18 micrograms inhalation powder, hard capsule
tiotropium
What Spiriva 18 micrograms are and what it is used for
Spiriva 18 micrograms help people with chronic obstructive pulmonary disease (COPD) 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 Spiriva 18 micrograms every day, not just when you have breathing problems or other symptoms of COPD.
Spiriva 18 micrograms 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 Spiriva 18 micrograms 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 Spiriva 18 micrograms 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 Spiriva 18 micrograms, see section 3, How to use Spiriva 18 micrograms, and the instructions for use (with pictures).
What you need to know before you use Spiriva 18 micrograms
Do not use Spiriva 18 micrograms
– if you are allergic to tiotropium, the active ingredient, or any other ingredient in 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 Spiriva 18 micrograms.
- 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.
- Spiriva 18 micrograms is a bronchodilator medicine for the maintenance treatment of your COPD disease. It should not be used to treat sudden attacks of shortness of breath 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 Spiriva 18 micrograms. If this occurs, you should immediately contact a doctor.
- Inhaled medicines such as Spiriva 18 micrograms may 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 narrow-angle glaucoma. Pain or discomfort in the eyes, blurred vision, and visual phenomena 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 tiotropium bromide and see a doctor immediately, preferably an eye specialist, if symptoms of narrow-angle glaucoma appear.
- 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, tell your doctor. It is imporable to determine whether Spiriva is the right medicine for you.
- Do not use Spiriva 18 micrograms more often than once a day.
Children and young people
Spiriva 18 micrograms are not recommended for children and adolescents under 18 years of age.
Other medicines and Spiriva 18 micrograms
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 Spiriva 18 micrograms have 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. 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.
Spiriva 18 micrograms contain lactose monohydrate
When Spiriva 18 micrograms are used according to the dosage recommendation, 1 capsule per day, each dose provides up to 5.5 mg of lactose monohydrate. If you cannot tolerate certain sugars or are allergic to milk protein (which may be present in small amounts in the ingredient lactose monohydrate ), you should contact your doctor before taking this medication.
How to use Spiriva 18 micrograms
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 tiotropium) once a day. Do not use more than the recommended dose.
Spiriva 18 micrograms are not recommended for children and adolescents under 18 years of age.
You should try to inhale the contents of the capsule at the same time each day. This is important because Spiriva 18 micrograms are effective for 24 hours.
The capsules are intended for inhalation only and should not be swallowed.
The HandiHaler inhaler, into which you will place the Spiriva capsule, makes a hole in the capsule so that the powder becomes available for inhalation.
Make sure you have a HandiHaler and that you can use it correctly. Instructions for using the HandiHaler can be found in the instructions for use.
Avoid exhaling through the HandiHaler.
If you have any problems using the HandiHaler, ask your doctor, nurse, or pharmacist to show you how it works.
You should clean the HandiHaler once a month. Instructions for cleaning the HandiHaler can be found in the instructions for use.
When using Spiriva 18 micrograms, be careful not to get any powder in the 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 have used too many Spiriva 18 micrograms
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 Spiriva 18 micrograms 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 Spiriva 18 micrograms
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 Spiriva 18 micrograms
Before you stop using Spiriva 18 micrograms, talk to your doctor or pharmacist.
If you stop using Spiriva 18 micrograms, COPD symptoms may worsen.
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 are listed by frequency as either common, uncommon, rare or reported.
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
- itching
- 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
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 the only reaction or as part of a severe hypersensitivity reaction ( anaphylactic reaction ) after taking Spiriva 18 micrograms. 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.
How to store Spiriva 18 micrograms
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.
After taking the first capsule from a blister, continue to take capsules for the next 9 days, one capsule per day, from the same blister.
The HandiHaler inhaler must be disposed of no later than 12 months after first use.
Store at a maximum of 25°C.
Do not freeze.
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 the active substance tiotropium (as bromide monohydrate).
When inhaled, 10 micrograms of tiotropium are released from the mouthpiece of the HandiHaler. Another ingredient is lactose monohydrate (which may contain small amounts of milk proteins).
Appearance and package sizes of the medicine
Spiriva 18 micrograms, inhalation powder, the hard capsule is a light green hard capsule, with the code TI 01 and the company logo printed on the capsule.
Package sizes:
Packaging of 30 capsules
Packaging of 60 capsules
Packaging of 90 capsules
Packaging with 10 capsules and 1 inhaler HandiHaler
Packaging with 30 capsules and 1 inhaler HandiHaler
Hospital packaging: 5 packages with 30 capsules each and 1 HandiHaler inhaler
Hospital packaging: 5 packages of 60 capsules each
In addition, there is a package with 1 HandiHaler inhaler.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
Manufacturer :
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim France
100-104 avenue de France
75013 Paris
France
Information provided by:
Boehringer Ingelheim AB, Box 92008, 120 06 Stockholm. Phone: 08 – 721 21 00
Email: info.sto@boehringer-ingelheim.com
This medicine is approved in the European Economic Area under the name: Spiriva 18 microgram/microgram/micro.