Tiotropium 2.5 microgram/ Olodaterol 2.5 microgram Inhalation solution
What Tiotropium/Olodaterol is used for:
- This product is used to help patients with chronic obstructive pulmonary disease (COPD) in breathing more easily.
- COPD is a chronic lung disease that leads to difficulty breathing and coughing.
- COPD is a disease that is linked with the respiratory problems known as chronic bronchitis and emphysema.
- COPD is a chronic respiratory problem and therefore you will need to use this inhaler on a daily basis and not only on an as needed basis when you are having breathing difficulties or other COPD symptoms.
- This medicine is also helpful when you are experiencing continuous shortness of breath linked to your respiratory problem and will therefore reduce the disease effects on your daily life.
- Additionally, it will allow you stay active for a longer period of time.
- This inhaler also assists in avoiding sudden and short-term worsening of your COPD signs and symptoms that can last for some days. This medicine gives an effect that lasts for 24 hours, therefore you will have to use your inhaler once daily only.
Do not use Tiotropium/Olodaterol:
- If you are allergic to Tiotropium, Olodaterol, or any of the ingredients in this medicine.
- Tell your doctor about the allergy and what signs you had.
- If you are allergic to atropine or medicines similar to it (e.g. oxitropium or ipratropium).
Warnings and Precautions:
- Stop the medication right away and talk to your doctor or pharmacist if you develop allergic reactions such as shortness of breath, skin rash, itching, swelling of the face or neck, decreased blood pressure and dizziness.
- Stop the medication right away and talk to your doctor if you develop chest tightness, coughing, difficulty breathing or wheezing right after inhaling your dose.
- Talk to your doctor before starting this medicine if you have narrow angle glaucoma (increased pressure in your eye), prostate problems, urination problems, or kidney problems.
- This medicine should not be used to treat sudden attacks to wheezing and breathing difficulties. It is intended for daily and regular maintenance use of your respiratory problem only.
- Make sure that you keep the inhalation spray away from your eyes since this medicine may precipitate if it enters your eye which may worsen narrow angle glaucoma. If this happens, wash your eyes with warm water immediately,
- stop using the inhaler and talk to your doctor or eye specialist immediately whenever you experience signs of an acute attack of narrow angle glaucoma such as blurred vision, red eyes, eye pain or discomfort, and seeing halos around lights or colored images. These signs and symptoms may also be accompanied by nausea, headache, or vomiting.
- This medicine may cause dry mouth, which may be associated with dental caries since it is used for long-term. Therefore, make sure that you take care of your oral hygiene.
- Talk to your doctor before starting this medicine if you have heart problems.
- Talk to your doctor before starting this medicine if you have asthma (a respiratory problem that causes difficulty breathing and wheezing), epilepsy, liver problems, diabetes (high blood glucose levels), thyrotoxicosis (type of problem in your thyroid gland), aneurysm (abnormal widening of an artery) or high blood pressure.
- Talk to your doctor before starting this medicine if you have a planned surgery.
- Do not use this inhaler for more than once a day.
- This medicine is not recommended in children and adolescents under 18 years.
- Talk to your doctor immediately if you experience heart side effects (e.g. increase in heart rate, increase in blood pressure, chest pain).
- This medicine has 0.0011 mg of benzalkonium chloride in each actuation which is a preservative that may cause breathing problems and wheezing especially if you have asthma.
- Talk to your doctor if you experience signs of low potassium levels like muscle spasm/weakness or abnormal heart rhythm.
- Do not use this inhaler with some medicines that contain long-acting beta-adrenergic agonists (e.g. salmeterol or formoterol) which are used for some respiratory problems.
- If you usually use some medicines known as short-acting beta-adrenergic agents (e.g. salbutamol), continue to take these medicines only for the relief of acute symptoms like shortness of breath.
Possible side effects:
- Possible rare but serious side effects include allergic reactions, signs of bronchospasm (may happen with any inhaled medicine), like unexpected chest tightness, wheezing, coughing, or breathlessness immediately after inhalation, seeing halos around lights or colored images with red eyes (glaucoma) and obstruction of intestines or lack of bowel movements.
- Uncommon side effects include faster heart rate, dizziness, dry mouth, hoarseness, cough and headache.
- Side effects of unknown frequency include dry skin, increased eye pressure, nasopharyngitis, inflammation of the tongue, heartburn, difficulties swallowing, sinuses inflammation, dental caries, ulcerations or infections of the skin and dehydration.
- Side effects that are known to happen with some medicines for breathing problems that are similar to tiotropium/olodaterol include chest pain, shaking, fatigue, nervousness, low blood pressure, low blood levels of potassium, muscle cramps, malaise and high blood sugar, or increased acidity in your blood.
Other medicines and Tiotropium/Olodaterol:
- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medications including prescription medicines, over the counter medicines, herbals, vitamins and supplements.
- If you are taking similar medications for your lung disease (e.g. anticholinergic or beta-adrenergic medicines).
- If you are taking beta blockers (used to treat high blood pressure or other heart problems e.g. propranolol, or to treat eye problems like glaucoma e.g. timolol).
- If you are taking medicines that can decrease potassium levels in your blood including steroids (e.g. prednisolone) and diuretics (medicines that increase urination).
- If you are taking medicines used to relieve breathing problems (e.g. theophylline).
- If you are taking tricyclic antidepressants or monoamine oxidase (MAO) inhibitors (like selegiline or moclobemide), which are medicines used for the treatment of neurological or psychiatric problems like Parkinson’s disease or depression.
How to take Tiotropium/Olodaterol:
- The recommended usual dose is to inhale 2 puffs once daily.
- Do not take higher than the recommended dose.
How To Use:
- Take this medicine exactly as prescribed by your doctor. Talk to your doctor or pharmacist if you are not sure.
- This medicine is not recommended for children and adolescents under 18 years.
- The effect of this medicine lasts for 24 hours, therefore make sure that you take your dose at the same time every day.
- Ask your healthcare provider on how to use the inhaler if you are not sure how to use it.
- Talk to your doctor if you feel that your breathing is getting worse.
- Before you take your dose, make sure to release one puff towards the ground if you have not used the inhaler for more than 7 days.
- If your inhaler has not been used for more than 21 days, make sure that you turn the clear base in the direction of the arrows present on the label until you hear a click (half a turn) while keeping the cap closed,
- then open the cap until it snaps completely open.
- Point the inhaler device facing the ground followed by pressing the dose-release button and then close the cap.
- Repeat the steps mentioned from turning the clear base half a turn to closing the cap until you see a cloud and then repeat three more times.
- Clean the mouthpiece including the metal part inside the mouthpiece with a damp cloth or tissue only, at least once a week.
- Do not worry if you notice a minor change in color in the mouthpiece as this should not affect your inhaler performance.
- If needed, wipe the outside of your inhaler device with a damp cloth.
- When you have used your inhaler with 6 cartridges, get a new re-usable pack containing an inhaler.
- To prepare your inhaler device for use, start by pressing on the safety catch while removing the clear base with your other hand by pulling it off making sure that you keep the cap closed, then insert the cartridge into the inhaler.
- Afterwards, put the inhaler on a firm surface and push it down firmly until you hear a click indicating that the cartridge has clicked into place.
- Make sure that you track the number of cartridges used by marking the check-box on the inhaler’s label.
- Then, place the clear base back into place until you hear a click.
- Then make sure that you turn the clear base in the direction of the arrows present on the label until you hear a click (half a turn) while keeping the cap closed, then open the cap until it snaps completely open.
- Point the inhaler device facing the ground followed by pressing the dose-release button and then close the cap.
- Repeat the steps mentioned from turning the clear base half a turn to closing the cap until you see a cloud and then repeat three more times.
- Your inhaler device is now ready to be used and will give 60 puffs (30 doses) per cartridge.
- To take a dose, start by turning the clear base in the direction of the arrows on the label until it clicks (half a turn) while keeping the cap closed.
- Then, open the cap until it becomes completely open. Exhale out slowly and fully seal your lips tightly around the mouthpiece without covering the air vents.
- Point your inhaler to the back of your throat. Press the dose-release button to release a dose.
- Inhale slowly and deeply through your mouth, press the dose-release button and keep on breathing slowly for as long as you can.
- Then, hold your breath for 10 seconds or for as long as you can.
- Repeat the mentioned steps from turning the clear base, opening the cap and pressing the dose-release button for a total of 2 puffs. Finally, close the cap until your next dose.
- The dose indicator of the device shows how many puffs remain in the cartridge (60 puffs for a new cartridge).
- Make sure that you replace the cartridge when the dose indicator shows 10 puffs remaining. If the dose indicator becomes red with an arrow, this means that your cartridge is used up and locked, therefore you need to turn the clear base to loosen it, then pull off the cartridge from the inhaler and replace the old cartridge with a new one.
How to store Tiotropium/Olodaterol:
- Keep out of the reach of children and pets
- Discard the device 12 months after first use
- Do not freeze the medicine
- Change the cartridge three months after insertion
- The recommended use is 6 cartridges per inhaler
- Do not use beyond the expiry date mentioned on the carton and the inhaler label
- Do not dispose medication in the wastewater or household waste.
- Ask your pharmacist how you can dispose medicines you no longer need
