ALOPURINOL TARBIS 100 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

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

1. What is Alopurinol Tarbis and what is it used for

This medicine contains the active substance alopurinol.

This medicine works by reducing the rate of certain chemical reactions in the body to decrease the level of uric acid in the blood and urine.

High levels of uric acid can cause:

• Gout
• Formation of kidney stones or certain types of kidney problems

In gout, uric acid builds up in the joints and tendons in the form of crystals. These crystals cause an inflammatory reaction. The inflammation makes the skin around certain joints swell, become sensitive, and hurt when touched lightly. It can also be observed that intense pain occurs when the joint is moved.

Alopurinol Tarbis is used in adults:

• to reduce uric acid levels when diet is not sufficient
• for the treatment and prevention of the aforementioned complications, in which the body produces too much uric acid.

In addition, Alopurinol Tarbis 100 mg may be used in children and adolescents under 15 years of age:

• to prevent and treat complications in which the body produces too much uric acid, for example during cancer treatment (e.g., leukemia)
• in certain enzymatic disorders such as Lesch-Nyhan syndrome.

2. What you need to know before you take Alopurinol Tarbis

Do not take Alopurinol Tarbis:

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

Warnings and precautions

Tell your doctor or pharmacist before taking this medicine if:

• you have liver and kidney problems. Your doctor may give you a lower dose or ask you to take it less frequently. They may also monitor you more closely.
• you are currently having a gout attack. Your doctor may also consider prescribing you a suitable pain reliever or another anti-gout medicine (colchicine) during the first 4 weeks of treatment.
• you have thyroid problems.
• you are of Chinese Han, Thai, or Korean descent.

Be careful with Alopurinol Tarbis:

Severe skin reactions(Hypersensitivity Syndrome, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) have been reported with the use of alopurinol. These can appear initially as reddish spots, with a bullet or circular shape (often with blisters in the middle) on the trunk of the body. Often, the rash can include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These potentially life-threatening skin reactions are usually preceded by symptoms similar to those of the flu (fever, headache, and body pain). The rash can progress to blistering and general peeling of the skin. If you develop a skin rash or these skin symptoms, stop taking alopurinol and consult your doctor immediately.

If you have experienced a severe skin reaction during treatment with alopurinol, you should not be treated with alopurinol again.

These severe skin reactions can be more frequent in people of Chinese Han, Thai, or Korean origin. Additionally, chronic kidney failure may increase the risk in these patients.

If you have cancer or Lesch-Nyhan syndrome, the amount of uric acid in your urine may increase. To prevent this, make sure to drink enough water to dilute your urine.

In case of kidney stones, the stones may become smaller and may enter your urinary tract, which could cause you problems. The amount of urine you produce should be at least 2 liters per day to reduce the risk of kidney stone formation. You should make sure to drink enough water.

Children and adolescents

Use in children is rarely indicated, except in some types of cancer (especially leukemia) and some enzymatic pathologies such as Lesch-Nyhan syndrome.

Other medicines and Alopurinol Tarbis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because alopurinol can affect the way some medicines work. Also, some other medicines can affect the way Alopurinol Tarbis works.

Tell your doctor if you are taking any of the following medicines:

• probenecid, benzbromarone, sulfinpyrazone (medicine to treat gout)
• acetylsalicylic acid
• 6-mercaptopurine or azathioprine (medicines used for cancer)

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

• ampicillin or amoxicillin (antibiotics): do not take alopurinol with ampicillin or amoxicillin as this may cause an increased frequency of skin rash. An alternative to ampicillin or amoxicillin should be used when available.
• warfarin (medicine used to thin the blood).
• chlorpropamide (medicine used to treat diabetes).
• theophylline (medicine used for respiratory or heart problems).
• Medicines used for chemotherapy (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides). Blood disorders occur more frequently when these medicines are taken together. Therefore, blood tests should be performed at regular intervals.
• vidarabine (used to treat herpes or chickenpox)
• cyclosporin (medicine used to reduce immune response)
• phenytoin (medicine used for epilepsy).
• didanosine (used to treat HIV infection)
• aluminum hydroxide. When taken together, alopurinol may have a reduced effect. There should be an interval of at least 3 hours between taking these medicines.
• furosemide and diuretics (medicine to remove excess fluid from the body), such as thiazides.
• ACE inhibitors (medicines for heart problems or high blood pressure), especially if you have kidney problems or chronic kidney failure.

Taking Alopurinol Tarbis with food, drinks, and alcohol

Foods with high purine content, such as organ meats like liver, sweetbreads, kidney, brain, heart, and tongue, as well as meat concentrate and alcohol, especially beer, should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take this medicine if you are pregnant unless your doctor advises you to.

Alopurinol is not recommended during breastfeeding. Your doctor will decide whether to discontinue breastfeeding or discontinue/abstain from alopurinol therapy.

Driving and using machines

You may feel drowsy, dizzy, or have coordination problems. If this happens, do not drive or use any tools or machines.

Alopurinol Tarbis contains lactose

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

3. How to take Alopurinol Tarbis

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

Adults

The recommended doseranges from 100 mg to 300 mg of alopurinol per day. You will usually start with a low dose to reduce the risk of side effects.

Your doctor may increase the dose to 600 mg up to 800 mg of alopurinol if necessary.

The maximum daily dose is 800 mg of alopurinol.

The tablets should be taken once a day after a meal, especially in patients with a sensitive stomach.

To avoid side effects, you should not take more than 300 mg of alopurinol in a single dose.

If a daily dose of more than 300 mg of alopurinol is indicated or if you experience gastrointestinal side effects (nausea, vomiting, diarrhea), the dose may be divided into several doses throughout the day.

Your doctor will indicate the correct dose.

Make sure to drink enough water while taking this medicine.

Elderly patients and patients with kidney or liver problems

If you are an elderly personor if you have reduced liver or kidney function, your doctor may prescribe a lower dose or advise you to take the tablets at longer intervals.

If you undergo dialysis two or three times a week, your doctor may prescribe a dose of 300 or 400 mg to be taken immediately after dialysis.

Your doctor will usually start with a low dose of alopurinol (e.g., 100 mg/day) to reduce the risk of possible side effects. Your dose will be increased if necessary.

Use in children and adolescents under 15 years of age

The daily dose is 10 mg/kg body weight up to a maximum of 400 mg/day, divided into three doses.

Method of administration

Oral use.

Take the tablet after a meal and swallow it with a glass of water, approximately at the same time every day.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Duration of treatment

The duration of treatment with this medicine depends on the underlying disease. Please take alopurinol regularly and for the time indicated by your doctor.

Continuous monitoring by your doctor is necessary. Your doctor should check your uric acid levels repeatedly and regularly through blood tests. At the same time, possible side effects should be observed, and you should talk to your doctor or pharmacist if you think the effect of this medicine is too strong or too weak.

If you take more Alopurinol Tarbis than you should

If you take more alopurinol than you should, contact your doctor or go to the hospital immediately. Take the medicine package with you. Signs of overdose may include nausea, vomiting, diarrhea, and dizziness.

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

If you forget to take Alopurinol Tarbis

If you forget to take a dose, do not take a double dose to make up for the forgotten doses.

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.

If you have any of the following side effects, stop taking this medicine immediately and inform your doctor.

Hypersensitivity (allergic reactions)

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 the skin, for example; ulcers in the mouth, throat, nose, genitals, or conjunctivitis (red and swollen eyes), blisters, or general peeling of the skin.
• Severe allergic reactions that include fever, skin rash, general discomfort, and abnormalities in blood tests and liver function tests (may be signs of a multi-organ sensitivity disorder).

Very rare(may affect up to 1 in 10,000 people)

• Severe and potentially life-threatening skin reaction (hypersensitivity reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis) (see section 2).
• Severe allergic reaction that causes swelling of the face or throat.
• Potentially life-threatening allergic reaction.

If you have gout, you may experience a gout attack when starting treatment with alopurinol.

It is more common to experience side effects if you have kidney or liver problems or if you are taking ampicillin or amoxicillin at the same time.

Other side effects

Common(may affect up to 1 in 10 people)

• Skin reactions (rash)
• Elevated thyroid-stimulating hormone levels in blood

Uncommon(may affect up to 1 in 100 people)

• Diarrhea
• Feeling sick (nausea) or being sick (vomiting)
• Abnormal liver function test results

Rare(may affect up to 1 in 1,000 people)

• Liver problems, such as liver inflammation

Very rare(may affect up to 1 in 10,000 people)

• May affect the lymph nodes
• Gastrointestinal bleeding
• Bruising more easily than usual, or you may develop sore throat or other signs of infection. These effects usually occur in people with liver or kidney problems. Inform your doctor as soon as possible.
• General weakness (asthenia), numbness, instability in the feet, feeling unable to move the muscles (paralysis), or loss of consciousness
• General feeling of discomfort or weakness
• Furunculosis (ulcerative inflammation of the skin)
• Chest pain (angina), high blood pressure, or slow pulse
• High urea levels in the blood (uremia)
• Blood in the urine (hematuria)
• Vomiting blood (hematemesis)
• Change in your normal bowel habit or excess fat in your stools (steatorrhea)
• Fluid accumulation leading to swelling (edema), particularly in the face (Quincke's edema)
• Enlargement of the breasts in men
• Feeling of tingling, prickling, numbness, or burning in the skin (paresthesia)
• Inflammation of the mouth mucosa
• High cholesterol levels in the blood (hyperlipidemia)
• Change in taste
• Hair loss or discoloration
• Infertility or erectile dysfunction
• Headache, dizziness, drowsiness, or vision disturbance
• Lack of coordination of voluntary muscle movements (ataxia), muscle pain
• Depression
• Cataracts
• Abnormal glucose metabolism (diabetes)

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

Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include stiffness in the neck, headache, nausea, fever, or mental confusion.

Seek medical attention immediately if this occurs.

Lichenoid skin rash (red-purple rash with itching or grayish-white lines on the mucous membranes).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. 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. Storing Alopurinol Tarbis

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 and blister after 'EXP'. The expiry date is the last day of the month shown.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Alopurinol Tarbis

The active ingredient is alopurinol.

Each tablet contains 100 mg of alopurinol.

The other excipients are:

Lactose monohydrate, corn starch, crospovidone (Type A and B), povidone (K 30) and magnesium stearate.

Appearance of the Product and Package Contents

Round tablets of 7.80 mm x 3.6 mm, white to off-white in color, engraved with a "U" and a "5" on one side and a scored line with an "H" on the other side.

The score line is only for fractionation and to facilitate swallowing, but not for dividing into equal doses.

Blisters containing 25, 30, 50, 90, 100 and 500 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Allopurinol Amarox 100 mg Tablets

Spain: Alopurinol Tarbis 100 mg Tablets EFG

Netherlands: Allopurinol Amarox 100 mg Tablets

Date of the Last Revision of this Leaflet: May 2025

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