Lerhasa

Patient Information Leaflet

LERHASA, 100 micrograms/dose, inhalation aerosol, suspension
Salbutamol (as salbutamol sulphate)
Please read all of this leaflet carefully before 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 nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet Contents

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

1. What LERHASA is and what it is used for

This inhaler contains salbutamol, which belongs to a group of medicines called bronchodilators.
These medicines help keep the airways open, making breathing easier. They also help reduce
chest tightness, wheezing and coughing.
The inhaler is used in adults, adolescents and children aged 4 to 11 years:

• for the treatment of breathing problems in patients with asthma and similar conditions (e.g. chronic bronchitis, emphysema).
• for the prevention of asthma symptoms triggered by physical exertion or other factors causing breathlessness (common triggers include house dust, pollen, cat and dog fur, and cigarette smoke).

2. Important information before using LERHASA

When not to use LERHASA

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

Warnings and precautions
Before starting treatment with this medicine, consult a doctor or pharmacist if the patient:

• has previously had a heart condition, such as irregular or rapid heartbeat, heart attack, or angina (chest pain)
• has severe or untreated high blood pressure
• has hyperthyroidism
• has low potassium levels in the blood
• has a dilated blood vessel (aneurysm)
• has diabetes (additional blood glucose monitoring is recommended at the beginning of treatment with this medicine)
• has a pheochromocytoma (a tumour of the adrenal gland). The adrenal glands are two glands located above the kidneys.
• previously had to discontinue this or another medicine used to treat this condition due to allergy or another problem
• is taking diuretics (water tablets), sometimes used in the treatment of high blood pressure or heart disease.

Cases of dental caries have been reported during salbutamol use. It is recommended, especially
in children, to maintain good oral hygiene and to have regular dental check-ups.
LERHASA and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take, especially:

• beta-blockers (beta-adrenergic receptor blockers), such as propranolol
• certain medicines used to treat depression, e.g. monoamine oxidase inhibitors (e.g. moclobemide), tricyclic antidepressants (e.g. amitriptyline)
• anaesthetics (e.g. halothane)
• medicines used in cardiac arrhythmias (e.g. digoxin)
• xanthines (used to facilitate breathing), such as theophylline
• steroids (e.g. cortisone)
• diuretics, such as furosemide.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant,
she should consult a doctor before using this medicine.
This medicine may be used during pregnancy only if the doctor considers it necessary. Do not change the dose independently; always use the medicine as directed by the doctor.
Information regarding passage of the medicine into breast milk is insufficient to assess risk to the infant.
Therefore, this medicine should only be used if prescribed by a doctor.
Driving and operating machinery
Studies on the effect of the medicine on the ability to drive vehicles have not been conducted.

3. How to use LERHASA

This medicine should always be used as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents aged 12 years and older
Relief of asthma attacks:
1–2 inhalations (100–200 micrograms), as needed.
Prevention of exercise-induced asthma or asthma triggered by provoking factors:
2 inhalations (200 micrograms) before exercise, administered 10–15 minutes prior to exposure to the trigger.
The maximum dose is 8 inhalations (800 micrograms) per day.
Children (aged 4 to 11 years)
Relief of asthma attacks:
1 inhalation (100 micrograms). If necessary, the dose may be increased to two inhalations.
Prevention of exercise-induced asthma or asthma triggered by provoking factors:
1 or 2 inhalations (100–200 micrograms) before exercise.
To prevent symptoms triggered by allergens or physical exertion, one or two inhalations should be taken, if necessary, 10–15 minutes before exposure to the triggering factor.
The recommended dose for long-term use is:
Adults, children aged 12 years and older: Up to two inhalations (200 micrograms) four times daily.
Typically, the maximum dose that may be taken within 24 hours is 8 inhalations (800 micrograms).
Children under 4 years of age may benefit from using this medicine with a paediatric spacer device equipped with a mask (such as a Babyhaler). Consult your doctor.
Contact your doctor if treatment is not sufficiently effective or if a higher than usual daily dose is required.
Salbutamol should be used as needed, not regularly.
If asthma is active (for example, if the patient experiences frequent symptoms or exacerbations such as breathlessness interfering with speaking, eating, or sleeping, coughing, wheezing, chest tightness, or reduced physical activity), inform your doctor immediately. The doctor may initiate or increase the dose of an asthma controller medicine, such as an inhaled corticosteroid.
If the medicine does not work as expected, inform your doctor as soon as possible (for example, if the patient requires higher doses to relieve breathing difficulties or if inhaler use does not relieve symptoms for at least 3 hours), as asthma may be worsening and another medicine may be necessary.
If the patient uses salbutamol more than twice a week to treat asthma symptoms, excluding use for preventing attacks before physical exertion, this indicates that asthma symptoms are not adequately controlled and the risk of severe asthma attacks (asthma exacerbations) may be higher, which can lead to serious complications and may be life-threatening or even fatal. Contact your doctor as soon as possible to review asthma treatment.
If the patient is using a medicine with anti-inflammatory action in the lungs, such as an inhaled corticosteroid, it is important to continue regular use even if the patient feels better.
Checking the inhaler:
Before first use, remove the protective cap, shake the inhaler well, and release two sprays into the air to ensure the inhaler is working properly.
If the inhaler has not been used for 5 or more days, shake it well and release two sprays into the air to ensure it is working.
Instructions for use:
Inhalations should be performed while sitting or standing, if possible.

1. Remove the protective cap.
2. Check both the inside and outside of the inhaler for any particles to ensure the mouthpiece is clean.

3. Before use, shake the inhaler well for several seconds to ensure the contents are properly mixed.

4. Hold the inhaler upright with the base pointing upwards, placing your thumb on the body of the canister below the mouthpiece. Breathe out as deeply as possible, but do not exhale into the mouthpiece.
5. Place the mouthpiece in the mouth between the teeth and seal lips around it, but do not bite it.
6. Immediately after starting to inhale through the mouth, press down on the top of the inhaler to release the dose, while simultaneously taking a slow and deep breath in.

7. Hold your breath, remove the inhaler from the mouth, and remove your finger from the top of the inhaler. Continue to hold your breath for as long as possible.
8. If another dose is prescribed, hold the inhaler upright, wait about half a minute, and repeat steps 3 to 7.
9. After use, always replace the protective cap on the mouthpiece to prevent dust or solid particles from entering. Press the cap firmly into place to ensure it is securely closed.

Patients who have difficulty coordinating inhaler use with inhalation may use a spacer device such as Volumatic (for adults and children over 5 years) or Babyhaler (for children aged 1 to 5 years).
Young children may require assistance from an adult to use the inhaler. Instruct the child to exhale and activate the inhaler immediately after the child begins to inhale.
Practice this technique together.
Cleaning the inhaler
To prevent blockage or if the inhaler becomes blocked, clean it at least once a week, following the instructions below.

1. Remove the metal canister from the plastic casing and remove the protective cap from the mouthpiece.
2. Rinse the plastic casing and the protective cap of the mouthpiece with warm water. Do not remove accumulated medicine residue around the mouthpiece with sharp instruments such as a pin. A mild detergent may be used, followed by thorough rinsing with clean water before drying. Do not immerse the metal canister in water.
3. Allow the plastic casing and the protective cap of the mouthpiece to dry in a warm place. Do not overheat.
4. Reassemble the casing and replace the protective cap on the mouthpiece.

Inhaler contents:
Shake the inhaler to check the amount of remaining medicine. Do not use LERHASA if, when shaken, no liquid is visible inside the inhaler.
Use in cold temperatures:
If the inhaler has been stored at a temperature below 0°C, warm it in your hands for 2 minutes before use, shake it well, and release two sprays into the air.
Use of a higher than recommended dose of LERHASA
In such a case, always contact your doctor or hospital immediately.
Typical symptoms of overdose include:

• tremor
• headache
• rapid heartbeat
• nausea or vomiting
• difficulty sitting still (excessive restlessness)
• irritability, restlessness
• seizures
• drowsiness
• chest pain
• psychotic reactions

Missed dose of LERHASA

• If a dose is missed, take the next dose according to the dosing schedule or if breathing difficulties worsen or wheezing occurs.
• Do not use a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop using LERHASA and immediately contact a doctor if any of the following very rare symptoms occur:

• allergic reaction, with symptoms such as swelling of the face, tongue or throat, difficulty swallowing, skin rash or hives, difficulty breathing
• sudden worsening of breathing difficulties after administration of this medicine. This may indicate a worsening of the disease and the need for rapid initiation of alternative treatment.

You should contact a doctor as soon as possible if the patient experiences:

• chest pain (symptom of angina pectoris)

Do not discontinue treatment with this medicine without medical advice. The frequency of this adverse reaction is unknown.

Other adverse reactions:
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 flushing of the skin

Very rare (may occur in fewer than 1 in 10,000 people):

• allergic reactions (see "You must stop using LERHASA and immediately contact a doctor")
• collapse
• itchy rash
• decreased blood pressure
• increased hyperactivity
• sleep disturbances
• irregular heartbeat
• sudden worsening of breathing difficulties after using the inhaler

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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine LERHASA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Immediately after use, replace the protective cap firmly back onto the mouthpiece and press down securely into the correct position. Do not force the protective cap on.
Store the inhaler in an inverted position with the mouthpiece pointing downwards.
The container is under pressure. Do not expose to temperatures above 50°C, even for short periods. Protect from high temperatures, direct sunlight, and frost. Do not pierce or burn the container, even if it is empty.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What LERHASA contains:
The active substance is 100 micrograms of salbutamol (as salbutamol sulphate) per metered dose (from the metering valve).
The delivered dose is 80 micrograms of salbutamol (as salbutamol sulphate).
The other component is propellant gas: norflurane (tetrafluoroethane or HFC-134a).
This medicine contains fluorinated greenhouse gases.
Each inhaler contains 17.54 g of norflurane (HFC-134a), equivalent to 0.025 tonnes of CO(_2)
(global warming potential GWP = 1430).

What LERHASA looks like and contents of the pack
This medicine is a white or almost white pressurised suspension for inhalation, contained in an aluminium pressurised canister fitted with a metering valve and placed in a white homopolymer polypropylene inhaler with a blue protective mouthpiece cap. The inhaler is enclosed in an aluminium foil pouch and then placed with the patient leaflet into a cardboard box.

Pack sizes:

• 1 pressurised canister containing 200 metered doses
• 2 pressurised canisters containing 200 metered doses each
• 3 pressurised canisters containing 200 metered doses each

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer and Importer
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoke Myto
Czech Republic
Synoptis Industrial Sp. Z.o.o.
Rabowicka 15
62-020 Swarzędz

This medicine is authorised in the European Economic Area countries under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego 3
00-728 Warsaw
Email: [email protected]