COLCHIMAX 0.5/5 mg TABLETS

Introduction

PATIENT INFORMATION LEAFLET

COLCHIMAX 0.5 mg/5 mg TABLETS

Contents of the pack

1. What COLCHIMAX 0.5 mg/5 mg is and what it is used for
2. What you need to know before you take COLCHIMAX 0.5 mg/5 mg
3. How to take COLCHIMAX 0.5 mg/5 mg
4. Possible side effects
5. Storage of 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 ingredients, colchicine and dicycloverine.

COLCHIMAX 0.5 mg/5 mg belongs to the group of medicines known as other anti-gout preparations.

COLCHIMAX 0.5 mg/5 mg is used in the treatment of acute gout attacks and chronic gout, prevention of acute attacks when starting treatment with other medicines that reduce uric acid levels in the blood and urine, and familial Mediterranean fever.

2. What you need to know before you take 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 (colon disease).
• You have stomach ulcers.
• You have reflux esophagitis (irritation of the esophagus by stomach contents).
• You have heart and/or blood diseases.
• You have glaucoma (increased intraocular pressure).
• You have prostate diseases.
• You have stomach and/or intestinal diseases.
• You have myasthenia gravis (an autoimmune disorder of the nerves that control muscles).
• You are pregnant.
• If you have recently taken or are taking other medicines (see use of other medicines).

Be careful with COLCHIMAX 0.5 mg/5 mg:

• If you experience diarrhea, nausea, vomiting, or abdominal pain during treatment, contact your doctor immediately, as you may need to adjust the dose or discontinue treatment.
• In elderly, children, and debilitated patients or those who abuse alcohol.
• In patients with liver and kidney disease. Your doctor may need to adjust the 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 (disorder of the nerves that regulate some bodily functions).
• During long-term treatment, serious muscle and kidney problems may appear.

If you take Colchimax, you should monitor the side effects that this medicine can cause in the blood (decrease in white blood cells, platelets, and red blood cells). Your doctor may perform periodic blood tests to monitor these side effects.

Taking COLCHIMAX 0.5 mg/5 mg with other medicines

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

Especially tell your doctor before taking colchicine if you have recently taken or are taking medicines that contain any of the following active ingredients, 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 macrolide group.
• Medicines used to treat fungal infections, such as itraconazole and ketoconazole.
• Medicines used to treat hypertension, such as verapamil and diltiazem.
• Medicines used to treat HIV, such as indinavir, nelfinavir, ritonavir, and saquinavir.

If you take Colchimax 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 immunosuppressive medicines, such as cyclosporine, muscle problems may be more likely to occur. Tell your doctor before taking colchicine.

If you take Colchimax with medicines used for mood disorders, such as imipramine, clomipramine, amitriptyline, and iproniazide, mental disorders, such as phenothiazine, alprazolam, and diazepam, narcotic analgesics, such as meperidine, antacids, and some medicines used to treat heart arrhythmias, such as procainamide, and sympathomimetic agents, such as noradrenaline, dopamine, and dobutamine, their action may be enhanced.

The absorption of vitamin B12 may be altered by chronic or high-dose administration of colchicine. Vitamin B12 doses may need to be increased.

Using COLCHIMAX 0.5 mg/5 mg with food and drinks

Do not take colchicine treatment at the same time as grapefruit juice, as it may decrease the elimination of colchicine from the body and harm you.

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.

Do not take this medicine if you are pregnant.

It is advised not to administer during breastfeeding, as colchicine and dicycloverine may pass into breast milk and harm your baby.

Driving and using machines

Patients taking Colchimax may occasionally experience drowsiness and blurred vision.

3. How to take COLCHIMAX 0.5 mg/5 mg

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Do not exceed the recommended doses.

Oral route:

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 can be administered 1 or 2 hours after the first dose. Do not take more than 4 tablets in 24 hours. Doses higher than 4 tablets per day have not shown greater efficacy but have shown an increase in side effects.

In 4 consecutive days of treatment, do not take more than 12 tablets in total. If necessary because gout attack pain persists, the previous treatment can be repeated but always after 3 days of rest.

• Preventive treatment of gout attacks during initial therapy with allopurinol or uricosurics:

The recommended dose as preventive treatment of gout attacks is 1 or 2 tablets per day. Your doctor will tell you how long to take Colchimax.

• Familial Mediterranean fever:

The recommended dose is 2 to 5 tablets per day. It can be divided into two daily doses or taken in a single dose. Your doctor will tell you how long to take Colchimax.

• Chronic gout treatment:

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

Children and adolescents under 18 years.

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

There is not enough data to establish recommendations in this age group.

• Familial Mediterranean fever:

There is not enough data to establish recommendations in this age group.

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

Consult your doctor immediately or go to the nearest hospital. In case of overdose or accidental massive ingestion, consult the Toxicology Information Service. Phone 91 562 04 20.

If you take doses higher than those indicated by your doctor, you may suffer from poisoning. Poisoning due to colchicine overdose 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 replace water and electrolytes intravenously.

The symptoms of colchicine overdose usually appear within the first 24 hours after taking the medicine, but may be delayed up to 1 week. Therefore, if you suspect an overdose, even without apparent signs, seek specialized medical attention immediately.

The most frequent symptoms of colchicine and dicycloverine toxicity are burning sensation and discomfort in the mouth and throat, difficulty swallowing and breathing, digestive disorders such as abdominal pain, nausea, vomiting, abundant diarrhea, sometimes bloody, confusion, alopecia (hair loss), and hypotension (low blood pressure), blurred vision, headache, dizziness, pupil dilation, and symptoms of excitement.

If you forget to take COLCHIMAX 0.5 mg/5 mg

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

If you have any other questions about 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.

The most common adverse reactions are:

• Nausea, vomiting, abdominal pain, and diarrhea.

High doses can cause skin rashes, very abundant diarrhea, gastrointestinal bleeding, and liver or kidney disorders.

It can also cause:

• Drowsiness, weakness, and headache.
• Blurred or double vision, pupil dilation, and increased ocular pressure.
• Urinary retention.
• Tachycardia.
• Breathing difficulties.
• Dry mouth.

On some occasions, the following have been detected:

• In prolonged treatments, alterations in blood cell counts, such as a decrease in the number of white blood cells (leukopenia), a decrease in the number of neutrophils (neutropenia), and a decrease in the number of platelets (thrombocytopenia).
• Azoospermia (absence of sperm).
• Alopecia (hair loss).
• Disorders in the nerves that control muscles, reversible when treatment is discontinued.
• Muscle disorders, such as rhabdomyolysis (decomposition of muscle fibers).
• Liver damage.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM. By reporting side 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of COLCHIMAX 0.5 mg/5 mg

• The active ingredients are: 0.5 mg of colchicine and 5 mg of dicycloverine.
• The other ingredients are: calcium phosphate dibasic dihydrate, cornstarch, magnesium stearate, and aluminum lake blue (E-133).

Appearance of the product and pack contents

It is presented 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 last revision of this leaflet:August 2019

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)