Nitrofurantoin RPH Pharma 100 mg prolonged-release capsules

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Nitrofurantoin RPH Pharma 100 mg prolonged-release (PR) capsules, but it will be referred to as Nitrofurantoin PR capsules throughout the rest of this leaflet.

1. What Nitrofurantoin PR capsules are and what they are used for
2. What you need to know before you take Nitrofurantoin PR capsules
3. How to take Nitrofurantoin PR capsules
4. Possible side effects
5. How to store Nitrofurantoin PR capsules
6. Contents of the pack and other information

• if you are allergic to nitrofurantoin, other nitrofurans or any of the other ingredients of this medicine (listed in section 6)
• if you have a disease of the kidneys which is severely affecting the way they work (ask your doctor if you are not sure)
• if you are in the final stages of pregnancy (labour or delivery) as there is a risk that it might affect the baby
• if you have porphyria (blood disorder)
• if in patients with G6PD (glucose-6-phosphate dehydrogenase) deficiency
• if in infants under three months of age
• if you are breast feeding a baby with suspected or known deficiency in an enzyme called G6PD (glucose-6-phosphate dehydrogenase).

Tell your doctor if you are not sure about any of the above.

Talk to your doctor, pharmacist or nurse before taking Nitrofurantoin PR Capsules:

• if you have diabetes
• if you are suffering from any illness causing severe weakness
• if you have anaemia (a decrease in red blood cells causing pale skin, weakness and breathlessness); a lack of vitamin B or abnormal levels of salts in your blood (your doctor will be able to advise you)
• if you have a history of allergic reactions
• if you have any problems with your kidneys
• if you have disease of the lungs

This medicine can also cause lung disease in patients with no previous medical history affecting their lungs. Lung disease can occur in patients on short-term or long-term treatment. Talk to your doctor if you experience trouble breathing, shortness of breath, a lingering cough, coughing up blood or mucus, or pain or discomfort when breathing. These may be symptoms of side effects affecting the lungs.

The above conditions may increase the chance of developing a side effect which causes damage to the nerves, altered sense of feeling, like pins and needles.

• if you lack an enzyme (body chemical) called glucose-6-phosphate dehydrogenase, which causes your red blood cells to be more easily damaged (this is more common in black people and people of Mediterranean, Middle Eastern or Asian origin. Your doctor will know)
• if you have any disease of the lungs, liver or nervous system. If you need to take Nitrofurantoin PR capsules for a number of months, your doctor may want to regularly check how your lungs and liver are working
• if you have false positive results on testing your urine for glucose
• if you have urine coloured yellow or brown
• if you experience fatigue, yellowing of the skin or eyes, itching, skin rashes, joint pain, abdominal discomfort, nausea, vomiting, loss of appetite, dark urine, and pale or gray-colored stools. It may be symptoms of liver disorder.

Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system. Nitrofurantoin PR capsules may interfere with the results of some tests for glucose in the urine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If they are taken with Nitrofurantoin PR capsules, their effect or the effect of Nitrofurantoin PR capsules may be changed.

• Antacids for indigestion (e.g. magnesium trisilicate)
• Medicines for gout (e.g. probenecid or sulfinpyrazone)
• Medicines for raised pressure in the eye (glaucoma), such as carbonic anhydrase inhibitors (e.g. acetazolamide)
• Medicines which make the urine less acidic (e.g. potassium citrate mixture)
• Medicines for infections, known as quinolones
• Typhoid vaccine, which is given for the prevention of typhoid.

If you are in doubt about any of these medicines, ask your doctor or pharmacist.

Nitrofurantoin PR capsules should be taken at meal times with food or milk. This will help to avoid stomach upset and also to help the absorption.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. As far as it is known Nitrofurantoin PR capsules may be used in pregnancy. However, it should not be used during labour or delivery because there is a possibility that use at this stage may affect the baby. If you want to breast feed, please consult with your doctor first.

Nitrofurantoin PR capsules may cause dizziness and drowsiness. You should not drive or operate machinery if you are affected this way until such symptoms go away.

If you have been told by your doctor that you are intolerant to some sugars and have to avoid them, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

Adults and children over 12 years old:

The normal dosage depends on the type of infection you have and instructions should be written on the label provided by the pharmacist. Consult your pharmacist or doctor if these instructions are not clear.

• For treatment of bladder infections: One capsule twice a day for seven days
• For prevention of bladder infections during surgery: One capsule twice a day on the day of the operation and three days thereafter.

Nitrofurantoin PR capsules are not recommended for children under 12 years of age.

Nitrofurantoin PR capsules should be taken with food or milk.

Capsules should be swallowed whole.

Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any left over capsules with you, as well as the container and label, so that the medical staff know what you have taken.

Do not worry. If you remember later on that day, take that day’s dose as usual. If you miss a whole day’s dose take the normal dose on the next day. Do not take a double dose to make up for a forgotten capsule. If you are not sure ask your doctor or pharmacist.

Your doctor will tell you how long to take the treatment. Do not stop earlier than you are told, even if you feel better. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

• Your lungs may react to Nitrofurantoin PR capsules. This may develop quickly, within a week of starting treatment or very slowly, especially in elderly patients. This may produce fever, chills, cough and shortness of breath associated with pneumonia. Scaring due to damaged lung tissue may occur
• Nitrofurantoin PR capsules may cause the liver to become inflamed, producing jaundice (yellowing of the skin or whites of the eyes)
• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely
• Blue or Purple coloration of the skin due to low oxygen levels. A condition known as cyanosis
• Symptoms of fever, flu, abdominal pain, diarrhea, blood in your stool and weakness. These could be signs of a condition known as cutaneous vasculitis
• Symptoms of fatigue, abdominal pain,joint pain and swelling. These could be signs of a condition known as hepatitis. In rare cases, it may cause liver failure which may be fatal.

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

• Loss of consciousness (collapse)
• Damage to bone marrow causing deficiency of the red blood cells (Anaemia).

Not known: frequency cannot be estimated from the available data

• Feeling sick (nausea) and headache
• Loose stools
• Loss of appetite, stomach ache, and being sick (vomiting)
• Diarrhea
• Dizziness, drowsiness
• Blood cells have been affected in some patients. This may result in bruising, delayed clotting of the blood, sore throat, fever, anaemia, and a susceptibility to colds or persistent cold
• The nerves outside the spinal cord may be affected causing changes to the sense of feeling and the use of muscles. In addition headache, extreme changes of mood or mental state, confusion, weakness, blurred vision may occur. These effects may be severe and in some instances permanent
• A variety of skin rashes or reactions have occurred in some patients. These may appear as flaking skin, a red rash or fever accompanied by rapid heart rate and severe rash with blistering. Other reactions may include inflammation of salivary glands (causing facial pains), inflammation of the pancreas gland (causing severe abdominal pain) and joint pains
• Short-term hair loss
• Raised pressure in the skull (causing severe headaches)
• Urinary infection by germs which are not sensitive to Nitrofurantoin PR capsules
• Inflammation of small blood vessel walls, causing skin lesions
• Liver inflammation due to turn of immune system against liver cells
• Inflammation of kidney tissue surrounding tubules, causing renal impairment.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA yellow card scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is nitrofurantoin. Each capsule contains 100mg nitrofurantoin as nitrofurantoin macrocrystals (anhydrous) and nitrofurantoin monohydrate.
• The other ingredients are lactose monohydrate, povidone K29/32, carbomer type A, talc, maize starch B, magnesium stearate and purified water.
• The capsule shell contains gelatin, titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172), sodium laurilsulfate

The hard gelatin capsule has a black opaque cap and ivory opaque body contain a yellow powder and round yellow tablet.

Nitrofurantoin PR capsules are available in blisters of 14 capsules.

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