URANTOIN/NITROFURANTOIN 100 MG TABLETS - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

if you get any of the side effects, talk to your doctor, pharmacist or nurse. this includes any possible side effects not listed in this leaflet. see section 4.

This product will be referred to as Nitrofurantoin Tablets for ease hereafter.

What is in this leaflet:

• 1. What Urantoin Tablets are and what they are used for

2. What you need to know before you take Urantoin Tablets

3. How to take Urantoin Tablets

4. Possible side effects

5. How to store Urantoin Tablets

6. Contents of the pack and other information

1. What Urantoin Tablets are and what they are used for

Nitrofurantoin (the active substance in Urantoin Tablets), is an antibiotic. It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract.

You must talk to a doctor if you do not feel better or if you feel worse.

2. what you need to know before you take urantoin tablets if you are allergic to urantoin, other medicines containing nitrofurantoin 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 you are a patient with G6PD (glucose-6-phosphate dehydrogenase) deficiency
• if your child is 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.

Warnings and precautions:

• 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) or 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.

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

• if you have any problems with your kidneys.
• 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 Urantoin Tablets 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 your urine is dark yellow or brown coloured.
• 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 grey-coloured stools. It may be symptoms of liver disorder.

Other medicines and Urantoin Tablets

Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines, including medicines obtained without prescription.

If they are taken with Urantoin Tablets their effect or the effect of Urantoin Tablets may be changed.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Antacids for indigestion (e.g. magnesium trisilicate)
• Medicines for gout (e.g. probenecid or sulfinpyrazone)
• Medicines which slow the passage of food through the stomach (e.g. atropine, hyoscine)
• 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. Urantoin Tablets may interfere with the results of some tests for glucose in the urine.

Urantoin Tablets with food and drink

Urantoin Tablets should always be taken with food or milk. Taking this medicine with food

or milk makes it work more effectively.

Pregnancy, breast-feeding and fertility:

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, Urantoin Tablets 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 your doctor first.

Driving and using machines:

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

Urantoin Tablets contain lactose and sodium

This medicine contains lactose (sugars). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains less than 1mmol sodium (23mg) per 50mg or 100mg tablet, that is to say essentially ‘sodium free’.

3. how to take urantoin tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults:

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. The usual doses are:

• For treatment of infections: Either one 50mg tablet or one 100mg tablet four times a day for seven days

For prevention of further infections: Either one 50mg tablet or one 100mg tablet at bedtime

For prevention of infections during surgery: One 50mg tablet four times a day on the day of the operation and three days thereafter.

Use in Children over three months of age

The dose depends on the weight of the child and will be provided by your doctor. Follow your doctor’s instruc­tions exactly.

Children below 3 months of age should not take Urantoin Tablets.

Medical Checks

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

Method of administration

Tablets should be swallowed whole. The score line is not intended for breaking the tablet.

Urantoin Tablets should always be taken with food or milk. Taking this medicine with food or milk makes it work more effectively.

If you take more Urantoin Tablets you should:

Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any left-over tablets with you, as well as the container and label, so that the medical staff knows what you have taken. You may experience symptoms of stomach ache, nausea and vomiting.

If you forget to take Urantoin Tablets

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 dose. If you are not sure ask your doctor or pharmacist.

If you stop taking Urantoin Tablets

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.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of them are mild and disappear when you stop taking Urantoin Tablets.

All medicines can cause allergic reactions although serious allergic reactions are rare. If you notice any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) STOP TAKING your medicine and go to a doctor immediately.

If you experience any of the side effects detailed below, stop taking Urantoin Tablets and consult your doctor.

• Your lungs may react to Urantoin Tablets. 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

• Jaundice (inflammation of the liver causing yellowing of the skin or whites of the eyes)
• 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
• Raised pressure in the skull (causing severe headaches)
• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely
• Blue or purple colouration of the skin due to low oxygen levels. A condition known as cyanosis
• Symptoms of fever, flu, abdominal pain, diarrhoea, blood in your stool and weakness. These could be signs of a condition known as cutaneous vasculitis
• Symptoms of jaundice, fatigue, abdominal pain, joint pain and swelling. These could be signs of a condition known as autoimmune hepatitis.
• 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

Please note that while taking Urantoin Tablets your urine may become dark yellow or brown coloured. This is quite normal and not a reason to stop taking the medicine.

Other side effects include:

• Loss of consciousness (collapse)

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)
• Diarrhoea
• Dizziness, drowsiness
• Depression, euphoria and psychotic reactions (characterised by hallucinations, delusions, memory loss and confusion)
• 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.
• Short-term hair loss
• Urinary infection by germs which are not sensitive to Urantoin Tablets
• 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
• Inflammation of optic nerve, which usually causes temporary vision loss that typically happens in only one eye and sometimes pain (optic neuritis)
• Repetitive, uncontrolled, involuntary eye movements which affect vision (nystagmus)
• The feeling that you or your environment is moving or spinning (vertigo)

Reporting of side effects

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 Yellow card Scheme: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.

5. how to store urantoin tablets

Keep this medicine out of the sight and reach of children.

Keep your medicine in a dry place, below 25°C in a well-closed container. Protect from light.

If your doctor tells you to stop the treatment, return any remaining tablets to the pharmacist. Only keep the medicine if the doctor tells you to.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month. Do not throw away any dispose of your medicines via waste water or household waste. Ask your pharmacist how to throw away dispose of medicines which you no longer require. These measures will help protect the environment.

6. contents of the pack and other informationthe active substance is nitrofurantoin. urantoin tablets are available in two strengths, containing either50 mg or 100 mg nitrofurantoin. the other ingredients are lactose, maize starch, pregelatinised maize starch, sodium starch glycollate, magnesium stearate and purified water.

What Urantoin Tablets looks like and contents of the pack

Both strengths are flat, yellow bevelled and scored tablets.

Both strengths of Urantoin tablets are available in containers and blister packs of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1,000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, P.C.1060, Cyprus

The Manufacturer

Meridian Healthcare (UK) Ltd, 208–214 York Road, London SW11 3SE.

This leaflet was last revised in January 2020