Colchimax 0.5/5 mg tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

COLCHIMAX 0.5 mg/5 mg TABLETS

Package leaflet

1. What COLCHIMAX 0.5 mg/5 mg is and what it is used for
2. What you need to know before taking COLCHIMAX 0.5 mg/5 mg
3. How to take COLCHIMAX 0.5 mg/5 mg
4. Possible side effects
5. How to store COLCHIMAX 0.5 mg/5 mg
6. Contents of the pack and other information

1. What COLCHIMAX 0.5 mg/5 mg is and what it is used for

COLCHIMAX 0.5 mg/5 mg is presented in the form of tablets for oral administration. Each tablet contains two active substances: colchicine and dicycloverine.

COLCHIMAX 0.5 mg/5 mg belongs to a group of medicines known as other antigout preparations.

COLCHIMAX 0.5 mg/5 mg is used for the treatment of acute gout attacks and chronic gout, prevention of acute attacks occurring at the beginning of treatment with other medications that cause a reduction in blood and urinary uric acid levels, and for periodic disease (familial Mediterranean fever).

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 taking COLCHIMAX 0.5 mg/5 mg

Do not take COLCHIMAX 0.5 mg/5 mg if:

• You are allergic to colchicine, dicycloverine, or any of the other ingredients of this medicine (listed in section 6).
• You have severe kidney disease and/or urinary retention or obstruction (you do not urinate normally).
• You are undergoing dialysis.
• You have severe liver disease.
• You have severe ulcerative colitis (a bowel disease).
• You have a stomach ulcer.
• You have reflux esophagitis (irritation of the esophagus caused by stomach contents).
• You have heart and/or blood disorders.
• You have glaucoma (increased intraocular pressure).
• You have prostate disorders.
• You have any stomach and/or intestinal disease.
• You have myasthenia gravis (an autoimmune disorder affecting nerves that control muscles).
• You are pregnant.
• You have recently taken or are currently taking other medicines (see use with other medicines).

Take special care with COLCHIMAX 0.5 mg/5 mg:

• If you experience diarrhea, nausea, vomiting, or abdominal pain during treatment. Contact your doctor immediately, as your dose may need to be adjusted or treatment discontinued.
• In elderly patients, children, debilitated patients, or those who abuse alcohol.
• In patients with liver or kidney disease. Your doctor may need to adjust your dose.
• In patients with heart disease.
• In patients with high blood pressure.
• In patients with thyroid disorders.
• In patients with prostate disorders.
• If you have a hiatal hernia.
• In patients with autonomic neuropathy (a disorder of nerves regulating certain bodily functions).
• During long-term treatment, serious muscle and kidney problems may occur.

When taking Colchimax, monitor for side effects this medicine may cause in the blood (reduction in white blood cells, platelets, and red blood cells). Your doctor may perform periodic blood tests to monitor these adverse effects.

Taking COLCHIMAX 0.5 mg/5 mg with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

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 Colchimax from the body:

• Medicines used to treat infections such as clarithromycin, erythromycin, telithromycin, azithromycin, and other antibiotics belonging to the group called 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 Colchimax 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 disease such as digoxin, and with immunosuppressant medicines such as cyclosporine, the risk of muscle-related problems may increase. Inform your doctor before taking colchicine.

If you take Colchimax with medicines used for mood disorders such as imipramine, clomipramine, amitriptyline, and iproniazid, with psychiatric agents such as phenothiazines, alprazolam, and diazepam, with narcotic analgesics such as meperidine, antacids, certain medicines used to treat heart arrhythmias such as procainamide, and sympathomimetic agents such as noradrenaline, dopamine, and dobutamine, their effects may be enhanced.

Long-term or high-dose administration of colchicine may interfere with vitamin B12 absorption. It may be necessary to increase vitamin B12 doses.

Use of COLCHIMAX 0.5 mg/5 mg with food and drinks

Do not take colchicine treatment at the same time as drinking 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 may 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 use this medicine during breastfeeding, as colchicine and dicycloverine may pass into breast milk and affect your baby.

Driving and use of machines

Patients taking Colchimax may occasionally experience drowsiness and blurred vision.

3. How to take COLCHIMAX 0.5 mg/5 mg

Follow exactly the instructions for use of 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 2 tablets at the first sign of an acute attack. If pain relief is not achieved, 1 or 2 tablets may be taken one or two hours after the first dose. Doses exceeding 4 tablets in 24 hours must not be administered. Doses higher than 4 tablets per day have not demonstrated greater efficacy, but do increase the risk of adverse effects.

Do not take more than 12 tablets in total over 4 consecutive days of treatment. If necessary, due to persistent pain from the gout attack, the previous treatment may be repeated, but always after a three-day rest period.

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

The recommended dose for prophylaxis of gout attacks is 1 or 2 tablets per day. Your doctor will tell you how long you should take Colchimax.

• Familial Mediterranean fever or periodic disease:

The recommended dose is 2 to 5 tablets per day. This may be administered as a single daily dose or divided into two daily doses. Your doctor will tell you how long you should take Colchimax.

• Treatment of chronic gout:

The recommended dose for treatment of chronic gout is 1 or 2 tablets per day. Your doctor will tell you how long you should take Colchimax.

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 or 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 between 5 and 10 years: 1 mg/day
• Children over 10 years: 1.5 mg/day

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

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

Method and route of administration

Oral use.

The tablets should be taken with a glass of water.

If you take more COLCHIMAX 0.5 mg/5 mg than you should

Contact your doctor immediately or go immediately to the nearest hospital. Take this leaflet and any remaining colchicine tablets with you.

If you take doses higher than those prescribed by your doctor, you may suffer 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 rehydration and electrolyte replacement.

Symptoms of colchicine 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 you suspect an overdose—even without apparent symptoms—you must seek specialized medical help immediately.

The most frequent symptoms of toxicity from colchicine and dicicloverine are burning sensation and discomfort in the mouth and throat, difficulty swallowing and breathing, gastrointestinal disturbances such as diffuse abdominal pain, nausea, vomiting, profuse diarrhea (in some cases bloody), confusion, alopecia (hair loss), hypotension (low blood pressure), blurred vision, headache, dizziness, pupil dilation, and symptoms of excitation.

If you forget to take COLCHIMAX 0.5 mg/5 mg

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 everyone will experience them.

The most frequent adverse reactions are:

• Nausea, vomiting, abdominal pain, and diarrhoea.

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

The following may also occur:

• Somnolence, weakness, and headache.
• Blurred or double vision, dilatation of the pupils, and increased intraocular pressure.
• Urinary retention.
• Tachycardia.
• Breathing difficulties.
• Dry mouth.

Occasionally reported are:

• In prolonged treatments, disturbances 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 of nerves controlling muscles, reversible upon discontinuation of treatment.
• Muscular disturbances such as rhabdomyolysis (breakdown of muscle fibres).
• Hepatic injury.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect 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 listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of COLCHIMAX 0.5 mg/5 mg

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

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Return unused containers and unwanted medicines to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unwanted medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of COLCHIMAX 0.5 mg/5 mg

• The active substances are: 0.5 mg of Colchicine and 5 mg of Dicycloverine.
• The other components are: calcium phosphate dibasic dihydrate, corn starch, magnesium stearate, brilliant blue aluminum lake (E-133).

Appearance of the medicine and contents of the pack

Pale blue tablets with a central score line.

Packaged in boxes containing 3 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 revision of this leaflet: December 2025

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