IPRAVENT Pressurised inhalation, solution Ref.[27780] Active ingredients: Ipratropium

Increasing use of any as required short-acting β₂ adrenoceptor agonist bronchodilators to relieve asthma symptoms, lack of relief from as required short-acting β₂ adrenoceptor agonist bronchodilators, short-acting bronchodilators becoming ineffective and/or increasing symptoms indicate deterioration of asthma control and patients should be reviewed by a doctor

It should be noted that an exacerbation of the clinical symptoms of asthma may be due to an acute respiratory tract bacterial infection and treatment may require appropriate antibiotics, an increase in the dose of any inhaled corticosteroids and/or a short course of oral conrticosteroids. A rapid acting, short acting inhaled β2 adrenoceptor agonist should always be available as rescue medication.

Hypersensitivity reactions following the use of ipratropium bromide have been seen and have presented as urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.

Caution is advocated in the use of anticholinergic agents in patients predisposed to or with narrow-angle glaucoma, or with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder-outflow obstruction).

As patients with cystic fibrosis may be prone to gastrointestinal motility disturbances, ipratropium bromide, as other anticholinergics, should be used with caution in these patients.

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 a β2 adrenoceptor agonist, has come into contact with the eyes. Thus patients must be instructed in the correct administration of ipratropium bromide and warned against the accidental release of the contents of the inhaler into the eye. Since ipratropium bromide is inhaled via a mouthpiece and with manual control, the risk of 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.

As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway. Ipravent CFC-Free Inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

This medicinal product contains a small amount of ethanol (8.4 mg in one single dose).

Ipratropium bromide has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in these patient populations.

There is evidence that the administration of ipratropium bromide with beta-adrenergic medicinal products 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. Preclinical studies have shown no embryotoxic or teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man.

Breastfeeding

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 ipratropium bromide is administered to nursing mothers.

Studies of HFA-134a administered to pregnant and lactating rats and rabbits have not revealed any special hazard.

Fertility

Preclinical studies performed with ipratropium bromide showed no adverse effect on fertility (see section 5.3). Clinical data on fertility are not available for ipratropium bromide. Therefore in case of planned pregnancy the product should be used with caution after consultation with doctor.

Ipratropium bromide has a moderate influence on the ability to drive or use machines.

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, blurred vision, visual halos and/or coloured images, red eyes, eye pain or discomfort during treatment with ipratropium bromide. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery and should contact their doctor straightaway.

If the eyes are affected in any way at all do not drive or operate machinery. Contact your doctor.

Many of the listed undesirable effects can be assigned to the anticholinergic properties of ipratropium bromide. As with all inhalation therapy ipratropium bromide may show symptoms of local irritation.

Adverse drug reactions were identified from data obtained in clinical trials and pharmacovigilance during post approval use of the medicinal product.

The most frequent side effects known from clinical trials were headache, throat irritation, cough, dry mouth, gastro-intestinal motility disorders (including constipation, diarrhea and vomiting), nausea, and dizziness.

Frequencies: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1,000 to <1/100, Rare ≥1/10,000 to <1/1,000, Very rare <1/10,000

Immune system disorder

Uncommon: Hypersensitivity¹, Anaphylactic reaction, Angioedema of tongue, lips and face

Nervous system disorders

Common: Headache, Dizziness

Eye disorders

Uncommon: Blurred vision, Mydriasis², Intraocular pressure increased², Glaucoma², Eye pain², Halo vision, Conjunctival hyperaemia, Corneal oedema

Rare: Accommodation disorder

Cardiac disorders

Uncommon: Palpitations, Supraventricular tachycardia

Rare: Atrial fibrillation, Heart rate increased

Respiratory, thoracic and mediastinal disorders

Common: Throat irritation, Cough

Uncommon: Bronchospasm, Paradoxical bronchospasm³, Laryngospasm, Pharyngeal oedema, Dry throat

Gastro-intestinal disorders

Common: Dry mouth, Nausea, Gastro-intestinal motility disorder

Uncommon: e.g. Diarrhoea, Constipation, Vomiting, Stomatitis

Skin and subcutaneous tissue disorders

Uncommon: Rash, Pruritus

Rare: Urticaria

Renal and urinary disorders

Uncommon: Urinary retention⁴

¹ Hypersensitivity reactions following the use of ipratropium bromide have been seen and have presented as urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis. If severe allergic reactions occur, ipratropium bromide should be discontinued immediately, do not use your Ipravent CFC-Free Inhaler again, talk to your doctor or pharmacist immediately.
² Ocular complications have been reported when aerolised ipratropium bromide, either alone or in combination with an β₂ adrenoceptor agonist, has come into contact with the eyes – see section 4.4.
³ As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid –acting inhaled bronchodilator and should be treated straightaway. Ipratropium bromide should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
⁴ 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.

Not applicable.