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NITROFURANTOIN 50 MG TABLETS, ARATOIN 50 MG TABLETS - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - NITROFURANTOIN 50 MG TABLETS, ARATOIN 50 MG TABLETS

2. what you need to know before you take nitrofurantoin tablets

[Do not take Nitrofurantoin Tablets if:

  • [ you are allergic to Nitroturantoin, other

  • 1 medicines containing nitrofurantoin or

। any of the other ingredients (listed in

[ Section 6)

  • [ you have a disease of the kidneys which [ is severely affecting the way they work । (ask your doctor if you are not sure) [ you are in the final stages of pregnancy [ (labour or delivery) as there is a risk [ that it might affect the baby i* you have porphyria (blood disorder) [ you are a patient with G6PD

[ (glucose-6-phosphate dehydrogenase)

deficiency

  • * your child is under three months of age i* you are breastfeeding 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:

  • [Talk to your doctor or pharmacist before [taking Nitrofurantoin tablets if: [ you have diabetes

f you are suffering from any illness

। causing severe weakness

  • [ you have anaemia (a decrease in red

[ blood cells causing pale skin,

1 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) ► you have a history of allergic reactions c 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 nen/es, causes [altered sense of feeling like pins and needles.

  • ! you lack an enzyme (body chemical)

I 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)

  • * you have any disease of the lungs, liver । or nervous system. If you need to take [ Nitroturantoin Tablets for a number of [ months, your doctor may want to regularly check how your lungs and

। liver are working

  • [ you have false positive results on

[ testing your urine for glucose

" your urine is dark yellow or brown

। coloured.

Talk to your doctor 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 Nitrofurantoin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take । any other medicines including medicines [ obtained without a prescription. If they are [ taken with Nitroturantoin Tablets their effect1 or the effect of N itrofurantoin 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 1 eye (glaucoma) such as carbonic anhydrase inhibitors (e.g. acetazolamide)
  • Medicines which make the urine less 1 acidic (e.g. potassium citrate mixture) i
  • Medicines for infections, known as quinolones
  • Typhoid vaccine, which is given for the 1 prevention of typhoid.

If you are in doubt about any of these medicines ask your doctor or pharmacist. [ Nitrofurantoin may interfere with the results 1 of some tests for glucose in the urine.

Nitrofurantoin Tablets with food and drink

Nitrofurantoin tablets should always be taken with food or milk. This will help to avoid stomach upset and also help the absorption to make the medicine work more[ effectively.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 is known Nitroturantoin 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 breastfeed, please consult your doctor [ first.

Driving and using machines

N itrofurantoin Tablets may cause dizziness [ and drowsiness. You should not drive or 1 operate machinery if you are affected this । way until such symptoms go away.

Nitrofurantoin Tablets contain lactose

This medicine contains lactose (sugars). If । you have been told by your doctor that you I have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Nitrofurantoin 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.

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:

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 Nitrofurantoin Tablets.

E E o o


^Medical Checks

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

[Method of administration

Tablets should be swallowed whole. The score line is not intended for breaking the iablet. Nitrofurantoin 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 Nitrofurantoin Tablets than you should

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

if you FORGET TO TAKE Nitrofurantoin Tablets

bo not worry. If you remember later on that bay, 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 pose to make up for a forgotten dose. If you are not sure ask your doctor or pharmacist.

If you STOP TAKING Nitrofurantoin [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 or [pharmacist.


4. Possible side effects


  • 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
  • sensation that you or your environment

are moving or spinning (vertigo)

  • unusual eye movements (nystagmus)
  • 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
  • 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
  • urinary infection by germs which are not sensitive to Nitrofurantoin 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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website 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.


Like all medicines, this medicine can cause bide effects, although not everybody gets [them. Most of them are mild and disappear [when you stop taking Nitrofurantoin 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 betailed below stop taking Nitrofurantoin [Tablets and consult your doctor.

  • [ your lungs may react to Nitrofurantoin [ Tablets. This may develop quickly, 1 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

  • 1 of the eyes) i* the nerves outside of the spinal cord I 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

I 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,

। diarrhoea, blood in your stool and 1 weakness. These could be signs of a [ condition known as cutaneous [ vasculitis

  • [ symptoms of jaundice, fatigue,

1 abdominal pain, joint pain and swelling. । These could be signs of a condition I known as autoimmune hepatitis [Please note that while taking Nitrofurantoin [Tablets your urine may become coloured [dark yellow or brown. This is quite normal and not a reason to stop taking the medicine.

[Other side effects include:

  • [Rare (may affect up to 1 in 1,000 people) [ loss of consciousness (collapse).

5. Howto store Nitrofurantoin Tablets


Keep this medicine out ofthe sight and reach of children. Do not store above 25’C. Do not open the container until you are ready to begin taking the course of treatment.

Do not use this medicine after the expiry । date which is stated on the bottle/label after [ 'Exp (MM/YY)’. The expiry date refers to the[ last day of that month. Medicines should not[ be disposed of via wastewater or household1 waste. Ask your pharmacist how to throw । away medicines you no longer use. These । measureswill help protect the environment.!


6. Contents of the pack and other information


What Nitrofurantoin Tablets contain

The active substance (which makes the medicine work) is Nitrofurantoin. Each tablet contains either 50mg or 10Omg of [ nitrofurantoin. The other ingredients are: [ lactose, maize starch, pregelatinised maize [ starch, sodium starch glycollate and magnesium stearate.

What Nitrofurantoin Tablets look like and] contents ofthe pack

Nitrofurantoin Tablets are flat, round bevelled, yellow scored tablets. Both 50 mg1 and 100 mg strengths are available in containers and blister packs of 28, 30, 50, [ 56, 60, 84,100, 250, 500 and 1,000 tablets.

Marketing Authorisation Holder and Manufacturer

Nitrofurantoin 50mg Tablets PL 08553/0087 [ Nitrofurantoin 100mg Tablets PL 08553/0088[

Dr Reddy’s Labora­tories (UK) Ltd, 6 Riverview Road, Beverley, HU17 OLD

Leaflet last revised: August 2019.

© Dr. Reddy’s Labora­tories (UK) Ltd


2252500.0


Artwork

Brand:

Dr Reddy’s

Product Name:

Nitrofurantoin

Strength:

50 mg & 100 mg

Form:

Tablets

Component:

Leaflet

Pack Size:

Various

Country:

UK

Date Created:

19/02/2019

Date Modified:

21 APR 2021

Version:

2.1

Technical Information


I Die Cut

Guides I

Min Font Size:

Printer:

Dimensions:

Project:


Colours



7pt

Haupt

130 × 400 mm

CC – BEC 135/2019


Dr. Reddy’s


Good Health Can’t Wait


Dr. Reddy’s Labora­tories (UK) Ltd 6 Riverview Road, Beverley, HU17 0LD, UK


Pg. 2


PIL MoCk-u

Nitrofurantoin

Sources: Original (products.mhra.gov.uk)