SPIOLTO^® RESPIMAT^® re-usable

1. What SPIOLTO RESPIMAT re-usable is and what it is used for

What SPIOLTO RESPIMAT re-usable is

SPIOLTO RESPIMAT re-usable contains two active substances called tiotropium and olodaterol. These belong to a group of medicines called long-acting bronchodilators. Tiotropium belongs to the subgroup of anticholinergics; olodaterol belongs to the subgroup of long acting beta2 agonists.

What SPIOLTO RESPIMAT re-usable is used for

SPIOLTO RESPIMAT re-usable is used for maintenance treatment in relieving symptoms in adult patients with chronic obstructive pulmonary disease (COPD). COPD is a long-term lung disease with common symptoms such as shortness of breath, persistent cough with mucus, wheezing and chest tightness. The term COPD is associated with the conditions chronic bronchitis and emphysema.

SPIOLTO RESPIMAT re-usable helps to open your airways and make it easier to get air in and out of the lungs.

As COPD is a long-term disease you should take SPIOLTO RESPIMAT re-usable every day and not only when you have breathing problems or other symptoms of COPD. This will help you when you have on-going shortness of breath related to your disease, and will help to minimise the effects of the disease on your everyday life.

2. What you need to know before you take SPIOLTO RESPIMAT re-usable

Do not use SPIOLTO RESPIMAT re-usable

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

Warnings and precautions

Talk to your doctor or pharmacist before using SPIOLTO RESPIMAT re-usable

• if you have asthma (you should not use SPIOLTO RESPIMAT re-usable for the treatment of asthma as it may increase risk of asthma-related hospitalisations and death).
• if you have diseases of the heart.
• if you have high blood pressure.
• if you have epilepsy.
• if you have a specific thyroid gland problem called thyrotoxicosis.
• if you have diabetes.
• if you have severe hepatic (liver) disease.
• if you have renal (kidney) disease.
• in case of a planned surgery.
• if you have an eye problem called narrow-angle glaucoma.
• if you have prostate problems
• if you have difficulty passing urine.

During treatment with SPIOLTO RESPIMAT re-usable

• Stop using the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called bronchospasm (see section 4).
• If your breathing has got worse or if you experience rash, swelling or itching directly after using your inhaler, stop using it and tell your doctor immediately (see section 4).
• If you experience any side effects affecting your heart (increase in pulse rate, increase in blood pressure and/or increase in symptoms like chest pain), tell your doctor immediately (see section 4).
• If you experience muscle spasm, muscle weakness or abnormal heart rhythm, consult your doctor as these may be related to low blood levels of potassium (see section 4).

When taking SPIOLTO RESPIMAT re-usable take care not to let any spray enter your eyes. This may result in eye pain or discomfort, blurred vision, seeing halos around lights or coloured images in association with red eyes (i.e. narrow angle glaucoma). Eye symptoms may be accompanied by headache, nausea or vomiting. Wash your eyes in warm water, stop using SPIOLTO RESPIMAT re-usable and immediately consult your doctor for further advice.

SPIOLTO RESPIMAT re-usable is indicated for the maintenance treatment of your chronic obstructive pulmonary disease. It should not be used to treat a sudden attack of breathlessness or wheezing.

Do not use SPIOLTO RESPIMAT re-usable together with certain medicines containing long-acting ß-adrenergic agonists, like salmeterol or formoterol.

If you regularly take certain medicines called short acting ß-adrenergic agents, like salbutamol, continue to use these only to relieve acute symptoms like breathlessness.

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.

Do not take SPIOLTO RESPIMAT re-usable more frequently than once daily.

Children and adolescents

SPIOLTO RESPIMAT re-usable should not be given to children or adolescents (below the age of 18 years).

Other medicines and SPIOLTO RESPIMAT re-usable

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines.

In particular, please tell your doctor if you are using:

• any medicines that may be similar to SPIOLTO RESPIMAT re-usable (contain similar active substances, such as anticholinergic drugs or ß-adrenergic agents). You may be more likely to get side effects.
• medicines called beta blockers that are used for high blood pressure or other heart problems (such as propranolol), or for the eye problem called glaucoma (such as timolol). This may result in loss of the effect of SPIOLTO RESPIMAT re-usable
• medicines that lower the amount of potassium in your blood. These include:
  
  • steroids (e.g. prednisolone),
  • diuretics (water tablets),
  • medicines for breathing problems such as theophylline.
  If you use these medicines together with SPIOLTO RESPIMAT re-usable you may experience symptoms of muscle spasm, muscle weakness or abnormal heart rhythm.
• medicines called tricyclic antidepressants or monoamine oxidase (MAO) inhibitors (like selegiline or moclobemide), that are used to treat neurological or psychiatric disorders like Parkinson’s disease or depression; the use of these drugs will increase the likelihood that you get side effects affecting your heart.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or 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

No studies on the effects on the ability to drive and use machines have been performed. If you feel dizzy or if blurred vision occurs while taking SPIOLTO RESPIMAT re-usable, do not drive or use any tools or machines.

SPIOLTO RESPIMAT re-usable contains Benzalkonium chloride

This medicine contains 0.0011 mg benzalkonium chloride in each actuation.
Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially if you have asthma.

3. How to use SPIOLTO RESPIMAT re-usable

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

SPIOLTO RESPIMAT re-usable is for inhalation use only.

Make sure that you know how to use your SPIOLTO RESPIMAT re-usable inhaler properly. Please refer to the instructions for use of the SPIOLTO RESPIMAT re-usable inhaler at the end of this leaflet.

Dosage

The recommended dose is:

SPIOLTO RESPIMAT re-usable is effective for 24 hours so you will need to use SPIOLTO RESPIMAT re-usable only ONCE A DAY, if possible at the same time of the day.

Each time you use it take TWO PUFFS.

As COPD is a long-term disease take SPIOLTO RESPIMAT re-usable every day and not only when you experience breathing problems. Do not take more than the recommended dose.

Use in children and adolescents

There is no relevant use of SPIOLTO RESPIMAT re-usable in the paediatric population (under 18 years).

If you take more SPIOLTO RESPIMAT re-usable than you should

You may be at a higher risk of experiencing a side effect such as dry mouth, constipation, difficulties passing urine, blurred vision, chest pain, high or low blood pressure, faster or irregular heartbeat or feeling of heart beat, dizziness, nervousness, difficulty in sleeping, anxiety, headache, shaking, muscle cramps, nausea, fatigue, malaise, low blood levels of potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm), high blood sugar, or too much acid in your blood (which may cause symptoms of nausea, vomiting, weakness, muscle cramps and more rapid breathing).

If you forget to take SPIOLTO RESPIMAT re-usable

If you forget to inhale a dose, take it as soon as you remember but do not take 2 doses at the same time or on the same day.

If you stop using SPIOLTO RESPIMAT re-usable

Before you stop taking SPIOLTO RESPIMAT re-usable, you should talk to your doctor or your pharmacist.

If you stop taking SPIOLTO RESPIMAT re-usable 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.

If any of the following occurs, please stop using this medicine and consult your doctor immediately.

• Immediate allergic reactions to SPIOLTO RESPIMAT re-usable are rare (they may affect up to 1 in 1,000 people). These reactions may occur individually or as part of a severe allergic reaction (anaphylactic reaction) after administration of SPIOLTO RESPIMAT re-usable. These include rash, nettle rash (urticaria), swelling of the mouth and face, sudden difficulties in breathing (angioneurotic oedema) or other hypersensitivity reactions (such as sudden reduction of your blood pressure or light headedness).
• As with all inhaled medications, tightness of the chest, associated with coughing, wheezing or breathlessness may occur immediately after inhalation (paradoxical bronchospasm). The frequency cannot be estimated from the available data.
• seeing halos around lights or coloured images in association with red eyes (glaucoma). The frequency cannot be estimated from the available data.
• blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic). The frequency cannot be estimated from the available data.

Other possible side effects:

Uncommon (may affect up to 1 in 100 people)

• faster heart beat (tachycardia)
• dizziness
• headache
• cough
• dry mouth

Rare (may affect up to 1 in 1,000 people)

• irregular heart beat (atrial fibrillation)
• rapid heartbeat (supraventricular tachycardia)
• feeling your heartbeat (palpitations)
• high blood pressure (hypertension)
• difficulties passing urine (urinary retention)
• painful urination (dysuria)
• sore throat (pharyngitis)
• inflammation of the larynx (laryngitis)
• inflammation of the gums (gingivitis)
• inflammation of the mouth (stomatitis)
• fungal infections of the mouth and throat (oropharyngeal candidiasis)
• nosebleed (epistaxis)
• hoarseness (dysphonia)
• difficulty in sleeping (insomnia)
• blurred vision
• tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm)
• constipation
• feeling sick (nausea)
• itching (pruritus)
• joint pain (arthralgia)
• swelling of joint
• back pain

Not known (frequency cannot be estimated from the available data)

• increase of the measured eye pressure
• nasopharyngitis (common cold)
• inflammation in sinuses (sinusitis)
• difficulties swallowing (dysphagia)
• inflammation of the tongue (glossitis)
• heart burn (gastrooesophageal reflux disease)
• dental caries
• infections or ulcerations of the skin
• dryness of the skin
• depletion of body water (dehydration)
• infections of the urinary tract

You may also experience side effects which are known to occur with certain medicines for breathing problems similar to SPIOLTO RESPIMAT re-usable (beta-adrenergic agents). These may be irregular heartbeat, chest pain, low blood pressure, shaking, nervousness, muscle cramps, fatigue, malaise, low blood levels of potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm), high blood sugar, or too much acid in your blood (which may cause symptoms of nausea, vomiting, weakness, muscle cramps and more rapid breathing).

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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SPIOLTO RESPIMAT re-usable

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 on the inhaler label after EXP. The expiry date refers to the last day of the month.

Do not store above 30ºC
Do not freeze.

SPIOLTO RESPIMAT re-usable inhaler should be discarded at the latest 3 months after first use.

Recommended use: 6 cartridges per inhaler
Note: The functioning of the Respimat re-usable inhaler has been demonstrated in tests for 540 actuations (corresponding to 9 cartridges).

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.

6. Contents of the pack and other information

What SPIOLTO RESPIMAT re-usable contains

The active substances are tiotropium and olodaterol. The delivered dose is 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. The delivered dose is the dose which is available for the patient after passing the mouthpiece.

The other ingredients are:
Benzalkonium chloride, disodium edetate, purified water and hydrochloric acid for pH adjustment

What SPIOLTO RESPIMAT re-usable looks like and contents of the pack

SPIOLTO RESPIMAT re-usable is composed of one cartridge with inhalation solution and one Respimat re-usable inhaler. The cartridge has to be inserted into the inhaler before the first use.

Single pack: 1 Respimat re-usable inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses)
Single refill pack: 1 cartridge providing 60 puffs (30 medicinal doses)

7. Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder for SPIOLTO RESPIMAT re-usable is:

Boehringer Ingelheim Singapore Pte Ltd
128 Beach Road,
#11-01 Guoco Midtown,
Singapore 189773

The manufacturer for SPIOLTO RESPIMAT re-usable is:

Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany

8. Product registration number

SIN 15890P

9. Date of revision

31 July 2023

Spiolto Respimat re-usable

INSTRUCTIONS FOR USE

SPIOLTO RESPIMAT re-usable (Tiotropium Bromide and Olodaterol)
Read these Instructions for Use before you start using SPIOLTO RESPIMAT re-usable.

You will need to use this inhaler only ONCE A DAY. Each time you use it take TWO PUFFS.

• If not been used for more than 7 days release one puff towards the ground.
• If not been used for more than 21 days repeat steps 4 to 6 until a cloud is visible. Then repeat steps 4 to 6 three more times.

How to care for your SPIOLTO RESPIMAT re-usable

Clean the mouthpiece including the metal part inside the mouthpiece with a damp cloth or tissue only, at least once a week.

Any minor discoloration in the mouthpiece does not affect your SPIOLTO RESPIMAT re-usable inhaler performance. If necessary, wipe the outside of your SPIOLTO RESPIMAT re-usable inhaler with a damp cloth.

When to replace the inhaler

When you have used an inhaler with 6 cartridges, get a new SPIOLTO RESPIMAT re-usable pack containing an inhaler.

Prepare for first use

1. Remove clear base

• Keep the cap closed.
• Press the safety catch while pulling off the clear base with your other hand.

2. Insert cartridge

• Insert the cartridge into the inhaler.
• Place the inhaler on a firm surface and push down firmly until it clicks into place.

3. Track cartridge and put clear base back

• Mark the check-box on inhaler’s label to track the number of cartridges.
• Put the clear base back into place until it clicks.

4. Turn

• Keep the cap closed.
• Turn the clear base in the direction of the arrows on the label until it clicks (half a turn).

5. Open

• Open the cap until it snaps fully open.

6. Press

• Point the inhaler toward the ground.
• Press the dose-release button.
• Close the cap.
• Repeat steps 4-6 until a cloud is visible.
• After a cloud is visible, repeat steps 4-6 three more times.

Your inhaler is now ready to use and will deliver 60 puffs (30 doses).

Daily use

When to replace the SPIOLTO RESPIMAT re-usable cartridge

The dose indication shows how many puffs remain in the cartridge.

60 Puffs remaining

Less than 10 puffs remaining. Obtain a new cartridge

Your cartridge is used up. Turn the clear base to loosen it. Your inhaler is now in a locked position. Pull off the cartridge from the inhaler. Insert a new cartridge until it clicks (refer to step 2). The new cartridge will stick out more than the very first cartridge (continue with step 3). Remember to put the clear base back to unlock the inhaler.