Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Atimos Modulite 12 micrograms/actuation pressurised inhalation solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Formoterol fumarate dihydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for? Atimos Modulite is an inhalation medicine delivering its active ingredient directly into your lungs where it is needed. It is used to treat the symptoms of wheezing and breathlessness in patients with moderate to severe asthma. Its active ingredient, formoterol fumarate, belongs to a group of medicines called bronchodilators: they make breathing easier by relaxing muscle spasms in the air passages of the lungs. Regular use of Atimos Modulite together with steroids (either by inhaler or by mouth), will help to prevent breathing problems over the long term. Atimos Modulite can also be used for the relief of symptoms such as cough, wheezing and shortness of breath in patients with chronic obstructive pulmonary disease (COPD) who require long-term regular bronchodilator therapy.
What you need to know before you take it
e Atimos Modulite Do not use Atimos Modulite:
- if you are allergic to formoterol or to any of the ingredients of this medicine Atimos Modulite (listed in section 6). •
to treat a sudden attack of breathlessness. It will not help. Use a reliever for this purpose and carry it with you at all times.
Warnings and precautions Talk to your doctor or pharmacist before using Atimos Modulite if you: •
• •
suffer from severe heart disease, especially a recent heart attack, a disease of the coronary vessels of the heart or severe weakness of the heart muscle (congestive heart failure) suffer from disorders of heart rhythm such as increased heart rate, heart valve defect or certain electrocardiogram abnormalities or any other heart disease have narrowing of the blood vessels, especially the arteries, or abnormal widening of the vessel wall suffer from high blood pressure
•
have high sugar levels in the blood (diabetes mellitus)
•
have low blood potassium levels
•
have an overactive thyroid gland
•
are suffering from epinephrine and nor-epinephrine producing tumours of the adrenal medulla.
•
are going to have any surgery or receive halogenated anaesthetics
•
Other medicines and Atimos Modulite: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without prescription. Some medicines may interfere with the action of Atimos Modulite, these include medicines:
- for treating abnormal heart rhythms (for example quinidine, disopyramide, procainamide)
- for treating heart disease (for example digitalis)
- for treating nasal congestion (for example ephedrine)
- called beta adrenergic blockers used to treat heart conditions or glaucoma (an increase of the pressure in the eye), as tablets or eye drops
- containing erythromycin (used to treat infections)
- for treating symptoms of depression: monoamine oxidase inhibitors (for example phenelzine and isocarboxazid) or tricyclic antidepressants (for example amitryptiline and imipramine)
- to treat severe mental disorders (for example chloropromazine and trifluperazine) • used to treat allergic reactions (such as antihistamines, for example terfenadine, astemizole, mizolastine) • used to treat bronchial asthma (for example theophylline, aminophylline or steroids) • used to increase urine production (such as diuretics) • • •
for treating Parkinsonism (for example levodopa) containing oxytocin, which causes uterus contraction. to treat an underactive thyroid gland (for example thyroxine)
The addition of anticholinergics (such as tiotropium or ipratropium bromide) to the treatment with Atimos Modulite, can help to open your airways even more. You have also been prescribed corticosteroids for your breathing problems. It is very important to keep using these regularly. Do not stop using them or change the dose when you start using Atimos Modulite. Pregnancy and breast feeding If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine Atimos Modulite. The use of Atimos Modulite during pregnancy is only indicated if absolutely necessary. Driving and using machines Atimos Modulite is unlikely to have any effect on the ability to drive and operate machinery. Atimos Modulite contains ethanol This medicine contains a small amount of ethanol (alcohol): 8.9 mg of alcohol (ethanol) in each actuation, which is equivalent to 0.25 mg/kg per dose of two actuations in adults and equivalent to 0.44 mg/kg per dose of two actuations in adolescents. The amount in two actuations of this medicine is equivalent to less than 1 ml of wine or beer. The small amount of alcohol in this medicine will not have any noticeable effects. 3. How to use Atimos Modulite Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. For Asthma The dose of Atimos Modulite you must inhale will depend on the type of asthma you have and how severe it is. Your dose will be decided by your doctor and it is important that you only take the prescribed dose, regularly. The usual dose for adults, including the elderly and adolescents 12 years and older is 1 puff in the morning and 1 puff in the evening. This means you need to take a total of 2 puffs (24 micrograms) of Atimos Modulite per day. If you suffer from more severe asthma your doctor may prescribe 4 puffs per day (48 micrograms), 2 puffs in the morning and 2 puffs in the evening. 4 puffs (48 micrograms) of Atimos Modulite is the maximum daily dose and it is important that you do not take more than the total daily dose that your doctor has told you to take. This product is not suitable for asthmatic children under 12 years old. For Chronic Obstructive Pulmonary Disease (COPD): The usual dose for adults, including the elderly and adolescents 18 years and older is 1 puff in the morning and 1 puff in the evening. This means you need to take a total of 2 puffs (24 micrograms) of Atimos Modulite per day. If you suffer from more severe COPD your doctor may prescribe 4 puffs per day (48 micrograms), 2 puffs in the morning and 2 puffs in the evening. 4 puffs (48 micrograms) of Atimos Modulite is the maximum daily dose and it is important that you do not take more than the total daily dose that your doctor has told you to take. Do not take more than 2 puffs at any one time. This product is not suitable for COPD patients under 18 years old. Do not use Atimos Modulite to treat a sudden attack of breathlessness. You should use a "reliever" inhaler prescribed by your doctor for this purpose, carry this medicine with you at all times. If you use more Atimos Modulite than you should: You may notice that your heart is beating faster than usual and that you feel shaky. You may also have a headache, tremor, feeling and being sick (nausea and vomiting) or feel sleepy. Contact your doctor as soon as possible for advice. If you forget to use Atimos Modulite: If you forget to use Atimos Modulite, take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the usual time. Do not double the dose. Do not stop or reduce the dose of Atimos Modulite or any other medicine for your breathing just because you feel better, without talking to your doctor first. It is very important to use these medicines regularly. Do not increase your dose of Atimos Modulite without talking to your doctor first. If you feel you are getting breathless or wheezy while using Atimos Modulite, you should continue to use Atimos Modulite but go to see your doctor as soon as possible, you may need additional treatment. Once your asthma is well controlled, your doctor may consider it appropriate to gradually reduce the dose of Atimos Modulite. Instructions for use It is important that you know how to use your inhaler properly. Your doctor, nurse or pharmacist will show you how to use your inhaler correctly. You must follow their instructions carefully so that you know how, when and
How to take it
in this leaflet. If you are not sure what to do or have problems in inhaling then ask your doctor, nurse or pharmacist for advice. Please read the back of this leaflet Item Chiesi
PAG. 1/2
CHIESI FARMACEUTICI S.p.A. – Parma – Italy NOT TO TAMPER THIS DOCUMENT
Artwork Owner: MS – mail: [email protected] MATERIAL TIPE: DESCRIPTION OF MATERIAL: FORMAT: DIMENSIONS mm: FONT AND min. SIZE:
MOCK-UP FOR SUBMISSION LEAFLET ATIMOS MOD.12mcg SPR.HFA UK F058 180 x 600 (after fold 180 x 38) Arial 9 pt
LAETUS CODE: or DATAMATRIX CODE:
Datamatrix Laetus code code is dummy is dummy
COLOUR PRINT N. 1:
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BACK
The laetus or datamatrix code assigned in the production code will be used to avoid the mix-up DIECUT
Reason of the change: New mock-up for UK submission: EU F-gas Regulation_labeling requirements Text received on 07/11/2024 From: Khayyam CHECK BY
Name:
Date:
PROOF N. /
1
DATE
FROM: /CHANGE FOR
14/11/24
START ACTIVITY
Testing your inhaler. If your inhaler is new or if it has not been used for 3 days or more, one puff should be released into the air before using it, to make sure that it works. You should stand or sit in the upright position when using your inhaler. 1. Remove the mouthpiece cover from the inhaler and hold it between the thumb and forefinger as shown. 2. Breathe out as far as is comfortable. 3. Hold the inhaler upright as shown with your thumb on the base below the mouthpiece; place the mouthpiece in your mouth between your teeth and close tightly your lips around it. 4. Breathe in deeply through your mouth and at the same time press down on the top of the inhaler to release a puff. 5. Hold your breath as long as is comfortable, then take the inhaler from your mouth. 6. If you are to take another puff, keep the inhaler upright and wait about half a minute before repeating steps 2 to 5. 7. After use always replace the mouthpiece cover to keep out dust and fluff. Replace firmly and snap into position.
1
2 1-2
3 3A
4 3B
5-6 4A
7 4B
Important: Do not rush steps 2, 3, 4 and 5. It is important that you start to breathe in as slowly as possible just before operating the inhaler.
4C
If you see 'mist' coming from the top of the inhaler or the sides of your mouth, Atimos Modulite will not get into your lungs as it should. Take another puff carefully following the instructions from Step 2 onwards. If you have weak hands it may be easier to hold the inhaler with both hands. Put the two forefingers on top of the inhaler and both thumbs on the bottom below the mouthpiece. Tell your doctor, nurse or pharmacist if you have any difficulties. Cleaning It is important to clean your inhaler regularly, at least once or twice a week to ensure that it works properly. •
Pull the metal canister out of the plastic case of the inhaler and remove the mouthpiece cover.
•
Rinse the plastic case and the mouthpiece cover in warm water.
•
Do not put the metal canister into water.
•
Leave to dry thoroughly in a warm place. Avoid excessive heat.
•
Replace the canister and mouthpiece cover.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine Atimos Modulite can cause side effects although not everybody gets them.
Possible side effects
are listed below according to their frequency. If you are not sure what the side effects below are, ask your doctor to explain them to you. If your breathing or wheezing gets worse after using your inhaler stop using Atimos Modulite and tell your doctor immediately. This is caused by narrowing of the airways in your lungs but it occurs only rarely. Common (may affect up to 1 in 10 people): unusually fast heart beat and palpitations, cough, trembling (fine tremor), headache. Uncommon (may affect up to 1 in 100 people): muscles cramps, pain in muscles, nausea, agitation, restlessness, sleep disorders, dizziness, abnormal or impaired sense of taste, throat irritation, abnormal rapid heart beat, disorders of heart rhythm with increase heart rate, abnormal low levels of potassium in the blood, increase in blood sugar levels, increase in the blood level of insulin, free fatty acids, glycerol and ketones, excessive sweating. Rare (may affect up to 1 in 1,000 people): missed heartbeats caused by too early contraction of the ventricles of the heart, feeling chest tightness, increase or decrease in blood pressure, wheezing immediately after using the inhaler, severe fall in blood pressure, inflammation of the kidneys, allergic reaction such as itching, rash, bronchospasm, urticaria, swelling of skin and mucous membrane persisting for several days. Very rare (may affect up to 1 in 10,000 people): worsening of asthma, difficulty breathing, swelling of the hands and/or feet, irregular heartbeat, reduced number of blood platelets, hyperexcitability, abnormal behaviour, hallucinations. Some side effects, such as tremor, nausea, abnormal or impaired sense of taste, throat irritation, excessive sweating, restlessness, headache, dizziness and muscle cramps, may ease during the course of one to two weeks of continued use of your asthma medication. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist immediately. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Atimos Modulite
- Keep this medicine out of the sight and reach of children.
- Do not use beyond three months from the date you get the inhaler from your pharmacist and never use after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.
- Do not store the inhaler above 30 C.
- If the inhaler gets very cold, take the metal canister out of the plastic case and warm it in your hands for a few o
minutes before use. Never use anything else to warm it up.
- Warning. The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister.
- Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Atimos Modulite contains: The active substance of Atimos Modulite is formoterol fumarate dihydrate. Each metered actuation provides 12 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose of 10.1 micrograms. The other ingredients are: hydrochloric acid, ethanol and norflurane (HFC-134a). This medicine contains fluorinated greenhouse gases. Each inhaler of 50 actuations contains 5.842 g of norflurane (HFC-134a) corresponding to 0.08 tonne CO2 equivalent (global warming potential GWP = 1430). Each inhaler of 100 actuations contains 9.087 g of norflurane (HFC-134a) corresponding to 0.013 tonne CO2 equivalent (global warming potential GWP = 1430). Each inhaler of 120 actuations contains 10.384 g of norflurane (HFC-134a) corresponding to 0.015 tonne CO2 equivalent (global warming potential GWP = 1430). What Atimos Modulite looks like and contents of the pack: Atimos Modulite is a pressurised inhalation solution contained in an aluminium can with plastic actuator and protective cap. Each pack contains 1 inhaler which provides 50, 100 or 120 puffs. Not all pack sizes may be marketed. Marketing Authorisation Holder: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, UK. Manufacturer responsible for batch release: Chiesi Farmaceutici S.p.A., Via S. Leonardo 96, 43122 Parma, Italy Alternative manufacturer responsible for batch release: Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, 1010 Wien, Austria This medicinal product has been authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Czech Republic Germany Portugal Estonia Spain Holland UK (Northern Ireland)
ATIMOS ATIFOR CHIESI ATIMOS ATIMOS BRONCORAL NEO ATIMOS ATIMOS MODULITE
Slovak Republic Hungary Slovenia Poland Latvia
ATIMOS ATIMOS ATIMOS ATIMOS ATIMOS
Is this leaflet hard to see or read? Phone 0161 488 5555 for help. This leaflet was last revised in 01/2025
CP0015/11
Item Chiesi
PAG. 2/2
Frequently asked questions about Atimos Modulite 12 micrograms/actuation pressurised inhalation solution
How do I take Atimos Modulite 12 micrograms/actuation pressurised inhalation solution?
Atimos Modulite 12 micrograms/actuation pressurised inhalation solution comes as inhaler containing 12mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Atimos Modulite 12 micrograms/actuation pressurised inhalation solution?
The active substance in Atimos Modulite 12 micrograms/actuation pressurised inhalation solution is formoterol fumarate dihydrate.
Are there equivalent medicines to Atimos Modulite 12 micrograms/actuation pressurised inhalation solution?
Medicines with the same active substance, strength and form include: Formoterol Easyhaler 12 micrograms per dose inhalation powder. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Atimos Modulite 12 micrograms/actuation pressurised inhalation solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Atimos Modulite 12 micrograms/actuation pressurised inhalation solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: formoterol fumarate dihydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the long-term symptomatic treatment of persistent, moderate to severe asthma in patients requiring regular bronchodilator therapy in combination with long-term anti-inflammatory therapy (inhaled and / or oral glucocorticoids).
Glucocorticoid therapy should be continued on a regular basis.
Atimos is indicated for the relief of broncho-obstructive symptoms in patients with chronic obstructive pulmonary disease (COPD).
4.2. Posology and method of administration
Posology
The dosage depends on the type and severity of disease.
The following dosages are recommended for adults, including elderly patients, and adolescents aged 12 years and above:
Asthma
Adults and adolescents aged 12 years and above
Usually one actuation in the morning and evening (24 micrograms of formoterol fumarate dihydrate per day). In severe cases, up to a maximum of two actuations in the morning and evening (48 micrograms of formoterol fumarate dihydrate per day).
The maximum daily dose is 4 actuations (48 micrograms of formoterol fumarate dihydrate).
Children younger than 12 years of age:
The safety and efficacy of Atimos Modulite in children younger than 12 years of age has not been established yet, therefore Atimos Modulite should not be used in children.
Chronic Obstructive Pulmonary Disease (COPD)
Adults (aged 18 years and above)
The usual dose is one actuation twice daily (one in the morning and one in the evening, 24 micrograms formoterol fumarate dihydrate per day).
The daily dose for regular use should not exceed 2 inhalations. If required, additional inhalations above those prescribed for regular therapy may be used for relief of symptoms, up to a maximum total daily dose of 4 inhalations (regular plus required). More than 2 inhalations should not be taken on any single occasion.
Patients should not use the inhaler beyond three months from the date of dispensing by the pharmacist (see section 6.4). Although Atimos Modulite has a rapid onset of action, long-acting inhaled bronchodilators should be used for maintenance bronchodilator therapy.
Atimos Modulite is not intended to relieve acute asthma attacks.
In the event of an acute attack, a short-acting β2-agonist should be used.
Patients should be advised not to stop or change their steroid therapy when Atimos Modulite is introduced.
If the symptoms persist or worsen, or if the recommended dose of Atimos Modulite fails to control symptoms (maintain effective relief), this is usually an indication of a worsening of the underlying condition.
Renal or hepatic impairment
There is no theoretical reason to suggest that Atimos Modulite dosage requires adjustment in patients with renal or hepatic impairment, however, no clinical data have been generated to support its use in these groups.
Method of Administration
To ensure proper administration of the drug, the patient should be shown how to use the inhaler by a physician or other health professional.
Before the first use of the inhaler and after 3 days or more of non-use one actuation should be discharged in the air in order to ensure a faultless function. As far as possible patients should stand or sit in an upright position when discharging the inhaler.
1. Remove the protecting cap from the mouthpiece.
2. Breathe out as deeply as possible.
3. Hold the canister vertically with its body upwards and put the mouthpiece between well-closed lips.
4. Deeply inspire through the mouth and, at the same time, press on the upper part of the inhaler to actuate the puff.
5. Hold breath as long as possible without any effort and, finally, remove the inhaler from the mouth.
Should a further puff be inhaled, the inhaler should be kept in a vertical position for about half a minute, then steps 2 to 5 repeated.
After use, close with the protecting cap.
IMPORTANT: do not perform steps 2 to 4 too quickly.
Should a part of gas be sprayed from the upper part of the inhaler or from the mouth side, operations should be performed again starting from step 2.
For patients with weak hand-grip it could be easier to hold the inhaler with both hands. Therefore, the upper part of the inhaler is held with both index fingers and its lower part is held with both thumbs.
The use of a spacer device with the inhaler is usually recommended for patients who have difficulty in coordinating inhalation with actuation, however, no clinical data are available for Atimos Modulite with spacers.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Atimos Modulite should not be used (and is not sufficient) as the first treatment for asthma.
Asthmatic patients who require therapy with long-acting ß2-agonists, should also receive optimal maintenance anti-inflammatory therapy with corticosteroids. Patients must be advised to continue taking their anti-inflammatory therapy after the introduction of formoterol even when symptoms decrease. Should symptoms persist, or treatment with ß2-agonists need to be increased, this indicates a worsening of the underlying condition and warrants a reassessment of the maintenance therapy.
Although Atimos may be introduced as add-on therapy when inhaled corticosteroids do not provide adequate control of asthma symptoms, patients should not be initiated on Atimos during an acute severe asthma exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Serious asthma-related adverse events and exacerbations may occur during treatment with Atimos. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of Atimos.
Atimos Modulite should be used strictly in accordance with the dosage recommendations (see section 4.2). Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Atimos Modulite. Regular review of patients as treatment is stepped down is important. The lowest effective dose of Atimos Modulite should be used.
The maximum daily dose should not be exceeded.
A sudden and progressive deterioration of the asthmatic disorder can be life-threatening and requires immediate medical intervention. Considerably exceeding the prescribed individual doses or the total daily dose can be hazardous due to the effects on the heart (cardiac arrhythmia, rise in blood pressure), in combination with changes in the salt concentrations in body fluids (electrolyte shifts), and must therefore be avoided.
Concomitant conditions
Caution should be observed when treating patients with third degree atrioventricular block, refractory diabetes mellitus, thyrotoxicosis, phaeochromocytoma, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure and occlusive vascular diseases, especially arteriosclerosis.
Formoterol may induce prolongation of the QTc-interval. Caution should be observed when treating patients with prolongation of the QTc-interval, eg. congenital or drug-induced (QTc > 0.44 seconds) and in patients treated with drugs affecting the QTc-interval (see section 4.5).
Due to the hyperglycaemic effects of ß2-agonists, additional blood glucose monitoring is recommended initially in diabetic patients.
If anaesthesia with halogenated anaesthetics is planned, it should be ensured that Atimos Modulite is not administered for at least 12 hours before the start of anaesthesia.
Paradoxical bronchospasm
As with every inhalation therapy, the potential for paradoxical bronchospasm should be considered. If it occurs, the treatment should be discontinued immediately and alternative therapy started (see section 4.8).
Hypokalaemia
Potentially serious hypokalaemia may result from ß2-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. The hypokalaemic effect may be potentiated by concomitant treatment with xanthine-derivatives, steroids and diuretics. The serum potassium levels should therefore be monitored.
Therefore potassium levels have to be regularly monitored particularly in patients with low basic potassium values or peculiar risks for decreased blood potassium levels. The monitoring should also be conducted if no decreased levels occurred under previous treatment with short acting β2-sympathomimetics. Where applicable, potassium has to be substituted.
Due to decreased serum potassium levels the effect of digitalis containing medicinal products is enhanced.
Atimos Modulite contains a small amount of ethanol (alcohol). The amount in two actuations of this medicine is equivalent to less than 1 ml of wine or 1 ml of beer.
The small amount of alcohol in this medicine will not have any noticeable effects.
4.5. Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been carried out with formoterol. There is a theoretical risk that concomitant treatment with other drugs known to prolong the QTc-interval may give rise to a pharmacodynamic interaction with formoterol and increase the possible risk of ventricular arrhythmias. Examples of such drugs include certain antihistamines (e.g. terfenadine, astemizole, mizolastine), certain antiarrhythmics (e.g. quinidine, disopyramide, procainamide), erythromycin and tricyclic antidepressants. Concomitant administration of other sympathomimetic substances such as other β2-agonists or ephedrine may potentiate the undesirable effects of Atimos Modulite and may require titration of the dose.
The simultaneous use of formoterol and theophylline can result in mutual potentiation of effects, and there is also the likelihood of increased undesirable effects such as cardiac dysrhythmia. Compounds which themselves potentiate sympathomimetic effects, such as L-dopa, L-thyroxine, oxytocin or alcohol, can also affect cardiovascular regulation when taken at the same time as formoterol.
Administration of Atimos Modulite to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants should be performed with caution, since the action of β2-adrenergic stimulants on the cardiovascular system may be potentiated.
Concomitant treatment with xanthine derivatives, steroids, or diuretics such as thiazides and loop diuretics may potentiate a rare hypokalaemic adverse effect of β2-agonists. Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
The bronchodilating effects of formoterol can be enhanced by anticholinergic drugs.
β-adrenergic blockers may weaken or inhibit the effect of Atimos Modulite. Therefore, Atimos Modulite should not be given together with β-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of formoterol in pregnant women. In animal studies formoterol has caused implantation losses as well as decreased early postnatal survival and birth weight. The effects appeared at considerably higher systemic exposures than those reached during clinical use of formoterol. Treatment with formoterol may be considered at all stages of pregnancy if needed to obtain asthma control, and if the expected benefit to the mother is greater than any possible risk to the fetus. The potential risk for human is unknown.
Breast-feeding
It is unknown whether formoterol are excreted in human milk. In rats, small amounts of formoterol have been detected in maternal milk. Administration of formoterol to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
A risk to the newborns/infants cannot be excluded.
4.7. Effects on ability to drive and use machines
Atimos Modulite has no influence on the ability to drive and use machines.
4.8. Undesirable effects
The most commonly reported adverse events of β2-agonist therapy, such as tremor and palpitations, tend to be mild and disappear within a few days of treatment. Adverse reactions, which have been associated with formoterol, are listed below by system organ class and frequency. Frequency is defined as: Very Common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10000, <1/1000), Very rare (<1/10000)
System organ Class
Adverse Reaction
Frequency
Blood and lymphatic system disorders
Thrombopenia
Very rare
Immune system disorders
Hypersensitivity reactions, e.g. angioedema, bronchospasm, exanthema, urticaria, pruritus.
Rare
Metabolism and nutrition disorders
Hypokalaemia, hyperglycaemia
Uncommon
Psychiatric disorders:
Agitation, restlessness, sleep disorder
Uncommon
Abnormal behaviour, hallucination
Very rare
Nervous system disorders
Tremor, headache
Common
Dizziness, taste disturbances
Uncommon
Central nervous system stimulation
Very rare
Cardiac disorders
Palpitations
Common
Tachycardia
Uncommon
Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles, Angina pectoris
Rare
Prolongation of QTc interval
Very rare
Vascular disorders
Variation in blood pressure
Rare
Respiratory, thoracic and mediastinal disorders
Cough
Common
Throat irritation
Uncommon
Bronchospasm paradoxical (see section 4.4)
Rare
Dyspnoea, exacerbation of asthma
Very rare
Gastrointestinal disorders
Nausea
Uncommon
Skin and subcutaneous tissue disorders
Hyperhidrosis
Uncommon
Musculoskeletal and connective tissue disorders
Muscle cramps, myalgia
Uncommon
Renal and urinary disorders
Nephritis
Rare
General disorders and admnistration site conditions
Oedema peripheral
Very rare
Nausea, dysgeusia, throat irritation, hyperhidrosis, restlessness, headache, dizziness and muscle cramps may resolve spontaneously within one to two weeks of continued treatment.
Central nervous system stimulating effects have been sporadically reported following inhalation of ß2-sympathomimetics, manifesting as hyperexcitability. These effects were mainly observed in children up to 12 years of age.
Treatment with ß2-agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9. Overdose
There is limited clinical experience on the management of overdose. An overdosage of Atimos Modulite would be likely to lead to effects that are typical of β2-adrenergic agonists: headache, tremor, palpitations. Symptoms reported from isolated cases are tachycardia, prolonged QTc interval, ventricular arrhythmias, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea, vomiting and somnolence.
Treatment of Overdose
Supportive and symptomatic treatment is indicated. Serious cases should be hospitalised. Use of cardioselective β-adrenergic blockers may be considered, but only subject to extreme caution since the use of β-adrenergic blocker medication may provoke bronchospasm.
Serum potassium should be monitored.
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