ALOPURINOL STADA 300 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Alopurinol Stada 300 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Alopurinol Stada and what is it used for

This medicine contains the active substance alopurinol.

This medicine works by reducing the rate of certain chemical reactions in the body to decrease the level of uric acid in the blood and urine.

High levels of uric acid can cause:

• Gout
• Formation of kidney stones or certain types of kidney problems

In gout, uric acid builds up in the joints and tendons in the form of crystals. These crystals cause an inflammatory reaction. The inflammation makes the skin around certain joints swell, become sensitive, and hurt when touched lightly. You may also notice that there is intense pain when moving the joint.

Alopurinol is used in adults:

• to reduce uric acid levels when diet is not sufficient
• for the treatment and prevention of the aforementioned complications, in which the body produces too much uric acid.

2. What you need to know before you take Alopurinol Stada

Do not take Alopurinol Stada:

• If you are allergic to alopurinol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor or pharmacist before taking this medicine if:

• you have liver and kidney problems. Your doctor may give you a lower dose or ask you to take it less frequently. They may also monitor you more closely.
• you are currently having a gout attack. Your doctor may also consider prescribing you a suitable pain reliever or another anti-gout medicine (colchicine) during the first 4 weeks of treatment.
• you have thyroid problems.
• you are of Chinese Han, Thai, or Korean descent.

Be careful with alopurinol:

Severe skin reactions(Hypersensitivity Syndrome, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) have been reported with the use of alopurinol. These can appear initially as reddish spots, with a bullet or circular shape (often with blisters in the middle) on the trunk of the body. Frequently, the rash can include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These potentially life-threatening skin reactions are usually preceded by symptoms similar to those of the flu (fever, headache, and body pain). The rash can progress to blistering and general peeling of the skin. If you develop a skin rash or these symptoms on the skin, stop taking alopurinol and consult your doctor immediately.

If you have experienced a severe skin reaction during treatment with alopurinol, you should not be treated with alopurinol again.

These severe skin reactions can be more frequent in people of Chinese Han, Thai, or Korean origin. Additionally, the risk of chronic kidney failure may increase in these patients.

If you have cancer or Lesch-Nyhan syndrome, the amount of uric acid in urine may increase. To prevent this, make sure to drink enough water to dilute your urine.

In case of having kidney stones, the stones will become smaller and may enter your urinary tract, which could cause you problems. The amount of urine you produce should be at least 2 liters per day to reduce the risk of kidney stone formation. You should make sure to drink enough water.

Other medicines and Alopurinol Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because alopurinol can affect the way some medicines work. Also, some other medicines can affect the way alopurinol works.

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

• probenecid, benzbromarone, sulfinpyrazone (medicine for treating gout)
• acetylsalicylic acid
• ampicillin or amoxicillin (antibiotics): do not take alopurinol with ampicillin or amoxicillin as this can cause an increased frequency of skin rash. An alternative to ampicillin or amoxicillin should be used when available.
• warfarin (medicine used to thin the blood).
• chlorpropamide (medicine used to treat diabetes).
• theophylline (medicine used for respiratory or heart problems).
• In combination with cytostatics (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, halogenated alkynes), blood dyscrasias occur more frequently than when these active substances are administered alone. Therefore, regular hematological checks should be performed.
• vidarabine (used to treat herpes or chickenpox)
• cyclosporine (medicine used to reduce the immune response)
• phenytoin (medicine used for epilepsy).
• didanosine (used to treat HIV infection)
• • aluminum hydroxide. If aluminum hydroxide is taken concomitantly, alopurinol may have a diminished effect, so it is convenient to leave an interval of at least 3 hours between taking both medicines. Therefore, regular hematological checks should be performed.
• furosemide and diuretics (medicine to eliminate excess fluid from the body), such as thiazides.
• ACE inhibitors (medicines for heart problems or high blood pressure), especially if you have kidney problems or chronic kidney failure.

It is especially important that you inform your doctor if you are taking any of the medicines listed below. Your doctor may need to reduce the dose of your medicine or monitor you more closely because there is a greater risk of side effects when alopurinol is taken at the same time as:

• 6-mercaptopurine (used to treat blood cancer)
• azathioprine (used to inhibit the immune system)

Avoid taking 6-mercaptopurine or azathioprine with alopurinol. When 6-mercaptopurine or azathioprine is administered with alopurinol, the dose of 6-mercaptopurine or azathioprine should be reduced because its activity will be prolonged. This could increase the risk of serious blood disorders. In this case, your doctor will closely monitor your blood count during treatment.

Go to the doctor immediately if you notice that you have any unexplained bruising, bleeding, fever, or sore throat.

Taking Alopurinol Stada with food, drinks, and alcohol

Foods with high purine content, such as organ meats like liver, sweetbreads, kidney, brain, heart, and tongue, as well as meat concentrates and alcohol, especially beer, should be avoided.

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.

Do not take this medicine if you are pregnant unless your doctor advises you to.

Alopurinol passes into breast milk. The use of alopurinol is not recommended during breastfeeding. The doctor will decide whether to discontinue breastfeeding or discontinue/abstain from alopurinol therapy.

Driving and using machines

The influence of alopurinol on the ability to drive and use machines is moderate. Do not drive or use machines unless you know how this medicine affects you.

You may feel drowsy, dizzy, or have coordination problems. If this happens, do not drive or use any tool or machine.

Alopurinol Stada contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Alopurinol Stada

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

The recommended dose is 300 mg of alopurinol per day. Usually, your doctor will start treatment with alopurinol at a low dose (e.g., 100 mg/day) to reduce the risk of possible side effects. Your dose will be increased if necessary. Other doses of this medicine are available if a lower dose is necessary.

Your doctor may increase the dose to 600 mg up to 800 mg of alopurinol if necessary.

The maximum daily dose is 800 mg of alopurinol.

The tablets should be taken once a day after a meal, especially in patients with a sensitive stomach.

To avoid side effects, do not take more than 300 mg of alopurinol in a single dose.

If a daily dose of more than 300 mg of alopurinol is indicated or if gastrointestinal side effects (nausea, vomiting, diarrhea) are experienced, the dose may be divided into several doses throughout the day.

Your doctor will indicate the correct dose.

Make sure to drink enough water while taking this medicine.

Elderly patients

If you are an elderly person, your doctor may prescribe a lower dose or advise you to take the tablets at longer intervals.

Patients with kidney or liver problems

Alopurinol 300 mg is not suitable if you have severely impaired liver or kidney functiondue to the high content of alopurinol. Other doses of this medicine may be more suitable; consult your doctor or pharmacist.

If you undergo dialysis two or three times a week, your doctor may prescribe a dose of 300 or 400 mg to be taken immediately after dialysis.

Use in children and adolescents under 15 years

Alopurinol 300 mg is not suitable for children due to the high content of alopurinol. Other doses of this medicine may be more suitable; consult your doctor or pharmacist.

Method of administration

Oral use.

Take the tablet after a meal and swallow it with a glass of water, approximately at the same time every day.

The tablet can be divided into equal doses (half).

Duration of treatment

The duration of treatment with this medicine depends on the underlying disease. Please take alopurinol regularly and for the time your doctor has indicated.

Continuous monitoring by your doctor is necessary. Your doctor should check your uric acid levels repeatedly and regularly through blood tests. At the same time, possible side effects should be observed, and you should talk to your doctor or pharmacist if you consider that the effect of this medicine is too strong or too weak.

If you take more Alopurinol Stada than you should

If you take more alopurinol than you should, contact your doctor or go to the hospital immediately. Take the package of this medicine with you. Signs of overdose may include nausea, vomiting, diarrhea, and dizziness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alopurinol Stada

If you forget to take a dose, do not take a double dose to make up for the forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you have any of the following side effects, stop taking this medicine immediately and inform your doctor.

Hypersensitivity (allergic reactions)

Rare(may affect up to 1 in 1,000 people)

• Fever and chills, headache, muscle pain (flu-like symptoms) and general malaise. Any change in the skin, for example; ulcers in the mouth, throat, nose, genitals, or conjunctivitis (red and swollen eyes), blisters, or generalized peeling of the skin.
• Severe allergic reactions that include fever, skin rash, general pain, and abnormalities in blood tests and liver function tests (may be signs of a multi-organ sensitivity disorder).

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

• Severe and potentially life-threatening skin reaction (hypersensitivity reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis) (see section 2).
• Severe allergic reaction that causes swelling of the face or throat.
• Potentially life-threatening allergic reaction.

If you have gout, you may experience a gout attack at the start of treatment with alopurinol.

It is more common to experience side effects if you have kidney or liver problems or if you are taking ampicillin or amoxicillin at the same time.

Other side effects

Common(may affect up to 1 in 10 people)

• Skin reactions (rash)
• Elevated levels of thyroid-stimulating hormone in blood

Uncommon(may affect up to 1 in 100 people)

• Feeling unwell (nausea) or being sick (vomiting)
• Abnormal liver function test results
• Diarrhea

Rare(may affect up to 1 in 1,000 people)

• Liver problems, such as liver inflammation

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

• May affect the lymph nodes
• Gastrointestinal bleeding
• On occasion, alopurinol tablets may produce effects on the blood that manifest with the appearance of more frequent bruising than usual, sore throat, or other signs of infection. These effects usually occur in people with kidney or liver problems. Inform your doctor as soon as possible if you have any of these symptoms.

• General weakness (asthenia), numbness, instability in the feet, feeling unable to move the muscles (paralysis), or loss of consciousness
• General feeling of malaise or weakness
• Furunculosis (ulcerative inflammation of the skin)

• Chest pain (angina), high blood pressure, or slow pulse
• High levels of urea in the blood (uremia)
• Blood in the urine (hematuria)
• Vomiting blood (hematemesis)
• Change in your normal bowel habit or excess fat in your stools (steatorrhea)
• Fluid accumulation leading to swelling (edema), particularly in the face (Quincke's edema)
• Enlargement of the breasts in men
• Feeling of tingling, prickling, stabbing, or burning in the skin (paresthesia)
• Inflammation of the mouth mucosa
• High levels of cholesterol in the blood (hyperlipidemia)
• Change in taste
• Hair loss or discoloration
• Infertility or erectile dysfunction
• Headache, dizziness, drowsiness, or vision disturbance
• Lack of coordination of voluntary muscle movements (ataxia), muscle pain
• Depression
• Cataracts
• Abnormal glucose metabolism (diabetes)

Frequency not known(cannot be estimated from the available data)

• Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include stiffness of the neck, headache, nausea, fever, or clouding of consciousness. If you present any of these symptoms, seek urgent medical attention.
• Lichenoid skin rash (red-purple skin rash with itching or grayish-white lines on the mucous membranes)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Alopurinol Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package and blister after 'EXP'. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

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 protect the environment.

6. Packaging Contents and Additional Information

Composition of Alopurinol Stada

The active ingredient is alopurinol.

Each tablet contains 300 mg of alopurinol.

The other excipients are lactose monohydrate, corn starch, povidone K 30, magnesium stearate, and anhydrous colloidal silica.

Product Appearance and Packaging Contents

Each 300 mg tablet is white, round, biconvex, with a score line on one side.

Alopurinol Stada 300 mg is available in packs of 28, 30, 50, 60, and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Aristo Pharma GmbH

Wallenroder

Straße 8-10,

13435 Berlin, Germany

or

Advance Pharma GmbH

Wallenroder

Straße 8-14,

13435 Berlin, Germany

Date of the Last Revision of this Leaflet:March 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/