COLCHICINE STRIDES 0.5 mg TABLETS

Introduction

• PATIENT INFORMATION LEAFLET

Patient Information Leaflet: Information for the User

Colchicine Strides 0.5 mg Tablets EFG

Read the entire leaflet carefully before starting to use this medication because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Colchicine Strides and what is it used for
2. What you need to know before taking Colchicine Strides
3. How to take Colchicine Strides
4. Possible side effects
5. Storage of Colchicine Strides
6. Package contents and additional information

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

Colchicine Stridescontains the active ingredient colchicine. It belongs to the group of anti-gout medications and is used to prevent or treat gout attacks.

Gout attacks in adults

Colchicine Strides is indicated in adults for the short-term treatment of acute gout, known as gout attacks, and to prevent recurrent gout.

The concentration of uric acid in the blood increases when the patient has gout. This can cause the formation of uric acid crystals in the synovial fluid. Colchicine inhibits the resulting inflammation.

Familial Mediterranean Fever

Colchicine Strides is indicated in patients with Familial Mediterranean Fever to prevent febrile episodes and amyloidosis (abnormal accumulation of proteins in tissues and organs).

You should consult your doctor if your condition worsens or does not improve after taking this medication.

2. What you need to know before taking Colchicine Strides

Do not take Colchicine Strides

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

Warnings and precautions

There is a slight difference between an effective dose of colchicine and a dose that can cause symptoms of pharmacological poisoning. This means that even a slightly higher dose than the recommended one can cause signs of pharmacological poisoning. If you experience symptoms such as nausea, vomiting, stomach pain, or diarrhea, stop taking colchicine and contact your doctor immediately (see also section 4).

Consult your doctor or pharmacist before starting to take this medication if any of the following situations apply to you or have applied in the past:

• If you have liver or kidney problems
• If you have a cardiovascular disease.
• If you have gastrointestinal tract problems.
• If you are an elderly person and feel weak.
• If you have a blood disorder.

Colchicine can cause severe deterioration in bone marrow function, which can lead to a decrease in certain white blood cells (agranulocytosis), platelet deficiency (thrombocytopenia), a decrease in red blood cells, and pigment due to the lack of production of red blood cells (aplastic anemia). Regular blood tests should be performed to monitor any changes

If you experience symptoms such as fever, inflammation in the mouth, sore throat, prolonged bleeding, bruising, or skin changes, stop taking this medication and contact your doctor immediately. These may be signs of a severe blood disorder, and your doctor may want to perform a blood test immediately (see also section 4).

Prolonged use of colchicine can cause a vitamin B12 deficiency.

Children and adolescents up to 18 years

In children, colchicine should only be prescribed under the strict supervision of a specialist doctor. There are no data available on the effect of long-term use of colchicine in children.

Other medications and Colchicine Strides

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

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

Contact your doctor if you take Colchicine Stridesin addition to other medications that may reduce the number of blood cells (which can affect the blood count) or that may have a negative impact on liver and kidney function.

If you take Colchicine Stridessimultaneously with any of the following medications, the likelihood of experiencing side effects due to colchicine poisoning increases, which can be very severe. You should inform your doctor or pharmacist if you are taking:

• Erythromycin, telithromycin, clarithromycin, and azithromycin (certain types of antibiotics). Concomitant use of these types of antibiotics and colchicine can cause pharmacological poisoning. If possible, do not use these types of antibiotics during treatment with colchicine. If it is not possible to use a different treatment, your doctor should reduce the dose of colchicine and monitor you.
• Ketoconazole, itraconazole, voriconazole (antifungals). You should not use these medications during treatment with colchicine.
• Ritonavir, atazanavir, amprenavir, saquinavir, nelfinavir, fosamprenavir, and indinavir (a type of protease inhibitor used in the treatment of HIV infection). You should not use these medications during treatment with colchicine.
• Verapamil, quinidine, and diltiazem (for the treatment of heart conditions).
• Cyclosporine (to reduce the body's resistance to infection by inhibiting the immune system).

Also, inform your doctor or pharmacist if you take any of the following medications:

• If you take any of the following medications during treatment with colchicine, it is likely that muscle disease (myopathy) and muscle tissue damage, accompanied by muscle cramps, fever, and a change in urine color (reddish-brown), will occur (rhabdomyolysis):
  • Simvastatin, fluvastatin, or pravastatin (statins used to reduce cholesterol levels).
  • Fibrates (used to reduce cholesterol and certain blood lipid levels).
  • Digoxin (used in the treatment of heart failure and arrhythmias).
  • Cimetidine (used to reduce stomach ulcers or intestinal ulcers) and tolbutamide (used to reduce blood sugar levels). These medications can increase the effect of colchicine.
  • Vitamin B12 (cyanocobalamin). Colchicine may reduce the absorption of vitamin B12 in the digestive tract.

Taking Colchicine Strides with food and drinks

You should not drink grapefruit juice during 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 medication.

Women of childbearing age

Gout treatment

Women who may become pregnant should use effective contraceptive methods during treatment and for at least 3 months after the end of treatment for gout with Colchicine Strides. If you become pregnant during this period, you should consult your doctor about the risks of congenital anomalies.

Pregnancy

Gout treatment

You should not use Colchicine Strides if you are pregnant or plan to become pregnant. If you become pregnant during treatment with Colchicine Strides or within 3 months after stopping treatment, you should consult your doctor about the risks of congenital anomalies.

Familial Mediterranean Fever treatment:

Since the course of untreated Familial Mediterranean Fever can also have a negative effect on pregnancy, the risks and benefits of treatment with Colchicine Strides during pregnancy should be considered if clinically necessary.

Breastfeeding

The active ingredient colchicine is excreted in breast milk.

Colchicine Strides should not be used for the treatment of gout in breastfeeding women.

In breastfeeding mothers with Familial Mediterranean Fever, a decision should be made to either stop breastfeeding or discontinue/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' partners should not become pregnant during treatment and for at least 6 months after stopping treatment with colchicine. If the partner becomes pregnant during this time, you should consult your doctor about the risks of congenital anomalies.

Male patients should not father children during treatment with colchicine and for at least 6 months after stopping treatment. If, despite this, a pregnancy occurs during this time, you should consult your doctor about the risks of congenital anomalies.

Familial Mediterranean Fever treatment:

Since the course of untreated Familial Mediterranean Fever can also cause infertility, the risks and benefits of using Colchicine Strides should be weighed, and treatment should only be considered if clinically necessary.

Driving and using machines

There are no data available on the influence of colchicine on the ability to drive and use machines. However, it may cause drowsiness and dizziness.

Colchicine Strides contains lactose

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

Colchicine Strides contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Colchicine Strides

Always follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Gout treatment

Treatment of an acute gout attack:

The recommended dose is 0.5 mg two or three times a day. Your doctor may prescribe an additional dose of 1 mg for the first day of treatment. Stop treatment if you experience gastrointestinal symptoms or if you have not had any effect after 2 or 3 days.

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

After completing a treatment cycle with Colchicine Strides (or with any other medication containing colchicine), do not start a new cycle until at least 3 days have passed.

Prevention of a gout attack:

The recommended dose is 0.5 mg or 1 mg per day, administered at night. Your doctor will indicate how long you should take Colchicine Strides.

If you have liver or kidney disease:

If you have liver or kidney dysfunction, the recommended dose is 0.5 mg of colchicine per day, and your doctor should closely monitor you. If you have severe liver or kidney failure, do not use this medication (see section 2).

Children and adolescents

Colchicine Strides is not indicated for the treatment of gout in children and adolescents.

Treatment of Familial Mediterranean Fever

The recommended dose is 1 mg or 3 mg per day. The daily dose can be administered as a single dose or divided into two daily doses (in the case of doses higher than 1 mg/day).

If you do not improve, your doctor may gradually increase the dose of colchicine up to a maximum dose of 3 mg per day. In the case of a reduction in the dose of colchicine, your doctor should monitor you to evaluate possible side effects.

Use in children and adolescents up to 18 years

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

• Children under 5 years: 0.5 mg per day
• Children from 5 to 10 years: 1 mg per day
• Children over 10 years: 1.5 mg per day

In children with amyloid nephropathy, the dose can be increased to 2 mg per day.

Dose in patients with liver or kidney failure

In case of liver or kidney failure, it is recommended to administer half the dose. If you have severe liver or kidney failure, do not use this medication (see section 2).

If you take more Colchicine Strides than you should

If you take more tablets of Colchicine Strides than you should, or if a child accidentally takes some tablets, there is a risk of poisoning. You should contact your doctor, pharmacist, or the emergency department of the nearest hospital immediately.

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

Signs of poisoning:

• After taking a too high dose of colchicine, the first symptoms of overdose do not appear until several hours later. These symptoms include a burning sensation in the throat, stomach, and skin, nausea, vomiting, abdominal cramps, and bloody diarrhea, which can cause excessive blood acidification, dehydration, decreased blood pressure, and cardiocirculatory shock.
• Between 24 and 72 hours after taking a too high dose, the following potentially fatal complications may appear: altered consciousness with possible delirium (hallucinations), coma, paralysis symptoms, difficulty breathing, fluid retention in the lungs, kidney damage, blood deficiency, and cardiac arrest.
• After 7 days of taking a too high dose, a temporary increase in white blood cell count (leukocytosis) and hair loss may occur.

If you forget to take Colchicine Strides

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

If you forget to take a dose, you should take it as soon as possible.

If it is almost time for your next dose, do not take the missed dose, just take the next dose and continue with the administration schedule.

In case of doubt, always consult your doctor or pharmacist.

If you stop taking Colchicine Strides

If you stop taking this medication suddenly, you may experience the symptoms you had before starting treatment again. Consult your doctor if you are thinking of stopping colchicine.

If you have any questions about this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Stop taking Colchicine Strides and contact your doctor or go to the emergency department of the nearest hospital immediately if you experience any of the following side effects:

• Nausea, vomiting, abdominal cramps, or diarrhea. These side effects are common (may affect 1 in 10 patients).
• Muscle weakness (myopathy), change in urine color (from reddish to brown) (rhabdomyolysis), muscle pain, and fatigue. These side effects are uncommon (may affect 1 in 100 patients).
• Infection with symptoms such as high fever, sore throat, mouth inflammation, and a severe form of anemia (aplastic anemia). These side effects are rare (may affect 1 in 1,000 patients).

Additionally, the following side effects are known:

Uncommon (may affect 1 in 100 patients):

• Hair loss, skin rash.

Rare (may affect 1 in 1,000 patients).

• Reduced sperm count in the semen or complete absence of sperm in the semen.
• Sore throat.

Very rare (may affect 1 in 10,000 patients):

• Neuropathy, neural inflammation that can cause pain, numbness, and frequently, a change in nerve function.

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

• Absence of menstrual periods for 6 months or more and appearance of pain and/or cramps during menstruation.

•Vitamin B12 deficiency.

Children and adolescents up to 18 years

There are no data available on the effect of long-term use of colchicine in children and adolescents up to 18 years.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Colchicine Strides

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

Store the blister in the outer packaging to protect it from light.

Do not use this medicine after the expiry date that appears on the packaging and on the blister after «EXP». The expiry date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Colchicine Strides

• The active ingredient is colchicine.
• The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), sodium carboxymethyl starch (Type A) [potato], povidone (E1201), magnesium stearate (E470b).

Appearance of Colchicine Strides and Package Contents

Colchicine Strides 0.5 mg tablets are round, white tablets engraved with C5 on one face and smooth on the other face.

Each tablet has a diameter of approximately 6.4 mm.

Colchicine Strides is available in packs with PVC-aluminum blisters containing 12, 30, or 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Strides Pharma (Cyprus) Limited

Themistokli Dervi, 3

Julia House, 1st Floor

Nicosia 1066

Cyprus

Manufacturer

Fairmed Healthcare GmbH

Maria-Goeppert-Straße 3

23562 Lübeck

Germany

This medicine is authorized in the EEA Member States under the following names:

Date of the last revision of this leaflet:06/2022.

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.es/