FLUNISOLIDE 0.1% Solution for nebulization
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Інструкція із застосування FLUNISOLIDE MYLAN JENERIKS
Зміст інструкції
Flunisolide Mylan Generics 0.1% solution for nebulizer
flunisolide
Generic medicine
Read this leaflet carefully before using 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Flunisolide Mylan Generics is and what it is used for
- 2. What you need to know before using Flunisolide Mylan Generics
- 3. How to use Flunisolide Mylan Generics
- 4. Possible side effects
- 5. How to store Flunisolide Mylan Generics
- 6. Contents of the pack and other information
1. What is Flunisolide Mylan Generics and what it is used for
This medicine contains the active ingredient flunisolide, which belongs to a group of medicines
called anti-inflammatory steroid drugs (“FAS”, glucocorticoids).
Flunisolide Mylan Generics is indicated for the treatment of allergic conditions affecting the
respiratory tract, such as:
- inflammation of the bronchi with difficulty in breathing (bronchial asthma, broncho-stenosis and chronic asthmatic bronchitis);
- chronic and seasonal rhinitis, including hay fever.
2. What you need to know before using Flunisolide Mylan Generics
Do not use Flunisolide Mylan Generics
- if you are allergic to flunisolide or to any of the other ingredients of this medicine (listed in section 6);
- if you have a lung infection (active or inactive pulmonary tuberculosis);
- if you have infections caused by bacteria, viruses or fungi;
- if you are pregnant or if you are breastfeeding (see the section “Pregnancy and breastfeeding”).
Warnings and precautions
Consult your doctor or pharmacist before using Flunisolide Mylan Generics.
Avoid using this medicine for prolonged periods and at high doses because side effects may occur
such as Cushing's syndrome (a condition caused by excessive production of a hormone, cortisol), Cushingoid appearance (characterized by localized obesity predominantly in the abdomen, face and
back), mucosal problems (atrophy), adrenal insufficiency (inability of the adrenal glands to
produce a sufficient amount of cortisol), bone fragility, eye problems (cataracts and glaucoma)
growth retardation in children and adolescents, bone fragility, eye problems (cataracts and
glaucoma), hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disorders
(especially in children) (see section “Possible side effects”).
If you use Flunisolide Mylan Generics for prolonged periods, allergic reactions may also occur
(sensitization phenomena).
Stop treatment if you experience any of these effects and do not exceed the recommended doses.
Consult your doctor if you cannot see well or experience other vision problems.
This medicine may mask the symptoms of infections and may cause new infections to occur.
Take special care in the following cases:
- if you need to switch from systemic corticosteroid therapy to treatment with flunisolide, especially if you are in a period of stress or have had a severe asthma attack, as this medicine may cause adrenal insufficiency. If this occurs, discontinue treatment gradually. The replacement of systemic corticosteroid therapy with topical 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.
- if you have severe nasal congestion or abundant mucus (secretion). In this case, initial treatment with medicines (topical vasoconstrictors) that clear the airways may be necessary to allow the aerosol to come into contact with the mucosa.
- if you have a lung infection (active or inactive tuberculosis infections) or have an infection not treated by fungi, bacteria or viruses or have an eye infection caused by the Herpes simplexvirus. Consult your doctor as, in these cases, it may be appropriate to avoid using this medicine.
- if you have or have had nasal trauma in the past, with lesions of the nasal septum or continuous nosebleeds (epistaxis), as this medicine delays wound healing (scarring processes);
- if you experience an alteration of the bacteria (flora) present in the respiratory tract (dysbiosis) during treatment. Consult your doctor as coverage therapy may be necessary.
- if you have an asthma attack in progress, as the medicine is not effective because its effect manifests only after a few days of treatment;
- if you experience symptoms of adrenal insufficiency such as loss of appetite (anorexia), abdominal pain, weight loss, fatigue, headache, nausea, vomiting, decreased blood glucose (hypoglycemia) with decreased consciousness and/or convulsions. These effects may occur following trauma, surgery, infections and rapid dose reduction.
For those who engage in sports: the use of this medicine without therapeutic necessity constitutes doping and
may still result in a positive doping test.
Children and adolescents
Avoid using this medicine for prolonged periods and at high doses because side effects may occur
such as growth retardation, hyperactivity, sleep disturbances, anxiety, depression, aggression and
behavioral disorders (especially in children) (see section 4).
Other medicines and Flunisolide Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
Some medicines may increase the effect of Flunisolide Mylan Generics and your doctor may want to
monitor you closely if you are taking these medicines (including some medicines for the
treatment of HIV: ritonavir, cobicistat).
Flunisolide Mylan Generics can be used during therapy with bronchodilators, chemotherapeutic agents and
in the replacement phase of oral corticosteroid therapy.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use Flunisolide Mylan Generics during the first three months of pregnancy.
Use this medicine after the first three months of pregnancy only if necessary and under the direct control of
your doctor.
Breastfeeding
If you are breastfeeding, use this medicine only if strictly necessary and under the direct
control of your doctor.
This medicine contains 518 mg of propylene glycol per dose (1 mg) equivalent to 20.72 mg/kg/day.
Driving and using machines
No data are available to establish the effects of Flunisolide Mylan Generics on the ability to drive
vehicles and operate machinery.
3. How to use Flunisolide Mylan Generics
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Method of administration:Use Flunisolide Mylan Generics with electric nebulizers, including ultrasonic ones, and
it can be diluted with physiological solution. The use of nebulizers may result in the production of residue
of the medicine that may adhere to the walls of the ampoule or to the bottom and therefore not be delivered. Take
this into account during the preparation phase of the medicine.
The recommended dose in adults is 1 mg (25 drops) twice a day.
Use in children
The recommended dose is 20 micrograms / Kg (corresponding to half a drop / Kg) twice a day.
To determine the dose based on weight, refer to the following table:
Instructions for use
- 1) To open the bottle, apply pressure to the dropper cap and twist it counterclockwise simultaneously.
- 2) After use, close the bottle by screwing the cap clockwise. Flunisolide Mylan Generics must be used with electric nebulizers, including ultrasonic ones, and can be diluted with physiological solution. Flunisolide Mylan Generics can be used during therapies with bronchodilators, chemotherapeutic agents and with corticosteroids in the replacement phase of oral corticosteroid therapy. If you use more Flunisolide Mylan Generics than you should
| Body weight | 5-7 kg | 8-10 kg | 11-13 kg | I 14-16 kg | 17-19 kg | 20-22 kg | 23-25 kg | 26-28 kg | 29-31 kg | 32-34 kg | 35-37 kg | 38-40 kg | >40 kg |
| Drops | 3 | 5 | 6 | 8 | 9 | 11 | 12 | 14 | 15 | 17 | 18 | 20 | 25 |
| mg | 0.12 | 0.20 | 0.24 | a 0.32 | 0.36 | 0.44 | 0.48 | 0.56 | 0.60 | 0.68 | 0.72 | 0.80 | 1.0 |
If you (or someone else) have used an excessive dose of Flunisolide Mylan Generics or if you think a
child may have accidentally used this medicine, immediately notify your doctor or
go to the nearest hospital Emergency Room.
Bring this leaflet, the bottle and its container to the hospital or doctor so they know
which medicine was taken.
In case of excessive use of this medicine in a short period of time, hormonal disorders may occur due to a block of the connection between the brain and the adrenal glands (suppression of the
hypothalamic-pituitary-adrenal function). If you experience these effects, reduce the dose immediately.
If you forget to use Flunisolide Mylan Generics
Do not use a double dose to make up for a missed dose.
If you stop using Flunisolide Mylan Generics
Do not abruptly stop treatment with this medicine. Before stopping treatment, consult your doctor who will tell you how to reduce the dosage gradually.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor if you experience any of the following side effects:
- cough, lowering and alteration of the voice (hoarseness), mild and temporary burning of the nasal mucosa;
- fungal infections in the mouth or throat. These infections can be prevented or reduced if, after administering this medicine by aerosol, the mouth is rinsed thoroughly.
- irritation of the nose, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhea), sore throat, irritation of the mouth and throat. If these effects are severe, stop treatment.
- nasal congestion, the appearance of benign nodules in the nose (nasal polyps), bone problems (osteoporosis), stomach and intestinal disorders (peptic ulcer), symptoms due to adrenal insufficiency such as low blood pressure and weight loss.
During prolonged treatment and with high doses, the following side effects may also occur:
Cushing's syndrome (a condition caused by excessive production of a hormone, cortisol), Cushingoid appearance (characterized by localized obesity predominantly in the abdomen, face and
back), adrenal insufficiency (inability of the adrenal glands to produce a sufficient amount
of cortisol), growth retardation in children and adolescents, bone fragility, eye problems
(cataract and glaucoma) and blurred vision, hyperactivity, sleep disorders, anxiety, depression, aggression,
behavioral disorders (especially in children) (see section “Warnings and precautions”).
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 Flunisolide Mylan Generics
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the bottle after Expiry. The expiry
date refers to the last day of that month.
Do not store at a temperature above 25°C. Store the product in the original packaging to
protect it from light.
Use this medicine within 30 days of first opening the bottle. Discard any remaining medicine.
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 Flunisolide Mylan Generics contains
The active ingredient is flunisolide. 100 ml of solution contains 100 mg of flunisolide (1 drop contains 40
micrograms of flunisolide).
The other ingredients are: propylene glycol, sodium chloride, purified water.
Description of the appearance of Flunisolide Mylan Generics and contents of the pack
Pack containing a 30 ml bottle.
Marketing authorisation holder and manufacturer
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)
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- Країна реєстрації
- Лікарська формаSolution for nebulization, 0.1%
- Код АТХR03BA03
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до FLUNISOLIDE MYLAN JENERIKSЛікарська форма: Solution for nebulization, 0.1%Діюча речовина: flunisolideВиробник: S.F. GROUP S.R.L.Потрібен рецептЛікарська форма: Solution for nebulization, 0.1%Діюча речовина: flunisolideВиробник: PIAM FARMACEUTICI S.P.A.Потрібен рецептЛікарська форма: Solution for nebulization, 0.1%Діюча речовина: flunisolideВиробник: GENETIC S.P.A.Потрібен рецепт
Аналоги FLUNISOLIDE MYLAN JENERIKS в інших країнах
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Аналог FLUNISOLIDE MYLAN JENERIKS у Іспанія
Лікарі онлайн щодо FLUNISOLIDE MYLAN JENERIKS
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Часті запитання
FLUNISOLIDE MYLAN JENERIKS потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у FLUNISOLIDE MYLAN JENERIKS — flunisolide. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
FLUNISOLIDE MYLAN JENERIKS виробляється компанією MYLAN S.P.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування FLUNISOLIDE MYLAN JENERIKS з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати FLUNISOLIDE MYLAN JENERIKS у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (flunisolide) включають AERFLU, AEROLID, ASMAFLU. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
