ALTYONZ CFC-FREE INHALER 20 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION - patient leaflet, side effects, dosage

Altyonz CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution

The name of this medicine is ‘Altyonz CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution’ which will be referred to as ‘Altyonz Inhaler’ throughout this 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, pharmacist or asthma nurse.

• – 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, pharmacist or asthma nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Altyonz Inhaler is and what it is used for

• 2. What you need to know before you use Altyonz Inhaler

• 3. How to use Altyonz Inhaler

• 4. Possible side effects

• 5. How to store Altyonz Inhaler

• 6. Contents of the pack and other information

1. what altyonz inhaler is and what it is used for

Altyonz Inhaler contains a medicine called ipratropium bromide. This belongs to a group of medicines called bronchodilators. It is used to make breathing easier for people with asthma or ‘chronic obstructive pulmonary disease’ (COPD), often referred to as chronic bronchitis.

If you have asthma or COPD, you may have difficulty in breathing, shortness of breath, wheezing or tightness in your chest.

Altyonz Inhaler works by opening up airways.

2. what you need to know before you use altyonz inhaler if you are allergic to ipratropium bromide or any of the other ingredients of this medicine (listed in section 6).

• If you are allergic to similar medicines which contain atropine or medicines like atropine.
• If you are pregnant, think you are pregnant, are likely to get pregnant or are breast-feeding.

Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Altyonz Inhaler.

Warnings and precautions

Talk to your doctor or pharmacist or asthma nurse before using Altyonz Inhaler if:

• you have glaucoma, or have been told that you may develop it.
• you have problems passing water (urine).
• you are a man who has prostate problems.
• you have cystic fibrosis.
• you have liver or kidney problems.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist or asthma nurse before using Altyonz Inhaler.

Ipratropium bromide is slow acting drug and therefore you will not get immediate relief after starting this medicine.

Talk to your doctor, pharmacist, or asthma nurse:

• If you are required to take a fast-acting reliever inhaler such as salbutamol more frequently than normal or if you are not getting relief from your reliever inhaler or if your symptoms are getting worse, this may be due to worsening of asthma and you should see your doctor straightaway.
• If your asthma seems to be getting worse you may have a bacterial infection and you must see your doctor. Your doctor may prescribe you antibiotics, may increase the dose of your inhaled corticosteroids and /or may start short course of oral corticosteroids.
• If you experience allergic reactions like skin rash and itching (urticaria) or a severe allergic reactions (anaphylaxis) with swelling of your mouth, tongue and lips and swelling of your face, sudden difficulties in breathing (bronchospasm) and/or a tightness in your throat you must see your doctor immediately.
• If you experience sudden difficulty in breathing, increased wheezing or shortness of breath after taking a dose of Altyonz inhaler you must stop using your Altyonz Inhaler and not use it again and you must use your fast-acting reliever inhaler straightaway. You must contact your doctor immediately.
• If any of the spray from the inhaler accidently gets into your eyes you must contact your doctor or asthma nurse as soon as possible.

Children and adolescents:

Other medicines and Altyonz Inhaler

Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines, including any inhalers or medicines obtained without a prescription. This includes herbal medicines. This is because Altyonz Inhaler can affect the way some other medicines work. Also some other medicines can affect the way Altyonz Inhaler works.

In particular, tell your doctor or pharmacist if you are taking/have taken any of the following medicines: Other inhalers to help you breathe more easily such as the reliever inhaler salbutamol.

Medicines called ‘Xanthines’ to help your breathing such as theophylline and aminophylline.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Altyonz Inhaler.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The effect of Altyonz Inhaler on fertility has not been studied and there are no fertility data available.

Driving and using machines

You may feel dizzy, or have difficulty focusing, dilated pupils, blurred vision, visual halos and/or coloured images, red eyes, eye pain or discomfort when using Altyonz Inhaler. If any of these symptoms occur do not drive or use any tools or machines. If your eyes are affected in any way at all do not drive or operate machinery and contact your doctor straightaway.

Operations

If you attend a hospital appointment or are admitted to hospital be sure to take your inhaler(s) and any other medicines (in their packaging if possible) with you. Some gases used in operations (anaesthetics gases) may affect how your inhaler works. If you are about to have surgery, make sure you mention that you are using Altyonz Inhaler to the doctor, dentist or anaesthetist.

Altyonz Inhaler contains ethanol (alcohol)

This medicine contains a small amount of ethanol (8.4 mg in one single dose).

3. how to use altyonz inhaler

Always use Altyonz Inhaler exactly as your doctor has told you. Check with your doctor if you are not sure.

Use in children:

This pressurised metered dose inhaler is not to be used in children 12 years of age and younger or in adolescents 13 to 17 years of age.

Use in adults (including the elderly) with either asthma or COPD:

• or 2 puffs to be inhaled three or four times daily.
• However, in early treatment some patients may need up to 4 puffs at a time to obtain maximum benefit.

Testing your Inhaler

When you use the inhaler for the first time you should test it to check that it works properly. Also do this if you have not used the inhaler for 3 or more days.

• 1. Remove the mouthpiece cover by gently pressing the sides with your thumb and index finger.

• 2. Point the mouthpiece away from you and press the canister twice (once at a time) to release two puffs into the air.

Using your Inhaler

• 1. Stand or sit upright while using the Altyonz Inhaler

• 2. Remove the mouthpiece cover.

• 3. Check inside and outside the mouthpiece of the inhaler to make sure that it is clean and free from dust and dirt and any loose objects before inhaling.

• 4. Hold the inhaler upright between the thumb(s) on the base of the mouthpiece and a forefinger (s)/index finger(s) on the top of the inhaler (the arrow on the base of the container should be pointing upwards) and breathe out slowly and deeply.

• 5. Immediately after breathing out place the mouthpiece in your mouth between your teeth and close your lips around it but do not bite it

• 6. Breathe in slowly and deeply, through the mouth and immediately after starting to breathe in press down firmly on the top of the inhaler to release one actuation (puff) and continue to breathe in steadily and deeply.

• 7. Hold your breath, remove the inhaler from the mouth and take away the finger from top of the inhaler. Continue to hold your breath for as long as is comfortable, for 10 seconds if possible.

• 8. Breathe out slowly. Do not breathe out into the inhaler.

• 9. If a second inhalation is required you should wait at least one minute and then repeat steps 4 to 8.

• 10. Replace the mouthpiece cover after use.

IMPORTANT

• Do not inhale too quickly, start breathing in as slowly and steadily as possible just before pressing the inhaler
• Do not rush through the entire procedure
• Elderly patients and patients with weak hands may use the inhaler with both hands

The mouthpiece has been designed specially for use with this medicine only. Do not use any other mouthpiece with the medicine and do not use the mouthpiece provided here with any other medicine.

Practice in front of a mirror the first few times. If you see “mist” coming from the top of your inhaler or the sides of your mouth you should start again.

People with weak hands may find it easier to hold the inhaler with both hands. Put the two forefingers on top of the inhaler and both thumbs on the bottom below the mouthpiece. Your doctor, nurse or pharmacist will be able to advise you.

The inhaler can be used with a device called Aerochamber Plus spacer. This may be useful for people who find it difficult to synchronise breathing in and inhaler actuation.

Please talk to your doctor if you have difficulties to use the Altoynz Inhaler.

If the Inhaler has been exposed to low temperatures, the patient should take the metal canister out of the plastic case and warm it in their hands for a minimum of two minutes.

When using your Altyonz Inhaler take care not to let any of the spray enter your eyes. If any of the spray from the inhaler accidently gets into your eyes you may get painful eyes, stinging or red eyes, dilated pupils, blurred vision, see colors or lights or halos around lights. If you get any of the above side effects, rinse the eye with cold tap water and immediately talk to your doctor, pharmacist or asthma nurse for further advice.

Cleaning your Inhaler

To prevent your inhaler from getting blocked up it should be cleaned at least once a week.

• Remove the canister and green mouthpiece cover.
• Wash and clean the white mouthpiece in warm soapy water.
• Rinse in warm water and allow to air dry without using any heating system.
• Make sure the small hole in the mouthpiece is washed through thoroughly.
• Once the mouthpiece is dry, replace the canister and the mouthpiece cover.

Do not put the metal canister into water.

Do not use more than your doctor has told you to use See your doctor straight away if:

• You feel that your inhaler is not working as well as usual. or
• You need to use the inhaler more than your doctor has recommended.

Your doctor may need to check how well your medicine is working. Your doctor may need to change your medicine.

Make sure you do not run out of Altyonz

The inhaler has been designed to deliver 200 puffs of your medicine. However, it is not possible to tell when the inhaler is empty and when the 200 puffs have been used. There may still be a small amount of fluid left over in the container. Please make sure that your inhaler is replaced after you have taken 200 puffs (usually after 3–4 weeks of regular use) so that you can be certain that you are getting the right amount of your medicine in each puff.

If you use more Altyonz than you should

If you use more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take all your inhalers and any other medicines you are taking (in their packaging if possible) with you. If you take too much or too many puffs you may get a dry mouth, a rapid heart rate or blurred vision.

If you forget to use your Altyonz Inhaler

• If you forget a dose, take it as soon as you remember it.
• However, if it is time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose

Do not stop using your Altyonz Inhaler unless your doctor tells you to

If you have any further questions on the use of this medicine ask your doctor or pharmacist or asthma nurse.

4. possible side effects

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

Tell your doctor straightaway if you notice any of the following serious side effects - you may need urgent medical treatment

• If after using Altyonz Inhaler you are wheezy or have other difficulties in breathing, do not use any more (unless you have been told to by your doctor). You may need to use a fast-acting reliever inhaler such as salbutamol to help your breathing. Your doctor may decide that you need different medicines to help your breathing.
• Paradoxical bronchospasm is uncommon and may affect up to 1 in 100 people. As with other inhaled medicines you may experience difficulty in breathing with an immediate worsening of your wheezing after taking a dose of this medicine. This is known as paradoxical bronchospasm and will respond to a fast-acting ‘reliever’ inhaler, your ‘blue’ inhaler and should be treated straightaway. You should stop using Altyonz Inhaler immediately and contact the doctor. The doctor will want to see you and examine your chest and will probably prescribe a different inhaler to treat your asthma or COPD or chronic bronchitis.
• Allergic reactions are uncommon and may affect up to 1 in 100 people, talk to your doctor or pharmacist immediately. The signs may include skin rash and itching. In severe reactions the signs include swelling of your mouth (tongue and lips) and face, sudden difficulties in breathing and a fall in your blood pressure. Tightening of your throat may occur. If allergic reactions occur, Altyonz should be stopped immediately; do not use your Altyonz Inhaler again; talk to your doctor or pharmacist straightaway.
• Palpitations (fast or uneven heart beats) or quickening of the heart rate (may affect up to 1 in 100 people).
• Increased heart rate or irregular heart rhythm such as atrial fibrillation (may affect up to 1 in 1000 people).
• If any of the spray from the inhaler accidently gets into your eyes you may get painful eyes, stinging or red eyes, dilated pupils, blurred vision, see colors or lights or halos around lights. If this happens, talk to your doctor immediately for advice. If you get problems with your eyes at any other time also talk to your doctor for advice. You may be developing increased pressure in your eyes (glaucoma), which will need treatment (straightaway). If your eyes are affected in any way do not drive or operate machinery.

See your doctor straightaway if you have any of these side effects.

The side effects described below have been experienced by people taking Altyonz Inhaler and they are listed as either common, uncommon or rare.

Common (may affect up to 1 in 10 people)

• Headache, dizziness
• Dry mouth, feeling sick (nausea), stomach upset or discomfort.
• Cough and throat irritation when you have just used Altyonz Inhaler

Uncommon (may affect up to 1 in 100 people)

• Itching, skin rash.
• Unexpected tightness of the chest, swelling of the throat, dry throat.
• Blurred vision, dilated pupils, increased pressure in the eye (glaucoma), painful eyes, stinging redness or swelling of the eyes, seeing colours, lights or halos around lights.
• Diarrhoea, constipation or being sick (vomiting).
• Mouth or lip sores.

Problems passing water (urine), especially if you already have problems passing urine.

Rare (may affect up to 1 in 1000 people)

• Difficulty focusing
• Nettle rash (urticaria)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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 altyonz inhaler

Keep this medicine out of the sight and reach of children

Do not use Altyonz Inhaler after the expiry date which is stated on the carton and canister label after EXP. The expiry date refers to the last day of that month.

Altyonz Inhaler should not be stored above 25oC. Keep away from direct sunlight and heat. Protect from frost.

If the Inhaler has been exposed to low temperatures, the patient should take the metal canister out of the plastic case and warm it in their hands for a minimum of two minutes.

The canister contains a pressurised liquid. Do not expose to temperatures higher than 50oC. Do not try to open, puncture or burn the canister even when apparently empty.

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

6. contents of the pack and other information the active substance is ipratropium bromide.

One metered dose (ex-valve) contains 20 micrograms ipratropium bromide (as the monohydrate). This is equivalent to a delivered dose (ex-actuator) of 18 micrograms ipratropium bromide (as the monohydrate). Each canister contains 200 actuations, each actuation containing 20 micrograms ipratropium bromide (as the monohydrate).

• The other ingredients are CFC-Free propellant, propellant HFA 134a (1,1,1,2– tetrafluoroethane), citric acid anhydrous, ethanol anhydrous and purified water. Altyonz Inhaler does not contain any chlorofluorocarbon (CFC) propellants.

What Altyonz Inhaler looks like and contents of pack.

Altyonz Inhaler is comprised of a pressurised aluminium canister which contains pressurised solution for inhalation sealed with a metering valve made up of a thermoplastic body and a metallic ferrule and spring and a plastic actuator made up of polypropylene having a white mouthpiece fitted with a green mouthpiece cover. Each carton contains one inhaler.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom

Manufacturer: S&D Pharma CZ, spol. s r.o, Theodor 28, 273 08 Pchery (Pharmos a.s. facility), Ceska Republika

Cipla Europe NV, De Keyserlei 58–60, Box-19, 2018, Antwerp, Belgium

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in 11/2018.