Patient Information Leaflet

COLCHICINESEID 0.5 mg Tablets

Table of Contents

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

Colchicina Seid belongs to a group of medications known as urate-lowering drugs.

Colchicina is used in the treatment of acute gout attacks and chronic gout, prevention of acute attacks upon initiation of treatment with other medications that cause a decrease in blood and urine uric acid levels and familial Mediterranean fever..

Treatment in adults of acute pericarditis and recurrent pericarditis in combination with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).

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 diseases.
• If you are pregnant.
• If you have recently taken 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 with Colchicina 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 debilitated 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.

Children and adolescents

The safety and efficacy of colchicine in the pediatric population for the treatment of pericarditis have not been established. No data are available.

Other medications and Colchicina Seid

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use any other medication.

Especially inform your doctor before taking colchicine, if you have recently taken or are taking medications that contain 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, fenofibric acid, 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 the chronic or high-dose administration of colchicine. You may need to increase your 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 highly unlikely that Colchicina Seid will affect your ability to drive and operate machinery.

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 2 tablets (1mgofcolchicine)at the first sign of acute attack. If pain relief is not achieved, 1 or 2 tablets (0.5mgto1mgofcolchicine)can be administered one or two hours after the first dose.

Do not administer doses greater than 4 tablets(2mgofcolchicine) in 24 hours. Doses greater than 4 tablets (2mgofcolchicine)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(6mgofcolchicine) in total. If necessary, due to persistent gout pain, the previous treatment can be repeated, but always after three days of rest(withouttreatment).

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

The recommended dose for prophylactic treatment of gout attacks is 1 or 2 tablets(0.5mgto1mgofcolchicine) per day. Your doctor will tell you how long you should take Colchicina Seid.

• Periodic disease or familial Mediterranean fever:

The recommended dose is 2 to4 tablets(1mgto2mgofcolchicine) 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 for chronic gout treatment is 1 or 2 tablets (0.5mgto1mgofcolchicine)per day. Your doctor will tell you how long you should take Colchicina Seid.

• Pericarditis treatment:

In adults, for the treatment of acute pericarditis as an adjunct to aspirin/AINE treatment (3 months) and for recurrent pericarditis (6 months).

• Body weight 70 kg or more: 1 tablet (0.5 mg ofcolchicine), twice a day(1 mgofcolchicineper day).
• Body weight less than 70 kg: 1 tablet (0.5 mg ofcolchicine), once a day (0.5 mg ofcolchicineper day).

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 in this age group.

• Periodic disease or familial Mediterranean fever:

The recommended dose in adolescents over 12 years is 2 to 4 tablets per day. It can be divided into two daily doses or a single dose.

The groove is only for breaking the tablet if it is difficult to swallow whole.

• Pericarditis treatment:

This medication is not recommended for children or adolescents for the treatment of pericarditis. See the section “Children and adolescents” in section 2.

If you take more Colchicina Seid 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. Phone91 562 04 20,indicatingthemedicationandtheamountingested.

If you take doses greater than 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 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, you should seek specialized medical assistance immediately.

The most common symptoms of toxicity are a 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), and hypotension (low blood pressure).

If you forget 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 thismedication, ask your doctororpharmacist.

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 hemorrhage, and liver or renal 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.
• Muscular alterations, such as rhabdomyolysis (decomposition of muscle fibers).
• Liver damage.

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

Adverse Effect Reporting

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 the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout 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.

Do not use this medication if you observe deterioration in the packaging.

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

Composition of Colchicina Seid

• The active principle is colchicine. Eachtablet contains 0.5 mg of colchicine.
• The other components (excipients)are:calcium dihydrogen phosphate, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and content of the packaging

White, round, biconvex, scored tablets.

This medication is presented in boxes containing a blister of 20 tablets.

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

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