Інструкція із застосування DANIFOS
Зміст інструкції
DANIFOS ADULTI 3 G GRANULATO PER SOLUZIONE ORALE
fosfomicina trometamolo
Generic 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 they have the same symptoms as you, 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 DANIFOS is and what it is used for
- 2. What you need to know before you take DANIFOS
- 3. How to take DANIFOS
- 4. Possible side effects
- 5. How to store DANIFOS
- 6. Contents of the pack and other information
1. What is DANIFOS and what is it used for
DANIFOS contains the active ingredient fosfomycin (as fosfomycin trometamol).
It is an antibiotic that works by killing bacteria that can cause infections.
DANIFOS is used to treat uncomplicated bladder infections in women and adolescents (>12 years).
DANIFOS is used as perioperative antibiotic prophylaxis for transrectal prostate biopsy in adult
men.
2. What you need to know before you take DANIFOS
Do not take DANIFOS
- if you are allergic to fosfomycin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist,before taking DANIFOS, if you suffer from any of the following conditions:
- persistent bladder infections
- previous episodes of diarrhoea after taking other antibiotics.
Conditions you should pay attention to
DANIFOS can cause serious side effects. These include allergic reactions and inflammation
of the large intestine. You should pay attention to some symptoms while taking this medi-
cine to reduce the risk of any problems. See “Serious side effects” in section 4.
Children and adolescents
Do not give this medicine to girls under the age of 12, as its safety
and efficacy have not been evaluated in this age group.
Other medicines and DANIFOS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription.
This is particularly important if you are taking:
- metoclopramide or other medicines that increase the movement of food through the stomach and intestines, because they can reduce the absorption of fosfomycin by your body;
- anticoagulants, as their ability to prevent blood clotting may be altered by fosfomycin and other antibiotics.
DANIFOS with food
Food can delay the absorption of fosfomycin. Therefore, this medicine should be taken on
an empty stomach (2-3 hours before or 2-3 hours after a meal).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, your doctor will only give you this medicine when it is clearly necessary.
Women who are breastfeeding can take a single oral dose of this medicine.
Driving and using machines
You may experience side effects such as dizziness, which can affect your ability to drive
vehicles or use machines.
DANIFOS contains sucrose
If your doctor has told you that you have an intolerance to some sugars, contact them before taking this
medicine.
DANIFOS contains sunset yellow FCF (E110)
It may cause allergic reactions.
DANIFOS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.
3. How to take DANIFOS
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
In case of treatment of uncomplicated bladder infection, in women and adolescents the recommended dose is 1 sachet of DANIFOS (3 g of fosfomycin).
If used as perioperative antibiotic prophylaxis for prostate biopsy, the recommended dose is 1 sachet of
DANIFOS (3 g of fosfomycin) 3 hours before the procedure and 1 sachet of DANIFOS (3 g of fosfomycin) 24 hours
after the procedure.
Use in patients with renal impairment
This medicine should not be used in patients with severe renal impairment (creatinine clearance <10 ml/min).
Use in children and adolescents
This medicine should not be used in girls under the age of 12 years.
Method of administration
For oral use.
Take this medicine by mouth, on an empty stomach (2-3 hours before or 2-3 hours after a meal), preferably
before going to bed, after emptying the bladder.
Dissolve the contents of one sachet in a glass of water and drink immediately.
If you take more DANIFOS than you should
If you accidentally take more than the prescribed dose, contact your doctor or pharmacist.
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.
manifest.
Serious side effects
While taking DANIFOS, if you develop any of the following symptoms, you should stop taking the medicine and contact your doctor immediately:
- anaphylactic shock, a type of potentially life-threatening allergic reaction (frequency not known). Symptoms include the sudden appearance of skin rashes, itching or hives on the skin and/or shortness of breath, wheezing or difficulty breathing
- swelling of the face, lips, tongue or throat with difficulty breathing (angioedema) (frequency not known)
- moderate to severe diarrhea, abdominal cramps, blood in the stool and/or fever may mean you have an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take medicines against diarrhea that inhibit intestinal motility (antidiarrheals).
Other side effects
Common(may affect up to 1 in 10 people):
- headache
- dizziness
- diarrhea
- nausea
- indigestion
- abdominal pain
- infection of the female genital organs, with symptoms such as inflammation, irritation, itching (vulvovaginitis).
Uncommon(may affect up to 1 in 100 people):
- vomiting
- skin rash
- urticaria
- itching.
Rare(may affect up to 1 in 1000 people):
- serious bacterial infections (superinfections caused by resistant bacteria)
- reduction in the number of red blood cells (aplastic anemia).
Not known(frequency cannot be estimated based on available data):
- allergic reactions
- constriction of the bronchi (bronchospasm)
- increased white blood cells (eosinophils) and platelets
- inflammation of the veins (phlebitis)
- loss of appetite (anorexia)
- vision disorders.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at: http://www.aifa/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store DANIFOS
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 and on the sachet after
Exp. The expiry date refers to the last day of that month.
Store in the original packaging. After preparation of the solution, the medicine must be taken immediately.
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 DANIFOS contains
The active ingredient is fosfomycin trometamol.
Each sachet of DANIFOS adults 3 g granules for oral solution contains 3.0 g of fosfomycin (as fo-
sfomycin trometamol 5.631 g).
The other excipients are: orange flavour (contains: maltodextrin, gum arabic (E414), sunset yellow
FCF (E110), butylated hydroxyanisole BHA (E320)), sodium saccharin sucrose, magnesium citrate.
Description of the appearance of DANIFOS and contents of the pack
DANIFOS is available in sachets containing white or almost white granules to be dissolved in water or in
another beverage.
The pack contains 1 or 2 sachets of 3 g.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 Milano
Italy
Manufacturer
LA.FA.RE. Farmaceutici S.r.l.
Via Sacerdote Benedetto Cozzolino, 77
80056 Ercolano (NA)
Italy
- Країна реєстрації
- Лікарська формаGranules for oral solution, 3 g
- Код АТХJ01XX01
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до DANIFOSЛікарська форма: Granules for oral solution, 3 GДіюча речовина: фосфомицинПотрібен рецептЛікарська форма: Granules for oral solution, 3 GДіюча речовина: фосфомицинВиробник: AUROBINDO PHARMA (ITALIA) S.R.L.Потрібен рецептЛікарська форма: Granules for oral solution, 3 GДіюча речовина: фосфомицинВиробник: DOC GENERICI SRLПотрібен рецепт
Аналоги DANIFOS в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог DANIFOS у Іспанія
Аналог DANIFOS у Польща
Аналог DANIFOS у Україна
Лікарі онлайн щодо DANIFOS
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на DANIFOS 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
DANIFOS потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у DANIFOS — фосфомицин. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
DANIFOS виробляється компанією PHARMACARE 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 DANIFOS 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 DANIFOS 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 (фосфомицин) включають BERNY, FOSFOMIKINA AUROBINDO, FOSFOMIKINA DOK. 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.
















