ALOPURINOL CINFA 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

alopurinol cinfa 100 mg tablets EFG

alopurinol

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others, it may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is alopurinol cinfa and what is it used for
2. Before taking alopurinol cinfa
3. How to take alopurinol cinfa
4. Possible side effects
5. Storage of alopurinol cinfa
6. Further information

1. What is alopurinol cinfa and what is it used for

alopurinol cinfa 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.

alopurinol cinfa is used to prevent the onset of gout and other conditions caused by excess uric acid in the body, such as kidney stones and certain types of kidney or metabolic diseases.

2. Before taking alopurinol cinfa

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

Do not take alopurinol cinfa:

• If you are allergic (hypersensitive) to alopurinol or any of the other ingredients of alopurinol cinfa.

Be careful with alopurinol cinfa:

• If you have an acute gout attack.
• If you are pregnant, think you may be pregnant, or are breastfeeding.
• If you have or have had any kidney or liver disease.
• If you are taking or are going to 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 infection.
• If a skin rash, peeling of the skin, blisters, or sores appear on the lips or in the mouth, wheezing (whistling), palpitations, or chest tightness, loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TO alopurinol cinfa. Stop treatment and contact your doctor immediately.

If you are not sure, consult your doctor.

You should stop treatment and contact your doctor as soon as possible if, while taking alopurinol cinfa, you experience any of the following symptoms:

• High fever.
• Pain in the joints or painful swelling of the groin, armpits, or neck.
• Jaundice (yellowing of the skin and eyes).
• Nausea or vomiting (which may be bloody).
• General feeling of discomfort.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, vision changes.
• Chest pain, high blood pressure, or slow pulse.
• Swelling (edema) of the ankles.
• Feeling of thirst, fatigue, and weight loss.
• Appearance of boils.
• Appearance of blood in urine.

It is possible that at the start of treatment with alopurinol cinfa, an acute gout attack may be triggered. Your doctor will recommend the use of certain medications to prevent this. In case of a gout attack, it is not necessary to stop treatment with alopurinol cinfa as long as an appropriate anti-inflammatory medication is used at the same time.

Severe skin rashes that can threaten the patient's life (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been described with the use of alopurinol cinfa, initially appearing as red spots or patches, often with a central blister.

Other additional signs that may appear are sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).

These life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can progress to the formation of generalized blisters or peeling of the skin.

The greatest risk 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 cinfa, you should not use alopurinol cinfa again at any time.

If you develop a rash or these symptoms, stop taking alopurinol cinfa, go immediately to a doctor, and inform them that you are taking this medication.

Use of other medications:

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Especially with the following drugs:

• 6-mercaptopurine and azathioprine (for the treatment of Crohn's disease),
• adenine arabinoside (for the treatment of viral infections),
• salicylate (anti-inflammatory) and uricosuric agents (probenecid),
• chlorpropamide (for the treatment of diabetes),
• cumarin anticoagulants (to prevent blood clotting),
• phenytoin (for the treatment of epilepsy),
• theophylline (for the treatment of asthma).

Administration of 6-mercaptopurine or azathioprine with alopurinol should be avoided. When 6-mercaptopurine or azathioprine is administered with alopurinol cinfa, 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.

If you take aluminum hydroxide at the same time, alopurinol may have a reduced effect, so there should be an interval of at least 3 hours between taking both medications.

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

Therefore, periodic hematological checks should be performed.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

Alopurinol passes into breast milk. The use of alopurinol cinfa is not recommended if you are pregnant or during the breastfeeding period.

Driving and using machines:

Due to its side effects (drowsiness, dizziness, and affectation of coordination), alopurinol cinfa may impair your ability to drive vehicles.

Do not drive, do not handle tools or machines until you are reasonably sure that the medication does not limit your abilities.

Important information about some of the ingredients of alopurinol cinfa:

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

3. How to take alopurinol cinfa

Follow the administration instructions of alopurinol cinfa indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The normal dose is:

Usually, your doctor will 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.

Adults

The usual dose of alopurinol cinfa to start treatment is 100 mg to 300 mg per day.

The dose may be increased up to 900 mg per day, depending on your case. In this case, and if stomach upset appears, it is recommended to divide the dose into several intakes per day and take them with food.

Children under 15 years

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

Elderly

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

Patient with liver or kidney impairment

If you have liver or kidney problems, your doctor will prescribe the lowest possible dose of alopurinol cinfa that achieves reduced uric acid levels and controls your symptoms. In case of kidney failure, your doctor may advise you to take less than 100 mg per day or tell you 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 cinfa than you should

In this case, consult the Toxicology Information Service. Phone 91 562 04 20 or go to your doctor.

In case of accidental ingestion of too much medication, go to your doctor without delay or to the emergency department of the nearest hospital. Bring this leaflet with you.

If you forget to take alopurinol cinfa

Do not take a double dose to make up for forgotten doses.

In case you forget to take a dose, take the next dose as soon as you remember.

Then, continue as you normally would.

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

If you stop treatment with alopurinol cinfa

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

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

4. Possible side effects

Like all medicines, alopurinol cinfa can cause side effects, although not everybody gets them.

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

The frequency of side effects is classified as:

Very common (at least 1 in 10 patients).

Common (at least 1 in 100 patients).

Uncommon (at least 1 in 1,000 patients).

Rare (at least 1 in 10,000 patients).

Very rare (less than 1 in 10,000 patients).

Frequency not known (cannot be estimated from the available data).

Infections and infestations:

• Very rare: Infection of the hair follicle.

Blood and lymphatic system disorders:

• Very rare: Decreased number of white blood cells (increases the risk of infections), red blood cells (can cause fatigue, tiredness), platelets (cells involved in blood clotting, with the appearance of bruises or bleeding more easily than usual.
• Sometimes, alopurinol tablets can produce effects on the blood that manifest with the appearance of more frequent bruising than usual, 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.

Immune system disorders:

• Uncommon: Hypersensitivity reactions (allergy: possible appearance of skin rash, peeling of the skin, blisters, or sores on the lips or in the mouth).
• Rare: Severe hypersensitivity reactions, with fever, skin rash, joint pain, and changes in blood and liver tests (these can be symptoms of multi-organ hypersensitivity disorder).
• Very rare: Angioimmunoblastic lymphadenopathy (inflammation in the armpits, neck, groin). Very rarely, convulsions, wheezing (whistling), palpitations, chest tightness, or loss of consciousness can occur. Severe allergic reaction potentially fatal.

Metabolism and nutrition disorders:

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

Psychiatric disorders:

• Very rare: Depression.

Nervous system disorders:

• Very rare: Weakness, numbness, or loss of consciousness, paralysis, uncoordinated movements, alteration of normal sensitivity (neuropathy), drowsiness, headache, alteration in taste.
• Frequency not known: Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include stiffness of the neck, headache, nausea, fever, or clouding of 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: Vertigo.

Cardiac disorders:

• Very rare: Chest pain or slow pulse.

Vascular disorders:

• Very rare: High blood pressure.

Gastrointestinal disorders:

• Uncommon: Nausea, vomiting, diarrhea.
• Very rare: Appearance of blood in vomit, excess fat in feces, mouth infections, changes in bowel habits.

Hepatobiliary disorders:

• Uncommon: Asymptomatic increases in liver function tests.
• Rare: Hepatitis.

Skin and subcutaneous tissue disorders:

• Common: Skin rash.
• Rare: Any change in your skin, for example, ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes), blisters, or generalized peeling.

• Very rare: Hives, drug-related skin rash, hair loss or discoloration, severe allergic reaction that causes swelling of the face or throat. Life-threatening skin rashes can occur (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).
• Frequency not known: Lichenoid skin rash (red-purple skin rash with itching or white-grayish lines on the mucous membranes).

Renal and urinary disorders:

• Very rare: Appearance of blood in urine.

Reproductive system 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.
• Rare: Fever and chills, headache, muscle pain (flu-like symptoms) and general malaise.

Investigations:

• Common: Elevated thyroid-stimulating hormone levels in blood.

Cases of fever with or without signs or symptoms of generalized hypersensitivity to alopurinol have been reported (see Immune system disorders).

Do not be alarmed by this list of adverse reactions, as it is possible that none of them will appear in your case.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of alopurinol cinfa

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

No special storage conditions are required. Store in the original package.

Do not use alopurinol cinfa after the expiration date that appears on the packaging, after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. 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. FURTHER INFORMATION

Composition of alopurinol cinfa:

The active ingredient is alopurinol. Each tablet contains 100 mg of alopurinol.

The other ingredients are: lactose, sodium croscarmellose, povidone K-30, and magnesium stearate.

Appearance of the product and package contents:

alopurinol cinfa is presented in the form of white tablets. Each package contains 25 or 100 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer:

TOWA PHARMACEUTICAL EUROPE S.L.

C/ San Martí, 75-97

Martorelles, 08107 Barcelona

Spain

Date of the last revision of this leaflet:January 2025

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