Spiriva 18 Microgram Inhalation Powder Hard Capsule
Assessed against UK PIL dated August 2005
APPROVED
By austino at 4:29 pm, 1/9/07
LANDMARK PHARMA LTD
PROPOSED TEXT: PATIENT INFORMATION LEAFLET
Page 1 of 3
PL (PI) 21828/0137
POM
Spiriva® 18 microgram Inhalation Powder, Hard Capsules (tiotropium)
PATIENT INFORMATION LEAFLET
This medicine is available using the above name but will be referred to as SPIRIVA INHALATION
POWDER throughout the following leaflet.
Please read this leaflet carefully.
This leaflet applies only to SPIRIVA INHALATION
POWDER. If you have any questions, or are unsure about anything, ask your doctor or pharmacist (chemist). Remember, SPIRIVA INHALATION POWDER is only for you; do not give it to anyone else, even if their symptoms are similar to yours.
What is in your Medicine?
The name of your medicine is SPIRIVA INHALATION POWDER.
Each capsule contains 18 micrograms of the active ingredient tiotropium (as bromide monohydrate). The capsule also contains the inactive ingredient lactose monohydrate. The capsules are light green hard capsules, containing a white powder, with ‘TI 01 ’ and company logo printed on the capsule.
The capsules contain powder which should be breathed in using the HANDIHALER device.
The product is available in the following packs:
A pack containing 30 capsules.
Manufacturer:
Your medicine is manufactured by Boehringer Ingelheim Pharma, GmbH & Co. KG, Ingelheim am Rhein, Germany.
Your medicine is procured from within the EU and repackaged on behalf of the Parallel Import Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0137
What is SPIRIVA INHALATION POWDER? SPIRIVA INHALATION POWDER is a medicine containing the active ingredient tiotropium. Tiotropium belongs to a group of medicines called bronchodilators. Bronchodilators help to improve your breathing by opening up your airways.
How SPIRIVA INHALATION POWDER helps you SPIRIVA INHALATION POWDER helps people who have chronic obstructive pulmonary disease (COPD) to breathe more easily. SPIRIVA INHALATION POWDER should be taken regularly once a day as directed by your doctor. You should not take it only when you have an attack and you should not take extra doses.
Chronic obstructive pulmonary disease (COPD) is a lung disease that causes shortness of breath and cough. It is nearly always caused by smoking. The
term COPD is associated with the conditions chronic bronchitis and emphysema.
Before you take SPIRIVA INHALATION POWDER Do not take SPIRIVA INHALATION POWDER if:
- you are under 18 years of age
- you are allergic to tiotropium, atropine or similar drugs such as ipratropium or oxitropium or if you are allergic to lactose
- you are taking any other medicinal products containing ipratropium or oxitropium. Ask your doctor for advice.
- you are pregnant, think you are pregnant or if you are breast-feeding. Ask your doctor for advice.
Take special care with SPIRIVA INHALATION POWDER if:
- you suffer from narrow angle glaucoma, prostate problems or have difficulty passing urine
- you have problems with your kidneys
Pregnancy
You should not use this medicine if you are pregnant or think that you may be pregnant.
Breast-feeding
This product is not generally recommended for breast-feeding mothers. Ask your doctor for advice.
Driving and using machines
Taking this product should not affect your ability to drive or use machines. However, if you do experience any side effects do not drive or operate machines and talk to your doctor.
Further important information about the product
Each capsule contains approximately 5 mg of lactose. When taken according to dosage recommendations, one capsule once a day, each dose supplies up to 5 mg lactose. This product is unsuitable for people with lactose insufficiency, galactosaemia or glucose/galactose malabsorption syndrome.
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed. In particular please tell your doctor or pharmacist if you are taking/have taken anticholinergic drugs for example ipratropium, oxitropium.
No interaction side effects have been reported when SPIRIVA INHALATION POWDER has been taken with other products used to treat COPD such as reliever inhalers e.g. salbutamol, methylxanthines e.g. theophylline and/or oral inhaled steroids e.g. prednisolone.
How to take SPIRIVA INHALATION POWDER
Follow your doctor's instructions about when and how to take your medicine. If you are unsure ask your doctor or pharmacist.
Original Application Date: 06/12/05
LANDMARK PHARMA LTD
PROPOSED TEXT: PATIENT INFORMATION LEAFLET PL (PI) 21828/0137 Page 2 of 3
The recommended dose is one capsule (18 micrograms of tiotropium) once a day. Do not take more than the recommended dose.
You should try to take the capsule at the same time every day. This is important because SPIRIVA INHALATION POWDER is effective over 24 hours.
Do not give to children under 18 years of age.
Do not swallow the capsules.
The HANDIHALER device, which you should put the SPIRIVA INHALATION POWDER capsule into, makes holes in the capsule and allows you to breathe in the powder.
Make sure that you have a HANDIHALER and that you can use it properly. The instructions for use of the HANDIHALER are provided in a separate leaflet.
Make sure that you do not blow into 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 your HANDIHALER once a month.
When taking SPIRIVA INHALATION POWDER
take care not to let any of the powder enter your eyes. If any powder does get into your eyes you may get blurred vision, eye pain and/or red eyes, you should wash your eyes in warm water immediately. Then talk to your doctor immediately for further advice.
What to do if an overdose is taken:
If you take more SPIRIVA INHALATION POWDER
than you should - talk to your doctor immediately.
What to do if you miss a dose:
If you forget to take a dose take one as soon as you remember but do not take two doses at the same time or on the same day. Then take your next dose as usual.
If your breathing gets worse straight after using your inhaler, stop using it immediately and tell your doctor straight away.
If you feel that your breathing is worsening, you should tell your doctor as soon as possible.
Possible side effects
All medicines can sometimes cause side effects.
The most common side effect with SPIRIVA INHALATION POWDER is dry mouth. This is usually mild and often stops on continuing treatment.
Other common side effects, experienced in between 1% to 2% of patients in one year studies, are constipation, inflammation of the sinuses (sinusitis), sore throat (pharyngitis), nosebleeds and throat infection e.g. moniliasis. Another common side effect is cough.
Rarely, SPIRIVA INHALATION POWDER may
make it difficult for you to pass urine (especially if you already have problems passing urine).
Rarely, SPIRIVA INHALATION POWDER may also cause your heart to beat faster or with an irregular beat.
Rarely, some patients have had allergic reactions to SPIRIVA INHALATION POWDER such as rash, urticaria (nettle rash), itching, swelling of the mouth and face or sudden difficulties in breathing.
In addition, in common with all inhaled medicines, some patients may experience an unexpected tightness of the chest and cough immediately after inhaling SPIRIVA INHALATION POWDER.
Some people taking SPIRIVA INHALATION
POWDER have also experienced feeling sick (nausea), hoarseness, dizziness and headache.
Eye problems, such as blurred vision or eye pain, can occur if SPIRIVA INHALATION POWDER
accidentally gets into your eyes. If this occurs wash your eyes in warm water immediately and then talk to your doctor immediately for further advice.
If you have any of these side effects and they become troublesome or do not go away after a short while talk to your doctor.
Storage:
Do not use SPIRIVA INHALATION POWDER after the expiry date shown on the blister foil and carton. Do not store above 25 °C. Do not place in the sun or on radiators etc.
Do not freeze.
Once you have taken your first capsule of SPIRIVA INHALATION POWdEr from the blister strip you must continue to take the capsules for the next 9 days, one capsule a day, from the same strip.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Further information
For further information on COPD, join the Open Air Patient Club.
Free membership of this club entitles you to complimentary Open Air newsletters which are for anyone concerned with long-standing breathing problems. Not just for patients, but for carers too, they hope to inform, educate, support and entertain all those who read them. The information provided is designed to complement that given by your doctor, practice nurse or pharmacist.
Original Application Date: 06/12/05
LANDMARK PHARMA LTD
PROPOSED TEXT: PATIENT INFORMATION LEAFLET PL (PI) 21828/0137 Page 3 of 3
To join the club, send your name and address (please print) to:
Open Air Freepost PO Box 70 Bracknell Berkshire RG12 4GR United Kingdom
SPIRIVA® and HANDIHALER® are trademarks of Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
Leaflet revision date: 14 November 2006 Ref: SPI0137-PILv1
Original Application Date: 06/12/05
Date of Amendment/Printing: 14/11/2006 Name: LANDMARK PHARMA LTD Signed: