KUROVENT 12 MCG Proszek do inhalacji, twarda kapsułka
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Treść ulotki
- WHAT IS KUROVENT 12 mcg INHALATION POWDER, HARD CAPSULES
- BEFORE TAKING KUROVENT 12 mcg POWDER FOR INHALATION,
- HOW TO TAKE KUROVENT 12 mcg POWDER FOR INHALATION, CAPSULES
- POSSIBLE SIDE EFFECTS
- HOW TO STORE KUROVENT 12 mcg POWDER FOR INHALATION,
- FURTHER INFORMATION
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally. Never give it to others: in fact, this medicine could be dangerous for other individuals, even if their symptoms are the same as yours. Inform your doctor or pharmacist.
- 1. What is KUROVENT 12 mcg powder for inhalation, hard capsules and what is it used for
- 2. Before you take KUROVENT 12 mcg powder for inhalation, hard capsules
- 3. How to take KUROVENT 12 mcg powder for inhalation, hard capsules
- 4. Possible side effects
- 5. How to store KUROVENT 12 mcg powder for inhalation, hard capsules
- 6. Further information
KUROVENT 12 mcg powder for inhalation, hard capsules R03AC13
Formoterol Fumarate (as dihydrate)
The active ingredient is formoterol fumarate dihydrate.
Each capsule contains 12.5 micrograms (mcg) of formoterol fumarate dihydrate equivalent to
12.0 micrograms (mcg) of formoterol fumarate.
The excipient is lactose monohydrate
Marketing Authorisation Holder
Italchimici SpA
Via Pontina 5 , Km 29,
00040 Pomezia (Roma)
Manufacturer and Control
LICONSA, Liberación Controlada de Sustancias Activas, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
E-19200 Azuqueca de Henares (Guadalajara), SPAIN
1. WHAT IS KUROVENT 12 mcg INHALATION POWDER, HARD CAPSULES
AND WHAT IT IS USED FOR
KUROVENT 12 mcg is supplied in a package containing 1 inhaler + 60 capsules or 100
capsules in blisters.
KUROVENT 12 mcg belongs to the group of medicines called selective beta-2-adrenergic agonists.
KUROVENT 12 mcg is used for the prevention and treatment of bronchospasm in patients with
obstructive bronchopneumopathies such as bronchial asthma and chronic bronchitis, with or without emphysema, as
well as for bronchospasm induced by allergens, exertion or cold.
2. BEFORE TAKING KUROVENT 12 mcg POWDER FOR INHALATION,
HARD CAPSULES
Do not take KUROVENT 12 mcg powder for inhalation, hard capsules:
- in case of hypersensitivity (allergy) to formoterol or in general to beta-2 agonists or to lactose (which contains small amounts of milk proteins) or to any of the excipients
- in case of cardiac arrhythmias, subvalvular aortic stenosis, hypertrophic cardiomyopathy
- in case of thyrotoxicosis
- in case of hypokalaemia
- in case of confirmed or suspected prolongation of the QT interval
Take care with KUROVENT 12 mcg powder for inhalation, hard capsules especially:
- if suffering from heart problems such as: ischemic heart disease, severe heart failure
- if suffering from aneurysm or severe heart failure
- if suffering from hypertension (high blood pressure)
- if suffering from diabetes, as blood glucose levels must be checked more frequently
- if suffering from severe acute asthma, as the risk of hypokalaemia is increased
- if paradoxical bronchospasm occurs, treatment should be discontinued immediately
- because treatment must be integrated with anti-inflammatory drugs for inhalation or oral corticosteroids
- in cases of premature labour or threat of abortion, as formoterol should not be used in these cases
- during labour, as it induces relaxation of the smooth uterine muscles
- if undergoing treatment for pheochromocytoma (tumour of the medulla of the adrenal glands)
Contact your doctor if the symptoms of asthma remain unchanged or worsen during treatment with KUROVENT. Do not interrupt the treatment with KUROVENT without first talking to your doctor.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
There is no adequate data regarding the use of formoterol in pregnant women.
Kurovent should not be used during pregnancy unless there are safer alternatives.
Breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Kurovent should not be used during breastfeeding.
Driving and operating machinery:
No effects have been observed.
In case of adverse effects, such as tremor and irritability, the ability to drive vehicles and operate machinery may be impaired.
For athletes:
The use of the drug without therapeutic necessity constitutes doping and may result in positive anti-doping tests.
Kurovent contains lactose:
If your doctor has diagnosed you with intolerance to sugars, contact your doctor before taking the product.
Taking other medicines:
Tell your doctor or pharmacist if you are taking other medicines, including those without a prescription.
Taking beta-adrenergic substances or ephedrine and anticholinergic substances may enhance the effects and adverse reactions of KUROVENT.
Taking a beta-blocker, even in the form of eye drops, may antagonize the effect of KUROVENT completely or partially.
KUROVENT may interact with monoamine oxidase inhibitors (drugs for the treatment of depression). Therefore, it should not be given to patients who are taking these substances and for up to 14 days after their discontinuation.
The concomitant administration of antidepressants and cardiac glycosides may increase the risk of arrhythmias.
Diuretics, xanthines (aminophylline, theophylline) and steroids may increase the hypokalaemic effect of formoterol. Their concomitant administration may cause severe arrhythmia, especially in patients with cardiac ischemia.
Hypokalaemia may increase the disposition for arrhythmia in patients treated with digitalis glycosides.
The bronchodilator effect of KUROVENT may be increased with the concomitant administration of corticosteroids and xanthine derivatives.
The concomitant use of KUROVENT and corticosteroids may increase blood glucose levels.
There is a high risk of arrhythmia in patients receiving concomitant anesthesia with halogenated hydrocarbons.
The effect of KUROVENT may be increased in patients treated with anticholinergic drugs (used for gastrointestinal, genitourinary and respiratory diseases), corticosteroids and xanthine derivatives (used for asthma symptoms).
Quinidine, disopyramide, procainamide, phenothiazides, antihistamines, tricyclic antidepressants and erythromycin may cause a prolongation of the QT interval and an increase in the risk of ventricular arrhythmia.
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3. HOW TO TAKE KUROVENT 12 mcg POWDER FOR INHALATION, CAPSULES
HARD
Always take KUROVENT 12 mcg exactly as your doctor has instructed. If you are not sure
you should consult your doctor or pharmacist.
KUROVENT 12 mcg is for inhalation use only.
Adults
The usual dose in adults involves administering 1 capsule (equal to formoterol fumarate
12 mcg) twice a day.
- Symptomatic treatment of bronchial asthma and chronic obstructive pulmonary diseases withreversible component: if it is necessary to control any symptoms, 1-2 additional capsules may be inhaled per day. If you take higher doses more than twice a week, consult your doctor.
- Prophylaxis of exercise-induced bronchospasm or beforeinevitable exposure toknown allergen:the usual dose is 1 capsule 15 minutes before the start of exercise or exposure to the allergen. Adult patients with severe asthma may inhale 2 capsules.
Children six years of age and over
- Symptomatic treatment of bronchial asthma and reversible chronic obstructive pulmonary diseases: the usual maintenance dose is 1 capsule twice a day.
- Prophylaxis of exercise-induced bronchospasm or beforeinevitable exposure toknown allergen:1 capsule 15 minutes before the start of exercise or exposure to the allergen.
KUROVENT 12 mcg should not be administered to children under six years of age.
If you feel that the effect of KUROVENT 12 mcg is too strong or too weak, contact your
doctor or pharmacist.
The doctor or pharmacist must give instructions on how to use the inhaler.
The gelatin capsule may fragment and small pieces of gelatin may go into your mouth or throat
with inhalation. This is reduced by puncturing the capsule only once.
The capsules must remain in the blister until the time of use.
Instructions for using the inhaler
- 1. Remove the cap.
- 2. Hold the base of the inhaler in a vertical position and rotate the mouthpiece in the direction indicated by the arrow.
- 3. Place the capsule in the appropriate compartment of the inhaler. It is important that the capsule is removed from the blister only immediately before administration.
- 4. Turn the mouthpiece to the closed position.
- 5. Hold the inhaler in a vertical position, press the buttons once. This will puncture the capsule. Release the buttons.
- 6. Exhale completely.
- 7. Put the mouthpiece in your mouth and tilt your head back slightly. Seal your lips around the inhaler and inhale rapidly and as deeply as possible.
- 8. Hold your breath for as long as possible while removing the inhaler from your mouth. Then breathe normally. Open the inhaler and check if there is still powder in the capsule: if so, repeat from step 6 to step 8.
- 9. After use, remove the empty capsule and close the inhaler.
Cleaning the inhaler:
To remove any residual powder, it is recommended to clean the inhaler and the appropriate
capsule compartment with a dry cloth. You can also use a soft toothbrush
for this purpose.
If you take more KUROVENT 12 mcg than you should:
Immediately notify your doctor or go to the nearest hospital if symptoms such as:
nausea, vomiting, tachycardia, tremor, headache, drowsiness, palpitations, ventricular arrhythmias,
metabolic acidosis, hypotension, hypokalemia and prolonged QTc interval appear.
KUROVENT 12 mcg can cause ischemic heart disease.
If you forget to take KUROVENT 12 mcg:
Do not take a double dose to make up for missed doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines, KUROVENT 12 mcg can cause side effects:
- Common:headache, palpitations and tremor.
- Uncommon: agitation, dizziness, anxiety, nervousness, insomnia, tachycardia (increased heart rate), aggravated bronchospasm (bronchial constriction causing difficulty breathing), muscle cramps, myalgia (muscle pain), sleep disorders, restlessness.
- Rare: hypersensitivity reactions (severe hypotension, angioedema, i.e. swelling of the extremities, abdomen, throat and other organs, bronchospasm, i.e. bronchial constriction causing difficulty breathing, exanthema, i.e. skin rash, urticaria and itching), nausea, taste disturbances, oropharyngeal irritation (irritation of the throat), cardiac arrhythmias (atrial fibrillation usually associated with palpitations, fainting and chest pain, supraventricular tachycardia, i.e. accelerated heart rhythm, extrasystoles, i.e. irregular heartbeat), hypokalaemia.
- Very rare: peripheral edema (swelling of the feet, hands and ankles), hyperglycemia (increased blood glucose levels which can cause thirst, frequent urination and fatigue), angina pectoris (intense pain due to constriction or pressure sensation in the chest), prolonged QTc interval (cardiac frequency abnormality), fluctuating blood pressure, paradoxical bronchospasm (constriction of the airways after treatment with the bronchodilator), hyperkalaemia.
An increase in blood levels of insulin, fatty acids and ketone bodies may also occur.
Some of these effects may disappear spontaneously; inform your doctor if they
persist or if they are very bothersome.
Inform your doctor or pharmacist.
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5. HOW TO STORE KUROVENT 12 mcg POWDER FOR INHALATION,
HARD CAPSULES
Do not store at a temperature above 25°C.
Store in the original package.
Do not use KUROVENT 12 mcg after the expiry date indicated on the package.
Keep out of the reach and sight of children.
To be sold on medical prescription only.
6. FURTHER INFORMATION
Marketing Authorisation Holder in Italy:
Italchimici SpA
Via Pontina 5, Km 29
00040 Pomezia (Rome)
Tel: 06-916391
November 2012
- Kraj rejestracji
- Postać farmaceutycznaInhalation powder, hard capsule, 12 MCG
- Kod ATCR03AC13
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki KUROVENTPostać farmaceutyczna: Pressurized solution for inhalation, 6 MCGSubstancja czynna: formoterolProducent: CHIESI FARMACEUTICI S.P.A.Wymaga receptyPostać farmaceutyczna: Inhalation powder, hard capsule, 12 MCGSubstancja czynna: formoterolProducent: SANDOZ S.P.A.Wymaga receptyPostać farmaceutyczna: Inhalation powder, hard capsule, 12 MICROGRAMSSubstancja czynna: formoterolProducent: EG S.P.A.Wymaga recepty
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KUROVENT wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w KUROVENT jest formoterol. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
KUROVENT jest produkowany przez ITALCHIMICI S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie KUROVENT jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić KUROVENT w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (formoterol) to m.in. ATIMOS, FORADIL, FORMOTEROLO EG. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
