Atrovent

Package Leaflet: Information for the Patient

ATROVENT, 0.25 mg/ml, Solution for Nebulisation

Ipratropium Bromide

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Atrovent and what is it used for

Atrovent is a bronchodilator with anticholinergic action. Atrovent is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for asthma.

2. Important information before using Atrovent

When not to use Atrovent

• if you are allergic to atropine or its derivatives (such as the active substance ipratropium bromide) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Atrovent, discuss with your doctor:

• if you have narrow-angle glaucoma (increased pressure in the eye),
• if you have urinary retention,
• if you have cystic fibrosis: gastrointestinal motility disturbances may occur.

You should immediately contact your doctor:

• in case of bronchospasm induced by inhalation: you should immediately stop using Atrovent, as this may be life-threatening. You should consult a doctor who will prescribe other treatment.
• in case of eye complications, such as: eye pain or discomfort, blurred vision, seeing a rainbow around lights or changes in colour vision accompanied by eye redness, you should immediately consult a doctor who will assess whether these symptoms may be due to complications (pupil dilation, increased eye pressure, narrow-angle glaucoma).
• if breathing problems do not improve or worsen: you should contact your doctor, who will verify the treatment plan. The doctor may consider the need to add other medications.

Never use a higher dose than prescribed, as this may lead to severe side effects.

• after administration of the medicine, immediate-type hypersensitivity reactions may occur, as confirmed by rare cases of urticaria, angioedema (sudden swelling of the skin or mucous membranes, which can cause breathing difficulties), rash, bronchospasm, swelling of the mucous membrane of the mouth and throat, and rapidly progressing, life-threatening allergic reactions.

Do not allow the liquid or the spray during inhalation to get into your eyes. It is recommended to administer the spray from the nebulizer through a mouthpiece. If a mouthpiece is not available and a mask is used for nebulisation, it must be well fitted.

Atrovent and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Unless your doctor has told you otherwise, you should avoid concomitant, prolonged use of Atrovent with other medicines belonging to the so-called anticholinergic group.

Medicines that stimulate beta-2-adrenergic receptors and xanthine preparations (theophylline) may enhance the bronchodilating effect.

When using Atrovent and beta-adrenergic receptor stimulants concomitantly, there is a risk of acute glaucoma in patients with narrow-angle glaucoma (see section Warnings and precautions).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Although non-clinical studies have not shown any adverse effects of ipratropium bromide on the unborn child, Atrovent should only be used during pregnancy if your doctor considers it necessary.

It is not known whether ipratropium passes into breast milk. Therefore, Atrovent should only be used in breastfeeding women if your doctor considers it necessary.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. However, during treatment with Atrovent, side effects such as dizziness, blurred vision, pupil dilation, and blurred vision may occur. Therefore, caution is recommended when driving a car or operating machinery.

Atrovent contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride per ml of solution.

The medicine may cause respiratory distress and bronchospasm (especially in patients with asthma).

3. How to use Atrovent

Atrovent should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

20 drops = approximately 1 ml; 1 drop = 0.0125 mg anhydrous ipratropium bromide

Your doctor will adjust the dosage to your individual needs. The recommended dosage is:

Maintenance treatment:

Adults (including the elderly) and adolescents over 14 years:

2.0 ml (40 drops = 0.5 mg anhydrous ipratropium bromide) 3 to 4 times a day

Children from 6 to 14 years:

Since the amount of information on the use of the medicine in this age group is limited, inhalations according to the recommended dosage below should be performed under medical supervision:

1.0 ml (20 drops = 0.25 mg anhydrous ipratropium bromide) 3 to 4 times a day

Children under 6 years:

Since the amount of information on the use of the medicine in this age group is limited, inhalations according to the recommended dosage below should be performed under medical supervision:

0.4 – 1.0 ml (8 - 20 drops = 0.1 – 0.25 mg anhydrous ipratropium bromide) 3 to 4 times a day

Administration of a daily dose greater than 2 mg anhydrous ipratropium bromide in adults and adolescents over 14 years and 1 mg in children under 14 years should be performed under medical supervision.

Method of administration

Atrovent should be used exactly as described below:

Atrovent is intended for inhalation use with suitable nebulisers. Do not use Atrovent orally.Atrovent can be administered using commercially available nebulisers. Patients should follow the manufacturer's instructions for proper use, maintenance, and cleaning of the nebuliser.

The dosage may depend on the method of inhalation and the quality of nebulisation. The duration of inhalation can be adjusted by the volume of the diluted solution.

The recommended dose of the medicine should be diluted with physiological saline to a volume of 3 - 4 ml, sprayed using a nebuliser, and inhaled until the solution is used up. Do not dilute Atrovent with distilled water. The diluted solution should be used immediately after preparation. Unused, diluted solution should be discarded. The solution should be diluted just before each use.

The medicine can be used in combination with inhalations of medicines in the form of a solution for nebulisation that facilitate the discharge and thinning of mucus, e.g. Mucosolvan inhalations, solution for nebulisation.

Do not use Atrovent and cromoglycic acid disodium simultaneously in the same nebuliser, as this may cause precipitation.

Using a higher dose of Atrovent than recommended

If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.

Mild symptoms of ipratropium bromide overdose may occur, such as: dryness of the mucous membrane of the mouth, blurred vision, and increased heart rate.

Missing a dose of Atrovent

If you have been prescribed Atrovent for regular use and you miss a dose, take it as soon as possible. However, do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

Stopping treatment with Atrovent

If you stop using Atrovent, breathing difficulties may recur or worsen. Therefore, you should use Atrovent for as long as your doctor recommends.

In any case, consult your doctor before stopping treatment with Atrovent.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atrovent can cause side effects, although not everybody gets them.

As with all inhaled medicines, Atrovent may cause local irritation symptoms. The most common side effects reported in clinical trials were: headache, throat irritation, cough, dryness of the mucous membrane of the mouth, gastrointestinal motility disturbances (including constipation, diarrhoea, and vomiting), nausea, and dizziness.

The following side effects have been reported during clinical trials and post-marketing surveillance of Atrovent.

The frequency of side effects is given according to the following classification:

Very common: occurs in more than 1 in 10 patients

Common: occurs in more than 1 in 100, but less than 1 in 10 patients

Uncommon: occurs in more than 1 in 1000, but less than 1 in 100 patients

Rare: occurs in more than 1 in 10,000, but less than 1 in 1000 patients

Very rare: occurs in less than 1 in 10,000 patients

Frequency not known (cannot be estimated from the available data)

Common (occurs in more than 1 in 100, but less than 1 in 10 patients):

• headache,
• dizziness,
• throat irritation,
• cough,
• dryness of the mucous membrane of the mouth,
• nausea,
• gastrointestinal motility disturbances.

Uncommon (occurs in more than 1 in 1000, but less than 1 in 100 patients):

• rapidly progressing, life-threatening allergic reactions (anaphylactic reactions),
• hypersensitivity,
• angioedema (sudden swelling of the skin or mucous membranes, which can cause breathing difficulties),
• palpitations,
• supraventricular tachycardia (abnormally fast heartbeat),
• bronchospasm,
• inhalation-induced (paradoxical) bronchospasm,
• laryngospasm (sudden contraction of the vocal cords, which can affect breathing and speech),
• swelling of the mucous membrane of the throat (swelling of the upper part of the throat),
• blurred vision,
• pupil dilation,
• increased intraocular pressure,
• glaucoma,
• eye pain,
• halo vision,
• conjunctival congestion,
• corneal oedema (swelling of the protective outer layer of the eye),
• dry throat,
• diarrhoea,
• constipation,
• vomiting,
• stomatitis,
• swelling of the mouth,
• urinary retention,
• rash,
• pruritus.

Rare (occurs in more than 1 in 10,000, but less than 1 in 1000 patients):

• atrial flutter (very rapid, irregular heartbeat),
• increased heart rate,
• accommodation disorders (blurred vision),
• urticaria.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorisation holder or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atrovent

There are no special precautions for storage.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and carton after EXP.

The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Atrovent contains

• The active substance is ipratropium bromide (Ipratropii bromidum). 1 ml (20 drops) contains 261 micrograms of ipratropium bromide monohydrate, equivalent to 250 micrograms of anhydrous ipratropium bromide.
• The other ingredients are: benzalkonium chloride, disodium edetate dihydrate, sodium chloride, hydrochloric acid (to adjust pH), purified water.

What Atrovent looks like and contents of the pack

1 bottle contains 20 ml of solution for nebulisation.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim/Rhein

Germany

Manufacturer:

Istituto de Angeli S.r.l.

Localita Prulli, 103/C

I-50066 Reggello (FI)

Italy