Spiriva

Spiriva is a bronchodilator that relaxes muscles in the airways and increases air flow to the lungs.

Spiriva is used to prevent bronchospasm (narrowing of the airways in the lungs) in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema. It is inhaled once daily.

Spiriva is available as a Spiriva Handihaler (a dry-powder capsule inhaler that requires manual loading) and Spiriva Respimat (a preloaded, propellant-free mist inhaler).

• Spiriva Respimat is also used to prevent asthma attacks in adults and children 6 years and older.
• Spiriva HandiHaler is not for use in children.

Use Spiriva exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Spiriva is not a rescue medicine. It will not work fast enough to treat a flare-up. Your doctor may prescribe a fast-acting inhalation medicine to treat a bronchospasm attack. Tell your doctor if it seems like your medications don't work as well.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Instructions For Use: Spiriva Handihaler

• Use Spiriva one time every day.
• Do not swallow Spiriva capsules.
• Only use Spiriva capsules with the Handihaler device.
• Do not use the Handihaler device to take any other medicine.

Spiriva comes as a powder in a Spiriva capsule that fits the Handihaler device. Each Spiriva capsule, containing only a small amount of Spiriva powder, is one full dose of medicine.

• Separate one blister from the blister card. Then take out one of the Spiriva capsules from the blister package right before you use it.
• After the capsule is pierced, take a complete dose of Spiriva by breathing in the powder by mouth two times, using the Handihaler device (take 2 inhalations from one Spiriva capsule). See the “Instructions for Use”.
• Throw away any Spiriva capsule that is not used right away after it is taken out of the blister package. Do not leave the Spiriva capsules open to air; they may not work as well.

Instructions for Use: Spiriva Respimat

Spiriva Respimat comes in a cartridge that is inserted into a special inhaler device provided with this medicine.

• Turning the base of the Respimat device until it clicks will release the medicine into the inhaler chamber.
• You will need 2 puffs to get a full dose.

Initial Setup (First-Time Use):

• Insert the Spiriva Respimat cartridge into the inhaler
• Prime the unit by actuating it toward the ground until an aerosol cloud is visible
• Repeat this process three more times
• The inhaler is now primed and ready for use

Repriming Instructions:

• After 3 days of non-use: Actuate the inhaler once before use
• After 21 days of non-use: Actuate the inhaler until an aerosol cloud is visible, then repeat three more times

Important Patient Instructions:

• Children should use Spiriva Respimat only with adult assistance
• Use Spiriva inhalation spray ONLY with the Spiriva Respimat inhaler
• Do NOT use the Spiriva Respimat inhaler for other medications
• Priming is essential to ensure appropriate medication content in each dose.
• The Spiriva Respimat inhaler will lock and cannot be turned after 30 doses (or 60 puffs) have been used.
• An indicator on the side of the inhaler will show when there are 14 puffs (or 7 days) of medicine left in the cartridge.

Spiriva is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

If you have symptoms of an allergic reaction, such as hives, a rash, itching, or facial swelling, stop taking Spiriva and call your doctor right away or go to the nearest hospital emergency room.

Spiriva Handihaler Capsules

Do not swallow Spiriva capsules. These capsules should only be used with the Handihaler device and inhaled through your mouth (oral inhalation).

Use only one capsule at a time.

Spiriva Respimat Inhaler

Do not spray Spiriva Respimat into your eyes.

The Spiriva Respimat cartridge is only for use with the Respimat inhaler device and should not be interchanged with any other Respimat device delivered product.

Spiriva Handihaler

Spiriva Handihaler is FDA-approved for:

• The maintenance treatment of bronchospasm associated with COPD, and for reducing COPD exacerbations in adults, as long-term, once-daily therapy.

Spiriva Respimat

Spiriva Respimat is FDA-approved for:

• The maintenance treatment of bronchospasm associated with COPD, and for reducing COPD exacerbations in adults, as long-term, once-daily therapy.
• The maintenance treatment of asthma in patients 6 years and older as long-term, once-daily therapy.

Do not use Spiriva if you are allergic to tiotropium, ipratropium (Atrovent, Combivent, DuoNeb), Spiriva, or any of the inactive ingredients in the Spiriva Handihaler or Spiriva Respimat. See the end of this guide for a complete list of ingredients.

Before using Spiriva, tell your healthcare provider about all your medical conditions, including if you:

• Have kidney problems
• Have glaucoma. Spiriva may make your glaucoma worse
• Have an enlarged prostate, problems passing urine, or a blockage in your bladder. Spiriva may makethese problems worse
• Have a severe allergy to milk proteins, and you are using Spiriva Handihaler
• Are pregnant or planning to become pregnant
• Are breastfeeding, or planning to breastfeed.

Spiriva Handihaler is not approved for anyone younger than 18 years old.

Spiriva Respimat is not approved for use by anyone with asthma younger than 6 years old. It is only approved for use in adults with COPD.

Pregnancy

It is not known if Spiriva could harm your unborn baby.

Breastfeeding

It is not known if Spiriva passes into breast milk. You and your doctor will decide if Spiriva is right for you while you breast-feed.

Common Side Effects

The most common side effects of Spiriva are:

• Upper respiratory tract infection
• Dry mouth
• Sinusitis
• Sore throat (pharyngitis)
• Non-specific chest pain
• Urinary tract infection
• Indigestion (dyspepsia)
• Runny nose (rhinitis).

Other side effects include:

• Constipation
• Increased heart rate
• Blurred vision.

Serious Side Effects

Spiriva can cause the following serious side effects:

• Allergic reactions. Symptoms may include: Raised red patches on your skin (hives) Itching Rash Swelling of the lips, tongue, or throat that may cause difficulty in breathing or swallowing

If you have these symptoms of an allergic reaction, stop taking Spiriva and call your doctor right away or go to the nearest hospital emergency room.

• Sudden narrowing and blockage of the airways into the lungs (bronchospasm). Spiriva may cause your breathing to worsen suddenly. If you have these symptoms of bronchospasm, stop taking Spiriva and call your doctor right away or go to the nearest hospital emergency room.
• New or worsened increased pressure in the eyes (acute narrow-angle glaucoma). Symptoms of acute narrow-angle glaucoma may include: Eye pain Blurred vision Seeing halos (visual halos) or colored images along with red eyes

Using only eye drops to treat these symptoms may not work. If you have these symptoms, stop taking Spiriva and call your doctor right away.

• New or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine or painful urination.

If you have these symptoms of urinary retention, stop taking Spiriva and call your doctor right away.

These are not all the possible side effects of Spiriva. Tell your doctor if you have any side effect that bothers you, or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

Adult Dose of Spiriva for Maintenance of COPD

• Tiotropium Capsule for Spiriva Handihaler: 18 mcg (2 inhalations from 1 capsule) via the Handihaler once a day
• Tiotropium Spray for Spiriva Respimat: 2 inhalations of 2.5 mcg via the Respimat once daily

Dose of Spiriva for Maintenance of Asthma (Patients 6+)

• Tiotropium Spray for Spiriva Respimat: 2 inhalations of 1.25 mcg via the Respimat once daily

If you miss a dose of Spiriva, take it as soon as you remember.

Do not use Spiriva more than once every 24 hours.

If you use more than your prescribed dose of Spiriva, call your doctor or a poison control center.

Overdose symptoms may include dry mouth, eye redness, constipation, stomach pain, and confusion or drowsiness.

Avoid getting the powder from a Spiriva capsule in your eyes. If this does happen, call your doctor.

Do not spray Spiriva Respimat into your eyes.

Avoid driving or participating in other hazardous activities until you know how Spiriva affects you. Your reactions could be impaired.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, and eyedrops, vitamins, and herbal supplements. Some of your other medicines or supplements may affect the way Spiriva works. Especially tell your doctor if you take a:

• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl and others);
• medicine to treat Parkinson's disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat an overactive bladder; or
• bronchodilator asthma medication.

Spiriva is an anticholinergic medicine. You should not take other anticholinergics while using Spiriva, including ipratropium. Ask your doctor or pharmacist if you are not sure if one of your medicines is an anticholinergic

Not all possible drug interactions are listed here. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

Spiriva Handihaler

• Do not store Spiriva capsules in the Handihaler device.
• Store Spiriva capsules in the sealed blister package at room temperature 68°F to 77°F (20°C to 25°C).
• Keep Spiriva capsules away from heat and cold (do not freeze).
• Store Spiriva capsules in a dry place. Throw away any unused Spiriva capsules that have been open to the air.

Ask your doctor or pharmacist if you have any questions about storing your Spiriva capsules.

Keep out of reach of children.

Spiriva Respimat

• Store Spiriva Respimat at room temperature 68°F to 77°F (20°C to 25°C).
• Avoid freezing
• After assembly, the Spiriva Respimat inhaler should be discarded within 3 months after first use or when the locking mechanism is engaged, whichever comes first.

Keep out of reach of children. Do not spray into eyes.

Spiriva Handihaler

Active: tiotropium

Inactive ingredient: lactose monohydrate.

Spiriva Respimat

Active: tiotropium

Inactive ingredients: benzalkonium chloride, edetate disodium, hydrochloric acid, and water for injection.

Spiriva Respimat is supplied in a carton containing one aluminum cartridge and one Respimat inhaler device.

• The Spiriva Respimat cartridge is only intended for use with the Respimat inhaler device and should not be interchanged with any other Respimat device delivered product.
• The Respimat inhaler device is a cylindrical-shaped plastic inhalation device with a gray colored body and a clear base.
• The clear base is removed to insert the cartridge. The inhaler contains a dose indicator.

Spiriva and Spiriva Respimat are distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Licensed from: Boehringer Ingelheim International GmbH.