COLCHICINE SEID 1 mg TABLETS

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 undergoing 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 especially careful withColchicine Seid:

• If you experience 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. Your doctor may need to adjust the dose.
• During long-term treatment, serious muscle and kidney problems may occur.

If you take Colchicine Seid, you should be monitored for 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.

Other medicines and Colchicine Seid

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Especially tell 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 high blood pressure, 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 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.

Chronic or high-dose administration of colchicine may alter vitamin B12 absorption. Vitamin B12 doses may need to be increased.

Using Colchicine Seid 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 may pass into breast milk and harm your baby.

Driving and using machines

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

Important information about some of the ingredients of this medicine

Colchicine Seid contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Colchicine Seid

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 1 tablet (1 mg of colchicine) at the first sign of an 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 take more than 2 tablets in 24 hours.

Doses higher than 2 tablets per day have not shown greater efficacy but have shown an increase in side effects.

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

• Preventive 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) is required or the dose needs to be divided into several daily doses (e.g., 0.5 g of colchicine 2 times a day), another available presentation should be used.

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

• Familial Mediterranean fever:

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

Use in children and adolescents under 18 years

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

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

• 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) daily. It can be divided into two daily doses or taken as a single dose.

If you take more Colchicine Seid 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, indicating the medicine and the amount ingested.

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.

Symptoms of 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 immediate medical attention.

The most frequent symptoms of toxicity are burning sensation and discomfort in the mouth and throat, difficulty swallowing and breathing, digestive disorders such as abdominal pain, nausea, vomiting, diarrhea, sometimes bloody, confusion, hair loss, and hypotension.

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 product, 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 side effects are:

• Nausea, vomiting, abdominal pain, and diarrhea.

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

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), a decrease in the number of platelets (thrombocytopenia).
• Azoospermia (absence of sperm).
• Hair loss (alopecia).
• 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 listed 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 to the Spanish Medicines and Health Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 carton after EXP. The expiry date refers to the last day of that month.

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 1 mg of colchicine.
• The other ingredients are: lactose, microcrystalline cellulose, povidone, methylene cellulose, magnesium stearate, erythrosine lake (E-127).

Appearance and packaging of the product:

Pink tablets.

This medicine is presented in boxes containing 2 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 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 Health Products (AEMPS) http://www.aemps.gob.es/