Alopurinol Stada 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Alopurinol Stada 100 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents

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

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

This medicine contains the active substance allopurinol.

This medicine works by slowing down certain chemical reactions in the body to reduce 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 trigger an inflammatory reaction. The inflammation causes the skin around certain joints to swell, become sensitive, and hurt even upon light touch. Severe pain may also occur when moving the joint.

Alopurinol is used in adults:

• to reduce uric acid levels when diet alone is insufficient
• for the treatment and prevention of the aforementioned complications in cases where the body produces too much uric acid.

Additionally, allopurinol 100 mg may be used in children and adolescents under 15 years of age:

• 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 starting to take Alopurinol Stada

Do not take Alopurinol Stada:

• If you are allergic to allopurinol or to 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 or kidney problems. Your doctor may prescribe a lower dose or advise you to take it less frequently. They may also monitor you more closely.
• you are currently experiencing a gout attack. Your doctor may also consider prescribing a suitable painkiller or another anti-gout medicine (colchicine) during the first 4 weeks of treatment.
• you have thyroid problems.
• you are of Han Chinese, Thai, or Korean ancestry.

Take special care with allopurinol:

Serious skin reactions (Hypersensitivity Syndrome, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) have been reported with the use of allopurinol. These may initially appear as red, target-shaped or circular spots (often with blisters in the center) on the trunk of the body. The rash frequently involves ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These potentially life-threatening skin reactions are often preceded by flu-like symptoms (fever, headache, and body aches). The rash may progress to blistering and widespread skin peeling. If you develop a skin rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately.

If you have previously experienced a severe skin reaction while being treated with allopurinol, you must not be treated with allopurinol again.

These serious skin reactions may be more common in people of Han Chinese, Thai, or Korean origin. Additionally, chronic renal failure may increase the risk in these patients.

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

If you have kidney stones, the stones may become smaller and enter your urinary tract, which could cause problems. You should produce at least 2 liters of urine per day to reduce the risk of kidney stone formation. Ensure you drink sufficient fluids.

Other medicines and Alopurinol Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because allopurinol may affect how some medicines work. Also, some other medicines may affect how allopurinol works.

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

• probenecid, benzbromarone, sulfinpyrazone (medicines used to treat gout)
• acetylsalicylic acid
• ampicillin or amoxicillin (antibiotics): do not take allopurinol with ampicillin or amoxicillin, as this may increase the likelihood of skin rash. An alternative to ampicillin or amoxicillin should be used when available.
• warfarin (a medicine used to thin the blood)
• chlorpropamide (a medicine used to treat diabetes)
• theophylline (a medicine used for breathing or heart problems)
• medicines used in chemotherapy (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides). Blood disorders occur more frequently when these medicines are taken together. Therefore, regular blood tests should be performed.
• vidarabine (used to treat herpes or chickenpox)
• cyclosporine (a medicine used to reduce immune response)
• phenytoin (a medicine used for epilepsy)
• didanosine (used to treat HIV infection)
• aluminium hydroxide. When taken together, this may reduce the effect of allopurinol. There should be an interval of at least 3 hours between taking these medicines.
• furosemide and diuretics (medicines to remove 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 renal 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, as there is an increased risk of side effects when allopurinol is taken at the same time as:

• 6-mercaptopurine (used to treat blood cancer)
• Azathioprine (used to suppress the immune system)

The concomitant administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine are administered together with allopurinol, the dose of 6-mercaptopurine or azathioprine should be reduced because their 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.

Contact your doctor immediately if you notice unexplained bruising, bleeding, fever, or sore throat.

Taking Alopurinol Stada with food, drinks and alcohol

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

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 medicine.

You should not take this medicine during pregnancy unless your doctor specifically recommends it.

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

Driving and using machines

The effect of allopurinol on the ability to drive and use machines is moderate. Do not drive or operate machinery unless you know how this medicine affects you.

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

Alopurinol Stada contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Alopurinol Stada

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

The recommended dose ranges from 100 mg to 300 mg of allopurinol per day. Generally, your doctor will start treatment with allopurinol at a low dose (e.g., 100 mg/day) to reduce the risk of possible adverse effects. Your dose may be increased if necessary.

Your doctor may increase the dose up to 600 mg or 800 mg of allopurinol per day, if needed.

The maximum daily dose is 800 mg of allopurinol.

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

To avoid side effects, no more than 300 mg of allopurinol should be taken in a single dose.

If a daily dose exceeding 300 mg of allopurinol is indicated or if gastrointestinal side effects occur (nausea, vomiting, diarrhea), the dose may be divided into several doses taken throughout the day.

Your doctor will determine the correct dose for you.

Make sure to drink enough water while taking this medicine.

Elderly patients and patients with kidney or liver problems

If you are elderly 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 of age

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

Method of administration

Oral use.

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

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

Duration of treatment

The duration of treatment with this medicine depends on the underlying condition. Please take allopurinol regularly and for as long as your doctor has instructed.

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

If you take more Alopurinol Stada than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating 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 missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse 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 aches (flu-like symptoms), and general malaise. Any skin changes, for example; mouth ulcers, sore throat, nose, genitals, or conjunctivitis (red and swollen eyes), blisters or widespread skin peeling.
• Severe allergic reactions including fever, skin rash, general pain, and abnormalities in blood tests and liver function tests (may be signs of a multi-organ hypersensitivity disorder).

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

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

If you have gout, you may experience a gout attack at the beginning of treatment with allopurinol.

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

Other adverse effects

Common (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 results in liver function tests
• Diarrhea

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

• Liver problems, such as inflammation of the liver

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 a sore throat or other signs of infection. These effects usually occur in people with liver or kidney problems. Inform your doctor as soon as possible.

• General weakness (asthenia), numbness, instability when walking, sensation of inability to move muscles (paralysis), or loss of consciousness

• General feeling of malaise or weakness

• Furunculosis (ulcerative skin inflammation)

• Chest pain (angina), high blood pressure, or slow pulse

• High levels of urea in the blood (uraemia)

• Blood in the urine (haematuria)

• Vomiting blood (haematemesis)

• Change in your normal bowel habits or excess fat in your stools (steatorrhoea)

• Fluid accumulation leading to swelling (oedema), particularly in the face (Quincke's oedema)

• Enlargement of the breasts in men

• Tingling, prickling, stinging, or burning sensation on the skin (paraesthesia)

• Inflammation of the mucous membrane of the mouth

• High levels of cholesterol in the blood (hyperlipidaemia)

• Change in taste

• Hair loss or discoloration

• Infertility or erectile dysfunction

• Headache, dizziness, drowsiness, or vision disturbances

• Lack of voluntary muscle coordination (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 neck stiffness, headache, nausea, fever, or altered consciousness. If you experience any of these symptoms, seek urgent medical attention.
• Lichenoid eruption (reddish-purple skin rash with itching or whitish-gray thread-like lines on mucous membranes)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Allopurinol Stada

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after 'EXP'. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alopurinol Stada

The active substance is allopurinol.

Each tablet contains 100 mg of allopurinol.

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

Appearance of the product and contents of the pack

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

Alopurinol Stada is available in packs containing 20, 25, 28, 30, 50, 60 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio 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 12-14,

13435 Berlin, Germany

Date of the most recent revision of this leaflet: March 2025

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