PATIENT INFORMATION LEAFLET

COLCHIMAX 0.5 mg/5 mg TABLETS

COLCHIMAX 0.5 mg/5 mg is presented in the form of tablets for oral administration. Each tablet contains two active ingredients, colchicine and diclofenac

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 at the start of treatment with other medicines that cause a decrease in uric acid in the blood and urine, and periodic disease (familial Mediterranean fever).

Do not take COLCHIMAX 0.5 mg/5 mg if:

• You are allergic to colchicine, diclofenac, or any of the other components of this medication (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 a stomach ulcer.
• You have esophagitis (irritation of the esophagus by stomach contents).
• You have heart and/or blood diseases.
• You have glaucoma (increased intraocular pressure).
• You have prostate disease.
• You have any stomach and/or intestinal diseases.
• You have myasthenia gravis (autoimmune disorder affecting nerve muscles).
• You are pregnant.
• You have taken recently or are taking other medications (see use of other medications).

Be especially careful with COLCHIMAX 0.5 mg/5 mg:

• In case of experiencing 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 diseases. Your doctor may need to adjust the dose.
• In patients with heart diseases.
• In patients with high blood pressure problems.
• In patients with thyroid function disorders.
• In patients with prostate problems.
• If you have hiatal hernia.
• In patients with autonomic neuropathy (disorder of nerves regulating some bodily functions).
• During long-term treatment, severe muscle and renal problems may occur.

If you take Colchimax, monitor the side effects it may cause in your blood (decreased white blood cells, platelets, and red blood cells). Your doctor may perform periodic blood tests to control these adverse effects.

Taking COLCHIMAX 0.5 mg/5 mg with other medications

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

Especially inform your doctor before taking colchicine if you have taken recently or are taking medications containing any of the following active ingredients, as it may affect the elimination of Colchimax from your body:

• Medications used to treat infections such as clarithromycin, erythromycin, telithromycin, azithromycin, and other macrolide antibiotics.
• Medications used to treat fungal infections, such as itraconazole and ketoconazole.
• Medications used to treat high blood pressure, such as verapamil and diltiazem.
• Medications used to treat HIV, such as indinavir, nelfinavir, ritonavir, and saquinavir.

If you take Colchimax with medications to lower cholesterol and triglyceride levels, such as atorvastatin, simvastatin, pravastatin, fluvastatin, gemfibrozil, fenofibrate, fenofibric acid, or bezafibrate, with medications for heart disease, such as digoxin, and with immunosuppressive medications, such as cyclosporine, muscle problems may be potentiated. Inform your doctor before taking colchicine.

If you take Colchimax with medications used to treat mood disorders, such as imipramine, clomipramine, amitriptyline, and iproniazid, mental alterations, such as phenothiazine, alprazolam, and diazepam, narcotic analgesics, such as meperidine, antacids, some medications used to treat heart arrhythmias, such as procainamide, and sympathomimetic agents, such as norepinephrine, dopamine, and dobutamine, their action may be potentiated.

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

Using COLCHIMAX 0.5 mg/5 mg with food and beverages

Do not take colchicine with grapefruit juice, as it may decrease the elimination of colchicine from your body and harm you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medication if you are pregnant.

It is recommended not to administer during lactation as colchicine and diclofenac may pass through breast milk to your baby.

Driving and operating machinery

Patients taking Colchimax may experience drowsiness and blurred vision.

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

Do not exceed the doses indicated below.

Oral administration:

Adults.

• Acute gout attack:

The recommended dose is 2 tablets at the first sign of acute attack. If pain relief is not achieved, 1 or 2 tablets can be administered one or two hours after the first dose. Do not administer doses exceeding 4 tablets in 24 hours. Doses exceeding 4 tablets per day have not demonstrated greater efficacy, but may increase the risk of adverse effects.

In 4 consecutive days of treatment, do not take more than 12 tablets in total. If necessary, due to persistent gout pain, the previous treatment can be repeated, but always after a three-day break.

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

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

• Periodic disease or familial Mediterranean fever:

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

• Chronic gout treatment:

The recommended dose as treatment for chronic gout 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 are not enough data to establish recommendations in this age group.

• Periodic disease or familial Mediterranean fever:

There are 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 ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you take doses exceeding those indicated by your doctor, you may experience intoxication. Colchicine overdoses are very serious. There is no specific antidote.

In case of intoxication due to ingestion of a large number of tablets, proceed to administer activated charcoal, perform gastric lavage, and replenish water and electrolytes intravenously.

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

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

If you forgot to take COLCHIMAX 0.5 mg/5 mg

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The most frequent adverse reactions are:

• Nausea, vomiting, abdominal pain, and diarrhea.

High doses may cause skin eruptions, very abundant diarrhea, gastrointestinal bleeding, and liver or kidney alterations.

It may also produce:

• Drowsiness, weakness, and headache.
• Blurred or double vision, dilated pupils, and increased eye pressure.
• Urinary retention.
• Tachycardia.
• Difficulty breathing.
• Dry mouth.

In some cases, the following have been detected:

• In prolonged treatments, alterations in the blood cell count, such as a decrease in the number of white blood cells (leucopenia), 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 upon suppressing treatment.
• Muscle alterations, such as rhabdomyolysis (muscle fiber decomposition).
• Liver injury.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not appearing in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medications for Human Use:www.notificaRAM.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of COLCHIMAX 0.5 mg/5 mg

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

Appearance of the product and contents of the packaging

It is presented in boxes containing 3 blisters of 20 tablets each.

Holder of the marketing authorization and responsible for manufacturing:

SEID, S.A. Carretera de Sabadell a Granollers, Km 15.

08185 Lliçà de Vall. Barcelona (Spain)

Date of the last review of this leaflet: August 2019

The detailed information of this medication is available on the website of theSpanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).