ALOPURINOL TECNIGEN 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

AlopurinolTecniGen100 mg tablets EFG

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, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if you think they are not serious. See section 4.

Contents of the pack

1. What Alopurinol TecniGen 100 mg is and what it is used for
2. What you need to know before you take Alopurinol TecniGen 100 mg
3. How to take Alopurinol TecniGen 100 mg
4. Possible side effects
5. Storage of Alopurinol TecniGen 100 mg
6. Contents of the pack and other information

1. What Alopurinol TecniGen 100 mg is and what it is used for

Alopurinol TecniGen 100 mg 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 TecniGen 100 mg 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 TecniGen 100 mg

Do not take AlopurinolTecniGen100 mg:

• If you are allergic to alopurinol or any of the other ingredients of Alopurinol TecniGen 100 mg.

Be careful with AlopurinolTecniGen100 mg

• If you are having 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 take 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, skin peeling, blisters, or ulcers on the lips or mouth appear, wheezing (whistling), palpitations, or chest tightness, loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TO Alopurinol TecniGen 100 mg. 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 TecniGen 100 mg, 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 TecniGen 100 mg, an acute gout attack may be triggered. Your doctor will recommend the use of certain medications to prevent this. If a gout attack occurs, it is not necessary to stop treatment with Alopurinol TecniGen 100 mg as long as an appropriate anti-inflammatory medication is used at the same time.

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 reactions 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 symptoms, stop taking alopurinol and consult your doctor immediately.

The period of highest 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 TecniGen, you should not use Alopurinol TecniGen again at any time.

Use of other medicines

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

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

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.

Alopurinol TecniGen 100 mg 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 coordination impairment), Alopurinol TecniGen 100 mg may affect your ability to drive vehicles. Do not drive, do not use tools or machines until you are reasonably sure that the medicine does not limit your abilities.

AlopurinolTecniGencontains lactose

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

3. How to take Alopurinol TecniGen 100 mg

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

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.

Oral use only. Swallow the tablet whole with the help of 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.

The normal dose is:

Adults:

The usual starting dose of Alopurinol TecniGen 100 mg 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 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 medicine in children is 100 to 400 mg per day.

Elderly patients:

Your doctor will recommend the lowest possible dose of Alopurinol TecniGen 100 mg to achieve reduction of uric acid levels and control of 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 TecniGen 100 mg that achieves reduction of uric acid levels and control of 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 AlopurinolTecniGen100 mg than you should

In this case, consult the Toxicology Information Service. Telephone 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 service of the nearest hospital. Bring this leaflet with you.

If you forget to take AlopurinolTecniGen100 mg

In case you forget to take a dose, take the next dose as soon as you remember. Then, continue as you usually do. 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 moment on.

If you stop treatment with AlopurinolTecniGen100 mg

Your doctor will indicate the duration of treatment with Alopurinol TecniGen 100 mg. 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, 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.

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 (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:Follicular infection

Blood and lymphatic system disorders

Very rare:Decrease in the 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 cause effects on the blood 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

Uncommon: Hypersensitivity reactions

Very rare: Angioimmunoblastic lymphadenopathy (inflammation in the armpits, neck, groin), 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 present 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

Very rare:Hives, drug-related skin eruptions, hair loss or discoloration. Severe allergic reaction that causes swelling of the face or throat.

Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur (see section 2).

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

Musculoskeletal and connective tissue disorders

Very rare:Muscle pain

Renal and urinary disorders

Rare:Stones in the urinary tract

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.

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").

Rare (affect less than 1 in 1000 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.
• Severe hypersensitivity reactions, with fever, skin rash, joint pain, and alterations in blood and liver tests (these can be symptoms of multi-organ hypersensitivity disorder).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if you think they are not serious. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alopurinol TecniGen 100 mg

Keep out of sight and reach of children.

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

Do not use Alopurinol this medicine 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 Alopurinol TecniGen 100 mg if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Alopurinol TecniGen 100 mg

• The active ingredient is alopurinol, 100 mg.
• The other components are: lactose monohydrate, corn starch, povidone, and magnesium stearate.

Product Appearance and Packaging Content

Alopurinol TecniGen 100 mg is available in two formats of 25 and 100 tablets.

The tablets are white or almost white, flat, round, scored, marked on one side with "I" and "56" on either side of the score and unmarked on the other side.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, nº 13. 3ºD

28108 - Alcobendas (Madrid)

SPAIN

Manufacturer

Tecnimede - Sociedade Tecnico-medicinal, S.a.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Date of the Last Revision of this Leaflet: November 2024

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/