URANTOIN/NITROFURANTOIN 100MG TABLETS

Active substance: NITROFURANTOIN

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PROPOSED
PATIENT INFORMATION LEAFLET

It is important that you tell your doctor if you are pregnant,
or likely to become pregnant, or if you are breast feeding.

URANTOIN / Nitrofurantoin 50 & 100 mg TABLETS

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:

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.



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

What is in your medicine?



Disorders of the nervous system

The name of this medicine is Urantoin which contains
nitrofurantoin BP and is available in strengths of 50 mg and 100
mg per tablet.



Porphyria

Urantoin 50 mg tablets contain 50 mg nitrofurantoin BP.

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).

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.

Also tell your doctor if you have vitamin B deficiency.

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.

The Product Licence Holder of Urantoin is: Chelonia Healthcare
Limited, Boumpoulinas 11, 3rd Floor, Nicosia, P.C.1060,
Cyprus

Can you take Urantoin with other medicines?

How does Urantoin work?

You can take these tablets with other medicines, but there
are some medicines that can interfere with Urantoin tablets.

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 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.

PROPOSED
Hypersensitivity
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:

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

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.

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.

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.

Keep your medicine in a dry place, below 25ºC 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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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