Colchicine Seid 1 mg tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

COLCHICINE SEID 1 mg tablets

Package leaflet contents

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

1. What Colchicina Seid is and what it is used for

Colchicine belongs to a group of medicines known as antigout agents.

Colchicina Seid is used to treat acute gout attacks and chronic gout, to prevent acute attacks when starting treatment with other medicines that reduce uric acid levels in blood and urine, and in familial Mediterranean fever (periodic disease).

In children, this medicine is indicated for Familial Mediterranean Fever for the prophylaxis of attacks and prevention of amyloidosis.

2. What you need to know before starting to take Colchicina Seid

Do not take Colchicina Seid:

• If you are allergic to colchicine or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe kidney disease.
• If you are undergoing dialysis.
• If you have severe liver disease.
• If you have severe gastrointestinal disorders.
• If you have a stomach ulcer.
• If you have heart diseases.
• If you have blood disorders.
• If you are pregnant.
• If you have recently taken or are currently taking other medicines (see section "Taking Colchicina Seid with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Colchicina Seid.

Take special care with Colchicina Seid:

• If you experience diarrhea, nausea, vomiting, or abdominal pain during treatment. Contact your doctor immediately, as it may be necessary to adjust the dose or discontinue treatment.
• In elderly patients, children, debilitated patients, or those who abuse alcohol.
• In patients with liver or kidney disease. Your doctor may need to adjust the dose.
• During long-term treatment, serious muscle and kidney problems may occur.

When taking Colchicina Seid, side effects affecting the blood (such as decreased white blood cells, platelets, and red blood cells) should be monitored. Your doctor may perform periodic blood tests to monitor these adverse effects.

Other medicines and Colchicina Seid

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor before taking colchicine if you have recently taken or are currently taking medicines containing any of the following active substances, as they may affect the elimination of Colchicina Seid from the body:

• Medicines used to treat infections such as clarithromycin, erythromycin, telithromycin, azithromycin, and other antibiotics belonging to the group known as macrolides.
• Medicines used to treat fungal infections, such as itraconazole and ketoconazole.
• Medicines used to treat hypertension, such as verapamil and diltiazem.
• Medicines used in the treatment of HIV, such as indinavir, nelfinavir, ritonavir, and saquinavir.

If you take Colchicina Seid together with medicines to lower cholesterol and triglyceride levels, such as atorvastatin, simvastatin, pravastatin, fluvastatin, gemfibrozil, fenofibrate, fenofibric acid, or bezafibrate, with medicines for heart diseases such as digoxin, or with immunosuppressive medicines such as cyclosporine, the risk of developing muscle-related problems may increase. Inform your doctor before taking colchicine.

The absorption of vitamin B12 may be altered by chronic administration or high doses of colchicine. It may be necessary to increase vitamin B12 doses.

Use of Colchicina Seid with food and drinks

Do not take Colchicina Seid at the same time as grapefruit juice, as it may reduce the elimination of colchicine from the body and therefore harm you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine if you are pregnant.

It is advised not to take this medicine during breastfeeding, as colchicine may pass into breast milk and affect your baby.

Driving and using machines

It is very unlikely that Colchicina Seid will affect your ability to drive or operate machinery.

Important information about some of the ingredients of this medicine

Colchicina Seid contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Colchicine Seid

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

Colchicine is potentially toxic, so it is important not to exceed the dose prescribed by your doctor.

Do not exceed the doses indicated below.

Oral use:

Adults

• Acute gout attack:

The recommended dose is 1 tablet (1 mg of colchicine) at the first sign of an acute attack. If pain relief is not achieved, the recommended regimen is 0.5 mg to 1 mg of colchicine one or two hours after the first dose.

Doses exceeding 2 tablets in 24 hours must not be administered.

Doses higher than 2 tablets per day have not demonstrated greater efficacy, but do increase the risk of adverse effects.

This dosing regimen may be used for up to a maximum of 4 consecutive days, with a total cumulative dose of 6 mg of colchicine over 4 days. If further treatment is needed because gout attack pain persists, the above regimen may be repeated, but only after at least 3 days without treatment, as a "washout period".

• Prophylaxis of gout attacks during initial therapy with allopurinol or uricosuric agents:

The recommended dose is 1 tablet (1 mg of colchicine) per day.

If a lower dose (less than 1 mg of colchicine) or divided doses (e.g., 0.5 mg of colchicine twice daily) are required, another available formulation should be used.

Your doctor will determine the treatment regimen and how long you should take colchicine.

• Familial Mediterranean fever (periodic disease):

The recommended dose is 1 to 2 tablets per day. This may be given as a single dose or divided into two daily doses. Your doctor will advise you on how long you should take Colchicine Seid.

• Treatment of chronic gout:

The recommended dose for the treatment of chronic gout is 1 tablet (1 mg of colchicine) per day. Your doctor will advise you on how long you should take Colchicine Seid.

Use in children and adolescents

• Acute gout attack, prevention of gout attacks, and chronic gout:

There are insufficient data to establish recommendations in this age group.

• Familial Mediterranean fever (periodic disease):

In children with Familial Mediterranean Fever, the recommended dosage is based on age. The following daily doses may be administered as a single dose or divided into two doses per day (for doses exceeding 1 mg/day):

• Children under 5 years: 0.5 mg/day
• Children aged 5 to 10 years: 1 mg/day
• Children over 10 years: 1.5 mg/day

The colchicine dose should be gradually increased (by increments of 0.25 mg) up to a maximum of 2 mg/day. Any dose increase must be closely monitored for adverse effects.

Method and route of administration

Oral use

The tablets should be taken with a glass of water.

If you take more Colchicine Seid than you should

Contact your doctor immediately or go to the nearest hospital without delay.

Bring this leaflet and any remaining colchicine tablets with you.

Taking doses higher than those prescribed by your doctor may result in poisoning. Colchicine overdose poisoning is very serious.

There is no specific antidote.

In case of poisoning due to ingestion of a large number of tablets, administer activated charcoal, perform gastric lavage, and provide intravenous fluid and electrolyte replacement.

Symptoms of overdose usually appear within the first 24 hours after taking the medicine, but in some cases may be delayed up to 1 week. Therefore, if overdose is suspected—even in the absence of apparent symptoms—immediate medical attention must be sought.

The most common symptoms of toxicity include a burning sensation and discomfort in the mouth and throat, difficulty swallowing and breathing, gastrointestinal disturbances such as diffuse abdominal pain, nausea, vomiting, profuse diarrhea (sometimes bloody), confusion, alopecia (hair loss), and hypotension (low blood pressure).

If you forget to take Colchicina Seid

Do not take a double dose to make up for missed doses.

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 everybody will experience them.

The most frequent adverse reactions are:

• Nausea, vomiting, abdominal pain, and diarrhoea.

High doses may cause skin rashes, profuse diarrhoea, gastrointestinal bleeding, and hepatic or renal disturbances.

On some occasions, the following have been observed:

• In prolonged treatments, changes in blood cell counts such as reduced number of white blood cells (leucopenia), reduced number of neutrophils (neutropenia), reduced number of platelets (thrombocytopenia).
• Azoospermia (absence of spermatozoa).
• Alopecia (hair loss).
• Disorders affecting nerves that control muscles, reversible upon discontinuation of treatment.
• Muscle disorders such as rhabdomyolysis (breakdown of muscle fibres).
• Liver injury.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Colchicina Seid

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Colchicina Seid:

• The active substance is: Colchicine. Each tablet contains 1 mg of colchicine.
• The other components are: lactose monohydrate, microcrystalline cellulose, povidone, methacrylate copolymer, magnesium stearate, erythrosine (E-127).

Appearance of the product and contents of the pack:

Pink tablets.

This medicine is presented in boxes containing 2 blisters of 20 tablets each.

Marketing Authorization Holder and Manufacturer:

SEID, S.A.

Carretera de Sabadell a Granollers, Km 15.

08185 Lliçà de Vall. (Barcelona)

Spain

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

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