Rinovagos

Package leaflet: Information for the patient

Rinovagos 0.02 mg/spray nasal spray, solution

Ipratropium bromide
Please read this entire leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rinovagos is and what it is used for

RINOVAGOS contains the active substance ipratropium bromide, which is an anticholinergic medicine belonging to the class of decongestants and other topical nasal preparations – other rhinological preparations, administered locally on the nasal mucosa.
RINOVAGOS is used in adults to reduce watery nasal discharge in chronic inflammation of the nasal mucosa due to nasal hyperreactivity (cholinergic vasomotor rhinitis).

2. What you need to know before using Rinovagos

Do not use Rinovagos

• if you are allergic to ipratropium bromide or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic (sensitive) to atropine or substances similar to atropine
• if you have optic nerve disease with increased eye pressure (angle-closure glaucoma)
• if you have an enlarged prostate (prostatic hypertrophy)
• if you have difficulty urinating (urinary retention syndrome)
• if you have a blockage or severe impairment in the passage of food, fluids, digestive secretions, and gas through the intestine (intestinal obstruction)

Warnings and precautions
Talk to your doctor or pharmacist before using Rinovagos

• if you have a genetic condition causing thick and sticky bodily secretions (cystic fibrosis), which may clog the lungs, digestive system, and other organs, as gastrointestinal disturbances (altered intestinal motility) may occur
• if you are pregnant, suspect you may be pregnant, or are breastfeeding

Use of RINOVAGOS may cause bronchoconstriction leading to breathing difficulties (bronchospasm).
Use of RINOVAGOS may trigger severe allergic reactions (anaphylaxis).
Stop using RINOVAGOS and consult your doctor immediately:

• if you experience allergic reactions (immediate hypersensitivity reactions) such as red, swollen, itchy skin welts (urticaria) and/or swelling of the face, lips, tongue, and throat and respiratory tract (angioedema/oropharyngeal edema)
• if you experience eye pain (ocular pain), difficulty focusing images (accommodation disorders), eye redness, colored halos or colored vision, burning sensation or feeling of sand in the eyes, and light sensitivity (corneal irritation), as these may be symptoms of optic nerve disease with increased eye pressure (angle-closure glaucoma). If these symptoms occur, contact your doctor immediately and start treatment with pupil-dilating eye drops.

Be careful not to spray Rinovagos into your eyes. If this happens, rinse immediately with cold water for several minutes. You may experience difficulty focusing images clearly (accommodation disorders) and increased light sensitivity, which may last for several hours.
Rare cases of eye complications such as pupil dilation (mydriasis), increased eye pressure, eye pain, redness, colored halos or colored vision (angle-closure glaucoma) have been reported when RINOVAGOS alone or in combination with other medicines that relax smooth muscle (beta-agonists) were accidentally sprayed into the eyes.

Children
RINOVAGOS is contraindicated in children.

Other medicines and Rinovagos
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
RINOVAGOS may enhance the effects of other medicines containing anticholinergics.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
RINOVAGOS must not be used during pregnancy and breastfeeding.
There are no clinical data available on fertility with ipratropium bromide.

Driving and using machines
Exercise caution when driving or operating machinery, as unexpected side effects such as dizziness, difficulty focusing images clearly (accommodation disorders), and pupil dilation (mydriasis) may occur.

Rinovagos contains benzalkonium chloride
This medicine contains 0.014 mg of benzalkonium chloride per dose (0.070 ml spray), equivalent to 0.2 mg/ml.
Benzalkonium chloride may cause irritation and swelling inside the nose, especially if used for prolonged periods.

3. How to use Rinovagos

Use this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults:
The recommended dose is
2 sprays per nostril, three to four times a day.
The maximum daily dose is 8 sprays in each nostril.
Children: This medicine must not be used in children

Instructions for use
It is not necessary to shake the bottle before use.
Before using Rinovagos for the first time, spray 4 times into the air to prime the dosing pump until a visible mist is produced.
Proceed as follows:

1. Carefully clean your nose
2. Remove the safety clip
3. Remove the protective cap
4. Hold the bottle with the nasal applicator pointing upwards
5. Insert the applicator into one nostril and slightly tilt your head backwards
6. Press to release the spray
7. Repeat the procedure in the other nostril
8. Replace the protective cap
9. Reapply the safety clip

If Rinovagos has not been used for more than one week, repeat the priming procedure by spraying one or more times into the air until a visible mist is produced.
For optimal distribution of the product, direct one spray toward the upper part of the nostril and the other toward the lower part.

If you use more Rinovagos than you should
If RINOVAGOS is ingested or used at doses higher than recommended, non-severe systemic effects may occur, such as dry mouth, difficulty focusing clearly (accommodation disorders), and increased heart rate.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you forget to use Rinovagos
Do not use a double dose to make up for the missed dose.
If you stop using Rinovagos
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
RINOVAGOS may locally cause crusts (nasal dryness), slight blood streaks in nasal mucus (nasal discharge containing blood), nasal itching and/or burning.
As demonstrated by experimental studies, RINOVAGOS administered at doses higher than recommended may temporarily and reversibly cause dry mouth (xerostomia), headache (cephalalgia), difficulty in clearly focusing images (accommodation disorders), and urinary disorders.

• Nasal dryness (crusting)
• Nasal itching and/or burning
• Headache
• Accommodation disorders (visual discomfort when focusing)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://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 Rinovagos

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
This date applies to the product in its original, unopened packaging, correctly stored.
Do not use this medicine more than 90 days after first opening the bottle.
No special storage precautions are required for this medicine.
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 Rinovagos contains

• The active substance is ipratropium bromide. One vial contains 4 mg of ipratropium bromide (equivalent to 4.17 mg of ipratropium bromide hydrate). Each spray delivers 0.02 mg of ipratropium bromide.
• The other components are: benzalkonium chloride, hypromellose, polyethylene glycol 300, purified water.

Description of the appearance of Rinovagos and contents of the pack
Rinovagos is a nasal spray.
14 ml vial equipped with a metering pump (complete with nasal nozzle, protective cap, and safety clip) providing 200 sprays.
Marketing Authorization Holder and Manufacturer
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan