Patient Information Leaflet: Package Insert

Alopurinol Stada 300 mg Tablets EFG

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

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

1. What is Alopurinol Stada 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. Storage of Alopurinol Stada

6. Contents of the pack and additional information

This medication contains the active ingredient alopurinol.

This medication works by reducing the speed 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 joints and tendons in the form of crystals. These crystals cause an inflammatory reaction. The inflammation causes the skin around certain joints to swell, become sensitive, and hurt only when touched lightly. It may also be observed 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.

Do not take Alopurinol Stada:

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

Warnings and precautions

Inform 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 experiencing a gout attack. Your doctor may also consider prescribing an appropriate analgesic or another gout medication (colchicine) during the first 4 weeks of treatment.
• You have thyroid problems.
• You have Chinese Han, Thai, or Korean ancestry.

Be especially careful with Alopurinol Stada:

Severe skin reactions(hypersensitivity syndrome, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis) have been reported with the use of allopurinol. These may initially appear as red patches, bullet-shaped or circular (often with blisters in the middle) on the trunk of the body. The rash may also include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These potentially fatal skin reactions usually precede symptoms similar to the flu (fever, headache, and body aches). The rash may progress to the formation of blisters and generalized peeling of the skin. If you develop a skin rash or these symptoms on your skin,stop taking allopurinol and consult your doctor immediately.

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

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

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

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

Other medications and Alopurinol Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications, including herbal medications. This is because allopurinol may affect the functioning of some medications. Some other medications may also affect the functioning of allopurinol.

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

• probencid, benzbromarone, sulfinpyrazone (gout medication)
• aspirin
• 6-mercaptopurine or azathioprine (cancer medications)
• ampicillin or amoxicillin (antibiotics): do not take allopurinol with ampicillin or amoxicillin as this may cause an increase in the frequency of skin rash. Use an alternative to ampicillin or amoxicillin when available.
• warfarin (blood-thinning medication)
• chlorpropamide (diabetes medication)
• theophylline (respiratory or cardiac problems medication)
• In combination with cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, haloalkanes), hematological disorders occur more frequently than when these active principles are administered alone. Therefore, regular hematological controls should be performed.
• vidarabine (used to treat herpes or varicella)
• ciclosporin (immunosuppressive medication)
• phenytoin (epilepsy medication)
• didanosine (used to treat HIV infection)
• • aluminum hydroxide. If taken concomitantly, allopurinol may have a reduced effect, so it is advisable to leave a gap of at least 3 hours between the two medications. Regular hematological controls should be performed.
• furosemide and diuretics (medications to eliminate excess body fluid), such as thiazides
• ACE inhibitors (medications for heart problems or high blood pressure), especially if you have kidney problems or chronic kidney disease.

Taking Alopurinol Stada with food, drinks, and alcohol

Avoid foods high in purines, such as organ meats like liver, kidneys, brain, heart, and tongue, as well as concentrated meat and alcohol, especially beer.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Alopurinol passes into breast milk. It is not recommended to use allopurinol during breastfeeding. Your doctor will decide whether to discontinue breastfeeding or discontinue/discontinue allopurinol therapy.

Driving and operating machinery

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

Alopurinol Stada contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Adults

The recommended dose is 300 mg of allopurinol per day. Your doctor will usually start treatment with allopurinol at a low dose (e.g., 100 mg/day) to reduce the risk of possible adverse effects. Your dose will increase if necessary.

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

The maximum daily dose is 800 mg of allopurinol.

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 allopurinol in a single dose.

If a daily dose of more than 300 mg of allopurinol is indicated or if gastrointestinal side effects (nausea, vomiting, diarrhea) occur, 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.

Older patients

If you are an older 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 reduced liver or kidney function due to the high content of allopurinol. Other doses of this medication 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 allopurinol. Other doses of this medication may be more suitable; consult your doctor or pharmacist.

Administration form

Oral administration.

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.

Treatment duration

The duration of treatment with this medication depends on the underlying disease. Please take allopurinol 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 speak with your doctor or pharmacist if you consider the effect of this medication to be 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 the hospital immediately. Bring the packaging 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Alopurinol Stada

If you forget to take a dose, do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Hyper-sensitivity (allergic reactions)

Rare(may affect 1 in 1,000 people)

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

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

• Severe and potentially fatal skin reaction (hypersensitivity reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis) (see section 2).
• Severe allergic reaction that causes facial or throat swelling.
• Severe and potentially fatal allergic reaction.

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

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 (hives)
• Elevated levels of thyroid-stimulating hormone in the blood

Uncommon(may affect 1 in 100 people)

• Feeling unwell (nausea) or 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 1 in 10,000 people)

• May affect lymph nodes
• Gastrointestinal bleeding
• In some cases, allopurinol tablets may produce effects on the blood that manifest with the appearance of more frequent bruises, 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, sensation of inability to move muscles (paralysis) or loss of consciousness
• General feeling of discomfort 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 normal bowel habits or excessive fat in stool (steatorrhea)
• Accumulation of fluid leading to swelling, particularly in the face (Quincke's edema)
• Enlargement of the breasts in men
• Sensation of tingling, prickling, stinging, or burning in the skin (paresthesia)
• Inflammation of the mucous membrane of the mouth
• 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 voluntary coordination of muscle movements (ataxia), muscle pain
• Depression
• Cataracts
• Abnormal glucose metabolism (diabetes)

Frequency not known(cannot be estimated from available data)

• Asymptomatic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever, or loss of consciousness. If you experience any of these symptoms, seek urgent medical attention.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, even if it is side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister pack after 'CAD'. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Alopurinol Stada

The active ingredient is allopurinol.

Each tablet contains 300 mg of allopurinol.

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

Appearance of the product and contents of the packaging

Each 300 mg tablet is white, round, biconvex, with a notch on one face.

The tablet can be divided into two equal halves.

Alopurinol Stada is available in packaging of 28, 30, 50, 60, and 100 tablets.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Aristo Pharma GmbH

Wallenroder

Straße 8-10,

13435 Berlin, Germany

or

Advance Pharma GmbH

Wallenroder

Straße 8-14,

13435 Berlin, Germany

Last review date of this leaflet:August 2022

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