PATIENT INFORMATION LEAFLET

Colchicine SEID 1 mg tablets

Colchicinabelongs to a group of medications known as uricosurics.

Colchicina Seid is used in the treatment of acute gout attacks and chronic gout, prevention ofacute attacks at the start of treatment with other medications that cause a decreasein blood and urine uric acid levels,and periodic disease (familial Mediterranean fever).

Do not take Colchicina Seid:

• If you are allergic to colchicine or any of the other components of this medication (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 diseases.
• If you have stomach ulcers.
• If you have heart disease.
• If you have blood disorders.
• If you are pregnant.
• If you have taken recently or are taking other medications (see section "Taking Colchicina Seid with other medications").

Warnings and precautions

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

Be especially careful withColchicina Seid:

• In case of experiencing 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, children, and weakened patients or those who abuse alcohol.
• In patients with liver and kidney diseases. Your doctor may need to adjust the dose.
• During long-term treatment, severe muscle and renal problems may occur.

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

Other medications and Colchicina Seid

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

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 Colchicina Seid from the 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 in the treatment of hypertension, such as verapamil and diltiazem.
• Medications used in the treatment of HIV, such as indinavir, nelfinavir, ritonavir, and saquinavir.

If you take Colchicina Seid with medications to lower cholesterol and triglyceride levels, such as atorvastatin, simvastatin, pravastatin, fluvastatin, gemfibrozil, fenofibrate, alpha-fenofibrate, or bezafibrate, with medications for heart disease, such as digoxin, and with immunosuppressive medications, such as cyclosporine, the risk of muscle problems may be increased. Inform your doctor before taking colchicine.

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

Use of Colchicina Seid with food and beverages

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you 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 breastfeeding as colchicine may pass through breast milk to your baby.

Driving and operating machinery

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

Important information about some of the components of this medication

Colchicina Seid contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as 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 1 tablet (1 mg of colchicine) at the first sign of 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.

Do not administer doses exceeding 2 tablets in 24 hours.

Doses above 2 tablets per day have not demonstrated greater efficacy, but have shown an increase in adverse effects.

This dosing regimen can be administered for up to 4 consecutive days with a total accumulated dose of 6 mg of colchicine in 4 days. If necessary, due to persistent gout pain, the previous regimen can be repeated, but always after at least 3 days without treatment, as a "washout" period.

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

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

If a lower dose (less than 1 mg of colchicine) or dividing the dose into multiple daily doses (e.g., 0.5 mg of colchicine twice a day) is required, use another available presentation.

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

• Periodic disease or familial Mediterranean fever:

The recommended dose is 1 to 2 tablets per day. It can be divided into two daily doses or a single dose. Your doctor will tell you how long you should take Colchicina Seid.

• Chronic gout treatment:

The recommended dose as chronic gout treatment is 1 tablet (1 mg of colchicine) per day. Your doctor will tell you how long you should take Colchicina Seid.

Use in children and adolescents under 18 years

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

There are not enough data to establish recommendations for this age group.

• Periodic disease or familial Mediterranean fever:

The recommended dose in adolescents over 12 years is 1 tablet (1 mg of colchicine) to 2 tablets (2 mg of colchicine) per day. It can be divided into two daily doses or a single dose.

If you take more Colchicina Seid than you should

Consult your doctor immediately or go to the nearest hospital immediately. In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone 91 562 04 20, indicating the medication and the amount ingested.

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

The symptoms of overdose usually appear within the first 24 hours after taking the medication, but in some cases, they 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 toxicity are a burning sensation and discomfort in the mouth and throat, difficulty swallowing and breathing, digestive disorders such as diffuse abdominal pain, nausea, vomiting, abundant diarrhea, sometimes bloody, confusion, alopecia (hair loss), and hypotension (decreased blood pressure).

If you forgot to take Colchicina Seid

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.

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 (decomposition of muscle fibers).
• Liver injury.

If you consider that any of the adverse effects you are experiencing is 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 listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medications for Human Use:www.notificaRAM.es.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 shown on the packaging, after CAD. 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 the containers and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Colchicina Seid:

• The active principle is: Colchicina. Eachtablet contains 1 mg of colchicina.
• The other components are: lactose, microcrystalline cellulose, polyvinylpyrrolidone, methylcellulose, magnesium stearate, erythrosine lake (E-127).

Appearance of the product and contents of the packaging:

Pink tablets.

This medication is presented in boxes containing 2 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

Last review date of this leaflet::September 2021

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