Allopurinol Cinfamed 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

alopurinol cinfamed 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 others, 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 effects not listed in this leaflet. See section 4.

Leaflet contents

1. What alopurinol cinfamed is and what it is used for
2. What you need to know before taking alopurinol cinfamed
3. How to take alopurinol cinfamed
4. Possible side effects
5. How to store alopurinol cinfamed

Pack contents and additional information

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

Alopurinol belongs to a group of medicines called enzyme inhibitors, which work by regulating the rate at which a specific chemical process occurs in the body. In this case, the result is a reduction in the level of uric acid in plasma and urine.

Alopurinol is used to prevent the occurrence of gout and other conditions caused by excess uric acid in the body, such as kidney stones and certain types of renal or metabolic disorders.

2. What you need to know before starting to take alopurinol cinfamed

Serious skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of alopurinol. Frequently, the rash may 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, and body aches. The rash may progress to blistering and widespread peeling of the skin. These serious skin reactions may be more common in individuals of Han Chinese, Thai, or Korean descent. In addition, having chronic kidney disease may increase the risk in these patients. If you develop a skin rash or these skin symptoms, stop taking alopurinol and consult your doctor.

Do not take alopurinol cinfamed

• if you are allergic to alopurinol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting to take alopurinol cinfamed:

• if you are experiencing 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 about to start taking any medicine for heart conditions or high blood pressure.
• if you notice you bruise more easily than before, or if you develop a sore throat or other signs of infection.
• if you develop a skin rash, skin peeling, blisters, or sores in the lips or mouth, throat, nose, genitals, and conjunctivitis (swollen, red eyes), wheezing, palpitations, chest tightness, or loss of consciousness: these symptoms may mean you are allergic to alopurinol. Stop treatment and contact your doctor immediately.

Life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) associated with alopurinol initially appear as red spots or circular lesions, often with a central blister.

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

If you develop Stevens-Johnson syndrome or toxic epidermal necrolysis while taking alopurinol, you must never use alopurinol again.

If you are unsure, consult your doctor.

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

• High fever.
• Joint pain or painful swelling of the groin, armpits, or neck.
• Jaundice (yellowing of the skin and eyes).
• Nausea or vomiting (which may contain blood).
• General feeling of being unwell.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, vision disturbances.
• Chest pain, high blood pressure, or slowed pulse.
• Swelling (edema) of the ankles.
• Feeling thirsty, tired, and weight loss.
• Appearance of boils.
• Blood in the urine.

An acute gout attack may be triggered at the beginning of treatment with alopurinol. Your doctor may recommend taking certain medications to prevent this. If a gout attack occurs, it is not necessary to stop alopurinol treatment, provided an appropriate anti-inflammatory medicine is used concurrently.

Other medicines and alopurinol cinfamed

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, especially the following: 6-mercaptopurine (used to treat blood cancer), azathioprine (used to suppress the immune system), vidarabine (adenine arabinoside), salicylates (aspirin, ...), uricosuric agents (probenecid, ...), chlorpropamide, theophylline, phenytoin, ampicillin, amoxicillin, cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides, mechlorethamine, cyclosporine, coumarin anticoagulants, didanosine, or aluminum hydroxide.

The administration of 6-mercaptopurine or azathioprine together with alopurinol should be avoided. When 6-mercaptopurine or azathioprine are administered together with alopurinol cinfamed, the dose of 6-mercaptopurine or azathioprine must 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.

Seek medical advice immediately if you notice unexplained bruising, bleeding, fever, or sore throat.

If aluminum hydroxide is taken concomitantly, the effect of alopurinol may be reduced; therefore, an interval of at least 3 hours should be left between taking the two medicines.

When alopurinol is administered in combination with cytostatic agents (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides), blood dyscrasias occur more frequently than when these active substances are administered alone.

Therefore, periodic hematological monitoring should be performed.

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.

The use of alopurinol is not recommended during pregnancy.

Alopurinol passes into breast milk. The use of alopurinol is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Due to its side effects (drowsiness, dizziness, and impaired coordination), alopurinol may impair your ability to drive.

Do not drive or operate tools or machinery until you are reasonably certain that this medicine does not affect your ability to do so safely.

alopurinol cinfamed contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take allopurinol cinfamed

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

For oral use only. Swallow the tablet whole with a little water. It is usually taken once daily, generally after a meal.

The score line is intended solely for dividing the tablet if you find it difficult to swallow it whole.

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.

The recommended dose is:

Adults:

The recommended starting dose of allopurinol is 100 to 300 mg. The dose may be increased up to 900 mg per day, depending on your individual condition. In such cases, and if stomach discomfort occurs, it is advisable to divide the dose into several administrations per day and take it with food.

Children under 15 years of age:

The recommended dose of this medicine in children is 100 to 400 mg daily.

Elderly patients:

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

Use in patients with impaired hepatic or renal function:

If you have liver or kidney problems, your doctor will prescribe the lowest effective dose of allopurinol required to reduce uric acid levels and control your symptoms. In case of renal insufficiency, your doctor may advise taking less than 100 mg per day or taking single doses of 100 mg at intervals longer than one day. If you are on dialysis two or three times a week, your doctor may prescribe a dose of 300–400 mg immediately after each dialysis session.

If you take more allopurinol cinfamed than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take allopurinol cinfamed

If you forget to take a dose, take it as soon as you remember. Then continue taking it as before. Do not take a double dose to make up for a missed dose.

If you miss several doses, it is best to contact your doctor so that he or she can decide what you should do from that point onward.

If you stop taking allopurinol cinfamed

Your doctor will determine the duration of treatment with allopurinol. Do not stop treatment early, even if you feel better.

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 experiences them.

The likelihood of adverse effects occurring is higher when there are renal and/or hepatic impairments.

The frequency of adverse effects is classified as follows:

Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Frequency not known (cannot be estimated from available data)

Infections and infestations

Very rare Hair follicle infection

Blood and lymphatic system disorders

Very rare Decrease in white blood cells (increases risk of infections), red blood cells (may cause tiredness, fatigue), platelets (cells involved in blood clotting, leading to bruising or bleeding more easily than usual).

Occasionally, allopurinol tablets may cause blood-related effects, manifesting as more frequent bruising than normal, sore throat, or other signs of infection. These effects usually occur in people with renal or hepatic problems. Inform your doctor as soon as possible if you experience any of these symptoms.

Immune system disorders

Uncommon Hypersensitivity reactions (allergy: possible appearance of skin rash, skin peeling, blisters or sores in the lips or mouth).

Rare Severe, serious hypersensitivity reactions associated with skin exfoliation, fever, joint pain, or painful swelling in the groin, armpits, or neck, jaundice (yellowing of the skin and eyes), and other skin and subcutaneous tissue disorders (see below).

Very rare Angioimmunoblastic lymphadenopathy (swelling in armpits, neck, groin), potentially life-threatening severe allergic reaction.

Very rarely, seizures, wheezing (whistling breathing), palpitations, chest tightness, or loss of consciousness may occur.

Metabolism and nutrition disorders

Very rare Diabetes mellitus (high blood sugar levels), increased blood lipid (fat) levels, increased blood uric acid levels.

Psychiatric disorders

Very rare Depression.

Nervous system disorders

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

Frequency not known 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.

Eye disorders

Very rare Cataracts, visual disturbances.

Ear and labyrinth disorders

Very rare Vertigo.

Cardiac disorders

Very rare Chest pain or slowed pulse.

Vascular disorders

Very rare High blood pressure.

Gastrointestinal disorders

Uncommon Nausea, vomiting, diarrhoea.

Very rare Blood in vomit, excess fat in stools, 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.

Very rare Hives, drug-type skin rashes that may be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2. What you need to know before taking alopurinol cinfamed), hair loss or discoloration, severe allergic reaction causing swelling of the face or throat.

Frequency not known Lichenoid skin eruption (reddish-purple rash with itching or white-gray thread-like lines on mucous membranes).

Renal and urinary disorders

Very rare Blood in urine.

Reproductive system and breast disorders

Very rare Male infertility, impotence, breast enlargement.

General disorders and administration site conditions

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

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

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, for example, mouth, throat, nose, genital ulcers, conjunctivitis (inflammation and redness of the eyes), blisters or widespread skin peeling.
• Severe hypersensitivity reactions, with fever, skin rash, joint pain, and abnormalities in blood tests and liver function tests (these may be symptoms of a multi-organ hypersensitivity disorder).

Additional investigations

Common Elevated blood levels of thyroid-stimulating hormone.

Cases of fever with or without evident signs or symptoms of generalized hypersensitivity to allopurinol 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 occur in your case.

Reporting of adverse effects

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

5. Storage of allopurinol cinfamed

Keep this medicine out of sight and reach of children.

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

Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of alopurinol cinfamed

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

The other components are: monohydrate lactose, corn starch, povidone and magnesium stearate.

Appearance of the product and contents of the pack

The tablets are white, cylindrical, biconvex, and have a score line on one side.

They are supplied in PVC/aluminum blisters, in cardboard boxes containing 25 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

FAES FARMA, S.A.

C/ Máximo Aguirre, 14 48940 Leioa

or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

Derio

48160 Vizcaya España

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: January 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84085/P_84085.html

QR code a: https://cima.aemps.es/cima/dochtml/p/84085/P_84085.html