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

Spiriva® 18 microgram Inhalation Powder Hard Capsules

(Tiotropium bromide)

The above product is known by the above name but will be referred to as Spiriva 18 microgram throughout this:

Patient Information Leaflet

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.

• 1) What Spiriva 18 microgram is and what it is used for

• 2) What you need to know before you use Spiriva 18 microgram

• 3) How to use Spiriva 18 microgram

• 4) Possible side effects

• 5) How to store Spiriva 18 microgram

• 6) Contents of the pack and other information

1) what spiriva 18 microgram is and what it is used for

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 for use provided on the other side of the leaflet.

2) what you need to know before you use spiriva 18 microgram

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.

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.
• 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.

3) how to use 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.

Spiriva 18 microgram 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 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 and that you can use it properly. The instructions for use of the HandiHaler are provided on the other side 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 on the other side of this leaflet.

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

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.

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
• 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)
• Nettle rash (urticaria)
• Itching (pruritus)
• Infections of the urinary tract
• 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

5) How to store Spiriva 18 microgram

• Keep out of the sight and reach of children.
• Do not take this medicine after the expiry date printed on the carton or blister label. The expiry date refers to the last day of the month.
• Once you have taken your first capsule from the blister strip you must continue to take the capsules for the next 9 days, one capsule a day, from the same strip. Discard unused capsules nine days after opening the blister strip. Discard the HandiHaler device 12 months after first use.
• Do not store above 25°C. Do not freeze.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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 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

Each light green hard gelatin capsule contains white or off-white powder. The capsule body is imprinted with the company logo and the capsule cap is printed with ‘TI 01’ in black ink. The light grey HandiHaler device has a grey mouthpiece and a chamber for the capsule. You must use the HandiHaler device with Spiriva 18 microgram capsules.

Spiriva 18 microgram is available as a combo pack containing blister strips of 30 capsules and a HandiHaler device.

PL 46420/0466 Spiriva 18 microgram Inhalation Powder Hard Capsules POM

Who makes and repackages your medicine?

Your medicine is manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D 55216 Ingelheim am Rhein, Germany. Procured from within the EU and repackaged by the Product Licence holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 15.11.2021

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

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HandiHaler® Instructions for use