FORASTMIN 12 mcg Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Forastmin, 12 micrograms powder for inhalation in a hard capsule
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Forastmin and what is it used for
4. Important information before using Forastmin
   1. When not to use Forastmin:
   2. This medicine should not be used in children under 18 years of age.
   3. Warnings and precautions
   4. The patient should inform their doctor if they have or have had:
   5. Forastmin and other medicines
   6. Forastmin with food and drink
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Laboratory tests
5. How to use Forastmin
   1. If the doctor does not prescribe otherwise, the usual dose for adults, including the elderly, is:
   2. How to use the inhaler
   3. Using a higher dose of Forastmin than recommended
   4. Contact a doctor immediately.
   5. Missing a dose of Forastmin
   6. Stopping treatment with Forastmin
6. Possible side effects
   1. If any of the following side effects occur, stop taking the medicine and consult a doctor immediately:
   2. Reporting side effects
7. How to store Forastmin
8. Contents of the packaging and other information
   1. What Forastmin contains
   2. What Forastmin looks like and contents of the packaging
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: patient information

Forastmin, 12 micrograms powder for inhalation in a hard capsule

Formoterol fumarate dihydrate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Forastmin and what is it used for
• 2. Important information before using Forastmin
• 3. How to use Forastmin
• 4. Possible side effects
• 5. How to store Forastmin
• 6. Contents of the packaging and other information

1. What is Forastmin and what is it used for

Forastmin contains formoterol, a substance that expands the airways and makes breathing easier (selective β-adrenergic receptor agonist).
Forastmin 12 micrograms of powder for inhalation is a medicine used in the long-term treatment of moderate or severe chronic asthma in patients who require regular treatment with a bronchodilator in combination with long-term anti-inflammatory treatment. Regular administration of glucocorticosteroids should be continued.
Forastmin is also indicated for the relief of bronchospasm symptoms (breathlessness caused by bronchial constriction) in patients with chronic obstructive pulmonary disease.
Treatment with this medicine should be initiated by a pulmonary specialist.
Forastmin capsules are for inhalation use only.

2. Important information before using Forastmin

When not to use Forastmin:

This medicine should not be used in children under 18 years of age.

Warnings and precautions

Before starting treatment with Forastmin, the patient should discuss it with their doctor or pharmacist.

• This medicine is not the same as other inhalation medicines containing formoterol. Do not switch to Forastmin from another formoterol-containing medicine without consulting your doctor.
• This medicine should only be used when long-term, regular treatment with a bronchodilator is necessary. This medicine should not be used instead of short-acting β-adrenergic receptor agonists in acute asthma attacks. In the event of such an attack, a short-acting β-adrenergic receptor agonist, i.e. another medicine, should be used.
• The need for regular use of this medicine to prevent bronchospasm caused by physical exertion may indicate inadequate control of asthma. The underlying treatment of asthma should be reassessed by the doctor.

Anti-inflammatory treatment
If the patient has asthma and requires regular use of this medicine, they should also receive regular doses of corticosteroids. The patient should not reduce the dose of corticosteroids on their own, even if the symptoms improve after starting treatment with Forastmin. If the symptoms do not improve or if it is necessary to increase the dose of Forastmin to relieve symptoms, the patient should inform their doctor.

The patient should inform their doctor if they have or have had:

• heart problems,
• hyperthyroidism,
• high blood pressure,
• diabetes (additional blood sugar testing may be necessary before using this medicine),
• adrenal gland tumor (pheochromocytoma),
• low potassium levels in the blood.

Forastmin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular:

• medicines used to treat depression, such as monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants,
• medicines used to treat heart conditions, such as arrhythmias (quinidine, disopyramide, procainamide) or heart failure (digitalis glycosides),
• medicines used to treat high blood pressure,
• β-adrenergic receptor blockers (in tablets or eye drops),
• diuretics,
• medicines used to treat asthma, such as theophylline or steroids,
• medicines used to treat allergies (terfenadine, astemizole, mizolastine) or schizophrenia (phenothiazines),
• medicines used to treat malaria (quinidine),
• other medicines used to treat arrhythmias or asthma (β-agonists, catecholamines, anticholinergic medicines, and corticosteroids).

If the patient is to be anesthetized, they should inform their doctor or dentist about the use of Forastmin.

Forastmin with food and drink

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy without consulting a doctor.
Breastfeeding should not be done while using this medicine without consulting a doctor.

Driving and using machines

No effect of Forastmin on the ability to drive and use machines is expected. However, if side effects such as dizziness occur, the ability to drive or use machines may be impaired.

Laboratory tests

This medicine contains an active substance that may cause positive results in doping tests.
Forastmin contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before using this medicine. However, the amount of lactose in this product (less than 20 milligrams per delivered dose) usually does not cause problems in people with lactose intolerance.

3. How to use Forastmin

This medicine should always be used as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
If shortness of breath or wheezing occurs while using Forastmin, the patient should continue using Forastmin and contact their doctor as soon as possible, as additional treatment may be necessary.
If asthma is well-controlled, the doctor may consider it appropriate to gradually reduce the dose of Forastmin.
For inhalation use only.
The capsules are for inhalation use only.
Do not swallow the capsules.
The active substance of this medicine is inhaled into the respiratory tract.
The medicine should be used correctly to be effective.
Important:Before using the medicine, the patient should wash and dry their hands thoroughly. This medicine should not be exposed to moisture.

If the doctor does not prescribe otherwise, the usual dose for adults, including the elderly, is:

Asthma
Long-term treatment: one inhalation once or twice a day. In individual cases, it may be necessary to use two inhalations once or twice a day.
Prevention of bronchospasm caused by physical exertion
One inhalation before expected physical exertion.
The daily dose should not exceed 4 inhalations.
No more than 2 inhalations should be used at a time.
Chronic obstructive pulmonary disease (COPD)
Long-term treatment: one inhalation once or twice a day.
Inhalations should not be performed more than twice a day.
If necessary, to relieve symptoms, additional inhalations can be used, in addition to those used regularly, up to a maximum daily dose of 4 inhalations (including both regularly used and additional doses).
No more than 2 inhalations should be used at a time.
Special patient groups
No dose adjustment is necessary in patients with renal or hepatic impairment.
If Forastmin is to be used instead of another formoterol-containing inhalation medicine, the dose may need to be adjusted.
Using more than 2 doses per day more than 2 times a week indicates that the underlying treatment is insufficient. In this case, the underlying treatment should be reconsidered.
Using higher doses usually does not provide additional benefits but may increase the risk of side effects, including serious ones.
If the patient feels that the effect of Forastmin is too strong or too weak, they should inform their doctor.

How to use the inhaler

The capsule should be removed from the packaging immediately before inhalation. Inside the inhaler, the capsule remains stable for 3 days.

• 1. Remove the protective cap from the inhaler.

• 2. Holding the inhaler in a vertical position, turn the mouthpiece in the direction of the arrow.

• 3. Place the capsule in the inhaler chamber.

• 4. Twist the mouthpiece to the initial position. From this moment on, the inhaler should be held vertically.
• 5. Holding the inhaler in a vertical position, press the red buttons on the sides of the device ONLY ONCE. Then release the buttons.

Note: During puncturing, the capsule may fragment! Small pieces of hypromellose from the capsule shell may enter the mouth and throat during inhalation. Like food, hypromellose is absorbed by the body and is not harmful. The risk of capsule fragmentation can be reduced by pressing the buttons that puncture the capsule only once, following the storage instructions for the capsules, and removing the capsules from the packaging immediately before inhalation.

• 6.a) Perform a deep exhalation (not through the inhaler).
• 6.b) Place the mouthpiece in the mouth and seal it with the lips. Tilt the head slightly back and perform one quick and deep inhalation through the mouthpiece. During inhalation, as the capsule rotates in the chamber and the powder is dispersed, a characteristic sound should be heard. If this sound does not occur, it may indicate that the capsule is "stuck" in the chamber. In this case, the inhaler should be opened and the capsule removed. Do not try to remove the capsule from the inhaler by repeatedly pressing the buttons that puncture the capsule.

• 6.c) After hearing the characteristic sound, hold the breath for as long as possible. Then remove the inhaler from the mouth, perform a slow exhalation, and start breathing normally. After using the inhaler, check if the inhalation was effective. To do this, open the inhaler and check if there is still powder in the capsule. If there is powder in the capsule, repeat the steps described in points 6.a to 6.c.

After inhalation
Open the inhaler, remove the empty capsule, turn the mouthpiece to the initial position, and put on the protective cap.
Cleaning the inhaler
The inhaler should be cleaned using a dry cloth. To do this, open the chamber where the capsule is placed and clean it of any powder residue. The mouthpiece should also be cleaned. Instead of a cloth, a soft brush can be used to clean the inhaler.
Note
Forastmin capsules can only be used with the provided inhaler. Under no circumstances should they be used with another inhaler.
The inhaler intended for Forastmin should not be used to inhale other medicines.

Using a higher dose of Forastmin than recommended

Contact a doctor immediately.

Overdose symptoms are the same as side effects, but they occur very quickly and may be more severe.
Overdose symptoms include:
Nausea, vomiting, headaches, palpitations, irregular and/or rapid heartbeat, severe tremors (especially of the hands), dizziness, restlessness, sleep disturbances, and chest pain.

Missing a dose of Forastmin

Do not take a double dose to make up for a missed dose.
If a dose of Forastmin is missed, it should be taken as soon as possible.
However, if it is almost time for the next dose (less than 6 hours), skip the missed dose and take the next regularly scheduled dose.

Stopping treatment with Forastmin

Do not stop using this medicine without consulting a doctor.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following side effects occur, stop taking the medicine and consult a doctor immediately:

• itching, rash, skin redness,
• swelling of the eyelids, lips, face, or throat,
• low blood pressure or fainting,
• worsening of wheezing and shortness of breath shortly after administration of the medicine.

In the assessment of side effects, the following frequency conventions have been used:
Very common: may occur in more than 1 in 10 people
Common: may occur in less than 1 in 10 people
Uncommon: may occur in less than 1 in 100 people
Rare: may occur in less than 1 in 1,000 people
Very rare: may occur in less than 1 in 10,000 people
Frequency not known: frequency cannot be estimated from the available data
The most commonly reported adverse events during treatment with β-adrenergic receptor agonists, such as tremors and palpitations, are usually mild and disappear after a few days of treatment.

Lactose contains small amounts of milk proteins, which may cause allergic reactions.
Tell your doctor about any side effects that occur. If necessary, the doctor will adjust the dose of the medicine. Do not change the dosage on your own without consulting a doctor. If serious side effects occur, stop using Forastmin and inform your doctor immediately.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Forastmin

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Forastmin contains

• The active substance of the medicine is formoterol fumarate dihydrate. Each hard capsule contains 12 micrograms of formoterol fumarate dihydrate. One delivered dose contains 9 micrograms of formoterol fumarate dihydrate.
• Other ingredients are: Capsule contents:
• lactose,
• lactose monohydrate (containing milk proteins). Capsule shell:
• hypromellose.

What Forastmin looks like and contents of the packaging

A HDPE bottle closed with a polypropylene cap containing a desiccant (colloidal silica). The inhaler is made of plastic.
Forastmin is available in packages containing:
60 hard capsules with powder for inhalation and one inhaler;
120 hard capsules with powder for inhalation and two inhalers;
180 hard capsules with powder for inhalation and three inhalers.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Bausch Health Poland sp. z o.o.
Kosztowska Street 21
41-409 Mysłowice, Poland
Bausch Health Poland sp. z o.o.
Przemysłowa Street 2
35-959 Rzeszów, Poland
SMB Technology S.A.
39 rue du Parc Industriel
B-6900 Marche-en-Famenne
Belgium

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Finland
Formaxa 12 micrograms powder for inhalation
Germany
Formoterol Stada 12 micrograms powder for inhalation
Greece
Formaxa 12 micrograms powder for inhalation
Poland
Forastmin
Date of last revision of the leaflet:December 2020