RESOCHIN 250 mg. 100 tablets
Prevention and treatment of malaria caused by four species of malarial agents, which are pathogenic to humans, with the exception of that caused by chloroquine-resistant strains. Extraintestinal amebiasis (form a parasitic disease) when nitroimidazolovite products are ineffective or may not be used.
Chronic polyarthritis (rheumatoid arthritis), including rheumatoid arthritis in children (juvenile). Systemic lupus erythematosus.
2. BEFORE YOU USE RESOCHIN
Do not use Rezohin
if you are allergic (hypersensitive) to chloroquine or any of the other ingredients of Rezohin;
if you are allergic (hypersensitive) to 4-Aminochinolines;
if you retinal damage (retinopathy) or damage to the visual field
if you suffer from disorders of hematopoiesis;
in patients with deficiency of the enzyme glucose-6-phosphate dehydrogenase (favizam; symptom: hemolytic anemia);
in patients with neurological disease myasthenia gravis;
in pregnant or lactating women (exceptions: malaria treatment and prevention).
Take special care with Rezohin
In order to check the presence of possible undesirable visual effects should be carried out a study of the eye before the onset of long-term treatment and be repeated at 3-month intervals during the course of treatment. At the first sign of retinopathy (loss of the ability to perceive red) treatment should be discontinued.
Blood counts should be checked before the start of continued treatment and then two-month intervals.
Epileptics treated with chloroquine require regular medical examinations.
Patients with impaired hepatic or renal function may further require dose adjustment.
Not recommended the use of chloroquine in patients with renal insufficiency with creatinine clearance less than 1U ml / miti, due to lack of data.
Chloroquine may prolong the QT-interval (the electrocardiogram).
Patients women who take chloroquine for long term prophylaxis of malaria must be sure to use adequate contraception methods during this treatment and be informed not to become pregnant three months after discontinuation of prophylactic treatment.
Rezohin should not be used in patients with psoriasis or porphyria (a metabolic disorder).
Rezohin should not be used in children for long term prophylaxis of malaria. Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Antacids and kaolin may reduce the absorption of chloroquine and recommended that these medicines be taken at least 4 hours after chloroquine.
It has been reported that chloroquine decreased immune response to the human diploid-cell anti-rabies vaccine (human diploid-cell rabies vaccine, HDCV). He found, however, adversely affects the immune response to other vaccines used for routine immunization (tetanus, diphtheria, measles, polio, typhoid and BCG). Center for Control and Prevention of Disease (Department of Health and Human Services, US) is currently recommended for the prevention of rabies HCDV be administered intramuscularly, to ensure sufficient efficacy.
Concomitant administration of phenylbutazone increases the likelihood of developing dermatitis (exfoliative).
Concurrent administration of probenecid increases the risk of sensitization.
Co-administration of corticosteroid derivatives can exacerbate existing diseases of the muscles and heart (myopathies and cardiomyopathies).
It is recommended that chloroquine should not be taken with substances with a degree of liver damage (such as isoniazid, amiodarone, carbamazepine, phenytoin, and fenotiazidi ketoconazole) or MAO inhibitors (such as phenelzine, tranylcypromine, isocarboxazid and selegiline).
Continuous co-administered with digoxin may lead to intoxication glycosides by increased plasma digoxin concentrations.
The effect of folic acid antagonists (methotrexate) was potentiated by chloroquine. Chloroquine is an antagonist to the action of neostigmine and pyridostigmine.
Concomitant use of cyclosporine can cause a sudden increase in plasma
concentrations of cyclosporine.
Chloroquine may reduce gastrointestinal absorption of ampicillin, it is therefore recommended
Ampicillin be taken at least 2 hours after chloroquine.
Cimetidine can reduce the release of chloroquine.
Concomitant use of mefloquine and bupropion may increase the risk of seizures.
Acute dystonic reaction was observed after concomitant administration of chloroquine and metronidazole.
Concomitant use of penicillamine can increase the potential for serious hematologic and / or renal adverse reactions associated with penicillamine, and skin reactions.
The combination of chloroquine and pyrimethamine / sulfadoksin significantly increases the risk of skin reactions.
Co acceptance of chloroquine and pratsikvantel may result in lower concentrations of pratsikvantel blood.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine. pregnancy
Data on adverse events following use of the drug during the first three months of pregnancy are very limited. The drug should be used during pregnancy only when absolutely illustrated. Benefit / risk must be taken into account when advising pregnant women, since the risk of malaria in pregnancy may exceed the damaging effects of chemotherapy.
Chloroquine crosses the placental barrier and can cause damage to organs of the fetus. Therefore chloroquine is contraindicated during pregnancy (except malaria). If there is a possibility of malaria, after assessment of the benefit / risk decision rule should be in favor of using chloroquine as malaria infection itself damaging the unborn child.
Before starting treatment with chloroquine should exclude pregnancy. This is true for all indications, except malaria. During treatment should be used effective contraception, which must last at least three months after treatment. In the prevention of malaria with chloroquine should be administered an effective form of contraception for the duration of the prophylaxis and three months thereafter.
2-4% of the dose chloroquine passes into breast milk. Although there are no known cases where infants were damaged by breast milk containing chloroquine, breast-feeding should be discontinued during treatment with this medication as a precaution.
Driving and using machines
Taking into account the side effects of chloroquine on the central nervous system (headache, dizziness, drowsiness, confusion) and vision (visual disturbances, damage to the retina) the ability to drive or operate machinery may be impaired. This applies especially to the start of treatment and during the treatment with alcohol and sedatives.
3. HOW TO USE RESOCHIN?
Always use Rezohin exactly as prescribed by your doctor. If you are not sure ask your doctor or pharmacist.
A) Prevention of malaria
310 mg of base (500 mg of salt) orally once a week
5 mg / kg (8,1 mg / kg salt) orally once per week up to a maximum dose of 310 mg base
Started 1-2 weeks before travel to malarial areas. It is each week on
same day while staying in malarial area and four weeks after leaving these areas.
According to the WHO guidelines of the cumulative total dose of 1 g base / kg body weight or 50-100 g total dose (base) is connected to the damage to the retina. The total cumulative dose should not exceed 50 g of chloroquine base.
If not prescribed otherwise, children receive oral doses corresponding to their body weight.
Duration of use
Prophylactic treatment should be continued at the same dose for a further 4-6 weeks after leaving the malarial area.
Then prevention should continue with a substance that does not contain chloroquine (drug of Rezohin).
Rezohin should not be applied for long term prophylaxis of malaria in children.
B) Treatment of Malaria
Unless otherwise prescribed, the total dose for the treatment of malaria caused by chloroquine-sensitive parasites is 25-30 mg chloroquine base / kg body weight. This dose should be administered orally, spread over a period of 3 - 4 days, in the early 10 mg chloroquine base / kg body weight, 6 hours later 5 mg chloroquine base / kg and the 5 mg / kg as a daily dose for the next 2-3 days.
Elderly initially received 4 x 250 mg tablets Rezohin, 6 hours later, 2 x 250 mg tablets Rezohin, then 2 x 250 mg tablets Rezohin day for the following 2-3 days. days:
Children receive an oral dose corresponding to their body weight.
B) chronic polyarthritis (rheumatoid arthritis), systemic lupus erythematosus
Due to the risk of developing retinopathy after prolonged use, the daily dose should not exceed 2,5 mg chloroquine base corresponding to a dose of 1 x 250 mg tablets Rezohin day.
Treatment can can be assessed soon after 4-12 weeks. If there is no improvement after 6 months, treatment should be discontinued.
According to the WHO guidelines of the cumulative total dose of 1 g base / kg body weight or 50-100, the total dose (base) is connected to the damage to the retina. The total cumulative dose should not exceed 50 g of chloroquine base.
The daily dose for children is also 2,5 mg chloroquine base / kg body weight. If there is no improvement after 6 months, treatment should be discontinued.
D) Ekstraintestinalna amoebiasis
Unless otherwise prescribed, standard adult dose of chloroquine for the treatment of amoebiasis ekstraintestinalnata applied in combination with other active substances 620 mg chloroquine base / day for two days, followed by 310 mg base / day for 14 - 28 days. Thus older received 4 x 250 mg tablets Rezohin daily for two days followed by 2 x 250 mg tablets Rezohin daily for 14-28 days.
Children receive respectively 10 mg base / kg body weight per day in a daily dosage for two days followed by 5 mg base / kg body weight as a daily dose for 14 to 28 days.
If you use more than the amount Rezohin
Rezohin acute overdose can cause death within 1-3 hours as a result of the paralyzing effect on the cardiovascular system and breathing.
Initial symptoms are characterized by headache, visual disturbances, heart rhythm disturbances.
Lowering blood pressure may be followed by shock with loss of consciousness and seizures.
Death occurs as a result of the suspension of respiratory and cardiac function.
Chronic overdose can lead to potentially fatal damage to the heart muscle (cardiomyopathy).
Treatment of overdose in humans
There is no known antidote. Should attempt to immediately eliminate the toxin by gastric lavage. Haemodialysis is not appropriate.
In the case where a child has accidentally taken tablets Rezohin should contact your doctor immediately and induce vomiting. Recommended the following procedures: Infants:
Ask the child to drink as much fruit juice diluted with water, then place it on the knee of an adult (head and face are down) so that the abdomen is gently pressed. Induce vomiting by irritating the back of the throat (pharynx) with your finger or the handle of a spoon. children:
Have the child drink warm salt water (1 tablespoon of salt a glass of water), then induce vomiting by irritating the back of the pharynx with a finger or the handle of a spoon. Children continue to drink salt water until they vomit clear liquid.
The tablets should be swallowed whole with a little water after a meal. The tablets should be taken on the same day in the week.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Rezohin can cause side effects, although not everybody
The majority of adverse reactions observed after administration of chloroquine were dose-dependent and occur mostly at plasma concentrations above 250 (xg / 1.
The following method of classification is used to evaluate the incidence of adverse reactions:
Common: Less than 1 in 10 patients but more than 1 in 100 patients
Uncommon: Less than 1 in 100 patients but more than 1 in 1000 patients
Rare: Less than 1 in 1000 patients, but more than 1 in 10 000 patients
Very rare: Less than 1 in 10 000 patients, including isolated cases.
Blood and lymphatic system
Rare: Decrease in the number of blood cells (agranulocytosis, pancytopenia, thrombocytopenia)
Very rare: Increase the number of certain white blood cells (eosinophilia) in the blood or tissues, methemoglobinemia
Very rare: hypersensitivity syndrome caused by medicine, pulmonary eosinophilia
Metabolism and nutrition
Rare: Deterioration of metabolic disorders (porphyria), porfirinuriya
Very rare: Acquired lipidosis (phospholipidosis)
Uncommon: anxiety reactions
Rare: Psychotic reactions
Uncommon: Confusion and disorientation, dizziness, headache, low blood pressure (hypotension), sleep disorders Par- and dysesthesia, drowsiness
Rare: Convulsions, peripheral neuropathy and polyneuropathy
Common: Eclipse of the cornea, vision, color blindness
Rare: Retinopathy / reversible / impairment of the visual field, scintillating scotoma
Rare: Loss of hearing, tinnitus
Uncommon: Low blood pressure, reduce the amplitude of the T wave of the electrocardiogram
Very rare: Damage to the heart muscle, abnormal electrocardiogram
Common: Gastrointestinal and abdominal pain, diarrhea, nausea, vomiting
Rare: Hepatic impairment, increased liver enzymes (transaminases)
Walleye: Hair loss, changes in hair color, photosensitivity reactions, itching, changes in skin color, change in color of the mouth, rash Very rare: Syndrome Stevens-Johnson, toxic epidermal necrolysis
Muscles and joints
Rare: Weakness in the muscles (myasthenia), muscle pain (myopathy)
General and local effects
Common: Weight decreased
Changes in laboratory test results
Rare: Abnormal laboratory tests
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE RESOCHIN?
Keep out of reach of children.
Rezohin not use after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
Do not store above 30 ° C.
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. FURTHER INFORMATION
The active substance is chloroquine (chloroquine). 1 tablet contains 250 mg of chloroquine phosphate (chloroquinephosphate), corresponding to 155 mg chloroquine (chloroquine). Other ingredients are: corn starch, talc, magnesium stearate, hypromellose, macrogol 4000, titanium (IV) oxide (E 171).
Rezohin looks like and contents of the pack?
Rezohin is available in packs of 50 or 100 film-coated tablets of 250 mg. Not all pack sizes may be marketed.