known).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report side effects directly via 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.
No special storage precautions are required.
Do not use this medicine after the expiry date stated on the pack after the word
EXP. The expiry date refers to the last day of that month. This date applies to the product in its original, undamaged packaging, correctly stored.
Do not dispose of any medicine 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 RINOCLENIL contains
The active substance is: beclometasone dipropionate.
Each container contains: 23.1 mg of beclometasone dipropionate (each spray delivers 100 micrograms).
The other components 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, supplied in a 30 ml bottle equipped with a metering pump and nasal applicator.
RINOCLENIL provides at least 200 sprays delivering 100 micrograms of beclometasone per spray.
Marketing Authorization Holder
Chiesi Farmaceutici S.p.A. – Via Palermo, 26/A – Parma.
Manufacturer
Batch release responsible manufacturer
ZETA Farmaceutici S.p.A., via Galvani, 10, 36066 Sandrigo (VI)
Alternative manufacturers responsible for batch release
Chiesi Farmaceutici S.p.A. – Parma facility, Via S. Leonardo, 96