Formoterol Stada 12 micrograms inhalation powder (hard capsule)
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Formoterol STADA 12 micrograms inhalation powder (hard capsule)
formoterol fumarate
Read the entire 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 must not give it to other people, 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 adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Formoterol Stada is and what it is used for
- What you need to know before using Formoterol Stada
- How to take Formoterol Stada
- Possible side effects
- How to store Formoterol Stada
- Contents of the pack and other information
1. What Formoterol Stada is and what it is used for
Formoterol Stada contains a substance called formoterol fumarate dihydrate. It belongs to a group of medicines known as "bronchodilators" or "long-acting beta agonists".
This medicine is used:
- In combination with inhaled corticosteroids as maintenance treatment for moderate to severe asthma.
- To prevent breathing difficulty caused by inhaling allergens (substances that cause allergy), cold air, or exercise.
- As maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD).
2. What you need to know before using Formoterol Stada
Carefully follow all instructions from your doctor or pharmacist, even if they differ from those contained in this leaflet.
Do not use Formoterol Stada:
- If you are allergic to formoterol or to any of the other ingredients of this medicine (listed in section 6).
Discuss with your doctor the risks and benefits of treating your asthma with this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Formoterol Stada.
Take special care with this medicine:
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If you have heart disease or a condition called "QT interval prolongation" (an abnormal electrical signal detected on your electrocardiogram).
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If you have high blood pressure.
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If you have hyperthyroidism (a disorder of the thyroid gland).
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If you have an aneurysm (a localized swelling in an artery caused by degeneration or weakening of the blood vessel wall).
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If you are diabetic or have been told by your doctor that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Treatment with formoterol may lead to increased blood sugar levels. Therefore, if you are diabetic, you will need to monitor your blood sugar levels.
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If you have phaeochromocytoma (a tumor of the adrenal gland that may affect blood pressure).
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If you have asthma, do not use Formoterol Stada as your only asthma medication. Use this medicine only in combination with an inhaled corticosteroid (ICS).
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If you experience difficulty breathing or wheezing while using this medicine, continue using Formoterol Stada but see your doctor as soon as possible, as you may need additional treatment.
Do not use this medicine to relieve sudden wheezing. Always carry a rescue inhaler such as salbutamol (a short-acting beta2 agonist) to treat sudden asthma symptoms.
Important information about this medicine
- Do not change or stop any treatments for your respiratory condition, including inhaled corticosteroids. Your doctor will adjust your treatment according to your needs.
- Once asthma is well controlled, your doctor may consider gradually reducing the dose of this medicine.
- If your asthma is well controlled with an inhaled corticosteroid alone, you should not use this medicine.
- Do not use this medicine if you only occasionally need a medicine like salbutamol (a short-acting beta2 agonist).
- While using Formoterol Stada, do not use other medicines with a similar effect, such as salmeterol (long-acting beta2 agonists).
- Do not start treatment with this medicine or increase the dose recommended by your doctor during an asthma attack.
Treatment with formoterol may cause low potassium levels in the blood. This may make you more susceptible to an irregular heartbeat. Therefore, your doctor may need to monitor your blood potassium levels, especially if you have severe asthma.
Talk to your doctor if you have any questions about how Formoterol Stada works or why it has been prescribed for you.
Elderly patients (aged 65 years and over)
If you are 65 years of age or older, you can use this medicine at the same dose as adults.
Children and adolescents
Formoterol Stada is not suitable for children under 6 years of age.
Children aged 6 years and older should only use this medicine if they are able to use it correctly (see section "How to use the capsules of this medicine with your inhaler"). They should only use the inhaler under adult supervision.
Other medicines and Formoterol Stada
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is especially important if you are taking any of the following medicines:
- Monoamine oxidase inhibitors (MAO inhibitors) or tricyclic antidepressants, which are medicines used to treat depression and mood disorders.
- Sympathomimetic agents, which are medicines similar to adrenaline and used to treat asthma and nasal congestion.
- Antihistamines, commonly used to prevent or treat the main symptoms of an allergic reaction.
- Steroids, often used to treat asthma and other inflammatory conditions.
- Diuretics, used to treat edema (water retention), heart failure, and high blood pressure.
- Beta-blockers, used to treat high blood pressure, heart failure, angina, anxiety, and irregular heartbeat. Certain eye drops used to treat glaucoma may contain beta-blockers.
- Quinidine, disopyramide, and procainamide, used to treat irregular heartbeat.
- Phenothiazine derivatives, used to control mental disorders such as schizophrenia, mania, psychotic states, and anxiety.
- Digitalis, used to treat heart failure and irregular heartbeat.
- Xanthine derivatives, used to treat asthma and chronic obstructive pulmonary disease.
- Macrolides (e.g., erythromycin), used to treat bacterial infections.
- Anesthetics such as halogenated hydrocarbons (e.g., halothane), used to induce anesthesia during surgery.
- Anticholinergics (e.g., ipratropium bromide), used to treat gastrointestinal and genitourinary disorders.
Your doctor may need to adjust or even stop the dose of one of these medicines.
If your doctor has prescribed other medicines that you must take regularly for your respiratory condition, it is important that you continue taking them as usual and that you DO NOT STOP or reduce the dose, even if you start to feel much better.
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.
Pregnancy
You should not use this medicine during pregnancy unless specifically instructed by your doctor. They will inform you of the potential risks of using formoterol during pregnancy.
Breastfeeding
Mothers taking this medicine should not breastfeed.
Driving and using machines
In some patients, this medicine may cause dizziness. If you feel dizzy, do not drive, operate machinery, or perform any activity that requires your attention.
Formoterol Stada contains lactose
It may cause allergic reactions in patients allergic to cow's milk protein.
If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
Use in athletes
Athletes are advised that this medicine contains a component that may result in a positive doping test.
3. How to use Formoterol Stada
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will determine the amount and frequency of Formoterol Stada based on your individual needs. Do not exceed the recommended dose. Remember to use your medicine regularly.
The effect of a dose lasts up to 12 hours.
Do not swallow the capsules. They must be used by inhaling the contents using the inhalation device.
Use in adults (including elderly patients)
Maintenance treatment of asthma
For the treatment of asthma, Formoterol Stada will always be prescribed together with an inhaled corticosteroid.
- The usual recommended dose is 1 capsule inhaled twice daily. In more severe cases, 2 capsules twice daily may be administered.
- In addition to the regular dose, you may occasionally need 1 or 2 extra capsules per day to relieve usual symptoms. If you need to take these additional doses more than twice a week, consult your doctor, as this may indicate worsening of the disease.
- The maximum recommended daily dose for adults is 4 capsules.
Prevention of breathing difficulties caused by inhaling allergens, cold air, or exercise
- The recommended dose is 1 capsule inhaled at least 15 minutes before exercise or exposure to an allergen or cold air.
- In some cases, your doctor may advise you to use 2 capsules to prevent wheezing and bronchospasm.
Maintenance treatment of COPD (chronic obstructive pulmonary disease)
- The recommended dose is 1 capsule inhaled twice daily, administered with the inhaler as described in the section “How to use the capsules of this medicine with your inhaler”. In more severe cases, 2 capsules inhaled twice daily may be administered.
Use in children and adolescents (from 6 years of age)
This medicine is not recommended for children under 6 years of age. See section 2, “Children and adolescents”, for further information.
Maintenance treatment of asthma
- The recommended dose is 1 capsule inhaled twice daily.
- The maximum recommended daily dose is 2 capsules.
Prevention of breathing difficulties caused by inhaling allergens, cold air, or exercise
- The recommended dose is 1 capsule inhaled at least 15 minutes before exercise or exposure to an allergen or cold air.
How to use the capsules of this medicine with your inhaler
Follow the instructions below to learn how to use this medicine correctly.
Use the capsules of this medicine only with the inhaler provided in the package. The inhaler included is specifically designed for use with this medicine.
Remove the capsule from the blister pack just before use. Ensure your fingers are completely dry to avoid wetting the capsule.
Do not swallow the capsule. The powder inside the capsule is for inhalation only.
Instructions for correct use
1st Remove the protective cap.
2nd Hold the base of the inhaler firmly and twist the mouthpiece in the direction of the arrow to open the device.
3rd Place the capsule into the compartment located in the base of the inhaler. It is important not to remove the capsule from its packaging until the moment of use.
4th Twist the mouthpiece back to the closed position.
5th Press the red buttons while keeping the inhaler in an upright position. Release the buttons.
6th Breathe out fully.
7th Place the mouthpiece in your mouth and tilt your head slightly backward. Close your lips firmly around the mouthpiece and inhale quickly and steadily, as deeply as possible.
8th Hold your breath as long as possible without discomfort while removing the inhaler from your mouth. Then breathe out. Open the inhaler to check whether any powder remains in the capsule. If so, repeat steps 6th to 8th.
9th After use, remove the empty capsule, close the mouthpiece, and replace the cap.
Cleaning the inhaler
To remove residual powder, clean the mouthpiece and capsule compartment with a dry cloth.
A clean, soft brush may also be used.
If you use more Formoterol Stada than you should
If you accidentally use more formoterol than prescribed by your doctor, you may experience nausea or vomiting, tremor, headache, dizziness (possible symptoms of high blood pressure), rapid heartbeat, or drowsiness. Inform your doctor immediately or go to the nearest emergency department. Medical attention may be required.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to use Formoterol Stada
Do not take a double dose to make up for a missed dose. If you forget a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
In some cases, severe asthma attacks have been observed (severe worsening of breathlessness, cough, wheezing (whistling sounds), or chest tightness, which may lead to hospitalization).
Some effects may be serious: If you experience any of these adverse effects, contact your doctor immediately:
Rare adverse effects: may affect up to 1 in 1,000 people.
- Bronchospasm (constriction of the airways causing difficulty breathing) with wheezing or coughing and breathing difficulties.
- Symptoms including muscle weakness, muscle spasms, and/or abnormal heart rhythm (this could indicate low potassium levels in the blood).
- Irregular heartbeat (including rapid heartbeat).
Very rare adverse effects: may affect up to 1 in 10,000 people.
- Constricting chest pain (a symptom of angina).
- Allergic reactions, for example, if you feel weak (low blood pressure), develop a skin rash, or experience itching or swelling of the face.
Other adverse effects:
Frequent adverse effects: may affect up to 1 in 10 people.
- Headache
- Tremor
- Palpitations
Uncommon adverse effects: may affect up to 1 in 100 people.
- Restlessness
- Anxiety
- Nervousness
- Sleep disorders
- Rapid heartbeat
- Throat irritation
- Dry mouth
- Muscle cramps
- Muscle pain
- Dizziness
Rare adverse effects: may affect up to 1 in 1,000 people.
- Nausea
Very rare adverse effects: may affect up to 1 in 10,000 people.
- Taste disturbance
- Swelling of the hands, ankles, or feet
- Excessive thirst, frequent urination, and prolonged fatigue (a possible indication of high blood sugar levels)
- QT interval prolongation
Frequency not known: cannot be estimated from available data.
- Cough
- Skin rash
- Headache and dizziness (symptoms of high blood pressure)
Some of these adverse effects may resolve spontaneously.
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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Formoterol Stada
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.
Do not store above 25°C.
Keep in the original packaging to protect from moisture.
Always discard the old inhaler and use the new one provided in the package.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Formoterol Stada
- The active substance is formoterol fumarate dihydrate. Each hard capsule contains 12 micrograms of formoterol fumarate (as formoterol fumarate dihydrate).
- The other components are micronized lactose monohydrate, semimicronized lactose monohydrate, and hard gelatin capsules.
Appearance of the product and contents of the pack
Formoterol Stada 12 micrograms inhalation powder (hard capsule) consists of colorless, transparent capsules containing white powder, which must be used with the inhaler provided in the pack.
Each pack contains 60 hard capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Manufacturer
Liconsa, S.A.
Avda. Miralcampo, Nº 7, Pol. Ind. Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain
Date of the most recent revision of this leaflet: May 2019
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/
Inhaler CE. The inhalation device complies with Directive 93/42/EEC.