Package Insert: Information for the User

Alopurinol Cinfamed 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 refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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.

Contents of the package and additional information

Alopurinol belongs to a group of medications 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 is used to prevent the onset of gout and other situations caused by excessive uric acid in the body, such as, for example, kidney stones and certain types of renal or metabolic diseases.

Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. The rash may include 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, and body aches. The rash may progress to the formation of blisters and generalized skin peeling. These severe skin reactions may be more common in people of Chinese, Thai, or Korean origin. Additionally, having chronic kidney disease may increase the risk in these patients. If you develop a skin rash or these symptoms, stop taking allopurinol and consult your doctor.

Do not take allopurinol cinfamed

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

Warnings and precautions

Consult your doctor before starting to take allopurinol cinfamed:

• 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 you develop a skin rash, skin peeling, blisters, or sores on the lips or in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes), wheezing (popping sounds), palpitations, or chest tightness, loss of consciousness: these symptoms may indicate that you are allergic to allopurinol. Suspend your treatment and contact your doctor immediately.

Severe skin reactions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) with the use of allopurinol, initially appear as red, circular spots or patches, often with a central blister.

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

If you develop Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of allopurinol, you should not use allopurinol again at any time.

If you are unsure, consult your doctor.

You should suspend your treatment and contact your doctor as soon as possible if, while you are taking allopurinol, 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 bloody).
• General feeling of discomfort.
• 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 of thirst, fatigue, and weight loss.
• Appearance of boils.
• Blood in the urine.

It is possible that an acute gout attack may precipitate at the beginning of treatment with allopurinol. Your doctor will recommend the use of certain medications to prevent it. If a gout attack occurs, it is not necessary to stop treatment with allopurinol as long as a suitable anti-inflammatory medication is used concurrently.

Other medications and allopurinol cinfamed

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription, especially the following: 6-mercaptopurine (used to treat blood cancer), azathioprine (used to inhibit the immune system), arabinoside of adenine (vidarabine), salicylates (aspirin, ...), uricosuric agents (probenecid, ...), chlorpropamide, theophylline, phenytoin, ampicillin, amoxicillin, cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents, mecloretamine, cyclosporine, anticoagulant coumarins, didanosine, or aluminum hydroxide.

6-mercaptopurine or azathioprine should not be administered together with allopurinol. When 6-mercaptopurine or azathioprine are administered together with allopurinol cinfamed, the dose of 6-mercaptopurine or azathioprine should be reduced because its activity will be prolonged. This may increase the risk of severe blood disorders. In this case, your doctor will closely monitor your blood count during treatment.

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

If you take aluminum hydroxide concomitantly, allopurinol may be attenuated, so you should leave a gap of at least 3 hours between taking both medications.

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

Therefore, periodic hematological controls should be performed.

Pregnancy and lactation

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

Allopurinol is not recommended for use during pregnancy.

Allopurinol passes into breast milk. Allopurinol is not recommended for use during lactation.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Due to its side effects (drowsiness, dizziness, and coordination impairment), allopurinol may impair your ability to drive vehicles.

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

Allopurinol cinfamed contains lactose

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

Oral administration only. Swallow the tablet whole with a little water. It is usually taken once a day, generally after a meal.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

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.

The recommended dose is:

Adults:

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

Children under 15 years:

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

Older patients:

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 longer intervals. 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 cinfamed than you should

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.

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

If you forgot to take alopurinol cinfamed

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 cinfamed

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 greater when there are kidney and/or liver abnormalities.

The frequency of side effects is classified as:

Very common(can affect more than 1 in 10 patients)

Common(can affect up to 1 in 10 patients)

Uncommon(can affect up to 1 in 100 patients)

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

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

Frequency not known(cannot be estimated from available data)

Infections and infestations

Very rareIngrown hair infection

Blood and lymphatic system disorders

Very rareDecreased white blood cell count (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).

In some cases, alopurinol tablets can cause blood-related effects 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.

Immune system disorders

UncommonReactions of hypersensitivity (allergy: possible appearance of skin rash, skin peeling, blisters, or sores on the lips or in the mouth).

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

Very rareLymphadenopathy angioimmunoblastic (inflammation in the armpits, neck, groin), potentially life-threatening allergic reaction.

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

Metabolism and nutrition disorders

Very rareDiabetes mellitus (high blood sugar levels), increased levels of lipids (fats) in the blood, increased uric acid levels in the blood.

Mental and behavioural disorders

Very rareDepression.

Nervous system disorders

Very rareWeakness, numbness, or loss of consciousness, paralysis, uncoordinated movements, altered normal sensitivity (neuropathy), drowsiness, headache, altered taste.

Frequency

Not knownAsymptomatic increases in liver function tests: meningitis aséptica (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.

Eye disorders

Very rareCataracts, visual disturbances.

Ear and labyrinth disorders

Very rareDizziness.

Cardiac disorders

Very rareChest pain or slowed pulse.

Vascular disorders

Very rareHigh blood pressure.

Gastrointestinal disorders

UncommonNausea, vomiting, diarrhea.

Very rareBlood in vomit, excessive fat in stools, mouth infections, changes in bowel habits.

Hepatobiliary disorders

UncommonAsymptomatic increases in liver function tests.

RareHepatitis.

Skin and subcutaneous tissue disorders

CommonSkin rash.

Very rareUrticaria, drug-induced skin eruptions that can threaten the patient's life (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2. What you need to know before starting to take alopurinol cinfamed), hair loss or discoloration, severe allergic reaction that causes facial or throat swelling.

Frequency not knownLichenoid skin eruption (red-violet skin rash with itching or white-grayish lines on mucous membranes).

Renal and urinary disorders

Very rareBlood in urine.

Reproductive and breast disorders

Very rareMale infertility, impotence, breast growth.

General disorders and administration site conditions

Very rareSwelling (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(can 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 ulcers, throat, nose, genital, and conjunctivitis (inflammation and redness of the eyes), blisters, or generalized peeling.
• Severe hypersensitivity reactions, with fever, skin rash, joint pain, and alterations in blood and liver function tests (these may be symptoms of multi-organ hypersensitivity disorder).

Complementary examinations

CommonElevated levels of thyroid-stimulating hormone in the blood.

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

Do not be alarmed by this list of side effects, as it is possible that none of them will occur 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 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.

Store in the original packaging.

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

Composition of alopurinol cinfamed

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

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

Appearance of the product and contents of the packaging

The tablets are white, cylindrical, biconvex, and have a notch on one of the faces.

They are presented in PVC/Aluminum blisters, in cardboard boxes of 25 and 100 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

FAES FARMA, S.A.

Máximo Aguirre Street, 14 48940 Leioa

or

FAES Farma, S.A.

Business and Technology Park of Bizkaia

Ibaizabal Bidea, Building 901

Derio

48160 Vizcaya Spain

or

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:January 2025

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

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and 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 to:https://cima.aemps.es/cima/dochtml/p/84085/P_84085.html