Allopurinol 300mg/5ml Oral Suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Allopurinol Oral Suspension is and what it is used for
2. What you need to know before you take Allopurinol Oral Suspension
3. How to take Allopurinol Oral Suspension
4. Possible side effects
5. How to store Allopurinol Oral Suspension
6. Contents of the pack and other information

• If you are allergic (hypersensitive) to allopurinol or any of the other ingredients of this medicine (listed in section 6).The signs of an allergic reaction may include swelling of your face, lips, tongue or throat, difficulty breathing or swallowing, severe itching of your skin with raised lumps

If you are not sure, talk to your doctor or pharmacist before taking Allopurinol Oral Suspension.

Talk to your doctor or pharmacist before taking allopurinol if:

• you are of Han Chinese, African or Indian origin
• you have problems with your liver or kidneys. Your doctor may give you a lower dose or ask you to take it less often than each day. They will also monitor you more closely.
• you have heart problems or high blood pressure and you take diuretics and/or a medicine called ACE-inhibitors.
• you are currently having an attack of gout.
• you have thyroid problems.

• Serious skin rashes (Hypersensitivity syndrome, Stevens- Johnson syndrome, toxic epidermal necrolysis) have been reported in patients taking allopurinol. Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by influenza-like symptoms fever, headache, body ache (flu-like symptoms). The rash may progress to widespread blistering and peeling of the skin. These serious skin reactions can be more common in people of Han Chinese, Thai or Korean origin. Chronic kidney disease may increase the risk in these patients additionally. If you develop a rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately.
• If you have cancer or Lesch-Nyhan syndrome the amount of uric acid may increase in your urine. To prevent this, you need to assure to drink sufficiently to dilute your urine.
• In case you have kidney stones, the kidney stones will become smaller and may enter your urinary tract.

Use in children is rarely indicated, except in some types of cancer (especially leukaemia) and certain enzyme disorders such as Lesch-Nyhan syndrome.

Tell your doctor or pharmacist if you are taking any of the following:

• aspirin
• theophylline, used for breathing problems
• medicines used for fits (epilepsy), phenytoin
• vidarabine, used to treat herpes or chickenpox
• antibiotics (ampicillin or amoxicillin)
• didanosine, used to treat HIV infection
• medicines used for cancer
• medicines used to reduce your immune response (immunosuppressants)
• medicines used to treat diabetes
• medicines for heart problems or high blood pressure such as ACE inhibitors or water tablets (diuretics)
• medicines used to thin your blood (anticoagulants), such as warfarin
• any other medicine to treat gout.

If aluminium hydroxide is taken concomitantly, allopurinol may have an attenuated effect. There should be an interval of at least 3 hours between taking both medicines.

With administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halogenides), blood dyscrasias occur more frequently than when these active substances are administered alone. Blood count monitoring should therefore be performed at regular intervals.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Allopurinol Oral Suspension can affect the way some medicines work. Also some other medicines can affect the way Allopurinol Oral Suspension works.

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding. Allopurinol is excreted in the human breast milk. Allopurinol during breast-feeding is not recommended.

You may feel drowsy, giddy or have problems with your coordination. If this happens, do not drive or use any tools or machines.

• This medicine contains 1.00g Liquid Maltitol in each 5ml - a type of sugar. 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 4.13 mg sodium benzoate in each 5ml. Sodium Benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
• This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially sodium free.

• The usual dose ranges from 100 to 400 mg each day.

• This medicine contains 300mg of allopurinol in each 5ml of suspension.
• Take this medicine by mouth. Take Allopurinol Oral Suspension with a glass of water.
• The bottle must be shaken well before using it.
• Use the syringe supplied with the pack. The dosing syringe provided has only been demonstrated to deliver doses accurately at 1.5 mL volume and above (equivalent to 90mg allopurinol and higher). Alternative measuring devices should be considered if low allopurinol doses are to be administered.

The syringe in the pack delivers:

• 30 mg for every 0.5 ml graduation mark
• 60 mg for every 1 ml graduation mark.

1. Shake the bottle for 5 seconds immediately prior to each use.
2. To open the bottle, press the cap down and turn it anti-clockwise (figure 1).
3. Put the syringe adaptor into the bottle neck (figure 2).
4. Take the syringe and put it into the adaptor opening (figure 3).
5. Turn the bottle upside down (figure 4).
6. Fill the syringe with a small amount of solution by pulling the plunger down (figure 4A).
Then push the plunger upward in order to remove any possible bubbles (figure 4B). Finally, pull the plunger down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor.
The top flat edge of the piston should be in line with the graduation mark you are measuring to (Figure 4C).
7. Turn the bottle the right way up (Figure 5A).
8. Remove the syringe from the adaptor
(Figure 5B).
9. Put the end of the syringe into your mouth and push the plunger slowly back in to take the medicine.
10.Wash the syringe with water and let it dry before you use it again (Figure 6).
11. Close the bottle with the plastic screw cap - leave the syringe adaptor in the bottle.

If you take more Allopurinol Oral Suspension than you should, contact a doctor or go to hospital straight away. Take the medicine pack with you. Signs of an overdose may include nausea, vomiting, diarrhoea and dizziness.

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.

Do not take a double dose to make up for a forgotten dose.

Do not stop taking your Allopurinol Oral Suspension without talking to your doctor.

Uncommon (may affect less than 1 in 100 people)

If you have a hypersensitivity (allergic) reaction, stop taking allopurinol and see a doctor straight away.

The signs may include:

• flaking skin, boils or sore lips and mouth
• very rarely signs may include sudden wheeziness, fluttering or tightness in the chest and collapse.

Rare (may affect less than 1 in 1000 people)

• fever and chills, headache, aching muscles (flu-like symptoms) and generally feeling unwell
• serious hypersensitivity reactions involving fever, skin rash, joint pain, and abnormalities in blood and liver function tests (these may be signs of a multi-organ sensitivity disorder).
• bleeding in the lips, eyes, mouth, nose or genitals.
• any changes to your skin, for example; ulcers of the mouth, throat, nose, genitals, conjunctivitis (red and swollen eyes), widespread blisters or peeling.

Very rare (may affect up to 1 in 10,000 people)

• serious allergic reaction which causes swelling of the face or throat
• serious potentially life-threatening allergic reaction

Do not continue to take allopurinol unless your doctor tells you to do so.

Common (may affect up to 1 in 10 people)

• skin rash
• increased level of thyroid stimulating hormone in the blood.

Uncommon (may affect up to 1 in 100 people)

• feeling sick (nausea) or being sick (vomiting)
• abnormal liver tests
• diarrhoea.

Rare (may affect up to 1 in 1000 people)

• liver problems such as liver inflammation

Very rare (may affect up to 1 in 10,000 people)

• occasionally allopurinol may affect your blood, which can manifest as bruising more easily than usual, or you may develop a sore throat or other signs of an infection. These effects usually occur in people with liver or kidney problems. Tell your doctor as soon as possible.
• allopurinol may affect the lymph nodes
• high temperature
• blood in your urine (haematuria)
• high levels of cholesterol in your blood (hyperlipidaemia)
• a general feeling of being unwell or feeling weak
• weakness, numbness, unsteadiness on your feet, feeling unable to move muscles (paralysis) or loss of consciousness
• headache, dizziness, drowsiness or disturbance of your vision
• chest pain (angina), high blood pressure or a slow pulse
• male infertility or erectile dysfunction
• enlargement of the breasts, in men as well as women
• a change in your normal bowel habit
• a change in taste
• cataracts
• hair loss or discolouration
• depression
• lack of voluntary coordination of muscle movements (ataxia)
• sensation of tingling, tickling, pricking or burning of skin (paraesthesia)
• build up of fluid leading to swelling (oedema) particularly of your ankles
• abnormal glucose metabolism (diabetes).Your doctor may wish to measure the level of sugar in your blood to check if this is happening.

Not known (cannot be estimated from available data):

Aseptic meningitis (inflammation of the membranes that surround the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever or consciousness clouding.

Seek medical attention immediately if these occur.

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.

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 at: www.mhra.gov.uk/yellowcard 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.

• The active substance is allopurinol. Each 5ml of oral suspension contains 300mg Allopurinol.
• The other ingredients are xanthan gum (E415), dispersible cellulose (E460), liquid maltitol (E965), sodium benzoate (E211), citric acid monohydrate (E330), strawberry flavour, sodium hydroxide (E524) and purified water.

Allopurinol 300mg/5ml Oral Suspension is an opaque to off-white suspension. It comes in a brown glass bottle holding 150 ml of solution with a 10 ml syringe and bottle adaptor.

Where higher doses are to be administered, dosing cups should be considered.