Salbutamol Glenmark

Package Leaflet: Information for the User

Salbutamol Glenmark 100 micrograms/dose pressurised inhalation suspension

salbutamol (as salbutamol sulfate)
equivalent medicine
Please read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Salbutamol Glenmark is and what it is used for

This inhaler contains salbutamol, which belongs to a group of medicines known as bronchodilators. These medicines help the airways in the lungs to stay open, making it easier for air to flow in and out. They also provide relief from chest tightness, wheezing and coughing.
The inhaler is used in adults, adolescents and children aged 4 to 11 years:

• to treat breathing difficulties in people with asthma and similar conditions (e.g. chronic bronchitis and emphysema);
• to prevent asthma triggered by physical exercise or other stimuli (common triggers include house dust, pollen, cats, dogs and cigarette smoke).

2. What you need to know before using Salbutamol Glenmark

Do not use Salbutamol Glenmark

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

Warnings and precautions
Talk to your doctor or pharmacist before using this medicine:

• if you have a history of heart problems, such as irregular or rapid heartbeat, myocardial infarction, or angina (chest pain)
• if you have severe and untreated high blood pressure
• if you have an overactive thyroid
• if you have low levels of potassium in the blood
• if you have arterial enlargement (aneurysm)
• if you have diabetes (additional monitoring of blood glucose levels is recommended at the beginning of treatment with this medicine)
• if you have a tumour of the adrenal medulla (pheochromocytoma). The adrenal medulla is part of the two glands located above the kidneys
• if you previously had to stop using this or another medicine for treating this condition due to allergies or other problems
• if you are taking diuretics, sometimes used to treat high blood pressure or heart problems.

Dental caries have been reported with the use of salbutamol. It is recommended, especially in children, to maintain good oral hygiene and to undergo regular dental check-ups.
Other medicines and Salbutamol Glenmark
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially the following:

• beta-blockers such as propranolol
• certain medicines for depression, e.g. monoamine oxidase inhibitors (e.g. moclobemide), tricyclic antidepressants (e.g. amitriptiline)
• anaesthetics (e.g. halothane)
• medicines for irregular heartbeat (e.g. digoxin)
• xanthines (used to aid breathing), such as theophylline
• steroids (e.g. cortisone)
• diuretics, such as furosemide.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine.
This medicine may be used during pregnancy if your doctor considers it necessary. Do not change the dose on your own; always follow your doctor's instructions.
There is insufficient information on whether this medicine passes into breast milk to assess the risk to the infant. Therefore, use this medicine only if recommended by your doctor.
Driving and using machines
No studies have been conducted on the ability to drive vehicles or operate machinery.
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Salbutamolo Glenmark

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, 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 asthma symptoms caused by exercise or stimuli:
2 inhalations (200 micrograms), 10-15 minutes before expected onset.
The maximum dose is 8 inhalations (800 micrograms) per day.
Children (4-11 years)
Relief of asthma attacks:
1 inhalation (100 micrograms). The dose may be increased to two inhalations if necessary.
Prevention of asthma symptoms caused by exercise or stimuli:
1 or 2 inhalations (100-200 micrograms) before exercise.
To prevent symptoms induced by exercise or allergens, one or two inhalations if necessary, 10-
15 minutes before expected onset.
The recommended dosage for long-term use is:
Adults, children aged 12 years and older: up to two inhalations (200 micrograms)
four times daily.
Generally, the maximum dose to be taken in 24 hours is 8 inhalations (800 micrograms).
Children under 4 years may benefit from using this medicine with a paediatric spacer chamber equipped
with a mask (such as a Babyhaler). Consult your doctor.
Contact your doctor if treatment is not effective enough or if you need to increase your daily dosage
beyond the usual amount.
Salbutamolo Glenmark should be used as needed rather than on a regular basis.
If asthma becomes active (e.g. frequent symptoms or exacerbations such as shortness of breath making it
difficult to speak, eat or sleep, coughing, wheezing, tight chest or limited physical ability), you must
inform your doctor immediately. Your doctor may start or increase a medicine to control asthma, such as
an inhaled corticosteroid.
Inform your doctor as soon as possible if the medicine does not seem to work as usual (e.g. you need
higher doses to relieve breathing problems, or the inhaler fails to provide relief for at least 3 hours),
since asthma may be worsening and you may require a different medicine.
If you use Salbutamolo Glenmark more than twice a week to treat asthma symptoms, except for
preventive use before exercise, this indicates poor asthma control and may increase the risk of severe
asthma attacks (asthma worsening) which can lead to serious complications and may be life-threatening
or even fatal.
If you are taking a daily medicine to treat lung inflammation, such as an inhaled “corticosteroid”, it is
important that you continue to use it regularly, even if you feel better.
Checking the inhaler:
Before using the inhaler for the first time, remove the protective cap from the mouthpiece, 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 days or more, shake it well and release two sprays into the air to ensure it functions.
Instructions for use:
Inhalation should be performed, whenever possible, while sitting or standing.

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

3. Shake the inhaler well for a few seconds before use to ensure its contents are adequately mixed.

4. Hold the inhaler upright, with the base of the canister facing upwards. Place your thumb at the base, below the mouthpiece. Breathe out as much as possible, but do not blow into the mouthpiece.
5. Place the mouthpiece in your mouth between your teeth, sealing your lips around it without biting it.
6. Just after starting to inhale through your mouth, press down on the top of the inhaler to release the spray, continuing to breathe in steadily and deeply.

7. Hold your breath, remove the inhaler from your mouth and take your finger off the top of the inhaler. Hold your breath as long as possible.
8. If a second puff is needed, keep the inhaler upright and wait about half a minute before repeating steps 3 to 7.
9. After use, the mouthpiece should always be covered to protect it from dust and foreign particles. Replace the protective cap firmly over the mouthpiece and press until you hear a click.

Patients who have difficulty coordinating the inhaler device may use a spacer device such as Volumatic
(adults and children over 5 years) or Babyhaler (children up to 5 years of age).
Young children may need an adult to operate the inhaler for them. Encourage the child to breathe out and
activate the inhaler only after the child begins to inhale. Practice this technique together.
Cleaning the inhaler
To prevent blockage of the inhaler or if it becomes blocked, clean it at least once a week as follows:

1. Remove the metal canister from the plastic inhaler holder and remove the protective cap from the mouthpiece.
2. Rinse the plastic holder and mouthpiece cap with warm water. Do not attempt to remove any medicine residue around the mouthpiece with a sharp object such as a pin. A mild detergent may be added to the water, but the mouthpiece must then be thoroughly rinsed with clean water before being left to dry. Do not immerse the metal canister in water.
3. Allow the plastic holder and mouthpiece cap to dry in a warm place, avoiding excessive heat.
4. Reinsert the metal canister and replace the mouthpiece cap.

Inhaler contents:
Shake the spray to check the amount of medicine remaining in the inhaler. Do not use Salbutamolo
Glenmark if you do not feel liquid when shaking the inhaler.
Use at low temperatures:
If the inhaler has been stored at temperatures below 0°C, warm it by holding it in your hands for 2
minutes, then shake it and spray twice into the air before use.
If you use more Salbutamolo Glenmark than you should
In this case, contact your doctor or go to hospital immediately.
Typical symptoms of overdose include:

• tremor
• headache
• rapid heartbeat
• nausea or vomiting
• inability to stay still
• irritability, excitement
• seizures
• drowsiness
• chest pain
• psychotic reactions.

If you forget to use Salbutamolo Glenmark

• If you forget a dose, take the next dose as scheduled, or if your breathing or breathlessness worsens.
• Do not take a double dose to make up for a forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop using this medicine and immediately contact your doctor if you develop any of the following
rare side effects:

• allergic reaction with symptoms such as swelling of the face, tongue or throat, difficulty swallowing, skin rash or hives, breathing difficulties
• immediate worsening of breathing after taking this medicine. This may mean that your condition is getting worse and urgent treatment with another medicine is required.

Contact your doctor as soon as possible if you experience:

• chest pain (a symptom of angina).

Do not stop using this medicine unless your doctor has told you to. The frequency of this occurrence is unknown.
Other side effects:
Common (may affect up to 1 in 10 people):

• tremor
• increased heart rate
• headache
• muscle cramps.

Uncommon (may affect up to 1 in 100 people):

• rapid heartbeat
• irritation of the mouth and throat.

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

• decrease in blood potassium levels
• hot flushes.

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

• allergic reactions (see "Stop Salbutamol Glenmark treatment and contact your doctor")
• collapse
• itchy rash
• decrease in blood pressure
• hyperactivity
• sleep disturbances
• irregular heartbeat
• worsening of breathing immediately after inhalation.

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

• lactic acidosis (a condition characterized by increased production of lactic acid in the body)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Salbutamol Glenmark

Keep this medicine out of the sight and reach of children.
Do not use the inhaler after the expiry date which is stated on the label and the carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Immediately after use, replace the cap onto the mouthpiece and press firmly until you hear a click.
Do not force the cap.
Store the inhaler upside down, with the mouthpiece facing downwards.
The canister contains a pressurised liquid. Do not expose it to temperatures above 50°C, even for short periods. Protect from heat, direct sunlight and frost. Do not pierce or burn the canister, even when it is empty.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Salbutamol Glenmark contains
The active substance is 100 micrograms of salbutamol (as salbutamol sulfate) per metered dose (from the valve).
The delivered dose is 80 micrograms of salbutamol (as salbutamol sulfate).
The other component is propellant gas: norflurane (tetrafluoroethane or HFC 134a).
This medicinal product contains fluorinated greenhouse gases.
Each inhaler contains 17.54 g of norflurane (HFC-134a), equivalent to 0.025 tonnes of CO₂
equivalent (global warming potential GWP = 1430).

Description of the appearance of Salbutamol Glenmark and contents of the pack
This medicine is a pressurized inhalation suspension, white to off-white in colour, contained in an aluminium canister with a metering valve and equipped with a white homopolymer propylene dispenser and a green dust cap.
Pack(s):

• 1 canister providing 200 metered doses
• 2 canisters providing 200 metered doses each
• 3 canisters providing 200 metered doses each.

Not all pack sizes may be marketed.

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

Manufacturer
Glenmark Pharmaceuticals s.r.o
Fibichova 143
566 17 Vysoké Mýto
Czech Republic
Synoptis Industrial Sp. Z.o.o.
Rabowicka 15
Swarzędz
Wielkopolskie, 62-020
Poland