Berodual® Respimat® 20/50 microgram/dose Solution for inhalation

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Composition

Efficacious medical components:
The delivered dose (the dose that leaves the mouthpiece of the Berodual Respimat) is 20 µg ipratropium bromide monohydrate and 50 µg fenoterol hydrobromide.

List of excipients:
Benzalkonium chloride, Disodium edetate, Water, purified, Hydrochloric acid

Therapeutic indications

Berodual Respimat is indicated for the prevention and treatment of bronchospasm in asthma and chronic obstructive pulmonary disease (COPD).

Concomitant anti-inflammatory therapy should be considered.

Contraindications

Hypersensitivity to the active substances, to any of the excipients (see 6.1 List of excipients), or to other atropine like substances. Hypertrophic obstructive cardiomyopathy or tachyarrhythmia.

Special warnings and precautions for use: In the case of acute, rapidly worsening of dyspnoea the patient should be advised that a doctor should be consulted immediately.

In the following conditions Berodual Respimat should only be used after careful risk/benefit assessment, especially when doses higher than recommended are used: in insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disorders, hyperthyroidism and pheochromocytoma.

Berodual Respimat, like other products containing anticholinergic drugs, should be used with caution in patients with prostatic hyperplasia or bladder-neck obstruction or predisposed to narrow-angle glaucoma.

There have been isolated reports of ocular complications (i.e. mydriasis, increased intraocular pressure, narrow-angle glaucoma and eye pain) when aerolised 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 Berodual Respimat. Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival and corneal congestion may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic eye drops should be initiated and specialist advice should be sought immediately.

Patients with cystic fibrosis may be more prone to gastro-intestinal motility disturbances when treated with inhaled anticholinergics.

Pregnancy and lactation:
There are no sufficient data from the use of Berodual Respimat in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women.
The potential of beta 2-agonists to inhibit uterine contraction should be taken into account. Preclinical studies have shown that fenoterol hydrobromide is excreted into breast milk. It is not known whether ipratropium is excreted into breast milk. But it is unlikely that ipratropium would reach the infant to an important extent, especially when taken by inhalation. However, because many drugs are excreted into breast milk, caution should be exercised when Berodual Respimat is administered to nursing mothers.

Undesirable effects

Uncommon:
Application site reaction (i.e. burning throat), Headache, Hypertension aggravated, Hoarseness, nervousness, tremor, Glossitis, mouth dry, nausea, stomatitis, Palpitation, pulse rate increased, Coughing; pharyngitis, Taste perversion, Urinary retention, Hot flushes.

Individual serious and/or frequently occurring adverse reactions
Burning throat, hoarseness, glossitis, stomatitis, coughing and pharyngitis are being considered as local irritation phenomena, mainly due to the inhaled route of administration.

Pharmacological class-adverse reactions
The following reactions were not observed in clinical trials but are known to be associated with products in the same pharmacological class as the components of Berodual Respimat.

Beta2-agonists
Vomiting, sweating, weakness, myalgia/muscle cramps and psychological alterations may occur. In rare cases decrease in diastolic blood pressure, increase in systolic blood pressure, arrhythmias, particularly after higher doses, have been observed. Potentially serious hypokalemia may result from beta2-agonist therapy.

Anticholinergic drugs
Gastro-intestinal motility disturbances and urinary retention. Ocular side effects like visual accommodation disturbances, mydriasis, increased intraocular pressure, eye pain and glaucoma have been reported.

Hypersensitivity reactions such as skin rash, angioedema of the tongue, lips and face and urticaria may occur.

As with other inhalation therapy, application-induced bronchospasm may occur immediately after dosing.

Information:
For further information please view the full prescribing information.

Pharmaceutical form and pack sizes

Berodual® Respimat®

Single pack: 1 Respimat Inhaler and 1 cartridge with 4,5 ml and 120 metered single doses

Double pack: 2 Respimat Inhalers and 2 cartridges with 4,5 ml each and 240 metered single doses.

Brand	Generic	Manufacturer	Size	Price	Exp.
Berodual Inhalation Soln Ipratropium Br : Fenoterol HBr	Ipratropium Br : Fenoterol HBr	Boehringer Ingelheim	Inhalation soln 20 mLx 1 (in dropper bottle)	US$29
Berodual Respimat metered-dose Inhaler 0.02 mg : 0.05 mg Per Puff	Ipratropium Br : Fenoterol HBr	Boehringer Ingelheim	200 Puff/10 mL x 1	US$27
Berodual Respimat metered-dose Inhaler 0.02 mg : 0.05 mg Per Puff	Ipratropium Br : Fenoterol HBr	Boehringer Ingelheim	200 Puff/10 mL x 3	US$74

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