ASSOLID 0.1% Раствор для небулайзера
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Инструкция по применению ASSOLID
Содержание инструкции
Assolid 1 mg/ml solution for nebulisation
Flunisolide
Equivalent medicine
Read this leaflet carefully before taking 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 their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What ASSOLID is and what it is used for
- 2. What you need to know before you take ASSOLID
- 3. How to take ASSOLID
- 4. Possible side effects
- 5. How to store ASSOLID
- 6. Contents of the pack and other information
1. What is ASSOLID and what is it used for
ASSOLID contains the active ingredient flunisolide, which belongs to a group of medicines
called glucocorticoids.
ASSOLID is indicated for the treatment of allergic respiratory diseases such as bronchial asthma,
asthmatic chronic bronchitis, chronic and seasonal rhinitis.
2. What you need to know before you take ASSOLID
Do not take ASSOLID
- if you are allergic to flunisolide or to any of the other ingredients of this medicine (listed in section 6)
- if you have active or quiescent (unmanifest) pulmonary tuberculosis
- if you have an infection (caused by bacteria, viruses or fungi)
- if you are in the last 6 months of pregnancy or if you are breastfeeding, unless after careful evaluation by your doctor (see section “Pregnancy and breastfeeding”). The medicine is not recommended in the first three months of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking ASSOLID.
The use of this medicine, especially if prolonged, may cause you allergic reactions and,
exceptionally, undesirable effects that affect the whole body, typical of the medicine. In such
cases you should stop treatment and institute appropriate therapy.
Rarely, the use of this medicine may cause a series of psychological and
behavioral effects including psychomotor hyperactivity (increased movements, restlessness),
sleep disturbances, anxiety, depression, aggression, behavioral disorders (predominantly
in children).
This medicine may mask the symptoms of infections and may cause new infections to occur.
Pay particular attention:
- if you have to switch from systemic corticosteroid therapy to treatment with flunisolide, especially if you are in a period of stress or if you have had a severe asthma attack, since this medicine may cause adrenal functional alterations (alteration of the ability of the adrenal glands to produce a sufficient amount of a hormone called cortisol). If this occurs, you should avoid abrupt discontinuation of systemic treatment. The replacement of systemic corticosteroid therapy with local therapy must be carried out under strict medical supervision. The doctor will indicate the dose and method of administration to switch from one therapy to another. You should also be monitored for adrenal cortical function and should undergo measurements of cortisol levels (the hormone produced by the adrenal glands), first thing in the morning, in a resting state.
- The effect of ASSOLID, as with all corticosteroids administered by inhalation, is not immediate. Therefore, you should be aware that ASSOLID is not effective in ongoing asthma crises and that you must adhere to regular use of this medicine for several days.
- if you have a lung infection (active or quiescent tuberculosis infections) or have an untreated infection caused by fungi, bacteria or viruses or have an eye infection caused by the Herpes simplex virus. You should use flunisolide, like all corticosteroids, with caution, if not avoid it.
- if you have or have had in the past nasal trauma, with lesions of the nasal septum or continuous nosebleeds (epistaxis), as this medicine delays wound healing (scarring processes);
- if you develop an alteration of the bacteria (flora) present in the respiratory tract (dysbiosis) during treatment. Consult your doctor as coverage therapy may be necessary.
Pay attention because during prolonged use of high doses of this medicine, adrenal activity inhibition, mucosal atrophy and other effects that affect
the whole organism may occur (see section 4 “Possible side effects”).
Pay attention in case of trauma, surgery, infections and rapid dose reduction
as these situations could cause an adrenal crisis.
It is important that you take the minimum effective dose for asthma control of inhaled corticosteroids
and that you are periodically monitored by your doctor.
If you take high doses, you should be monitored by your doctor and your dose should be
gradually reduced.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
This medicine is not recommended for children under four years of age.
Other medicines and ASSOLID
Tell your doctor if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of ASSOLID and your doctor may want to keep you
under close observation if you are taking these medicines (including some medicines for the
treatment of HIV: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Taking ASSOLID is not recommended in the first three months of pregnancy; in the further
period and during breastfeeding, take ASSOLID only when absolutely necessary and under
direct medical supervision.
Driving and operating machinery
No effects on the ability to drive and operate machinery are known.
This medicine contains 21 mg/kg of propylene glycol per daily dose.
3. How to take ASSOLID
Take this medicine following the instructions of your doctor or pharmacist exactly.
If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1 mg (19 drops) 2 times a day.
Use in children
The recommended dose is 500 micrograms (9 - 10 drops) 2 times a day.
ASSOLID is not recommended for children under four years of age.
Method of administration:
Use ASSOLID with electric nebulizers and do not dilute it. The use of nebulizers may determine
the production of residues of the medicine that may adhere to the walls of the ampoule or to the bottom and
therefore not be delivered. Therefore, take this into consideration during the preparation phase of
the medicine.
If you take more ASSOLID than you should
Do not exceed the recommended doses because, in case of excessive administration of
this medicine, in a short period of time, hormonal disorders may occur
(suppression of the hypothalamic-pituitary-adrenal function).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In particular:
- cough, lowering and alteration of the voice (hoarseness), mild and temporary burning of the nasal mucosa;
- fungal infections in the mouth or throat that have disappeared quickly after appropriate local therapy. These infections can be prevented or reduced if, after administering this medicine, the mouth is rinsed thoroughly;
- irritation of the nose, nosebleeds (epistaxis), stuffy nose, runny nose (rhinorrhea), sore throat, irritation of the mouth and throat. If these effects are severe, stop treatment;
- nasal congestion, appearance of benign nodules in the nose (nasal polyps).
In the case of prolonged treatments with high doses, the following effects may occur: problems
with the bones (osteoporosis), disorders of the stomach and intestines (peptic ulcer), symptoms due
to adrenal insufficiency (such as reduced blood pressure, weight loss, loss of appetite, abdominal
pain, fatigue, headache, nausea, vomiting, hypoglycemia with reduced
state of consciousness and/or convulsions) Cushing's syndrome, Cushingoid appearance (moon
face, obesity, red striae on the skin of the abdomen, swelling), delayed growth in children and
adolescents, reduced bone mineral density (osteoporosis), cataract (clouding of the
lens which is a type of lens located in the front part of the eye), glaucoma (increased
pressure inside the eye).
Furthermore, side effects that may occur, with unknown frequency, are:
- psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disorders (mainly in children). Another side effect that may occur with unknown frequency is blurred vision.
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
Reporting side effects can help provide more information on the safety of
this medicine.
5. How to store ASSOLID
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 label after Exp. The date
of expiry refers to the last day of that month.
Store in the original package to protect the medicine from light.
The opened package must be used within thirty days. Any excess product 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. Contents of the pack and other information
What ASSOLID contains
- The active ingredient is flunisolide. 100 ml of solution contains 100 mg of flunisolide. One drop contains 52 micrograms of flunisolide.
- The other ingredients are: Propylene glycol, Sodium chloride, Purified water
Description of the appearance of ASSOLID and contents of the pack
Solution for nebulisation. 30 ml bottle of solution at a concentration of 1 mg/ml.
Marketing Authorisation Holder
Konpharma s.r.l., via Pietro Della Valle 1, 00193 Roma
Manufacturer
GENETIC S.p.A.
Contrada Canfora – 84084 Fisciano (SA)
Italy
Lachifarma S.r.l. – Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Adriatica - Zona Industriale
73010 Zollino (LE)
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- Страна регистрации
- Форма выпускаSolution for nebulization, 0.1%
- Код АТХR03BA03
- 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 ASSOLIDФорма выпуска: Solution for nebulization, 0.1%Действующее вещество: flunisolideПроизводитель: S.F. GROUP S.R.L.Отпускается по рецептуФорма выпуска: Solution for nebulization, 0.1%Действующее вещество: flunisolideПроизводитель: PIAM FARMACEUTICI S.P.A.Отпускается по рецептуФорма выпуска: Solution for nebulization, 0.1%Действующее вещество: flunisolideПроизводитель: GENETIC S.P.A.Отпускается по рецепту
Аналоги ASSOLID в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог ASSOLID в Испания
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
ASSOLID требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ASSOLID — flunisolide. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ASSOLID 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 ASSOLID 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 ASSOLID 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 (flunisolide) включают AERFLU, AEROLID, ASMAFLU. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
