Leaflet: information for the user

Formoterol STADA 12 micrograms powder for inhalation (hard capsule)

formoterol fumarate

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6.Contents of the pack and additional information

Formoterol Stada contains a substance called formoterol fumarate dihydrate. It belongs to a group of medicines called “bronchodilators” or “long-acting beta agonists”.

This medicine is used:

• Together 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 for symptom relief in patients with chronic obstructive pulmonary disease (COPD).

Follow carefully 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 any of the other components of this medication (listed in section 6).

Discuss with your doctor about the risks and benefits of treating your asthma with this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Formoterol Stada.

Be especially careful with this medication:

• If you have any heart disease or any "prolongation of the QT interval" (abnormal electrical signal detected in your electrocardiogram).

• If you have high blood pressure.

• If you have hyperthyroidism (thyroid gland disease).

• If you have an aneurysm (localized dilation of an artery caused by degeneration or weakening of the vascular wall).

• If you are diabetic or if your doctor has warned you that you have intolerance to some sugars, consult your doctor before taking this medication.

The treatment with formoterol may lead to an increase in blood sugar levels. Therefore, if you are diabetic, you will need to control your blood sugar levels.

• If you have pheochromocytoma (a tumor of the adrenal gland that can affect blood pressure).

• Do not use Formoterol Stada as your only asthma medication. Use this medication only with an inhaled corticosteroid (ICS).

• If you feel that you have difficulty breathing or wheezing (whistling sounds) during the use of this medication, you should continue using Formoterol Stada, but you should see your doctor as soon as possible, as you may need additional treatment.

Do not use this medication to relieve sudden wheezing. Always carry a rescue inhaler such as salbutamol (short-acting beta2 agonist) to treat sudden asthma symptoms.

Important information about this medication

• Do not change or interrupt any of the treatments for controlling or treating your respiratory problems, including inhaled corticosteroids. Your doctor will adjust your treatment according to your needs.
• Once your asthma is well-controlled, your doctor may consider reducing the dose of this medication gradually.
• If you are well-controlled with an inhaled corticosteroid, do not use this medication.
• Do not use this medication if you only need, from time to time, a medication such as salbutamol (short-acting beta2 agonist).
• While using Formoterol Stada, do not use other medications with similar effects, such as salmeterol (long-acting beta2 agonists).
• Do not start treatment with this medication or increase the recommended dose by your doctor while experiencing an asthma attack.

The treatment with formoterol may lead to low potassium levels in the blood. This may make you more susceptible to an abnormal heart rhythm. Therefore, your doctor may need to control your potassium levels in the blood, especially if you have severe asthma.

Consult your doctor if you have any doubts about how Formoterol Stada works or why you have been prescribed this medication.

Patients aged 65 years or older

If you are 65 years or older, you can use this medication at the same dose as adults.

Children and adolescents

Formoterol Stada is not suitable for children under 6 years.

Children aged 6 years or older should only use this medication if they are able to handle it correctly (see "How to use the capsules of this medication with your inhaler"). They should only use the inhaler under the supervision of an adult.

Other medications and Formoterol Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is especially important if you are taking any of the following medications:

• Monamine oxidase inhibitors (MAOIs) or tricyclic antidepressants, which are medications used to treat depression and mood disorders.
• Sympathomimetics, which are medications similar to adrenaline and used to treat asthma and nasal congestion.
• Antihistamines, which are usually used to prevent or treat the main symptoms of an allergic reaction.
• Glucocorticoids, which are often used to treat asthma and other inflammatory diseases.
• Diuretics, which are used to treat edema (water retention), heart failure, and high blood pressure.
• Beta-blockers, used to treat high blood pressure, heart failure, angina, anxiety, abnormal heart rhythm. Certain eye drops used to treat glaucoma may contain beta-blockers.
• Quinidine, disopyramide, and procainamide, used to treat abnormal heart rhythm.
• Phenothiazine derivatives, used to control mental disorders such as schizophrenia, mania, psychotic states, and anxiety.
• Digitals, used to treat heart failure and abnormal heart rhythm.
• Xanthine derivatives, which are used to treat asthma and chronic obstructive pulmonary disease.
• Macrolides (e.g. erythromycin), used to treat bacterial infections.
• Anesthetics such as halothane, used to produce anesthesia during surgery.
• Anticholinergics (e.g. ipratropium bromide), used to treat gastrointestinal and genitourinary disorders.

Your doctor may need to change or even discontinue the dose of one of the medications.

If your doctor has prescribed you other medications that you need to take regularly to treat your respiratory disease, it is essential that you continue taking them as usual and DO NOT INTERRUPT or reduce the dose, even if you start feeling much better.

Pregnancy, lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not use this medication during pregnancy unless your doctor tells you to. They will inform you of the potential risk of using formoterol during pregnancy.

Lactation

Mothers taking this medication should not breastfeed.

Driving and operating machinery

In some patients, this medication may cause dizziness. If you feel dizzy, do not drive, operate machinery, or perform any other activity that requires your attention.

Formoterol Stada contains lactose

It may cause allergic reactions in patients with milk protein allergy.

If your doctor has told you that you have intolerance to certain sugars, consult with them before taking this medication.

Use in athletes

Inform athletes that this medication contains a component that may result in a positive analytical result in doping control.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Your doctor will instruct you on the amount and frequency of use of Formoterol Stada according to your needs. Do not exceed the recommended dose. Remember to use your medication.

The effect of the dose lasts up to 12 hours.

Do not swallow the capsules. They must be used by inhaling the contents of the same with the inhalation device.

Use in adults (including the elderly)

Maintenance treatment of asthma

For the treatment of asthma, Formoterol Stada will always be prescribed along with an inhaled corticosteroid.

• The usual recommended dose is 1 capsule inhaled twice a day. In more severe cases, 2 capsules may be administered twice a day.
• In addition to the usual dose, you may occasionally need 1 or 2 additional capsules per day to relieve common symptoms. If you need to receive these additional doses more than twice a week, consult your doctor as it may indicate a worsening of the disease.
• The maximum recommended daily dose for adults is 4 capsules.

Prevention of breathing difficulty caused by inhaling allergens, cold air, or exercise

• The recommended dose is 1 capsule inhaled at least 15 minutes before exercise or exposure to allergens 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 a day, which should be administered with the inhaler as described in the "Using the capsules of this medication with your inhaler" section. In more severe cases, 2 capsules may be administered twice a day.

Use in children and adolescents (from 6 years of age)

This medication is not recommended for children under 6 years of age. See the "Children and adolescents" section in section 2. What you need to know before starting to use Formoterol Stada.

Maintenance treatment of asthma

• The recommended dose is 1 capsule inhaled twice a day.
• The maximum recommended daily dose is 2 capsules per day.

Prevention of breathing difficulty caused by inhaling allergens, cold air, or exercise

• The recommended dose is 1 capsule inhaled at least 15 minutes before exercise or exposure to allergens or cold air.

Using the capsules of this medication with your inhaler

Follow the instructions below to learn how to use this medication.

Use the capsules of this medicationonly with the inhalerprovided in the package. The inhaler included in the package has been specifically developed for use with this medication.

Remove the capsule from the blister just before use. Make sure your fingers are completely dry to prevent the capsule from becoming moist.

Do not swallow the capsule. The powder in the capsule is only for inhalation.

Instructions for correct use

1. Remove the protective cap.

2. Hold the inhaler firmly and turn the mouthpiece in the direction of the arrow to open the device.

3. Place the capsule in the compartment located at the base of the inhaler. It is essential not to remove the capsule from the package until the time of use.

4. Turn the mouthpiece to the closing position.

5. Press the red buttons while holding the inhaler in a vertical position. Release the buttons.

6. Breathe out completely.

7. Insert the mouthpiece into the mouth and tilt the head slightly backward. Press the mouthpiece with the lips and breathe in rapidly and constantly to the greatest depth possible.

8. Retain the breath as long as possible without feeling discomfort while removing the inhaler from the mouth. Then, exhale the air. Open the inhaler to see if there is powder left in the capsule. If so, repeat steps 6 to 8.

9. After use, remove the empty capsule, close the mouthpiece, and replace the protective cap.

Cleaning the inhaler

To remove residual powder, clean the mouthpiece and the 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 your doctor prescribed, you may feel nausea or vomiting, or experience rapid heartbeat, headache, dizziness (possible symptoms of high blood pressure), or drowsiness. Inform your doctor immediately or go to the nearest emergency service. You may need medical attention.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the package and the medication leaflet to the healthcare professional.

If you forgot to use Formoterol Stada

Do not take a double dose to compensate for the missed doses. If you forgot a dose, use it as soon as you remember. If it is almost time for the next dose, skip that dose and continue with your regular dosing schedule.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

In some cases, severe asthma attacks (severe shortness of breath, cough, wheezing (whistling), or chest tightness, which may lead to hospitalization) have been observed.

Some side effects can be severe:If you experience any of these side effects,inform your doctor immediately:

Rare side effects: may affect up to 1 in 1,000 people.

• Bronchospasm (bronchial constriction causing difficulty breathing) with rapid breathing or cough and difficulty breathing.
• Symptoms that include muscle weakness, muscle spasms, and/or abnormal heart rhythm (this could mean you have low potassium levels in your blood).
• Irregular heartbeat (including rapid heart rate).

Very rare side effects: may affect up to 1 in 10,000 people.

• Oppressive chest pain (angina symptom).
• Allergic reactions, for example if you feel weak (low blood pressure), if a skin rash appears, or if you experience itching or swelling of the face.

Other side effects:

Frequent side effects: may affect up to 1 in 10 people.

• Headache
• Tremor
• Palpitations

Rare side effects: may affect up to 1 in 100 people.

• Restlessness
• Anxiety
• Nervousness
• Sleep disorders
• Fast heart rate
• Irritation of the throat
• Dry mouth
• Muscle cramps
• Muscle pain
• Dizziness

Rare side effects: may affect up to 1 in 1,000 people.

• Nausea

Very rare side effects: may affect up to 1 in 10,000 people.

• Alteration of taste
• Swelling of the hands, ankles, or feet
• Excessive thirst, frequent urination, and fatigue over a long period of time (a possible indication of high blood sugar levels)
• Prolongation of the QT interval

Unknown frequency: cannot be estimated from available data.

• Cough
• Skin rash
• Headache and dizziness (symptoms of high blood pressure)

Some of these side effects may disappear spontaneously

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from moisture.

Always discard the old inhaler and use the new one provided in the packaging.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will be helping to protect the environment.

Composition of Formoterol Stada

• The active ingredient 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 packaging

Formoterol Stada 12 micrograms powder for inhalation (hard capsule), are colourless and transparent capsules that contain white powder and must be used with the inhaler provided in the packaging.

Each package contains 60 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Liconsa, S.A.

Avda. Miralcampo, Nº 7, Pol. Ind. Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet:May 2019

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

CE-marked inhaler. The inhalation device complies with Directive 93/42/CEE.