What it is and what it is used for

for

ABCD tiotropium

Spiriva® 18 microgram, inhalation powder, hard capsule 300901-23

Spiriva® 18 microgram, inhalation powder, hard capsule

Spiriva 18 microgram helps people who have chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a chronic lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. As COPD is a chronic disease you should take Spiriva 18 microgram every day and not only when you have breathing problems or other symptoms of COPD. Spiriva 18 microgram is a long-acting bronchodilator that helps to open your airways and makes it easier to get air in and out of the lungs. Regular use of Spiriva 18 microgram can also help you when you have on-going shortness of breath related to your disease and will help you to minimise the effects of the disease on your everyday life. It also helps you to be active longer. Daily use of Spiriva 18 microgram will also help to prevent sudden, short-term worsening of your COPD symptoms which may last for several days. The effect of this medicine lasts for 24 hours, so you only need to use it once a day. For correct dosing of Spiriva 18 microgram please see section 3. How to use Spiriva 18 microgram and the instructions on how to use the HandiHaler device provided at the end of the leaflet. 2. What you need to know before you use Spiriva 18 microgram

tiotropium

Do not use Spiriva 18 microgram

• if you are allergic (hypersensitive) to tiotropium, its active ingredient, or to any other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to atropine or substances related to it, e.g. ipratropium or oxitropium.

ABCD

Warnings and precautions Talk to your doctor or pharmacist before using Spiriva 18 microgram.

• Talk to your doctor if you suffer from narrow angle glaucoma, prostate problems or have difficulty passing urine.
• If you have problems with your kidneys, please consult your doctor.
• Spiriva 18 microgram is indicated for maintenance treatment of your chronic obstructive pulmonary disease, it should not be used to treat a sudden attack of breathlessness or wheezing.
• Immediate allergic reactions such as rash, swelling, itching, wheezing or breathlessness may occur after administration of Spiriva 18 microgram. If this occurs, please consult your doctor immediately.
• Inhaled medicines such as Spiriva 18 microgram may cause tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation. If this occurs, please consult your doctor immediately.

Mandatory in

File information

TD

Printfile

Issue date of TD:

17.06.2016

Yes

Yes

PPM SKU:

P007281

No

Yes

PPM SKU version:

023

No

Yes

Issue date of artwork:

04.01.2023

No

Yes

Print colors:

BLACK

No

Yes

No

Yes

Mat. No. Pack. Site:

300901-23

Min. font size:

8.5 pt

Legend case version:

V4.0 01/OCT/2012 (please do not change or remove it)

Perigord No : 676607 P6

Technical information a = Batch No.

b = Expiry date

c = Manufacturing date

d = Price/Sample/Clinic

Technical colors BI-Diecut-Legendcase

Free area

Gluepoints

Additional Requirements of Packaging site Template name: TD-PI_540x325_90x65

Index: h

Only for BI-internal use, Template according to Drawing no.: SP-14-0046-001-B_Index_a

MASS D 0,35 mm MASS E 1,0 mm MASS F 8,0 mm MASS G 0,65 mm Example Technical information Control Code Type: Laetus Mini

• Take care not to let the inhalation powder enter your eye as this may result in precipitation or worsening of narrow-angle glaucoma, which is a disease of the eyes. Eye pain or discomfort, blurred vision, seeing halos around lights or coloured images in association with red eyes may be signs of an acute attack of narrow-angle glaucoma. Eye symptoms may be accompanied by headache, nausea or vomiting. You should stop using tiotropium bromide and immediately consult your doctor, preferably an eye specialist, when signs and symptoms of narrow-angle glaucoma appear.
• Dry mouth, which has been observed with anti-cholinergic treatment, may in the long term be associated with dental caries. Therefore, please remember to pay attention to oral hygiene.
• In case you have suffered from a myocardial infarction during the last 6 months or from any unstable or life threatening irregular heart beat or severe heart failure within the past year, please, inform your doctor. This is important to decide if Spiriva is the right medicine for you to take.
• Do not use Spiriva 18 microgram more frequently than once daily. Children and adolescents Spiriva 18 microgram is not recommended for children and adolescents under 18 years. Other medicines and Spiriva 18 microgram Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines available without prescription. Please tell your doctor or pharmacist if you are using/have used similar medicines for your lung disease, such as ipratropium or oxitropium. No specific side effects have been reported when Spiriva 18 microgram has been used together with other products used to treat COPD such as reliever inhalers, e.g. salbutamol, methylxanthines, e.g. theophylline and/or oral and inhaled steroids e.g. prednisolone. Pregnancy and breast-feeding If you are pregnant or breast-feeding or think you may be pregnant, or you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not use this medicine unless specifically recommended by your doctor. Driving and using machines The occurrence of dizziness, blurred vision, or headache may influence the ability to drive and use machinery. Spiriva 18 microgram contains lactose monohydrate When taken according to dosage recommendations, one capsule once a day, each dose supplies up to 5.5 mg lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, or an allergy to milk proteins (which may be contained in small amounts in the ingredient lactose monohydrate), contact your doctor before taking this medicinal product.

How to take it

Spiriva 18 microgram Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is to inhale the contents of 1 capsule (18 micrograms of tiotropium) once a day. Do not use more than the recommended dose. You should try to use the capsule at the same time every day. This is important because Spiriva 18 microgram is effective over 24 hours. The capsules are only for inhalation and not for oral intake. Do not swallow the capsules. The HandiHaler device, which you should put the Spiriva capsule into, makes holes in the capsule and allows you to breathe in the powder. Make sure that you have a HandiHaler device and that you can use it properly. Read the instructions on how to use the HandiHaler device which are provided at the end of this 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. Cleaning instructions for the HandiHaler are provided at the end of this leaflet, see "Instructions on how to use the HandiHaler device". When taking Spiriva 18 microgram, 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. If you feel that your breathing is worsening, you should tell your doctor as soon as possible. Use in children and adolescents Spiriva 18 microgram is not recommended for children and adolescents under 18 years. If you use more Spiriva 18 microgram than you should If you inhale from more than 1 capsule of Spiriva 18 microgram in a day, you should talk to your doctor immediately. You may be at a higher risk of experiencing a side effect such as dry mouth, constipation, difficulties passing urine, increased heart beat, or blurred vision. If you forget to use Spiriva 18 microgram 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 you stop using Spiriva 18 microgram Before you stop using Spiriva 18 microgram, you should talk to your doctor or your pharmacist. If you stop using Spiriva 18 microgram the signs and symptoms of COPD may worsen. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• nettle rash (urticaria)
• itching (pruritus)
• infections of the urinary tract Not known (frequency cannot be estimated from the available data):
• depletion of body water (dehydration)
• dental caries
• severe allergic reaction (anaphylactic reaction)
• infections or ulcerations of the skin
• dryness of the skin
• swelling of joints Serious side effects include allergic reactions which cause swelling of the face or throat (angioedema) or other hypersensitivity reactions (such as sudden reduction of your blood pressure or dizziness) may occur individually or as part of severe allergic reaction (anaphylactic reaction) after administration of Spiriva 18 microgram. In addition, in common with all inhaled medicines, some patients may experience an unexpected tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation (bronchospasm). If any of these occur, please consult your doctor immediately. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Spiriva 18 microgram Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the blister foil. The expiry date refers to the last day of that month. Once you have taken your first capsule from the blister you must continue to take the capsules for the next 9 days, one capsule a day, from the same blister.

The side effects described below have been experienced by people taking this medicine and they are listed according to frequency as either common, uncommon, rare or not known.

Discard the HandiHaler device 12 months after first use.

Common (may affect up to 1 in 10 people):

• dry mouth: this is usually mild

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Uncommon (may affect up to 1 in 100 people):

• dizziness
• headache
• taste disorders
• blurred vision
• irregular heart beat (atrial fibrillation)
• inflammation of the throat (pharyngitis)
• hoarseness (dysphonia)
• cough
• heart burn (gastrooesophageal reflux disease)
• constipation
• fungal infections of the oral cavity and throat (oropharyngeal candidiasis)
• rash
• difficulty passing urine (urinary retention)
• painful urination (dysuria) Rare (may affect up to 1 in 1,000 people):
• difficulty in sleeping (insomnia)
• seeing halos around lights or coloured images in association with red eyes (glaucoma)
• increase of the measured eye pressure
• irregular heart beat (supraventricular tachycardia)
• faster heart beat (tachycardia)
• feeling your heart beat (palpitations)
• tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm)
• nosebleed (epistaxis)
• inflammation of the larynx (laryngitis)
• inflammation of the sinuses (sinusitis)
• blockage of intestines or absence of bowel movements (intestinal obstruction including ileus paralytic)
• inflammation of the gums (gingivitis)
• inflammation of the tongue (glossitis)
• difficulties swallowing (dysphagia)
• inflammation of the mouth (stomatitis)
• feeling sick (nausea)
• hypersensitivity, including immediate reactions
• serious allergic reaction which causes swelling of the face or throat (angioedema)

Do not store above 25°C. Do not freeze.

Contents of the pack and other information

What Spiriva 18 microgram contains The active substance is tiotropium. Each capsule contains 18 microgram of the active ingredient tiotropium (as bromide monohydrate). During inhalation, 10 microgram tiotropium are delivered from the mouthpiece of the HandiHaler. The other ingredient is lactose monohydrate (which may contain small amounts of milk proteins). What Spiriva 18 microgram looks like and contents of the pack Spiriva 18 microgram, inhalation powder, hard capsule is a light green hard capsule containing the inhalation powder, with the product code TI 01 and company logo printed on the capsule. The product is available in the following packs: A pack containing 30 capsules A pack containing 60 capsules A pack containing 90 capsules A pack containing 10 capsules and 1 HandiHaler A pack containing 30 capsules and 1 HandiHaler Hospital pack: Bundle pack containing 5 cardboard boxes of 30 capsules plus HandiHaler device Hospital pack: Bundle pack containing 5 cardboard boxes of 60 capsules Furthermore, a pack containing 1 HandiHaler device is available. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer The marketing authorisation holder for Spiriva 18 microgram is: Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany The manufacturer for Spiriva 18 microgram is: Boehringer Ingelheim Pharma GmbH & Co. KG Binger Straße 173 55216 Ingelheim am Rhein Germany This medicine is authorised in the member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Austria, Liechtenstein, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Malta, United Kingdom (Northern Ireland), Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden Spiriva Bulgaria

СПИРИВА

This leaflet was last revised in 12/2022

Instructions on how to use the HandiHaler device

The HandiHaler is an inhalation device that enables you to inhale the medicine contained in the Spiriva capsule – that your doctor has prescribed for your breathing problems. The HandiHaler is especially designed for Spiriva. You must not use it to take any other medicine. The HandiHaler is for you only and intended for multiple uses.

Remember to carefully follow your doctor's instructions for using Spiriva. After first use, you can use your HandiHaler for up to one year to take your medication.

Blister handling

1

4

7

To release the dust cap press the piercing button completely in and let go.

Close the mouthpiece firmly until you hear a click, leaving the dust cap open.

Raise the HandiHaler to your mouth and close your lips tightly around the mouthpiece. Keep your head in an upright position and breathe in slowly and deeply but at a rate sufficient to hear or feel the capsule vibrate. Breathe in until your lungs are full; then hold your breath as long as comfortable and at the same time take the HandiHaler out of your mouth. Resume normal breathing. Repeat steps 6 and 7 once, in order to empty the capsule completely.

A Separate the Spiriva blister strips by tearing along the perforation.

2

5

8

B

Open the dust cap completely by pulling it upwards.

Hold the HandiHaler device with the mouthpiece upwards and press the piercing button completely in only once, and release. This makes holes in the capsule and allows the medicine to be released when you breathe in.

Open the mouthpiece again. Tip out the used capsule and dispose. Close the mouthpiece and dust cap for storage of your HandiHaler device.

Peel back foil (only immediately before use) using the tab until one capsule is fully visible.

Then open the mouthpiece by pulling it upwards.

In case a second capsule is exposed to air inadvertently this capsule has to be discarded.

Cleaning your HandiHaler

The HandiHaler 1

Dust cap

2

Mouthpiece

3

Base

4

Piercing button

5

Centre chamber

3

6

Remove a Spiriva capsule from the blister (only immediately before use, see blister handling) and place it in the centre chamber ( 5 ), as illustrated. It does not matter which way the capsule is placed in the chamber.

Breathe out completely. Important: Please avoid breathing into the mouthpiece at any time.

C Clean the HandiHaler once a month. Open the dust cap and mouthpiece. Then open the base by lifting the piercing button. Rinse the complete inhaler with warm water to remove any powder. Dry the HandiHaler thoroughly by tipping excess of water out on a paper towel and air-dry afterwards, leaving the dust cap, mouthpiece and base open. It takes 24 hours to air dry, so clean it immediately after use so that it will be ready for your next dose. If needed, the outside of the mouthpiece may be cleaned with a moist but not wet tissue.

Remove capsule. Spiriva capsules contain only a small amount of powder so that the capsule is only partially filled.