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SPIRIVA 18 microgram makes it easier for patients with chronic obstructive pulmonary disease (COPD) to breathe. Chronic obstructive pulmonary disease (COPD) is a permanent lung disease accompanied by shortness of breath and cough. The term COPD is also used as a name to cover the symptoms of chronic obstructive bronchitis and emphysema. COPD is a chronic disease, so you should use SPIRIVA 18 microgram every day and not just when you have breathing problems or other symptoms of COPD. SPIRIVA is a long-acting bronchodilator that expands the airways and thereby makes it easier for the lungs to breathe in and out. Regular use of SPIRIVA can alleviate the shortness of breath that occurs in this disease, thereby boosting physical activity and helping you to reduce the effects of the disease on your everyday life. Daily use of SPIRIVA may furthermore prevent the onset of acute (sudden) temporary episodes of worsening disease, which may last for up to several days. The effect of this medicine lasts for 24 hours, so SPIRIVA only needs to be used once a day. How to use Recommended dose: Inhale the contents of 1 capsule (18 micrograms of tiotropium) once a day. Do not inhale more than 1 capsule per day. The capsule contents should be inhaled at the same time each day. This is important because the effect of SPIRIVA lasts for 24 hours. The capsules are intended for inhalation only, not for oral use. The capsules must not be swallowed. The HandiHaler inhaler, into which the SPIRIVA capsule is inserted, pierces the capsule at the push of a button, thereby allowing inhalation of the powder. Use in children and adolescents SPIRIVA 18 microgram is not recommended for children and adolescents under 18 years of age. Warnings and precautions Do not use SPIRIVA 18 microgram If you are allergic (hypersensitive) to the active substance tiotropium or to the excipient lactose monohydrate (may contain small amounts of milk proteins); If you are allergic (hypersensitive) to atropine or derivatives of this substance, e. g. ipratropium or oxitropium. Warnings and precautions Talk to your doctor or pharmacist before using SPIRIVA. Talk to your doctor if you suffer from narrow-angle glaucoma or prostate problems or have difficulties in passing urine. Talk to your doctor if you have problems with your kidneys. SPIRIVA 18 microgram is indicated for the long-term treatment of your chronic obstructive pulmonary disease; it should not be used to treat sudden attacks of breathlessness or wheezing. Immediate-type allergic reactions, such as rash, swelling, itching, wheezing or breathlessness, may occur after the use of SPIRIVA. If this happens, please contact your doctor immediately. Inhaled medicines such as SPIRIVA may cause chest tightness, coughing, wheezing or breathlessness immediately after inhalation. If this happens, please contact your doctor immediately. If any eye signs or symptoms occur, you should stop treatment with tiotropium bromide and seek medical advice immediately; if possible, from an eye specialist. Dry mouth, which has been observed during treatment with medicines of this group of active substances (anticholinergics), might lead to tooth delay (caries) if it persists over prolonged periods. Thorough dental hygiene must therefore be ensured. Do not use SPIRIVA more frequently than once a day. Side Effects Common (may affect up to 1 in 10 patients treated): Dry mouth: This is usually mild Serious side effects include allergic reactions with swelling of the face or throat (angioedema) or other hypersensitivity reactions (such as sudden drop in blood pressure or dizziness). These can occur either individually or as part of a severe allergic reaction (anaphylactic reaction) after use of SPIRIVA 18 microgram. As with all inhaled medicines, chest tightness, coughing, wheezing or shortness of breath (bronchospasm) may occur unexpectedly in some patients immediately after inhalation. In such cases, tell your doctor immediately. Storage Information Do not store above 25°C. Do not freeze. Drug Interactions Tell your doctor or pharmacist if you are using or have recently used similar medicines for your lung disease, such as ipratropium or oxitropium. No specific side effects have been observed with use of SPIRIVA 18 microgram together with other medicines for the treatment of COPD, such as inhalants for acute symptoms (e. g. salbutamol), methylxanthines (e. g. theophylline) and/or oral and inhaled steroids (e. g. prednisolone). Ingredients The active substance is tiotropium. The other ingredient is lactose monohydrate (may contain small amounts of milk proteins). Specifications SPIRIVA 18 microgram is an inhalation powder in a light-green, hard capsule printed with the product code “TI 01” and the company logo.
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