Inaspir 25 micrograms/inhalation suspension for inhalation under pressure

Patient Information Leaflet

Introduction

Patient Information Leaflet

Inaspir 25 micrograms/inhalation, pressurised inhalation suspension

salmeterol (xinafoate)

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Inaspir is and what it is used for

Inaspir belongs to a group of medicines called bronchodilators.

Inaspir is indicated for the regular long-term treatment of reversible airway obstruction caused by asthma and chronic bronchitis (COPD). In asthma, it will be administered in combination with long-term anti-inflammatory therapy using inhaled or oral glucocorticoids.

2. What you need to know before using Inaspir

Do not use Inaspir

• if you are allergic to salmeterol 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 Inaspir:

• If you have ever had to stop taking any other medication for your condition due to allergy or other reasons.
• If you are being treated for a thyroid disorder.
• If you are being treated for high blood pressure.
• If you are being treated for heart problems.
• If you have diabetes mellitus.
• If you tend to have low levels of potassium in your blood.
• If you are being treated with ketoconazole (a medicine used to treat fungal infections).

If you are using Inaspir for the treatment of your asthma, your doctor will want to see you regularly to monitor your symptoms. Contact your doctor immediately if:

• Your asthma worsens.
• You have increasing difficulty breathing.
• You experience more wheezing.
• You feel more short of breath than usual.
• You need to use your rescue medication more frequently.

If any of the above situations occur, do not increase the number of Inaspir doses (your breathing condition may worsen and you could become seriously ill). Contact your doctor, as your asthma treatment may need to be changed.

Patients who have previously used Inaspir should be aware that the current formulation does not contain chlorofluorocarbon (CFC) propellants for aerosols. It must be used exactly as directed by your doctor. Your doctor may adjust your dosing regimen.

The active ingredient in CFC-free Inaspir is exactly the same as in the previous CFC-containing Inaspir. The only differences you may notice are the taste and the sensation of the spray in your mouth, as well as the sound of the inhaler during use. These changes are due to the switch from CFC propellants. This modification does not affect the drug's mechanism of action. CFC-free Inaspir can be used in the same way as the previous version.

Other medicines and Inaspir

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Important information about some of the ingredients of Inaspir

Use in athletes: this medicine contains salmeterol, which may cause a positive result in doping control tests.

3. How to use Inaspir

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

Remember to use your medicine. IT IS VERY IMPORTANT THAT IT IS USED REGULARLY EVERY DAY. This will help you remain symptom-free throughout the day and night.

Your doctor will indicate how long your treatment with Inaspir should last. Do not stop treatment earlier, even if you feel better, unless your doctor tells you to do so.

Inaspir is for inhalation use only and must not be used in children under 4 years of age.

If Inaspir has been prescribed for your asthma, you must continue using any other medication you are taking to control your asthma. These should include an inhaled or oral corticosteroid. Continue taking the same doses as before, unless your doctor tells you otherwise. Do this even if you feel better. Do not stop taking your inhaled (or oral) corticosteroid when you start using Inaspir.

It is very important that you follow your doctor's instructions regarding how many times and how often you should use Inaspir. The instructions for use are given below. If you have difficulties or do not understand the instructions, ask your doctor or pharmacist.

Recommended dose:

Adults

• Two inhalations (50 micrograms) twice daily. If your doctor advises, this dose may be increased to four inhalations (100 micrograms) twice daily.

Use in children and adolescents

• Children over 4 years of age: two inhalations (50 micrograms) twice daily.

If you think the effect of Inaspir is too strong or too weak, inform your doctor or pharmacist.

Instructions for use:

Before using the inhaler for the first time, or if it has not been used for one week or longer, remove the mouthpiece protector by gently pressing the sides, shake the inhaler well, and release two sprays into the air to ensure proper functioning of the inhaler.

Using the inhaler:

1. Remove the mouthpiece protector by gently pressing the sides.

1. Check that there are no foreign particles inside or outside the inhaler, including the mouthpiece.

1. Shake the inhaler well to ensure removal of any foreign particles and to properly mix the contents of the inhaler.

1. Hold the inhaler vertically between your index finger and thumb, placing your thumb on the base, below the mouthpiece.

1. Breathe out as much air as possible, then place the mouthpiece in your mouth between your teeth, closing your lips around it, but without biting it.

1. Immediately after starting to breathe in through your mouth, press down on the top of the inhaler to release the medication, and continue breathing in deeply and steadily.

1. Hold your breath and remove the inhaler from your mouth, removing your finger from the top of the inhaler. Continue holding your breath for as long as possible.

2. If a second inhalation is required, keep the inhaler in the upright position and wait approximately half a minute before repeating steps 3 to 7.

3. Replace the mouthpiece protector by firmly pushing and fitting it until you hear a click.

Important

Do not perform steps 5, 6, and 7 too quickly. It is important to start inhaling as slowly as possible, just before pressing the inhaler.

Practice in front of a mirror the first few times. If you see a "mist" escaping from the top of the inhaler or from the sides of your mouth, start again from step 2.

Patients who have difficulty coordinating the use of the inhaler with inhalation may use an appropriate spacer device (BABYHALER, a spacer for children up to 5 years of age).

Young children may need help, with parents operating the inhaler for them. Encourage the child to breathe out, and operate the inhaler just after the child begins to inhale. Practice the technique together. Older children or people with weak hands should hold the inhaler with both hands; place both index fingers on top of the inhaler and both thumbs on the base, below the mouthpiece.

If your doctor has given you different instructions for using the inhaler, follow them carefully. Inform your doctor if you have any difficulty.

Cleaning:

Clean the inhaler at least once a week.

1. Remove the mouthpiece protector.
2. Do not remove the cartridge from the plastic casing.
3. Clean the mouthpiece inside and outside, as well as the plastic casing, with a dry cloth, tissue paper, or a small amount of cotton.
4. Replace the mouthpiece protector.

DO NOT IMMERSE THE METAL CANISTER IN WATER.

Consult your doctor or pharmacist if you have any doubts.

If you use more Inaspir than you should

If you have used more Inaspir than you should, you may notice your heart beating faster than usual, headache, tremors, increased blood pressure, low potassium levels in the blood, feeling restless and/or dizzy. Contact your doctor or pharmacist immediately or contact the Toxicology Information Service at telephone: 91 562 04 20. If the dose taken was very high, go immediately to your doctor or the nearest hospital emergency department. Take this leaflet or the medicine with you.

If you forget to use Inaspir

If you forget to take a dose, do not worry. Inhale a dose as soon as you remember, then continue as before.

Do not take a double dose to make up for forgotten doses.

If you have any other 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.

Some people may be allergic to medicines. If you experience any of the following symptoms shortly after using Inaspir, STOP taking this medicine and contact your doctor immediately:

• Sudden onset of wheezing or tightness in the chest.
• Swelling of the eyelids, face, or lips.
• Skin rash (hives) or urticaria anywhere on the body.

Some people, particularly those taking high doses of this type of medicine, may occasionally feel slightly agitated, experience headaches, or notice their heart beating faster than normal. However, these effects usually disappear with continued treatment. If this sensation persists, inform your doctor, but do not stop treatment unless instructed to do so.

The following are adverse effects associated with salmeterol. Inform your doctor if you experience any of the following symptoms:

Frequent adverse effects (may affect up to 1 in 10 people)

• Tremor and headache. These are characteristic of this type of medication and usually disappear over time. Tremor occurs more frequently if you receive doses higher than 50 micrograms twice daily.
• Palpitations, which normally resolve over time.
• Muscle cramps.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Hypersensitivity reactions with skin rash (rash).
• Nervousness.
• Tachycardia (occurs more frequently if you receive doses higher than 50 micrograms twice daily).

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

• Hypokalaemia (low potassium levels in the blood).
• Insomnia.
• Dizziness.

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

• Hypersensitivity reactions including oedema (swelling) and angioedema (skin reaction with redness, swelling, itching, and breathing difficulty), bronchospasm (contraction of the bronchi causing breathing difficulty), and anaphylactic shock (severe allergic reaction).
• Hyperglycaemia (elevated blood glucose levels). If you have diabetes, you may need to monitor your blood sugar levels more frequently and may require adjustment of your diabetes treatment.
• Cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, and extrasystoles (heart rhythm disturbances).
• Irritation of the throat or pharynx, paradoxical bronchospasm (narrowing of the bronchial walls leading to reduced airflow and breathing difficulty).
• Nausea.
• Arthralgia (joint pain).
• Non-specific chest pain.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Inaspir

Place the mouthpiece protector by firmly pushing and snapping it closed so that the cap is securely in place.

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

Do not store above 30°C. Do not freeze.

Store in the original packaging to protect from direct sunlight.

If the inhaler is very cold, remove the cartridge and warm it with your hand for a few minutes before use. Do not use any other method to warm it.

The cartridge contains pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce, break, or burn the cartridge, even if it is empty.

Do not use this medicine after the expiry date stated on the packaging after 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 unused medicines and empty containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inaspir

• The active substance is 25 micrograms of salmeterol (as xinafoate) per dose.
• The other component is norflurane (HFA 134a).

This medicinal product contains fluorinated greenhouse gases.

Each inhaler contains 12 g of HFC-134a (also known as norflurane or HFA 134a), equivalent to 0.0172 tonnes of CO2 (global warming potential GWP = 1,430).

Appearance of the product and contents of the pack

Inaspir is a pressurized inhalation suspension. Each inhaler provides 120 doses.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

Glaxo Wellcome Productions, S.A.S

23, Rue Lavoisier - Zone Industrielle Nº 2 (Evreux La Madeleine) - F-27000 - France

or

Glaxo Wellcome, S.A.

Avda. de Extremadura, 3

Aranda de Duero (Burgos) - Spain.

Date of the most recent revision of this leaflet: 01/2025

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