Betamican 25 microgram/inhalation suspension for inhalation in pressurized container
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Betamican 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 other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Betamican is and what it is used for
- What you need to know before using Betamican
- How to use Betamican
- Possible side effects
- How to store Betamican
- Contents of the pack and other information
1. What Betamican is and what it is used for
Betamican belongs to a group of medicines called bronchodilators.
Betamican 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 using Betamican
Do not use Betamican
- if you are allergic to salmeterol or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Betamican:
- 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 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 Betamican to treat 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 doses of Betamican (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 used Betamican 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 dosage regimen.
The active ingredient in CFC-free Betamican is exactly the same as in the CFC-containing Betamican. The only differences you may notice are the taste and the sensation of the spray in the 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 Betamican can be used in the same way as the previous formulation.
Other medicines and Betamican
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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Important information about some of the components of Betamican
Use in athletes: this medicine contains salmeterol, which may produce a positive result in doping control tests.
3. How to use Betamican
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 determine the duration of your treatment with Betamican. Do not stop treatment early, even if you feel better, unless your doctor tells you to do so.
Betamican is for inhalation use only and must not be used in children under 4 years of age.
If Betamican 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 Betamican.
It is very important that you follow your doctor's instructions regarding how many times and how often you should use Betamican. 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: two inhalations (50 micrograms) twice daily.
If you feel that the effect of Betamican 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 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:
- 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.
- Hold the inhaler vertically 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 it without biting.
- 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 in vertical position and wait approximately half a minute before repeating steps 3 to 7.
-
Replace the mouthpiece protector firmly, pressing and adjusting it until you hear a click.
IMPORTANT
Do not carry out steps 5, 6, and 7 too quickly. It is important to start breathing in as slowly as possible, just before pressing the inhaler.
Practice in front of a mirror the first few times. If you see a "kind of 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 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 hand strength 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 experience any difficulty.
Cleaning:
Clean the inhaler at least once a week.
- Remove the mouthpiece cap.
- Do not remove the cartridge from the plastic housing.
- Wipe the mouthpiece inside and outside, as well as the plastic housing, with a dry cloth, a paper tissue, 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 Betamican than you should
If you have used more Betamican than recommended, you may experience: faster heartbeat 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 call the Toxicology Information Service at: 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 Betamican
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 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 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 Betamican, STOP taking this medicine and inform 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 resolve 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 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), 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 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Betamican
Replace the mouthpiece protector by firmly pushing and snapping it into place so that the cap is securely positioned.
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 their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Betamican
- 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).
Nature and contents of the container
Betamican 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
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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/