Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder)

1. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) © The Swiss Pharmacy

2. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) are used for the long-term, once- daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Tiova Rotacaps are indicated to reduce exacerbations in COPD patients. © The Swiss Pharmacy

3. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Tiova Rotacaps (Tiotropium Bromide Inhalation Powder) are manufactured by Cipla Limited, India in the strength of 18 mcg. They are available in a bottle containing 30 rotacaps (Capsules containing dry inhalation powder). © The Swiss Pharmacy

4. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Chemical Structure © The Swiss Pharmacy

5. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) The active ingredient present in Tiova rotacaps is Tiotropium Bromide. Each Tiova rotacap contains 18 mcg of Tiotropium (as Tiotropium Bromide Monohydrate). The dosage form is dry powder for inhalation. © The Swiss Pharmacy

6. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Uses of Tiova 18 mcg Rotacaps: Tiova 18 mcg Rotacaps (Generic Tiotropium Bromide Inhalation Powder) are used to treat chronic obstructive pulmonary disease (COPD). COPD is a lung disease that also includes chronic bronchitis (swelling of the tubes leading to the lungs) and emphysema (damage to the air sacs in the lungs). It is also used as maintenance treatment for asthma in adults and children 6 years of age and older. Tiotropium belongs to the family of medicines known as bronchodilators. Bronchodilators are breathed in through the mouth to help open up the bronchial tubes (air passages) in the lungs. It is taken by inhalation (an inhaler) and will increase the flow of air to the lungs. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

7. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) How Does Tiova (Generic Tiotropium Bromide Inhalation Powder) Work?: Tiova (Generic Tiotropium Bromide Rotacaps) 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 Inhaler (Asthalin Inhaler), also called Salbutamol. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

8. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Recommended Adult Dosage For most Adults (Including the Elderly) patients, the dose of Tiova Rotacaps Tiova Rotacaps (Tiotropium Bromide Inhalation Powder) is as given below: The recommended dosage is inhalation of the contents of one capsule once daily with the Cipla Rotahaler (HandiHaler device) at the same time of day. More frequent administration or a greater number of inhalations is not recommended. No dosage adjustment is required for geriatric, hepatically-impaired, or renally-impaired patients. However, patients with moderate to severe renal impairment, who are being treated with Tiova 18 microgram Rotacaps, should be monitored closely. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

9. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Recommended Adult Dosage Tiotropium Bromide Capsules (Tiova Rotacaps) are only for inhalation and not for oral intake. Tiotropium Bromide Capsules must not be swallowed. Tiotropium Bromide Capsules should only be inhaled with the Cipla Rotahaler/HandiHaler device. There is no relevant use in the paediatric population (below 18 years) in the indication. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

10. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Cipla Rotahaler Tiova Rotacaps are used in a plastic device called a Rotahaler. When used in your Cipla Rotahaler (Generic HandiHaler device), your Tiova Rotacaps provide a measured amount of medicine for you to breathe into your lungs. Your Tiova Rotacaps help you to breathe more easily. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

11. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Cipla Rotahaler 1.Hold the Rotahaler vertically and position the two halves of the Rotahaler such that the fin is not directly below the rotacap hole. 2.Remove the rotacap from its bottle and insert it into the rotacap hole with its transparent end facing downwards 3.Hold the mouth piece firmly with one hand and rotate the base 4.Breathe out fully and place the mouthpiece of the Rotahaler between your teeth. 5.Close your lips tightly around it & tilt your head slightly backward & breathe in through the mouth rapidly & deeply. 6.Hold your breath for 10 seconds or for as long as you are comfortable and then breathe out normally. In case some powder remains repeat step 4. 7.Open the Rotahaler and dispose the empty capsule. 8.You can continue to use your Rotahaler daily for up to 6 months. Then discard it and replace with a new one. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

12. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Contraindications ➔Tiova Rotacaps are 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 rotacaps. In clinical trials with Tiotropium Bromide Capsules (Tiova Rotacaps), 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=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

13. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Storage Instructions Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) 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=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

14. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Warnings Not for Acute Use: Use of Tiova Rotacaps (Tiotropium Bromide Inhalation Powder) 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 Rotacaps 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=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

15. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Warnings Paradoxical Bronchospasm: Inhaled medicines, including Tiova Rotacaps (Tiotropium Bromide Inhalation Powder), 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 Rotacaps should be stopped and other treatments considered. Worsening of Narrow-Angle Glaucoma: Tiova Rotacaps 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=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

16. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Warnings Worsening of Urinary Retention: Tiova Rotacaps 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. Tiova 18 microgram is not recommended for children and adolescents under 18 years URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

17. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Possible Side Effects The most common Tiotropium Bromide Inhalation Powder (Tiova Rotacaps) 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 Inhalation Powder (Tiova Rotacaps) 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=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

18. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Possible Side Effects Clinical Trials Experience in Chronic Obstructive Pulmonary Disease: Clinical Trials Experience in Chronic Obstructive Pulmonary Disease: Other reactions that occurred in the Tiotropium Bromide Inhalation Powder (Tiova Rotacaps) 5 mcg group at an incidence of 1% to 3% and at a higher incidence rate on Tiotropium Bromide Inhalation Powder 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=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

19. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Possible Side Effects Clinical Trials Experience in Asthma: Clinical Trials Experience in Asthma: Other reactions that occurred in the Tiotropium Bromide Inhalation Powder (Tiova Rotacaps) 2.5 mcg group at an incidence of 1% to 2% and at a higher incidence rate on Tiotropium Bromide Inhalation Powder 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=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

20. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Overdosage High doses of Tiotropium Bromide Inhalation Powder (Tiova Rotacaps) 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 Inhalation Powder 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 Rotacaps is unlikely, since it is not well absorbed systemically. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy

21. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Tiova Rotacaps During Pregnancy Tiotropium Bromide Inhalation Powder (Tiova Rotacaps) 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 Inhalation Powder (Tiova Rotacaps) use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. 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 Rotacaps during pregnancy. © The Swiss Pharmacy

22. Tiova Rotacaps (Generic Tiotropium Bromide Inhalation Powder) Tiova Rotacaps Tiova Rotacaps (Tiotropium Bromide Inhalation Powder) are manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html https://www.theswisspharmacy.com/product_info.php?info=p9609_Tiotropium-Bromide-Capsules-for-HandiHaler.html © The Swiss Pharmacy