InfoCons Consumer Protection informs you – Colchicine AGEPHA Pharma – Package Leaflet

Before anything else

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.

ℹ️ 1. What Colchicine AGEPHA Pharma is and what it is used for

Colchicine AGEPHA Pharma contains colchicine which is used in adults with heart disease (stable for at least 6 months ) caused by narrowing or blockage of blood vessels supplying the heart muscle (coronary heart disease) that is stable to reduce the risk of :

• heart attack ,
• stroke caused by blocked blood supply to part of the brain (ischaemic stroke ),
• the need for procedure s to restore blood flow to the heart when reduced oxygen supply to the heart muscle is causing symptoms (ischaemia- driven coronary revascularisation) ,
• and death caused by diseases of the heart or blood vessels.

It is used along with standard therapies.

The way that the active substance in Colchicine AGEPHA Pharma , colchicine, works is not fully understood. However, it is thought that it reduces inflammation by limiting the movement of certain white blood cells to areas of inflammation and by disrupting the release of inflammatory substances inside these cells. This is thought to prevent damage to the heart and blood vessels.

⚠️ 2. What you need to know before you take Colchicine AGEPHA Pharma

Do not take Colchicine AGEPHA Pharma

• If you are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6).
• If you have severe kidney or liver problems.
• If you have blood problems
• If you take certain medicines called strong CYP3A4 inhibitors or P -glycoprotein inhibitors :

23 • Atazanavir, Darunavir/Ritonavir, Indinavir, Lopinavir/Ritonavir, Nelfinavir, Ritonavir, Saquinavir, Tipranavir/Ritonavir (used to treat HIV infection)

• Itraconazole, Ketoconazole (used to treat fungal infections)
• Clarithromycin, Telithromycin (used to treat bacterial infections)
• Nefazodone ( used to treat depression)
• Cyclosporine (used to prevent organ rejection / treat immune conditions)
• Ranolazine (used to treat chest pain / angina) Ask your healthcare provider if you are not sure. Taking these medicines with Colchicine AGEPHA Pharma may cause the level of colchicine to be too high in your body which can cause life- threatening side effects or death.

Warnings and precautions

Talk to your doctor or pharmacist before taking Colchicine AGEPHA Pharma if one or more of the following applies to you :

• have liver or kidney problems ;
• have stomach and gut ( gastrointestinal ) problems ;
• have a severe blood disorder .

Colchicine AGEPHA Pharma can decrease activity in the bone marrow (myelosuppression) leading to low levels of blood cells including white blood cells (leucopenia), white blood cell known as granulocytes (granulocytopenia), platelets, components that help the blood to clot (thrombocytopenia) , all types of blood cells (pancytopenia), and a condition in which the bone marrow is unable to produce blood cells (aplastic anaemia). This can be life- threatening or fatal.

Stop taking Colchicine AGEPHA Pharma and contact your doctor immediately if you develop any problems affecting your stomach or gut as these are often the first sign of side effects caused by Colchicine AGEPHA Pharma . These include:

• nausea (feeling sick) ;
• vomiting;
• stomach pain , and ;
• diarrhoea (see also section 4 ‘Possible side effects’).
• have been diagnosed with severe heart failure (New York Heart Association Class III or IV) or have been told your heart pumping function is severely reduced — your doctor may decide if Colchicine AGEPHA Pharma is not suitable for you .

Colchicine AGEPHA Pharma can cause side effects affecting the nerves and muscle s (neuromuscular) , and the b reakdown of muscles often leading to kidney damage (rhabdomyolysis) . Patients should contact their doctor if they develop relevant symptoms such as muscle pain, tenderness, dark coloured urine.

Children and adolescents

Colchicine AGEPHA Pharma should not be used in children or adolescents.

Other medicines and Colchicine AGEPHA Pharma

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

The following medicines may increase the risk of side effects with Colchicine AGEPHA Pharma by increasing the amount of Colchicine AGEPHA Pharma in the blood:

• amprenavir, fosamprenavir (pro-drug of amprenavir), ( used to treat HIV infection )
• aprepitant (used to treat nausea and vomiting)
• diltiazem, verapamil (used to treat high blood pressure)
• Erythromycin (used to treat bacterial infections)
• Fluconazole (used to treat fungal infections)
• Atorvastatin, rosuvastatin, simvastatin (used to treat high cholesterol) 24 – Fibrates, gemfibrozil (used to treat high triglycerides / cholesterol)
• Digoxin (used to treat irregular heartbeat and abnormal heart rhythm )
• Norethindrone/Ethinyl Estradiol (used as a birth control medicine to prevent pregnancy ) Do not take Colchicine AGEPHA Pharma with f ollowing stong CYP3A4 and P -gp inhibitors as they are contra indicated:
• Clarithromycin, Telithromycin (used to treat bacterial infections)
• Itraconazole, Ketoconazole (used to treat fungal infections)
• Atazanavir, Darunavir/Ritonavir, Indinavir, Lopinavir/Ritonavir, Nelfinavir, Ritonavir, Saquinavir, Tipranavir/Ritonavir (used to treat HIV infection)
• Cyclosporine (used to prevent organ rejection / treat immune conditions)
• Nefazodone (used to treat depression)
• Ranolazine (used to treat chest pain / angina) Colchicine AGEPHA Pharma with food and drink Avoid eating grapefruit or drinking grapefruit juice while taking Colchicine AGEPHA Pharma . It can increase your chances of getting serious side effects.

Women of childbearing potential and men This medicine affects how cells divide and could have an effect on the unborn child in the event of conception during this treatment. Therefore, women who can become pregnan t should use effective birth control ( contraception) while taking Colchicine AGEPHA Pharma and for at least 1 month after stopping treatment . Male patients should not father a child during and for at least 3 months following termination of colchicine therapy .

Pregnancy, breastfeeding and fertility

If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

This medicine affects cell division and is known to cross the placenta in humans . The available data do not show any risk for the unborn child, but cases of genetic abnormalities , including Down syndrome , have been reported in association with colchicine, although this risk has not been confirmed in studies .

Therefore, Colchicine AGEPHA Pharma should not be used during pregnancy unless the clinical condition of the woman requires treatment with colchicine.

Breast -feeding The active substance in Colchicine AGEPHA Pharma , colchicine , passes into breast milk. I f you are breast -feeding ask your doctor for advice before taking Colchicine AGEPHA Pharma . Your doctor will decide whether you should stop breast -feeding .

Fertility

If you are planning to have children, discuss this with your doctor before starting Colchicine AGEPHA Pharma .

Driving and using machines

Colchicine has no influence on the ability to drive and use machines.

Colchicine AGEPHA Pharma contains lactose

Colchicine AGEPHA Pharma contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Colchicine AGEPHA Pharma .

💊 3. How to take Colchicine AGEPHA Pharma

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

25 The recommended dose is 0 .5 mg taken once daily. Colchicine AGEPHA Pharma can be taken with or without food.

Do not change your dose or stop taking Colchicine AGEPHA Pharma without talking to your healthcare provider first.

Colchicine AGEPHA Pharma is available as tablets which are taken by mouth.

If you take more Colchicine AGEPHA Pharma than you should

If you take more Colchicine AGEPHA Pharma than you are supposed to, contact your doctor or nearest hospita l accident and emergency department immediately. Take this leafl et and any remaining tablets with you so that you can show the doctor what you have taken.

At too high a dose Colchicine AGEPHA Pharma can cause serious side effects which can be life- threatening. Early symptoms of overdose (which appear on average after 3 hours but can take longer) may include feeling sick ( nausea ), vomiting, stomach pain, bloody diarrhoea and low blood pressure.

If you forget to take Colchicine AGEPHA Pharma

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

If you forget to take a dose and it is almost time for your next dose, do not take the missed dose at all and continue with your prescribed dosing regimen.

Only take the missed dose as soon as you remember, if there is enough time before your next dose.

Always check with your doctor or pharmacist if you are unsure.

If you stop taking Colchicine AGEPHA Pharma

When you suddenly stop taking this medicine, the symptoms that you were experiencing before starting treatment may reoccur. Always talk to your doctor if you consider stopping taking colchicine.

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.

Stop taking Colchicine AGEPHA Pharma and immediately contact a doctor or the nearest hospital accident and emergency department if you develop the following side effects.

Signs of overdose or serious toxicity Severe or persistent diarrhoea, nausea, vomiting or abdominal pain may be early signs of colchicine overdose, which can be serious or life -threatening.

Muscle problems Muscle pain, tenderness or weakness, especially if you also feel unwell, have a fever, or notice dark or reddish -brown urine. These may be signs of rhabdomyolysis (a serious breakdown of muscle that can lead to kidney damage).

Muscle pain, tenderness or weakness – Rare (may affect up to 1 in 1,000 people) Rhabdomyolysis – Not known (frequency cannot be estimated from available data) Blood disorders Symptoms such as unusual bruising or bleeding, frequent infections with fever, sore throat or mouth ulcers, unusual tiredness, pale skin or shortness of breath. These may be signs of serious blood problems such as low levels of blood cells (including leukopenia, neutropenia, thrombocytopenia , pancytopenia or other bone -marrow disorders).

Not known (frequency cannot be estimated from available data

26 Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Very common (may affect more than 1 in 10 people)

• diarrhoea
• feeling sick (nausea)

Common (may affect up to 1 in 10 people)

• being sick (vomiting)
• abdominal pain or discomfort

Uncommon (may affect up to 1 in 100 people)

• lung infection (pneumonia)
• increased liver enzymes (transaminases)
• bleeding inside the skull (intracranial haemorrhage)

Rare (may affect up to 1 in 1,000 people)

• muscle pain (myalgia)

Not known (frequency cannot be estimated from the available data)

• muscle disease (myopathy)
• severe muscle damage (rhabdomyolysis)
• low levels of blood cells (including neutropenia, leukopenia, thrombocytopenia , pancytopenia )
• bone marrow depression (reduced production of blood cells)

Reporting of side effects

If you get 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 via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information about the safety of this medicine.

🌡️ 5. How to store Colchicine AGEPHA Pharma

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.

The expiry date refers to the last day of that month.

• This medicinal product does not require any special temperature storage conditions.
• Store in the original packag e in order to protect from light.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Colchicine AGEPHA Pharma contains

• The active substance is colchicine. Each tablet contains 0.5 mg of colchicine.
• The other excipients are gelatin, lactose monohydrate, magnesium stearate, potato starch and talc.

What Colchicine AGEPHA Pharma looks like and contents of the pack

Colchicine AGEPHA Pharma tablets are w hite to slightly yel low, round, biconvex tablets, debossed with ‘L1’ on one side and plain on the other side ( approx. 6.0 mm diameter and approx. 3.1 mm thickness) packed in Alu/PVC blister pack (30 tablets).

Marketing Authorisation Holder and Manufacturer

AGEPHA P harma s.r.o.

27 Diaľničná cesta 5 903 01 Senec Slovak ia This leafl et was last revised in {MM/YYYY} —————————————————————————————————————- Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Colchicine AGEPHA Pharma (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/26/2048).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.