Tiotropium Bromide Powder for Inhalation

The main ingredient of this product is tiotropium bromide. Excipients: lactose.

This product is a hard capsule, and the contents are white powder.

This product is a bronchodilator, suitable for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, the maintenance treatment of dyspnea and the prevention of acute attacks.

The recommended dose of tiotropium is once daily, with one capsule inhaled each time using the HandiHaler (powder inhaler) inhalation device. This product can only be inhaled using the HandiHaler (powder inhaler) inhalation device. The recommended dose should not be exceeded. Tiotropium capsules should not be swallowed. Special Populations Elderly patients can use tiotropium at the recommended dose. Patients with renal insufficiency can use tiotropium at the recommended dose. However, for patients with moderate to severe renal insufficiency (creatinine clearance ≤50ml/min), the use of tiotropium should be closely monitored as with other drugs that are mainly excreted by the kidneys (see [Precautions]). Patients with hepatic insufficiency can use tiotropium at the recommended dose (involved in [Pharmacokinetics]). There is no experience with the use of tiotropium in pediatric patients, so this product is not recommended for patients under 18 years of age. Instructions for Use The following method is used to guide patients to inhale the required medication from tiotropium capsules using the HandiHaler? (powder inhaler) inhalation device. Remember to use tiotropium exactly as directed by your doctor. The HandiHaler inhalation device is designed for use with tiotropium capsules and should not be used with any other medication. Your HandiHaler inhalation device can be used continuously for one year. The HandiHaler inhalation device includes: 1) Dust cap 2) Mouthpiece 3) Base 4) Piercing button 5) Central chamber 1. Pull up to open the dust cap and then open the mouthpiece. 2. Remove a capsule from the blister pack (only remove it immediately before use) and place it in the central chamber as shown. You can place the capsule in any way. 3. Close the mouthpiece firmly until you hear a click, leaving the dust cap open. 4. Holding the HandiHaler device with the mouthpiece facing up, press the green piercing button once fully and then release it. This will pierce many small holes in the capsule, allowing the medication to be released when you inhale. 5. Exhale completely (take a deep breath first). Note: Avoid exhaling into the mouthpiece at all times. 6. Lift the HandiHaler device to your mouth, hold the mouthpiece tightly with your lips, keep your head vertical, and breathe in slowly and deeply at a rate fast enough to hear the capsule vibrate. When your lungs are fully filled, hold your breath for as long as possible, remove the HandiHaler device from your mouth, and resume normal breathing. Repeat steps 5 and 6 once, and the medicine in the capsule can be completely sucked out. 7. Open the mouthpiece again, pour out the used capsule and discard it. Close the mouthpiece and dust cap, and store the HandiHaler device. Clean your HandiHaler inhalation device: Clean the HandiHaler? device once a month. Open the dust cap and mouthpiece, then push up the puncture button to open the base, rinse the inhaler with warm water to remove the powder, place the HandiHaler (powder inhaler) device on a paper towel to absorb the moisture, then keep the dust cap, mouthpiece and base open and let it dry in the air for 24 hours. Therefore, it should be cleaned just after use to ensure the next use. If necessary, the outside of the mouthpiece can be cleaned with slightly damp tissue paper. A. Divide the sore-like strip into two plates along the perforation on the blister package. B. Uncover the aluminum foil on the back of the blister (only immediately before use) and use a capsule to fully expose it. C. Take out the capsule.

a) In clinical trials with a total of 906 patients receiving tiotropium for 1 year, the most common adverse reaction was dry mouth. Dry mouth occurred in approximately 14% of patients. Dry mouth reactions are usually mild and disappear with continued treatment. b) The following table lists the reporting rates of this adverse reaction, which are from clinical trials in which patients received tiotropium for 1 year (according to the WHO organ system classification): Frequency of adverse reactions Systemic allergic reactions: Rare (i.e. 0.1%, 1%) Gastrointestinal disorders: Dry mouth Very common (i.e. 10%) Constipation Common (i.e. 1%, 10%) Heart rate and rhythm disorders: Tachycardia Rare (i.e. 0.1%, 1%) = Palpitations Rare (i.e. 0.1%, 1%) Immune system disorders:

It is contraindicated in patients with a history of hypersensitivity to tiotropium, atropine or their derivatives, such as ipratropium or oxitropium, or to the excipient lactose in this product.

Although formal drug interaction studies have not been conducted, no adverse reactions have been found when tiotropium inhalation powder is used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines, oral or inhaled steroids, etc., which are commonly used to treat chronic obstructive pulmonary disease (COPD). Tiotropium has not been studied in combination with other anticholinergic drugs and is therefore not recommended for concomitant use with other anticholinergic drugs.

Store below 25°C, do not freeze.

18 micrograms (based on tiotropium, equivalent to 22.5 micrograms of tiotropium bromide monohydrate)