ALOPURINOL CINFAMED 300 mg TABLETS

Introduction

Package Leaflet: Information for the User

alopurinol cinfamed 300 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is alopurinol cinfamed and what is it used for
2. What you need to know before you take alopurinol cinfamed
3. How to take alopurinol cinfamed
4. Possible side effects
5. Storing alopurinol cinfamed
6. Contents of the pack and other information

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

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

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

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 blistering 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 skin symptoms, stop taking alopurinol and consult your doctor.

Do not take alopurinol cinfamed

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

Warnings and precautions

Consult your doctor before starting to take alopurinol cinfamed:

• if you are having an acute attack of gout.
• 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 medicine for heart disease or high blood pressure.
• if you notice that you bruise more easily than before or if you get a sore throat or other signs of infection.
• if a skin rash, peeling of the skin, blisters, or ulcers appear on the lips or in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes), wheezing (whistling), palpitations, or chest tightness, loss of consciousness: these symptoms may mean that you are allergic to alopurinol. Stop treatment and contact your doctor immediately.

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

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

If you develop Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of alopurinol, you should never take alopurinol again.

If you are not sure, consult your doctor.

You should stop treatment and contact your doctor as soon as possible if, while you are taking alopurinol, 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 being unwell.
• 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, tiredness, and weight loss.
• Appearance of boils.
• Appearance of blood in urine.

It is possible that when starting treatment with alopurinol, an acute attack of gout 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 as long as an appropriate anti-inflammatory medication is used at the same time.

Other medicines and alopurinol cinfamed

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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, salicylates (aspirin, ...), uricosuric agents (probenecid, ...), chlorpropamide, theophylline, phenytoin, ampicillin, amoxicillin, cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides, mecloretamine, cyclosporine, coumarin anticoagulants, didanosine, or aluminum hydroxide.

Concomitant administration of 6-mercaptopurine or azathioprine with alopurinol should be avoided. When 6-mercaptopurine or azathioprine is administered with alopurinol cinfamed, 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 your doctor immediately if you notice that you have any unexplained bruising, bleeding, fever, or sore throat.

If you are taking aluminum hydroxide at the same time, alopurinol may have a reduced effect, so you should leave an interval of at least 3 hours between taking both medicines.

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

Therefore, periodic hematological checks 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 if you are pregnant.

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 affect your ability to drive or operate machinery.

Do not drive, operate machinery, or use tools until you are reasonably sure that the medicine does not limit your abilities.

alopurinol cinfamed contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to take alopurinol cinfamed

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Normally, 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.

The recommended dose is:

Adults:

The recommended dose of alopurinol to start 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 stomach upset occurs, it is recommended to divide the dose into several intakes per day and take it with food.

Children under 15 years:

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

Elderly patients:

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

Use in patients with impaired liver or kidney function:

If you have liver or kidney problems, your doctor will prescribe the lowest possible dose of alopurinol 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 cinfamed than you should

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

In case of accidental ingestion of a large amount of medicine, 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 cinfamed

In case you forget to take a dose, take the next dose as soon as you remember. Then, continue as you normally would. Do not take a double dose to make up for forgotten doses.

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

If you stop taking 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The frequency of side effects is classified as:

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 the available data)

Infections and infestations

Very rareFolliculitis (infection of the hair follicles)

Blood and lymphatic system disorders

Very rareDecreased number of white blood cells (increases the risk of infections), red blood cells (may cause fatigue, weakness), platelets (cells involved in blood clotting, with the appearance of bruises or bleeding more easily than usual).

Sometimes, alopurinol tablets can cause blood effects that manifest with the appearance of more frequent bruises 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

UncommonHypersensitivity reactions (allergy: possible appearance of skin rash, peeling of the skin, blisters, or ulcers on the lips or in the mouth).

RareSerious hypersensitivity reactions, associated with peeling, 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 disorders (see below).

Very rareAngioimmunoblastic lymphadenopathy (inflammation in the armpits, neck, or groin), potentially fatal severe allergic reaction.

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

Metabolism and nutrition disorders

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

Psychiatric disorders

Very rareDepression.

Nervous system disorders

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

Frequency not knownAseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include stiff neck, headache, nausea, fever, or altered consciousness. If you experience any of these symptoms, seek urgent medical attention.

Eye disorders

Very rareCataracts, visual disturbances.

Ear and labyrinth disorders

Very rareVertigo.

Cardiac disorders

Very rareChest pain or slow pulse.

Vascular disorders

Very rareHigh blood pressure.

Gastrointestinal disorders

UncommonNausea, vomiting, diarrhea.

Very rareAppearance of blood in vomit, excess fat in feces, mouth infections, changes in bowel habits.

Hepatobiliary disorders

UncommonAsymptomatic increases in liver function tests.

RareHepatitis.

Skin and subcutaneous tissue disorders

CommonSkin rash.

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

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

Renal and urinary disorders

Very rareAppearance of blood in urine.

Reproductive system 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(may affect up to 1 in 1,000 people)

• Fever and chills, headache, muscle pain (flu-like symptoms), and general malaise.
• 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 of the skin.
• Severe hypersensitivity reactions, with fever, skin rash, joint pain, and changes in blood and liver tests (these may be symptoms of a multi-organ hypersensitivity disorder).

Investigations

CommonElevated 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alopurinol Cinfamed

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

Do not use this medicine after the expiry date which is stated on the carton after CAD. The expiry date is the last day of the month indicated.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Alopurinol Cinfamed

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

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

Appearance of the Product and Package Contents

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

They are presented in PVC/Aluminum blisters, in cardboard boxes of 30 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

FAES FARMA, S.A.

C/ Máximo Aguirre, 14 48940 Leioa

or

Faes Farma, S.A.

Bizkaia Science and Technology Park

Ibaizabal Bidea, Building 901

Derio

48160 Vizcaya Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Leaflet:January 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84086/P_84086.html

QR code to: https://cima.aemps.es/cima/dochtml/p/84086/P_84086.html