20 micrograms / dose inhalation spray , solution of 
ipratropium bromide

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Atrovent is and what it is used for 
2. What you need to know before you use Atrovent 
3. How to use Atrovent 
4. Possible side effects 
5. How to store Atrovent 
6. Contents of the packaging and other information

1. What Atrovent is and what it is used for

Atrovent has a tracheal dilating effect. Atrovent has an effect within 15 minutes after inhalation. The maximum effect is reached after 1-2 hours. The effect lasts for up to 6 hours.

Atrovent is used in asthma and chronic obstructive pulmonary disease (COPD), which is a chronic respiratory disease with difficulty breathing. Ipratropium bromide found in Atrovent may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you use Atrovent

Do not use Atrovent:

  • if you are allergic to ipratropium bromide or any of the other ingredients of this medicine (listed in section 6).
  • in case of hypersensitivity to atropine or similar substances, eg hyoscyamine or scopolamine.

Warnings and cautions

Talk to your doctor or pharmacist before using Atrovent:

  • if you have glaucoma with a narrow ventricular angle.
  • if you have prostate enlargement or bladder narrowing.
  • if you have cystic fibrosis. In people with cystic fibrosis, the risk of developing bowel function may increase.

Stop taking Atrovent and contact a doctor immediately if:

  • you get a severe allergic reaction (see section 4 Possible side effects ).
  • after inhalation of the medicine, you suddenly have a spasm in the airways (see section 4 Possible side effects ).

Do not inhale more than your doctor prescribes. Always consult a doctor if breathing difficulties persist or worsen despite treatment. In the case of acute deterioration of lung function, a doctor should be consulted immediately.

In rare cases, eye problems (pupillary enlargement, the pressure increase in the eye, glaucoma with a narrow ventricular angle, eye pain) have been reported when Atrovent comes into contact with the eyes. It is therefore important to use Atrovent inhalation spray according to the instructions, especially for patients who have glaucoma with a narrow ventricular angle. If Atrovent accidentally gets into the eyes, the eyes should be rinsed with running water.

Pain or discomfort from the eyes, visual phenomena, and at the same time red eyes can be signs of acute glaucoma with a narrow ventricular angle. Seek an ophthalmologist immediately in such cases.

Atrovent can cause dry mouth, which in long-term treatment can lead to tooth and oral mucosal damage. Teeth should be thoroughly cleaned with fluoride toothpaste twice daily.

Other drugs and Atrovent

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tracheal dilators of a different type (so-called beta-2 stimulators, ie medicines containing eg salbutamol or terbutaline ) and medicines containing theophylline or similar substances may potentiate the effect of Atrovent. In one who is suffering from glaucoma with a narrow chamber angle, the combination of Atrovent and beta-2-agonists increases the risk of acute glaucoma.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Limited experience of use during pregnancy. Therefore, consult a physician if you use Atrovent more than temporarily during pregnancy.

It is not known if Atrovent passes into breast milk. Therefore, consult a physician before regular use during breast-feeding.

Driving and using machines

Atrovent can cause dizziness and blurred vision. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Atrovent

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Atrovent inhalation spray is primarily intended for regular use.

The recommended dose for adults (including the elderly) and children over 6 years:

2 inhalations are 4 times daily. Max 12 inhalations / day.

Contact a doctor if you feel that the maximum dose is not enough.

Use for children

Experience in treating children is limited. Treatment of children under the age of 12 should therefore take place under the supervision of healthcare professionals.

Instructions for use

Before a new Atrovent inhalation spray is used for the first time or not used for 3 days, two doses should be expelled into the air.

Do this every time Atrovent inhalation is used:

  1. Remove the protective cap from the nozzle.
  2. Exhale deeply (outside the inhaler).
  3. Hold the inhalation spray vertically with the bottom facing up (Fig. 1) and close your lips around the mouthpiece. Fig. 1
  4. Inhale deeply and at the same time press the bottom of the inhalation spray (this releases a dose ).
  5. Hold your breath for a few seconds, then take one inhalation spray from your mouth and exhale.
  6. Replace the protective cap.

The container is opaque. It is therefore not possible to see when it is empty. Each pack gives 200 doses. When these doses have been consumed, the bottle still appears to contain a small amount of liquid. However, the packaging should be replaced with a new one to be sure of getting the right dose.

The nozzle should be cleaned at least once a week by first removing the cap and removing the medicine container and then rinsing the nozzle with warm water until no drug or dirt residue can be seen. Allow to air dry and then insert the medicine container and put on the lid.

The nozzle has been designed to deliver the right dose of Atrovent. Other nozzles should not be used for Atrovent, nor should the Atrovent nozzle be used for other medicines.

There is overpressure in the aerosol bottle. It must not be exposed to force or temperature above 50 ° C.

4. Possible side effects

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

Stop taking Atrovent and contact a doctor immediately if:

  • you get swelling of the face, tongue, or throat, difficulty swallowing, hives, difficulty breathing, or a sudden feeling of fainting. This may be a sign of an allergic reaction or angioedema.
  • after inhalation of the medicine, you experience sudden, acute wheezing or shortness of breath (respiratory cramps).

This may occur in less common cases in connection with the use of Atrovent.

Common (may affect up to 1 in 10 people): Dizziness, headache, cough, irritation of the throat, disorders of intestinal function, dry mouth (careful oral hygiene is important), nausea.

Uncommon (may affect up to 1 in 100 people): Hypersensitivity. Ocular disorders such as glaucoma, pressure increases in the eye, visual disturbances, mydriasis, eye pain. Cardiac arrhythmia ( supraventricular tachycardia ), palpitations, cramping of the larynx, swelling of the throat, dry throat, swelling of the oral mucosa, vomiting, diarrhea, constipation, inflammation of the oral mucosa, rash, itching, difficulty urinating.

Rare (may affect up to 1 in 1,000 people): Difficulty adjusting vision at different distances, atrial fibrillation, increased heart rate, hives.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Atrovent

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

The spray container must not be exposed to direct sunlight, heat, or frost.

There is overpressure in the aerosol bottle. It must not be exposed to force or temperature above 50 ° C.

Do not use this medicine after the expiry date which is stated on the label. The expiration date is the last day of the specified month.

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

6. Contents of the packaging and other information

Content declaration

The active substance is ipratropium bromide monohydrate equivalent to 20 micrograms of anhydrous ipratropium bromide per dose.

-The other ingredients are anhydrous ethanol, anhydrous citric acid, purified water, and propellant norflurane (HFA 134a).

Marketing Authorization Holder and Manufacturer

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

Information is provided by

Boehringer Ingelheim AB

Box 92008

120 06 Stockholm

Tel 08-721 21 00

email: info.sto@boehringer-ingelheim.com

Muhammad Nadeem

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