Spiriva (tiotropium bromide)

• Spiriva HandiHaler is a prescription medicine used each day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
• Spiriva HandiHaler helps make your lungs work better for 24 hours. Spiriva HandiHaler relaxes your airways and helps keep them open. You may start to feel like it is easier to breathe on the first day, but it may take longer for you to feel the full effects of the medicine. Spiriva HandiHaler works best and may help make it easier to breathe when you use it every day.
• Spiriva HandiHaler reduces the likelihood of flare-ups and worsening of COPD symptoms (COPD exacerbations). A COPD exacerbation is defined as an increase or new onset of more than one COPD symptom such as cough, mucus, shortness of breath, and wheezing that requires medicine beyond your rescue medicine.

Spiriva HandiHaler 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.

It is not known if Spiriva HandiHaler is safe and effective in children.

Do not use Spiriva HandiHaler if you:

• are allergic to tiotropium, ipratropium(Atrovent®), or any of the ingredients in Spiriva HandiHaler. 

Symptoms of a serious allergic reaction to Spiriva HandiHaler may include:

• raised red patches on your skin (hives)
• itching
• rash
• swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing

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

Before taking Spiriva HandiHaler, tell your doctor about all your medical conditions, including if you:

• have kidney problems.
• have glaucoma. Spiriva HandiHaler may make your glaucoma worse.
• have an enlarged prostate, problems passing urine, or a blockage in your bladder. Spiriva HandiHaler may make these problems worse.
• are pregnant or plan to become pregnant. It is not known if Spiriva HandiHaler could harm your unborn baby.

Spiriva HandiHaler can cause serious side effects, including: Allergic reaction. 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 HandiHaler 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). Your breathing suddenly gets worse.

If you have these symptoms of bronchospasm, stop taking Spiriva HandiHaler 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 HandiHaler 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, painful urination.

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

Other side effects with Spiriva HandiHaler include:

• upper respiratory tract infection
• dry mouth
• sinus infection
• sore throat
• non-specific chest pain
• urinary tract infection
• indigestion
• runny nose
• constipation
• increased heart rate
• blurred vision

These are not all the possible side effects with Spiriva HandiHaler. Tell your doctor if you have any side effect that bothers you or that does not go away.

For oral inhalation only. Do not swallow Spiriva capsules, as the intended effects on the lungs will not be obtained. The contents of the Spiriva capsules should only be used with the HandiHaler device.

The recommended dose of Spiriva HandiHaler is two inhalations of the powder contents of one Spiriva capsule, once-daily, with the HandiHaler device. Do not take more than one dose in 24 hours.

For administration of Spiriva HandiHaler, a Spiriva capsule is placed into the center chamber of the HandiHaler device. The Spiriva capsule is pierced by pressing and releasing the green piercing button on the side of the HandiHaler device. The tiotropium formulation is dispersed into the air stream when the patient inhales through the mouthpiece.

No dosage adjustment is required for geriatric, hepatically-impaired, or renally-impaired patients. However, patients with moderate to severe renal impairment given Spiriva HandiHaler should be monitored closely for anticholinergic effects.

Sympathomimetics, Methylxanthines, Steroids

Spiriva HandiHaler has been used concomitantly with short-acting and long-acting sympathomimetic (beta-agonists) bronchodilators, methylxanthines, and oral and inhaled steroids without increases in adverse reactions.

Anticholinergics

There is potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of Spiriva HandiHaler with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

Before taking Spiriva HandiHaler, tell your doctor about all your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if Spiriva HandiHaler could harm your unborn baby.
• are breast-feeding or plan to breast-feed. It is not known if Spiriva HandiHaler passes into breast milk. You and your doctor will decide if Spiriva HandiHaler is right for you while you breast-feed.
• have a severe allergy to milk proteins. Ask your doctor if you are not sure.