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NALIDIXIC ACID 300MG/5ML ORAL SUSPENSION

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Patient Information Leaflet
Tell your doctor if you get any of these side effects:
n feeling sick (nausea)
n diarrhoea
n upset stomach
n headache
n dizziness
n a difference in the way you taste or smell things.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Nalidixic Acid Oral Suspension
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Keep out of the reach and sight of children
Do not store above 25°C. Do not allow to freeze
Do not use after the expiry date which is stated on the label and carton (Exp: month, year)
The expiry date refers to the last day of that month
Do not use Nalidixic Acid Oral Suspension if you notice a change in the appearance or
smell of the medicine. Talk to your pharmacist
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. Further information

What Nalidixic Acid Oral Suspension contains
n The active ingredient is Nalidixic Acid
n The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate
(E216), propylene glycol (E1520), sorbic acid (E200), sodium carboxymethylcellulose
(E466), sucrose, sorbitol solution (E420), colloidal silicon dioxide, polysorbate 80 (E433),
simethicone emulsion, ponceau 4R (E124), raspberry and strawberry flavours (containing
propylene glycol), dill water and purified water.
What Nalidixic Acid Oral Suspension looks like and contents of the pack
A pale pink suspension with an odour of fruit and dill.
It comes in a brown glass bottle holding 150ml of suspension.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park,
Braithwaite Street, Leeds, LS11 9XE, UK.
This leaflet was last approved in March 2010
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Nalidixic Acid 300mg/5ml Oral Suspension
Read all of this leaflet carefully before you start taking this medicine.
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your doctor or pharmacist.
n This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
n If any of these side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nalidixic Acid Oral Suspension is and what it is used for

2. Before you take Nalidixic Acid Oral Suspension
3. How to take Nalidixic Acid Oral Suspension
4. Possible side effects
5. How to store Nalidixic Acid Oral Suspension
6. Further information

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1. What Nalidixic Acid Oral Suspension is and what it is used for
The name of your medicine is Nalidixic Acid Oral Suspension. It contains Nalidixic Acid. This
belongs to a group of medicines called antibiotics.
Nalidixic Acid is given to treat urinary tract infections and stomach infections.
2. Before you take Nalidixic Acid Oral Suspension
Do not take Nalidixic Acid Oral Suspension and tell your doctor if:
n you are allergic (hypersensitive) to Nalidixic Acid Oral Suspension or any other
ingredients in this liquid (listed in Section 6). The signs of an allergic reaction include a
rash, itching or shortness of breath
n you have epilepsy or a problem that causes fits
n you have a blood problem known as porphyria where you may have too many red blood
cells
n you have kidney problems
n This medicine should not be given to children under 3 months old.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your
doctor or pharmacist before taking this medicine.
Take special care with Nalidixic Acid Oral Suspension
Before you take Nalidixic Acid, tell your doctor if:
n you have glucose-6-phosphate dehydrogenase deficiency (G-6 PD). This is a genetic
disorder where the red blood cells are broken down under stressful conditions or due to
taking medicines
n you have liver problems
n you have a disease which hardens the arteries in your brain (cerebral artheriosclerosis). If
you have this, Nalidixic Acid may increase the risk of fits.
You should not have too much exposure to sunlight whilst taking this medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking Nalidixic Acid Oral Suspension.



Continued overleaf

Having tests
n if you are having urine tests, please tell the doctor that you are taking Nalidixic Acid Oral
Suspension as it may interfere with the results
n if you are taking this medicine for more than two weeks your doctor may perform tests to
check your blood, liver and kidney function.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is because Nalidixic Acid
Oral Suspension can affect the way some other medicines work. Also,
some medicines can affect the way Nalidixic Acid Oral Suspension works.
In particular, tell your doctor if you are taking any of the following:
n medicines that stop clots from forming, such as warfarin
n medicines containing iron, aluminium, zinc, magnesium or calcium
n non-steroidal anti-inflammatories (NSAIDs) used to treat pain and swelling such as aspirin
and ibuprofen
n chloramphenicol, nitrofurantoin and tetracycline used to treat infections
n probenecid used to treat gout
n melphalan used in the treatment of bone marrow cancer
n ciclosporin used after organ transplants
n oral contraceptive pill
n strontium ranelate used to treat brittle bones (osteoporosis)
n sucralfate used to treat stomach problems.
Nalidixic Acid can stop the oral typhoid vaccination from working.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking Nalidixic Acid Oral Suspension.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, planning to become
pregnant or are breast-feeding.
Driving and using machines
This medicine is not likely to affect you being able to drive or use any tools or machines.
Important information about what is in Nalidixic Acid Oral Suspension
This medicine contains:
n methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This
allergy may happen some time after starting the medicine
n sucrose and sorbitol. If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this product. The product contains 0.45g
of sucrose per 5ml dose. You should take this into account if you have diabetes. Sucrose
may be harmful to your teeth
n colouring agent ponceau 4R (E124) which may cause allergic reactions.
3. How to take Nalidixic Acid Oral Suspension
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the
doctor or pharmacist if you are not sure.
Taking this medicine
n this medicine contains 300mg of Nalidixic Acid in each 5ml
n take this medicine by mouth
n shake the bottle well before using it
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n as this medicine is an antibiotic, always finish the prescribed course.



Adults and older people:
The usual dose for adults and older people is:
n 900mg (3 x 5ml spoonsful) four times a day
n normally, you should take this for 7 days
n for long lasting infections 600mg (2 x 5ml spoonsful) four times a day.
Children:
The usual dose for children is:
n 1ml of suspension for each kilogram of the child’s body weight (for


example, 2kg is equal to 2ml of suspension)
n your doctor will work out the exact amount that your child will take
n children under 3 months should not be given this medicine.
If you take more Nalidixic Acid Oral Suspension than you should
If you take more Nalidixic Acid Oral Suspension than you should, talk to
a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor
knows what you have taken.
If you forget to take Nalidixic Acid Oral Suspension
n if you forget a dose, take it as soon as you remember it. However, if it is nearly time for
the next dose, skip the missed dose
n do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Nalidixic Acid Oral Suspension
Keep taking this medicine until the course is finished, unless you get any of the side effects
listed in section 4 below. Keep taking it even if you start to feel better after a few days.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Nalidixic Acid Oral Suspension can cause side effects although not
everybody gets them.
If you have an allergic reaction to Nalidixic Acid Oral Suspension see a doctor straight away
An allergic reaction may include:
n any kind of skin rash, flaking skin, itching, boils or sore lips and mouth
n sudden wheezing, fluttering or tightness of the chest or collapse
n swelling of the face, lips, mouth, tongue or throat.
If you get any of the following side effects, stop taking Nalidixic Acid Oral Suspension and
see your doctor as soon as possible:
n changes in vision
n skin rash, itching or a skin rash that has been caused by exposure to bright light
n feeling confused, depressed or excited
n fits
n fever, sore throat, ulcers in the mouth and throat, chest pains, fast heartbeat, headache,
unusual tiredness or weakness, unusual bleeding and unexplained bruises. These may be
a sign that you have a blood disorder
n severe headache or numbness or weakness of the arms and legs, especially in children.
This may be due to an increase in pressure inside the head
n difficulty in sleeping or feeling drowsy
n seeing or hearing things that are not there (hallucinations). This may be due to taking too
much medicine
n yellowing of the skin and of the eyes
n muscle weakness, painful, swollen or bruised joints. You may hear or feel a snap or pop
near your joints and be unable to move the affected area. These may be signs that you
have damaged or torn a tendon.
Continued overleaf

Expand Transcript

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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