Інструкція із застосування TSOLISTAM
Зміст інструкції
Zolistam 10 mg modified-release tablets
mizolastine
Read this leaflet carefully before you start 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 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 Zolistam is and what it is used for
- 2. What you need to know before you take Zolistam
- 3. How to take Zolistam
- 4. Possible side effects
- 5. How to store Zolistam
- 6. Contents of the pack and other information
1. What is Zolistam and what is it used for
The active ingredient in Zolistam is mizolastine. Mizolastine is an antihistamine.
Zolistam is used to reduce the symptoms caused by:
- hay fever (seasonal allergic rhinoconjunctivitis)
- other allergic reactions that can cause irritation to the eyes and nose (persistent allergic rhinoconjunctivitis)
- urticaria (itchy skin rashes such as hives).
2. What you need to know before you take Zolistam
Do not take Zolistam
- if you are allergic to mizolastine or any of the other ingredients of this medicine (listed in section 6)
- if you are taking a macrolide antibiotic (e.g. erythromycin, clarithromycin, azithromycin)
- if you are taking an imidazole-based antifungal medicine (e.g. ketoconazole, fluconazole, itraconazole, used for the treatment of fungal infections)
- if you have liver problems
- if you have heart problems
- if you have previously had an irregular heartbeat or a very slow heart rate
- if you have an abnormal ECG (recording of the heart's electrical activity)
- if you are already taking medicines to treat irregular heartbeat
- if you suffer from an abnormality in the level of salts in the blood, in particular if potassium levels are low.
Tell your doctor or pharmacist before taking this medicine if you believe that any of the above conditions apply to you or if you have any doubts.
Warnings and precautions
Elderly– Zolistam can cause drowsiness and a fast or irregular heartbeat in some people – these effects are more common in the elderly.
Blood tests
Your doctor may prescribe periodic blood tests and other tests to monitor the effectiveness of the medicine, especially if:
- you suffer from diabetes (blood sugar levels are not controlled)
- the level of salts in the blood sometimes varies (electrolyte imbalance)
- you have heart rhythm problems (cardiac arrhythmia)
Other medicines and Zolistam
Tell your doctor or pharmacist if you are taking or have recently taken:
- a macrolide antibiotic such as e.g. erythromycin, clarithromycin, azithromycin
- an imidazole-based antifungal medicine such as e.g. ketoconazole, fluconazole, itraconazole. These medicines must not be taken in combination with Zolistam.
Tell your doctor or pharmacist if you are also taking:
- cimetidine (medicine used to treat stomach ulcers)
- cyclosporine (an immunosuppressant drug)
- nifedipine (medicine used to treat high blood pressure or heart disease) because these medicines can affect the levels of Zolistam (mizolastine) in the blood.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Zolistam with food and drink
Zolistam can be taken with food or between meals.
Zolistam does not alter the effects of alcohol. However, as with all medicines, do not consume alcohol in excess while taking Zolistam.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
The safety of mizolastine has not been established for use during pregnancy. However, as with all medicines, the use of mizolastine should be avoided during pregnancy, especially during the first trimester.
Mizolastine is excreted in breast milk, so the use of Zolistam is not recommended during breastfeeding.
Driving and using machines
Drowsiness may occur following the intake of this medicine. If this happens, do not use tools or machinery.
Zolistam contains lactose– Contact your doctor before taking Zolistam if you have been told by your doctor that you have an intolerance to some types of sugars.
Zolistam contains castor oil which can cause stomach upset and diarrhoea.
3. How to take Zolistam
Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult
your doctor or pharmacist.
Adults, including the elderly and children 12 years and older.
The usual dose is one tablet (10 mg) per day.
The tablets should be swallowed with plenty of water.
If you take more Zolistam than you should
If you believe you have taken too many Zolistam tablets, contact your doctor or the nearest emergency
room immediately.
If you forget to take Zolistam
If you forget to take a Zolistam tablet, take the next tablet at the usual time.
Do not take a double dose to make up for a missed tablet.
If you stop taking Zolistam
Tell your doctor if you wish to stop treatment before completing the course of therapy.
If you have any further questions on 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.
Inform your doctor immediately and stop treatment with Zolistam if you experience dizziness, swelling
of the face, lips, tongue or throat and difficulty breathing, as these signs could
be a manifestation of a serious allergic reaction.
Common side effects(may affect up to 1 in 10 people):
- dry mouth, headache, dizziness, drowsiness, lack of strength
- diarrhoea, nausea
- stomach pain, indigestion
- increased appetite associated with weight gain.
Uncommon side effects(may affect up to 1 in 100 people):
- anxiety and depression
- changes in the values found in blood tests that indicate liver function
- low blood pressure, fast or irregular heartbeat
- joint pain and muscle pain.
Very rare side effects(may affect up to 1 in 10,000 people):
- reduction in the number of white blood cells, which can lead to an increased incidence of infections
- serious allergic reactions that can cause dizziness, swelling of the face, lips, tongue or throat and difficulty breathing
- widespread skin rashes (urticaria), itching
- fainting.
Frequency not known(the frequency cannot be estimated from available data):
- vomiting
In addition, some subjects treated with Zolistam have reported: shortness of breath or difficulty breathing,
worsening of asthma or mild changes in blood sugar and salt levels. Your doctor may
request a series of blood tests to monitor progress.
Some antihistamines (anti-allergy medicines) have been associated with abnormalities in the recording
of the electrical activity of the heart, increasing the risk of irregular heartbeat.
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 www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Zolistam
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 after “Exp.” The expiry
date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
If Zolistam is supplied in aluminium/PVC blister packs or in polypropylene tubes with a
polyethylene closing cap, do not store at a temperature above 25°C.
If supplied in aluminium/(oPA/aluminium/PVC) blister packs, Zolistam does not require any particular
storage temperature.
Refer to the storage conditions stated on the pack.
Do not use Zolistam if you notice that the tablets change colour.
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 Zolistam contains
- The active ingredient is mizolastine.
- Each tablet contains 10 mg of mizolastine.
- The other components are: o Core: hydrogenated castor oil, lactose monohydrate, microcrystalline cellulose, tartaric acid, povidone, anhydrous colloidal silica, magnesium stearate. o Coating: hypromellose, titanium dioxide (E171), propylene glycol.
Description of the appearance of Zolistam and contents of the pack
The tablets are oblong, white, with a score line on one side and the marking “MZI 10”
on the other.
The medicinal product is available in packs of 4, 7, 10, 15, 20, 30, 50 or 100 tablets in blisters in
aluminium/(oPA/aluminium/PVC), in aluminium/PVC or in polypropylene containers with a
polyethylene closing cap.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milano - Italy
Exclusive distributor for sales:
Farmaceutici Caber S.r.l. - Via del Mare, 36 - Pomezia (RM)
Manufacturers
Sanofi Winthrop Industrie
- 30 - 36 Avenue Gustave Eiffel 37100 Tours - France
or
Pharmasearch Limited
IDA Industrial Estate
Dublin Road
Loughrea
CO.GALWAY - Ireland

- Країна реєстрації
- Лікарська формаModified-release tablet, 10 MG
- Код АТХR06AX25
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до TSOLISTAMЛікарська форма: Film-coated tablet, 5 MGДіюча речовина: ДеслоратадинВиробник: N.V. ORGANONПотрібен рецептЛікарська форма: Coated tablet, 20 MGДіюча речовина: БиластинВиробник: AUROBINDO PHARMA (ITALIA) S.R.L.Потрібен рецептЛікарська форма: Film-coated tablet, 5 MGДіюча речовина: ДеслоратадинВиробник: S.F. GROUP S.R.L.Потрібен рецепт
Аналоги TSOLISTAM в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог TSOLISTAM у Іспанія
Лікарі онлайн щодо TSOLISTAM
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на TSOLISTAM онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
TSOLISTAM потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у TSOLISTAM — mizolastine. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
TSOLISTAM виробляється компанією OPELLA HEALTHCARE ITALY S.R.L.. 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 TSOLISTAM 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 TSOLISTAM 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 (mizolastine) включають AERIUS, ALYNE, AREMAS. 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.
















