Sabumalin

Package leaflet: information for the patient

Sabumalin, 100 micrograms/dose, inhalation aerosol, suspension
Salbutamolum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Sabumalin is and what it is used for
2. Important information before using Sabumalin
3. How to use Sabumalin
4. Possible side effects
5. How to store Sabumalin
6. Contents of the package and other information

1. What Sabumalin is and what it is used for

Sabumalin is used in the treatment of breathing difficulties caused by the following conditions:
bronchial asthma
chronic obstructive pulmonary disease (COPD), including:

• chronic bronchitis
• emphysema.

Additionally, Sabumalin is used for prevention of bronchial asthma symptoms triggered by:
physical exertion or
allergens such as house dust, pollen, cat hair, dog hair, and cigarette smoke.

Sabumalin dilates the airways, facilitating airflow. Sabumalin should be used primarily to relieve symptoms rather than for continuous treatment.
Sabumalin is indicated for use in adults, adolescents, and children aged 4 to 11 years.

2. Important information before using Sabumalin

When not to use Sabumalin:

• if the patient is allergic to salbutamol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Sabumalin, consult a doctor if the patient has any of the following conditions:
heart disease, such as irregular or rapid heartbeat or a history of angina pectoris
severe and untreated hypertension
hyperthyroidism
low blood potassium levels
arterial dilation (aneurysm)
diabetes (at the beginning of treatment with Sabumalin, additional monitoring of blood glucose levels is recommended)
adrenal medulla tumour (adrenal glands are two glands located above the kidneys).

Sabumalin and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
The following medicines may interact with Sabumalin and affect each other's action:
medicines affecting the heart and blood vessels that may constrict airways and contain active substances with names ending in “-ol”, such as propranolol (beta-blockers). These may cause bronchoconstriction.
some medicines used to treat depression:

• monoamine oxidase inhibitors (e.g. moclobemide)
• tricyclic antidepressants, such as amitriptyline
  anaesthetics (medicines causing partial or complete loss of sensation), such as halothane
  medicines used for heart rhythm disorders, such as digoxin
  xanthine derivatives (used to facilitate breathing), such as theophylline
  steroids (a group of hormones), such as cortisone
  diuretics, such as furosemide

Pregnancy and breastfeeding
Experience with the use of this medicine during pregnancy is limited. However, untreated asthma during pregnancy poses a risk to the unborn child. Therefore, Sabumalin may be used during pregnancy only if the physician considers it absolutely necessary.
Do not change the dose independently; always use the medicine as directed by the physician.
It is not known whether salbutamol passes into breast milk. Therefore, Sabumalin may be used during breastfeeding only if the physician considers it absolutely necessary.
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Studies on the effect of the medicine on the ability to drive vehicles and operate machinery have not been conducted. Therefore, such activities should not be undertaken until it is established how the medicine affects the patient's organism.

Sabumalin contains ethanol
This medicine contains 0.72 mg of alcohol (ethanol) per measured dose, equivalent to 2.1% v/v. The amount of alcohol in a measured dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use Sabumalin

This medicine should always be used exactly as directed by the doctor. If in doubt, consult the doctor or pharmacist.
Sabumalin should be used only when needed, not on a regular basis.
If a patient experiences active asthma (for example, frequent symptoms or exacerbations such as breathlessness interfering with speaking, eating, or sleeping, coughing, wheezing, chest tightness, or reduced physical performance), they should immediately inform their doctor, who may initiate or increase the dose of a medicine that helps maintain control of asthma symptoms, such as an inhaled corticosteroid.
If the patient feels that the medicine is not working as well as usual, they should inform their doctor as soon as possible (for example, if higher doses are needed to relieve breathing difficulties, or asthma symptoms do not subside within at least 3 hours after using the inhaler), because asthma may be worsening and another medicine may be required.
If the patient uses Sabumalin more than twice a week to relieve asthma symptoms, excluding preventive use before physical exertion, this indicates poorly controlled asthma and increases the risk of severe asthma attacks (asthma exacerbations), which may lead to serious complications, be life-threatening, or even fatal. The patient should contact their doctor promptly to review their asthma treatment regimen.
If the patient is using a medicine with anti-inflammatory action in the lungs, e.g., an "inhaled corticosteroid", it is important to continue using it regularly, even if they feel better.

Recommended dosage:
Adults and adolescents aged 12 years and older
Relief of symptoms:
1–2 inhalations, as needed.
Prevention of exercise-induced or allergen-induced asthma symptoms:
2 inhalations 10–15 minutes before exposure to the triggering factor.
Maximum dose: 8 inhalations per day.

Children aged 4 to 11 years
Relief of symptoms:
1 inhalation, as needed. The dose may be increased to two inhalations if necessary.
Prevention of exercise-induced or allergen-induced asthma symptoms:
1 inhalation, or if necessary, 2 inhalations 10–15 minutes before exposure to the triggering factor.
Maximum dose: 8 inhalations per day.

Children under 4 years of age
The effect of the medicine has not yet been studied in children of this age, so a dosage cannot be established.

Contact the doctor if treatment is not sufficiently effective or if more doses per day than usual are needed. Never increase the dose or change the timing of administration without the doctor's approval.

Checking the inhaler before use
If a new inhaler is being used, or if the previous inhaler has not been used for at least 7 days, its function should be checked. To do this, remove the protective cap, shake the inhaler, and spray the medicine twice into the air.

Method of administration
Inhalations should be performed while sitting or standing, if possible.

1. Remove the protective cap. Check that the outer and inner parts of the mouthpiece are clean.

2. Shake the inhaler for several seconds before use.

3. Holding the inhaler upright with the base pointing upwards, place the thumb below the mouthpiece on the body of the container. Breathe out as deeply as possible, but do not exhale into the mouthpiece.
4. Place the mouthpiece in the mouth between the teeth and close lips around it (do not bite).
5. Immediately after starting to inhale through the mouth, press down on the top of the inhaler to release the dose. Continue inhaling slowly and deeply.

6. Hold the breath for 5–10 seconds. Remove the inhaler from the mouth and remove the finger from the top of the device.
7. If a second inhalation is needed, keep the inhaler in an upright position and wait about half a minute, then repeat steps 2 to 6.
8. After use, always replace the cap on the mouthpiece to protect it from dust and contamination. Press the cap firmly to ensure a tight seal.

Some people have difficulty releasing the dose immediately after starting inhalation. In such cases, and especially in children, a spacer device (e.g., Vortex or AeroChamber) may be used. For instructions on using the spacer, refer to the patient information leaflet provided with the device.

Cleaning
To prevent blockage or if the inhaler becomes blocked, clean it according to the instructions below. This should be done at least once a week. It is best to clean the inhaler just before going to bed.

1. Remove the metal canister from the plastic casing and take off the mouthpiece cap.
2. Rinse the plastic casing and mouthpiece cap under warm water. If medicine residue is visible around the mouthpiece, do not attempt to clear it with a sharp object such as a pin. A mild detergent may be used. Rinse thoroughly with clean water after washing. Do not immerse the metal canister in water.
3. Allow the plastic casing and mouthpiece cap to dry in a warm place. Avoid excessive heat.
4. Reassemble the casing and mouthpiece cap.

If the inhaler becomes blocked and immediate use is required, perform the following steps:

1. Hold the inhaler upright with the base of the canister facing upwards. Rotate the metal canister clockwise inside the plastic casing by one full turn.

2. Remove the metal canister from the plastic casing.

3. Hold the base of the canister facing upwards. With the fingers of the other hand, gently pull down the small white plastic stem carefully. Do not use any tools, such as tweezers.

4. Reinsert the canister into the plastic casing.

Contents of the inhaler
Shake the inhaler to check the amount of remaining medicine. Do not use Sabumalin if no liquid is visible inside the inhaler when shaken.

Use in low temperatures
If the inhaler has been stored at temperatures below 0°C, warm it in the hands for 2 minutes before use, shake it, and spray the medicine twice into the air.

Use of a higher than recommended dose of Sabumalin
In such cases, always contact a doctor or hospital immediately.
Typical symptoms of overdose include:
tremor
headache
increased heart rate
nausea or vomiting
inability to sit still
irritability, restlessness
seizures
drowsiness

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following very rare symptoms occur, stop taking the
medicine Sabumalin and contact your doctor immediately:
signs of an allergic reaction, such as:

• swelling of the face, tongue or throat
• difficulty swallowing
• symptoms resembling urticaria (hives)
• breathing difficulties

Worsening of breathing difficulties immediately after administration of Sabumalin, even though it relieves symptoms, may indicate an exacerbation of the disease and the need for rapid initiation of alternative treatment.

You should contact your doctor as quickly as possible if:
the patient experiences chest pain (angina symptoms) during treatment with
Sabumalin. Do not stop taking the medicine without consulting your doctor. The frequency of this adverse reaction is unknown.

Adverse reactions may occur with the following frequency:
Common (may occur in fewer than 1 in 10 people):
tremor
increased heart rate
headache
muscle cramps

Uncommon (may occur in fewer than 1 in 100 people):
rapid heartbeat
irritation of the mouth and throat

Rare (may occur in fewer than 1 in 1,000 people):
decreased blood potassium levels
sudden skin redness (especially of the face)

Very rare (may occur in fewer than 1 in 10,000 people):
reduced arterial pressure
collapse
increased activity
sleep disturbances
irregular heartbeat
itchy rash

Frequency not known (cannot be estimated from available data):
lactic acidosis (a condition in which excessive lactic acid is produced in the body)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sabumalin medicine

Keep the medicine out of sight and reach of children.
Do not store at temperatures above 30°C.
Store the inhaler in a horizontal or inverted position, with the mouthpiece pointing downwards.
The container holds pressurized liquid. Do not expose to temperatures above 50°C, even for a short time. Protect from high temperatures, direct sunlight, and frost! Do not pierce or burn the container, even if it is empty.
Do not use Sabumalin medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the indicated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Sabumalin contains
The active substance is salbutamol.
Each metered dose contains 100 micrograms of salbutamol (as sulphate).
Each dose delivered via the mouthpiece contains 90 micrograms of salbutamol (as sulphate).
The other ingredients are: norflurane (HFA 134a), anhydrous ethanol and oleic acid.

What Sabumalin looks like and contents of the pack
The medicine is a white suspension contained in an aluminium container with a metering valve and a polypropylene mouthpiece.

Pack sizes:
200 metered doses (corresponding to 8.5 g of inhalation aerosol, suspension).
2 x 200 metered doses (corresponding to 2 x 8.5 g of inhalation aerosol, suspension).
3 x 200 metered doses (corresponding to 3 x 8.5 g of inhalation aerosol, suspension).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer:
AEROPHARM GmbH
Francois-Mitterrand-Allee 1
07407 Rudolstadt, Germany

For further detailed information about the medicine and its names in other European Economic Area member countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. +48 22 209 7000
{Logo of the Marketing Authorisation Holder}