FOSFOMICINA 3 G Granulki do sporządzania roztworu doustnego
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Treść ulotki
FOSFOMICINA DOC Adults 3 g granules for oral solution
Generic medicine
Read this leaflet carefully before taking this medicine because 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, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What is FOSFOMICINA DOC and what it is used for
- 2. What you need to know before you take FOSFOMICINA DOC
- 3. How to take FOSFOMICINA DOC
- 4. Possible side effects
- 5. How to store FOSFOMICINA DOC
- 6. Contents of the pack and other information
1. What is FOSFOMICINA DOC and what is it used for
Fosfomicina belongs to a group of medicines called urinary antimicrobial agents.
FOSFOMICINA DOC is indicated in the prevention and treatment of acute uncomplicated lower urinary tract infections caused by germs sensitive to fosfomicina.
2. What you need to know before you take FOSFOMICINA DOC
Do not take FOSFOMICINA DOC
- if you are allergic to fosfomicina or to any of the other ingredients of this medicine (listed in section 6);
- if you have severe kidney problems;
- if you have difficulty urinating;
- if you are undergoing hemodialysis. Children under 12 years of age should not take this medicine.
Warnings and precautions
Talk to your doctorbefore taking FOSFOMICINA DOC if you are in any of the following conditions:
- if you have previously shown symptoms of allergic reactions to fosfomicina because, during treatment, severe life-threatening allergic reactions may occur. If reactions of this type occur, stop taking the medicine and consult a doctor immediately.
- if you experience severe or prolonged diarrhea during or after use of the medicine (even weeks after the last dose) as it may be a symptom of a severe inflammation of the intestine (pseudomembranous colitis).
- if you think you may be pregnant or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
Other medicines and FOSFOMICINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant administration of metoclopramide (a medicine that prevents vomiting) reduces the oral absorption of fosfomicina. Other drugs that increase gastrointestinal motility may produce similar effects.
Concomitant administration of antacids or calcium salts may cause a reduction in plasma and urinary concentrations of fosfomicina.
With the use of fosfomicina, an increase in the activity of some anticoagulants (vitamin K antagonists) may occur. It is not clear whether this effect is due to the medicine or the ongoing infection.
FOSFOMICINA DOC with food and drink
Food may delay the absorption of fosfomicina trometamol, resulting in a reduction in peak plasma concentrations and urinary concentrations. Therefore, it is recommended to administer FOSFOMICINA DOC on an empty stomach (one hour before or 2-3 hours after a meal).
Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. FOSFOMICINA DOC should only be administered to pregnant or breastfeeding women if a real therapeutic need exists.
Driving and using machines
Dizziness may occur with the use of fosfomicina. This may affect your ability to drive vehicles and use machines.
Important information about some excipients:
This medicine contains sucrose: patients with intolerance to sugars should contact their doctor before taking this medicine; use with caution in patients with diabetes or who are following a low-calorie diet.
This medicine contains sunset yellow FCF (E110) which may cause allergic reactions.
This medicine contains saccharin.
3. How to take FOSFOMICINA DOC
Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The doctor will prescribe the duration of treatment. Do not interrupt the treatment before as established by him
because in this case the expected results may not be obtained.
The contents of one sachet must be dissolved in half a glass (50-75 ml) of cold water or other
beverage, mixing until completely dissolved and must be taken immediately after
preparation.
It is recommended to administer FOSFOMICINA DOC on an empty stomach (see "FOSFOMICINA DOC
with food and beverages”), preferably before bedtime after emptying the bladder.
Dosage
Adults and adolescents (12-18 years)
In acute uncomplicated infections of the lower urinary tract sustained by germs sensitive to fosfomycin, the
dosage is one 3 g sachet in a single daily administration.
In the prevention of urinary tract infections in surgical procedures and transurethral diagnostic maneuvers,
treatment involves the administration of two 3 g doses: the first sachet is administered
3 hours before the procedure, the second sachet is administered 24 hours after the first dose.
Generally, clinical symptoms disappear after 2-3 days.
The eventual persistence of some local symptoms after treatment is not necessarily an expression of
therapeutic failure, but a more probable consequence of previous inflammatory processes.
Elderly and other clinically relevant situations:
In elderly patients and in clinically more challenging cases (bedridden patients, recurrent infections)
two 3 g doses may be necessary, administered 24 hours apart.
If you take more FOSFOMICINA DOC than you should
If you accidentally take doses of FOSFOMICINA DOC higher than those prescribed, contact
immediately your doctor or pharmacist.
In case of overdose it is necessary to promote the urinary elimination of the active ingredient through
adequate administrationof fluids.
If you forget to take FOSFOMICINA DOC
If you forget to take a dose of the medicine, do not take a double dose to compensate for the missed dose
of the dose.
If you forget to take a dose of medicine, take it as soon as you remember; however, if the time
to take the next dose is near, skip taking the dose you forgot and take the next dose
at the prescribed time.
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.
Contact your doctor as soon as possible if you experience any of the following side effects.
Common(may affect up to 1 in 10 people):
- vulvovaginitis, headache, dizziness, digestive problems such as diarrhea, dyspepsia (feeling of fullness with acidity), nausea.
Uncommon(may affect up to 1 in 1,000 people):
- paresthesia (altered sensitivity of some parts of the body), vomiting, abdominal pain, skin rash, urticaria, itching, fatigue. Rare(may affect up to 1 in 10,000 people):
- superinfections from antibiotic-resistant bacteria, tachycardia (fast heartbeat), aplastic anemia (reduction in the number of red blood cells). Other side effectshave been observed, but their frequency cannot be established from the available data; these include:
- skin reactions with redness, urticaria (itchy red blisters) and angioedema (swelling) and anaphylaxis (severe allergic or hypersensitivity reactions). If you experience reactions of this type, stop taking the medicine and consult your doctor or pharmacist immediately;
- vision disturbances;
- colitis (inflammation of the intestine) associated with antibiotics;
- loss of appetite;
- phlebitis (formation of blood clots in the veins);
- hypotension (low blood pressure);
- asthma;
- dyspnea (breathing problems);
- bronchospasm (severe difficulty breathing);
- liver problems with a transient increase in liver enzymes (transaminases);
- angioedema (swelling);
- slight increase in the count of eosinophilic leukocytes and platelets (blood cells), slight petechial reaction (small red spots on the skin).
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 “www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store FOSFOMICINA DOC
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 pack and on the sachet. The expiry date
refers to the last day of that month.
Storage conditions:
store in the original package.
Do not dispose of any medicine in the 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 FOSFOMICINA DOC contains
- The active substance is fosfomycin trometamol. Each sachet contains 3.0 g of fosfomycin (corresponding to 5.631 g of fosfomycin trometamol).
- The other ingredients are: sodium saccharin (E954), sucrose, calcium hydroxide (E526), orange aroma (contains: maltodextrin, dextrose, gum arabic (E414), sunset yellow FCF (E110), butylated hydroxyanisole BHA (E320)).
Description of the appearance of FOSFOMICINA DOC and contents of the pack
FOSFOMICINA DOC is available in sachets containing white or almost white granules to be dissolved in
water or another beverage.
The pack contains 1 or 2 sachets of 3 g.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano - Italy.
Manufacturer:
Special Product’s Line S.p.A. - Strada Paduni 240 - 03012 Anagni (Frosinone) – Italy.
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- Kraj rejestracji
- Postać farmaceutycznaGranules for oral solution, 3 G
- Kod ATCJ01XX01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki FOSFOMIKINA DOKPostać farmaceutyczna: Granules for oral solution, 3 GSubstancja czynna: fosfomycinWymaga receptyPostać farmaceutyczna: Granules for oral solution, 3 gSubstancja czynna: fosfomycinProducent: PHARMACARE S.R.L.Wymaga receptyPostać farmaceutyczna: Granules for oral solution, 3 GSubstancja czynna: fosfomycinProducent: AUROBINDO PHARMA (ITALIA) S.R.L.Wymaga recepty
Odpowiedniki FOSFOMIKINA DOK w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik FOSFOMIKINA DOK w Hiszpania
Odpowiednik FOSFOMIKINA DOK w Polska
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Często zadawane pytania
FOSFOMIKINA DOK wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w FOSFOMIKINA DOK jest fosfomycin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
FOSFOMIKINA DOK jest produkowany przez DOC GENERICI SRL. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie FOSFOMIKINA DOK jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić FOSFOMIKINA DOK w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (fosfomycin) to m.in. BERNY, DANIFOS, FOSFOMIKINA AUROBINDO. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
