Combivent Respimat

The recommended adult dose of ipratropium – salbutamol using the Respimat® inhalation device is 1 actuation, inhaled four times daily. Your doctor may recommend additional inhalations as needed. The maximum number of inhalations in a 24-hour period is 6.

To use the Respimat® inhaler, insert the Respimat® cartridge into the inhaler device. After the cartridge has been inserted into the inhaler, the device must be primed by loading a dose and pressing the dose release button with the inhaler pointed towards the ground, until a cloud of medication is released. Repeat 3 more times to ensure that the inhaler is ready for use.When the device is used regularly, the inhaler does not need to be re-primed. If more than 3 days have passed since last using the inhaler, it must be re-primed by actuating the inhaler once. If more than 21 days have passed since last using the inhaler, it should be primed as though it were new.

Your doctor or another health care professional, such as your pharmacist, should teach you how to use the Respimat® inhalation device. If you are unsure of how to use the device, contact your doctor or pharmacist.

After 3 months of use, safely discard the device and canister, even if there is still medication remaining in the canister.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use Combivent Respimat on a regular schedule as prescribed by your doctor. If you miss a dose of Combivent Respimat, and no respiratory symptoms occur, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you miss a dose and respiratory symptoms occur, then take the missing dose and continue with your regular dosing schedule. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Combivent Respimat at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may alter your sense of taste; it may cause palpitations (rapid and strong heart beat); it may cause shakiness. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Cartridge

Each actuation of aqueous solution contains 20 µg of ipratropium and 100 µg of salbutamol. Nonmedicinal ingredients: benzalkonium chloride, disodium edetate, hydrochloric acid, and purified water.

Inhalation device

The Respimat® inhalation device is a grey reusable plastic device with an orange cap that is specially designed for administering Combivent solution via oral inhalation.

Do not use ipratropium - salbutamol inhalation solution if you:

• are allergic to salbutamol, ipratropium, or any ingredients of Combivent Respimat
• are allergic to atropine or related medications
• have certain types of abnormal heart rhythms (tachyarrhythmias)
• have certain types of heart disease (hypertrophic obstructive cardiomyopathy)

There may be an interaction between ipratropium – salbutamol inhalation solution and any of the following:

• aclidinium
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Atomoxetine
• atropine
• azelastine
• belladonna
• Benztropine
• beta-blockers (e.g., Propranolol, Nadolol)
• Betahistine
• botulinum toxin
• fast acting bronchodilators (e.g., salbutamol, terbutaline)
• long acting bronchodilators (e.g., formoterol, salmeterol)
• caffeine
• cannabis
• chloroquine
• corticosteroids (e.g., cortisone, Prednisone)
• Cyclobenzaprine
• Darifenacin
• decongestant cold medications (e.g., phenylephrine, Pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• dipivefrin
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Domperidone
• Donepezil
• efavirenz
• Epinephrine
• Flavoxate
• Galantamine
• glycopyrrolate
• HIV protease inhibitors (e.g., darunavir, indinavir, lopinavir, saquinavir, tipranavir)
• ketotifen
• Linezolid
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methylphenidate
• Metoclopramide
• Midodrine
• mifepristone
• Mirabegron
• Modafinil
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Rasagiline, Selegiline, Tranylcypromine)
• narcotics (e.g., Codeine, Morphine, Oxycodone)
• orphenadrine
• Oxybutynin
• potassium chloride
• Primaquine
• quinidine
• quinine
• quinolone antibiotics (e.g., levofloxacin, moxifloxacin, Ofloxacin)
• Rivastigmine
• scopolamine
• secretin
• selective serotonin reuptake inhibitors (SSRI; e.g., Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• Solifenacin
• Tetrabenazine
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• tiotropium
• Tolterodine
• Topiramate
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• umeclidinium

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Combivent Respimat. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Combivent Respimat.

Cystic Fibrosis: People with cystic fibrosis may be more likely to have stomach discomfort (due to changes in how quickly food moves through the stomach and intestines) while using Combivent Respimat.

Diabetes: Ipratropium – salbutamol inhalation solution may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Combivent Respimat.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Combivent Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Combivent Respimat, and whether any special monitoring is needed.

Dizziness/blurred vision: Ipratropium - salbutamol may cause dizziness or blurred vision, affecting your ability to safely drive or operate machinery. Avoid these and other hazardous tasks until you know how Combivent Respimat affects you.

Heart conditions: Combivent Respimat can cause increased heart rate and blood pressure, making certain heart conditions worse. If you have heart disease, high blood pressure, irregular heart beat, heart failure, or have had a recent heart attack, discuss with your doctor how Combivent Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Combivent Respimat, and whether any special monitoring is needed.

Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways, which make breathing difficult. If you experience this problem when using ipratropium - salbutamol, stop using Combivent Respimat immediately. Speak to your doctor if you experience any problems with breathing while taking this or other inhaled medications.

Pheochromocytoma: If you have been diagnosed with pheochromocytoma (a tumour of the adrenal gland), discuss with your doctor how Combivent Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Combivent Respimat, and whether any special monitoring is needed.

Potassium levels: Decreases in blood levels of potassium may occur with the use of Combivent Respimat. This rarely causes problems, but potassium levels should be monitored by your doctor. If you experience unexplained muscle cramps, weakness, fatigue, or constipation, contact your doctor.

Thyroid disease: People who have an over-active thyroid gland may be more sensitive to the effects of ipratropium - salbutamol. If you have thyroid disease, discuss with your doctor how Combivent Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Combivent Respimat, and whether any special monitoring is needed.

Urinary tract problems: Ipratropium – salbutamol inhalation solution can cause difficulty with starting urine flow. If you have an enlarged prostate or bladder retention, discuss with your doctor how Combivent Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Combivent Respimat, and whether any special monitoring is needed.

Vision concerns: Combivent Respimat may cause symptoms of glaucoma or cause existing glaucoma to become worse. Avoid spraying Combivent Respimat into your eyes. If this happens, rinse your eyes with clear water immediately. Report any changes in your vision, including blurred vision, halos, and eye pain, to your doctor immediately.

Worsening symptoms: If Combivent Respimat does not begin to help your symptoms quickly, or you find that you have increased difficulty breathing, or you need to use Combivent Respimat more frequently, contact your doctor immediately.

Pregnancy: The safety of ipratropium – salbutamol inhalation solution use during pregnancy has not been determined. Although Combivent Respimat should not be used during pregnancy unless the benefits outweigh the risks, sometimes the benefit to the mother does outweigh risks to the developing baby. If you become pregnant while taking Combivent Respimat, contact your doctor immediately.

Breast-feeding: It is not known if ipratropium – salbutamol inhalation solution passes into breast milk. If you are a breast-feeding mother and are taking Combivent Respimat, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Combivent Respimat have not been established for children.

This product must be inhaled by mouth. Carefully follow the package's instructions. If needed, ask your pharmacist for additional information or for a demonstration. This medication is typically used 4 times a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Use it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up.