Leaflet: information for the user

Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation

(sulfate of terbutaline)

Terbasmín Turbuhaler contains the active pharmaceutical ingredient terbutaline.The terbutaline belongs to a group of medicines called bronchodilatorsand works by widening the airways and facilitating breathing.It is indicated for asthmabronchial, chronic bronchitis, emphysema and other respiratory conditions that are accompanied by bronchoconstriction (contraction of the bronchi).Wheninspiredthrough the mouthpiece of the inhaler, the medication reaches the lungs.

Do not use Terbasmin Turbuhaler 500 microgramos/inhalación polvo for inhalation:

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

Warnings and precautions:

• If you have previously experienced any unusual reaction to othermedicaments, inform your doctor.
• In certain casesTerbasmin Turbuhalershould be administered with special caution. You will always need to inform your doctor of any other conditions you may have, especially if you havea history of heart disease, irregular heart rhythm, angina pectoris, diabetes or a thyroid function disorder (hyperthyroidism).
• This medication has been prescribed for the treatment of the condition you suffer from. Do not use it for another condition unless your doctor tells you to. Do not give it to anyone else..
• There is a small risk of accumulation of part of the medication in the mouthpiece towards the end of the life of the inhaler, so it is advisable that,whenever possible, you rinse your mouth after each inhalation

Use of Terbasmin Turbuhaler 500 microgramos/inhalación polvo for inhalation with other medications:

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

• Certain medications called beta-blockers, used to lower blood pressure, in heart conditions orsomeeye drops.
• The concurrent use of TerbasminTurbuhalerand some medications may produce effects on electrolyte balance (decreased potassium levels) in the blood. This effect is usually insignificant, but in certain cases it may affect heart rhythm.

Pregnancy, breastfeeding and fertility:

Consult your doctor or pharmacist before using any medication.

Inform your doctor before using this medication if you are pregnant, intend to become pregnant or are breastfeeding. You will always need to exercise special caution when using medicationsduring pregnancy or breastfeeding. No adverse effects have been observed in pregnant women orthose breastfeedingwho have been treated with this medication. However, inform your doctor as soon as possible if you become pregnant during treatment with Terbasmin Turbuhaler.

Use in athletes:

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Driving and operating machinery:

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

Terbasmin Turbuhaler contains lactose

This medication contains lactose, a type of sugar.If your doctor has told you that you have a lactose intolerance, consult with him before using this medication. The amount of lactose in this medication 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 with an allergy to cow's milk proteins.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Remember to use your medication.

Form of use and route of administration:

This medication is administered via inhalation.

Terbasmin Turbuhaler should be used preferably when needed, rather than regularly.

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

Children may not use the dosing system properly. Therefore, it is essential to ensure that the child can follow the usage instructions correctly.

Terbasmin Turbuhaler should be used preferably when needed, rather than regularly.

Seek immediate medical attention if your asthma symptoms (cough, difficulty breathing, wheezing, or chest tightness) worsen or if you lack enough air 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 need additional medication to control your disease.Do not increase the dose of Terbasmin Turbuhaler without consulting your doctor first.

If you use Terbasmin Turbuhaler more than two times 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 have serious complications and may even be life-threatening. You should consult your doctor as soon as possible to review your asthma treatment.

If you use a daily medication for lung inflammation, for example, “inhaled corticosteroids,” it is essential to 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 indicate the duration of your treatment with Terbasmin Turbuhaler. Do not administer more doses than your doctor has indicated.

The recommended doses of Terbasmin Turbuhaler are as follows:

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

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

The effect of Terbasmin Turbuhaler is usually perceived within 5 minutes after inhalation, and its duration is up to 6 hours. Treatment with Terbasmin Turbuhaler is effective even in 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
• Unusual dizziness or somnolence

Contact your doctor if any of these symptoms concern you.

If you have used more Terbasmin Turbuhaler than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

Do not use a double dose to compensate for the missed doses.

Terbasmin Turbuhaler should be used preferably when needed, rather than regularly.

However, if your doctor has prescribed a regular treatment, and you forget to use one of the doses, perform the recommended inhalations as soon as you remember. If you are close to the time of the next dose, it is better to wait for that moment.

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

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects are usually not produced during the use of Terbasmin Turbuhaler. If they do occur, they are mild in nature and disappear on their own within one or two weeks of treatment. However, inform your doctor about the following adverse effects that are bothersome or do not disappear.

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

• Tremors
• Headache

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

• Accelerated heart rate
• Low potassium levels in the blood
• Muscle cramps

Unknown frequency*:

• Irregular heart rhythm
• Nausea (feeling of discomfort)
• Restlessness, agitation, or difficulty sleeping
• Allergic reactions such as itching and rash
• Bronchospasm (contraction of the muscles of the airways, causing "wheezing")**

? The observed side effects are from post-marketing reports, therefore the frequency is unknown.

? ? Inhaled medications can 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 experience these symptoms while using Terbasmin Turbuhaler, inform your doctor, but do not stop using it unless your doctor tells you to.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es .

By reporting adverse effects, you can contribute to providing more information about the safety of this medicine.

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

Always replace the cap after using Terbasmin Turbuhaler.

Do not store at a temperature above 30 °C.

Do not use this medication after the expiration date that appears on the packaging and on the inhaler label after CAD/EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Terbasmin Turbuhaler 500 micrograms/inhalation powder for inhalation

Cada dosis (inhalación) contiene:

• Principio activo: 500 microgramos de sulfato de terbutalina.
• El excipiente es lactosa.

Aspecto del producto y contenido del envase

Terbasmin Turbuhaler se presenta en forma de polvo para inhalación. El polvo contiene únicamente terbutalina.

500 microgramos/dosis:Cada inhalador contiene120 dosis.

Titular de la autorización de comercialización y responsable de la fabricación:

El titular es:

Laboratorio Lailan, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

España

El responsable de la fabricación es:

AstraZeneca AB

SE-151 36 Södertälje

Suecia

Instrucciones

Cómo preparar su nuevo inhalador de Terbasmin Turbuhaler

Antes de utilizar sunuevoinhalador de Terbasmin Turbuhalerpor primera vez, debe preparar el inhalador para su uso como se indica a continuación:

• Desenrosque y levante la tapa. Usted podría escuchar un sonido de traqueteo.
• Mantenga su Terbasmin Turbuhaler en posición vertical con la rosca azul en la parte inferior.
• Gire la rosca azul hasta el tope en una dirección. Luego vuelva a girarla hasta el tope en la otra dirección (no importa en qué dirección gire primero).
• Usted debe oír unclick.
• Repita este procedimiento otra vez, girando la rosca azul en ambas direcciones.
• Su inhalador de Terbasmin Turbuhaler está ahora listo para ser utilizado.

Cómo realizar una inhalación

Cada vez que necesite realizar una inhalación, siga las instrucciones que se indican a continuación:

1.-Desenrosque y levante la tapa blanca. Usted podría escuchar un sonido de traqueteo.

2.-Sostenga el inhalador en posición vertical con la rosca de color azul en la parte inferior.

3.-No sostenga la boquilla mientras carga el Turbuhaler. Para cargar el Turbuhaler con una dosis, gire la rosca de color azul hasta el tope en una dirección y luego vuelva a girarla hasta el tope en la otra dirección (no importa en qué dirección primero). Deberá oir un“click”característico. En este momento el Turbuhaler está cargado y listo para ser utilizado. Cargue el Turbuhaler sólo cuando necesite utilizarlo.

4.-Sostenga el inhalador sin acercarlo a la boca. Expulse el aire suavemente (tanto como pueda pero sin que le resulte incómodo). No lo expulse a través del Turbuhaler.

5.-Sitúe la boquilla suavemente entre los dientes, cierre los labios e inspire por la boca tan enérgica y profundamente como pueda. No muerda ni presione la boquilla con los dientes.

6.-Retire el inhalador de la boca y después expulse el aire suavemente. La cantidad de fármaco liberada es muy pequeña, lo que significa que puede que no note su sabor tras la inhalación. Sin embargo, si ha seguido las instrucciones de empleo puede tener la seguridad de haber inhalado la dosis, y de que el fármaco ha llegado a sus pulmones.

7.-Si tiene que realizar una segunda inhalación, repita los pasos 2 a 6.

8.-Vuelva a colocar la tapa firmemente tras su utilización.

9.-Enjuague su boca con agua cada vez que inhale su dosis, si es posible, con el fin de eliminar cualquier medicamento que permanezca en su boca.

Como con todos los inhaladores, los cuidadores se deben asegurar de que los niños a los que se les ha prescrito Terbasmin Turbuhaler realicen correctamente la técnica de inhalación, tal y como se ha descrito más arriba.

No trate de separar ni de girar la boquilla; está fijada al Turbuhaler y no debe separarse. La boquilla se puede girar, pero no la gire innecesariamente. No utilice el Turbuhaler si está dañado o si la boquilla se ha desprendido del Turbuhaler.

Limpieza del Turbuhaler

Limpie la parte externa de la boquilla 1 vez a la semana con un paño seco; no utilice ni agua ni líquidos.

Cuándo empezar un nuevo Turbuhaler

El indicador de dosis muestra cuántas dosis quedan en el Turbuhaler, empezando en 120 dosis cuando está lleno.

El indicador de dosis está marcado en intervalos de 10 dosis, por lo que no se muestran todas las dosis. Cuando vea por primera vez una marca roja en el extremo de la ventana indicadora, quedan aproximadamente 20 dosis. Durante las últimas 10 dosis el fondo del indicador de dosis es de color rojo. Cuando el “0” en el fondo de la ventana indicadora de color rojo alcanza el centro de esta, deberá empezar un nuevo Turbuhaler.

Nota:

• La rosca puede seguir girándose y haciendo“click”aunque el Turbuhaler esté vacío.
• El sonido que se aprecia al agitar el inhalador es producido por un agente desecante y no por el fármaco, por lo que no indica la cantidad de fármaco que queda en el Turbuhaler.
• Si carga su inhalador de Terbasmin Turbuhaler más de una vez por error antes de tomar su dosis, usted solamente inhalará una dosis. Sin embargo, el indicador de dosis registrará todas las dosis cargadas.

Fecha de la última revisión de este prospecto: diciembre 2022

La información detallada y actualizada de este medicamento está disponible en la página Web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) http://www.aemps.gob.es/