Package Leaflet: Information for the User

Alopurinol Teva 300 mg Tablets EFG

Read this 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. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, see section 4.

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

2. What you need to know before you start taking Alopurinol Teva

3. How to take Alopurinol Teva

4. Possible side effects

5. Storage of Alopurinol Teva

6. Contents of the pack and additional information

Alopurinol Teva belongs to a group of medicines called enzyme inhibitors, which act by controlling the speed at which a certain chemical process occurs in the body, in this case, resulting in a decrease in the level of uric acid in plasma and urine. This medicine is used to prevent the onset of gout and other situations caused by excess uric acid in the body, such as, for example, kidney stones and certain types of renal or metabolic diseases.

Do not take Alopurinol Teva

- if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alopurinol Teva

• if you have an acute gout attack.
• if you are pregnant, think you may be pregnant or are breastfeeding your child.
• if you have or have had any kidney or liver disease.
• if you are taking or will start taking any medication for heart disease or high blood pressure.
• if you notice that you bruise more easily than before or if you have a sore throat or other signs of an infection.
• if a skin rash, skin peeling, blisters or sores on the lips or in the mouth, wheezing (whistling), palpitations or chest tightness, loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TOalopurinol. Suspend your treatment and contact your doctor immediately.

You should suspend your treatment and contact your doctor as soon as possible if, while you are taking this medication, you present any of the following symptoms:

- High fever.

- Pain in the joints or painful swelling of the ankles, armpits or neck.

- Ictericia (yellowing of the skin and eyes).

- Nausea or vomiting (which may be with blood).

- General feeling of discomfort.

- Weakness, numbness or loss of consciousness.

- Headache, drowsiness, dizziness, vision disturbances.

- Chest pain, high blood pressure or slowing of the pulse.

- Swelling (edemas) of the ankles.

- Feeling of thirst, fatigue and weight loss.

- Appearance of boils.

- Appearance of blood in urine.

It is possible that an acute gout attack may precipitate at the beginning of treatment with this medication. Your doctor will recommend the use of certain medications to prevent it. In the event of a gout attack, treatment with this medication does not need to be suspended as long as an appropriate anti-inflammatory medication is used concurrently.

Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of alopurinol. The rash often includes ulcers in the mouth, throat, nose, genitals and conjunctivitis (inflammation and redness of the eyes). These severe skin reactions are often preceded by flu-like symptoms such as fever, headache, body aches. The rash may progress to the formation of blisters and generalized skin peeling. These severe skin reactions may be more frequent in people of Chinese Han, Thai or Korean origin.Additionally, the risk of developing chronic renal insufficiency may increase in these patients. If you develop a skin rash or these symptoms on the skin, stop taking alopurinol and consult your doctor immediately.

The period of highest risk of appearance of severe skin reactions is during the first weeks of treatment.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of alopurinol, you should not use Alopurinol Teva again at any time.

Taking Alopurinol Teva with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, especially the following: 6-mercaptopurine (for the treatment of certain types of cancer), azathioprine (to prevent rejection in transplants and the treatment of autoimmune diseases), arabinoside of adenine (vidarabine, for the treatment of viral infections), salicylates (aspirin, for the treatment of pain), uricosuric agents (probenecid, for the treatment of gout), chlorpropamide (for the treatment of diabetes), theophylline (for asthma), phenytoin (for epilepsy), ampicillin (antibiotic), amoxicillin (antibiotic), cyclophosphamide (for rheumatoid arthritis and the treatment of certain types of cancer), doxorubicin (for the treatment of certain types of lymphomas), bleomycin (for the treatment of certain types of cancer), procarbazine (for the treatment of certain types of cancer), mechlorethamine (for the treatment of certain types of cancer), cyclosporine (to prevent rejection in transplants), anticoagulant coumarins (to prevent the formation of blood clots) and didanosine (for the treatment of HIV) and captopril.

Administration of 6-mercaptopurine or azathioprine with alopurinol should be avoided. When 6-mercaptopurine or azathioprine are 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 severe blood disorders. In this case, your doctor will closely monitor your blood count during treatment.

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

If you are taking aluminum hydroxide concomitantly, alopurinol may have a reduced effect, so it is advisable to leave a gap of at least 3 hours between taking both medications.

In the administration of alopurinol in combination with cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood disorders occur more frequently than when these active ingredients are administered alone.

Therefore, periodic hematological controls should be performed.

Pregnancy and breastfeeding

This medication is not recommended if you are pregnant. Alopurinol passes into breast milk. This medication is not recommended during the lactation period

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

Due to its side effects (drowsiness, dizziness and coordination impairment), this medication may impair your ability to drive vehicles. Do not drive, do not operate tools or machines until you are reasonably sure that the medication does not limit your abilities.

Alopurinol Teva contains lactose and sodium

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

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

Generally, your doctor will start treatment with alopurinol at a low dose (e.g., 100 mg/day) to reduce the risk of possible adverse effects. Your dose will be increased if necessary.

Oral administration only.

The tablet can be divided into equal doses.

The tablets can be taken directly or divided in half with the help of a little water. It is usually taken once a day, generally after a meal.

The recommended dose is:

Adults:

The usual starting dose of alopurinol for treatment is 100 to 300 mg. The dose may be increased up to 900 mg per day, depending on your case. In this case, and if gastrointestinal discomfort appears, it is recommended to divide the dose into several daily doses and take them with food.

Children under 15 years:

The usual dose of this medication in children is 100 to 400 mg per day.

Older adults:

Your doctor will recommend the lowest possible dose of alopurinol to reduce uric acid levels and control your symptoms.

Use in patients with liver or kidney dysfunction:

If you have liver or kidney problems, your doctor will prescribe the lowest possible dose of alopurinol that can reduce uric acid levels and control your symptoms. In case of renal insufficiency, your doctor may advise you to take less than 100 mg per day or to take single doses of 100 mg at intervals greater than one day. If you are on dialysis 2 or 3 times a week, your doctor may prescribe a dose of 300-400 mg immediately after each dialysis session.

If you take more Alopurinol Teva than you should

In this case, consult the Toxicological Information Service. Phone 91 562 04 20 or visit your doctor.

In case of accidental ingestion of a large amount of medication, go to your doctor immediately or to the nearest hospital emergency room. Bring this leaflet with you.

If you forgot to take Alopurinol Teva

If you forget to take a dose, take the next dose as soon as you remember. Then, continue as you normally do. Do not take a double dose to compensate for the missed doses.

If you forget several doses, it is best to contact your doctor to decide what you should do from then on.

If you interrupt treatment with Alopurinol Teva

Your doctor will indicate the duration of treatment with alopurinol. Do not stop treatment before, even if you feel better.

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

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

The likelihood of them occurring is higher when there are kidney and/or liver abnormalities.

If you experience any of the following symptoms, stop taking the medicine and inform your doctor immediately.

The frequency of side effects is classified as:

Very common (≥1/10)

Common (≥ 1/100 to <1)

Uncommon (≥ 1/1,000 to <1)

Rare (≥1/10,000 to <1)

Very rare (<1)

Frequency unknown (cannot be estimated from available data)

Infections and infestations

Very rare:Folliculitis

Blood and lymphatic system disorders

Very rare:Decreased white blood cell count (increases the risk of infections), red blood cell count (may cause fatigue, lethargy), platelet count (cells involved in blood clotting, with bruising or bleeding more easily than usual).

Immune system disorders

Uncommon:Hypersensitivity reactions

Very rare:Lymphadenopathy angioimmunoblastic (inflammation in the armpits, neck, and groin).

Metabolism and nutrition disorders

Very rare:Diabetes mellitus (high blood sugar levels), increased lipid levels (fats) in the blood, increased uric acid levels in the blood.

Mental and behavioural disorders

Very rare:Depression

Nervous system disorders

Very rare:Weakness, numbness, or loss of consciousness, paralysis, uncoordinated movements, altered sensitivity (neuropathy), drowsiness, headache, altered taste.

Not known:Asymptomatic 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.

Eye disorders

Very rare:Cataracts, visual disturbances.

Ear and labyrinth disorders

Very rare:Vestibular disorders

Cardiac disorders

Very rare:Chest pain or slowed pulse.

Vascular disorders

Very rare:High blood pressure

Gastrointestinal disorders

Uncommon:Nausea, vomiting, diarrhea

Very rare:Bleeding in the vomit, excessive fat in the stool, oral infections, changes in bowel habits.

Hepatobiliary disorders

Uncommon:Asymptomatic increases in liver function tests.

Rare:Hepatitis

Skin and subcutaneous tissue disorders

Common:Skin rash

Very rare:Urticaria, drug-induced skin eruptions, hair loss or discoloration. Skin eruptions may threaten the patient's life (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

Frequency unknown:Maculopapular rash (red-violet rash with itching or white-gray lines on mucous membranes)

Musculoskeletal and connective tissue disorders

Very rare:Muscle pain

Renal and urinary disorders

Rare:Urinary tract stones

Very rare:Blood in the urine

Reproductive and breast disorders

Very rare:Male infertility, impotence, breast growth.

General disorders and administration site conditions

Very rare:Swelling (edema) of the ankles, general malaise, fatigue, fever.

Cases of fever with or without evident signs or symptoms of a generalized hypersensitivity reaction to allopurinol have been reported (see "Immune system disorders").

Common (may affect up to 1 in 10 patients)

- Elevated levels of thyroid-stimulating hormone in the blood.

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

- Fever and chills, headache, muscle pain (flu-like symptoms) and general malaise.

- Any change in your skin, such as mouth ulcers, throat, nose, genital, and conjunctivitis (inflammation and redness of the eyes), blisters or generalized peeling.

- Severe hypersensitivity reactions, with fever, rash, joint pain, and alterations in blood and liver tests (these may be symptoms of multi-organ hypersensitivity disorder).

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

- In some cases, allopurinol tablets may cause blood effects that manifest as frequent bruising, sore throat, and 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.

- Severe allergic reaction causing swelling of the face or throat.

- Potentially fatal allergic reaction.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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 after “CAD”. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

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 point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alopurinol Teva

-The active ingredient is alopurinol. Each tablet contains 300 mg of Alopurinol.

- The other components are: lactose monohydrate, cornstarch without gluten, carboxymethyl starch sodium (type A) (from potato), anhydrous colloidal silica, powdered cellulose (E-460), povidone (K-30), sodium lauryl sulfate, and magnesium stearate.

Appearance ofAlopurinol Tevaand contents of the packaging

White, round, biconvex tablets with the inscription "2K1 2K1" and scored on one face and smooth on the other. The tablet can be divided into equal doses.

They are presented in packs of 30 tablets, containing 3 blisters of 10 tablets and a leaflet.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor, Alcobendas

28108 Madrid

Spain

Responsible for manufacturing

Teva Pharmaceutical Works Private Limited Company

Pallagi Street 13, H-4042 Debrecen

Hungary

Last review date of this leaflet: December 2024

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