Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation

Patient Information Leaflet

Introduction

Patient Information Leaflet

Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation

(terbutaline sulfate)

Package leaflet contents

1. What Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation is and what it is used for
2. What you need to know before using Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation
3. How to use Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation
4. Possible side effects
5. How to store Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation
6. Contents of the pack and other information

1. What Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation is and what it is used for

Terbasmin Turbuhaler contains the drug terbutaline. Terbutaline belongs to a group of medicines called bronchodilators and works by widening the airways and making breathing easier. It is indicated for bronchial asthma, chronic bronchitis, emphysema, and other respiratory conditions associated with bronchoconstriction (narrowing of the bronchi). When inhaled through the mouthpiece of the inhaler, the medicine reaches the lungs.

2. What you need to know before using Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation

Do not use Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation:

If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

Warnings and precautions:

• If you have previously experienced any unusual reaction to other medicines, inform your doctor.
• In certain cases, Terbasmin Turbuhaler must be administered with special caution. You should always inform your doctor of any other medical conditions you may have, especially if you have a history of heart disease, irregular heartbeat, angina pectoris, diabetes, or thyroid dysfunction (hyperthyroidism).
• This medicine has been prescribed for you to treat your specific condition. Do not use it for another condition unless your doctor instructs you to do so. Do not give it to anyone else.
• There is a small risk of accumulation of part of the medicine in the mouthpiece towards the end of the inhaler's life, so it is advisable that, whenever possible, you rinse your mouth after each inhalation.

Using Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation with other medicines

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription. Some medicines may alter the effect of Terbasmin Turbuhaler when used together, for example:

• Certain medicines known as beta-blockers, used to lower blood pressure, for heart conditions, or in some eye drops.
• The concomitant use of Terbasmin Turbuhaler and certain medicines may affect the body's electrolyte balance (reduction in blood potassium levels). This effect is usually not significant, but in certain cases it may influence heart rhythm.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Inform your doctor before using this medicine if you are pregnant, planning to become pregnant, or breastfeeding. You should always exercise particular caution when using medicines during pregnancy or breastfeeding. No harmful effects have been observed in pregnant or breastfeeding women treated with this medicine. However, inform your doctor as soon as possible if you become pregnant during treatment with Terbasmin Turbuhaler.

Use in athletes:

Athletes are advised that this medicine contains a component that may result in a positive doping test.

Driving and use of machines

Terbasmin Turbuhaler does not affect the ability to drive or operate machinery.

Terbasmin Turbuhaler contains lactose

This medicine contains lactose, which is a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before using this medicine. The amount of lactose in this medicine usually does not cause problems in people with lactose intolerance.

Lactose may contain small amounts of residual milk proteins. It may cause allergic reactions in patients allergic to cow's milk proteins.

3. How to use Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again. Remember to use your medicine.

Method of administration and route of administration:

This medicine is administered by inhalation.

Terbasmin Turbuhaler should preferably be used when needed, rather than on a regular basis.

Before using Terbasmin Turbuhaler for the first time, it is important that you read the information included in the section “How to use Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation” and carefully follow the instructions.

Children may not be able to use the dosing system properly. Therefore, it is important to ensure that the child can correctly follow the instructions for use.

Terbasmin Turbuhaler should preferably be used when needed, rather than on a regular basis.

Seek immediate medical attention if your asthma symptoms (cough, difficulty breathing, wheezing, or chest tightness) worsen, or if you are too short of breath to speak, eat, or sleep.

Contact your doctor as soon as possible if you need to use Terbasmin Turbuhaler more frequently than usual to relieve your breathing problems. You may require additional medication to control your condition. Do not increase the dose of Terbasmin Turbuhaler without first consulting your doctor.

If you use Terbasmin Turbuhaler more than twice a week to treat your asthma symptoms, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (worsening of asthma) that can lead to serious complications, may be life-threatening, or even fatal. You should consult your doctor as soon as possible to review your asthma treatment.

If you are using a daily medication for lung inflammation, such as inhaled corticosteroids, it is important that you continue using it regularly, even if you feel better.

Dosage, frequency of administration, and duration of treatment:

The dose of Terbasmin Turbuhaler 500 micrograms should be individualized. Your doctor will advise you on the duration of your treatment with Terbasmin Turbuhaler. Do not administer more doses than your doctor has prescribed.

The recommended doses of Terbasmin Turbuhaler are as follows:

Usual dose for adults and children over 12 years of age: 1 inhalation (500 micrograms) as needed. If necessary, the dose may be increased up to 3 inhalations (1500 micrograms) in a single dose. The total dose must not exceed 12 inhalations (6000 micrograms) in 24 hours.

Usual dose for children aged 3 to 12 years: 1 inhalation (500 micrograms) as needed. If necessary, the dose may be increased up to 2 inhalations (1000 micrograms) in a single dose. The total dose must not exceed 8 inhalations (4000 micrograms) in 24 hours.

The effect of Terbasmin Turbuhaler is usually felt within 5 minutes after inhalation and lasts up to 6 hours. Treatment with Terbasmin Turbuhaler is effective even during an acute asthma attack.

If you use more Terbasmin Turbuhaler than you should

Use only the number of inhalations prescribed by your doctor, as using more inhalations will increase the risk of adverse effects without improving efficacy.

The most common symptoms and signs that may occur after an overdose are:

• Nausea
• Headache
• Fast or irregular heartbeat
• Muscle cramps
• Nervousness, restlessness, tremors
• Dizziness or unusual drowsiness

Contact your doctor if any of these symptoms concern you.

If you have used more Terbasmin Turbuhaler than prescribed, consult your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used. It is advisable to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to use Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation:

Do not use a double dose to make up for missed doses.

Terbasmin Turbuhaler should preferably be used when you need it, rather than on a regular basis.

However, if your doctor has prescribed regular treatment and you forget to take a dose, take the recommended inhalations as soon as you remember. If it is almost time for your next dose, it is preferable to wait until then.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects are usually not experienced during the use of Terbasmin Turbuhaler. If they do occur, they are generally mild and disappear on their own after one or two weeks of treatment. However, inform your doctor of any adverse effects that are bothersome or do not go away.

Very common adverse effects (may affect more than 1 in 10 patients):

• Tremors
• Headache

Common adverse effects (may affect up to 1 in 10 patients):

• Increased heart rate
• Low blood potassium levels
• Muscle cramps

Frequency unknown*:

• Irregular heartbeat
• Nausea (feeling unwell)
• Agitation, restlessness, or difficulty sleeping
• Allergic reactions such as itching and rash
• Bronchospasm (contraction of the muscles in the airways, causing "wheezing")**

? The adverse effects observed come from post-marketing reports, therefore their frequency is unknown.

?? Inhaled medicines may cause bronchospasm.

Although the exact frequency is not known, some people may occasionally experience chest pain (due to heart problems such as angina). If you develop these symptoms while using Terbasmin Turbuhaler, inform your doctor, but do not stop using it unless your doctor tells you to.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

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

5. Storage of Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation

Keep this medicine out of the sight and reach of children.

Always replace the cap after using Terbasmin Turbuhaler.

Do not store above 30 °C.

Do not use this medicine after the expiry date stated on the packaging and on the label of the inhaler after CAD/EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a pharmacy’s SIGRE collection point. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation

Each dose (inhalation) contains:

• Active substance: 500 micrograms of terbutaline sulfate.
• The excipient is lactose.

Nature of the product and pack size

Terbasmin Turbuhaler is presented as a powder for inhalation. The powder contains only terbutaline.

500 micrograms/dose: Each inhaler contains 120 doses.

Marketing Authorization Holder and Manufacturing Responsible Party:

The Marketing Authorization Holder is:

Laboratorio Lailan, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

The Manufacturing Responsible Party is:

AstraZeneca AB

SE-151 36 Södertälje

Sweden

Instructions

How to prepare your new Terbasmin Turbuhaler inhaler

Before using your new Terbasmin Turbuhaler inhaler for the first time, you must prepare the inhaler for use as follows:

• Unscrew and lift the cap. You may hear a rattling sound.
• Hold your Terbasmin Turbuhaler upright with the blue screw at the bottom.
• Turn the blue screw fully in one direction, then turn it fully in the opposite direction (it does not matter which direction you turn first).
• You should hear a click.
• Repeat this procedure once more, turning the blue screw in both directions.
• Your Terbasmin Turbuhaler inhaler is now ready for use.

How to inhale

Each time you need to inhale, follow the instructions below:

1.- Unscrew and lift the white cap. You may hear a rattling sound.

2.- Hold the inhaler upright with the blue screw at the bottom.

3.- Do not hold the mouthpiece while loading the Turbuhaler. To load a dose into the Turbuhaler, turn the blue screw fully in one direction, then turn it fully in the opposite direction (it does not matter which direction first). You should hear a characteristic “click”. At this point, the Turbuhaler is loaded and ready for use. Only load the Turbuhaler when you are ready to use it.

4.- Hold the inhaler away from your mouth. Gently breathe out (as much as you can without discomfort). Do not breathe out through the Turbuhaler.

5.- Gently place the mouthpiece between your teeth, close your lips, and inhale quickly and deeply through your mouth. Do not bite or press the mouthpiece with your teeth.

6.- Remove the inhaler from your mouth and then breathe out gently. The amount of medication released is very small, meaning you may not taste it after inhalation. However, if you have followed the instructions correctly, you can be sure that you have inhaled the dose and that the medication has reached your lungs.

7.- If a second inhalation is needed, repeat steps 2 to 6.

8.- Replace the cap firmly after use.

9.- Rinse your mouth with water each time you inhale your dose, if possible, to remove any medication that may remain in your mouth.

As with all inhalers, caregivers must ensure that children prescribed Terbasmin Turbuhaler perform the inhalation technique correctly, as described above.

Do not attempt to detach or rotate the mouthpiece; it is fixed to the Turbuhaler and must not be removed. The mouthpiece can be rotated, but avoid doing so unnecessarily. Do not use the Turbuhaler if it is damaged or if the mouthpiece has become detached.

Cleaning the Turbuhaler

Clean the external part of the mouthpiece once a week with a dry cloth; do not use water or liquids.

When to start a new Turbuhaler

The dose indicator shows how many doses remain in the Turbuhaler, starting at 120 doses when full.

The dose indicator is marked in intervals of 10 doses, so not every dose is displayed. When you first see a red mark at the end of the indicator window, approximately 20 doses remain. During the last 10 doses, the background of the dose indicator turns red. When the “0” at the bottom of the red indicator window reaches the center of the window, you should start using a new Turbuhaler.

Note:

• The screw may continue to turn and produce a “click” even when the Turbuhaler is empty.
• The sound heard when shaking the inhaler is caused by a desiccant and not by the medication, so it does not indicate the amount of medication remaining in the Turbuhaler.
• If you accidentally load your Terbasmin Turbuhaler more than once before inhaling, you will only inhale one dose. However, the dose counter will record all doses loaded.

Date of latest revision of this leaflet: December 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/