COLCHICINE TIOFARMA 0.5 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Colchicine Tiofarma 0.5 mg tablets

Colchicine Tiofarma 1 mg tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Colchicine Tiofarma contains the active substance colchicine. It belongs to the group of anti-gout medicines and is used to prevent or treat gout attacks.

Gout attacks in adults

Colchicine is used in adults for the short-term treatment of acute gout attacks and to prevent the recurrence of gout.

In gout, there is an increase in the concentration of uric acid in the blood. This can lead to the precipitation of uric acid crystals in the joint fluid. Colchicine inhibits the resulting inflammatory response.

Familial Mediterranean Fever

Colchicine is also indicated in Familial Mediterranean Fever (a hereditary disease with recurrent fever and inflammation attacks) to prevent fever attacks and amyloidosis (abnormal protein precipitation in tissues and organs).

Consult a doctor if you do not feel better or if you worsen.

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

Do not take Colchicine Tiofarma if:

• You are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6)
• You have a severe blood disorder
• You have severe kidney problems
• You have severe liver problems

Warnings and precautions

There is a small difference between an effective dose of Colchicine and a dose that causes symptoms of pharmacological intoxication (see section 3). This means that even a slightly higher dose than the suitable one can cause acute signs of pharmacological intoxication. If you experience symptoms such as nausea (discomfort), vomiting, stomach pain, and diarrhea, stop taking Colchicine and contact your doctor immediately (see also section 4 "Possible side effects").

Consult your doctor or pharmacist before taking this medicine if one or more of the following situations apply to you or have applied in the past.

• If you have liver or kidney problems.
• If you have a vascular or heart disease.
• If you have problems in the gastrointestinal tract.
• If you are an elderly person and are debilitated.
• If you have a blood disorder.

Colchicine may cause a severe decrease in bone marrow function (disappearance of certain white blood cells [agranulocytosis], scarcity of blood platelets [thrombocytopenia], decrease in red blood cells and pigment due to a lack of red blood cell production [aplastic anemia]).

You should have regular blood tests to monitor any changes.

If you present symptoms such as fever, mouth inflammation, sore throat, prolonged bleeding, bruising, or skin problems, stop taking this medicine and contact your doctor immediately. These could be signs that you have a serious blood problem and your doctor may want to have a blood test done immediately (see also section 4 "Possible side effects").

Long-term use of colchicine may lead to a vitamin B12 deficiency.

Children and adolescents up to 18 years

For use in children, colchicine should only be prescribed under the supervision of a medical specialist. There is limited data on the effect of long-term use of colchicine in children, but it is expected that the frequency, type, and severity of side effects will be the same as in adults.

Other medicines and Colchicine Tiofarma

Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medicine.

Caution is recommended when this product is used with medicines that may alter blood counts or negatively affect liver and kidney function. In that case, contact your doctor.

If Colchicine is taken with any of the following medicines, it is more likely that side effects will appear due to colchicine toxicity and that these will be very serious. You should inform your doctor or pharmacist if you are taking:

• erythromycin, telithromycin, clarithromycin, and azithromycin (certain antibiotics, medicines used to treat bacterial infections). The use of this type of antibiotic during the period in which you receive treatment with colchicine may cause pharmacological intoxication. If possible, do not use this type of antibiotic during the period in which you receive treatment with colchicine. If it is not possible to administer another treatment, your doctor may reduce the dose of colchicine and keep you under surveillance;
• ketoconazole, itraconazole, voriconazole (antifungal medicines). You should not use these medicines during the period in which you receive treatment with colchicine;
• ritonavir, atazanavir, amprenavir, saquinavir, nelfinavir, fosamprenavir, and indinavir (certain protease inhibitors used to treat HIV infection). You should not use these medicines during the period in which you receive treatment with colchicine;
• verapamil, quinidine, and diltiazem (medicines used to treat heart diseases).
• cyclosporine (a medicine to reduce the body's resistance to infection by suppressing the immune system).

Also, inform your doctor or pharmacist if you are taking any of the following:

• Taking the following medicines during the period in which you receive treatment with colchicine may cause a severe muscle disease (myopathy) and muscle tissue breakdown, which are accompanied by muscle cramps, fever, and reddish-brown urine color (rhabdomyolysis):
• • simvastatin, fluvastatin, or pravastatin (statins, medicines used to reduce cholesterol).
  • fibrates (medicines used to reduce cholesterol and some fats in the blood).
  • digoxin (a medicine used to treat heart failure and arrhythmias).

• cimetidine (used to reduce intestinal or gastric ulcers) and tolbutamide (used to reduce blood sugar). These may increase the effect of colchicine.
• vitamin B12 (cyanocobalamin). It is possible that the absorption of vitamin B12 in the gastrointestinal tract may be reduced by colchicine.

Using Colchicine Tiofarma with food and drinks

You should not eat grapefruit or drink grapefruit juice during the period in which you receive treatment with colchicine.

Pregnancy, breastfeeding, and fertility

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.

Women of childbearing age:

Gout treatment

Women of childbearing age should use effective contraceptives during gout treatment with Colchicine and for at least 3 months after the end of such treatment. If pregnancy occurs during this time, genetic counseling should be sought.

Pregnancy:

Gout treatment:

You should not use Colchicine Tiofarma if you are pregnant or may become pregnant. If pregnancy occurs during treatment with Colchicine or in the 3 months following the end of treatment, genetic counseling should be sought.

Familial Mediterranean Fever treatment:

Since the progression of untreated Familial Mediterranean Fever can also negatively affect pregnancy, the use of Colchicine during pregnancy should be weighed against the potential risks and may be considered if clinically necessary.

Breastfeeding:

The active substance colchicine is excreted in breast milk.

Colchicine Tiofarma should not be used in women with gout who are breastfeeding.

In breastfeeding mothers with Familial Mediterranean Fever, a decision should be made on whether to stop breastfeeding or to interrupt/not start treatment with colchicine, taking into account the benefit of breastfeeding for the baby and the benefit of treatment for the woman.

Fertility:

Gout treatment:

Male patients should not father a child during treatment with colchicine and for at least 6 months after the end of such treatment. If pregnancy occurs during this time, genetic counseling should be sought.

Familial Mediterranean Fever treatment:

Since the progression of untreated Familial Mediterranean Fever can also lead to infertility, the use of Colchicine should be weighed against the potential risks and may be considered if clinically necessary.

Driving and using machines

No data are available on the influence of colchicine on the ability to drive and use machines. However, the possibility of drowsiness or dizziness should be taken into account.

Colchicine Tiofarma contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Colchicine Tiofarma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it is essentially "sodium-free".

3. How to take Colchicine Tiofarma

Important warning!

Do not exceed the recommended dose. Overdose, including that derived from ignoring interactions, can lead to a very painful and irreversible intoxication with a fatal outcome. See sections 2, 3, and 4 of this leaflet.

The medicine should be kept out of the reach of other people before and after use.

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

Colchicine in a dose that is too high is potentially toxic, so it is important not to exceed the dose prescribed by your doctor.

Contact your doctor or pharmacist if you think the effect of the colchicine tablets is too strong or too weak.

Use in adults

Use for gout

Treatment of an acute gout attack:

The recommended dose is 0.5 mg two to three times a day. Your doctor may prescribe an additional 1 mg for the first day of treatment. The treatment should be stopped if gastrointestinal symptoms appear or if there is no effect after 2 or 3 days.

You should not take more than 6 mg of Colchicine Tiofarma during a treatment cycle.

After completing a cycle of Colchicine Tiofarma (or another medicine that contains colchicine), you should not start another cycle until at least three days have passed.

Prevention of a gout attack:

The recommended dose is 0.5-1 mg/day and should be taken at night. Your doctor will indicate how long you should take Colchicine.

Use for Familial Mediterranean Fever

The daily dose can be taken as a single dose or divided into two daily doses (for doses greater than 1 mg/day). The recommended initial dose is between 1.0 and 1.5 mg/day. If you do not feel better, your doctor may gradually increase the dose of colchicine up to a maximum of 3 mg/day. Your doctor should carefully monitor you for side effects with any increase in the dose of colchicine.

Use in children and adolescents up to 18 years of age

Use for gout

Colchicine should not be used for the treatment of gout in children and adolescents.

Use for Familial Mediterranean Fever

In children with Familial Mediterranean Fever, the recommended initial dose is based on age.

• Children under 5 years: 0.5 mg/day
• Children between 5 and 10 years: 1 mg/day
• Children over 10 years: 1.5 mg/day

If you do not feel better, your doctor may gradually increase the dose of colchicine up to a maximum of 2 mg/day. Your doctor should carefully monitor you for side effects with any increase in the dose of colchicine.

In children with amyloid nephropathy, it may be necessary to increase the dose up to 2 mg/day. If you have liver or kidney failure, the initial dose should be reduced and you should be carefully monitored (see "Dose in case of liver or kidney failure" below).

Use in elderly patients

The selection of dose for elderly patients should be done with caution and reflect the greater frequency of decreased renal and hepatic function, the presence of other diseases, and the use of other medicines in these patients.

Dose in case of liver or kidney failure

If you have liver or kidney failure, you should be closely monitored.

If you have mild or moderate liver or kidney failure and are being treated for gout, the recommended dose is 0.5 mg of colchicine per day.

If you have mild or moderate liver or kidney failure and are being treated for Familial Mediterranean Fever, the recommended dose will be reduced by half.

If you have severe liver or kidney failure, you should not use this medicine; see section "Do not take Colchicine Tiofarma".

Method of administration

The tablets should be swallowed whole with a glass of water.

If you take more Colchicine Tiofarma than you should

If you take more tablets of Colchicine than you should or if, for example, a child has taken some tablets by accident, there is a risk of intoxication. You should contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

Signs of intoxication

• After ingestion of a dose that is too high of colchicine tablets, early symptoms of overdose appear after several hours. These symptoms include a burning sensation in the throat, stomach, and skin, nausea, vomiting, abdominal cramps, and bloody diarrhea, which can lead to a low pH level in the blood, dehydration, decreased blood pressure, and shock.
• Later, 24-72 hours after ingestion of a dose that is too high, the following life-threatening complications may appear: altered consciousness with possible delirium (hallucinations), coma, paralysis symptoms, respiratory depression, fluid retention in the lungs, kidney damage, blood scarcity, and cardiac arrest.
• About 7 days after ingestion of a dose that is too high, there may be a temporary increase in white blood cells (leukocytosis) and hair loss.

If you forget to take Colchicine Tiofarma

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

If you forget to take a dose, take it as soon as you remember. If the time for your next dose is near, do not take the forgotten dose and continue with your prescribed regimen. In case of doubt, always consult your doctor or pharmacist.

If you stop taking Colchicine Tiofarma

If you suddenly stop taking this medicine, it is possible that the symptoms you were suffering from before starting treatment may reappear. Always consult your doctor if you consider stopping the colchicine.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Colchicine and contact a doctor or the emergency service of the nearest hospital immediately if you experience any of the following adverse effects:

• Nausea, vomiting, abdominal cramps, and diarrhea. The frequency of these adverse effects is frequent (may affect up to 1 in 10 people)
• Muscle weakness (myopathy), reddish-brown urine coloration (rhabdomyolysis), muscle pain, fatigue. The frequency of these adverse effects is infrequent (may affect up to 1 in 100 people)
• Infection with symptoms such as high fever, severe sore throat, and oral ulcers, and a severe form of anemia (aplastic anemia). The frequency of these adverse effects is rare (may affect up to 1 in 1,000 people)

In addition, the following adverse effects are known:

Frequency not known (cannot be estimated from the available data):

• Hair loss, skin rash
• Reduction in the number of sperm in the seminal fluid or total absence of sperm in the seminal fluid
• Sore throat
• Neuropathy (nerve disease), nerve inflammation that can cause pain, numbness, and, occasionally, altered nerve function

• Absence of menstruation for a period of 6 months or more, and pain and/or cramps during menstruation
• Vitamin B12 deficiency
• Liver damage

Children and Adolescents up to 18 years of age

It is expected that the frequency, type, and severity of adverse effects will be the same as in adults.

Reporting of Side Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Colchicine Tiofarma

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

Store below 25°C. Keep the blister pack in the outer packaging to protect it from light.

Do not use this medicine after the expiration date stated on the carton, label, and blister pack after "CAD". The expiration date is the last day of the indicated month.

The validity period after the first opening of the container is 6 months.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the Package and Additional Information

Composition of Colchicine Tiofarma

• The active ingredient is colchicine.
• The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), potato starch carboxymethylamide, and magnesium stearate (E572).

Appearance of the Product and Contents of the Package

Colchicine Tiofarma 0.5 mg tablets are white, round tablets with the inscription "0.5" on one face.

Colchicine Tiofarma 1 mg tablets are white, oval tablets with the inscription "C1C" on one face.

Colchicine Tiofarma tablets are packaged in:

• Blisters with 10 tablets per blister and 3 blisters per carton, or
• Blisters with 10 tablets per blister and 10 blisters per carton, or
• White plastic containers with 250 tablets in a carton.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Tiofarma B.V.

Benjamin Franklinstraat 5 – 10

3261 LW Oud-Beijerland

Netherlands

Date of the Last Revision of this Prospectus: March 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/