ALMEIDA 0.375% + 0.075% Roztwór do nebulizacji
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Treść ulotki
Almeida 1,875 mg/0,5 ml + 0,375 mg/0,5 ml solution for nebulisation, 0.375% + 0.075% solution for nebulisation
Salbutamol and ipratropium bromide
Equivalent medicine
Read this leaflet carefully before you start to use this medicine as it contains important
information for you.
- 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 only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Almeida is and what it is used for
- 2. What you need to know before you use Almeida
- 3. How to use Almeida
- 4. Possible side effects
- 5. How to store Almeida
- 6. Contents of the pack and other information
1. What Almeida is and what it is used for
Almeida is a medicine consisting of an association of two active substances for the therapy of obstructive (narrowing) diseases of the bronchi: salbutamol (beta-agonist) and ipratropium bromide (anticholinergic).
Almeida is indicated for the treatment of bronchospasm (contraction of the bronchial muscles) in adult patients with chronic obstructive pulmonary disease (a disease that makes it difficult to empty the air from the lungs).
2. What you need to know before you take Almeida
Do not take Almeida
- if you are allergic to salbutamol and/or ipratropium bromide or to any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to atropine or to active substances similar to atropine
- if you suffer from severe heart disease;
- if you suffer from glaucoma (eye disease of the optic nerve);
- if you suffer from prostatic hypertrophy (enlargement of the prostate gland);
- if you suffer from urinary retention (the inability of the urinary bladder to empty);
- if you suffer from intestinal obstruction (the arrest of the progression of the contents of the intestine).
Warnings and precautions
Consult your doctor or pharmacist before taking Almeida if:
- you have an obstruction of the vessels that carry blood to the heart (coronary artery disease);
- you have an irregular heartbeat;
- you have high blood pressure (hypertension);
- you suffer from a thyroid disease caused by its increased activity (hyperthyroidism);
- you are affected by pheochromocytoma, a tumor that produces chemicals that cause an increase in blood pressure and an acceleration of the heartbeat;
- you suffer from diabetes (a disease characterized by high levels of glucose in the blood due to reduced production of insulin by the pancreas);
- you suffer from cystic fibrosis. Treatment with Almeida may predispose you more to gastrointestinal disorders
Contact your doctor if you experience chest pain, severe difficulty breathing with increased wheezing or shortness of breath, visual disturbances such as eye pain, blurred vision, colored images, pupil dilation, or if you perceive a worsening of your health conditions if:
- you suffer from ischemic heart disease (a heart condition that occurs following a reduction in blood flow due to a narrowing of the coronary arteries),
- you suffer from tachyarrhythmia (irregular and accelerated heartbeat),
- you have severe heart failure (the inability of the heart to pump the adequate amount of blood necessary for the body's needs)
Therapy with Almeida may determine a decrease in potassium in the blood (hypokalemia), even severe, therefore your doctor will prescribe you periodic checks.
A condition known as lactic acidosis has been reported in association with high therapeutic doses of salbutamol, mainly in patients treated for acute bronchospasm (see sections 3 and 4). Increased plasma lactate levels can lead to shortness of breath and hyperventilation, even if your wheezing improves. If you think the medicine is no longer effective and that you need to use the nebulizer more than your doctor has recommended, contact your doctor immediately.
During treatment, immediate hypersensitivity reactions may occur with the appearance in rare cases of urticaria, angioedema, paradoxical bronchospasm (sudden involuntary contraction of the bronchi and difficulty breathing) and anaphylaxis.
Be careful not to spray the solution into your eyes, especially if you are at risk of glaucoma (an eye condition caused by increased intraocular pressure); when ipratropium bromide (one of the active ingredients of Almeida) has come into contact with the eye, isolated cases of eye complications (such as mydriasis, blurred vision, visual halos or colored images, increased intraocular pressure, angle-closure glaucoma, eye pain) have been reported.
Use in children and adolescents
Almeida is not indicated in children and adolescents (under 18 years of age).
For those who play sports
The use of the drug without therapeutic necessity constitutes doping and may still result in positive anti-doping tests.
Other medicines and Almeida
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including those available without a prescription.
Tell your doctor if you are taking:
- beta-blockers, such as propranolol (medicines used for heart disease and to lower blood pressure);
- xanthine derivatives, e.g.: theophylline and aminophylline, (medicines that relax the bronchial muscles);
- corticosteroids (medicines used for the treatment of inflammatory states);
- diuretics (medicines that lower blood pressure).
- antidepressants (tricyclic antidepressants and monoamine oxidase inhibitors)
- anticholinergic medicines
- digoxin - medicine used for the treatment of heart failure
- if you are going to undergo surgery. Some anesthetics may affect the effects of Almeida. If you are going to undergo surgery, inform your doctor, dentist or anesthesiologist that you are being treated with Almeida
Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The doctor will prescribe Almeida to you only if necessary.
Driving and operating machinery
During treatment, dizziness, disturbances in image focusing, pupil dilation (mydriasis), blurred vision may occur. If this happens, avoid driving or operating machinery.
Almeida (the solution in the multi-dose bottle) contains para-hydroxybenzoates.They can cause allergic reactions (even delayed) and, exceptionally, bronchospasm (narrowing of the bronchi).
3. How to take Almeida
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use with nebulizers
Adults
Inhalation with electric nebulizers, for outpatient or home use:
Dilute 5 drops with 2 ml of distilled water or sterile saline solution;
Nebulization duration: 10 - 15 minutes, to be repeated 2 - 3 times a day.
Inhalation with electric respirators (Intermittent Positive Pressure Breathing), for hospital use:
Dilute 2 drops with 1 ml distilled water or with sterile saline solution: 6 inspirations;
Alternatively, dilute 2 drops with 5 ml distilled water or with sterile saline solution: duration
inhalation 2 minutes;
or dilute 1 drop with 5 ml distilled water or with sterile saline solution: inhalation duration 10
minutes.
Adults
The recommended dose is: 10 drops, 3 - 4 times a day
Use in children and adolescents
Almeida is not indicated in children and adolescents (under 18 years of age).
Instructions for use
Single-dose containers:
To open the single-dose container, twist the cap.
Multi-dose bottle:
To prevent the bottle from being easily opened, a dropper has been used for which opening requires
a non-instinctive, but rational movement.
To open the bottle, apply pressure to the dropper ring and twist it in
a counterclockwise direction simultaneously. To close the bottle, screw the ring clockwise as usual.
If you take more Almeida than you should
In case of ingestion/administration of an excessive dose of Almeida, consult your doctor or the nearest
hospital.
In case of overdose, tremors, increased heart rate, increased
breathing rate (tachypnea) and metabolic acidosis (alteration of blood acidity) may occur.
If you forget to take Almeida
Do not take a double dose to make up for a missed dose.
If you stop taking Almeida
Do not stop using this medicine without consulting your doctor.
If you have any doubts 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 everybody gets them.
Conditions to which you should pay attention
- Onset of chest pain
- Severe breathing difficulties
- Eye pain with blurred vision, pupil dilation → Contact your doctor immediately if you experience any of these symptoms and stop therapy Rare side effects- (may affect up to 1 in 1,000 people)
- headache, tension, dizziness (sensation of movement or rotation), drowsiness, muscle tremors, agitation, psychomotor hyperactivity
- dry mouth, nausea, irritation of the mouth and throat, intestinal motility disorders (diarrhea, constipation and vomiting), stomatitis
- hypersensitivity, anaphylaxis and angioedema
- accommodation disorders of vision (blurred vision), pupil dilation (mydriasis), eye pain, dilation of superficial ocular vessels (conjunctival hyperemia), glaucoma, increased eye pressure
- peripheral vasodilation (red and warm skin) for high dosages
Very rare side effects- (may affect up to 1 in 10,000 people)
- cardiac arrhythmias (irregular heartbeat) including atrial fibrillation, supraventricular tachycardia and extrasystole,
- myocardial ischemia (reduced oxygenation of the heart),
- angina (chest pain)
Side effects with unknown frequency- (frequency cannot be estimated on the basis of available data):
- irritability,
- hypokalemia (reduction of potassium in the blood),
- paradoxical bronchospasm (constriction of the bronchi) and hyperventilation (increased number of breathing acts immediately after inhalation),
- cough, dysphonia, throat irritation, throat dryness
- increased systolic blood pressure / decreased diastolic blood pressure
- asthenia
- urticaria, pruritus, excessive sweating (hyperhidrosis)
- muscle pain, cramps, muscle weakness urinary retention
- a condition known as lactic acidosis which can cause stomach pain,hyperventilation, shortness of breath despite your wheezing improving, cold feet and hands,irregular heartbeat or thirst.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Almeida
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in intact packaging, correctly stored.
Store at a temperature not exceeding 25°C.
The contents of the single-dose container must be used immediately after opening; discard any residue.
After opening the aluminium wrapper containing the single-dose containers, these must be used within 7 days; after this period, discard any remaining single-dose containers.
The contents of the multi-dose bottle can be used for up to 28 days from the first opening of the bottle; after this period, discard any residue.
6. Contents of the pack and other information
What Almeida contains
Almeida 1.875 mg/0.5 ml + 0.375 mg/0.5 ml solution for nebulisation (in single-dose containers)
- The active ingredients are: salbutamol and ipratropium bromide. Each single-dose container contains 1.875 mg of salbutamol (2.25 mg as salbutamol sulfate) and 0.375 mg of ipratropium bromide.
- The other component is: water for injections.
One 0.5 ml container is equivalent to 10 drops. One drop (0.05 ml) contains: 187.5 micrograms of
salbutamol and 37.5 micrograms of ipratropium bromide.
Almeida 0.375% + 0.075% solution for nebulisation (in multi-dose bottle)
- The active ingredients are: salbutamol and ipratropium bromide. 100 ml of solution contains 0.375 g of salbutamol (0.450 g as salbutamol sulfate) and 0.075 g of ipratropium bromide.
- The other components are: ethyl p-hydroxybenzoate, methyl p-hydroxybenzoate, water for injections.
Description of the appearance of Almeida and contents of the pack
Solution for nebulisation. The solution may be pale yellow in colour.
- Pack of 30 single-dose containers of 0.5 ml
- Multi-dose bottle of 15 ml
Marketing Authorisation Holder
I.B.N. Savio S.r.l. - Via del Mare 36, Pomezia (RM)
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)
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- Kraj rejestracji
- Postać farmaceutycznaSolution for nebulization, 0.375% + 0.075%
- Kod ATCR03AL02
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki ALMEIDAPostać farmaceutyczna: Solution for nebulization, 0.375% + 0.075%Substancja czynna: salbutamol and ipratropium bromideProducent: NEOPHARMED GENTILI S.P.A.Wymaga receptyPostać farmaceutyczna: Aerosol, 15 MG + 3 MGSubstancja czynna: salbutamol and ipratropium bromideProducent: NEOPHARMED GENTILI S.P.A.Wymaga receptyPostać farmaceutyczna: Solution for nebulization, 0.375% + 0.075%Substancja czynna: salbutamol and ipratropium bromideProducent: KONPHARMA S.R.L.Wymaga recepty
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ALMEIDA wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w ALMEIDA jest salbutamol and ipratropium bromide. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
ALMEIDA jest produkowany przez I.B.N. SAVIO S.R.L. 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 ALMEIDA 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 ALMEIDA 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 (salbutamol and ipratropium bromide) to m.in. BIWIND, BREVA, INASAL. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
