Spiriva Respimat filler Inhaler
Spiriva Respimat helps patients with chronic obstructive pulmonary disease (COPD) or asthma breathe easier. COPD is a chronic lung disease that causes shortness of breath and cough. The term COPD is associated with conditions of chronic bronchitis and emphysema. Asthma is a long-standing illness characterized by inflammation and narrowing of the airways.
Because COPD and asthma are chronic illnesses, you should use Stopworm every day, not just when you have respiratory problems or other symptoms. In the treatment of asthma, you should use Stopiva Respimat in addition to the so-called. inhaled corticosteroids and long-acting beta-2 agonists.
Spiriva Respimat is a long-acting bronchodilator that expands the airways and helps you breathe in and out more easily. Regular use of Spiriva Respimat can also help you when you are currently in a condition characterized by shortness of breath associated with your illness and help reduce the effects of the disease on your daily life. It also helps to prolong your activity. The daily use of Spiriva Respimat will also prevent episodes of sudden short-term exacerbation of your COPD symptoms that may last for several days.
For the correct dosage of Spiriva Respimat, see section 3. How to use Spiriva Respimat and the Instructions for Use listed on the back of the leaflet.
2. What you need to know before using Spiriva Respimat
Do not use Spiriva Respimat
- if you are allergic (hypersensitive) to tiotropium or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic (hypersensitive) to atropine or other atropine derivatives, such as ipratropium or oxytropium.
Warnings and precautions
Talk to your doctor or pharmacist before using Stopiva Respimat.
Talk to your doctor if you suffer from angle-closure glaucoma, prostate problems, or have difficulty urinating.
If you have kidney problems, talk to your doctor.
When using Spiriva Respimat, be especially careful about the spray from getting into your eyes. This can cause pain or an unpleasant sensation in the eyes, blurred vision, colored circles or light spots associated with redness of the eyes (called closed-angle glaucoma). Eye symptoms can be accompanied by headache, nausea and vomiting. Wash your eyes with warm water, discontinue using tiotropium bromide and seek medical advice immediately.
If you experience shortness of breath or experience rash, swelling or itching immediately after inhalation, stop using Spiriva Respimat and tell your doctor immediately.
During anticholinergic therapy, dry mouth is observed, which may be associated with dental caries over a prolonged period. Therefore, it is necessary to pay special attention to oral hygiene.
Spiriva Respimat is used for maintenance treatment in patients with chronic obstructive pulmonary disease or asthma. Do not use this medicine in the event of a sudden / acute onset of shortness of breath or shortness of breath. For this purpose, your doctor should prescribe you another inhaler ("emergency therapy"). Follow your doctor's instructions.
If Spiriva Respimat is prescribed for your asthma, it should be a supplement to your treatment, which includes inhaled corgicosteroids and long-acting beta-2 agonists. Continue to take inhaled corgicosteroids as prescribed by your doctor, even if you feel better.
If you have had myocardial infarction in the last 6 months, unstable or life-threatening irregular heart rhythm, or severe heart failure in the last year, tell your doctor. This is important to determine if Spirava is the right medicine for you.
Do not take Spiriva Respimat more than once a day.
Tell your doctor if you find your breathing difficult.
If you have cystic fibrosis, tell your doctor as Spirava Respimat may worsen your symptoms of cystic fibrosis.
Spiriva Respimat is not recommended for use in children below the age of 6 years.
Other Medicines and Spiriva Respimat
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Please tell your doctor or pharmacist if you are using / have used anticholinergic medicinal products, such as ipratropium or oxytropium.
No specific side effects have been reported with the concomitant use of Spiriva Respimat with other medicinal products intended for the treatment of COPD, such as inhalation drugs (eg salbutamol), methylxanthines (eg, theophylline), antihistamines, mucolytics
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before using this medicine.
You should not take this medicine unless specifically recommended by your doctor.
Driving and using machines
There are no studies on the effects of tiotropium on the ability to drive and use machines. In the event of dizziness or blurred vision, this may affect the ability to drive and use machines.
Spiriva Respimat contains benzalkonne chloride
This medicine contains 0.0011 mg of injectable benzalkonium chloride.
Benzalkonium chloride can cause wheezing and difficulty breathing (bronchospasm), especially if you have asthma.
3. How to use Spiriva Respimat
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Stopiva Respimat is for inhalation use only.
The recommended dose for patients 6 years and older is:
The effect of Spiriva Respimat lasts for 24 hours, which is why you should use Stiriva. Respond only once a day, if possible at the same time of day. Each use includes TWO INJECTS.
Side effect COPD incidence Frequency Asthma
Dizziness of Unholy Unholy
Oral fungus infection and throat (oropharyngeal candidiasis) Uncommon Uncommon
Difficulty passing urine (urinary retention) Uncommon With unknown frequency
Constipation Uncommon Rare
Rash of Uncommon Uncommon
Itching (pruritus) Uncommon Rare
Increase in intraocular pressure Rare With unknown frequency
Serious allergic reaction that causes swelling of the mouth and face or throat (angioneurotic edema) Rare Rare
Sleep Disorders (Insomnia) Rare Uncommon
Heart rhythm disorders (atrial fibrillation, ventricular tachycardia) Rare unknown frequency
Unpleasant sensations in the cardiac area (palpitations) Rare
Nasal bleeding (epistaxis) Rare Rare
Inflammation of the tongue (glossitis) Rare With unknown frequency
Heart rate (tachycardia) Rare With unknown frequency
Tightening of the chest accompanied by cough, wheezing or shortness of breath immediately after inhalation (bronchospasm) Rare Uncommon
Swallowing difficulty (dysphagia) Rare With unknown frequency
Seeing a halo around lights or color images accompanied by redness of the eyes (glaucoma) Rare With unknown frequency
Blurred vision Rare With unknown frequency
Larynx inflammation (laryngitis) Rare With unknown frequency
Tooth decay Rare With unknown frequency
Gingivitis (gingivitis) Rare Rare
Hives (hives) Rare Rare
Hives (hives) Rare With unknown frequency
Skin dryness Rare With unknown frequency
Urinary tract infections Rare Rare
Stomach acids (gastroesophageal reflux disease) Rare With unknown frequency
Hypersensitivity, incl. rapid type C reactions unknown frequency Rare
Mouth inflammation (stomatitis) Frequency unknown Rare
Fluid loss in the body (dehydration) With unknown frequency With unknown frequency
Sinus Inflammation (Sinusitis) With Unknown Frequency With Unknown Frequency
Intestinal obstruction or lack of peristalsis (intestinal obstruction, including paralytic ileus) Unknown frequency With unknown frequency
Frequency nausea Frequency nausea
Severe allergic reaction (anaphylactic reaction) With unknown frequency With unknown frequency
Joint swelling With unknown frequency With unknown frequency
Immediate allergic reactions such as rash, stinging fever (urticaria), swelling of the mouth and face, or sudden difficulty in breathing (angioneurotic edema), or other hypersensitivity reactions (such as a sudden decrease in your blood pressure, may cause dizziness or dizziness). as part of a severe allergic reaction (anaphylactic reaction) after administration of Spiriva Respimat.
In addition, as with all inhalation medicines, some patients may experience unexpected chest heaviness associated with a cough, shortness of breath, or shortness of breath immediately after inhalation (bronchospasm).
If any of these occur, contact your doctor immediately.
5. How to store Respiva Respiratory System
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and the label of the inhaler. The expiration date corresponds
The expiry date refers to the last day of that month.
Do not freeze.
Shelf life after initial use;
Replace the cartridge no later than 3 months after insertion.
Do not use the reusable inhaler for more than one year.
Recommended use: 6 cartridges per inhaler
Note: the functioning of the Spiriva Respimat Test has been demonstrated in 540 injection tests (which corresponds to 9 fillers).
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Spiriva Respimat contains
The active substance is tiotropium. 2.5 micrograms of tiotropium (2 injections represent one drug dose), equivalent to 3,124 micrograms of tiotropium bromide monohydrate, are released per injection. The released dose is the dose taken by the patient after passing the mouthpiece.
The other ingredients are:
Benzalkonium chloride, disodium edetate, purified water and 3.6% hydrochloric acid to adjust pH.
What Spiriva Respimat looks like and contents of the pack
Spiriva Respimat 2.5 micrograms is made up of one cartridge containing a solution for inhalation and one inhaler Respimat. The cartridge must be placed in the inhaler before first use.
Single pack: 1 reusable inhaler and one filler providing 60 sprays (30 drug doses)
Triple packaging: 1 reusable inhaler and 3 fillers, each providing 60 sprays (30 drug doses)
Single cartridge cartridge: 1 cartridge providing 60 sprays (30 drug doses)
Triple packing cartridge: 3 cartridges, each providing 60 sprays (30 drug doses)
Not all pack sizes may be marketed.