Beglan 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
Beglan 25 micrograms/inhalation, suspension for inhalation 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; 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; do 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 such effects are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Beglan is and what it is used for
- What you need to know before you use Beglan
- How to use Beglan
- Possible side effects
- How to store Beglan
- Contents of the pack and other information
1. What Beglan is and what it is used for
Beglan belongs to a group of medicines called bronchodilators.
Beglan 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 concomitantly in combination with long-term anti-inflammatory therapy with inhaled or oral glucocorticoids.
2. What you need to know before you start using Beglan
Do not use Beglan
- 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 starting to use Beglan:
- 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 thyroid disorders.
- If you are being treated for high blood pressure.
- If you are being treated for heart problems.
- If you have diabetes mellitus.
- If you are prone to low levels of potassium in the blood.
- If you are being treated with ketoconazole (a medicine used to treat fungal infections).
If you are using Beglan 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 doses of Beglan (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 Beglan 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 Beglan is exactly the same as in the previous CFC-containing Beglan. 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. CFC-free Beglan can be used in the same way as the previous formulation.
Other medicines and Beglan
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 Beglan
Use in athletes: this medicine contains salmeterol, which may produce a positive result in doping control tests.
3. How to use Beglan
Follow exactly the administration instructions for this medicine as 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 tell you how long your treatment with Beglan should last. Do not stop treatment earlier, even if you feel better, unless your doctor tells you to do so.
Beglan should only be used by inhalation and must not be used in children under 4 years of age.
If Beglan 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 Beglan.
It is very important that you follow your doctor's instructions regarding how many times and how frequently you should use Beglan. 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 feel that the effect of Beglan is too strong or too weak, inform your doctor or pharmacist.
Instructions for use:
Before first use of the inhaler, or if it has not been used for one week or more, 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:
- Remove the mouthpiece protector by gently pressing the sides.
-
Check that there are no foreign particles inside or outside the inhaler, including the mouthpiece.
-
Shake the inhaler well to ensure removal of any foreign particles 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 your teeth, closing your lips around the device, but without biting it.
- Immediately after starting to inhale through your mouth, press down on the top of the inhaler to release the medication, and continue inhaling slowly and deeply.
- 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.
-
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 and fitting it until you hear a click.
IMPORTANT
Do not perform steps 5, 6, and 7 too quickly. It is important to begin 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 the 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.
- Remove the mouthpiece protector.
- Do not remove the cartridge from the plastic casing.
- Clean the mouthpiece and the plastic casing inside and outside with a dry cloth, paper tissue, or a small amount of cotton.
- 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 Beglan than you should
If you have used more Beglan than you should, you may experience: faster heartbeat than usual, headache, tremors, increased blood pressure, low potassium levels in the blood, feeling of restlessness and/or dizziness. Contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20. If the dose taken was very high, go to your doctor or the nearest hospital emergency department immediately. Take this leaflet or the medicine with you.
If you forget to use Beglan
If you forget 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 missed 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 Beglan, STOP taking this medicine and contact your doctor immediately:
- Sudden onset of wheezing or chest tightness.
- 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 headache, or notice their heart beating slightly faster than normal. These effects usually disappear with continued treatment. If this sensation persists, 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 higher than 50 micrograms twice daily.
- Palpitations, which usually disappear 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 blood potassium levels).
- 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 difficulty breathing), bronchospasm (contraction of the bronchi causing breathing difficulty), and anaphylactic shock (severe allergic reaction).
- Hyperglycaemia (high 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 disorders).
- 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 effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can 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 Beglan
Place the mouthpiece protector by firmly pushing and snapping it shut so that the cap stays 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 it 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. Return unused or expired containers and medicines to the SIGRE collection point at your pharmacy. 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 Beglan
- The active substance is 25 micrograms of salmeterol (as xinafoate) per dose.
- The other component is norflurane (HFA 134a).
This medicine 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
Beglan is a pressurised suspension for inhalation. 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
Manufacturer:
Glaxo Wellcome Productions, S.A.S
23, Rue Lavoisier - Zone Industrielle No. 2 (Evreux La Madeleine) - F-27000 - France
Date of the most recent revision of this leaflet: 01/2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/