NITROFURANTOINA 50 mg Kapsułki Twarde

Treść ulotki

1. Nitrofurantoina Mylan Pharma 50 mg hard capsules, 100 mg hard capsules
   1. What is Nitrofurantoina Mylan Pharma and what is it used for
   2. What you need to know before taking Nitrofurantoina Mylan Pharma
   3. How to take Nitrofurantoina Mylan Pharma
   4. Possible side effects
   5. How to store Nitrofurantoina Mylan Pharma
   6. Package Contents and Other Information

Nitrofurantoina Mylan Pharma 50 mg hard capsules, 100 mg hard capsules

Nitrofurantoina

Generic medicine

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, pharmacist or nurse.
‐ 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 may be harmful.
‐ If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Nitrofurantoina Mylan Pharma is and what it is used for
• 2. What you need to know before you take Nitrofurantoina Mylan Pharma
• 3. How to take Nitrofurantoina Mylan Pharma
• 4. Possible side effects
• 5. How to store Nitrofurantoina Mylan Pharma
• 6. Contents of the pack and other information

1. What is Nitrofurantoina Mylan Pharma and what is it used for

Nitrofurantoina Mylan Pharma belongs to a class of medicines called nitrofurans. The active ingredient, nitrofurantoin, kills most of the bacteria that cause urinary tract infections.
Nitrofurantoina Mylan Pharma is used to treat acute (sudden) urinary tract infections.
A urinary tract infection is an inflammation of the urinary tract. This infection can cause
symptoms such as pain and burning during urination, frequent urination in small amounts, and pain in the
lower abdomen.
Nitrofurantoina Mylan Pharma treats these symptoms. This medicine is also prescribed for the
prevention of infections (for example, due to the insertion of a urinary catheter or in case of
surgery on the urinary tract).
Nitrofurantoina Mylan Pharma may sometimes be used for the long-term treatment of persistent
urinary tract infections that are resistant to other medicines.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Nitrofurantoina Mylan Pharma

Do not take Nitrofurantoina Mylan Pharma

• If you are allergic to nitrofurantoin or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from a severe kidney disease (ask your doctor if you are unsure)
• If you suffer from porphyria (reduced production of red pigment in the blood)
• If you are deficient in an enzyme called G6PD (glucose-6-phosphate dehydrogenase), which can quickly damage red blood cells
• In children under 3 months of age
• If you have ever had a lung or liver reaction or peripheral neuropathy (tingling,

numbness or weakness in the limbs) while using nitrofurantoin or other nitrofurans.
If you are not sure if any of the above applies to you, consult your doctor.

Warnings and precautions
Talk to your doctor if you experience fatigue, yellowing of the skin or eyes, itching, skin rashes, joint pain, abdominal discomfort, feeling unwell (nausea), vomiting, loss of
appetite, dark urine and pale or gray stools. These may be symptoms of a liver disease.
During long-term treatment, especially in elderly people, regular monitoring is required in order to detect possible side effects as early as possible.
In some individuals of Black or Afro-Caribbean, Mediterranean, Middle Eastern or
West Asian origin, anemia may develop during treatment. If you belong to this
group and experience fatigue (feeling tired), dizziness and shortness of breath during
treatment, stop taking this medicine and contact your doctor.
If you experience a feeling of tingling or numbness in your hands or feet during treatment or
a feeling of weakness in the limbs, stop taking this medicine and contact your
doctor. The possibility of these side effects increases when, for example, your kidneys are not
functioning properly. If you have diabetes or are anemic, or suffer from a condition that causes severe weakness
or have had allergic reactions previously, inform your doctor.
Problems with the lungs or liver may occur: see “Possible side effects”. If such problems occur, the use of Nitrofurantoina Mylan Pharma must be stopped
immediately.

Other medicines and Nitrofurantoina Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Some of these medicines can change the effect of Nitrofurantoina
Mylan Pharma.

• Antacids for indigestion (e.g. magnesium trisilicate).
• Medicines for gout (e.g. probenecid or sulfinpyrazone).
• Medicines that slow down the passage of food through the stomach (e.g. atropine, hyoscine).
• Medicines to treat increased pressure in the eye (glaucoma), such as carbonic anhydrase inhibitors (e.g. acetazolamide).
• Medicines to reduce the acidity of the urine (e.g. potassium citrate mixture).
• Medicines to treat infections, known as quinolones.
• Typhoid vaccine, given to prevent typhoid fever.

If you are unsure about any of these medicines, ask your doctor or pharmacist for advice.
Nitrofurantoina Mylan Pharma can affect the results of a number of tests for determining
glucose in the urine.

Nitrofurantoina Mylan Pharma with food and drink
Nitrofurantoina Mylan Pharma should always be taken with food or milk. Taking this
medicine with food or milk makes it more effective and will help prevent stomach upset.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
As far as is known, nitrofurantoin can be taken during pregnancy. However, it should not be used
during labour or delivery because use in these stages may cause harm to the baby.
If you wish to breastfeed, ask your doctor before taking this medicine.

Driving and operating machinery
Nitrofurantoina Mylan Pharma can cause dizziness and drowsiness. If you experience these disorders, wait
until they have disappeared before driving vehicles or operating machinery.

Nitrofurantoina Mylan Pharma contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Nitrofurantoina Mylan Pharma

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
Nitrofurantoina Mylan Pharma capsules should be taken orally, swallowed with meals or with
a little milk or yogurt. This way the medicine is better tolerated and leads to better results.
The recommended dose is:

Acute uncomplicated lower urinary tract infections:
For adults and children over 12 years of age, 1 capsule of 50 mg, 4 times a day (1 capsule with
each meal and 1 before bedtime). Generally use for 5 to 7 days or at least for 3 days after the
urine is no longer infected.
In children aged between 5 and 12 years: 3 to 6 mg/kg of body weight per day divided into
4 doses per day, for 7 days or at least for 3 days after the urine is no longer infected.
These capsules may not be suitable for use in children of this age group.

Short-term prophylaxis of urinary tract surgery and bladder catheter insertion
(adults and children over 12 years of age):
4 x 50 mg per day on the day of surgery and for the next 3 days.

Long-term treatment of urinary tract infections(adults and children over 12 years of age):
1 capsule of 50 or 100 mg per day usually in the evening before bedtime and after the last urination: for
a maximum of 6 months.
When you start treatment, symptoms may decrease rapidly, usually within 1-3 days.
They usually disappear completely at the end. However, it is always necessary to complete
the entire treatment cycle completely. The symptoms may have disappeared, but this does not
mean that all bacteria have already been killed. If you stop treatment too early, the symptoms
may quickly return, which is annoying for you and medically inappropriate. If, after 3 days, the discomfort has not disappeared or has not been significantly reduced, contact
your doctor again.

If you take more Nitrofurantoina Mylan Pharma than you should
Contact your doctor or pharmacist immediately or go to the nearest hospital emergency room.
Always bring the remaining capsules, the container and the package with you, so that the
medical staff knows what you have taken.

If you forget to take Nitrofurantoina Mylan Pharma
Do not worry. If you remember later on the same day, take the dose for that day as usual.
If you skip a dose for an entire day, take the normal dose the next day. Do not take a
double dose to make up for a missed dose. If you have any doubts, ask your doctor or
pharmacist.

If you stop taking Nitrofurantoina Mylan Pharma
Your doctor will tell you how long to take the medicine. Do not stop treatment before
you are told to, even if you feel better. Talk to your doctor, pharmacist or nurse if you want to
stop treatment earlier.
If you have any questions about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are rare.
If you experience sudden shortness of breath, difficulty breathing, swelling of the eyelids, face or
lips, skin rash or itching (especially widespread over the body), stop
taking this medicine and seek immediate medical attention.
If any of the following side effects occur, stop taking
Nitrofurantoina Mylan Pharma and consult your doctor.
The urine of patients taking nitrofurantoin may present a colour ranging from dark yellow to
brown. This is normal and disappears after treatment.
If you notice any of the following side effects, inform your doctor immediately:

• Lung problems. These can develop rapidly, within a week of starting treatment, or very slowly, especially in elderly patients, and can cause fever, chills, cough and shortness of breath associated with pneumonia and tissue damage.
• Nitrofurantoin can cause liver inflammation, resulting in jaundice (yellowing of the skin and/or eyes).
• Blood cells have been affected in some patients, causing bruising, delayed blood clotting, sore throat, fever, anaemia and sensitivity to cold or persistent colds.
• increased pressure in the skull (which causes severe headaches)
• severe allergic skin reactions (DRESS syndrome)
• various skin reactions, including skin peeling (dandruff), redness, rash or fever accompanied by a rapid heart rate and severe rash associated with blisters.

Very common (may affect more than 1 in 10 people):

• urinary tract infection due to bacteria not sensitive to nitrofurantoin
• temporary hair loss

Rare (may affect up to 1 in 1,000 people):

• loss of appetite
• feeling unwell (nausea)
• loss of consciousness (collapse)
• greyish or bluish discoloration of the skin, nails, lips or around the eyes (cyanosis)

Not known (frequency cannot be estimated from available data):

• headache
• diarrhoea
• stomach pain, feeling unwell (vomiting)
• dizziness, drowsiness
• neurological disorders, resulting in changes in sensation and muscle activity. Also, headache, extreme mood changes or mental disorders, confusion, weakness, visual disturbances.
• a feeling or state of intense excitement and happiness (euphoria)
• other reactions may include: inflammation of the salivary glands (causing facial pain), inflammation of the pancreas (causing severe abdominal pain), joint pain
• inflammation of the blood vessels of the skin
• inflammation of the liver due to abnormal antibodies against liver cells (autoimmune hepatitis)
• inflammation of the walls of small blood vessels, causing skin lesions
• inflammation of the liver due to a reaction of your immune system against liver cells
• Inflammation of the kidney tissue surrounding the tubules, causing kidney failure

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. 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 Nitrofurantoina Mylan Pharma

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the package and blister. The expiry
date refers to the last day of that month.
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. Package Contents and Other Information

What Nitrofurantoina Mylan Pharma contains
The active ingredient is nitrofurantoin. Nitrofurantoina Mylan Pharma capsules are available in
two dosages, containing 50 mg or 100 mg of nitrofurantoin.
The other ingredients are:
Capsule content: corn starch, lactose monohydrate (see section 2 “Nitrofurantoina
Mylan Pharma contains lactose”), talc.
Capsule shell: Titanium dioxide (E171), gelatin, yellow iron oxide (E172).

Description of the appearance of Nitrofurantoina Mylan Pharma and package contents
Nitrofurantoina Mylan Pharma 50 mg hard capsules are hard gelatin capsules with a
yellow cap and a white body.
Nitrofurantoina Mylan Pharma 100 mg hard capsules are hard gelatin capsules with a
yellow cap and a yellow body.
Nitrofurantoina Mylan Pharma is available in blister packs containing 20 or 30 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Manufacturer
Iasis Pharmaceuticals Hellas Αβεε, 137, Filis Ave, Kamatero, Attiki, 13451, Greece.
Iasis Pharmaceuticals Hellas S.A. – Koropi, Archimidous Street, Koropi Attikis, 19400 Greece

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Croatia PREVURO 50 mg hard capsules
Italy Nitrofurantoina Mylan Pharma
Netherlands Nitrofurantoïne MC Mylan 50 mg, hard capsules
Nitrofurantoïne MC Mylan 100 mg, hard capsules
United Kingdom (Northern Ireland) Nitrofurantoin 50 mg hard capsules
Nitrofurantoin 100 mg hard capsules