PATIENT INFORMATION LEAFLET

Atrovent Nasal 0.30 mg/ml nasal spray solution

Ipratropium bromide

Read this leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Atrovent Nasalbelongs to a group of medications called anticholinergic bronchodilators, which act by relaxing the bronchial muscle, thusfacilitating air passage and thereforebreathing.

Rhinitis is aninflammation of the nasal mucosa.Atrovent Nasal is a medication used torelieve symptoms of rhinorrhea(nasal discharge)caused byrhinitis of allergic and non-allergic origin.

No use AtroventNasal

• If you are allergic (hypersensitive) to ipratropium bromide or substances similar to ipratropium such as atropine or its derivatives, or to any of the other components of Atrovent Nasal.

Tenga especial cuidado con AtroventNasal

• If you are predisposed to narrow-angle glaucoma (increased intraocular pressure), benign prostatic hyperplasia (prostate enlargement), or bladder neck obstruction (if the urethra is obstructed).
• If you have cystic fibrosis (a disease that alters the secretions of mucous and sweat glands, affecting various organs), you may be more prone to gastrointestinal motility disorders.

After administration of Atrovent Nasal, immediate hypersensitivity reactions (rapid-onset allergic reactions) such as urticaria, angioedema (sudden skin or mucous membrane swelling), pharyngeal edema (swelling in the mouth and throat), and anaphylaxis (generalized allergic reaction) may occur.

Isolated cases of eye complications, for example, mydriasis (pupil dilation), narrow-angle glaucoma (increased intraocular pressure), eye pain due to ipratropium bromide aerosol spray in the eyes alone or in combination with an adrenergic agonist (medications that dilate bronchial muscle, such as salbutamol), have been reported. Therefore, it is essential to follow the doctor's instructions strictly for the correct administration of Atrovent Nasal.

Eye pain or discomfort, blurred vision, halos (diffuse lights), or colored images, along with conjunctival congestion (inflammation of the conjunctiva) and corneal edema (loss of corneal transparency), may be signs of acute narrow-angle glaucoma (increased intraocular pressure). In case any combination of these symptoms is observed, the doctor should be notified immediately.

Uso de otros medicamentos

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

No increased risk of side effects has been described when using Atrovent Nasal with other medications, such as antihistamines (medications used to treat allergies), decongestants, or nasal steroids (medications used to reduce nasal mucosa inflammation), which are commonly prescribed for perennial rhinitis (year-round rhinitis). Although Atrovent Nasal passes into the bloodstream in minimal amounts, there is a possibility of potentiation of its effect if administered with other anticholinergic medications, including ipratropium bromide inhalation aerosols.

Embarazo

Consult your doctor or pharmacist before using any medication.

Although no risk has been demonstrated in preclinical studies, the safety of Atrovent Nasal during pregnancy has not been established. In case of suspected or confirmed pregnancy, the benefits of treatment should be weighed against the potential risks to the fetus.

Lactancia

Consult your doctor or pharmacist before using any medication.

The passage of ipratropium bromide into breast milk is unknown. However, it is unlikely that ipratropium bromide will pass to the infant in significant amounts, especially when administered nasally. Nevertheless, due to the possibility of many medications passing into breast milk, caution should be exercised in breastfeeding women.

Conducción y uso de máquinas

No studies are available on the effects on the ability to drive and use machines. However, it is warned that adverse effects such as dizziness, eye focusing difficulties, pupil dilation, and blurred vision may occur during treatment with Atrovent nasal. Therefore, caution is recommended when driving and using machines. If patients experience these effects, they should avoid potentially hazardous activities such as driving or using machines.

Atrovent Nasal contiene cloruro de benzalconio

This medication contains 0.25 mg of benzalkonium chloride in each ml.

Benzalkonium chloride may cause irritation or inflammation within the nose, especially when used for prolonged periods of treatment.

Follow exactly the administration instructions for Atrovent Nasal as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will determine the duration of treatment.

If you consider that the action of Atrovent Nasal is too strong or too weak, inform your doctor or pharmacist.

The administration of Atrovent Nasal should be adapted to the individual needs of each patient; patients should be under medical supervision during treatment.

The normal dose is:

Adults and adolescents over 12 years:2 sprays in each nasal cavity, 2-3 times a day.

Children from 6 to 12 years:2 sprays in each nasal cavity, 2 times a day.

However, the optimal dose may vary according to the individual response of each patient and should be established by the doctor.

Administration mode:

1) Remove the protective cap.

2) Before using the sprayer for the first time, pressseveral times(approximately 7 times) until the first nebulization is released (see figure 1). To activate the pump, hold the bottle with your thumb, index, and middle fingers.

Make sure the bottle is directed upwards and is away from your eyes. Press the bottle firmly and quickly with your thumb (figure 1). The pump will now be ready for use.

(figure 1)

If the pump has not been used for more than 24 hours, it must be reactivated with 1or2 sprays.

3) Before using the nasal sprayer, blow your nose to clean the nasal cavities.

4) Closewith a fingerone of the nasal cavities and tilt your head slightly forward. Hold the bottle as indicated in figure 1, insert the nasal applicator of the same into the other nasal cavity (see figure 2). Direct the applicator towards the posterior and external part of the nose.

(figure 2)

5) Activate the pump once, pressing firmly and quickly upwards with your thumb. After each spray, take a deep breath and exhale through your mouth.

6) After spraying and removing the applicator, tilt your head back for a few seconds to allow the spray to diffuse over the posterior part of the nose.

7) Apply another spray in the same nasal cavity following the same procedure.

8) Apply two sprays in the other nasal cavity following the same instructions.

9) Replace the protective cap after use.

If AtroventNasal has been sprayed accidentally onto your eyes, wash them immediately with cold water.

If the nasal applicator becomes clogged, remove the protective cap. Place the nasal applicator under the hot water tap for about a minute. Dry the nasal applicator, reactivate the pump (operation 2) and replace the protective cap.

If you use more Atrovent Nasal than you should

No specific symptoms of overdoseshave been described. Due to the wide safety marginandthe fact that the use ofAtroventNasalis topical, severe anticholinergic symptoms are not expected. Minor anticholinergic symptoms such as dry mouth, visual accommodation disorders, and increased blood pressure may occur.

If you have used more Atrovent Nasal than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

Like all medications, Atrovent Nasal can produce adverse effects, although not everyone will experience them.

The frequent adverse effects (occurring in at least 1 in 100 patients) are headache; throat irritation, nasal dryness, nasal bleeding, and nasal discomfort.

The infrequent adverse effects (occurring in at least 1 in 1,000 patients) are anaphylactic reactions (severe allergic reactions), hypersensitivity, dizziness, halos or colored images associated with eye redness (glaucoma), increased intraocular pressure, eye pain, pupil dilation, visual accommodation disorder (difficulty focusing the eye), blurred vision, halos or colored images, eye redness, corneal edema (corneal swelling), supraventricular tachycardia, atrial fibrillation, increased heart rate, dry mouth and throat, bronchospasm (chest tightness, wheezing, or shortness of breath), laryngospasm (larynx constriction causing breathing difficulty), pharyngeal edema (throat swelling), oral edema (mouth swelling), stomatitis (inflammation of the mouth), skin rash, angioedema (face, lip, mouth, tongue, or throat swelling that can cause difficulty swallowing or breathing), urinary retention, gastrointestinal motility disorders, and nausea.

The rare adverse effects (occurring in at least 1 in 10,000 patients) are palpitations, pruritus (itching), and urticaria.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use Atrovent Nasal after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

No special conservation conditions are required.

Do not use after 12 months of opening the packaging for the first time.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Atrovent Nasal

• The active ingredient is bromide of ipratropium. Each ml of solution contains 0.31 mg of bromide of ipratropium monohydrate (equivalent to 0.30 mg of bromide of anhydrous ipratropium). A free-flowing spray releases 21.7 micrograms of bromide of ipratropium monohydrate, equivalent to 21 micrograms of bromide of anhydrous ipratropium.
• The other components are: sodium chloride, benzalkonium chloride, disodium edetate, hydrochloric acid, and purified water.

Appearance of the product and contents of the package

Package with 15 ml (180 sprays) of nasal spray solution.

Marketing Authorization Holder

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)
Spain

Responsible for Manufacturing

Istituto De Angeli S.r.l.

Localita i Prulli

50066 Reggello (Florence)

or

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG

Birkendorfer Strasse, 65

D-88397 Biberach am der Riss

Germany

This leaflet was approved in July 2013

Detailed and updated information on this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/.