Allopurinol Tarbis 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Alopurinol Tarbis 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

This medicine contains the active substance allopurinol.

This medicine works by slowing down certain chemical reactions in the body to reduce 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 accumulates in the joints and tendons in the form of crystals. These crystals trigger an inflammatory reaction. The inflammation causes the skin around certain joints to swell, become sensitive, and hurt even upon light touch. Severe pain may also occur when moving the joint.

Alopurinol Tarbis is used in adults:

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

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

• to prevent and treat complications in conditions where 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 taking Alopurinol Tarbis

Do not take Alopurinol Tarbis:

• If you are allergic to allopurinol or to 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 or kidney problems. Your doctor may prescribe a lower dose or advise you to take it less frequently. They may also monitor you more closely.
• you are currently experiencing a gout attack. Your doctor may also consider prescribing an appropriate painkiller or another gout medication (colchicine) during the first 4 weeks of treatment.
• you have thyroid problems.
• you are of Han Chinese, Thai, or Korean ancestry.

Take special care with Alopurinol Tarbis:

Serious skin reactions (Hypersensitivity Syndrome, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) have been reported with the use of allopurinol. These may initially appear as reddish, target-shaped or circular spots (often with blisters in the center) on the trunk of the body. The rash frequently involves mouth ulcers, sore throat, nasal sores, genital ulcers, and conjunctivitis (inflammation and redness of the eyes). These potentially life-threatening skin reactions are often preceded by flu-like symptoms (fever, headache, and body aches). The rash may progress to blistering and widespread skin peeling. If you develop a skin rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately.

If you have previously experienced a severe skin reaction while being treated with allopurinol, you must not be treated with allopurinol again.

These serious skin reactions may be more common in individuals of Han Chinese, Thai, or Korean origin. Additionally, chronic renal failure may increase the risk in these patients.

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

If you have kidney stones, the stones may become smaller and enter your urinary tract, which could cause problems. You should produce at least 2 liters of urine per day to reduce the risk of kidney stone formation. Ensure you drink enough fluids.

Children and adolescents

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

Other medicines and Alopurinol Tarbis

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

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

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

The administration of 6-mercaptopurine or azathioprine together with allopurinol should be avoided. When 6-mercaptopurine or azathioprine are administered together with Alopurinol Tarbis,
the dose of 6-mercaptopurine or azathioprine should 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.

• ampicillin or amoxicillin (antibiotics): do not take allopurinol with ampicillin or amoxicillin, as this may increase the frequency of skin rash. An alternative to ampicillin or amoxicillin should be used when available.
• warfarin (a medicine used to thin the blood)
• chlorpropamide (a medicine used to treat diabetes)
• theophylline (a 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)
• cyclosporine (a medicine used to reduce immune response)
• phenytoin (a medicine used for epilepsy)
• didanosine (used to treat HIV infection)
• aluminium hydroxide. When taken together, allopurinol may have reduced effectiveness. There should be an interval of at least 3 hours between taking these medicines.
• furosemide and diuretics (medicines 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 renal failure.

Taking Alopurinol Tarbis with food, drinks, and alcohol

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

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.

You should not take this medicine during pregnancy unless your doctor advises you to do so.

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

Driving and using machines

You may feel drowsy, dizzy, or have coordination problems. If this occurs, do not drive or operate any tools or machinery.

Alopurinol Tarbis contains lactose

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

3. How to take Alopurinol Tarbis

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

Adults

The recommended dose ranges from 100 mg to 300 mg of allopurinol per day. Generally, treatment starts 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 allopurinol, if necessary.

The maximum daily dose is 800 mg of allopurinol.

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

To avoid side effects, no more than 300 mg of allopurinol should be taken in a single dose.

If a daily dose exceeding 300 mg of allopurinol is indicated or if gastrointestinal side effects (nausea, vomiting, diarrhea) occur, the dose may be divided into several doses throughout the day.

Your doctor will determine the correct dose for you.

Make sure to drink plenty of water while taking this medicine.

Elderly patients and patients with kidney or liver problems

If you are an elderly person or have impaired 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 generally start you on a low dose of allopurinol (e.g., 100 mg/day) to reduce the risk of possible side effects. Your dose may 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 each day.

The score line is intended solely for ease of splitting and swallowing, but not for dividing into equal doses.

Duration of treatment

The duration of treatment with this medicine depends on the underlying condition. Please take allopurinol regularly and for as long as your doctor has instructed.

Ongoing monitoring by your doctor is necessary. Your doctor should regularly and repeatedly check your uric acid levels through blood tests. At the same time, possible side effects should be monitored, and you should speak with 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 allopurinol than you should, contact your doctor or go to hospital immediately. Take the medicine’s packaging with you. Signs of overdose may include nausea, vomiting, diarrhea, and dizziness.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 missed dose.

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 may cause adverse effects, although not everyone experiences them.

If you experience any of the following adverse 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 aches (flu-like symptoms), and general malaise. Any skin changes, for example; mouth ulcers, throat, nose, genitals or conjunctivitis (red and swollen eyes), blisters or widespread peeling of the skin.
• Severe allergic reactions including fever, rash, general pain, and abnormalities in blood tests and liver function tests (these may be signs of a multi-organ hypersensitivity disorder).

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

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

If you have gout, you may experience a gout attack at the beginning of treatment with allopurinol.

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

Other adverse effects

Frequent (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 unwell (nausea) or being sick (vomiting)
• Abnormal results in liver function tests

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

• Liver problems, such as inflammation of the liver

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 a 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, unsteadiness when walking, sensation of inability to move muscles (paralysis), or loss of consciousness
• General feeling of malaise or weakness
• Furunculosis (ulcerative skin inflammation)
• Chest pain (angina), high blood pressure, or slow pulse
• High levels of urea in the blood (uraemia)
• Blood in the urine (haematuria)
• Vomiting blood (haematemesis)
• Change in your normal bowel habits or excess fat in your stools (steatorrhoea)
• Fluid accumulation leading to swelling (oedema), particularly in the face (Quincke's oedema)
• Enlargement of the breasts in men
• Tingling, prickling, stabbing, or burning sensation in the skin (paraesthesia)
• Inflammation of the mucous membrane of the mouth
• High levels of cholesterol in the blood (hyperlipidaemia)
• Change in taste
• Hair loss or discoloration
• Infertility or erectile dysfunction
• Headache, dizziness, drowsiness, or vision disturbances
• Lack of voluntary muscle coordination (ataxia), muscle pain
• Depression
• Cataracts
• Abnormal glucose metabolism (diabetes)

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

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

Seek immediate medical attention if this occurs.

Lichenoid skin eruption (reddish-purple itchy rash or white-grey thread-like lines on the mucous membranes).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 outer packaging and on the blister after 'EXP'. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alopurinol Tarbis

The active substance is allopurinol.

Each tablet contains 100 mg of allopurinol.

The other excipients are:

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

Appearance of the product and contents of the pack

Round tablets of 7.80 mm x 3.6 mm, white to off-white in colour, 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 intended solely to facilitate breaking the tablet and swallowing, but not for dividing the tablet into equal doses.

Blister packs containing 25, 30, 50, 90, 100 and 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

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

Germany: Allopurinol Amarox 100 mg mg Tabletten

Spain: Alopurinol Tarbis 100 mg mg tablets EFG

The Netherlands: Allopurinol Amarox 100 mg mg tabletten

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/