21 micrograms / dose nasal spray / solution

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.
  • Contact the pharmacy staff if you need more information or advice.
  • 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.
  • Do not use Atrovent Nasal for more than 14 days without a doctor’s recommendation or if symptoms worsen or do not improve.

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

1. What Atrovent Nasal is and what it is used for

What is Atrovent Nasal
Atrovent Nasal contains ipratropium bromide, which belongs to the group of anticholinergics. When ipratropium bromide is sprayed into the nose, the amount of fluid (runny nose) that forms in the nasal mucosa decreases within 15 minutes.


What is Atrovent Nasal used for?

Atrovent Nasal is used in adults from 18 years of age to reduce the amount of runny nose in case of allergic rhinitis (which is caused by eg pollen) or non-allergic rhinitis (which can be triggered by eg temperature changes). The runny nose in these conditions is clear and watery. 

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 professionals if you have any further questions, and always follow their instructions.

What you need to know before using Atrovent Nasal

Do not use Atrovent Nasal

  • if you are allergic to ipratropium bromide, benzalkonium chloride, or any of the other ingredients of this medicine (listed in section 6)
  • if you are hypersensitive to atropine or similar substances, such as hyoscyamine or scopolamine

Warnings and cautions

Talk to your doctor or pharmacist before using Atrovent Nasal if you have any of the following symptoms:

  • prostate enlargement,
  • bladder narrowing (makes it difficult to empty the bladder)
  • eye disease glaucoma ( glaucoma ) with a narrow chamber angle
  • cystic fibrosis. In people with cystic fibrosis, the risk of developing bowel function may increase.

Try to avoid getting the spray in your eyes. If Atrovent Nasal is accidentally sprayed into the eyes, the eyes should be rinsed with running cold water. In rare cases, eye problems (pupillary enlargement, pressure increase in the eye, glaucoma with a narrow ventricular angle , eye pain) have been reported when Atrovent Nasal comes into contact with the eyes. 

Eye irritation and pain, visual phenomena and red, irritated eyes, may be signs of acute glaucoma with a narrow ventricular angle . Seek an ophthalmologist immediately in such cases. 

Atrovent Nasal can cause dry mouth, which increases the risk of damage to the teeth. To protect your teeth, you should use a toothpaste that contains fluoride and brush your teeth thoroughly twice a day.
 

Atrovent Nasal may in rare cases give rise to allergic reactions immediately after use. They may appear as hives or swelling of the upper respiratory tract.

Stop taking Atrovent Nasal and contact your doctor immediately if you get any of the following symptoms ( angioedema ):

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing.

Children and young people

Use in children and adolescents under 18 years of age is not recommended.

Other medicines and Atrovent Nasal

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

Do not use it at the same time as another nasal spray containing ipratropium bromide. 
The effect of Atrovent Nasal can be enhanced if you use other forms of Atrovent or other medicines with a similar effect (anticholinergic medicines) at the same time. Talk to your treating physician before using Atrovent Nasal.

In one who is suffering from glaucoma with narrow chamber angle , the combination of Atrovent Nasal and some bronchodilator drugs (beta-2 agonists, for example salbutamol and terbutaline ) increase 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.


Do not use Atrovent Nasal during pregnancy and lactation without a doctor’s recommendation.

Driving and using machines

Atrovent Nasal can cause dizziness and visual disturbances. If you get these side effects, avoid driving and using machines.

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.

Atrovent Nasal contains benzalkonium chloride

Atrovent Nasal contains the preservative benzalkonium chloride which may cause irritation of the nasal mucosa.

How to use Atrovent Nasal

Always use this medicine exactly as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure. The recommended dose for adults is:

2 sprays in each nostril 2-3 times daily.

Do not exceed the recommended dosage . 

Do not use Atrovent Nasal for more than 14 days without a doctor’s recommendation or if symptoms worsen or do not improve.


Instructions for use

Read the operating instructions carefully and follow the instructions.

1. Remove the protective cover.

2. Before using the nasal spray for the first time, spray several times in the air until an even shower comes from the spray bottle (see figure 1). Hold the bottle with your thumb against the bottom, middle finger, and index finger on each side of the tip. Make sure the bottle is upright and keep it away from the eyes (Figure 1). Press your thumb quickly and firmly against the bottom. The spray is now ready for use. If the pump has not been used for 24 hours, spray in the air again 1-2 times.

Figure 1

Figure 1

3. Sniff out the nose.

4. Close one nostril by placing a finger on the side of the nose. Bend your head slightly forward. Hold the bottle as in Figure 1 and insert the tip of the bottle into the other nostril (Figure 2). The tip of the bottle should be directed obliquely backward and outwards towards the nose wing.

Figure 2


Figure 2

5. Activate the nasal spray by pushing the thumb upwards quickly and firmly. Inhale deeply through the nose and exhale through the mouth.

6. After each spraying, remove the bottle from the nose and tilt the head back for a few seconds so that the spray is evenly distributed.

7. Repeat steps 4-6 in the same nostril.

8. Repeat steps 4-7 in the other nostril.

9. Replace the protective cover.
 

Cleaning: Clean the nasal spray regularly. Remove the protective cap, keep the tip under running lukewarm water for a few minutes, and let it dry. Spray according to point 2 and replace the protective cap.

4. Possible side effects

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

Contact a doctor immediately and stop using Atrovent Nasal if you notice any of the following:

  • Signs of an allergic reaction such as difficulty breathing, talking, or swallowing, swelling of the face, lips, tongue, or throat (has been reported, occurs in an unknown number of users)
  • respiratory or laryngeal spasm (may affect up to 1 in 100 people)
  • Palpitations and increased heart rate or disturbance of heart rhythm (may affect up to 1 in 100 people)
  • Visual disturbances, eye pain (including blurred vision, worsening of glaucoma, or increased pressure in the eye) (may affect up to 1 in 100 people)

Common (may affect up to 1 in 10 people):

Headache, nose irritation, nosebleeds, dry nose, throat irritation.


Uncommon (may affect up to 1 in 100 people):

Dizziness, dry mouth, dry mouth, nausea, intestinal dysfunction, inflammation of the oral mucosa, swelling of the oral mucosa, difficulty emptying the bladder.


Rare (may affect up to 1 in 1,000 people):

Itching, 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 Nasal

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

Store Atrovent Nasal with the protective cap tightly closed.
 

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.

The bottle should not be used more than 1 year after it was first opened.

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 (as ipratropium bromide monohydrate).
  • The other ingredients are purified water, sodium chloride, disodium edetate 0.5 mg / ml and benzalkonium chloride 0.25 mg / ml ( preservative ) and hydrochloric acid for pH adjustment.

What the medicine looks like and the contents of the pack

The pack contains about 180 doses = 15 ml. 

Marketing Authorization Holder and Manufacturer

Sanofi AB

Box 30052

104 25 Stockholm 

Manufacturer

Instituto De Angeli Srl

Loc. Prulli, 103 / C

I-50066 Reggello (FI)

Italy

Muhammad Nadeem

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