Foster

Beclometasone dipropionate, formoterol fumarate dihydrate.

The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each actuation/metered dose from the inhaler contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
Excipients/Inactive Ingredients: The other ingredients are: ethanol anhydrous, hydrochloric acid, propellant: norflurane (HFA 134-a).

Foster is a pressurised inhalation solution containing two active substances which are inhaled through the mouth and delivered directly into the lungs.
The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate. Beclometasone dipropionate belongs to a group of medicines called corticosteroids which have an anti-inflammatory action reducing the swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators which relax the muscles in the airways and helps the patient to breathe more easily.
Together these two active substances make breathing easier, by providing relief from symptoms such as shortness of breath, wheezing and cough in patients with asthma or COPD and also help to prevent the symptoms of asthma.

Asthma: Foster is indicated in the regular treatment of asthma in adult patients in whom: asthma is not adequately controlled by using inhaled corticosteroids and 'as needed' short-acting bronchodilators; or asthma is responding well to treatment with both corticosteroids and long-acting bronchodilators.
COPD: Foster can also be used to treat the symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a long term disease of the airways in the lungs which is primarily caused by cigarette smoking.

Foster is for inhalation use.
Always use Foster exactly as told by the doctor or pharmacist. Check with the doctor or pharmacist if unsure.
Asthma: The doctor will give regular check-up to make sure the patient is taking the optimal dose of Foster. The doctor will adjust the treatment to the lowest dose that best controls the symptoms.
Foster can be prescribed in two different ways: a) use Foster every day to treat the asthma together with a separate 'reliever' inhaler to treat sudden worsening of asthma symptoms, such as shortness of breath, wheezing and cough; b) use Foster every day to treat the asthma and also use Foster to treat sudden worsening of the asthma symptoms, such as shortness of breath, wheezing and cough.
Using Foster together with a separate 'reliever': Adults and the elderly: The recommended dose is one or two puffs twice daily.
The maximum daily dose is 4 puffs.
Remember: The patient should always have his/her quick-acting 'reliever' inhaler at all times to treat worsening symptoms of asthma or a sudden asthma attack.
Using Foster as the only asthma inhaler: Adults and the elderly: The recommended dose is one puff in the morning and one puff in the evening.
The patient should also use Foster as a 'reliever' inhaler to treat sudden asthma symptoms.
If the patient gets asthma symptoms, take one puff and wait a few minutes.
If the patient does not feel better, take another puff.
Do not take more than 6 reliever puffs per day.
The maximum daily dose of Foster is 8 puffs.
If the patient feels the need for more puffs each day to control the asthma symptoms, contact the doctor to seek advice. He/she may need to change the treatment.
Use in children and adolescents less than 18 years of age: Children and adolescents aged less than 18 years must not take this medicine.
Chronic obstructive pulmonary disease (COPD): Adults and the elderly: The recommended dose is two puffs in the morning and two puffs in the evening.
At-risk patients: Older people do not need to have their dose adjusted. No information is available regarding the use of Foster in people with liver or kidney problems.
Foster is effective for the treatment of asthma in a dose of beclometasone dipropionate which may be lower than that of some other inhalers containing beclometasone dipropionate. If the patient has been using a different inhaler containing beclometasone dipropionate previously, the doctor will advise on the exact dose of Foster that should be taken for asthma.
Do not increase the dose: If the patient feels that the medicine is not very effective, always talk to the doctor before increasing the dose.
If the patient forgets to use Foster: Take it as soon as remembered. If it is almost time for the next dose, do not take the missed dose, just take the next dose at the correct time. Do not double the dose.
If the patient stops using Foster: Do not lower the dose or stop using the medication.
Even if the patient is feeling better, do not stop taking Foster or lower the dose. If the patient wants to do this, talk to the doctor. It is very important to use Foster regularly even though the patient may have no symptoms.
If breathing gets worse: If the patient develops worsening shortness of breath or wheezing (breathing with an audible whistling sound), straight after inhaling the medicine, stop using Foster inhaler immediately and use the quick-acting 'reliever' inhaler straightaway. The patient should contact the doctor straightaway. The doctor will assess the symptoms and if necessary may start a different course of treatment. The doctor will evaluate symptoms and if necessary start a new treatment. See Side Effects.
If the asthma gets worse: If the symptoms get worse or are difficult to control (e.g. using the 'reliever' inhaler more frequently) or if the 'reliever' inhaler or Foster does not improve the symptoms, see the doctor immediately. The asthma may be getting worse and the doctor may need to change the dose of Foster or prescribe alternative treatment.
If the patient has any further questions on the use of this product, ask the doctor or pharmacist.
Method of administration: Before using the inhaler for the first time or if the patient has not used the inhaler for 14 days or more, release one puff into the air to make sure the inhaler is working properly. Whenever possible, stand or sit in an upright position when inhaling.
1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister vertically with its body upwards and put the lips around the mouthpiece. Do not bite the mouthpiece.
4. Breathe in slowly and deeply through the mouth and, just after starting to breathe in press down on the top of the inhaler to release one puff.
5. Hold the breathe for as long as possible and, finally, remove the inhaler from the mouth and breathe out slowly. Do not breathe into the inhaler.
After use, close with the protective cap.
If the patient needs to take another puff, keep the inhaler in the vertical position for about half a minute, then repeat steps 2 to 5.
Important: Do not perform steps 2 to 5 too quickly.
If the patient sees 'mist' coming from the top of the inhaler or the sides of the mouth, start again from step 2.
If the patient has weak hands, it may be easier to hold the inhaler with both hands: hold the upper part of the inhaler with both index fingers and its lower part with both thumbs.
To lower the risk of a fungal infection in the mouth and throat, rinse the mouth or gargle with water or brush the teeth each time the inhaler is used.
If the patient thinks the effect of Foster is too much or not enough, tell the doctor or pharmacist.
If the patient finds it difficult to operate the inhaler while starting to breathe in the patient may use the AeroChamber Plus spacer device. Ask the doctor, pharmacist or a nurse about this device.
Cleaning: Remove the cap from the mouthpiece and regularly (once weekly) wipe the outside and inside of the mouthpiece with a dry cloth. Do not use water or other liquids to clean the mouthpiece.
It is important that the patient reads the package leaflet which is supplied with the AeroChamber Plus spacer device and that the patient follows the instructions on how to use the AeroChamber Plus spacer device and how to clean it, carefully.

Taking more formoterol than the patient should can have the following effects: feeling sick, being sick, heart racing, palpitations, disturbances of heart rhythm, certain changes in the electrocardiogram (heart trace), headache, trembling, feeling sleepy, too much acid in the blood, low blood potassium levels, high levels of glucose in the blood. The doctor may wish to carry out some blood tests to check the blood potassium and blood glucose levels.
Taking too much beclometasone dipropionate can lead to short-term problems with the adrenal glands. This will get better within a few days. However, the doctor may need to check the serum cortisol levels.
Tell the doctor in case of any of these symptoms.

Do not use Foster if the patient is allergic or thinks he/she is allergic to one or other of the active ingredients of Foster or if the patient is allergic to other medicines or inhalers used to treat asthma or to any of the other ingredients of Foster (see Description), contact the doctor for advice.

Talk to the doctor or pharmacist or nurse before using Foster: If the patient has any heart problem, such as angina (heart pain, pain in the chest), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries around the heart (coronary heart disease), valvular heart disease or any other known abnormalities of the heart or if the patient has a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a condition where the heart muscle is abnormal).
If the patient has narrowing of the arteries (also known as arteriosclerosis), if the patient has high blood pressure or if there is aneurysm (an abnormal bulging of the blood vessel wall).
If the patient has disorders of the heart rhythm such as increased or irregular heart rate, a fast pulse rate or palpitations or if the patient has been told that the heart trace is abnormal.
If the patient has an overactive thyroid gland.
If the patient has low blood levels of potassium.
If the patient has any disease of the liver or kidneys.
If the patient has diabetes (if the patient inhales high doses of formoterol the blood glucose may increase and therefore may need to have some additional blood tests to check the blood sugar when starting to use this inhaler and from time to time during treatment).
If the patient has a tumour of the adrenal gland (known as phaeochromocytoma).
If the patient is due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop taking Foster at least 12 hours before the anaesthesia.
If the patient is being, or has ever been, treated for tuberculosis (TB) or if the patient has a known viral or fungal infection of the chest.
If the patient must avoid alcohol for any reason.
If any of the previously mentioned applies to the patient, always inform the doctor before using Foster.
If the patient has or had any medical problems or any allergies or if the patient is not sure as to whether he/she can use Foster talk to the doctor, asthma nurse or pharmacist before using the inhaler.
Treatment with a beta-2 agonist like the formoterol contained in Foster can cause a sharp fall in the serum potassium level (hypokalaemia).
If the patient has severe asthma, take special care. This is because a lack of oxygen in the blood and some other treatments the patient may be taking together with Foster, such as medicines for treating heart disease or high blood pressure, know as diuretics or 'water tablets' or other medicines used to treat asthma can make the fall in potassium level worse. For this reason the doctor may wish to measure the potassium levels in the blood from time to time.
If the patient takes higher doses of inhaled corticosteroids over long periods, the patient may have more of a need for corticosteroids in situations of stress. Stressful situations might include being taken to hospital after an accident, having a serious injury or before an operation.
In this case, the doctor will decide whether the patient may need to increase the dose of corticosteroids and may prescribe some steroid tablets or a steroid injection.
Should the patient need to go to the hospital, remember to take all the medicines and inhalers, including Foster and any medicines or tablets bought without a prescription, in their original package, if possible.
Contact the doctor if the patient experiences blurred vision or other visual disturbances.
Driving and using machines: Foster is unlikely to affect the ability to drive and use machines. However, if the patient experiences side effects such as dizziness and/or trembling, the ability to drive or operate machinery may be affected.
Foster contains alcohol: Foster contains a small amount of alcohol. Every actuation (puff) from the inhaler contains 7 mg of ethanol.
Use in children and adolescents: Foster should not be used in children and adolescents less than 18 years old, until further data become available.

Pregnancy, breast-feeding and fertility: There are no clinical data on the use of Foster during pregnancy.
Foster should not be used if the patient is pregnant, thinks that she might be pregnant or is planning to become pregnant, or if she is breast-feeding, unless advised to do so by the doctor.

Like all medicines, Foster can cause side effects, although not everybody gets them.
As with other inhaler treatments there is a risk of worsening shortness of breath and wheezing immediately after using Foster and this is known as paradoxical bronchospasm. If this occurs, the patient should stop using Foster immediately and use the quick-acting 'reliever' inhaler straightaway to treat the symptoms of shortness of breath and wheezing. The patient should contact the doctor straightaway.
Tell the doctor immediately if the patient experiences any hypersensitivity reactions like skin allergies, skin itching, skin rash, reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat.
Other possible side effects are listed as follows according to their frequency: Common (affecting less than 1 in 10 people): Fungal infections of the mouth and throat, headache, hoarseness, sore throat. Pneumonia (infection of the lung) in COPD patients.
Tell the doctor if the patient has any of the following while taking Foster. They could be symptoms of a lung infection: fever or chills; increased mucus production, change in mucus colour; increased cough or increased breathing difficulties.
Uncommon (affecting less than 1 in 100 people): Palpitations, unusual fast heart beat and disorders of heart rhythm, some changes in the electrocardiogram (ECG), flu symptoms, fungal infections of the vagina, inflammation of the sinuses, rhinitis, inflammation of the ear, throat irritation, cough and productive cough, asthma attack.
Nausea, abnormal or impaired sense of taste, burning of the lips, dry mouth, swallowing difficulties, indigestion, upset stomach, diarrhoea. Pain in muscle and muscle cramps, reddening of the face, increased blood flow to some tissues in the body, excessive sweating, trembling, restlessness, dizziness, nettle rash or hives.
Alterations of some constituents of the blood: fall in the number of white blood cells, increase in the number of blood platelets, a fall in the level of potassium in the blood, increase in blood sugar level, increase in the blood level of insulin, free fatty acid and ketones.
The following side effects have also been reported as 'uncommon' in patients with chronic obstructive pulmonary disease: Reduction of the amount of cortisol in the blood caused by the effect of corticosteroids on the adrenal gland; Irregular heart beat.
Rare (affecting less than 1 in 1,000 people): Feeling chest tightness, missed heartbeat (caused by too early contraction of the ventricles of the heart), increase or decrease in blood pressure, inflammation of the kidney, swelling of skin and mucous membrane persisting for several days.
Very rare (affecting less than 1 in 10,000 people): Shortness of breath, worsening of asthma, a fall in the number of blood platelets, swelling of the hands and feet.
Using high-dose inhaled corticosteroids over a long time can cause in very rare cases systemic effects: These include problems with how the adrenal glands work (adrenosuppression), decrease in bone mineral density (thinning of the bones), growth retardation in children and adolescents, increased pressure in the eyes (glaucoma), cataracts.
Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable: these events are more likely to occur in children but the frequency is unknown.
Reporting of side effects: If the patient gets any side effects talks to the doctor, pharmacist or nurse. This includes any possible side effects not listed in the monographs. The patient can also report side effects directly via the national reporting system.
By reporting side effects, the patient can help provide more information on the safety of this product.

Tell the doctor if the patient is taking or has recently taken any other medicines including medicines obtained without a prescription. Some medicines may increase the effects of Foster and the doctor may wish to monitor the patient carefully if the patient is taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Do not use beta blockers with this medicine. Beta blockers such as atenolol, propranolol and sotalol are used to treat a number of conditions including high blood pressure and heart conditions such as abnormal heart rhythms and heart failure; timolol is used to treat glaucoma. If the patient needs to use beta blockers, including beta blockers in eye drops, the effect of formoterol may be reduced or formoterol may not work at all. On the other hand, using other beta adrenergic drugs (drugs which work in the same way as formoterol) may increase the effects of formoterol.
Using Foster together with: medicines for treating abnormal heart rhythms (quinidine, disopyramide, procainamide), medicines used to treat allergic reactions (antihistamines), medicines for treating symptoms of depression or mental disorders such as monoaminoxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), phenothiazines can cause some changes in the electrocardiogram (ECG, heart trace). They may also increase the risk of disturbances of heart rhythm (ventricular arrhythmias).
Medicines for treating Parkinson's Disease (L-dopa), to treat an underactive thyroid gland (L-thyroxine), medicines containing oxytocin (which causes uterine contraction) and alcohol can lower the heart's tolerance to beta-2 agonists, such as formoterol.
Monoaminoxidase inhibitors (MAOIs), including drugs with similar properties like furazolidone and procarbazine, used to treat mental disorders, can cause a rise in blood pressure.
Medicines for treating heart disease (digoxin) can cause a fall in the blood potassium level. This may increase the likelihood of abnormal heart rhythms.
Other medicines used to treat asthma (theophylline, aminophylline or steroids) and diuretics (water tablets) may cause a fall in the potassium level.
Some anaesthetics can increase the risk of abnormal heart rhythms.

Store in a refrigerator at 2°C to 8°C.
During use: For a maximum of 2 months.
Do not refrigerate or store the inhaler above 30°C.
If the inhaler has been exposed to severe cold, take the canister out of the mouthpiece and warm it with the hands for a few minutes before using. Never warm it by artificial means.
Warning: The canister contains a pressurised liquid. Do not expose the canister to temperatures higher than 50°C. Do not pierce the canister.
Medicines should not be disposed via waste water or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Antiasthmatic & COPD Preparations

R03AK08 - formoterol and beclometasone ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.

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