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Foster Nexthaler 100 mcg/ 6 mcg. 120 doses

Product Code: Foster Nexthaler 100 mcg/ 6 mcg. 120 doses
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What is Foster Neckhaler and what it is used for
Foster Nexthaler is a powder that breathes through the mouth and penetrates deep into your lungs. It contains two active substances: beclomethasone dipropionate anhydrous and formoterol fumarate dihydrate.
Beclomethasone dipropionate belongs to a group of medicines called corticosteroids (often referred to as steroids only). Corticosteroids are used to treat asthma symptoms as well as prevent them from occurring. They reduce the inflammation, swelling and irritation of the small airways in the lungs;
Formoterol fumarate dihydrate belongs to a group of medicines called long acting bronchodilators. These drugs relax the muscles and expand the airways, making it easier to inhale and exhale air from the lungs.
These two active substances make your breathing easier. This prevents the development of asthma symptoms, such as shortness of breath, wheezing and coughing.
Foster Nexalhaler is used to treat asthma in adults.

Foster Nexalhaler is used to treat asthma when:
Asthma is not adequately controlled by inhaled corticosteroids and "if needed" by short acting bronchodilators;
Asthma responds well to treatment with the combination of corticosteroids and long-acting bronchodilators.

2. What you need to know before taking Foster Nexthaller
Do not use Foster Nexthaller:
If you are allergic to beclomethasone dipropionate anhydrous, formoterol fumarate dihydrate or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Do not take the medicine to treat acute symptoms of asthma such as shortness of breath, wheezing and coughing; In asthma worsening or acute asthmatic attacks. To alleviate the symptoms, you should use the so-called A "relieving" inhaler that you should always carry with you.

Ask your doctor before applying Foster Nextalhaler if you have any of the following:
Heart problems, including known disorders so far in the functioning of the heart and / or its function;
Heart rhythm abnormalities such as rapid or irregular heart beat, rapid heartbeat or palpitations, or if you have been told that your electrocardiogram has been disturbed;
High blood pressure;
Arterial narrowing (known as atherosclerosis) or if you are known to have aneurysm (abnormal blood vessel wall swelling);
Thyroid overactivity;
Low blood potassium levels;
Diseases of the liver or kidneys;
Diabetes. If you inhale high doses of formoterol, your blood sugar may increase. You may need to perform further blood sugar tests at the beginning of treatment with this inhaler and from time to time during the treatment period;
Adrenal tumor (known as pheochromocytoma);
If you need to use anesthetics. Depending on the type of anesthetic, you may need to stop taking Foster Nexthaler at least 12 hours before starting anesthesia;
If you are or have been treated for tuberculosis (TB) or have a viral or fungal infection of the chest;
If any of these conditions apply to you, always tell your doctor before taking Fox Nectahler.
If you are not sure if you can use Fox Nectahler, talk to your doctor, nurse or pharmacist before using the inhaler.
Your doctor may recommend that you periodically measure your blood potassium levels, especially if your asthma is severe. Like most bronchodilators, Fox Neckhaler may cause a sharp drop in serum potassium levels (hypokalaemia). This is due to the lack of oxygen in the blood when combined with some other therapies you may be taking concurrently with Foster Nectahler, possibly resulting in a significant drop in potassium levels.
If you take prolonged periods of high doses of corticosteroids for inhaled use, a higher dose may be required in stressful situations. Stress-causing situations may be admission to a hospital after an accident, after serious injury or before surgery. In these cases, your doctor will decide if you need to increase the dose of corticosteroids and may prescribe steroid tablets or injections.
If you have to go to a hospital, you should take all the medications and inhalers with you, including Fox Neckhaler, as well as over-the-counter medicines or tablets, possibly in their original packaging.
Other drugs and Foster Nexthaller
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is necessary because Fox Neckhaler may affect the way the other medicine works. On the other hand, some drugs can also influence Foster Nexhthaler's action.

Do not use beta blockers with this medicine. Beta blockers are medicines used to treat many conditions that have heart problems, high blood pressure or glaucoma (increased intraocular pressure). If you need to take beta blockers (including eye drops), the formoterol effect may decrease or be missed.

Co-administration of Foster Nectahler with any of the following medicines:
Other medicines that work in the same way as formoterol (ie beta adrenergic medicines commonly used to treat asthma) may increase the effect of formoterol
Quinidine, disopyramide, procainamide (to treat abnormal heart rhythm);
Some antihistamine drugs, such as terfenadine (to treat allergic reactions);
Monoamine oxidase inhibitors or tricyclic antidepressants, such as phenelzine, isocarboxazide, amitriptyline and imipramine;
Phenothiazines (for the treatment of depression or psychiatric disorders). May cause changes in the electrocardiogram (ECG). In addition, they may increase the risk of heart rhythm disturbances (ventricular arrhythmias)
L-dopa (for the treatment of Parkinson's disease);
L-tyrosine (for the treatment of hypothyroidism);
Medicines containing oxytocin (causing uterine contractions). May reduce the tolerability of your heart to beta-adrenergic drugs such as formoterol
Monoamine oxidase inhibitors (MAOI) (for the treatment of psychiatric disorders), incl. Medicines with similar properties such as furazolidone and procarbazine may cause an increase in blood pressure
Digoxin (for the treatment of heart disease) can cause a drop in blood potassium levels. This may increase the likelihood of abnormal heart rhythm

Other medicines for the treatment of asthma (theophylline, aminophilin or steroids);
Diuretics may cause a drop in potassium levels
Some anesthetics may increase the risk of abnormal heart rhythm
Fox Neckhaler and alcohol
You should avoid taking alcohol unless you have discussed it with your doctor first. Alcohol may reduce the cardiovascular tolerance to formoterol, one of the active ingredients of Foster  Neckhaler.

Pregnancy and breastfeeding
There are no clinical data on the use of Fox Nextalhaler during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. You must use Foster Nectahlar during pregnancy only after consultation and advice from your doctor. Your doctor will decide whether to stop using Foster Nextalhaler during breastfeeding, or you should take Foster Nextalhaler but abstain from breastfeeding. Always follow strictly the doctor's advice.

Driving and using machines
Foster Nexhthaller is unlikely to affect the ability to drive or operate machinery.
However, if you experience side effects, such as dizziness and / or trembling, your ability to drive or operate machinery may be affected.

Fox Nexthaler contains lactose
The excipient lactose contains small amounts of milk proteins that can cause reactions in allergic patients.

3. How to take Foster Nectahler
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Foster Nexthaler forms an extraphilic aerosol, which causes more of the dose to penetrate into your lungs. Therefore, your doctor may prescribe a lower dose of this inhaler than your previous inhalers.
Your doctor will perform regular check-ups to make sure you are taking the right dose of Fox Neckhaler. When the physician determines that asthma is well controlled, he may consider phasing out Foster Nexthaller's dose. Under no circumstances change the dose without consulting your doctor.
How much Foster Nexthaller to apply
Adults and Elderly:
The recommended dose is 1 or 2 inhalations twice a day.
The maximum dose is 4 inhalations per day.
Do not increase the dose.
If you feel that the medicine is not effective, always talk to your doctor before increasing the dose.

Remember: you always need to carry your quick-acting "relieving" inhaler in case of asthma symptoms or a sudden asthma attack.

How to Use Foster Nektaller
Foster Nexalhaler is used by inhalation.
This pack contains an inhaler called Nextahaler sealed in a protective bag that contains your medicine in powder form. The inhaler allows you to inhale your medicine.

Please read the instructions at the end of this leaflet for more information on how to administer and clean the Nexhthaller inhaler.
Whenever possible, get upright or sit upright while inhaled.

If you use more of the necessary dose of Fox Nectahler, you should:
Contact your doctor immediately or go for advice at the nearest Emergency Hospital. Take the medicine with you so that doctors can see what you have taken;
Unwanted effects may occur. Tell your doctor if you have any unusual symptoms because he / she may want to carry out further studies or decide what to take if necessary.
If you forget to take Foster Nexthaller
Take the dose as soon as you remember. If it is almost time for the next dose, do not take the dose you missed, just take the next dose at the right time. Do not take a double dose.

If you stop taking Fox Nectahler:
Even if you feel better, do not stop taking and do not lower the dose of Fox Nektaller. If necessary, seek advice from your doctor. Foster Nexthaller's regular intake is particularly important, even in the absence of symptoms.

If your breathing does not change:
If symptoms do not improve after inhalation of Fox Nectahler, you may be using it incorrectly. Therefore, you should read the instructions for proper use at the end of this leaflet and / or contact your doctor to instruct you again on the correct application.

If your asthma gets worse:
If you experience a worsening or difficulty in controlling asthma symptoms (ie if you use your "relieving" inhaler more often) or if the "relieving" inhaler does not improve the symptoms of the disease, continue to use Foster Nextalhaler but immediately visit your doctor For advice. In case of asthma, your doctor may change the dose of Fox Nectahler or prescribe alternative treatment.

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

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
As with other types of inhalers, there is a risk of worsening of shortness of breath, coughing and wheezing immediately after administration of Fox Neckhaler, known as paradoxical bronchospasm. If this occurs, you should stop applying Foster Nexhthaler immediately and treat your symptoms with your fast-acting "relieving" inhaler. You should consult your doctor immediately.
Tell your doctor immediately if you experience allergic reactions that include skin reactions, skin pruritus, skin rashes, skin redness, swelling of the skin or mucous membranes, especially of the eyes, face, lips and throat.

Other possible side effects of Foster Nectahler are listed below, according to their frequency.
You should immediately consult yours
If you experience any of the side effects listed below: if they cause you anxiety, if they are severe or if they continue for several days;
If you are annoyed in some way, or if there is something you do not understand.
Your doctor will assess your condition and, if necessary, may recommend starting another treatment. You may be advised not to use Foster Nectahler.

Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Symptoms of a cold, sore throat;
Fungal infections (mouth and throat). Rinsing the mouth or gargle with water and brushing the teeth immediately after inhalation can help to prevent these side effects;
Worsening of asthma symptoms, difficulty breathing;
Abnormally fast heartbeat;
An unusually slow pulse;
Stiff chest pain;
Feeling weak;
A feeling of fatigue and anxiety;
Changes in ECG;
Low levels of cortisol in your urine or blood;
High blood potassium levels;
High blood glucose level;
High blood lipid levels.
Adverse effects that have been observed with inhalation of similar medicines containing beclomethasone dipropionate and / or formoterol are:
Irregular heart rhythm;
Abnormal or debilitating sensation of taste;
Muscle aches and muscle cramps;
Anxiety, dizziness;
Feeling excited;
Sleep disturbances;
Drop in potassium levels in the blood.
Applying high doses of inhaled corticosteroids over an extended period of time can cause systemic effects including:
Problems in adrenal function (adrenoreception);
Thinning of the bones;
Growth retardation in children and adolescents;
Increased intraocular pressure (called glaucoma), cataracts (eye catching);
Rapid weight gain, especially in the area of the face and body;
Sleep problems, depression or anxiety, restlessness, nervousness, over-agitation or excitement. These effects are more likely to occur in children;
Abnormal behavior.
If you get any of these effects, talk to your doctor or pharmacist. This includes any possible side effects not mentioned in this leaflet.

5. How to store Foster Nexthaller
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package, the envelope and the label. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture. Remove the inhaler from the envelope immediately before first use.

Before the first opening of the envelope:
This medicinal product does not require any special storage conditions.

After first opening the envelope:
Store below 25 ° C.
The medicinal product should be used for up to 6 months after the first opening of the envelope. Use the label on the packaging to record the date of the envelope opening.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
For more information on how to store Nexhaler, please read the instructions at the end of this leaflet.

6. Package Contents and Additional Information
What does Foster Nexthaller contain?
The active substances are beclomethasone dipropionate anhydrous and formoterol fumarate dihydrate.
Each injected dose of the inhaler contains 100 micrograms beclomethasone dipropionate anhydrous and 6 micrograms formoterol fumarate dihydrate. This corresponds to a dose delivered by the mouthpiece corresponding to 81.9 micrograms beclomethasone dipropionate anhydrous and 5.0 micrograms formoterol fumarate dihydrate.
Other excipients are: lactose monohydrate (which contains small amounts of milk proteins) and magnesium stearate.

What does Foster Nexthaller look like and contents of the pack
This medicinal product is a white to off-white powder for inhalation contained in a plastic container called Nextahler.
Each package may contain one, two or more inhalers, each individual inhaler providing 120 inhalations.
Each inhaler is placed in a separate protective bag (aluminum foil wrapper).
Not all packs may be placed on the market.


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