Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ipratropium bromide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR The name of your medicine is ATROVENT UDVs, 2 ml (called ATROVENT in the rest of this leaflet). You use it with a device called a 'nebuliser'. This changes your medicine into a mist for you to breathe in. ATROVENT contains a medicine called ipratropium bromide. This belongs to a group of medicines called anticholinergics which act as bronchodilators. It is used to make breathing easier for people who have breathing difficulties, such as in chronic asthma or chronic obstructive pulmonary disease (COPD).
ATROVENT can be taken at the same time as medicines called 'beta2-agonist bronchodilators' such as salbutamol. ATROVENT works by opening up your airways. 2. BEFORE YOU USE ATROVENT UDVs, 2 ml Do not use ATROVENT if:
In particular, tell your doctor or pharmacist if you are taking any of the following:
How many dose units Adults (including the elderly) and adolescents over 12 years
Mandatory in
File information
TD
Printfile
Issue date of TD:
10/JUL/2020
Yes
Yes
PPM SKU:
P012598
No
Yes
PPM SKU version:
006
No
Yes
Issue date of artwork:
22/JUL/2020
No
Yes
Print colors:
PAN BLACK
No
Yes
No
Yes
Mat. No. Pack. Site:
65NOT1011/E
Min. font size:
8.8 pt
Legend case version:
V4.0 01/OCT/2012 (please do not change or remove it)
Perigord No : 556370 p2
Technical information a = Batch No.
b = Expiry date
c = Manufacturing date
d = Price/Sample/Clinic
Technical colors BI-Diecut-Legendcase
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because ATROVENT can affect the way some other medicines work. Also some other medicines can affect the way ATROVENT works.
65NOT1011/E
Package leaflet: Information for the user
Free area
Gluepoints
MESSAGE TO OUR SUPPLIER : Page 1 is always the front side. The text direction can be in landscape or portrait.
Additional information Bottle pack :
4010/3-8-9-11
Dimension :
280 x 200 mm
Dimension of the leaflet after folding :
35 x 200 mm
direction of travel 1. Get your nebuliser ready by following the manufacturer's instructions. Ask your doctor if you are not sure how to use it. 2. • Open the pouch and remove the strip of unit dose vials. Carefully separate a new dose unit from the strip
Use a mouthpiece or a tight fitting mask. If any of the liquid or mist accidentally gets into your eyes you may get painful, stinging or red eyes, dilated pupils, blurred vision, see colours or lights. If this happens, talk to your doctor for advice. If you get problems with your eyes at any other time, talk to your doctor for advice.
Other side effects include:
If you use more ATROVENT than you should If you use more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
Uncommon (affects less than 1 in 100 people)
If you forget to use ATROVENT
Common (affects less than 1 in 10 people)
Rare (affects less than 1 in 1000 people)
5. HOW TO STORE ATROVENT UDVs, 2 ml Do not use this medicine after the expiry date which is stated on the carton and the vial label. The expiry date refers to the last day of the month. Store below 25°C. Keep vials in the outer carton in order to protect from light. Keep out of the sight and reach of children. 6. FURTHER INFORMATION What ATROVENT UDVs, 2 ml contain ATROVENT UDVs, 2 ml contain a nebuliser solution. Each single dose unit contains 500 micrograms of the active ingredient ipratropium bromide as Ipratropium Bromide monohydrate Ph. Eur. in 2 ml of solution. The other ingredients are: sodium chloride, hydrochloric acid and purified water. What ATROVENT UDVs, 2 ml looks like and contents of the pack Your medicine should be used with a nebuliser. This changes ATROVENT into a mist for you to breathe in. ATROVENT UDVs, 2 ml are available in cartons containing 20 and 60 single dose units. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for ATROVENT UDVs, 2 ml is held by: Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berks., RG12 8YS, United Kingdom. ATROVENT UDVs, 2 ml are manufactured by: Laboratoire Unither Espace Industriel Nord 151 rue André Durouchez – CS 28028 80084 Amiens Cedex 2, France This leaflet was revised in August 2020. © Boehringer Ingelheim Ltd 2020
65NOT1011/E
How to use your nebuliser Read through numbers 1 to 6 first, before starting to use your nebuliser.
direction of travel 1. Get your nebuliser ready by following the manufacturer's instructions. Ask your doctor if you are not sure how to use it. 2. • Open the pouch and remove the strip of unit dose vials. Carefully separate a new dose unit from the strip
Use a mouthpiece or a tight fitting mask. If any of the liquid or mist accidentally gets into your eyes you may get painful, stinging or red eyes, dilated pupils, blurred vision, see colours or lights. If this happens, talk to your doctor for advice. If you get problems with your eyes at any other time, talk to your doctor for advice.
Other side effects include:
If you use more ATROVENT than you should If you use more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
Uncommon (affects less than 1 in 100 people)
If you forget to use ATROVENT
Common (affects less than 1 in 10 people)
Rare (affects less than 1 in 1000 people)
your nebuliser Read through numbers 1 to 6 first, before starting to use your nebuliser.
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
ATROVENT UDVs, 2 ml Do not use this medicine after the expiry date which is stated on the carton and the vial label. The expiry date refers to the last day of the month. Store below 25°C. Keep vials in the outer carton in order to protect from light. Keep out of the sight and reach of children. 6. FURTHER INFORMATION What ATROVENT UDVs, 2 ml contain ATROVENT UDVs, 2 ml contain a nebuliser solution. Each single dose unit contains 500 micrograms of the active ingredient ipratropium bromide as Ipratropium Bromide monohydrate Ph. Eur. in 2 ml of solution. The other ingredients are: sodium chloride, hydrochloric acid and purified water. What ATROVENT UDVs, 2 ml looks like and contents of the pack Your medicine should be used with a nebuliser. This changes ATROVENT into a mist for you to breathe in. ATROVENT UDVs, 2 ml are available in cartons containing 20 and 60 single dose units. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for ATROVENT UDVs, 2 ml is held by: Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berks., RG12 8YS, United Kingdom. ATROVENT UDVs, 2 ml are manufactured by: Laboratoire Unither Espace Industriel Nord 151 rue André Durouchez – CS 28028 80084 Amiens Cedex 2, France This leaflet was revised in August 2020. © Boehringer Ingelheim Ltd 2020
65NOT1011/E
The active substance in Atrovent UDVs, 2 ml is ipratropium bromide.
This leaflet reproduces the patient information leaflet approved for Atrovent UDVs, 2 ml, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
ATROVENT UDVs are indicated for treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD).
ATROVENT UDVs are indicated, when used concomitantly with inhaled beta2-agonists, for treatment of reversible airways obstruction as in acute and chronic asthma.
The dosage should be adapted to the individual needs of the patient. In children aged 12 years and under, only ATROVENT 250 UDVs, 1 ml should be used. The following doses are recommended:
Adults (including the elderly) and adolescents > 12 years of age:
250 - 500 micrograms (i.e. one vial of 250 micrograms in 1 ml or 1 vial of 500 micrograms in 2 ml) 3 to 4 times daily.
For treatment of acute bronchospasm, 500 micrograms.
Repeated doses can be administered until the patient is stable. The time interval between the doses may be determined by the physician.
It is advisable not to exceed the recommended daily dose during either acute or maintenance treatment. Daily doses exceeding 2 mg in adults and adolescents > 12 years of age should only be given under medical supervision.
Children 6 - 12 years of age:
250 micrograms (i.e. one vial of 250 micrograms in 1ml) up to a total daily dose of 1mg (4 vials).
The time interval between doses may be determined by the physician.
Children 0 – 5 years of age (for treatment of acute asthma only):
125 – 250 micrograms (i.e. half to one vial of 250 micrograms in 1 ml) up to a total daily dose of 1 mg (4 vials).
Ipratropium bromide should be administered no more frequently than 6 hourly in children under 5 years of age.
For acute bronchospasm, repeated doses may be administered until the patient is stable.
The patient should be instructed that in the case of acute or rapidly worsening dyspnoea a physician should be consulted immediately.
Private purchase of nebuliser devices for use at home to deliver rescue therapy for the acute treatment of asthma in children and adolescents is not recommended.
Only specialists in respiratory medicine should initiate and clinically manage use of nebulisers and associated nebulised medicines at home for acute treatment of asthma in children and adolescents.
Children should be trained in the correct use of their device to deliver rescue therapy and use should be supervised by a responsible adult.
Urgent medical assistance should be sought if worsening asthma symptoms are not relieved by rescue medicines, even if there is short-term recovery following use of prescribed nebulised medication.
ATROVENT UDVs may be combined with a short-acting beta2-agonist in the same nebuliser chamber, for simultaneous administration where co-administration is required. The solution should be used as soon as possible after mixing and any unused solution should be discarded.
ATROVENT UDVs can be administered using a range of commercially available nebulising devices. The dose of nebuliser solution may need to be diluted in order to obtain a final volume suitable for the particular nebuliser being used (usually 2 – 4 mL); if dilution is necessary use only sterile sodium chloride 0.9% solution.
ATROVENT UDVs and disodium cromoglycate inhalation solutions that contain the preservative benzalkonium chloride should not be administered simultaneously in the same nebuliser as precipitation may occur.
The unit dose vials are intended only for inhalation with suitable nebulising devices and must not be taken orally or administered parenterally.
Please refer to the patient information leaflet for instructions on use with a nebuliser.
ATROVENT UDVs are contraindicated in patients with known hypersensitivity to atropine or its derivatives (such as the active substance ipratropium bromide) or to any other component of the product.
Use of the nebuliser solution should be subject to close medical supervision during initial dosing.
Hypersensitivity
Immediate hypersensitivity reactions following the use of ATROVENT have been demonstrated by cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.
Paradoxical bronchospasm
As with other inhalation therapy, inhalation induced bronchoconstriction may occur with an immediate increase in wheezing after dosing. This should be treated straight away with a fast acting inhaled bronchodilator. ATROVENT UDVs should be discontinued immediately, the patient assessed and, if necessary, alternative treatment instituted.
Ocular complications
Caution is advocated in the use of anticholinergic agents in patients predisposed to or with narrow-angle glaucoma.
There have been isolated reports of ocular complications (i.e. mydriasis, increased intra-ocular pressure, narrow-angle glaucoma, eye pain) when aerosolised ipratropium bromide, either alone or in combination with an adrenergic beta2-agonist, has come into contact with the eyes during nebuliser therapy.
Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
Patients must be instructed in the correct administration of ATROVENT UDVs. Care must be taken not to allow the solution or mist to enter the eyes. It is recommended that the nebulised solution is administered via a mouthpiece. If this is not available and a nebuliser mask is used, it must fit properly. Patients who may be predisposed to glaucoma should be warned specifically to protect their eyes.
Renal and urinary effects
ATROVENT UDVs should be used with caution in patients with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder-outflow obstruction).
Gastro-intestinal motility disturbances
As patients with cystic fibrosis may be prone to gastro-intestinal motility disturbances, ATROVENT, as with other anticholinergics, should be used with caution in these patients.
The chronic co-administration of ATROVENT inhalation with other anticholinergic drugs has not been studied. Therefore, the chronic co-administration of ATROVENT with other
anticholinergic drugs is not recommended.
There is evidence that the administration of ATROVENT with beta-adrenergic drugs and xanthine preparations may produce an additive bronchodilatory effect.
The risk of acute glaucoma in patients with a history of narrow-angle glaucoma (see section Special warnings and precautions for use) may be increased when nebulised ipratropium bromide and beta2-agonists are administered simultaneously.
Pregnancy
The safety of ATROVENT during human pregnancy has not been established. The benefits of using ATROVENT during a confirmed or suspected pregnancy must be weighed against the possible hazards to the unborn child. Nonclinical studies have shown no embryotoxic or teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man.
Lactation
It is not known whether ipratropium bromide is excreted into breast milk. It is unlikely that ipratropium bromide would reach the infant to an important extent, however caution should be exercised when ATROVENT is administered to nursing mothers.
Fertility
Clinical data on fertility are not available for ipratropium bromide. Nonclinical studies performed with ipratropium bromide showed no adverse effect on fertility (see section 5.3).
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as dizziness, accommodation disorder, mydriasis and blurred vision during treatment with ATROVENT. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.
Many of the listed undesirable effects can be assigned to the anticholinergic properties of ATROVENT. As with all inhalation therapy ATROVENT may show symptoms of local irritation.
Summary of the safety profile
The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastro-intestinal motility disorders (including constipation, diarrhoea and vomiting), nausea, and dizziness.
Tabulated summary of adverse reactions
The following adverse reactions have been reported during use of ATROVENT in clinical trials and during the post-marketing experience.
Frequencies
Very common
≥ 1/10
Common
≥ 1/100 < 1/10
Uncommon
≥ 1/1,000 < 1/100
Rare
≥ 1/10,000 < 1/1,000
Very rare
< 1/10,000
MedDRA System Organ Class
Adverse reaction
Frequency
Immune system disorders
Hypersensitivity
Uncommon
Anaphylactic reaction
Uncommon
Angioedema of tongue, lips & face
Uncommon
Nervous system disorders
Headache
Common
Dizziness
Common
Eye disorders
Blurred vision
Uncommon
Mydriasis (1)
Uncommon
Intraocular pressure increased (1)
Uncommon
Glaucoma (1)
Uncommon
Eye pain (1)
Uncommon
Halo vision
Uncommon
Conjunctival hyperaemia
Uncommon
Corneal oedema
Uncommon
Accommodation disorder
Rare
Cardiac disorders
Palpitations
Uncommon
Supraventricular tachycardia
Uncommon
Atrial fibrillation
Rare
Heart rate increased
Rare
Respiratory, thoracic and mediastinal disorders
Throat irritation
Common
Cough
Common
Bronchospasm
Uncommon
Paradoxical bronchospasm(2)
Uncommon
Laryngospasm
Uncommon
Pharyngeal oedema
Uncommon
Dry throat
Uncommon
Gastrointestinal disorders
Dry mouth
Common
Nausea
Common
Gastro-intestinal motility disorder
e.g. Diarrhoea
Constipation
Common
Uncommon
Uncommon
Vomiting
Uncommon
Stomatitis
Uncommon
Skin and subcutaneous tissue disorders
Rash
Uncommon
Pruritus
Uncommon
Urticaria
Rare
Renal and urinary disorders
Urinary retention(3)
Uncommon
(1) ocular complications have been reported when aerolised ipratropium bromide, either alone or in combination with an adrenergic beta2-agonist, has come into contact with the eyes – see section 4.4.
(2) as with other inhalation therapy, inhalation induced bronchoconstriction may occur with an immediate increase in wheezing after dosing. This should be treated straight away with a fast acting inhaled bronchodilator. ATROVENT UDVs should be discontinued immediately, the patient assessed and, if necessary, alterative treatment instituted.
(3) the risk of urinary retention may be increased in patients with pre-existing urinary outflow tract obstruction.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
No symptoms specific to overdosage have been encountered. In view of the wide therapeutic window and topical administration of ATROVENT, no serious anticholinergic symptoms are to be expected. As with other anticholinergics, dry mouth, visual accommodation disturbances and tachycardia would be the expected symptoms and signs of overdose.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Atrovent UDVs, 2 ml. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.