500 micrograms of colchicine tablets 

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Colchimex is and what it is used for 
2. What you need to know before taking Colchimex 
3. How to take Colchimex 
4. Possible side effects 
5. How to store Colchimex 
6. Contents of the packaging and other information 

1. What Colchimex is and what it is used for

Colchimex contains the active substance colchicine and belongs to a group of medicines called gout medicines.

Gout attacks in adults

In gout, crystals of uric acid precipitate in the joints, causing pain and inflammation. Uric acid is one of the body’s waste products.

Colchimex is used in adults for short-term treatment of acute gout, so-called gout attacks, and to prevent recurrent gout.

Colchimex is also used to prevent acute gout attacks when starting treatment with other medicines, such as allopurinol and probenecid.

Familial Mediterranean fever in children and adolescents

Familial Mediterranean fever is a hereditary disease that causes pain and swelling in the joints and organs of the body.

In children (4 years and older) and adolescents, Colchimex is used to treat familial Mediterranean fever for relief during attacks and to prevent the accumulation of protein in tissues and organs, such as the kidneys, which can cause kidney failure.

Colchicine contained in Colchimex may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Colchimex

Do not take Colchimex:

  • if you are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6).
  • if you have a serious blood disorder
  • if you have severe kidney problems
  • if you have severe liver problems
  • if you have kidney or liver problems and are taking any of the following medicines:
    • clarithromycin or telithromycin (used to treat infections)
    • ritonavir, atazanavir, or indinavir (antiviral agents used to treat HIV infection )
    • cyclosporine (used to inhibit the body’s immune system)
    • ketoconazole or itraconazole (used to treat fungal infections)
    • verapamil or quinidine (heart medicine).

Women of childbearing potential should not use Colchimex without the use of an effective contraceptive during and up to 12 weeks after treatment. Consult a doctor.

Warnings and cautions

Talk to your doctor or pharmacist before taking Colchimex:

  • if you have ever had liver or kidney problems
  • if you have ever had heart problems
  • if you have ever had problems with your digestive system
  • if you are older (especially older than 65 years) or debilitated. 

Colchimex can be toxic, so it is important that you do not exceed the dose prescribed by your doctor.

End the treatment as soon as the gout pain has stopped

Colchimex has a so-called narrow therapeutic window, which means that the difference between an effective dose and a dose that causes serious side effects is small. Therefore, you should stop taking Colchimex and contact a doctor immediately if you experience symptoms such as nausea, vomiting, abdominal pain, and diarrhea (see also section 4, Possible side effects ).

Colchimex may cause severe deterioration of bone marrow function leading to a decrease in certain white blood cells ( agranulocytosis ), a decrease in the number of red blood cells and pigments ( aplastic anemia ), and/or a low platelet count ( thrombocytopenia ). You need to have regular blood tests to monitor for any changes.

If you experience symptoms such as fever, inflammation of the mouth, sore throat, prolonged bleeding, bruising, or skin problems, stop taking this medicine and contact a doctor immediately. This may be a sign that you have a serious problem with your blood and your doctor may prescribe immediate blood tests (see also section 4, Possible side effects ).

If you need to take blood or urine samples, you must tell your doctor that you are taking Colchimex as the tablets may affect the results, such as false-positive urine test results for red blood cell count or hemoglobin. Colchimex can reduce the uptake of fat, sodium, potassium, nitrogen, xylose, and even sugars from the stomach and intestines.

Other medicines may increase the risk of side effects from Colchimex. It is therefore important to read the sections “Do not take Colchimex” and “Other medicines and Colchimex”.

If you see another doctor or go to a hospital, remember to tell them which medicines you are already taking.

Other medicines and Colchimex

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Taking other medicines during treatment with Colchimex may affect the effect of Colchimex or the other medicine.

Taking Colchimex with any of the following medicines increases the likelihood of side effects caused by colchicine toxicity and these can be serious and life-threatening. Talk to your doctor/pharmacist if you are taking:

  • certain antibiotics, such as erythromycin, clarithromycin, and telithromycin (used to treat infections).
  • drugs for infection, such as ritonavir, atazanavir, amprenavir, saquinavir, nelfinavir, fosamprenavir, and indinavir (used to treat HIV infection ).
  • ciclosporin (a medicine used to counteract organ rejection after transplantation or to treat psoriasis and rheumatoid arthritis ).
  • certain medicines for the heart, such as verapamil, quinidine, and diltiazem.
  • antifungals, such as itraconazole, ketoconazole, and fluconazole (used to treat fungal infections).

If you are being treated with any of the above medicines, your doctor may adjust your dose of Colchimex or temporarily stop your treatment with Colchimex. If you suffer from liver or kidney problems and are being treated with any of the above medicines, you may not be able to take Colchimex.

It is also important to tell your doctor or pharmacist if you are taking any of the following:

  • so-called sympathomimetics (medicines used to treat asthma or nasal congestion), as Colchimex may potentiate the effects of these medicines.
  • medicines that inhibit the nervous system (some medicines used to treat anxiety and sleep disorders), as Colchimex may increase the sensitivity of these medicines.
  • Drugs called statins and fibrates (used to lower cholesterol ), because you may be at higher risk for certain side effects.
  • aprepitant or nefazodone, as these may increase the risk of toxic effects caused by colchicine.
  • vitamin B12 for anemia. Colchimex can prevent the absorption of vitamin B12.

Colchimex with food and drink

Grapefruit juice can increase the amount of colchicine in the blood and thereby increase the risk of serious side effects. Therefore, you should not drink grapefruit juice during treatment with Colchimex.

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.

Women of childbearing potential

Treatment of gout:

Women of childbearing potential must use effective contraception during treatment and for at least 3 months after stopping treatment with Colchimex for gout. If pregnancy should still occur during this period, you must talk to a doctor about the risk of birth defects.

Pregnancy

Treatment of gout:

You should not use Colchimex if you are or may become pregnant. If pregnancy should still occur during treatment with Colchimex or within 3 months after stopping treatment, you must talk to a doctor about the risk of birth defects.

Treatment of FMF:

As the course of FMF without treatment may also have a negative impact on pregnancy, the use of Colchimex during pregnancy should be weighed against the potential risks and treatment may be considered if there is a clinical need.

Breast-feeding

The active substance colchicine passes into breast milk.

Colchimex should not be used in breastfeeding women for gout.

In breastfeeding mothers with FMF, a decision must be made whether to discontinue/refrain from breast-feeding or to discontinue/refrain from treatment with colchicine after taking into account the benefit of breastfeeding for the child and the benefit of treatment for the woman.

Fertility

Treatment of gout:

Male patients should have children during treatment and for at least 6 months after stopping colchicine treatment. If pregnancy should still occur during this time, you must talk to a doctor about the risk of birth defects.

Treatment of FMF:

As the course of FMF without treatment may also lead to infertility, the use of Colchimex should be weighed against the potential risks and treatment may be considered if there is a clinical need.

Driving and using machines

Colchimex has no or negligible effect on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Colchimex contains lactose

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

3. How to take Colchimex

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will tell you how many tablets to take and how long to take them.

The active substance colchicine can be very toxic, so it is important that you do not exceed the dose prescribed by your doctor.

Swallow the tablet whole with a glass of water.

Gout in adults

Treatment of acute gout ( gout attack):

The recommended dose is 2 tablets as a starting dose, followed by 1 tablet after one hour. No more tablets should then be taken in 12 hours. If necessary, treatment with Colchimex can then be resumed with a maximum dose of 1 tablet three times daily until the symptoms have ceased.

The treatment should be stopped when the symptoms have eased or after taking a total of 12 tablets. You should not take more than 12 tablets during one treatment.

After stopping treatment with Colchimex (or any other medicine containing colchicine), do not start a new treatment until three days at the earliest.

Dose to prevent gout attack when treatment with another drug is started:

The recommended dose is 1 tablet twice daily.

Your doctor will inform you how long Colchimex treatment should last.

Older

Colchimex will be prescribed with caution and you will be closely monitored by your doctor.

If you have kidney or liver problems

Your doctor may reduce your dose of Colchimex or prolong the interval between doses and you should be closely monitored for side effects.

Familial Mediterranean fever in children and adolescents

Colchimex is prescribed under the supervision of a specialist who has the required knowledge of familial Mediterranean fever. Dose one is based on age and the recommended starting dose is:

  • Children under 5 years: 1 tablet once daily
  • Children from 5 to 10 years: 2 tablets daily
  • Children over 10 years and adolescents: 3 tablets daily

The dose of Colchimex should be increased step by step up to a maximum of 4 tablets per day. Your doctor will inform you on how to proceed. All dose increases should be closely monitored for adverse reactions.

Doses of 2 tablets per day can be given as a single dose or divided into two doses daily. Your child’s doctor will inform you about this.

If you take more Colchimex then you should

Colchimex is in the high dose to be highly toxic and even fatal. Early symptoms of overdose (which on average occur after 3 hours, but which may occur later) may include nausea, vomiting, abdominal pain, bloody diarrhea, and low blood pressure.

If you forget to take Colchimex

If you forget to take a dose of Colchimex, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. Do not take the tablets at shorter intervals than prescribed by your doctor.

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.

Stop taking Colchimex and contact your doctor or nearest emergency department immediately if you experience any of the following side effects:

  • Nausea, vomiting, abdominal cramps, abdominal pain, and diarrhea (see also section 2, Warnings and precautions). These are common side effects (may affect up to 1 in 10 people).
  • Symptoms such as fever, inflammation of the mouth, sore throat, prolonged bleeding, bruising, or skin problems. These may be signs that you have a serious problem with your blood caused by bone marrow depression (see also section 2, Warnings and Precautions). These have the frequency of rare side effects (may affect up to 1 in 1,000 people).
  • Unexplained muscle pain, muscle cramps, or muscle weakness. These have the frequency of less common side effects (may affect up to 1 in 100 people).

Other side effects that may occur:

Common (may affect up to 1 in 10 people):

  • Nausea, vomiting, diarrhea, abdominal cramps, and abdominal pain

Uncommon (may affect up to 1 in 100 people):

  • Decreased white blood cell count
  • Hair loss
  • Myopathy; muscle stiffness, muscle weakness, muscle pain

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

  • High platelet count
  • Nasal bleeding
  • Hives; rash with a smooth, red area on the skin covered with small confluent nodules, red or purple discolorations in the skin, redness of the skin or mucous membrane, swelling ( edema )
  • Impaired ability to produce sperm (low sperm count) 

Very rare (may affect up to 1 in 10,000 people):

  • Nerve damage 

Unknown: frequency cannot be determined from available data.

  • Liver damage

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Colchimex

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

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton and jar after EXP. The expiration date is the last day of the specified 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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is colchicine. 1 tablet contains 500 micrograms of colchicine.
  • The other ingredients are lactose monohydrate, corn starch, and magnesium stearate. 

What the medicine looks like and the contents of the pack

Colchimex tablets are white or slightly yellow, biconvex uncoated tablets (5.5 mm in diameter) with Evans 126 embossed on one side and smooth on the other side.

Child-resistant, safety-sealed packaging (plastic jars) containing 20, 28, 30, 50, 60, 100 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

RPH Pharmaceuticals AB

Lagervägen 7,

136 50 Jordbro

Manufacturer

Recipharm Limited

Vale of Bardsley

Ashton-Under-Lyne

OL7 9RR

UK

Local representative

Astimex Pharma AB

Isafjordsgatan 36

164 40 Kista

Tel. 08-5151 1535

info@astimex.se

Muhammad Nadeem

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