Colchicine rph

Patient Information Leaflet

Colchicine RPH, 500 micrograms, tablets
Colchicinum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Colchicine RPH is and what it is used for
2. Important information before taking Colchicine RPH
3. How to take Colchicine RPH
4. Possible side effects
5. How to store Colchicine RPH
6. Contents of the pack and other information

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

Colchicine RPH contains the active substance colchicine. It belongs to a group of medicines used in the treatment of gout.

Acute gout attacks in adults
In gout, crystals of uric acid – a by-product of metabolism – deposit in the joints, causing pain and inflammation.
Colchicine RPH is used in adults for the short-term treatment of acute gout attacks and for the prevention of recurrent gout attacks.
Colchicine RPH is also used to prevent acute gout attacks in patients who have recently started treatment with other medicines such as allopurinol and probenecid.

Familial Mediterranean fever in children and adolescents
Familial Mediterranean fever is an inherited disease causing joint pain and swelling, as well as inflammation of internal organs.
In children (from the age of 4 years) and adolescents, Colchicine RPH is used in the treatment of familial Mediterranean fever to alleviate symptoms during disease flares and to prevent the pathological deposition of proteins in tissues and internal organs, such as the kidneys, which may lead to kidney failure.

2. Information before using Colchicine RPH

When not to use Colchicine RPH:

• If the patient is allergic to colchicine or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe blood disease.
• If the patient has severe kidney disease.
• If the patient has severe liver disease.
• If the patient has kidney or liver disease and is taking any of the following medicines:
  • clarithromycin or telithromycin (medicines used to treat infections);
• ritonavir, atazanavir, or indinavir (antiviral medicines used in the treatment of HIV infection);
• cyclosporine (used to suppress the body's immune system);
• ketoconazole or itraconazole (medicines used to treat fungal infections);
• verapamil and quinidine (heart medicines).

Warnings and precautions
Before starting treatment with Colchicine RPH, discuss this with your doctor or pharmacist:

• If the patient has ever had liver or kidney disease.
• If the patient has ever had heart disease.
• If the patient has ever had gastrointestinal problems.
• If the patient is elderly (especially if aged 65 years or older) or is generally weakened.

Colchicine RPH may be harmful, so it is important that the patient does not take a higher dose than prescribed by the doctor.
If pain subsides, the medicine should be discontinued.
Colchicine RPH has a narrow therapeutic index, meaning there is a very small difference between the effective dose and the dose causing adverse effects. Therefore, if the patient experiences symptoms such as nausea, vomiting, abdominal pain, or diarrhoea, the use of Colchicine RPH must be stopped immediately and the patient should contact their doctor without delay (see section 4 "Possible side effects").
Colchicine RPH may cause severe bone marrow dysfunction leading to a reduction in certain white blood cells (agranulocytosis), a reduction in red blood cells and the pigment within them (aplastic anaemia), and/or a reduction in platelets (thrombocytopenia). The patient should have regular blood tests to monitor for any abnormalities.
If the patient develops symptoms such as fever, mouth mucosal inflammation, sore throat, prolonged bleeding, increased tendency to bruise, or skin problems, the use of this medicine must be stopped and the patient should contact their doctor immediately. These may be symptoms of a serious blood disorder, and the doctor may wish to perform blood tests immediately (see section 4 "Possible side effects").
If the patient needs to undergo blood or urine tests, they must inform the doctor about the use of Colchicine RPH, as this medicine may affect test results—for example, it may lead to false-positive results in urine tests for red blood cells or haemoglobin levels. Colchicine RPH may impair the absorption from the stomach and intestines of fats, sodium, potassium, nitrogen, xylose, and other sugars.
The risk of adverse effects with Colchicine RPH may be increased by certain medicines. It is therefore important to read the sections titled "When not to take Colchicine RPH" and "Colchicine RPH and other medicines".
If the patient sees another doctor or is admitted to hospital, they must remember to inform medical staff about all medicines currently being taken.

Colchicine RPH and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including any medicines the patient plans to take. Taking other medicines during treatment with Colchicine RPH may affect the action of this medicine or the action of other concomitantly used medicines.
When Colchicine RPH is taken together with any of the following medicines, the likelihood of adverse effects caused by colchicine toxicity increases. These effects may be serious and life-threatening. Inform your doctor or pharmacist if the patient is taking:

• certain antibiotics such as erythromycin, clarithromycin, or telithromycin (medicines used to treat infections);
• antiviral medicines such as ritonavir, atazanavir, amprenavir, saquinavir, nelfinavir, fosamprenavir, and indinavir (medicines used in the treatment of HIV infection);
• cyclosporine (a medicine used to prevent organ transplant rejection and in the treatment of psoriasis and rheumatoid arthritis);
• certain heart medicines such as verapamil, quinidine, and diltiazem;
• antifungal medicines such as itraconazole, ketoconazole, and fluconazole (medicines used to treat fungal infections).

If the patient is taking any of the above-mentioned medicines, the doctor may decide to adjust the dose of Colchicine RPH or temporarily discontinue treatment. If the patient has liver or kidney disease and is taking any of the above-mentioned medicines, they may not be able to take Colchicine RPH at all.
If the patient is taking any of the following medicines, they should also inform their doctor or pharmacist:

• so-called sympathomimetic medicines (medicines used to treat asthma and nasal congestion), as Colchicine RPH may intensify their effects;
• medicines that depress the nervous system (some medicines used to treat anxiety and sleep disorders), as Colchicine RPH may increase the patient's sensitivity to these medicines;
• medicines belonging to statins and fibrates (used to lower cholesterol levels), as this may increase the risk of certain adverse effects;
• aprepitant or nefazodone, as they may increase the risk of colchicine-induced toxic effects;
• vitamin B12 for anaemia, as Colchicine RPH may impair the absorption of vitamin B12.

Colchicine RPH with food and drink
Grapefruit juice may increase the blood concentration of colchicine, exposing the patient to a risk of severe adverse effects. Grapefruit juice must not be consumed during treatment with Colchicine RPH.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using 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 Colchicine RPH for gout. If pregnancy occurs during this period, consult a doctor about the risk of fetal harm.

Pregnancy
Treatment of gout:
Colchicine RPH must not be used if the patient is pregnant or may become pregnant. If pregnancy occurs during treatment with Colchicine RPH or within 3 months after treatment ends, consult a doctor about the risk of fetal harm.
FMF treatment:
Since untreated FMF progression may negatively affect pregnancy, the use of Colchicine RPH during pregnancy should be considered in relation to the potential risk, and treatment may be considered if there is a clinical need.

Breastfeeding
The active substance colchicine passes into breast milk.
Colchicine RPH for gout must not be used in breastfeeding women.
In breastfeeding women with FMF, a decision must be made whether to discontinue or suspend breastfeeding or to discontinue or suspend colchicine therapy, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the woman.

Fertility
Treatment of gout:
Male patients should not father a child during treatment and for at least 6 months after stopping colchicine treatment. If pregnancy occurs during this time, consult a doctor about the risk of fetal harm.
FMF treatment:
Since untreated FMF progression may lead to infertility, the use of Colchicine RPH should be considered in relation to the potential risk, and treatment may be considered if there is a clinical need.

Driving and using machines
Colchicine RPH is unlikely to affect the ability to drive or operate machinery.

Colchicine RPH contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Colchicine RPH

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Your doctor will inform you how many tablets to take and for how long.
The active substance in this medicine, colchicine, may be highly toxic, therefore it is important
not to exceed the dose prescribed by your doctor.
Tablets should be swallowed whole with a glass of water.

Acute gout in adults
Treatment of an acute gout attack:
The recommended initial dose is 2 tablets, followed by 1 tablet one hour later. No further tablets should
be taken for the next 12 hours. If symptoms persist after this time, treatment with Colchine RPH may be
resumed, maintaining a maximum dose of 1 tablet three times daily until symptoms subside.
Treatment should be stopped when symptoms have resolved or when the total number of tablets taken
during the treatment course reaches 12. Do not take more than 12 tablets in total during a single
treatment cycle.
Do not start another treatment cycle with Colchicine RPH (or any other medicine containing colchicine)
unless at least three days have passed since the end of the previous cycle.

Dose for prevention of gout attacks when treatment has been initiated with other medicines:
The recommended dose is 1 tablet twice daily.
Your doctor will inform you how long to continue taking Colchicine RPH.

Elderly patients
Colchicine RPH will be prescribed with caution, and the patient's condition will be closely monitored by
the doctor.

Patients with kidney or liver disease
Your doctor may reduce the dose of Colchicine RPH or extend the interval between doses, and you should
be closely observed for adverse effects.

Familial Mediterranean fever in children and adolescents
Colchicine RPH is recommended for patients under the supervision of a specialist doctor with sufficient
knowledge of familial Mediterranean fever. The dose depends on the patient's age, and the recommended
initial doses are:

• for children under 5 years of age: 1 tablet once daily,
• for children aged 5 to 10 years: 2 tablets daily,
• for children over 10 years of age and adolescents: 3 tablets daily.

The dose of Colchicine RPH should be gradually increased up to a maximum of 4 tablets daily. Your doctor
will advise you how to do this. Each time the dose is increased, the patient should be closely monitored
for adverse effects.
Starting from a dose of 2 tablets daily, the medicine may be given as a single dose or divided into two
doses taken twice daily; your child's doctor will provide appropriate information on this.

If you take more Colchicine RPH than you should
If you take more Colchicine RPH than recommended, or if, for example, a child accidentally swallows
the medicine, you should contact your doctor or the emergency department of the nearest hospital
immediately. Take this leaflet and any unused medicine with you.
In case of overdose, Colchicine RPH may be highly toxic and even fatal. Early signs of overdose (which
typically appear about 3 hours after ingestion, although they may occur later) may include nausea,
vomiting, abdominal pain, bloody diarrhoea, and hypotension.

If you forget to take Colchicine RPH
If you miss a dose of Colchicine RPH, take it as soon as possible. Do not take a double dose to make up
for a missed dose. Do not take tablets more frequently than prescribed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the adverse reactions listed below, treatment with Colchicine RPH must be discontinued and immediate medical advice must be sought from a doctor or the nearest hospital emergency department:

• Nausea, vomiting, stomach cramps, abdominal pain and diarrhoea (see section 2 Warnings and precautions for use). These adverse reactions are common (occurring in no more than 1 in 10 people).
• Symptoms such as fever, inflammation of the mucous membrane of the mouth, sore throat, prolonged bleeding, increased tendency to bruising or skin disorders. These may be symptoms of a severe blood disorder caused by suppression of bone marrow function (see section 2 Warnings and precautions for use). These adverse reactions are rare (occurring in no more than 1 in 1000 people).
• Muscle pain, muscle cramps or muscle weakness without an obvious cause. These adverse reactions are uncommon (occurring in no more than 1 in 100 people).

Other possible adverse reactions:
Common (may affect up to 1 in 10 people):

• Nausea, vomiting, diarrhoea, stomach cramps, abdominal pain.

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

• Decrease in white blood cell count
• Hair loss
• Myopathy; muscle stiffness, muscle weakness, muscle pain.

Rare (may affect up to 1 in 1000 people):

• Increased platelet count
• Nosebleeds
• Urticaria; skin rash consisting of flat red areas covered with small merging lumps, red or purple discolouration of the skin, redness of the skin or mucous membranes, swelling.

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

• Nerve damage.

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

• Liver damage.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can also be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Colchicine RPH

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the outer carton and bottle following the abbreviation EXP. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Colchicine RPH contains

• The active substance is colchicine. Each tablet contains 500 micrograms of colchicine.
• The other ingredients are: lactose monohydrate, maize starch, magnesium stearate.

What Colchicine RPH looks like and contents of the pack
Colchicine RPH tablets are white or yellowish, biconvex, uncoated tablets (5.5 mm in diameter),
with the imprint "Evans 126" on one side and smooth on the other.
The tablets are available in packs (polypropylene (PP) bottles) with HDPE closures that are child-resistant and provide tamper evidence, contained in a cardboard box with 20, 28, 30, 50, 60, 100 or 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
RPH Pharmaceuticals AB
Box 603
101 32 Stockholm
Sweden

Manufacturer/Importer
Recipharm Leganés S.L.U.
Calle Severo Ochoa 13,
28914 Leganés
Spain

This medicinal product is authorised in the European Economic Area under the following names:
Sweden: Colchimex 500 microgram tablets
Iceland: Colchimex 500 microgram tablets
Denmark: Colchimex 500 microgram tablets