Package Insert: Information for the Patient

Alopurinol Stada 100 mg Tablets EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3. How to take Alopurinol Stada

4. Possible adverse effects

5. Storage of Alopurinol Stada

6. Contents of the package 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 the 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 can 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.

Alopurinol 100 mg can also 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.

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 give you a lower dose or ask you to take it less frequently. They may also monitor you more closely.
• You currently have a gout attack. Your doctor may also consider prescribing you 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(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 origin. Additionally, chronic renal insufficiency 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 to 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. 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 thinner)
• chlorpropamide (diabetes medication)
• theophylline (respiratory or cardiac problems medication)
• chemotherapy medications (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents). Blood disorders occur more frequently when these medications are taken together. Regular blood tests should be performed.
• vidarabine (used to treat herpes or varicella)
• ciclosporin (immunosuppressant medication)
• phenytoin (epilepsy medication)
• didanosine (used to treat HIV infection)
• aluminum hydroxide. When taken together, it may reduce the effect of allopurinol. There should be an interval of at least 3 hours between taking these medications.
• furosemide and diuretics (medication 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 renal insufficiency.

Taking Alopurinol Stada with food, drinks, and alcohol

Avoid foods high in purine, 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 is not recommended 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 ranges from 100 mg to 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 be increased 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.

Patients of advanced age and patients with kidney or liver problems

If you are an older 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 of body weight up to a maximum of 400 mg/day, divided into three doses.

Administration form

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 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 that the effect of this medication 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 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 aches (symptoms similar to the flu) 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 a 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 (urticaria)
• 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
• Diarrea

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 the lymph nodes
• Gastrointestinal bleeding
• Bleeding or bruising more easily than usual, or 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 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 stools (steatorrhea)
• Accumulation of fluid leading to swelling, particularly in the face (Quincke's edema)
• Enlargement of the breasts in men
• Feeling 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
• Loss of hair or discoloration
• Infertility or erectile dysfunction
• Headache, dizziness, drowsiness, or visual disturbances
• 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 the 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.

This medication does not require special storage conditions.

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 the 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 alopurinol.

Each tablet contains 100 mg of alopurinol.

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 100 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 20, 25, 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 prospectus:April 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/