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Allopurinol Tablets Bp 300mg

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Patient Information Leaflet GB 726-9855-APIL


SOVEREIGN

■MB MEDICAL

Allopurinol Tablets BP 100 mg and 300 mg

Allopurinol

Read all of this leaflet carefully before you start taking this medicine.

-    Please keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    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.

-    If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Allopurinol Tablets BP 100 mg and 300 mg are and what they are used for

2.    Before you take Allopurinol Tablets BP 100 mg and 300 mg

3.    How to take Allopurinol Tablets BP 100 mg and 300 mg

4.    Possible side effects

5.    How to store Allopurinol Tablets BP 100 mg and 300 mg

6.    Further information

1.    WHAT ALLOPURINOL TABLETS BP 100 MG AND 300 MG ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Allopurinol Tablets BP.

They are available in the strengths of 100 mg and 300 mg. The active substance in your Allopurinol Tablets BP is allopurinol.

Allopurinol is used to prevent gout and other conditions associated with excess uric acid in the body, including kidney stones and certain types of kidney disease.

2.    BEFORE YOU TAKE ALLOPURINOL TABLETS BP 100 MG AND 300 MG

Do not take this medicine if:

•    you ever had an allergy to Allopurinol, or any of the other ingredients (please refer to section 6, Further information, for the full list of ingredients) of the tablets (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing). Serious skin rashes (Hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of 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). 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 or Thai origin. If you develop a rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately;

•    you are having an attack of gout at the moment.

If you are not sure about any of these, check with your doctor or pharmacist.

Take special care and tell your doctor or pharmacist if:

•    you are pregnant or breast-feeding;

•    you have other concomitant diseases such as liver or kidney diseases;

•    you are taking other medicines;

•    you normally suffer from or have suffered from kidney stones;

•    you suffer from any malignant disease (cancer with the ability to spread).

Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars. This is because Allopurinol Tablets contain lactose, a type of sugar.

Taking other medicines

Tell your doctor if you are taking any other medicines, especially the following:

•    Medicines for the treatment of cancer called 6-mercaptopurine, azathioprine, doxorubicin, bleomycin, procarbazine, cyclophosphamide or mechloroethamine;

•    A medicine used to treat viral infections called Vidarabine (adenine arabinoside);

•    Medicines used to treat painful and inflammatory conditions (aspirin or other salicylates);

•    A medicine used to treat diabetes called chlorpropamide;

•    Medicines used to help thin the blood (e.g. warfarin, coumarin anticoagulants);

•    A medicine called phenytoin which is used to treat convulsions (fits);

•    A medicine called theophylline which is used to treat asthma;

•    Medicines called ampicillin and amoxicillin which are used to treat bacterial infections;

•    A medicine called ciclosporin which is used to help suppress the immune system.

Allopurinol may interfere with the actions of these drugs, either lowering or increasing their effect. Some of these interferences may be dangerous, so tell your doctor or pharmacist about any other medicines you are taking.

Other special warnings

•    If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking.

•    Whilst you are taking this medicine, your doctor may want to give you a check up from time to time.

•    Tell your doctor that you are taking Allopurinol Tablets BP if you are going to have an operation of any kind.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, inform your doctor about your condition and always ask for advice from your doctor or pharmacist.

Driving and operating machinery

It is not advisable to drive or operate machinery for several hours after taking Allopurinol Tablets BP, because somnolence (sleepiness), vertigo (balance disorder) and ataxia (loss of muscle coordination) have been reported after taking the medicine. You should not drive or operate machinery if you feel dizzy or tired while taking Allopurinol Tablets BP.

3. HOW TO TAKE ALLOPURINOL TABLETS BP 100 MG AND 300 MG

You must take your Allopurinol Tablets the way your doctor has told you to. The amount of Allopurinol Tablets that people can take varies. The label on your pack will tell you how many tablets to take and how often to take them. If the label does not say or if you are not sure, ask your doctor or pharmacist.

For adults, the usual starting dose is in the range of 100 -300 mg daily, which may be taken as a single dose, after a meal. The tablets should be taken with a little water to make swallowing easier. The dose may be increased up to 900 mg daily, depending on the severity of your condition.

If you are an elderly patient

Your doctor will prescribe the lowest dose of Allopurinol Tablets that best controls your symptoms.

If Allopurinol Tablets BP 100 mg and 300 mg has been prescribed for children or adolescents

The usual dose is in the range of 100-400 mg daily. Always follow the advice of your doctor or pharmacist.

If you suffer from a liver disease

Your doctor will prescribe the lowest dose of Allopurinol Tablets that best controls your symptoms. Your doctor will arrange for you to have liver function tests during the early stages of your treatment.

If you suffer from a kidney condition

Your doctor will prescribe the lowest dose of Allopurinol Tablets that best controls your symptoms. If you have serious kidney problems, your doctor may prescribe less than 100 mg per day, or tell you to take a single dose of 100 mg at longer intervals than one day. If you have dialysis two or three times a week, your doctor may prescribe a dose of 300 - 400 mg which is to be taken straight after dialysis with none taken in the interim period.

If you take more tablets than you should

Contact your doctor or local hospital accident and emergency department immediately. Take this leaflet or the pack of tablets with you to show the doctor what you have taken.

If you forget to take your medicine

If you forget to take a dose, just take the next dose at the usual time, DO NOT take a double dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines allopurinol can cause side effects,

although not everybody gets them.

The incidence of side effects is generally low and mostly of a minor nature. The incidence of side effects is higher in patients that have existing kidney or liver problems.

Stop taking Allopurinol Tablets immediately and go to your doctor or casualty department if you experience the following:

•    A reaction of any kind such as flu-like symptoms (fever and chills, headache, aching muscles) and generally feeling unwell, skin rash, flaking skin, ulcers of the mouth, throat, nose or genitals, conjunctivitis (red and swollen eyes), widespread skin blisters or peeling, joint pain, abnormalities in blood and liver function tests.

These skin reactions may rarely become very severe (conditions known as multi-organ sensitivity disorder, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis);

•    Inflammation of the liver (hepatitis) which may be accompanied by jaundice (yellowing of the skin and eyes);

•    Inflammation of the blood vessels (vasculitis);

•    Seizures;

•    Sudden wheeziness, fluttering or tightness in the chest; collapse.

THESE SYMPTOMS MAY MEAN THAT YOU ARE ALLERGIC TO ALLOPURINOL TABLETS. Do not take any more tablets unless your allergic reaction was relatively mild and the doctor tells you to do so.

Also tell your doctor or pharmacist immediately if:

•    you have a high temperature;

•    you have joint pain or painful swelling in the groin, armpits or neck;

•    you experience nausea and vomiting (in some cases blood may be present);

•    you experience a general feeling of being unwell;

•    you experience weakness, numbness or loss of consciousness;

•    you have headaches, experience dizziness, drowsiness or disturbances in your vision;

•    you have chest pain, high blood pressure or slow pulse;

•    you have retention of fluid leading to swelling (oedema) particularly of the ankles;

•    you are feeling thirsty, tired or losing weight; these may be symptoms of diabetes. Your doctor may wish to measure the level of sugar in your blood to help to decide if this is happening.

Rarely, Allopurinol Tablets may affect your blood or lymphatic system (conditions known as agranulocytosis, aplastic anaemia and thrombocytopenia which affect the blood counts in your body). These effects have usually occurred in people with liver or kidney problems. If you feel very tired, experience unexpected bruising or bleeding, or more infections (e.g. colds and sore throats) than usual please tell your doctor. Your doctor may decide to conduct tests on your blood periodically as a result of these symptoms.

Allopurinol Tablets may also cause the following side effects:

•    Impotence or infertility;

•    Enlargement of the breasts in men (a condition known as gynaecomastia);

•    Changes in your normal bowel habit;

•    Changes in taste perception;

•    Ulcers of the mouth, lips or gums;

•    Cataracts;

•    Boils;

•    Hair loss or discolouration;

•    Depression;

•    Sleepiness;

•    Nerve damage (a condition known as neuropathy);

•    Pins and needles (a condition known as paraesthesia);

•    Loss of coordination (a condition known as ataxia);

•    Chest pain;

•    Increased blood pressure (hypertension);

•    Increased cholesterol in the blood;

•    Blood in urine.

If any side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE ALLOPURINOL TABLETS BP 100 MG AND 300 MG

Store in a dry place. Do not take this medicine after the expiry date shown on the pack.

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN

Return any unused medicine to your pharmacist.

6.    FURTHER INFORMATION

What Allopurinol Tablets BP 100 mg and 300 mg contain:

Allopurinol Tablets BP 100 mg contain allopurinol 100 mg. The tablets are white, biconvex and 9.5 mm in diameter. One side is embossed “AP” and “100” separated by a breakline. Allopurinol Tablets BP 300 mg contain allopurinol 300 mg. The tablets are white, biconvex and 11 mm in diameter. One side is embossed “AP” and “300” separated by a breakline. Both strengths also contain the following inactive ingredients: lactose, maize starch, povidone, sodium starch glycollate and stearic acid.

Allopurinol Tablets BP 100 mg and Allopurinol Tablets BP 300 mg are available in securitainers (white bodies, blue lids) containing 21, 100, 250, 500 or 1000 tablets.

Marketing Authorisation Holder and Manufacturer:

Waymade Plc trading as Sovereign Medical,

Sovereign House,

Miles Gray Road,

Basildon,

Essex.

SS14 3FR.

This leaflet does not contain all the available information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The information in this leaflet applies only to Allopurinol Tablets BP 100 mg and 300 mg.

Date of preparation of the leaflet: January 2013

SOVEREIGN

■Mfl MEDICAL