Tiova Inhaler (Generic Tiotropium Bromide Inhaler)

1. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) © The Swiss Pharmacy

2. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Tiova Inhaler (Generic Tiotropium Bromide Inhaler) is used for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations. Tiova Inhaler is also used for the long-term, once-daily, maintenance treatment of asthma in patients 12 years of age and older with severe asthma who experienced one or more severe asthma exacerbations in the preceding year. © The Swiss Pharmacy

3. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Tiova Inhaler (Generic Tiotropium Bromide Inhaler) is manufactured by Cipla Limited, India in the strength of 9 mcg. © The Swiss Pharmacy

4. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Chemical Structure © The Swiss Pharmacy

5. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) The active ingredient contained in Tiova Inhaler is Tiotropium Bromide. Each actuation of Tiova inhaler delivers Tiotropium Bromide Monohydrate equivalent to 9 mcg of Tiotropium. The dosage form is Inhalation aerosol for inhalation. © The Swiss Pharmacy

6. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Uses of Tiova 9 mcg Inhaler: Tiova Inhaler (Generic Tiotropium Bromide Inhaler) is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). It must be used regularly to prevent wheezing and shortness of breath. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Tiotropium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school.This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler such as Albuterol (Asthalin Inhaler), also called Salbutamol in some countries as prescribed. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

7. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Uses of Tiova 9 mcg Inhaler: It helps people who have chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a chronic lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. As COPD is a chronic disease you should use Tiova 9 micrograms inhaler every day and not only when you have breathing problems or other symptoms of COPD. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Tiotropium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

8. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Recommended Adult Dosage For most Adults patients, the dose of Tiova Inhaler Tiotropium Bromide Inhaler) is as given below: The recommended dosage of Tiotropium Bromide is 2 puffs of Tiova Inhaler once daily. Tiova Inhaler may be used with a Zerostat/Zerostat VT Spacer device in patients who find it difficult to synchronize aerosol actuation with inspiration of breath. The recommended dose of Tiova inhaler should not be The recommended dose of Tiova inhaler should not be exceeded. exceeded. Tiova Inhaler (Generic URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

9. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Recommended Adult Dosage Geriatric patients can use Tiotropium Bromide inhaler at the recommended dose. Renally impaired patients can use Tiotropium Bromide at the recommended dose. For patients with moderate to severe impairment (creatinine clearance 50 ml/min or lower), Tiova inhaler should be used only if the expected benefit outweighs the potential risk. Hepatically impaired patients can use Tiotropium Bromide inhaler at the recommended dose URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

10. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Contraindications ➔Tiova Inhaler is contraindicated in patients with a known hypersensitivity to Tiotropium Bromide, or to Atropine or its derivatives, e.g. Ipratropium or Oxitropium or any component of Tiova inhaler. In clinical trials with Tiotropium Bromide inhaler (Tiova Inhaler), immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

11. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Storage Instructions Tiova Inhaler (Generic Tiotropium Bromide Inhaler) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

12. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Warnings Not for Acute Use: Use of Tiova Inhaler (Generic Tiotropium Bromide Inhaler) is intended as a once-daily maintenance treatment for COPD and asthma and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. In the event of an acute attack, a rapid-acting beta2- agonist should be used. Immediate Hypersensitivity Reactions: Discontinue Tiova Inhaler at once and consider alternatives if immediate hypersensitivity reactions, including angioedema, bronchospasm, or anaphylaxis, occur. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

13. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Warnings Paradoxical Bronchospasm: Inhaled medicines, including Tiova Inhaler (Generic Tiotropium Bromide Inhaler), may cause paradoxical bronchospasm. If this occurs, it should be treated immediately with an inhaled short-acting beta2-agonist such as Albuterol Inhaler. Treatment with Tiova Inhaler should be stopped and other treatments considered. Worsening of Narrow-Angle Glaucoma: Tiova Inhaler should be used with caution in patients with narrow-angle glaucoma. Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if this occurs. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

14. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Warnings Worsening of Urinary Retention: Tiova Inhaler (Generic Tiotropium Bromide Inhaler) should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patient to consult a physician immediately if this occurs. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

15. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Possible Side Effects The most common Tiotropium Bromide Inhaler (Tiova Inhaler) side effects in patients with COPD with an incidence rate of greater than 3% in the placebo-controlled trials with treatment durations of between 4 and 48 weeks were pharyngitis, cough, dry mouth, and sinusitis. The most common Tiotropium Bromide Inhaler (Tiova Inhaler) side effects in patients with Asthma with an incidence rate of greater than 2% in the placebo-controlled trials with treatment durations of between 12 and 52 weeks) were pharyngitis, sinusitis, bronchitis, and headache in adults. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

16. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Possible Side Effects Clinical Trials Experience in Chronic Obstructive Pulmonary Disease: Other reactions that occurred in the Tiotropium Bromide Inhaler (Tiova Inhaler) 5 mcg group at an incidence of 1% to 3% and at a higher incidence rate on Tiotropium Bromide Inhalation 5 mcg than on placebo included: Cardiac disorders: palpitations; Gastrointestinal disorders: constipation; gastroesophageal reflux disease; oropharyngeal candidiasis; Nervous system disorders: dizziness; Respiratory system disorders (Upper): dysphonia; Skin and subcutaneous tissue disorders: pruritus, rash; Renal and urinary disorders: urinary tract infection. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

17. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Possible Side Effects Clinical Trials Experience in Asthma: Other reactions that occurred in the Tiotropium Bromide Inhaler (Tiova Inhaler) 2.5 mcg group at an incidence of 1% to 2% and at a higher incidence rate on Tiotropium Bromide Inhalation 2.5 mcg than on placebo included: Nervous system disorders: dizziness; Gastrointestinal disorders: oropharyngeal, candidiasis, diarrhea; Respiratory system disorders (Upper): cough, rhinitis allergic; Renal and urinary disorders: urinary tract infection; General disorders and administration site conditions: pyrexia; and Vascular disorders: hypertension. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

18. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Tiova Inhaler Overdosage High doses of Tiotropium Bromide Inhaler (Tiova Inhaler) may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 340 mcg of Tiotropium Bromide Inhaler in healthy volunteers. Additionally, no relevant adverse effects, beyond dry mouth, were observed following a 7-day dosing of up to 170 mcg of Tiotropium Bromide in healthy volunteers. In a multiple-dose study in COPD patients with a maximum daily dose of 43 mcg of Tiotropium Bromide over 4 weeks, no significant undesirable effect has been observed. Acute intoxication by inadvertent oral ingestion of Tiotropium Bromide Inhaler is unlikely, since it is not well absorbed systemically. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

19. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Tiova Inhaler During Pregnancy Tiotropium Bromide Inhaler (Tiova Inhaler) has been classified by the US FDA as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. The limited human data with Tiotropium Bromide Inhaler (Tiova Inhaler) use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

20. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Tiova Inhaler During Pregnancy Based on animal reproduction studies, no structural abnormalities were observed when Tiotropium Bromide was administered by inhalation to pregnant rats and rabbits during the period of organogenesis at doses 790 and 8 times, respectively, the maximum recommended human daily inhalation dose (MRHDID). Increased post-implantation loss was observed in rats and rabbits administered Tiotropium at maternally toxic doses 430 times and 40 times the MRHDID, respectively. As a precautionary measure, it is preferable to avoid the use of Tiova Inhaler during pregnancy. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

21. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Tiova Inhaler During Breastfeeding It is unknown whether Tiotropium Bromide is excreted in human breast milk. Despite studies in rodents which have demonstrated that excretion of Tiotropium Bromide in breast milk occurs only in small amounts, use of Tiova Inhaler is not recommended during breast-feeding. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy

22. Tiova Inhaler (Generic Tiotropium Bromide Inhaler) Tiova Inhaler Tiova Inhaler (Generic Tiotropium Bromide Inhaler) is manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9807_Tiova-Inhaler.html © The Swiss Pharmacy