Serevent 25 micrograms/inhalation, suspension for inhalation in pressurized container
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Serevent 25 micrograms/dose, inhalation suspension in pressurised container
salmeterol (xinafoate)
Read all of this leaflet carefully before you start using this medicine, because 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 may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Serevent is and what it is used for
- What you need to know before you use Serevent
- How to use Serevent
- Possible side effects
- How to store Serevent
- Contents of the pack and other information
1. What Serevent is and what it is used for
Serevent belongs to a group of medicines called bronchodilators.
Serevent is indicated for the regular long-term treatment of reversible airway obstruction caused by asthma and chronic bronchitis (COPD). In asthma, it should be administered concomitantly in combination with long-term anti-inflammatory therapy with inhaled or oral glucocorticoids.
2. What you need to know before using Serevent
Do not use Serevent
- 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 Serevent:
- If you have ever had to stop taking any other medication for your condition due to allergic problems 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 Serevent 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 shortness 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 Serevent doses (your breathing condition may worsen and you may become seriously ill). Contact your doctor, as your asthma treatment may need to be changed.
Patients who have previously been treated with Serevent 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 Serevent is exactly the same as in the previous CFC-containing Serevent. 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 replacement of the propellant to eliminate CFCs. This modification does not affect the drug's mechanism of action. The CFC-free Serevent can be used in the same way as the previous formulation.
Other medicines and Serevent
Inform 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 Serevent
Use in athletes: this medicine contains salmeterol, which may produce a positive result in doping control tests.
3. How to use Serevent
Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.
Remember to use your medicine. IT IS VERY IMPORTANT TO USE IT REGULARLY EVERY DAY. This will help you remain symptom-free throughout the day and night.
Your doctor will determine how long you should take Serevent. Do not stop treatment early, even if you feel better, unless your doctor tells you to do so.
Serevent must only be used by inhalation and must not be used in children under 4 years of age.
If Serevent 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 Serevent.
It is very important that you follow your doctor's instructions on how many times and how often you should use Serevent. 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: two inhalations (50 micrograms) twice daily.
If you think the effect of Serevent 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 squeezing the sides, shake the inhaler well, and release two sprays into the air to ensure the inhaler is working properly.
Using the inhaler:
- Remove the mouthpiece protector by gently squeezing the sides.
-
Check that there are no foreign particles inside or outside the inhaler, including the mouthpiece.
-
Shake the inhaler well to ensure any foreign particles are removed and to properly mix the contents of the inhaler.
- Hold the inhaler upright between the index finger and thumb, placing the thumb on the base, below the mouthpiece.
- Breathe out as much air as possible, then place the mouthpiece in your mouth between the teeth, sealing your lips around it without biting.
- Immediately after starting to breathe in slowly through your mouth, press down on the top of the inhaler to release the medicine, and continue to breathe in deeply and steadily.
- Hold your breath and remove the inhaler from your mouth, removing your finger from the top of the inhaler. Continue to hold your breath for as long as possible.
-
If a second inhalation is required, keep the inhaler upright and wait approximately half a minute before repeating steps 3 to 7.
-
Replace the mouthpiece protector by firmly pushing it on and securing it until you hear a click.
IMPORTANT
Do not carry out steps 5, 6, and 7 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 the mouth, start again from step 2.
Patients who find it difficult to coordinate the use of the inhaler with inhalation may use a suitable spacer device (BABYHALER, a spacer device for children up to 5 years of age).
Young children may need assistance, with their parents operating the inhaler for them. Encourage the child to breathe out, and then operate the inhaler just after the child begins to inhale. Practice the technique together. Older children or individuals with weak hands should hold the inhaler with both hands; place both index fingers on the top of the inhaler and both thumbs under 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.
- Remove the mouthpiece cap.
- Do not remove the cartridge from the plastic housing.
- Clean the mouthpiece and the plastic housing inside and out with a dry cloth, tissue paper, or a small amount of cotton.
- Replace the mouthpiece cap.
Do NOT immerse the METAL CANISTER in water.
Consult your doctor or pharmacist if you have any doubts.
If you use more Serevent than you should
If you have used more Serevent than recommended, you may notice: faster heartbeat than usual, headache, tremors, increased blood pressure, low blood potassium levels, feeling restless and/or dizzy. Contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20. If the dose taken is 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 Serevent
If you forget to take a dose, do not worry. Inhale one dose as soon as you remember, then continue as before.
Do not take a double dose to make up for a missed dose.
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 can 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 Serevent, 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 shaky, have a headache, or notice their heart beating faster than normal. These effects usually disappear with continued treatment. If these sensations persist, inform your doctor, but do not stop treatment unless instructed to do so by your doctor.
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 exceeding 50 micrograms twice daily.
- Palpitations, which normally resolve with 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 exceeding 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), 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 (disturbances in heart rhythm).
- Irritation of the throat or pharynx, paradoxical bronchospasm (narrowing of the bronchial walls causing 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 via 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 Serevent
Replace the mouthpiece cover 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 a 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 containers and unused medicines at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Serevent
- 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
Serevent is a pressurized suspension for inhalation. Each inhaler delivers 120 doses.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline, S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Tel: +34 900 202 700
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 latest 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/