Package Insert: Information for the User

Resochín®155 mg Film-Coated Tablets

Chloroquine

Read this package insert carefully before starting to take the medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Resochín belongs to the group of antiparasitic drugs as an antimalarial.

It is indicated for:

• prevention and treatment of malaria (paludism)
• rheumatoid arthritis, spondyloarthritis (inflammatory disease of the spine)
• connective tissue diseases (systemic autoimmune diseases) and collagen diseases, such as systemic lupus erythematosus (chronic autoimmune disease), scleroderma (connective tissue disease), sarcoidosis (multisystem inflammatory disease), actinodermatitis (skin disease), rosacea (chronic skin alteration) and malignant herpetiform dermatitis (skin disease that causes itching and eruptions)
• other protozoal or helminthic infections: giardiasis (intestinal disease caused by the protozoan G. Lamblia), extraintestinal amebiasis (disease caused by the parasite Entoameba histolytica), hepatic distoma (liver disease caused by parasites), paragonimiasis (disease caused by helminths) and mucosal American leishmaniasis (disease caused by the protozoan Leishmania)

Do not take Resochín

• if you are allergic to chloroquine or to any of the other components of this medicine (listed in section 6)
• if you have any eye disease
• if you have any blood disease
• if you have hemolytic anemia (glucose-6-phosphatase deficiency)
• if you have myasthenia gravis (autoimmune disease that causes muscle weakness and fatigue)
• if you have skin disorders, such as psoriasis
• if you have porphyria (hereditary metabolic disorder)
• if you have epilepsy
• if you have a severe liver or kidney disease
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”)

Do not take Resochínwith the medicines listed in the section “Other medicines and Resochín”.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Resochín.

Some people treated with Resochín may experience mental health problems such as irrational thoughts, hallucinations, confusion, aggression, paranoia, depression, or thoughts of self-harm or suicide, even those who have never had similar problems before. If you or someone around you notices any of these adverse effects (see section 4), consult a doctor immediately.

Before starting a long-term treatment, your doctor will perform an eye examination and then perform periodic examinations every three months.Consult your doctor as soon as you notice any visual changes.

Your doctor will instruct you when to have periodic blood tests to control the number of blood cells.

You should inform your doctor if you have:

• liver disease
• kidney disease

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Chloroquine may cause a decrease in blood glucose levels. Please consult your doctor about the signs and symptoms of low blood glucose levels. Blood glucose level testing may be necessary.

During treatment and at least 3 months after treatment, avoid pregnancy (see section “Pregnancy and breastfeeding”)

Chloroquine may cause cardiac rhythm disturbances in some patients: be cautious when using chloroquine if you have a congenital prolongation of the QT interval, if you have a family history of QT interval prolongation, if you have an acquired prolongation of the QT interval (observed on an ECG, an electrical recording of the heart), if you have heart disease, if you have a history of heart attack (myocardial infarction) or if you have an imbalance of electrolytes in the blood (especially low potassium or magnesium levels, see section "Other medicines and Resochín”).

If you notice palpitations or irregular heartbeat during the treatment period, inform your doctor immediately. The risk of heart problems may increase with increasing doses. Therefore, follow the recommended dose.

Other medicines and Resochín

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medicine.

Inform your doctor if you are taking any of the following medicines:

- Medicines that are known to affect heart rhythm. This includes medicines used for abnormal heart rhythms (antiarrhythmics), for depression (tricyclic antidepressants), for psychiatric disorders (antipsychotics), for bacterial infections (e.g., a group of medicines called macrolides, including azithromycin), and for malaria (paludism) (such as halofantrine).

Do not take Resochín with the following medicines:

• antacids and kaolin,
• rabies vaccine administered intradermally,
• phenylbutazone (medicine for pain and/or fever relief),
• probencid (medicine for gout treatment),
• corticosteroids,
• monoamine oxidase inhibitors (MAOIs) such as phenelzine, tranylcypromine, isocarboxazid, and selegiline, and potentially hepatotoxic drugs such as isoniazid, amiodarone, carbamazepine, phenytoin, phenothiazines, and ketoconazole) or MAOIs (such as phenelzine, tranylcypromine, isocarboxazid, and selegiline).
• digoxin (medicine for heart failure treatment),
• methotrexate (medicine for some types of cancer and/or diseases affecting the immune system such as psoriasis or rheumatoid arthritis),
• neostigmine and pyridostigmine,
• cyclosporine,
• ampicillin (medicine for various infections),
• cimetidine (medicine for ulcers),
• mefloquine,
• bupropion (medicine to help quit smoking),
• penicillamine,
• metronidazole, pyrimethamine/sulfadoxine, praziquantel (medicines for parasite infections).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Generally, Resochín should not be taken during pregnancy. However, your doctor will instruct you if it is necessary to take it if you are pregnant.

Contraception:

During treatment and at least 3 months after treatment, avoid pregnancy

This medicine is excreted in breast milk; your doctor will instruct you on whether to continue breastfeeding or not.

Driving and operating machinery:

Resochín may cause adverse effects such as headache, dizziness, drowsiness, or confusion that may impair your ability to drive vehicles or operate machinery. This is especially important when starting treatment or taking alcohol or other sedatives.

Follow exactly the administration instructions of this medication indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Resochín is administered orally. Take the tablets, whole or broken, with a little water after the main meals.

Your doctor will determine the dosage of Resochín according to your pathology.

Malaria (Paludismo):

Your doctor will determine the treatment schedule, as it will depend on the region and the sensitivity of the parasites.

• Preventive therapy:

Adults: in general, a starting dose of 2 tablets is recommended, administered one week before starting the trip, or, if the treatment is initiated upon embarking on the trip, 4 tablets administered in two equal doses separated by an interval of 6 hours.

The maintenance dose is 2 tablets per week, taken exactly on the same day of the week.

Children: a starting dose of 5 mg of chloroquine base per kg of body weight is recommended one week before embarking on the trip, or, if the treatment is initiated upon embarking on the trip, 10 mg of chloroquine base per kg divided into 2 equal doses separated by an interval of 6 hours.

The maintenance dose is 5 mg of chloroquine base per kg of body weight per week, taken exactly on the same day of the week.

Preventive therapy should be continued until 4 weeks after leaving the risk area.

• Treatment of malaria:

Adults: in general, it is recommended to take 620 mg of chloroquine base (4 tablets) on the first and second days, and 310 mg of chloroquine base (2 tablets) on the third day.

Children: the doctor will determine the dose according to the child's body weight.

Rheumatoid arthritis, spondylitis (spinal rheumatic disease):

Adults: 1 tablet per day.

Children: the doctor will determine the dose according to the child's body weight.

The duration of treatment, at a dose of 1 tablet per day, should not exceed 2 years.

Lupus erythematosus (chronic autoimmune disease):

Adults: 3 tablets per day for the first 10 days, followed by 1 tablet per day for 3-5 weeks.

Children: the doctor will determine the dose according to the child's body weight.

Actinodermatitis (skin disease):

Adults: 1 tablet per day for several weeks, followed by 1 tablet taken 2 or 3 days a week.

Children: the doctor will determine the dose according to the child's body weight.

Rosacea (chronic skin redness):

Adults: 3 tablets per day for the first 10 days, 2 tablets per day for the next 10 days, and finally 1 tablet per day for several months.

Children: the doctor will determine the dose according to the child's body weight.

Lambliasis (intestinal disease caused byG. Lamblia):

Adults: 3 tablets per day for 5 consecutive days.

Children: the doctor will determine the dose according to the child's body weight.

Sarcoidosis (multisystem inflammatory disease):

Adults: 1-2 tablets per day for 3-6 months.

Children: the doctor will determine the dose according to the child's body weight.

Amebiasis extraintestinal (disease caused by the parasiteEntamoeba histolytica):

Adults: 3 tablets per day for the first week, 2 tablets per day for the second week, and 1 tablet per day for the third week.

Children: the doctor will determine the dose according to the child's body weight.

Follow these instructions unless your doctor has given you different instructions.

Remember to take your medication.

If you estimate that the action of Resochín is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the duration of your treatment with Resochín. Do not suspend the treatment before, as it will have no effect.

If you take more Resochín than you should:

You may experience headache, vision disturbances, and heart rhythm disturbances. You may experience a drop in blood pressure, followed by shock, loss of consciousness, and convulsions. You may even die from cardiorespiratory arrest.

Go immediately to a hospital. A gastric lavage should be performed as soon as possible.

If you accidentally take more chloroquine than you should, inform your doctor immediately.

You may experience the following effects: cardiac problems, which lead to an irregular heartbeat.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Resochín:

Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Resochín may cause side effects, although not everyone will experience them.

Frequent (less than 1 in 10 but 1 or more in 100 patients):

- abdominal pain

- loss of appetite

- diarrhea

- nausea

- vomiting

- weight loss

- visual disturbances

Uncommon (less than 1 in 100 but 1 or more in 1,000 patients):

- headache

- cardiac alterations, hypotension

- confusion

- dizziness

- muscle weakness

- insomnia or drowsiness

- nervousness

- sensation of tingling.

Rare (less than 1 in 1,000 but 1 or more in 10,000 patients):

- light intolerance

- liver injury and worsening of existing liver injuries

- alteration of liver function test results

- changes in blood cell count

- worsening or precipitation of porphyria (familial metabolic disease)

- muscle weakness

- seizures

- emotional changes

- neuropathy

- worsening of psoriasis

- hair loss

- itching

- alterations in skin, hair, and mucous membrane pigmentation

- hearing loss, alteration of auditory sensation

- retinal changes

- heart muscle disease (myocarditis) that may be fatal in the case of prolonged treatment at high doses (see section 2, Warnings and precautions).

Very rare (less than 1 in 10,000 patients):

- hypersensitivity syndrome (drug reaction characterized by fever, skin rash, and internal organ involvement)

- acquired methemoglobinemia (disease of hemoglobin that prevents oxygen transport)

- abnormal ECG, in prolonged treatments, especially at high doses, may cause cardiomyopathy in some cases.

- eosinophilia in blood and tissues

- Stevens-Johnson syndrome (erythema multiforme vesiculobulosis of the skin and other organs)

- toxic epidermal necrolysis (severe skin alteration that progresses with blisters and exfoliation of the skin)

- reversible phospholipidosis (increase in phospholipids).

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

-reduction in blood glucose level

- abnormal heart rhythm

- irregular heart rhythm that may be life-threatening (observed on ECG) (see section 2, Warnings and precautions);

- depression or thoughts of self-harm or suicide, anxiety, confusion, irrational thoughts, paranoia, aggression, sleep disturbances, agitation, euphoria or hyperexcitement, lack of concentration.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for human use: www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packagingafter “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Resochín:

-The active ingredient is chloroquine. Each tablet contains 250 mg of chloroquine diphosphate equivalent to 155 mg of chloroquine base.

-The other components (excipients) are: cornstarch, talc, magnesium stearate, hypromellose, macrogol 4000, and titanium dioxide (E171).

Appearance of the product and contents of the package

Resochín film-coated tablets are white to slightly brownish in color.

Resochín tablets are presented in blister-type packaging of 50 tablets.

Holder of the marketing authorization and Responsible for manufacturing:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: March 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/