Nitrofurantoin 50mg Tablets
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PATIENT INFORMATION LEAFLET
URANTOIN / Nitrofurantoin 50 & 100 mg TABLETS
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF URANTOIN.
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION.
What is in your medicine?
The name of this medicine is Urantoin which contains nitrofurantoin BP and is available in strengths of 50 mg and 100 mg per tablet.
Urantoin 50 mg tablets contain 50 mg nitrofurantoin BP.
Urantoin 100 mg tablets contain 100 mg nitrofurantoin BP.
Both strengths are flat round yellow tablets scored on one side and contain lactose, maize starch, pregelatinised maize starch, sodium starch glycollate, magnesium stearate.
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.
The Manufacturer of Urantoin is: Meridian Healthcare (UK)
Ltd, 208-214 York Road, London SW11 3SE.
The Product Licence Holder of Urantoin is: Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, P.C. 1060,
Cyprus
How does Urantoin work?
Urantoin is an antibacterial drug which is helpful in the prevention and treatment of bacterial infection of the urinary tract.
Why have you been prescribed Urantoin?
Urantoin is used for the treatment of and prevention of acute or recurring inflammation of certain parts of the kidney and lower urinary tract by infections shown to be due to certain known bacteria and occurring either independent of, or following certain surgical operations.
If you are not sure why you have been prescribed Urantoin, then please ask your doctor.
Check before you take Urantoin tablets
Before taking this medicine, tell your doctor if you have ever had any unusual or allergic reactions to Nitrofurantoin, or any of the other ingredients of Urantoin, or other medicines of the nitrofurans group.
Also tell your doctor or pharmacist if you are allergic to any other substances such as foods, preservatives or dyes.
It is important that you tell your doctor if you are pregnant, or likely to become pregnant, or if you are breast feeding.
The presence of other medical problems may affect the use of this medicine. Make sure, therefore, to tell your doctor or pharmacist if you have any other medical problems, especially:
• you have problems with your kidneys (other than infection). Your doctor will assess whether you may take nitrofurantoin depending on how well your kidneys are working.
• Anaemia
• Diabetes
• Lung disease
• Liver disease
• Disorders of the nervous system
• Porphyria
Also tell your doctor if you have vitamin B deficiency.
It is very important that you tell your doctor if you are of African, Mediterranean, Middle Eastern or Asian origin, or if you suffer from a deficiency known as glucose-6-phosphate dehydrogenase. This deficiency causes destruction of blood cells; it is extremely rare in white people (Caucasians).
Use in pregnancy and while breast-feeding
This medicine should not be used during pregnancy unless your doctor considers it essential. Because this medicine may pass into the breast milk, its use should be avoided during breast feeding unless your doctor advises that you may.
Can you take Urantoin with other medicines?
You can take these tablets with other medicines, but there are some medicines that can interfere with Urantoin tablets.
It is very important to tell your doctor or pharmacist about all the medicines which you are taking, whether prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere. This includes medicines such as barbiturates, phenytoin, magnessium trisilicate, probenicid, anticholinergics, sulfinyprazone and carbonic anhydrase inhibitors, ciprofloxacin, norfloxacin, or any other quinolone anti-infective medicines.
There is an increased absorption of Urantoin with food and with anticholinergic drugs such as imipramine, amitriptyline, propantheline.
When and how to take Urantoin tablets.
Urantoin tablets are taken by mouth and only in the doses prescribed by your doctor. Do not take more of it and do not take it more often or for a longer time than your doctor ordered.
Do not stop taking your medicine or change the dose unless your doctor tells you to.
You will be prescribed the lowest dose necessary to control your symptoms.
Take the dosages prescribed by your doctor. Below are examples of usual doses given.
Usual dosages stated below:
To be taken with food or milk.
Adults:
Uncomplicated acute urinary tract infections:
50 mg (one 50 mg tablet) three times a day for three days.
Severe chronic recurrence:
100 mg (one 100 mg tablet/ two 50 mg tablets) three times a day for seven days.
Long-term suppression:
100 mg (one 100 mg tablet/ two 50 mg tablets) once a day or 2.4 mg per kg. bodyweight per day if treatment duration less than 3 months and 50 mg (one 50 mg tablet) once a day or 1.2 mg per kg. bodyweight per day if treatment duration more than 3 months.
Prophylaxis (prevention):
50 mg (one 50 mg tablet) three times a day for duration of any surgical procedure and continue for 3 days thereafter.
Children (above 3 months of age) with uncomplicated acute lower urinary tract infection:
1.2-2.4 mg per kg. bodyweight per day.
Elderly: 50 mg (one 50 mg tablet) twice a day.
What to do if too many tablets are taken at the same time
If you accidentally take more tablets than recommended contact your nearest doctor or hospital casualty department at once. Take any remaining tablets with you and keep in the original container or packaging so that they can be identified.
What if you miss a dose?
If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not take two doses at once.
If you feel that this medicine is not working as well after you have taken it for a short time (1 week) do not increase the dose, instead check with your doctor.
What side effects can Urantoin have?
Respiratory
Acute or chronic pulmonary (lung) reactions may occur. Acute reactions usually occur within the first week of treatment and will clear when treatment with Urantoin is stopped.
Acute pulmonary infections may be recognised by fever, chills, cough, chest pain, difficulty in breathing.
In patients who have received continuous treatment for six months or more, chronic pulmonary reactions may occur, and this is more common in elderly patients. Such patients will experience excessive tiredness, breathlessness on exertion and cough, and rarely fever.
Gastro-Intestinal
Loss of appetite and feeling of sickness have been reported, also, less common, vomiting, abdominal pain and diarrhoea. Taking Urantoin with food or milk may reduce these reactions.
Hepatitis (liver disease) and jaundice (yellowing of the skin and eyeballs) may rarely occur.
Hypersensitivity
Allergic skin reactions with rashes, itching, fluid build-up in the tissue below the skin and presenting as spots or lumps may occur and also, rarely, a condition known as exfoliative dermatitis (flaking/peeling skin) and erythema multiforme (a condition in which inflamed patches appear on the palms and face).
Other hypersensitivity reactions may include inflammation of the saliva producing glands, inflammation of the pancreas, painful swelling of the joints, difficulty in breathing, swelling of the face and neck and drug fever. Tell the doctor immediately in the event of any of these symptoms occuring.
Blood Disorders
Various blood disorders may occur and stopping treatment has generally returned these blood disorders to normal.
Nervous System
The nerves of the hands, feet and toes may undergo changes, there may be rapid eye movements, dizziness, vertigo (spinning sensation), weakness, headache and excessive drowsiness. If you experience numbness or tingling in any part of the body you should stop taking the medicine and see your doctor straight away.
Miscellaneous
Hair loss (alopecia) has been reported. Bacteria known as Pseudomonas may occur in addition to other present bacterial infection.
If you experience any of the above reactions or side-effects, or notice anything unusual which you are worried about, consult your doctor.
Storing your medicine
You must keep the medicine in a safe place where children cannot get it. Your medicine could harm them.
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.
On the label you will find the words "Expiry Date" followed by numbers indicating the day, month and year. This is the date when the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your doctor or pharmacist.
A reminder
REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours.
This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.
This leaflet was prepared in July 2014