Spiriva

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines and eye drops, vitamins, and herbal supplements. Some of your other medicines or supplements may affect the way Spiriva works. Spiriva is an anticholinergic medicine. You should not take other anticholinergic medicines while using Spiriva, including ipratropium. Ask your doctor or pharmacist if you are not sure if one of your medicines is an anticholinergic.

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.

It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to help reduce any unwanted effects.

This medicine will not stop bronchospasm that has already started. Your doctor will give you another medicine to use in case of an acute attack.

Tiotropium may cause allergic reactions, including anaphylaxis and angioedema. Check with your doctor right away if you develop a skin rash, itching, trouble breathing, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs after using this medicine.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Check with your doctor right away if you have any changes to your eyes, such as eye pain, eye discomfort, blurred vision, visual halos, or colored images with red eyes while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine, or painful urination.

This medicine may cause dizziness or blurred vision. Avoid driving, using machines, or doing anything else that could be dangerous if you are dizzy or not able to see well.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Arm, back, or jaw pain
• chest pain or discomfort
• chest tightness or heaviness
• fast or irregular heartbeat
• nausea
• sweating
• trouble breathing

• Cough
• difficulty with swallowing
• dizziness
• hives, itching, or skin rash
• painful blisters on the trunk of body
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest
• unusual tiredness or weakness

• Fainting
• fast, pounding, or irregular heartbeat or pulse
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• bladder pain
• bloody or cloudy urine
• body aches or pain
• chest pain
• chills
• congestion
• cough
• difficult, burning, or painful urination
• dry mouth
• dryness of the throat
• ear congestion
• fever
• frequent urge to urinate
• headache
• heartburn
• hoarseness
• indigestion
• loss of voice
• lower back or side pain
• pain or tenderness around the eyes and cheekbones
• runny or stuffy nose
• sneezing
• sore throat
• stomach discomfort, upset, or pain
• tender, swollen glands in the neck
• voice changes

• Bloody nose
• blurred vision
• bone pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• canker sores
• difficulty having a bowel movement (stool)
• discouragement
• feeling sad or empty
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• irritability
• lack of appetite
• leg pain
• loss of interest or pleasure
• muscle pain
• nausea
• painful or difficult urination
• sore mouth or tongue
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• sweating
• swelling or inflammation of the mouth
• tiredness
• trouble concentrating
• trouble sleeping
• unexplained weight loss
• vomiting

• Bloating
• change in vision
• diarrhea
• red skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Spiriva HANDIHALER (tiotropium bromide inhalation powder) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Spiriva HANDIHALER is indicated to reduce exacerbations in COPD patients.

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 [see Overdosage (10)].

The recommended dose of Spiriva HANDIHALER is two inhalations of the powder contents of one Spiriva capsule, once-daily, with the HANDIHALER device [see Patient Counseling Information (17)]. 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 [see Patient Counseling Information (17)].

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 [see Warnings and Precautions (5.6), Use in Specific Populations (8.5, 8.6, 8.7), and Clinical Pharmacology (12.3)].

A Spiriva capsule is for use only in the HandiHaler device. Do not take the capsule by mouth. Use only one capsule at a time.

Before using tiotropium, tell your doctor if you have narrow-angle glaucoma, or an enlarged prostate or bladder obstruction.

Spiriva is used to prevent bronchospasm attacks. Do not use this medication to treat a bronchospasm attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medication to treat an attack.

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

This medicine may cause dizziness or blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Using Spiriva with other drugs that cause blurred vision, constipation, or difficult urination can worsen these effects. Avoid using cold or allergy medicine, over-the-counter sleep medicine, a muscle relaxer, or medicine to prevent nausea or motion sickness.

Common side effects of Spiriva include: xerostomia. Other side effects include: infection and skin rash. See below for a comprehensive list of adverse effects.

Applies to tiotropium: inhalation aerosol, inhalation capsule

General

The most commonly reported adverse reaction was dry mouth, usually mild and often resolved during continued treatment.
Other reactions consistent with possible anticholinergic effects included constipation, tachycardia, blurred vision, glaucoma (new onset or worsening), dysuria, and urinary retention.[Ref]

Respiratory

Very common (10% or more): Pharyngitis (11.5%)
Common (1% to 10%): Respiratory tract infection, cough, sinusitis, rhinitis, epistaxis, dysphonia, chest pain, laryngitis
Rare (less than 0.1%): Epistaxis, bronchospasm,
Postmarketing reports: Pharyngolaryngeal pain, throat irritation, hoarseness[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, angina pectoris (including aggravated angina pectoris)
Uncommon (0.1% to 1%): Atrial fibrillation
Rare (less than 0.1%): Palpitations, supraventricular tachycardia, tachycardia[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash
Rare (less than 0.1%): Angioneurotic edema, urticaria, skin infection, skin ulcer, dry skin[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth, constipation, gastroesophageal reflux, oropharyngeal candidiasis, dyspepsia, abdominal pain, vomiting
Uncommon (0.1% to 1%): Dysphagia, gingivitis, intestinal obstruction including ileus paralytic, stomatitis (including ulcerative stomatitis)
Rare (less than 0.1%): Dental caries, glossitis
Frequency not reported: Nausea
Postmarketing reports: Oral candidiasis, throat irritation, mouth ulceration[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Urinary retention, dysuria[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reactions
Rare (less than 0.1%): Angioedema, hypersensitivity (including immediate reactions)
Frequency not reported: Anaphylactic reactions[Ref]

Metabolic

Common (1% to 10%): Hypercholesterolemia, hyperglycemia
Frequency not reported: Dehydration[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, arthritis, skeletal pain, leg pain
Frequency not reported: Join swelling[Ref]

Nervous system

Common (1% to 10%): Dizziness, paresthesia
Uncommon (0.1% to 1%): Headache, insomnia, taste disorder[Ref]

Ocular

Common (1% to 10%): Cataract
Uncommon (0.1% to 1%): Blurred vision
Rare (less than 0.1%): Glaucoma, intraocular pressure increased[Ref]

Other

Common (1% to 10%): Edema, infections, moniliasis, influenza-like symptoms, herpes zoster[Ref]

Psychiatric

Common (1% to 10%): Depression[Ref]

Some side effects of Spiriva may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B1 US FDA pregnancy category: C Comments: The safety and effectiveness have not been studied during labor and delivery.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses. There is a very limited amount of data regarding the use of tiotropium in pregnant women. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.