INASAL 0.375% + 0.075% Раствор для небулайзера
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Инструкция по применению INASAL
Содержание инструкции
INASAL 3.75 mg/ml + 0.75 mg/ml 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, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What INASAL is and what it is used for
- 2. What you need to know before you use INASAL
- 3. How to use INASAL
- 4. Possible side effects
- 5. How to store INASAL
- 6. Contents of the pack and other information
1. What is INASAL and what is it used for
INASAL is a medicine consisting of an association of two active ingredients for the therapy of
obstructive (narrowing) diseases of the bronchi: salbutamol (beta-agonist) and ipratropium
bromide (anticholinergic).
INASAL is indicated for the treatment of bronchospasm (contraction of the bronchial muscles) in
adult patients with chronic obstructive bronchopneumopathy (a disease that makes it difficult to empty
air from the lungs).
Consult your doctor if you do not feel better or if you feel worse.
2. What you need to know before using INASAL
Do not use INASAL
- if you are allergic to salbutamol or ipratropium bromide or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to atropine or active substances similar to atropine;
- In case of heart disease;
- In case of glaucoma (increased pressure inside the eye);
- In case of prostatic hypertrophy (enlarged prostate);
- In case of urinary retention syndromes and intestinal obstruction.
Warnings and precautions
Consult your doctor or pharmacist before taking INASAL 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 INASAL may predispose you 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 notice a worsening of your health condition in case of:
- you suffer from ischemic heart disease (a heart condition that occurs following a reduction in blood flow due to narrowing of the coronary arteries),
- you suffer from tachyarrhythmia (irregular and accelerated heartbeat),
- you suffer from severe heart failure (the heart's inability to pump the adequate amount of blood needed by the body).
Therapy with INASAL 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 paragraphs 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, consult your doctor immediately.
Immediate hypersensitivity reactions with the appearance in rare cases of urticaria, angioedema, paradoxical bronchospasm (sudden involuntary contraction of the bronchi and difficulty breathing) and anaphylaxis may occur during treatment.
Be careful not to spray the solution into your eyes, especially if you suffer from glaucoma (an eye condition caused by increased intraocular pressure); when ipratropium bromide (one of the active ingredients of INASAL) has come into contact with the eye, isolated cases of eye complications (such as mydriasis, blurred vision, visual halos or colored images, increased eye pressure, angle-closure glaucoma, eye pain) have been reported.
Children and adolescents
Inasal is not indicated in children and adolescents (under 18 years of age).
Other medicines and INASAL
Tell your doctor or pharmacist if you are taking, have recently taken or might 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 have surgery. Some anesthetics may affect the effects of INASAL. If you are going to have surgery, inform your doctor, dentist or anesthesiologist that you are being treated with INASAL.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before using this medicine.
The doctor will prescribe INASAL to you only if absolutely 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.
INASAL contains para-hydroxybenzoates. They can cause allergic reactions (even delayed) and, exceptionally, bronchospasm.
“For athletes: the use of the drug without therapeutic necessity constitutes doping and can still result in positive doping tests”.
3. How to use INASAL
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
- Use with nebulizersAdultsFor inhalation with electric nebulizers, for outpatient or home useDilute 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.
For inhalation with electric respirators (Intermittent Positive Pressure Breathing), for use
in hospital
It is possible to dilute 2 drops with 1 ml of distilled water or sterile saline solution: 6
inspirations;
alternatively, dilute 2 drops with 5 ml: inhalation duration 2 minutes;
or dilute 1 drop with 5 ml: inhalation duration 10 minutes.
Use in children and adolescents
INASAL is not indicated in children and adolescents (under 18 years of age).
Instructions for use
To prevent the bottle from being easily opened, a dropper has been used which requires a
non-instinctive but rational movement to open.
To open the bottle, apply pressure to the dropper ring and twist it counterclockwise simultaneously. To close the bottle, screw the ring clockwise as usual.
If you use more INASAL than you should
In case of ingestion/accidental intake of an excessive dose of INASAL, contact 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 INASAL
Do not take a double dose to make up for a missed dose
If you stop taking INASAL
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 you should pay attention to
- 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 disorder 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 based on available data):
- irritability,
- hypokalemia (reduced potassium in the blood),
- paradoxical bronchospasm (constriction of the bronchi) and hyperventilation (increased number of respiratory acts immediately after inhalation),
- cough, dysphonia, throat irritation, dry throat,
- increased systolic blood pressure / decreased diastolic 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, talk to your doctor, pharmacist or nurse. You can also report side effects
to 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 INASAL
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 pack. The expiry date
refers to the last day of that month.
DO NOT STORE ABOVE 25°C
The contents of the multi-dose container can be used for up to 10 months from the first opening of the
container; after this period, any remaining medicine must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What INASAL contains
- The active ingredients are: Salbutamol and Ipratropium bromide. 100 ml of solution contains: 0.375 g of salbutamol (as Salbutamol Sulfate g 0.450) and 0.075 g of Ipratropium bromide. One drop contains: 187.5 micrograms of salbutamol and 37.5 micrograms of ipratropium bromide
- The other ingredients are: Ethyl p-hydroxybenzoate, methyl p-hydroxybenzoate, purified water.
Description of the appearance of INASAL and package contents
Solution for nebulization. Multidose bottle of 15 ml.
The solution of INASAL may be pale yellow in color.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
KONPHARMA S.r.l. – Via Pietro della Valle, 1 – 00193 Rome - Italy
Manufacturer
Special Product’s Line S.p.A. –
Via Fratta Rotonda Vado Largo, 1 -03012 Anagni (FR) Italy
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- Страна регистрации
- Форма выпускаSolution for nebulization, 0.375% + 0.075%
- Код АТХR03AL02
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги INASALФорма выпуска: Solution for nebulization, 0.375% + 0.075%Действующее вещество: salbutamol and ipratropium bromideПроизводитель: I.B.N. SAVIO S.R.LОтпускается по рецептуФорма выпуска: Solution for nebulization, 0.375% + 0.075%Действующее вещество: salbutamol and ipratropium bromideПроизводитель: NEOPHARMED GENTILI S.P.A.Отпускается по рецептуФорма выпуска: Aerosol, 15 MG + 3 MGДействующее вещество: salbutamol and ipratropium bromideПроизводитель: NEOPHARMED GENTILI S.P.A.Отпускается по рецепту
Аналоги INASAL в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог INASAL в Испания
Аналог INASAL в Польша
Аналог INASAL в Украина
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
INASAL требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество INASAL — salbutamol and ipratropium bromide. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
INASAL производится компанией KONPHARMA S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения INASAL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить INASAL в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (salbutamol and ipratropium bromide) включают ALMEIDA, BIWIND, BREVA. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
