18 micrograms inhalation powder, hard capsule
tiotropium
What Tiogiva is and what it is used for
Tiogiva helps people with chronic obstructive pulmonary disease (COPD) to breathe easier. COPD is a chronic lung disease that can cause shortness of breath and cough. The diagnosis of COPD is also associated with chronic bronchitis and emphysema. Because COPD is a chronic disease, you should use Tiogiva every day, not just when you have breathing problems or other symptoms of COPD.
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. Regular 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. It also helps you stay active for longer. Daily use of Tiogiva will also help prevent sudden, short-term worsening of COPD symptoms, which can last for several days. The effect of the drug lasts for 24 hours, so you only need to use it once a day. For the correct dosage of Tiogiva, see section 3. How to use Tiogiva, as well as the instructions for use at the end of the leaflet.
The tiotropium contained in Tiogiva may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Tiogiva
Do not use Tiogiva
- if you are allergic to tiotropium, the active ingredient, or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to atropine or similar substances, eg ipratropium or tiotropium.
Warnings and precautions
Talk to your doctor or pharmacist before using Tiogiva:
- Tell your doctor if you suffer from narrow-angle glaucoma, prostate problems, or have problems emptying your bladder.
- If you have kidney problems, discuss them with your doctor.
- Tiogiva is a bronchodilator medicine for the maintenance treatment of your COPD disease. It should not be used to treat sudden attacks of breathlessness or wheezing or wheezing.
- Immediate hypersensitivity reactions such as skin rash, swelling, itching, wheezing or wheezing or shortness of breath may occur after administration of Tiogiva. If this occurs, you should immediately contact a doctor.
- Inhaled medicines such as Tiogiva can cause chest tightness, coughing, wheezing or wheezing or shortness of breath immediately after inhalation. If this occurs, you should immediately contact a doctor.
- Be careful that the inhalation powder does not get into the eyes, as this can trigger or worsen the eye disease of narrow-angle glaucoma. Pain or discomfort in the eyes, blurred vision and visual phenomena such as rings of light or colored images associated with red eyes can be signs of an acute attack of narrow-angle glaucoma. Symptoms from the eyes may be accompanied by headache, nausea, or vomiting. Stop using Tiogiva and see a doctor immediately, preferably an eye specialist, if symptoms of narrow-angle glaucoma appear.
- A dry mouth, which has been observed during treatment with anticholinergic drugs, can lead to dental caries during long-term treatment. Therefore, be careful with oral hygiene. – If you have had a heart attack in the last 6 months, or suffered from unstable or life-threatening heart rhythm disturbances or severe heart failure in the last year. It is important to be able to determine whether Tiogiva is the right medicine for you.
- Do not use Tiogiva more often than once a day.
Children and young people
Tiogiva is not recommended for children and adolescents under 18 years of age.
Other medicines and Tiogiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including non-prescription medicines.
Tell the doctor or pharmacist if you are using/have used similar medicines for your lung diseases such as ipratropium or tiotropium.
No specific side effects have been reported when Tiogiva has been used together with other drugs used in the treatment of COPD, such as bronchodilators for inhalation such as salbutamol, methylxanthines such as theophylline, and/or oral and inhaled steroids such as prednisolone.
Pregnancy and breastfeeding
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. You should not use this medicine during pregnancy and breastfeeding unless your doctor recommends it anyway.
Driving ability and use of machinery
If dizziness, blurred vision, or headache occurs, it may affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tiogiva contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine
How to use Tiogiva
- Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
- The recommended dose is the inhalation of the contents of 1 capsule (18 micrograms of tiotropium) once a day. Do not use more than the recommended dose. – Tiogiva is not recommended for children and adolescents under the age of 18.
- You should try to inhale the contents of the capsule at the same time each day. This is important because Tiogiva is effective for 24 hours.
- The capsules are intended for inhalation only and should not be swallowed.
- The Tiogiva inhaler, into which you will place the Tiogiva capsule, makes a hole in the capsule so that the powder becomes available for inhalation.
- The capsules may only be inhaled using the inhaler supplied with Tiogiva capsules. Do not use other inhalers to administer Tiogiva capsules.
- Make sure you have a Tiogiva inhaler and that you can use it correctly. Instructions for using the inhaler can be found at the end of the leaflet. If you have any problems using the inhaler, ask your doctor, nurse, or pharmacist to show you how it works.
- When using Tiogiva, be careful not to get the powder in your eyes. If you get powder in your eyes, you may experience blurred vision, eye pain, and/or red eyes. In this case, immediately rinse your eyes with lukewarm water. Then speak to your doctor immediately for further advice.
- If your breathing worsens, contact your doctor as soon as possible.
If you use too much Tiogiva
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.
If you have used more than one capsule of Tiogiva per day, you should talk to your doctor immediately. You may be at greater risk of side effects such as dry mouth, constipation, difficulty emptying the bladder, palpitations, and blurred vision.
If you forget to use Tiogiva
If you forget a dose, take one dose as soon as you remember, but do not take two doses at the same time or on the same day. Then take the next dose as usual.
If you stop using Tiogiva
Before you stop using Tiogiva, talk to your doctor or pharmacist. If you stop using Tiogiva, your COPD symptoms may get worse.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects described below have been reported by people using the medicine and they are listed by frequency as either common, uncommon, rare, or have been reported.
Serious side effects include allergic reactions leading to swelling of the face and throat ( angioedema ) or other hypersensitivity reactions (such as a rapid drop in blood pressure or dizziness) that may occur as a single reaction or as part of a severe hypersensitivity reaction ( anaphylactic reaction ) after taking Tiogiva. In addition, as with other inhaled medicines, some patients may experience unexpected pressure in the chest, coughing, wheezing, or shortness of breath immediately after inhalation. If you experience any of these, contact a doctor immediately.
Common (may affect up to 1 in 10 users):
- dry mouth: usually mild
Uncommon (may affect up to 1 in 100 users):
- dizziness
- headache
- taste changes
- blurred vision
- irregular heartbeat ( atrial fibrillation )
- inflammation of the throat
- huskiness
- cough
- heartburn
- constipation
- fungal infection of the mouth and throat
- rash
- difficulty emptying the bladder
- pain when emptying the bladder
Rare (may affect up to 1 in 1,000 users):
- insomnia
- visual phenomena such as rings of light or colored images associated with red eyes ( glaucoma )
- increased pressure in the eye
- irregular heartbeat ( supraventricular tachycardia )
- faster heartbeat
- palpable heartbeat
- pressure on the chest, associated with coughing, wheezing or wheezing or shortness of breath after inhalation ( bronchospasm )
- nosebleed
- inflammation of the larynx
- inflammation of the sinuses
- blockage in the bowels or no bowel movements
- inflammation of the gums
- inflammation of the tongue
- difficulty swallowing
- inflammation of the oral mucosa
- nausea
- hypersensitivity, including immediate reactions
- severe allergic reactions causing swelling of the face and throat ( angioedema )
- hives ( urticaria )
- itching ( pruritus )
- infection in the urinary tract
Has been reported (occurring in an unknown number of users):
- loss of body fluid ( dehydration )
- dental caries
- severe allergic reaction ( anaphylactic reaction )
- infection and wounds in the skin
- dry skin
- swollen joints
How to store Tiogiva
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister foil. The expiration date is the last day of the specified month.
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.
Store at a maximum of 30°C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is tiotropium. Each capsule contains 18 micrograms of tiotropium (as tiotropium bromide). When inhaled, 10 micrograms of tiotropium are released from the inhaler’s mouthpiece.
The medicine also contains:
- capsule contents: lactose (see section 2)
- capsule shell: hypromellose
- ink on the capsule: shellac, black iron oxide, propylene glycol, ammonia, potassium hydroxide.
Appearance and package sizes of the medicine
Tiogiva inhalation powder, the hard capsule is a colorless and transparent hard capsule, marked “T10” and containing a white powder.
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.
- Box of 30 capsules (3 blister cards) and an inhaler
- Box of 60 capsules (6 blister cards) and an inhaler
- Box of 90 capsules (9 blister cards) and an inhaler
- Box of 30 capsules (3 blister cards)
- Box of 60 capsules (6 blister cards)
- Box of 90 capsules (9 blister cards)
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Nordic AB
Propellergatan 2
211 15 Malmö
Manufacturer
Helm AG
Nordkanalstrasse 28
20097 Hamburg
Germany