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 monohydrate 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 Inhaler CFC-FREE. This is an inhaler and 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 with asthma or 'chronic obstructive pulmonary disease' (COPD), often referred to as chronic bronchitis. You may have difficulty breathing, shortness of breath, wheezing or tightness in your chest. ATROVENT works by opening up your airways.
3. HOW TO USE ATROVENT INHALER CFC-FREE Always use ATROVENT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Follow these instructions to get the best results. If anything is unclear after reading this leaflet, ask your doctor or pharmacist. How much to use Adults (including the elderly)
2. BEFORE YOU USE ATROVENT INHALER CFC-FREE Do not use ATROVENT if:
Testing Your Inhaler To make sure that your inhaler is working, test fire it twice into the air before using it for the first time and whenever your inhaler has not been used for 3 days or more.
Take special care with ATROVENT Check with your doctor or pharmacist before using this medicine if:
2
Hold the inhaler as shown in the picture (with the arrow on the label pointing upwards) and breathe out gently.
3
your inhaler Read through numbers 1 to 6 first, before starting to use your inhaler.
1
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any inhalers and medicines obtained without a prescription. This includes herbal medicines. This is because ATROVENT can affect the way some other medicines work. Also some other medicines can affect the way ATROVENT works. In particular, tell your doctor or pharmacist if you are taking/ have taken any of the following medicines:
4
Remove the cap from the mouthpiece.
1…2…3… 4…5…6…7… 8…9…10
5
6
After use, replace the cap on the mouthpiece.
The mouthpiece has been designed specially for use with this product only. Do not use any other mouthpiece with the product and do not use the mouthpiece provided here with any other product. If you find breathing in and pressing the inhaler at the same time (step 3) difficult you should talk to your doctor or pharmacist, as you could use a spacer device (Aerochamber PlusTM) with your inhaler. A spacer is a device designed to make step 3 easier. A spacer is generally a plastic container with a mouthpiece at one end and a hole for inserting the mouthpiece of the inhaler at the other end. The puff of medicine from your inhaler is sprayed into the spacer and the puff of medicine stays there, inside the spacer, until you breathe in through your mouth from the spacer with the spacer mouthpiece in your mouth and with your lips closed around it. This means that you do not have to worry about breathing in and pressing the inhaler at the same time.
ATROVENT contains alcohol This medicine contains about 8 mg of alcohol (ethanol) in each puff. The amount in each puff of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
P003469-017
Mandatory in
File information
TD
Printfile
Issue date of TD:
22.11.2012
Yes
Yes
PPM SKU:
P003469
No
Yes
PPM SKU version:
017
No
Yes
Issue date of artwork:
01.11.2024
No
Yes
Print colors:
BLACK
No
Yes
Mat. No. Pack. Site:
P003469-017
No
Yes
Min. font size:
9 pt
Legend case version:
V4.0 01/OCT/2012 (please do not change or remove it)
Perigord No : 844444 P2
Technical information a = Batch No.
b = Expiry date
c = Manufacturing date
d = Price/Sample/Clinic
Technical colors BI-Diecut-Legendcase
Free area
Gluepoints
Additional Requirements of Packaging site Template name: TD-PI_190x420
Index: c
Example Technical information Control Code Type: Laetus Code
When using your ATROVENT Inhaler CFC-Free take care not to let any of the spray enter your eyes. If any of the spray 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. You may be developing glaucoma, which will need treatment straight away.
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 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.
Cleaning It is important to clean your inhaler regularly. Otherwise it may not work properly.
Like all medicines, ATROVENT can cause side effects, although not everybody gets them. Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
ATROVENT should not be stored above 25°C. Keep away from direct sunlight and heat. Protect from frost. The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not try to open, puncture or burn the canister even when apparently empty. Keep out of the sight and reach of children. 6. FURTHER INFORMATION What ATROVENT INHALER CFC-FREE contains Each inhaler contains 200 puffs. Each puff contains 20 micrograms of ipratropium bromide (as the monohydrate). The other ingredients are: HFA 134a (1,1,1,2 – tetrafluoroethane), citric acid anhydrous, ethanol anhydrous and purified water. This medicine contains fluorinated greenhouse gases. Each inhaler contains 12.33g of HFA-134a corresponding to 0.01763 tonne CO2 equivalent (global warming potential GWP = 1430). What ATROVENT INHALER CFC-FREE looks like and contents of the pack Your medicine is an inhaler, which contains a pressurised solution for inhalation. Each carton contains one inhaler. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation is held by: Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berks., RG12 8YS, United Kingdom. and the product is manufactured by: Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany. This leaflet was revised in November 2024. © Boehringer Ingelheim Ltd 2024
ATROVENT INHALER CFC-FREE Do not use this medicine after the expiry date which is stated on the carton and the canister label. The expiry date refers to the last day of the month.
Atrovent Inhaler CFC-Free comes as inhaler. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Atrovent Inhaler CFC-Free is ipratropium bromide monohydrate.
This leaflet reproduces the patient information leaflet approved for Atrovent Inhaler CFC-Free, 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 Inhaler CFC-Free is indicated for the regular treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD) and chronic asthma.
For inhalation use.
Adults (including the elderly):
Usually 1 or 2 puffs three or four times daily, although some patients may need up to 4 puffs at a time to obtain maximum benefit during early treatment.
Children:
6-12 years of age:
Usually 1 or 2 puffs three times daily.
< 6 years of age:
Usually 1 puff three times daily.
In order to ensure that the inhaler is used correctly, administration should be supervised by an adult.
The recommended dose should not be exceeded.
If therapy does not produce a significant improvement, if the patient's condition gets worse or if a reduced response to treatment becomes apparent, medical advice must be sought. The patient should be instructed that in the case of acute or rapidly worsening dyspnoea a physician should be consulted immediately.
Administration
The correct administration of ipratropium bromide from the inhaler is essential for successful therapy. For detailed information on instructions for use please refer to the Patient Information Leaflet.
The canister should be pressed twice to release two metered doses into the air before the inhaler is used for the first time, or when the inhaler has not been used for 3 days or more, to ensure that the inhaler is working properly and that it is ready for use.
Before each occasion on which the inhaler is used the following should be observed:
1. Remove protective cap.
2. Hold the inhaler upright (the arrow on the base of the container should be pointing upwards), breathe out gently and then close the lips over the mouthpiece
3. Breathe in slowly and deeply, pressing the base of the canister firmly at the same time; this releases one metered dose. Hold the breath for 10 seconds or as long as is comfortable, then remove the mouthpiece from the mouth and breathe out slowly.
4. If a second inhalation is required you should wait at least one minute and then repeat Points 2 and 3 above.
5. Replace the protective cap after use.
The inhaler can be used with the Aerochamber Plus™ spacer device. This may be useful for patients, e.g. children, who find it difficult to synchronise breathing in and inhaler actuation.
The canister is not transparent. It is therefore not possible to see when it is empty. The inhaler will deliver 200 puffs. When the labelled number of doses have been used (usually after 3 – 4 weeks of regular use) the inhaler may still appear to contain a small amount of fluid. However the inhaler should be replaced so that you can be certain that you are getting the right amount of your medicine in each actuation.
WARNING:
The plastic mouthpiece has been specially designed for use with ATROVENT Inhaler CFC-Free to ensure that each metered dose contains the correct amount of medicine. The mouthpiece must never be used with any other pressurised inhalation, solution nor must ATROVENT Inhaler CFC-Free be used with any mouthpiece other than the one supplied with the product.
The mouthpiece should always be kept clean. To clean the mouthpiece, the canister and dustcap must be removed. The mouthpiece should then be washed in warm soapy water, rinsed and allowed to air-dry without using any heating system. Care should be taken to ensure that the small hole in the mouthpiece is flushed through thoroughly. The canister and dustcap should be replaced once the mouthpiece is dry.
ATROVENT Inhaler CFC-Free is 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.
Hypersensitivity
Hypersensitivity reactions following the use of ipratropium bromide have been seen and have presented as 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 Inhaler CFC-free 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 intraocular 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. Thus patients must be instructed in the correct administration of ATROVENT Inhaler CFC-Free and warned against the accidental release of the contents into the eye. Since the inhaler is applied via mouth piece and manually controlled, the risk for the mist entering the eyes is limited. Antiglaucoma therapy is effective in the prevention of acute narrow-angle glaucoma in susceptible individuals and patients who may be susceptible to glaucoma should be warned specifically on the need for ocular protection.
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 should be informed when starting treatment that the onset of action of ipratropium bromide is slower than that of inhaled sympathomimetic bronchodilators.
Renal and urinary effects
ATROVENT Inhaler CFC-free 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 gastrointestinal motility disturbances, ipratropium bromide, as with other anticholinergics, should be used with caution in these patients.
Excipients
This medicine contains about 8 mg of alcohol (ethanol) in each actuation.
The amount in each actuation of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
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 ipratropium bromide with beta-adrenergic drugs and xanthine preparations may produce an additive bronchodilatory effect.
There is no experience of the use of this product in pregnancy and lactation in humans. It should not be used in pregnancy or lactation unless the expected benefits to the mother are thought to outweigh any potential risks to the fetus or neonate.
Pregnancy
The safety of ipratropium bromide during human pregnancy has not been established. The benefits of using ipratropium bromide 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.
Studies of HFA-134a administered to pregnant and lactating rats and rabbits have not revealed any special hazard.
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
Common
e.g. Diarrhoea
Constipation
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 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 ipratropium bromide, 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. 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. 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 Inhaler CFC-Free. 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.
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