Colhicine Rph

Package Leaflet: Information for the Patient

Colchicine RPH, 500 micrograms, tablets

Colchicine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 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 to treat gout.

Gout attacks in adults

In gout, uric acid crystals accumulate in the joints, causing pain and inflammation. Colchicine RPH is used in adults for the short-term treatment of acute gout attacks and to prevent recurrent attacks. Colchicine RPH is also used to prevent acute gout attacks in people who have started 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 internal organs. In children (from 4 years of age) and adolescents, Colchicine RPH is used to treat Familial Mediterranean Fever to alleviate symptoms during attacks and to prevent the accumulation of pathological proteins in tissues and internal organs, such as the kidneys, which can lead to kidney failure.

2. Important information before taking Colchicine RPH

When not to take Colchicine RPH:

• If you are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6).
• If you have severe blood disease.
• If you have severe kidney disease.
• If you have severe liver disease.
• If you have kidney or liver disease and are taking any of the following medicines:
• clarithromycin or telithromycin (antibiotics used to treat infections);
• ritonavir, atazanavir, or indinavir (antiviral medicines used to treat HIV infection);
• cyclosporin (used to suppress the immune system);
• ketoconazole or itraconazole (antifungal medicines);
• verapamil and quinidine (heart medicines).

Warnings and precautions

Before taking Colchicine RPH, discuss with your doctor or pharmacist:

• If you have ever had liver or kidney disease.
• If you have ever had heart disease.
• If you have ever had gastrointestinal problems.
• If you are elderly (especially if you are over 65 years old) or weakened.

Colchicine RPH can be harmful, so it is essential that you do not take more than the prescribed dose. If the pain goes away, stop taking the medicine. Colchicine RPH has a narrow therapeutic index, which means that the difference between the effective dose and the dose that causes side effects is very small. If you experience symptoms such as nausea (vomiting), vomiting, abdominal pain, and diarrhea, stop taking Colchicine RPH and contact your doctor immediately (see section 4 "Possible side effects"). Colchicine RPH can cause severe bone marrow disorders leading to a decrease in the number of certain white blood cells (agranulocytosis), a decrease in the number of red blood cells and the substance that fills them (aplastic anemia), and (or) a decrease in the number of platelets (thrombocytopenia). You should have regular blood tests to monitor for any abnormalities. If you experience symptoms such as fever, oral mucositis, sore throat, prolonged bleeding, increased bruising, or skin problems, stop taking the medicine and contact your doctor immediately. These may be symptoms of a severe blood disorder, and your doctor may want to perform blood tests immediately (see section 4 "Possible side effects"). If you need to have a blood or urine test, tell your doctor that you are taking Colchicine RPH, as it may affect the results of these tests, for example, by causing false-positive results for red blood cell count or hemoglobin in urine. Colchicine RPH may interfere with the absorption of fats, sodium, potassium, nitrogen, xylose, and other sugars from the stomach and intestines. The risk of side effects from Colchicine RPH may be increased by certain medicines. It is essential to read the sections entitled "When not to take Colchicine RPH" and "Colchicine RPH with other medicines". If you are taking any of the medicines listed above and have kidney or liver disease, you may not be able to take Colchicine RPH. If you are taking any of the medicines listed below, you should also inform your doctor or pharmacist:

• so-called sympathomimetic medicines (used to treat asthma and nasal congestion), as Colchicine RPH may enhance their effects;
• medicines that suppress the nervous system (some medicines used to treat anxiety disorders and sleep problems), as Colchicine RPH may increase your sensitivity to these medicines;
• statins and fibrates (used to lower cholesterol levels), as this may increase the risk of certain side effects;
• aprepitant or nefazodone, as they may increase the risk of toxic effects from colchicine;
• vitamin B12 due to anemia, as Colchicine RPH may prevent the absorption of vitamin B12.

Colchicine RPH with food and drink

Grapefruit juice may increase the levels of colchicine in the blood, putting you at risk of severe side effects. Do not drink grapefruit juice while taking Colchicine RPH.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 age

Treatment of gout: Women of childbearing age must use effective contraception during treatment with Colchicine RPH and for at least 3 months after stopping treatment for gout. If pregnancy occurs during this period, you should discuss with your doctor the risk of harm to the fetus.

Pregnancy

Treatment of gout: Do not take Colchicine RPH if you are pregnant or think you may be pregnant. If you become pregnant during treatment with Colchicine RPH or within 3 months of stopping treatment, you should discuss with your doctor the risk of harm to the fetus. Treatment of FMF: Since even the progression of untreated FMF can have a negative impact on pregnancy, the use of Colchicine RPH during pregnancy should be considered in relation to the potential risk, and treatment may be considered if clinically necessary.

Breastfeeding

The active substance colchicine passes into breast milk. Colchicine RPH should not be used in breastfeeding women. In the case of breastfeeding women with FMF, a decision should be made to either stop breastfeeding or stop/discontinue colchicine therapy, taking into account the benefit of breastfeeding to the child and the benefit of treatment to the woman.

Fertility

Treatment of gout: Male patients should not father a child during treatment with colchicine and for at least 6 months after stopping treatment. If pregnancy occurs during this period, you should discuss with your doctor the risk of harm to the fetus. Treatment of FMF: Since even the progression of untreated FMF can lead to infertility, the use of Colchicine RPH should be considered in relation to the potential risk, and treatment may be considered if clinically necessary.

Driving and using machines

Colchicine RPH is unlikely to affect your ability to drive or use machines.

Colchicine RPH 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 Colchicine RPH

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will tell you how many tablets to take and for how long. The active substance of this medicine, colchicine, can be very toxic, so it is essential that you do not exceed the dose prescribed by your doctor. Swallow the tablets whole with a glass of water.

Gout in adults

Treatment of acute gout attack: The recommended initial dose is 2 tablets, followed by 1 tablet after 1 hour. Do not take any more tablets for the next 12 hours. If necessary, treatment with Colchicine RPH can be resumed, with a maximum dose of 1 tablet three times a day until symptoms resolve. Treatment should be stopped when symptoms resolve or when a total of 12 tablets have been taken. Do not take more than 12 tablets in a single treatment course. Do not start a new course of treatment with Colchicine RPH (or any other colchicine-containing medicine) until at least 3 days have passed since the end of the previous course.

Dose used to prevent gout attacks, if treatment is started with other medicines:

The recommended dose is 1 tablet twice a day. Your doctor will tell you how long to take Colchicine RPH. Elderly patientsColchicine RPH will be prescribed with caution, and the patient's condition will be closely monitored by the doctor. If you have kidney or liver diseaseYour doctor may reduce the dose of Colchicine RPH or increase the time between doses, and you will be closely monitored for side 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 a day,
• for children between 5 and 10 years of age, 2 tablets a day,
• for children over 10 years of age and adolescents, 3 tablets a day.

The dose of Colchicine RPH should be increased gradually to a maximum of 4 tablets a day. Your doctor will tell you how to do this. Each time the dose is increased, the patient's condition should be closely monitored for side effects. From a dose of 2 tablets a day, the medicine can be given as a single dose or divided into two doses and given twice a day; the child's doctor will provide information on this.

If you take more Colchicine RPH than you should

If you take more Colchicine RPH than you should or if, for example, a child accidentally swallows the medicine, contact a doctor or the emergency department of your nearest hospital immediately. Take this leaflet and any remaining Colchicine RPH with you. If you take too much Colchicine RPH, it can be very toxic, even life-threatening. Early symptoms of overdose (which usually occur within 3 hours, but may occur later) may include nausea, vomiting, abdominal pain, bloody diarrhea, and a drop in blood pressure.

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 forgotten dose. Do not take tablets at shorter intervals than prescribed by your doctor. 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.

If you experience any of the following side effects, stop taking Colchicine RPH and contact your doctor or the emergency department of your nearest hospital immediately:

• Nausea (vomiting), vomiting, stomach cramps, abdominal pain, and diarrhea (see section 2 "Warnings and precautions"). These side effects are common (affecting up to 1 in 10 people).
• Symptoms such as fever, oral mucositis, sore throat, prolonged bleeding, increased bruising, or skin problems. These may be symptoms of a severe blood disorder (see section 2 "Warnings and precautions"). These side effects are rare (affecting up to 1 in 1,000 people).
• Muscle pain, muscle cramps, or muscle weakness without apparent cause. These side effects are uncommon (affecting up to 1 in 100 people).

Other side effects that may occur:
Common(affecting up to 1 in 10 people):

• Nausea (vomiting), vomiting, diarrhea, stomach cramps, abdominal pain.

Uncommon(affecting up to 1 in 100 people):

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

Rare(affecting up to 1 in 1,000 people):

• Increased platelet count
• -Nosebleeds
• Hives; rash with flat, red patches on the skin covered with small, merging bumps, red or purple discoloration of the skin, redness of the skin or mucous membranes, swelling
• Impaired sperm production (low sperm count in semen).

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

• Nerve damage.

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

• Liver damage.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Colchicine RPH

Keep this medicine out of the sight and reach of children. Store in a temperature below 25°C. 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. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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, cornstarch, magnesium stearate.

What Colchicine RPH looks like and contents of the pack

Colchicine RPH tablets are white or yellowish, biconvex, uncoated tablets (with a diameter of 5.5 mm) with the inscription Evans 126 on one side and smooth on the other. The tablets are available in packs (polypropylene (PP) bottles with HDPE child-resistant closure) containing 20, 28, 30, 50, 60, 100, and 120 tablets in a cardboard box. 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 Member States of the European Economic Area under the following names:

Sweden: Colchimex 500 microgram tabletter
Iceland: Colchimex 500 mikrógramm tabletter
Denmark: Colchimex 500 mikrogram tabletter

Date of last revision of the leaflet: