SPIRIVA 18MICROGRAMSINHALATION POWDER HARD CAPSULE - patient leaflet, side effects, dosage

Package leaflet: Information for the user

(tiotropium bromide monohydrate)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Spiriva 18 microgram inhalation powder, hard capsules but will be referred to as Spiriva throughout this leaflet.

What is in this leaflet:

• 1. What Spiriva is and what it is used for

• 2. What you need to know before you use Spiriva

• 3. How to use Spiriva

• 4. Possible side effects

• 5. How to store Spiriva

• 6. Contents of the pack and other information

1. what spiriva is and what it is used for

Spiriva 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 every day and not only when you have breathing problems or other symptoms of COPD.

Spiriva 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 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 will also help to prevent sudden, shortterm 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 please see section 3.How to use Spiriva and the instructions for use provided on the other side of the leaflet.

2. what you need to know before you use spirivado not use spiriva- 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.

Warnings and precautions

Talk to your doctor or pharmacist before using Spiriva – 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 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. If this occurs, please consult your doctor immediately.

• – Inhaled medicines such as Spiriva may cause tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation. If this occurs, please consult your doctor immediately.

– 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 narrowangle 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 anticholinergic 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 more frequently than once daily.

Children and adolescents

Spiriva is not recommended for children and adolescents under 18 years.

Other medicines and Spiriva

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 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 contains lactose monohydrate

When taken according to dosage recommendations, one capsule once a day, each dose supplies up to 5.5mg 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.

3. how to use spiriva

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.

Spiriva is not recommended for children and adolescents under 18 years.

You should try to use the capsule at the same time every day. This is important because Spiriva 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 and that you can use it properly. The instructions for use of the HandiHaler are provided on the other side of this leaflet.

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 on the other side of this leaflet.

When taking Spiriva, 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.

If you use more Spiriva than you should

If you inhale from more than 1 capsule of Spiriva 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

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

Before you stop using Spiriva, you should talk to your doctor or your pharmacist. If you stop using Spiriva 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.

4. possible side effects

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

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.

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

• – Dry mouth: this is usually mild

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

• – Dizziness

• – Headache

• – Taste disorders

• – Blurred vision

• – Irregular heart beat (atrial fibrillation)

• – Sore 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)

• – Allergic reactions (hypersensitivity), including immediate reactions

• – Serious allergic reaction which causes swelling of the face or throat (angioedema)

• – 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)

• – Tooth decay (dental caries)

• – Severe allergic reaction (anaphylactic reaction)

• – Infections or ulcerations of the skin

• – Dryness of the skin

• – Swelling of joints

5. how to store spiriva

Keep out of the sight and reach of children.

Do not store above 25° C.

Do not place in the sun or on radiators. Do not freeze.

Do not use the capsules after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month.

Once you have taken your first capsule from your blister strip you must continue to take the capsules for the next 9 days, one capsule a day, from the same strip.

After starting to use, discard the HandiHaler device after 12 months.

If the capsules become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

Remember if your doctor tells you to stop using this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other informationwhat spiriva containseach capsule contains 18 micrograms of the active ingredient tiotropium (as the bromide monohydrate). (delivered dose: 10 microgram tiotropium).

Spiriva also contains the following:

Lactose monohydrate

What Spiriva looks like and contents of the pack

Spiriva is a light-green gelatin capsule that contains a white powder for inhalation and is marked ‘TI 01’ on the cap with a logo on the body for use in a grey circular plastic HandiHaler® device.

Spiriva is available in the following packs: A pack contains 30 capsules.

A pack containing 30 capsules and a Handihaler.

Manufactured by: Boehringer Ingelheim Pharma KG, D-55216 Ingelheim am Rhein, Germany.

Procured from within the EU and repackaged by the

Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Spiriva® 18 microgram inhalation powder, hard capsules; PL 18799/2635

I POM I

Leaflet date: 27.09.2019 ।------1

Spiriva and HandiHaler are registered trademarks of Boehringer Ingelheim Pharma GmbH & Co. KG.

See overleaf for instructions on how to use HandiHaler.

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 0208 515 3763 to obtain the leaflet in a format suitable for you.

Make sure that you do not blow into the HandiHaler.

HandiHaler® Instructions for use:

Blister handling

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.

Separate the blister strips by tearing along the perforation.

Remember to carefully follow your doctor’s instruc­tions for using Spiriva. The HandiHaler is especially designed for Spiriva. You must not use it to take any other medicine. You can use your HandiHaler for up to one year to take your medicine.

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.

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

Cleaning your HandiHaler

The HandiHaler

O Dust cap

© Mouthpiece

© Base

0 Piercing button

© Centre chamber