ALOPURINOL STADA 100 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Alopurinol Stada 100 mg Tablets EFG

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Alopurinol Stada and what is it used for
2. What you need to know before taking Alopurinol Stada
3. How to take Alopurinol Stada
4. Possible side effects
5. Storage of Alopurinol Stada
6. Package contents and additional information

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

This medication contains the active ingredient alopurinol.

This medication 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 accumulates 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 intense pain occurs 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.

Additionally, alopurinol 100 mg may be used in children and adolescents under 15 years:

• to prevent and treat complications in which the body produces too much uric acid, for example during cancer treatment (e.g., leukemia)

• in certain enzymatic disorders such as Lesch-Nyhan syndrome.

2. What you need to know before taking Alopurinol Stada

Do not take Alopurinol Stada:

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

Warnings and precautions

Tell your doctor or pharmacist before taking this medication if:

• you have liver and kidney problems. Your doctor may administer 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 an appropriate pain reliever or another anti-gout medication (colchicine) during the first 4 weeks of treatment.
• you have thyroid problems.
• you have Chinese Han, Thai, or Korean ancestry.

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 initially appear as reddish spots, bull's-eye shaped or circular (often with blisters in the middle) on the torso. The rash often includes 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 flu-like symptoms (fever, headache, and body aches). The rash can progress to blistering and generalized peeling of the skin. If you develop a skin rash or these skin symptoms, 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, chronic kidney failure may increase the risk 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 kidney stones, the stones may 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 drink enough water.

Other medications and Alopurinol Stada

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

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

• probenecid, benzbromarone, sulfinpyrazone (medication for 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 (medication used to thin the blood).
• chlorpropamide (medication used to treat diabetes).
• theophylline (medication used for respiratory or cardiac problems).
• medications used in chemotherapy (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halogenides). Blood disorders occur more frequently when these medications are taken together. Therefore, blood tests should be performed at regular intervals.
• vidarabine (used to treat herpes or chickenpox)
• cyclosporine (medication used to reduce the immune response)
• phenytoin (medication used for epilepsy).
• didanosine (used to treat HIV infection)
• aluminum hydroxide. When taken together, it may reduce the effect of alopurinol. There should be an interval of at least 3 hours between taking these medications.
• furosemide and diuretics (medication to remove excess fluid from the body), such as thiazides.
• ACE inhibitors (medications 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 medications listed below. Your doctor may need to reduce the dose of your medication or monitor you more closely, as there is a higher 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)

Administration of 6-mercaptopurine or azathioprine with alopurinol should be avoided. 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 high in purine, 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not take this medication if you are pregnant unless your doctor recommends it.

The use of alopurinol is not recommended during breastfeeding. Your doctor will decide whether to discontinue breastfeeding or discontinue/abstain from alopurinol therapy.

Driving and using machines

Alopurinol's influence on the ability to drive and use machines is moderate. Do not drive or use machines unless you know how this medication affects you.

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

Alopurinol Stada contains lactose

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

3. How to take Alopurinol Stada

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Adults

The recommended doseranges from 100 mg to 300 mg of alopurinol per day. Your doctor will usually 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.

Your doctor may increase the dose to 600 mg 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 sensitive stomachs.

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 medication.

Elderly patients and patients with kidney or liver problems

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

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

The daily dose is 10 mg/kg body weight up to a maximum of 400 mg/day, divided into three doses.

Method of administration

Oral route.

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 halves.

Duration of treatment

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

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 think the effect of this medication 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. Bring the package of this medication 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 medication 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 missed doses.

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone gets them.

If you have any of the following side effects, stop taking this medication 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 skin changes, such as ulcers in the mouth, throat, nose, genitals, or conjunctivitis (red and inflamed eyes), blisters, or generalized peeling of the skin.
• Severe allergic reactions that include fever, skin rash, general discomfort, 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 when starting 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

Frequent(may affect up to 1 in 10 people)

• Skin reactions (rash)
• Elevated thyroid-stimulating hormone levels 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
• Bruising more easily than usual, or you may develop sore throat or other signs of infection. These effects usually occur in people with liver or kidney problems. Tell your doctor as soon as possible

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

• Chest pain (angina), high blood pressure, or slow pulse
• High urea levels in blood (uremia)
• Blood in urine (hematuria)
• Vomiting blood (hematemesis)
• Change in normal bowel habits or excess fat in 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 cholesterol levels in 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 available data)

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Alopurinol Stada

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and blister after 'EXP'. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Alopurinol Stada

The active ingredient is alopurinol.

Each tablet contains 100 mg of alopurinol.

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

Appearance of the Product and Packaging Content

Each 100 mg tablet is white, round, biconvex, with a score on one side.

Alopurinol Stada is available in packs of 20, 25, 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/