Package Insert: Information for the User

Dolquine 200 mg Coated Tablets

hydroxychloroquine sulfate

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

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

Dolquine belongs to a group of medications called antimalarials.

Dolquine is indicated for:

Adults

• Treatment of acute or chronic rheumatoid arthritis.
• Treatment of systemic and discoid lupus erythematosus.
• Prevention and treatment of uncomplicated malaria (paludism) caused by sensitive species of Plasmodium (parasites that cause malaria), when first-line treatments are not suitable or unavailable.

Adolescents (12 years of age and older) and children(9 to 11 years of age with a body weight of more than31 kg)

• Prevention and treatment of uncomplicated malaria (paludism) caused by sensitive species of Plasmodium (parasites that cause malaria), when first-line treatments are not suitable or unavailable.

Do not take Dolquine

• if you are allergic to hydroxychloroquine or any of the other components of this medication (listed in section 6).
• if you have any retinal alterations.
• in long-term treatments in children.
• if the malaria is caused by a parasite resistant to chloroquine, Dolquine cannot be used for prevention or treatment.
• if you are taking any of the following medications:

• Artemether/lumefantrine and mefloquine (used to treat malaria).
• Natalizumab (used to treat multiple sclerosis).
• Live virus vaccines.
• Pimecrolimus and Tacrolimus (used to treat skin inflammation (eczema)).
• Moxifloxacin (antibiotic).
• Agalsidase alpha and beta (used to treat a hereditary disorder called Fabry disease).

If you are unsure, consult your doctor or pharmacist before taking this medication.

Some people treated with Dolquine may experience mental health problems such as irrational thoughts, anxiety, hallucinations, confusion, or depression, including 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dolquine

• if you have:

• skin alterations such as psoriasis,
• serious kidney diseases,
• deficiency of an enzyme called glucose-6-phosphatase dehydrogenase (hemolytic anemia),
• any liver disease,
• myasthenia gravis (autoimmune disease that causes muscle weakness and fatigue),
• alcoholism.
• if the malaria parasites arePlasmodium vivaxandPlasmodium ovaleprimaquine must also be administered to prevent recurrences,

• if you are being treated with Dolquineand have porphyria (a hereditary metabolic disorder) it can worsen the condition,
• if you have neurological alterations (epilepsy),
• if you are an elderly patient you should be especially careful to distinguish the visual alterations caused by the disease or age from those caused by the medication,
• if you have visual alterations. Before starting a long-term treatment with Dolquine your doctor will perform an eye examination and then perform periodic examinations. Consult your doctor as soon as you notice any visual alteration.
• if you have an inactive chronic infection by the hepatitis B virus.

Avoid exposure to the sun (even on cloudy days) and ultraviolet lamps (UVA), while using this medication.

If you take Dolquine for a long period, your doctor will likely perform periodic check-ups. You should inform your doctor of any new or unusual symptoms and circumstances whenever you visit.

Hydroxychloroquine can cause a decrease in blood glucose levels. Please consult your doctor about the signs and symptoms of low blood glucose levels. It may be necessary to check your blood glucose levels.

Severe skin eruptions have been reported with the use of hydroxychloroquine (see section 4 possible adverse effects). Often, the rash can consist of ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and inflamed eyes). These severe skin eruptions are often preceded by flu-like symptoms, such as fever, headache, and body aches. The skin rash can progress to generalized blisters and skin peeling. If you experience these skin symptoms, stop taking hydroxychloroquine and contact your doctor immediately.

Other medications and Dolquine

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

These instructions may also apply to medications that have been used before or may be used afterwards.

Dolquine may affect the mechanism of action of some medications and some medications may affect Dolquine.

Inform your doctor or pharmacist if you are taking any of the following medications, as it may be necessary to modify the dose of one of them:

• Antacids and calcium carbonate.
• Medications for diabetes such as insulin.
• Anthelmintics (used to eliminate intestinal worms).
• Antipsychotics: phenothiazines (used to treat mental disorders).
• Medications used for the heart (digoxin and some beta blockers).

Some medications may increase the number of side effects caused by Dolquine or decrease its effects, including:

• Dapsone (used to treat leprosy and some skin diseases).
• Inactivated vaccines.
• Echinacea (traditional herbal medicine for colds).
• Trastuzumab (used to treat some types of cancer).

Inform your doctor or pharmacist if you are taking any of the following medications:

• Aminoglycoside antibiotics.
• Cimetidine (reduces stomach acid production).
• Neostigmine and pyridostigmine (for severe muscle weakness).
• Tacrolimus (in organ transplant patients).
• Phenylbutazone (anti-inflammatory drug).
• Hepatotoxic drugs.
• Medications that may cause skin irritation, damage the liver or eyes.
• Bupropion (used to treat depression).
• Leflunomide (anti-inflammatory drug).

Taking Dolquine with food and drinks

It is recommended to take Dolquine with food or milk.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Dolquine may be associated with a small increase in the risk of major malformations and should not be used during pregnancy unless your doctor considers that the benefits outweigh the risks.

Breastfeeding

Dolquine passes into breast milk. Dolquine should not be used during breastfeeding unless your doctor considers that the benefits outweigh the risks.

Consult your doctor or pharmacist before taking any medication if you are pregnant or breastfeeding. Your doctor will indicate whether Dolquine is suitable for you.

Driving and operating machinery

Do not drive or operate tools or machines until you know how this medication affects you. You may experience adverse effects such as dizziness and visual disturbances.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dolquine is administered orally. Swallow the tablets whole during meals or with a glass of milk. The groove is only for breaking the tablet if it is difficult to swallow it whole.

The recommended doses are indicated below:

Adults

• Treatment ofrheumatoid arthritis

• Initial dose:2 to3 tablets (400 to600 mg) per day according to the patient's response to the medication. If adverse effects appear, the initial dose should be reduced and then (5-10 days) gradually increased.
• Maintenance dose:once an adequate response has been obtained (usually 4-12 weeks), continue with a maintenance dose of 1 or 2 tablets (200-400 mg) per day.

The maximum daily dose for long-term treatment is6.5 mg/kg of ideal body weight.

• Treatment ofsystemic lupus erythematosus

• Initial dose: 2 tablets (400 mg) per day or 1 tablet (200 mg) every 12 hours, according to the patient's response.

• Maintenance dose: 1 or 2 tablets (200 to400 mg) per day.

The maximum daily dose for long-term treatment is6.5 mg/kg of ideal body weight.

• Prevention and treatment ofuncomplicated malaria

Consult an expert. Before starting treatment, the Plasmodium species should be identified by reliable tests and its sensitivity known.

Prevention of uncomplicated malaria:2 tablets (400 mg) once a week, exactly the same day each week.

Prevention should start two weeks before exposure and continue until four weeks after leaving the endemic area. If prevention was not started before exposure, a double initial dose (4 tablets) can be administered in two separate doses 6 hours apart and continue as indicated above until 8 weeks after leaving the endemic area.

Treatment of acute uncomplicated malaria:

First dose: 4 tablets (800 mg).

Second dose: 2 tablets (400 mg), 6 hours after the first dose.

Third dose: 2 tablets (400 mg), 24 hours after the first dose.

Fourth dose: 2 tablets (400 mg), 48 hours after the first dose.

The maximum total dose is 10 tablets (2000 mg).

Adolescents (12 years of age and older) and children (9 to 11 years of age with a body weight of 31 kg or more)

• Prevention and treatment ofuncomplicated malaria

Prevention of uncomplicated malaria:6.5 mg/kg of ideal body weight once a week, without exceeding the recommended dose for adults.

Prevention should start two weeks before exposure and continue until four weeks after leaving the endemic area. If prevention was not started before exposure, a double initial dose can be administered in two separate doses 6 hours apart and continue as indicated above until 8 weeks after leaving the endemic area.

Treatment of acute uncomplicated malaria:

First dose: 13 mg/kg, without exceeding 4 tablets (800 mg).

Second dose: 6.5 mg/kg, without exceeding 2 tablets (400 mg), 6 hours after the first dose.

Third dose: 6.5 mg/kg, without exceeding 2 tablets (400 mg), 24 hours after the first dose.

Fourth dose: 6.5 mg/kg, without exceeding 2 tablets (400 mg), 48 hours after the first dose.

The maximum total dose for complete treatment will not exceed 30 mg/kg of ideal body weight, without exceeding the recommended dose for adults.

Use in patients with liver or kidney problems:

Your doctor will decide if the dose needs to be adjusted if you have liver or kidney problems.

If you take more Dolquine than you should

If you take more Dolquine than your doctor has indicated, you may experience headache, drowsiness, visual disturbances, circulatory collapse, seizures, and cardiac arrest.

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 forget to take Dolquine

If you forget to take a dose, take it as soon as you remember. However, if there is little time left for the next dose, skip the missed dose.

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

If you interrupt treatment with Dolquine

Consult your doctor before stopping treatment.

If you have forgotten to take several doses, consult your doctor to indicate the dosage schedule to follow until you reach your maintenance dose.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects can occur at certain frequencies, which are defined as follows:

Frequent(may affect between 1 and 10 in every 100 patients)

• Headache.
• Problems in the cornea (a part of the eye) that may cause blurred vision, seeing halos or discomfort from light and loss of visual acuity.
• Nausea, diarrhea, abdominal pain, loss of appetite and vomiting.
• Weight loss.

Infrequent(may affect between 1 and 10 in every 1,000 patients)

• Mood changes, feeling nervous,seeing, feeling, or hearing things that are not real are symptoms of psychosis.
• Convulsions, uncontrolled movement of the eyes.
• Deafness,ringing in the ears and feeling like everything is spinning (vertigo).
• Various types of skin eruptions.
• Changes in skin color and mucous membranes.
• Itching.
• Alteration in hair color (graying).
• Hair loss (alopecia).
• Skin eruption upon exposure to sunlight.
• Muscle disease.

Rare(may affect between 1 and 10 in every 10,000 patients)

• Failure of the bone marrow(tissue inside the bone that generates blood cells).
• Diseases of the retina (a part of the eye) that may lead to loss of vision.
• Heart muscle disease.
• Muscle weakness.

Very rare(may affect fewer than 1 in every 10,000 patients)

• Abnormal liver function and liver insufficiency.
• Poriasis (a skin disease).

Frequency not known(cannot be estimated from available data)

• Decrease in the number of blood cells (anemia, leukopenia, thrombocytopenia), dissolution of red blood cells (in individuals with glucose-6-phosphate dehydrogenase deficiency) andagranulocytosis (lack of white blood cells).
• Nightmares.
• Inability to coordinate movements.
• Paralysis of the extraocular muscle.
• Sudden feeling of difficult breathing (bronchospasm) and respiratory insufficiency.
• Urticaria.
• Acceleration or precipitation of porphyria (familial metabolic disease).
• Irritability and fatigue.
• Loss of foveal reflex (retinal (a part of the eye) affection).
• Decrease in blood glucose level.
• Depression or thoughts of self-harm or suicide.
• Illusions.
• Nervousness or anxiety.
• Confusion.
• Agitation.
• Difficulty sleeping.
• Euphoria or overexcitement.

Stop taking Dolquine and see a doctor immediately if you notice any of the following serious side effects; you may need urgent medical treatment:

• Liver problems. Symptoms may include a general feeling of discomfort, with or without jaundice (yellowing of the skin and eyes), dark urine, nausea, vomiting and/or abdominal pain. Rare cases of liver insufficiency (including fatal cases) have been observed.

• Severe skin reactions (see section 2, Warnings and precautions) such as:

If you consider that any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experienceany type of side effect, consult your doctor, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store at a temperature above 30 °C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dolquine

• The active ingredient is hydroxychloroquine sulfate. Each coated tablet contains 200 mg of hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine base).
• The other components are:
• • Core:

• microcrystalline cellulose (E 460i),
• calcium dihydrogen phosphate,
• crospovidone,
• magnesium stearate (E 470b).
• • Coating: Opadry Y-1-7000 White, whose components are: hypromellose (E 464), macrogol and titanium dioxide (E 171).

Appearance of the product and contents of the packaging

Oblong coated tablets, white in color, scored.

It is presented in packaging of 30 and 60 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

PRODUCTS AND TECHNOLOGY, S.L

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal

Barcelona- Spain

Local representative

LABORATORIOS RUBIÓ, S.A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal

Barcelona- Spain

Responsible for manufacturing

LABORATORIOS RUBIÓ, S.A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal

Barcelona- Spain

Last review date of this leaflet:

October 2023

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