Package leaflet: Information for the user

Sabumalin 100 micrograms/dose pressurised inhalation, suspension

Salbutamol

Read all of this leaflet carefully before you start using this medicinebecause 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 Sabumalin is and what it is used for

2. What you need to know before you use Sabumalin

3. How to use Sabumalin

4. Possible side effects

5. How to store Sabumalin

6. Contents of the pack and other information

1. What Sabumalin is and what it is used for

Sabumalinis used to treatbreathing difficulties caused by the following diseases:

• asthma

• chronic obstructive pulmonary disease (COPD) including

- chronic bronchitis

- emphysema

Sabumalin is additionally used to prevent asthma symptomscaused by:

• exercise or

• triggers, such as house dust, pollen, cats, dogs and cigarette smoke

Sabumalinexpands the airways, allowing the air to flow more freely. Sabumalin should primarily be used to relieve symptoms rather than as a regular treatment.

Sabumalin is indicated for adults, adolescent and children from 4 to 11 years.

2. What you need to know before you use Sabumalin

Do not useSabumalin

Warnings and precautions

Talk to your doctor before using Sabumalin if any of the following conditions apply to you:

• severe heart disease

• a history of heart disease, irregular heart rhythm or angina

• severe and untreated high blood pressure

• an overactive thyroid gland

• too little potassium in the blood

• enlarged artery (aneurysm)

• diabetes (extra checks of blood glucose levels are recommended when beginning treatment with Sabumalin )

• tumour of the adrenal medulla (pheochromocytoma). The adrenal medulla are two glands situated above the kidneys.

Other medicines and Sabumalin

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

The following medicines can influence or be influenced by Sabumalin:

This may cause spasms in the lung airways.

• anaesthetics (agent that induces partial or total loss of sensation), such as halothane

• medicines against irregular heartbeat, such as digoxin

• xanthin derivatives (used to help breathing), such as theophylline

• steroids (group of hormones), such as cortisone

• diuretics (water tablets), such as furosemide

Pregnancy and breast-feeding

Limited knowledge exists regarding use during pregnancy, but there also is a risk for the unborn child, if your asthma is untreated during pregnancy. Therefore, you should use Sabumalin only if your doctor indicates it is clearly necessary. Do not change the dosage by yourself, but always use it according to your doctor’s recommendation.

It is unknown, whether salbutamol passes into the mother´s milk. Therefore, only use Sabumalin if your doctor indicates it is clearly necessary.

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.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Therefore, do not drive or operate machines until you know how the medicine is affecting you.

3. How to use Sabumalin

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

The recommended dose is:

Adults and adolescents aged 12 years and over

1-2 inhalations as required.

2 inhalations 10-15 minutes beforehand

Children (4-11 years)

1 inhalation as required. The dose may be increased to two inhalations if required.

1 inhalation, or 2 if necessary 10-15 minutes beforehand

Children below 4 years of age

No recommendations can be made for dosage since the effect has not yet been determined.

Contact your doctor if the treatment is not effective enough or if you need more doses per day than usual. Never increase your dose or change the duration of use without your doctor´s approval.

Inhaler test before use:

Check that the inhaler is functioning, if you use a new inhaler or if it has not been used for 7 days or more. Remove the protective cap, shake the inhaler and spray twice into the air.

Instructions for use:

Inhale sitting or standing, wherever possible.

Some people find it difficult to release a puff of medicine just after they start to breathe in. In this case, as well as for children, the Vortex^®or AeroChamber^®Plus spacer device can be used. Please refer to the product information of the spacer device for its correct handling.

Cleaning

To prevent the inhaler blocking up or if it does block up, clean it at least once a week, as follows:

Inhaler content:

Shake the spray to check the remaining amount of medicine in your inhaler. Do not use

Sabumalin if you do not detect any liquid in the inhaler while shaking.

Cold temperature use:

If the inhaler has been stored beneath 0 °C, warm it in your hands for 2 minutes, shake it and spray into the air twice before use.

If you use more Sabumalin than you should

In this case always contact your doctor or hospital.

Typical symptoms of overdose are:

• trembling

• headache

• rapid heart beat

• nausea or vomiting

• inability to keep still

• irritability, excitation

• seizures

• sleepiness

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.

Stop using Sabumalin and contact your doctorimmediately if you develop any of the following:

• swelling of the face, tongue or throat

• difficulties in swallowing

• signs which resemble nettle sting

• breathing difficulties

Side effects can occur with the following frequencies:

Common, may affect up to 1 in 10 people:

• trembling

• increased heart rate

• headache

• muscle cramps

Uncommon, may affect up to 1 in 100 people:

rapid heartbeat

Rare, may affect up to 1 in 1,000 people:

• reduced potassium level in the blood

• flushing

Very rare, may affect up to 1 in 10,000 people:

• allergic reactions, See “Stop using Sabumalin and contact your doctor”

• decreased blood pressure

• collapse

• increased activity

• increased excitability

• hallucinations

• sleep disturbances

• irregular heart rhythm

• itchy rash

• worsening of breathing immediately after taking your inhaler

Frequency not known (the frequency cannot be estimated from the available data):

Although it is not known exactly how often this happens, some people may occasionally experience chest pain (due to heart problems such as angina). Tell your doctor if you develop these symptoms whilst receiving treatment with Sabumalin, but do not stop using this medicine unless told to do so.

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 via the national reporting system listed in Appendix V*.

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

5. How to store Sabumalin

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 label and carton. The expiry date refers to the last day of that month.

Do not store above 30 °C.

Store the inhaler lying flat or in an inverted position, with the mouthpiece pointing downward.

The canister contains a pressurized liquid. Do not expose to temperatures higher than 50 °C, even for a short period of time. Protect from heat, direct sunlight and frost! Do not pierce or burn the canister, even when empty.

Do not throw away any medicines via wastewater. 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 Sabumalin contains

One metered dose contains 100 micrograms salbutamol (as sulphate).

The delivered dose through the mouthpiece is 90 micrograms of salbutamol (as sulphate).

What Sabumalin looks like and contents of the pack

This medicinal product is a white pressurised inhalation suspensioninaluminium containers with metering valve and plastic applicator.

Packs containing

200 metered doses equal to 8.5 g pressurised inhalation, suspension.

2 x 200 metered doses equal to 2 x 8.5 g pressurised inhalation, suspension .

3 x 200 metered dosesequal to3 x 8.5 g pressurised inhalation, suspension.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

{Name and address}

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Manufacturer:

Aeropharm GmbH

François-Mitterrand-Allee 1, 07407 Rudolstadt

Germany

+49 (0) 3672 479-0

+49 (0) 3672 479-102

service@aeropharm.de

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

SE/H/601:

Belgium: Salbutamol Sandoz 100µg Aërosol, suspensie

Germany: Salbutamol Sandoz 100 mikrogramm Dosieraerosol Druckgasinhalation, Suspension

Denmark: Salbutamol Sandoz

Estonia: Salbutamol Sandoz 100 mikrogrammi/annuses

Finland: Salbutamol Sandoz

Greece: Salbutamol/Sandoz

Hungary: Salbutamol Sandoz 100 mikrogramm/adag túlnyomásos inhalációs szuszpenzió

Italy: Salbutamolo Sandoz 100 mcg sospensione pressurizzata per inalazione

Lithuania: Salbutamol Sandoz 100 mikrogramų/išpurškime suslėgta inhaliacinė suspensija

Latvia: Salbutamol Sandoz 100 microgrami/aerosols inhalacijam, suspensija

Netherlands: Salbutamol Sandoz aërosol 100 µg/dosis, aërosol, suspensie 100 microgram per dosis

Norway: Salbutamol Sandoz

Poland: Sabumalin

Portugal: Salbutamol Sandoz

Slovenia: Salbulin 100 mikrogramov/odmerek inhalacijska suspenzija pod tlakom

Spain: Salbutamol Sandoz 100 mcg/dosis suspensión para inhalación en envase a presión

Sweden: Sabumalin

United Kingdom: AirSalb CFC-free inhaler 100 microgram/dose

This leaflet was last revised in 23 November 2015

[To be completed nationally]