Nitrofurantoin Mylan Pharma

Package leaflet: Information for the patient

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

Nitrofurantoin
Equivalent medicine
Please read all of 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, pharmacist or nurse.
‐ This medicine has been prescribed for you only. Do not give it to other people, even if their
symptoms are the same as yours, as it may be harmful.
‐ If you experience any side effect, including those not listed in this leaflet, tell your doctor,
pharmacist or nurse. See section 4.
Contents of this leaflet:

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

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

Nitrofurantoin Mylan Pharma belongs to a class of medicines called nitrofurans. The active substance, nitrofurantoin, kills most of the bacteria that cause urinary tract infections.
Nitrofurantoin 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.
Nitrofurantoin Mylan Pharma treats these symptoms. This medicine may also be prescribed for the prevention of infections (for example, due to the insertion of a urinary catheter or urinary tract procedures).
Nitrofurantoin Mylan Pharma may sometimes be used for long-term treatment of persistent urinary tract infections that are resistant to other medicines.
If you do not feel better or if you feel worse, speak to your doctor.

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

Do not take Nitrofurantoin Mylan Pharma

• If you are allergic to nitrofurantoin or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney disease (ask your doctor if you are unsure)
• if you have porphyria (reduced production of the red pigment in the blood)
• if you lack an enzyme called G6PD (glucose-6-phosphate dehydrogenase), which may rapidly damage red blood cells
• in children under 3 months of age
• if you have ever had a pulmonary or hepatic reaction, or peripheral neuropathy (tingling,
  numbness, or weakness in the limbs) during treatment with nitrofurantoin or other nitrofurans.

If you are unsure whether 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, malaise (nausea), vomiting, loss of appetite, dark urine, or pale or grey stools. These may be symptoms of liver disease.

During long-term treatment, especially in elderly patients, regular monitoring is required in order to detect possible adverse effects as early as possible.

Anaemia may occur in individuals of African, Afro-Caribbean, Mediterranean, Middle Eastern, or Western Asian descent during treatment. If you belong to one of these groups and experience fatigue (feeling of tiredness), dizziness, or shortness of breath during treatment, stop taking this medicine and contact your doctor.

If you experience tingling or numbness in the hands or feet, or a feeling of weakness in the limbs during treatment, stop taking this medicine and contact your doctor. The risk of these adverse effects increases, for example, if your kidneys are not functioning properly. If you have diabetes, anaemia, a condition causing severe weakness, or have previously had allergic reactions, inform your doctor.

Lung or liver problems may occur: see "Possible side effects". If such problems occur, the use of Nitrofurantoin Mylan Pharma must be stopped immediately.

Other medicines and Nitrofurantoin Mylan Pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some of these medicines may alter the effect of Nitrofurantoin Mylan Pharma.

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

If you have any doubts about any of these medicines, ask your doctor or pharmacist.

Nitrofurantoin Mylan Pharma may affect the results of certain urine glucose tests.

Nitrofurantoin Mylan Pharma with food and drink

Nitrofurantoin Mylan Pharma should always be taken with food or milk. Taking this medicine with food or milk makes it more effective and helps prevent stomach upset.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist 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, as its use at these stages may cause harm to the baby.

If you wish to breastfeed, consult your doctor before taking this medicine.

Driving and using machines

Nitrofurantoin Mylan Pharma may cause dizziness and drowsiness. If you experience these symptoms, wait until they have resolved before driving or operating machinery.

Nitrofurantoin Mylan Pharma contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Nitrofurantoin Mylan Pharma

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The capsules of Nitrofurantoin Mylan Pharma should be taken orally, swallowed during meals or with some milk or yoghurt. This improves tolerance and leads to better results.
The recommended dose is:
Uncomplicated acute lower urinary tract infections:
For adults and children over 12 years of age: 1 capsule of 50 mg, 4 times daily (1 capsule with each meal and 1 before bedtime). Treatment should usually last from 5 to 7 days or at least 3 days after urine is no longer infected.
For girls aged between 5 and 12 years: 3 to 6 mg/kg body weight per day divided into 4 daily doses, for 7 days or at least 3 days after 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 surgical procedures and insertion of bladder catheters (adults and children over 12 years of age):
4 x 50 mg daily on the day of the procedure and for the following 3 days.
Long-term treatment of urinary tract infections (adults and children over 12 years of age):
1 capsule of 50 or 100 mg daily, usually in the evening before bedtime and after the last urination: for up to 6 months.
When starting treatment, symptoms may decrease rapidly, usually within 1–3 days. Eventually, they usually disappear completely. However, it is essential to always complete the entire course of treatment. Symptoms may have disappeared, but this does not mean that all bacteria have been eradicated. If treatment is stopped too early, symptoms may quickly reappear, which is unpleasant for you and medically inappropriate. If after 3 days the condition has not disappeared or significantly improved, contact your doctor again.
If you take more Nitrofurantoin Mylan Pharma than you should
Contact your doctor, pharmacist or go immediately to the nearest hospital emergency department. Always bring the remaining capsules, the container, and the packaging so that medical staff can see what you have taken.
If you forget to take Nitrofurantoin Mylan Pharma
Do not worry. If you remember later the same day, take the dose as usual. If you miss an entire day's dose, take the normal dose the next day. Do not take a double dose to make up for the forgotten dose. If you have any doubts, consult your doctor or pharmacist.
If you stop taking Nitrofurantoin Mylan Pharma
Your doctor will tell you how long to take the medicine. Do not stop treatment earlier than instructed, even if you feel better. Speak with your doctor, pharmacist, or nurse if you wish to discontinue treatment earlier.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
All medicines can cause allergic reactions, although serious allergic reactions are rare.
If you suddenly develop shortness of breath, breathing difficulties, swelling of the eyelids, face or
lips, rash or itching (especially widespread over the whole body), stop taking this medicine and see a doctor immediately.
If any of the side effects listed below occur, stop taking Nitrofurantoin Mylan Pharma and consult your doctor.
The urine of patients taking nitrofurantoin may turn from dark yellow to brown. This is normal and disappears after treatment ends.
If you notice any of the following side effects, inform your doctor immediately:

• Lung problems. These may develop rapidly, within one week of starting treatment, or very slowly, especially in elderly patients, and may cause fever, chills, cough and shortness of breath associated with pneumonia and tissue damage.
• Nitrofurantoin may cause inflammation of the liver, leading to 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 cold-like symptoms.
• increased pressure inside the skull (causing severe headaches)
• severe skin allergic reactions (DRESS syndrome)
• various skin reactions, including skin peeling (dandruff-like scaling), redness, rash or fever accompanied by rapid heartbeat and severe skin rash associated with blistering.

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

• urinary tract infections 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 skin, nails, lips or area around the eyes (cyanosis)

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

• headache
• diarrhoea
• stomach ache, feeling unwell (vomiting)
• dizziness, drowsiness
• neurological disorders, resulting in changes in sensation and muscle activity. Also headache, extreme mood changes or mental disturbances, 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 blood vessels in the skin
• liver inflammation due to abnormal antibodies against liver cells (autoimmune hepatitis)
• inflammation of the walls of small blood vessels, causing skin lesions
• liver inflammation due to an immune system reaction against liver cells
• inflammation of the kidney tissue surrounding the tubules, leading to kidney failure

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 Nitrofurantoin Mylan Pharma

Keep this medicine out of the sight and reach of children.
This medicine has no special storage requirements.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 Nitrofurantoin Mylan Pharma contains
The active substance is nitrofurantoin. Nitrofurantoin Mylan Pharma capsules are available in
two strengths, containing 50 mg or 100 mg of nitrofurantoin.
The other components are:
Capsule contents: maize starch, lactose monohydrate (see section 2 “Nitrofurantoin Mylan Pharma contains lactose”), talc.
Capsule shell: Titanium dioxide (E171), gelatin, yellow iron oxide (E172).
Description of the appearance of Nitrofurantoin Mylan Pharma and pack sizes
Nitrofurantoin Mylan Pharma 50 mg hard capsules are hard gelatin capsules with a yellow cap and white body.
Nitrofurantoin Mylan Pharma 100 mg hard capsules are hard gelatin capsules with a yellow cap and yellow body.
Nitrofurantoin 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 European Economic Area countries under the
following names:
Croatia PREVURO 50 mg tvrde kapsule
Italy Nitrofurantoin Mylan Pharma
Netherlands Nitrofurantoïne MC Mylan 50 mg, harde capsules
Nitrofurantoïne MC Mylan 100 mg, harde capsules
United Kingdom (Northern Ireland) Nitrofurantoin 50 mg hard capsules
Nitrofurantoin 100 mg hard capsules