SPIRIVA® 18 micrograms INHALATION POWDER, HARD

CAPSULES

(tiotropium bromide)

Your medicine is known with the above name but will be referred to as Spiriva 18 microgram throughout the following 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.

What is in this leaflet:

• 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

Uncommon (mayaffect upto 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)

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 in UK via the Yellow Card Scheme at: 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.

5. how to store spiriva 18 microgram

. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

• Spiriva 18 microgram should not be stored above 25°C. Do not freeze.
• Discard the HandiHaler ® device 12 months after first use.
• Once you have taken your first capsule of Spiriva 18 microgram from the blister strip you must continue to take the capsules for the next 9 days, one capsule a day, from the same strip.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• 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 informationwhat spiriva 18 microgram contains each hard capsule contains 18 micrograms of the active ingredient, tiotropium (as the bromide monohydrate)

• Spiriva 18 microgram also contain the following: lactose monohydrate.

What Spiriva 18 microgram looks like and contents of the pack

• Spiriva 18 microgram is a light green capsule marked ‘Tl 0T with a company logo in black ink containing a white powder.
• Spiriva 18 microgram is available in packs containing 30 capsules and 1 HandiHaler.

Product Licence holder

The product is procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd., Chemilines House, Alperton Lane, Wembley, HAO 1DX.

Manufacturer

|POM| PL: 19488/0495

Leaflet revision date: 24 November 2021

Blind or partially sighted? Is this leaflet hard to see or read? Call 02087997607 to obtain the leaflet in large print, tape, CD or Braille.

Handi Haler® Instructions for use

Dear Patient,

The HandiHalef® enables you to inhale the medicine contained in the Spiriva® capsule – that your physician has prescribed for your breathing problems.

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

To release the dust cap press the piercing button completely in and

Open the dust cap completely by pulling it upwards.

Then open the mouthpiece by pulling it upwards.

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.

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

S495 LEAFLET Spiriva 20211124

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.

Breathe out completely.

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

Raise the HandiHaleh® 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.

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

Cleaning your HandiHaler®:

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 right after you have used it and 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.

Blister handling

Separate the blister strips by tearing along the perforation.

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.

S495 LEAFLET Tiotropium 20211124

PACKAGE LEAFLET: INFORMATION FOR THE USER

TIOTROPIUM 18 micrograms INHALATION POWDER, HARD CAPSULES

Your medicine is known with the above name but will be referred to as Tiotropium Capsules throughout the following 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.

What is in this leaflet:

• 1. What Tiotropium Capsules is and what it is used for

• 2. What you need to know before you use Tiotropium Capsules

• 3. How to use Tiotropium Capsules

• 4. Possible side effects

• 5. How to store Tiotropium Capsules

• 6. Contents of the pack and other information

1. what tiotropium capsules is and what it is used for

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

Tiotropium Capsules 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 Tiotropium Capsules 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 Tiotropium Capsules 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 Tiotropium Capsules please see section 3. How to use Tiotropium Capsules and the instructions for use provided on the other side of the leaflet.

2. what you need to know before you use tiotropium capsules

Do not use Tiotropium Capsules

• – 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 Tiotropium Capsules

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.

Tiotropium Capsules 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 Tiotropium Capsules. If this occurs, please consult your doctor immediately.

Inhaled medicines such as Tiotropium Capsules 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 Tiotropium Capsules more frequently than once daily.

Children and adolescents

Tiotropium Capsules is not recommended for children and adolescents under 18 years.

Other medicines and Tiotropium Capsules

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 Tiotropium Capsules 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.

Tiotropium Capsules 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 tiotropium capsules

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.

Tiotropium Capsules 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 Tiotropium Capsules 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 Tiotropium Capsules, 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 Tiotropium Capsules than you should

If you inhale from more than 1 capsule of Tiotropium Capsules 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 Tiotropium Capsules

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 Tiotropium Capsules

Before you stop using Tiotropium Capsules, you should talk to your doctor or your pharmacist. If you stop using Tiotropium Capsules 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 (mayaffect upto 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)

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 Tiotropium Capsules. 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 in UK via the Yellow Card Scheme at: 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.

5. how to store tiotropium capsules

. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

• Tiotropium Capsules should not be stored above 25°C. Do not freeze.
• Discard the Handi Haler ® device 12 months after first use.
• Once you have taken your first capsule of Tiotropium Capsules from the blister strip you must continue to take the capsules for the next 9 days, one capsule a day, from the same strip.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• 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 informationwhat tiotropium capsules contains each hard capsule contains 18 micrograms of the active ingredient, tiotropium (as the bromide monohydrate)

• Tiotropium Capsules also contain the following: lactose monohydrate.

What Tiotropium Capsules looks like and contents of the pack

• Tiotropium Capsules is a light green capsule marked ‘Tl 0T with a company logo in black ink containing a white powder.
• Tiotropium Capsules is available in packs containing 30 capsules and 1 HandiHaler.

Product Licence holder

The product is procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd., Chemilines House, Alperton Lane, Wembley, HAO 1DX.

Manufacturer

|POM| PL: 19488/0495

Leaflet revision date: 24 November 2021

Blind or partially sighted? Is this leaflet hard to see or read? Call 02087997607 to obtain the leaflet in large print, tape, CD or Braille.

Handi Haler® Instructions for use

Dear Patient,

The HandiHalef® enables you to inhale the medicine contained in the Spiriva® capsule – that your physician has prescribed for your breathing problems.

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

To release the dust cap press the piercing button completely in and

Open the dust cap completely by pulling it upwards.

Then open the mouthpiece by pulling it upwards.

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.

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

S495 LEAFLET Spiriva 20211124

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.

Breathe out completely.

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

Raise the HandiHaleh® 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.

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

Cleaning your HandiHaler®:

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 right after you have used it and 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.

Blister handling

Separate the blister strips by tearing along the perforation.

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.

S495 LEAFLET Tiotropium 20211124

PACKAGE LEAFLET: INFORMATION FOR THE USER

TIOTROPIUM 18 micrograms INHALATION POWDER, HARD CAPSULES

Your medicine is known with the above name but will be referred to as Tiotropium Capsules throughout the following 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.

What is in this leaflet:

• 1. What Tiotropium Capsules is and what it is used for

• 2. What you need to know before you use Tiotropium Capsules

• 3. How to use Tiotropium Capsules

• 4. Possible side effects

• 5. How to store Tiotropium Capsules

• 6. Contents of the pack and other information

1. what tiotropium capsules is and what it is used for

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

Tiotropium Capsules 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 Tiotropium Capsules 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 Tiotropium Capsules 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 Tiotropium Capsules please see section 3. How to use Tiotropium Capsules and the instructions for use provided on the other side of the leaflet.

2. what you need to know before you use tiotropium capsules

Do not use Tiotropium Capsules

• – 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 Tiotropium Capsules

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.

Tiotropium Capsules 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 Tiotropium Capsules. If this occurs, please consult your doctor immediately.

Inhaled medicines such as Tiotropium Capsules 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 Tiotropium Capsules more frequently than once daily.

Children and adolescents

Tiotropium Capsules is not recommended for children and adolescents under 18 years.

Other medicines and Tiotropium Capsules

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 Tiotropium Capsules 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.

Tiotropium Capsules 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 tiotropium capsules

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.

Tiotropium Capsules 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 Tiotropium Capsules 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 Tiotropium Capsules, 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 Tiotropium Capsules than you should

If you inhale from more than 1 capsule of Tiotropium Capsules 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 Tiotropium Capsules

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 Tiotropium Capsules

Before you stop using Tiotropium Capsules, you should talk to your doctor or your pharmacist. If you stop using Tiotropium Capsules 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 (mayaffect upto 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)

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 Tiotropium Capsules. 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 in UK via the Yellow Card Scheme at: 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.

5. how to store tiotropium capsules

. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

• Tiotropium Capsules should not be stored above 25°C. Do not freeze.
• Discard the Handi Haler ® device 12 months after first use.
• Once you have taken your first capsule of Tiotropium Capsules from the blister strip you must continue to take the capsules for the next 9 days, one capsule a day, from the same strip.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• 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.
• Tiotropium Capsules also contain the following: lactose monohydrate.
• Tiotropium Capsules is a light green capsule marked ‘Tl 0T with a company logo in black ink containing a white powder.
• Tiotropium Capsules is available in packs containing 30 capsules and 1 HandiHaler.

Product Licence holder

The product is procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd., Chemilines House, Alperton Lane, Wembley, HAO 1DX.

Manufacturer

|POM| PL: 19488/0495

Leaflet revision date: 24 November 2021

Blind or partially sighted? Is this leaflet hard to see or read? Call 02087997607 to obtain the leaflet in large print, tape, CD or Braille.

Handi Haler® Instructions for use

Dear Patient,

The HandiHaler enables you to inhale the medicine contained in the Spiriva® capsule – that your physician has prescribed for your breathing problems.

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 HandiHaleh® for up to one year to take your medicine.

To release the dust cap press the piercing button completely in and

Open the dust cap completely by pulling it upwards.

Then open the mouthpiece by pulling it upwards.

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.

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

S495 LEAFLET Tiotropium 20211124