Arehin

1. What is Arechin and what is it used for

Arechin is an antimalarial medicine. The active substance of the medicine is chloroquine phosphate, which acts on the protozoa that cause malaria, such as Plasmodium vivax, P. malariae, P. ovale, and some strains of P. falciparum. The medicine also acts on the amoeba that causes amoebic dysentery (Entamoeba histolytica). The medicine has anti-inflammatory properties, although the mechanism is not fully understood.

Indications for use

• Malaria. Prevention and treatment of acute attacks, as well as maintenance treatment of malaria caused by Plasmodium vivax, Plasmodium malariae, Plasmodium ovale, and chloroquine-sensitive strains of Plasmodium falciparum.
• Amoebic dysentery and liver abscess caused by Entamoeba histolytica, usually in combination with amoebicidal agents that act in the intestinal lumen.
• Various forms of lupus erythematosus, systemic (SLE), chronic, and discoid (DLE) lupus erythematosus.
• Rheumatoid arthritis.

2. Important information before taking Arechin

When not to take Arechin:

• if the patient is allergic to chloroquine phosphate, 4-aminoquinoline derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has retinal or visual field changes caused by 4-aminoquinoline derivatives;
• if the patient is taking amiodarone (a medicine used to treat irregular heartbeat).

Warnings and precautions

Before starting treatment with Arechin, the patient should discuss it with their doctor. The patient should consult their doctor, even if the following warnings refer to past situations.
The patient should exercise caution when taking chloroquine in the following patient groups.

• Patients with retinal disorders (except for the treatment of acute malaria); during long-term use, a full ophthalmological examination should be performed every 3 months due to the risk of retinal damage (retinopathy). If abnormalities are found, treatment should be discontinued immediately.
• Patients with blood disorders; in patients treated with chloroquine for a long time, blood counts should be monitored. If disorders unrelated to the disease process occur, treatment should be discontinued.
• Patients with a deficiency of the enzyme glucose-6-phosphate dehydrogenase in the blood (chloroquine may damage red blood cells in these patients).
• Patients with severe gastrointestinal disorders.
• Patients with a history of epilepsy or taking antiepileptic drugs (chloroquine may cause seizures).
• Patients with psoriasis (a skin disease), porphyria, or myasthenia gravis (chloroquine may exacerbate the course of these diseases).

In all patients treated for a long time, neurological examinations should be performed every 3-6 months to detect muscle weakness early. If abnormalities are found, the medicine should be discontinued.
During long-term treatment, the patient should avoid sun exposure and UV radiation.
Chloroquine may cause a decrease in blood glucose levels. The patient should ask their doctor about symptoms related to low blood glucose levels. Glucose level monitoring may be necessary.
Chloroquine may cause heart rhythm disorders in some patients.
Patients with congenital or acquired QT interval prolongation (visible on an ECG) and with known risk factors, patients with heart rhythm disorders or a history of heart attack, patients with electrolyte imbalance (especially low potassium or magnesium levels), should exercise caution when taking chloroquine.
If the patient experiences palpitations or irregular heartbeat while taking chloroquine, they should discontinue treatment immediately and have an ECG performed and inform their doctor.
In patients treated with chloroquine, cardiomyopathy may occur, leading to heart failure, sometimes fatal. If symptoms of cardiomyopathy occur (irregular heartbeat, shortness of breath, swelling of the lower limbs, excessive fatigue, fainting), the patient should contact their doctor immediately.
The risk of heart problems may increase with increasing doses. Therefore, the patient should follow the dose recommended by their doctor.
In some patients treated with Arechin, mental health disorders may occur, such as irrational thoughts, hallucinations, disorientation, aggression, paranoia, depression, or suicidal thoughts, even in patients who have not had such problems before. If the patient or someone around them notices the occurrence of such side effects (see section 4), they should seek medical help immediately.

Children and adolescents

The medicine is not intended for use in children under 14 years of age.

Arechin and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Chloroquine should be used with caution in patients taking medicines that affect heart rhythm.
Chloroquine should not be taken with amiodarone (a medicine used to control heart rhythm).
Halofantrine should not be taken at the same time as chloroquine.
Chloroquine may increase the level of cyclosporine (a medicine used mainly after transplants) in the blood.
During antimalarial treatment, the patient should not be vaccinated against rabies, as this may reduce the effectiveness of the vaccine. Rabies vaccination should be performed before starting antimalarial treatment.
Taking penicillamine (a medicine used mainly for metal poisoning) with chloroquine may increase the level of penicillamine in the blood, increasing the risk of severe side effects related to the blood and/or kidneys and skin allergic reactions.
Chloroquine significantly reduces the level of praziquantel (an antiparasitic medicine) in the blood.
Antacids (aluminum, calcium, and magnesium salts) reduce the absorption of chloroquine. The patient should maintain a 2-hour interval between taking chloroquine and any of these medicines.
Cimetidine (a medicine used for stomach diseases) increases the level of chloroquine in the blood.
Taking chloroquine and hydroxychloroquine with amiodarone (a medicine used for heart rhythm disorders) is contraindicated due to the increased risk of heart rhythm disorders.
Hydroxychloroquine and probably chloroquine increase the level of digoxin (a medicine used for heart diseases) in the blood.
Chloroquine taken at the same time as mefloquine (a medicine used for malaria prevention) increases the risk of seizures.
Chloroquine may exacerbate the symptoms of myasthenia gravis (a chronic disease characterized by rapid muscle fatigue and weakness) and thus reduce the effect of neostigmine and pyridostigmine.

Arechin with food and drink

Tablets should be taken after meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
The medicine should not be used during pregnancy, unless the potential benefit to the mother outweighs the risk to the fetus.
Chloroquine passes into breast milk. In malaria prevention, the medicine can be used only if prescribed by a doctor.
The patient should not breastfeed during long-term use of high doses of chloroquine for rheumatic disease.

Using Arechin in patients with kidney and/or liver disorders

The medicine should be used with caution in patients with liver function disorders (especially in the course of acute alcoholic liver damage), in people with alcoholism, and in patients with kidney diseases. Chloroquine should not be used for malaria prevention in patients with end-stage renal failure.

Using Arechin in elderly patients

No special dosage is required for elderly patients.

Driving and using machines

Chloroquine may affect the ability to drive and use machines.
Therefore, the patient should exercise caution when performing tasks that require maintaining psycho-physical fitness.

3. How to take Arechin

This medicine should always be taken according to the doctor's recommendations. If the patient has any doubts, they should consult their doctor, pharmacist, or nurse.

Malaria Prophylactically

Orally, one week before traveling to an endemic area and during the stay in the endemic area, and for 4 weeks after returning - 1 time a week, 2 tablets (500 mg) on the same day of the week.
Therapeutically (malaria attack)
Plasmodium vivaxand Plasmodium ovaleinfection

• Day 1: first dose 4 tablets (1000 mg), after 6 hours 2 tablets (500 mg)
• Day 2: 2 tablets (500 mg)
• Day 3: 2 tablets (500 mg)

Plasmodium falciparumand Plasmodium malariaeinfection

• Day 1: first dose 4 tablets (1000 mg), after 6-8 hours 2 tablets (500 mg)
• Day 2: 2 tablets (500 mg),
• Day 3: 2 tablets (500 mg)

Amoebic dysentery and liver abscess

For 2 days, 2 times a day, 2 tablets (500 mg), i.e., 4 tablets (1000 mg) per day, then for 2 to 3 weeks, 2 times a day, 1 tablet (250 mg), i.e., 2 tablets (500 mg) per day.
If necessary, the dosage may be reduced or increased, and treatment may be repeated.

Lupus erythematosus

Initially, 1 tablet (250 mg) is taken 2 times a day for 1 to 2 weeks, and then the maintenance dose is usually 1 tablet (250 mg) per day.

Rheumatoid arthritis

The usual dose is 1 tablet (250 mg) per day.
To achieve improvement, the medicine should be taken for several weeks. To achieve maximum effect, several months of treatment are necessary. If there is no improvement after 6 months of treatment (i.e., reduction of joint swelling, improvement of mobility), the medicine should be discontinued.
After discontinuing the medicine, the disease may recur. In this case, it is recommended to resume treatment with chloroquine, if there are no ophthalmological contraindications.

Patients with kidney and/or liver disorders

In patients with kidney failure, the dosage of chloroquine is changed.
In malaria, in patients with creatinine clearance >50 ml/min and 10-50 ml/min, the dosage does not change.
If the creatinine clearance is >10 ml/min, the dose is reduced by 50%, i.e.,:

• Day 1: first dose 2 tablets (500 mg), after 6 hours 1 tablet (250 mg)
• Day 2: 1 tablet (250 mg)
• Day 3: 1 tablet (250 mg)

Using Arechin in children and adolescents

The medicine is intended for adults and adolescents over 14 years of age.
Tablets should not be divided.

Taking a higher dose of Arechin than recommended

If a higher dose of the medicine than recommended is taken, the patient should immediately consult a doctor or pharmacist.
Overdose of chloroquine is very dangerous and difficult to treat.
Symptoms of overdose include: nausea, vomiting, decreased blood pressure, increasing tinnitus, blurred and unclear vision, weakness, hemoglobinuria (excretion of free hemoglobin in the urine), oliguria, heart rhythm disorders leading to irregular heartbeat, sudden cardiac arrest, seizures, respiratory arrest, coma, acute allergic symptoms, which are characterized by swelling, redness, blistering, and blistering, as well as laryngeal edema, fever, shortness of breath.
Overdose of the medicine leading to circulatory failure, respiratory failure, and severe heart rhythm disorders may cause death.
After severe poisoning, the following may occur: widening of the QRS complex, bradycardia, nodal rhythm, QT interval prolongation, atrioventricular block, ventricular tachycardia, torsade de pointes, ventricular flutter.
After overdose, the patient should immediately consult a doctor, and the stomach should be completely emptied by inducing vomiting (only in conscious patients) or gastric lavage.
Symptomatic treatment is used.
Activated charcoal introduced into the stomach through a gastric tube (after gastric lavage and within 30 minutes of chloroquine administration) reduces the absorption of this medicine.
In cases of severe poisoning, intravenous infusions are used.

Missing a dose of Arechin

The patient should take the missed dose as soon as possible.
The patient should not take a double dose to make up for the missed dose.

Discontinuing Arechin

If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Arechin can cause side effects, although not everybody gets them.

The patient should immediately contact their doctor if they experience the following side effects: difficulty breathing, face, lip, tongue, throat swelling, itching rash, or hives.

Very common (may affect more than 1 in 10 people): insomnia.
Common (may affect up to 1 in 10 people): depression.
Rare (may affect up to 1 in 1000 people):

• cardiomyopathy (heart muscle disease), which can lead to death when chloroquine is used for a long time in high doses.
• liver function disorders, hepatitis, liver function test abnormalities.
• psychiatric disorders, such as anxiety, agitation, confusion, hallucinations, delirium.

Other side effects of the medicine, whose frequency is unknown (frequency cannot be determined from available data):

• abnormal heart rhythm and heart rhythm disorders that can be life-threatening.
• irregular heartbeat (changes in the electrocardiogram).
• blood pressure drops.
• anemia, changes in blood counts (agranulocytosis, decreased white blood cell count, thrombocytopenia, decreased granulocyte count), bone marrow suppression, hemolysis (red blood cell breakdown) in patients with glucose-6-phosphate dehydrogenase deficiency.
• depression or suicidal thoughts, anxiety, disorientation, aggression, paranoia, sleep disturbances, agitation, euphoria or excessive excitement, lack of concentration.
• seizures, epileptic seizures, mood changes and behavioral changes (psychosis, psychomotor agitation, mania), headaches.
• blurred vision, partial or complete loss of vision, accommodation disorders, double vision, changes in the retina (retinopathy) or cornea, visual field changes.
• nerve-type hearing loss, hearing loss in patients with pre-existing hearing damage, tinnitus.
• gastrointestinal and intestinal disorders, anorexia, nausea, vomiting, diarrhea, colic.
• graying, hair loss, itching, hives, rash, skin discoloration, mucous membrane discoloration, nail discoloration, skin allergic reactions, lichen planus-like changes, psoriasis exacerbation, erythema multiforme, severe skin reactions (Stevens-Johnson syndrome), toxic epidermal necrolysis.
• neuromyopathy and myopathy (muscle diseases, muscle weakness).
• hypersensitivity to light, allergic and anaphylactic reactions, including hives, angioedema.
• decreased blood glucose levels.

Some patients may experience other side effects not listed in this leaflet.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Arechin

The medicine should be stored in a place that is out of sight and reach of children.
The patient should not use Arechin after the expiry date stated on the packaging.
Store at a temperature below 25°C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Arechin contains

• The active substance of the medicine is chloroquine phosphate
• One tablet contains 250 mg of chloroquine phosphate
• Other ingredients are: potato starch, gelatin, magnesium stearate, colloidal silica anhydrous.

What Arechin looks like and what the packaging contains

The tablet is white or almost white, round, flat on both sides, with a "-" sign embossed on one side.
Each packaging contains 30 tablets.
Tablets are packaged in a glass vial with a leaflet or in PVC/Al blisters containing 10 tablets, placed in a cardboard box with a patient leaflet.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last update of the leaflet: