COLCHICINE SEID 0.5 mg TABLETS

Introduction

Patient Information Leaflet

COLCHICINESEID 0.5 mg tablets

Contents of the pack

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

1. What is Colchicine Seid and what is it used for

Colchicine Seid belongs to a group of medicines known as anti-gout agents.

Colchicine 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.

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

2. What you need to know before you take Colchicine Seid

Do not take Colchicine Seid:

• If you are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6).
• If you have severe kidney disease.
• If you are on dialysis.
• If you have severe liver disease.
• If you have severe gastrointestinal disease.
• If you have stomach ulcers.
• If you have heart disease.
• If you have blood disorders.
• If you are pregnant.
• If you have recently taken or are taking other medicines (see section "Taking Colchicine Seid with other medicines").

Warnings and precautions

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

Be particularly careful with Colchicine 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 disease. It may be necessary for the doctor to adjust the dose.
• During long-term treatment, serious muscle and kidney problems may appear.

If you take Colchicine Seid, 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.

Children and adolescents

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

Other medicines and Colchicine Seid

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Especially inform your doctor before taking colchicine if you have recently taken or are taking medicines that contain any of the following active substances, as the elimination of Colchicine Seid from the body may be affected:

• 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 Colchicine Seid with medicines to lower cholesterol and triglyceride levels, such as atorvastatin, simvastatin, pravastatin, fluvastatin, gemfibrozil, fenofibrate, fenofibric acid, or bezafibrate, with medicines for the treatment of heart diseases, such as digoxin, and with immunosuppressive medicines, such as cyclosporine, 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. It may be necessary to increase the doses of vitamin B12.

Using Colchicine Seid with food and drinks

Do not take Colchicine Seid 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 may pass into breast milk and harm your baby.

Driving and using machines

It is unlikely that Colchicine Seid will affect your ability to drive or use machines.

3. How to take Colchicine Seid

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Do not exceed the recommended doses.

Oral route:

Adults

• Acute gout attack:

The recommended dose is 2 tablets (1 mg of colchicine) at the first sign of an acute attack. If pain relief is not achieved, 1 or 2 tablets (0.5 mg to 1 mg of colchicine) can be administered 1 or 2 hours after the first dose.

Do not administer doses higher than 4 tablets (2 mg of colchicine) in 24 hours. Doses higher than 4 tablets (2 mg of colchicine) 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 (6 mg of colchicine) in total. If necessary because gout attack pain persists, the previous treatment can be repeated but always after 3 days of rest (without treatment).

• 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 (0.5 mg to 1 mg of colchicine) per day. Your doctor will tell you how long you should take Colchicine Seid.

• Familial Mediterranean fever:

The recommended dose is 2 to 4 tablets (1 mg to 2 mg of colchicine) per day. It can be divided into two daily doses or taken in a single dose. Your doctor will tell you how long you should take Colchicine Seid.

• Chronic gout treatment:

The recommended dose as treatment for chronic gout is 1 or 2 tablets (0.5 mg to 1 mg of colchicine) per day. Your doctor will tell you how long you should take Colchicine Seid.

• Pericarditis treatment:

In adults for the treatment of acute pericarditis as a complement to treatment with aspirin/NSAIDs (3 months) and for recurrent pericarditis (6 months).

• Body weight of 70 kg or more: 1 tablet (0.5 mg of colchicine), twice a day (1 mg of colchicine per day).
• Body weight less than 70 kg: 1 tablet (0.5 mg of colchicine), once a day (0.5 mg of colchicine per 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.

• 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 taken in a single dose.

The score line is only to facilitate breaking the tablet if you find it difficult to swallow it whole.

• Pericarditis treatment:

The use of this medicine is not recommended in children or adolescents for the treatment of pericarditis. See section "Children and adolescents" in section 2.

If you take more Colchicine Seid than you should

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

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 overdose usually appear within the first 24 hours after taking the medicine, but sometimes they can be delayed up to 1 week. Therefore, if you suspect an overdose, even without apparent signs, you should seek immediate medical attention.

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 abdominal pain, nausea, vomiting, abundant diarrhea, sometimes bloody, confusion, alopecia (hair loss), and hypotension (decreased blood pressure).

If you forget to take Colchicine Seid

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

If you have any further questions on 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.

On some occasions, the following have been detected:

• In prolonged treatments, changes in blood cell counts, such as a decrease in the number of white blood cells (leukopenia), a decrease in the number of neutrophils (neutropenia), a decrease in the number of platelets (thrombocytopenia).
• Azoospermia (absence of sperm).
• Alopecia (hair loss).
• Disorders in the nerves that control the muscles, reversible when treatment is discontinued.
• Muscle disorders, such as rhabdomyolysis (breakdown 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 Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Colchicine Seid

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 which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Do not use this medicine if you notice any deterioration in the packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Colchicine Seid

• The active substance is colchicine. Each tablet contains 0.5 mg of colchicine.
• The other ingredients (excipients) are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and pack contents

White, round, biconvex tablets, scored.

This medicine is available in boxes containing one blister pack of 20 tablets.

Marketing authorization holder and manufacturer:

SEID, S.A.

Carretera de Sabadell a Granollers, Km. 15

08185 - Lliçà de Vall (Barcelona)

Spain

Date of last revision of this leaflet:September 2021

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