Spiriva RESPIMAT solution for inhalation 60 doses
Spiriva RESPIMAT solution for inhalation 60 doses
What Spiriva Respimat and what it is used
Spiriva Respimat helps patients with chronic obstructive pulmonary disease ( COPD ) to breathe more easily. COPD is a chronic lung disease which causes shortness of breath and cough . The term COPD was associated with states of chronic bronchitis and emphysema . Since COPD is a chronic disease , you should take Spiriva Respimat every day , not just when you have breathing problems or other symptoms of COPD.
Spiriva Respimat is a long-acting bronchodilator that widens the airways and helps you inhale and exhale easier. Regular use of Spiriva Respimat can also help when you are currently in a state characterized by shortness of breath related to your disease and will help to reduce the effects of the disease on your everyday life. It also helps to extend the period of your activity. Daily use of Spiriva Respimat and prevent short episodes of sudden worsening of your symptoms associated with COPD , which may last several days.
The proper dosage of Spiriva Respimat see section 3 . How to use Spiriva Respimat and instructions for use indicated on the reverse side of the leaflet.
2 . What you should know before using Spiriva Respimat
Please read the following questions and if your answer is yes, ask your doctor before using Spiriva Respimat :
Are allergic ( hypersensitive) to you tiotropium , atropine or similar medicines such as ipratropium or oxitropium ?
Are you taking other medicines containing ipratropium or oxitropium ?
Are you pregnant , planning a pregnancy or breast-feeding Do you ?
Do you suffer from blurred vision , eye pain / or redness ) , increased prostate or difficulty urinating ?
Do you have kidney problems ?
Spiriva Respimat not use :
if you are allergic (hypersensitive) to the active ingredient tiotropium or any of the other ingredients of this medicine (listed in Section 6) ;
if you are allergic (hypersensitive) to atropine or other drugs derived from atropine, ipratropium or oxitropium .
Warnings and Precautions
When using Spiriva Respimat , be especially careful not to spray gets into your eyes . This can cause pain or discomfort in the eyes, blurred vision , colored circles or bright spots associated with redness of the eye ( called . Narrow-angle glaucoma) . Eye symptoms may be accompanied by headache, nausea and vomiting. Wash your eyes with warm water , stop using tiotropium bromide and seek advice from your doctor.
If you experience difficulty breathing or develop a rash , swelling or itching immediately after inhalation , stop using Spiriva Respimat and contact your doctor immediately .
During anticholinergic therapy is dry mouth observed that prolonged period may be associated with dental caries . For this reason , it is necessary to pay special attention to oral hygiene.
Spiriva Respimat is applied for the maintenance treatment in patients with chronic obstructive pulmonary disease . Should not be used for sudden / acute attack of shortness of breath or difficulty breathing.
Tell your doctor if you suffer from heart disease , especially conditions under which affect your heart rhythm ( rhythm disorders ) . Violations of rhythm may include irregular heartbeat , slow strokes heart rate (bradycardia ) , or accelerating heartbeat (tachycardia) . It is important to establish whether Spiriva Respimat is the right medicine for your use .
Spiriva Respimat not take more than once daily.
Tell your doctor if you feel that your breathing is difficult .
If you have cystic fibrosis, inform your doctor as Spiriva Respimat may worsen your symptoms of cystic fibrosis.
Children and adolescents
Spiriva Respimat is not recommended for use in children and adolescents under 18 years.
Other medicines and Spiriva Respimat
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Please tell your doctor or pharmacist if you are taking / have taken anticholinergic drugs such as ipratropium or oxitropium .
Not reported specific adverse events during concomitant use of Spiriva Respimat with other medicinal products for the treatment of COPD , such as inhaled drugs to support action , such as salbutamol, methylxanthines such as theophylline and / or steroids for oral and inhalation , e.g. prednisone .
Pregnancy and lactation
If you are pregnant or if you have doubts about an existing pregnancy or breastfeeding should not take this medicine unless you have been specifically recommended by your doctor.
Ask your doctor before taking this medicine.
Driving and using machines
No studies on the effects of tiotropium on ability to drive and use machines. If you experience dizziness or blurred vision , this can affect the ability to drive and use machines.
3 . How to use Spiriva Respimat
Always take this medicine exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
Spiriva Respimat is for inhalation use.
The usual dose is:
Spiriva Respimat effect of continued 24 hours , so you must use the Spiriva Respimat only once a day , if possible at the same time of day. Any use includes two sprays .
Since COPD is a chronic disease , use Spiriva Respimat every day , not just when you feel difficulty in breathing . Do not take more than the recommended dose.
Spiriva Respimat is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy.
Make sure you are using your inhaler correctly Spiriva Respimat . The instructions for using the inhaler Spiriva Respimat are applied on the reverse side of this sheet.
If you take more dose Spiriva Respimat
If you breathed more than two sprays of Spiriva Respimat day , you should inform your doctor immediately. You may be at increased risk of side effects such as dry mouth, constipation , difficulty urinating , increased heart rate , or blurred vision .
If you forget to take Spiriva Respimat
If you forget to take your daily dose ( two puffs once daily ) , do not worry . Take it as soon as you remember but do not take two doses at once or on the same day. Then, take your next dose as usual.
If you stop taking Spiriva Respimat
Before stopping with Spiriva Respimat should consult with your doctor or pharmacist. If you stop treatment with Spiriva Respimat , possible signs and symptoms of COPD worsen .
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Assessment of adverse reactions is based on the following frequencies :
Common: affects 1 to 10 users in 100 ;
Uncommon: affects 1 to 10 patients in 1000 ;
Rare: affects 1 to 10 users in 10,000 ;
Not known from the available data can not be estimated frequency .
Adverse reactions listed below have been reported in patients taking this medicine and are listed according to frequency of occurrence as common, uncommon , rare or not known .
dry mouth : usually mild .
abnormal heart rhythm (atrial fibrillation , supraventricular tachycardia) ;
feeling the heart beat ( palpitations) ;
increased heart rate ( tachycardia)
nosebleeds ( epistaxis ) ;
sore throat ( pharyngitis ) ;
hoarseness ( dysphonia ) ;
fungal infections of the mouth and throat ( oropharyngeal candidiasis ) ;
difficulty in swallowing ( dysphagia ) ;
itching ( pruritus) ;
difficulty urinating ( urinary retention ) ;
pain during urination ( dysuria ) .
colored circles or bright spots associated with redness of the eye ( glaucoma) ;
increased intraocular pressure;
blurred vision ;
tightness in the chest associated with a coughing , difficulty breathing or shortness of breath immediately after inhalation ( bronchospasm) ;
inflammation of the larynx ( laryngitis ) ;
acids ( gastroesophageal reflux disease ) ;
dental caries ;
inflammation of the gums ( gingivitis ) ;
inflammation of the tongue ( glossitis )
infection in the mouth ( stomatitis);
serious allergic reactions causing swelling of the mouth and face or throat ( angioneurotic edema) ;
hives ( urticaria) ;
infections or ulcers on the skin;
dry skin ;
urinary tract infection .
loss of body water ( dehydration) ;
insomnia ( insomnia) ;
inflammation of the sinuses ( sinusitis ) ;
bowel obstruction or lack of movement in the bowel ( intestinal obstruction , including paralytic ileus ) ;
Hypersensitivity reactions, including immediate reactions ;
Immediate allergic reactions such as rash , hives ( urticaria) , swelling of the mouth and face or sudden difficulty in breathing ( angioneurotic edema) or other hypersensitivity reactions may occur after administration of Spiriva Respimat . If these reactions occur , contact your doctor immediately.
In addition, as with all drugs for inhalation , some patients may experience sudden chest discomfort associated with a fit of coughing , difficulty breathing or shortness of breath immediately after inhalation ( bronchospasm) .
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .
5 . How to store Spiriva Respimat
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and label the inhaler. The expiry date refers to the last day of that month. Spiriva Respimat inhaler should be discarded later than three months from first use (see instructions for use on the reverse side).
Do not freeze .
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
Spiriva Respimat contents
The active substance is tiotropium . When an injection is released 2.5 micrograms tiotropium ( 2 sprays constitute a dosage form ) which are equivalent to 3,124 micrograms of tiotropium bromide monohydrate. The delivered dose is the dose administered to the patient after its passage through the mouthpiece.
Other ingredients are: benzalkonium chloride, edetate disodium , and purified water 3.6% , hydrochloric acid for pH adjustment .
Spiriva Respimat looks like and contents of the pack
Spiriva Respimat 2.5 micrograms is composed of a cartridge containing a solution for inhalation and an inhaler Respimat . The cartridge should be placed in the dispenser prior to initial use .
Single pack : 1 Respimat inhaler and a filler , providing 60 puffs (30 medicinal doses).
Double pack : 2 unit packs each containing 1 Respimat inhaler and a cartridge , providing 60 puffs (30 medicinal doses).
Triple Pack : 3 packs , each containing 1 Respimat inhaler and a filler , providing 60 puffs (30 medicinal doses).
Eightfold packaging 8 single packs , each containing 1 Respimat inhaler and a cartridge , providing 60 puffs (30 medicinal doses).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The holder of the marketing authorization for Spiriva Respimat is : Boehringer Ingelheim International GmbH, Germany.
Spiriva Respimat manufacturer of is:
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany.
Instructions for use Spiriva Respimat Inhaler
How to use your inhaler Spiriva Respimat
This leaflet explains how to use and store carefully Spiriva Respimat your inhaler . Please read and follow these instructions carefully. See also section 3 . How to use Spiriva Respimat the reverse side of the leaflet.
Spiriva Respimat inhaler releases the drug dose slowly and gently , making it suitable for inhaled into your lungs.
Spiriva Respimat inhaler enables you to inhale the medicine contained in the cartridge . Quantity in the magazine provides 60 puffs (30 medicinal doses). It is necessary to use the inhaler once a day, if possible at the same time of day. In any use made two sprays . When used according to directions for use , the amount of the drug is enough for 30 days. In carton you will find inhaler refill Spiriva Respimat . Before the first use of the inhaler , the cartridge should be placed therein.
1 ) Installing the cartridges
It is necessary to follow the steps 1-6 prior to initial use :
1. Push the button while pulling the transparent envelope without opening the green cap .
2 . Remove the cartridge from the carton . Tap the narrow part of the magazine into the inhaler until it clicks into place. The filler must be injected directly against a rigid surface in order to ensure that it is driven all the way inward. The cartridge does not completely fit in the inhaler , so that the lower portion of a silver filler will remain visible .
Do not remove the cartridge once to put into the inhaler .
3 . Refit the transparent shell. More not remove the transparent cover.
2 ) Preparation of Spiriva Respimat inhaler for the first time use :
4 . Hold the inhaler Spiriva Respimat upright closed green cap. Turn the shell in the direction of the red arrow on the label until it clicks (half a rotation) .
5 . Open the green cap until it clicks , and it is fully open .
6 . Spiriva Respimat inhaler Aim down. Press release dosage. Close the green cap.
Repeat steps 4 , 5 and 6 to the visible appearance of aerosol.
Repeat steps 4 , 5 and 6 three more times to bring the inhaler able to use.
Now Spiriva Respimat inhaler Your ready for use.
These steps will not affect the number of doses contained . After training in the use Spiriva Respimat inhaler Your will contain 60 sprays (30 medicinal doses).
Everyday use of the inhaler Spiriva Respimat
It is necessary to use this inhaler only once a day . Every time you use take two puffs .
I. Hold the inhaler Spiriva Respimat upright closed green cap to avoid accidental splashing dose . Turn the transparent shell in the direction of the red arrows on the label until it clicks (half a turn).
II. Open the green cap until fully open with a click . Exhale slowly and completely and spread her lips mouthpiece without covering the air vents . Spiriva Respimat inhaler Point to his throat. While slow, deep breath through his mouth , press the release button on the dose and continue to breathe slowly as far as you can. Hold your breath for 10 seconds , or as long as you can.
III. Repeat steps I and II so as to take the entire dose .
Using the inhaler will be imposed only once a day.
Close the green cap until the next use of the inhaler Spiriva Respimat .
If you did not use Spiriva Respimat inhaler more than 7 days , squirt one dose in the air. Spiriva Respimat inhaler if you have not used more than 21 days , repeat steps 4 to 6 to the visible appearance of aerosol. Then repeat steps 4 to 6 three more times.
When to replace the Spiriva Respimat inhaler with a new
Spiriva Respimat inhaler contains 60 puffs (30 medicinal doses). The dose indicator shows approximately how much medicine remains . The advent of the indicator in the red zone separating scale means that the drug has remained approximately 7 days (14 injections ) . This is the time when you need to be prescribed Spiriva Respimat inhaler new . Once the indicator reaches the end of the red zone (ie all 30 doses have already been used ) , Spiriva Respimat inhaler is now empty and locked automatically. Therefore, the transparent envelope can no longer be rotated .
Spiriva Respimat inhaler should be discarded later than three months after its first use , even if it is not used all the medicine .
In the event that ...
In the event that ...
What to do
I can not easily turned transparent shell. a) Spiriva Respimat inhaler is already prepared and ready for use.
b) Spiriva Respimat inhaler is locked after 60 puffs (30 medicinal doses).
a) The inhaler Spiriva Respimat can be used immediately.
b) Prepare and use your new inhaler Spiriva Respimat .
When opened completely separate the cap from the inhaler.
Too much you opened the cap. The cap can be easily attached again .
I pressed the button to release the dose. The transparent cover is not rotated . Turn the transparent casing until it clicks ( half a turn).
The springs of the transparent shell is reset after it has been rotated . The transparent envelope has not been rotated sufficiently .