18 micrograms\u00a0inhalation powder, hard capsule
tiotropium<\/p>\n\n\n\n
Tiogiva helps people with chronic\u00a0obstructive pulmonary disease\u00a0(COPD) to breathe easier.\u00a0COPD is a\u00a0chronic\u00a0lung disease that can cause shortness of breath and cough<\/a>.\u00a0The diagnosis of COPD is also associated with\u00a0chronic\u00a0bronchitis\u00a0and\u00a0emphysema.\u00a0Because COPD is a\u00a0chronic\u00a0disease, you should use Tiogiva every day, not just when you have breathing problems or other symptoms of COPD.<\/p>\n\n\n\n Tiogiva is a long-acting bronchodilator medicine that helps open your airways and makes it easier to get air in and out of the lungs.\u00a0Regular use of Tiogiva can also help when you experience a period of breathlessness due to your illness and help minimize the effects of the illness in your daily life.\u00a0It also helps you stay active for longer.\u00a0Daily use of Tiogiva will also help prevent sudden, short-term worsening of COPD symptoms, which can last for several days.\u00a0The effect of the drug lasts for 24 hours, so you only need to use it once a day.\u00a0For the correct\u00a0dosage\u00a0of Tiogiva, see section 3. How to use Tiogiva, as well as the instructions for use at the end of the leaflet.<\/p>\n\n\n\n The tiotropium contained in Tiogiva may also be approved to treat other conditions not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions. Talk to your doctor or pharmacist before using Tiogiva:<\/p>\n\n\n\n Tiogiva is not recommended for children and adolescents under 18 years of age.<\/a><\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including non-prescription medicines.<\/p>\n\n\n\n Tell the doctor or pharmacist if you are using\/have used similar medicines for your lung diseases such as ipratropium or tiotropium.<\/p>\n\n\n\n No specific\u00a0side effects\u00a0have been reported when Tiogiva has been used together with other drugs used in the treatment of COPD, such as bronchodilators for\u00a0inhalation\u00a0such as\u00a0salbutamol, methylxanthines such as theophylline, and\/or oral and inhaled\u00a0steroids\u00a0such as\u00a0prednisolone.<\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.\u00a0You should not use this medicine during pregnancy and breastfeeding unless your doctor recommends it anyway.<\/p>\n\n\n\n If dizziness, blurred vision, or headache occurs, it may affect the ability to drive or use machines.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0A description of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0Discuss with your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine<\/a><\/p>\n\n\n\n If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.<\/p>\n\n\n\n If you have used more than one capsule of Tiogiva per day, you should\u00a0talk to your doctor\u00a0immediately<\/strong>.\u00a0You may be at greater risk of\u00a0side effects\u00a0such as\u00a0dry mouth, constipation<\/a>, difficulty emptying the bladder, palpitations, and blurred vision.<\/p>\n\n\n\n If you forget a\u00a0dose, take one\u00a0dose\u00a0as soon as you remember, but\u00a0do not take<\/strong>\u00a0two\u00a0doses\u00a0at the same time or on the same day.\u00a0Then take the next\u00a0dose\u00a0as usual.<\/p>\n\n\n\n Before you stop using Tiogiva, talk to your doctor or pharmacist. If you stop using Tiogiva, your COPD symptoms may get worse.<\/p>\n\n\n\n If you have any further questions about this medicine, ask your doctor or pharmacist.<\/a><\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.\u00a0The side effects\u00a0described below have been reported by people using the medicine and they are listed by frequency as either common, uncommon, rare, or have been reported.<\/p>\n\n\n\n Serious\u00a0side effects\u00a0include<\/strong>\u00a0allergic reactions leading to swelling of the face and throat (\u00a0angioedema\u00a0) or other\u00a0hypersensitivity reactions\u00a0(such as a rapid drop in blood pressure or dizziness) that may occur as a single reaction or as part of a severe\u00a0hypersensitivity reaction\u00a0(\u00a0anaphylactic reaction\u00a0) after taking Tiogiva.\u00a0In addition, as with other inhaled medicines, some patients may experience unexpected pressure in the chest, coughing, wheezing, or shortness of breath immediately after\u00a0inhalation.\u00a0If you experience any of these, contact a doctor immediately.<\/p>\n\n\n\n Common (may affect up to 1 in 10 users):<\/strong><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 users):<\/strong><\/p>\n\n\n\n Rare (may affect up to 1 in 1,000 users):<\/strong><\/p>\n\n\n\n Has been reported (occurring in an unknown number of users):<\/strong><\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Use before the expiry date stated on the carton and blister foil. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Use the capsule immediately after opening the blister. Use only the inhaler provided in the package. If you have an associated refill pack with only Tiogiva capsules, you can use the inhaler you already have. After using the same inhaler for 6 months, replace it with a new one.<\/p>\n\n\n\n Store at a maximum of 30\u00b0C.<\/p>\n\n\n\n Medicines must not be thrown into the drain or among the household waste.\u00a0Ask the pharmacist how to dispose of medicines that are no longer used.\u00a0These measures will help to protect the environment.<\/p>\n\n\n\n The active substance is tiotropium.\u00a0Each capsule contains 18 micrograms of tiotropium (as tiotropium bromide).\u00a0When\u00a0inhaled, 10 micrograms of tiotropium are released from the inhaler’s mouthpiece.<\/p>\n\n\n\n The medicine also contains:<\/p>\n\n\n\n Tiogiva\u00a0inhalation powder, the hard capsule is a colorless and transparent hard capsule, marked “T10” and containing a white powder.<\/p>\n\n\n\n The medicine is supplied in blister cards. The blister cards are in a box and, depending on the packaging, the box may also contain an inhaler (MRX003-R). The inhaler is white with a red push button.<\/p>\n\n\n\n
<\/p>\n\n\n\nWhat you need to know before you use Tiogiva<\/h2>\n\n\n\n
Do not use Tiogiva<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and Tiogiva<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
Tiogiva contains lactose<\/h2>\n\n\n\n
How to use Tiogiva<\/h2>\n\n\n\n
If you use too much Tiogiva <\/h2>\n\n\n\n
If you forget to use Tiogiva<\/h2>\n\n\n\n
If you stop using Tiogiva<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Tiogiva<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n
Appearance and package sizes of the medicine<\/h2>\n\n\n\n