DOLQUINE 200 mg FILM-COATED TABLETS

2. What you need to know before you take Dolquine

Do not take Dolquine

• if you are allergic to hydroxychloroquine or any of the other ingredients of this medicine (listed in section 6).
• if you have any retinal disease.
• for long-term treatment in children.
• if the malaria is caused by a parasite resistant to chloroquine, Dolquine must not be used for prevention or treatment.
• if you are taking any of the following medicines:

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

If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Some people taking Dolquine may experience mental health problems such as irrational thoughts, anxiety, hallucinations, confusion, or depression, including thoughts of self-harm or suicide, even if they have never had similar problems before. If you or others around you notice any of these side effects (see section 4), consult a doctor immediately.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dolquine

• if you have:

• skin disorders such as psoriasis,
• severe kidney disease,
• deficiency of an enzyme called glucose-6-phosphate dehydrogenase (hemolytic anemia),
• any liver disease,
• myasthenia gravis (an autoimmune disease that causes muscle weakness and fatigue),
• alcoholism.
• if the malaria parasites are Plasmodium vivaxand Plasmodium ovale, primaquine should also be given to prevent relapses,

• if you are being treated with Dolquine and have porphyria (a hereditary metabolic disorder), the condition may worsen,
• if you have neurological disorders (epilepsy),
• if you are an elderly patient, you should be especially careful to distinguish between visual disturbances caused by the disease or age and those caused by the medicine,
• if you have visual disturbances. Before starting 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 disturbances.
• if you have a chronic inactive hepatitis B virus infection.

Avoid exposure to the sun (even when cloudy) and to ultraviolet (UVA) lamps while using this medicine.

If you take Dolquine for a long time, your doctor will probably perform regular check-ups. You should report any new or unusual symptoms and circumstances whenever you visit your doctor.

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

Severe skin reactions have been reported with the use of hydroxychloroquine (see section 4, possible side effects). Often, the rash can consist of ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and inflamed eyes). These severe skin reactions 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 medicines and Dolquine

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Note that these instructions may also apply to medicines that you have used before or may use after.

Dolquine may affect the action of some medicines and some medicines may affect Dolquine.

Tell your doctor or pharmacist if you are taking any of the following medicines, as it may be necessary to adjust the dose of one of them:

• Kaolin and antiacids.
• Medicines for diabetes, such as insulin.
• Anthelmintics (used to eliminate intestinal worms).
• Antipsychotics: phenothiazines (used to treat mental disorders).
• Medicines used for the heart (digoxin and some beta blockers).

Some medicines 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 (a traditional herbal medicine for the supportive treatment of the common cold).
• Trastuzumab (used to treat some types of cancer).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Aminoglycoside antibiotics.
• Cimetidine (reduces stomach acid production).
• Neostigmine and pyridostigmine (for severe muscle weakness).
• Tacrolimus (in case of organ transplantation).
• Phenylbutazone (non-steroidal anti-inflammatory).
• Hepatotoxic drugs.
• Medicines that may cause skin irritation, liver or eye damage.
• Bupropion (used to treat depression).
• Leflunomide (antirheumatic).

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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Dolquine may be associated with a small increased risk of major birth defects 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.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding. Your doctor will tell you if Dolquine is suitable for you.

Driving and using machines

Do not drive or use tools or machines until you know how this medicine affects you. Side effects such as dizziness and visual disturbances may occur.

3. How to take Dolquine

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Dolquine is administered orally. Swallow the tablets whole without chewing during meals or with a glass of milk. The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

The recommended doses are indicated below:

Adults

• Treatment of rheumatoid arthritis

• Initial dose: 2 to 3 tablets (400 to 600 mg) per day, according to the patient's response to the medicine. If side effects appear, the initial dose should be reduced and then increased gradually (5-10 days).
• Maintenance dose: once an adequate response is achieved (usually 4-12 weeks), a maintenance dose of 1 or 2 tablets (200-400 mg) per day will be continued.

The maximum daily dose for long-term treatment is 6.5 mg/kg ideal body weight.

• Treatment of systemic 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 to 400 mg) per day.

The maximum daily dose for long-term treatment is 6.5 mg/kg ideal body weight.

• Prevention and treatment of uncomplicated malaria

Expert advice should be sought. Before starting treatment, the Plasmodium species should be identified by reliable tests and their sensitivity known.

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

Prevention should start 2 weeks before exposure and continue until 4 weeks after leaving the endemic area. If prevention was not started before exposure, a double initial dose (4 tablets) can be given in two doses 6 hours apart and continued as indicated above until 8 weeks after leaving the endemic area.

Treatment of acute uncomplicated malaria attack:

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 over 31 kg)

• Prevention and treatment of uncomplicated malaria

Prevention of uncomplicated malaria:6.5 mg/kg ideal body weight once a week, not exceeding the recommended adult dose.

Prevention should start 2 weeks before exposure and continue until 4 weeks after leaving the endemic area. If prevention was not started before exposure, a double initial dose can be given in two doses 6 hours apart and continued as indicated above until 8 weeks after leaving the endemic area.

Treatment of acute uncomplicated malaria attack:

First dose: 13 mg/kg, not exceeding 4 tablets (800 mg).

Second dose: 6.5 mg/kg, not exceeding 2 tablets (400 mg), 6 hours after the first dose.

Third dose: 6.5 mg/kg, not exceeding 2 tablets (400 mg), 24 hours after the first dose.

Fourth dose: 6.5 mg/kg, not exceeding 2 tablets (400 mg), 48 hours after the first dose.

The maximum total dose for complete treatment will not exceed 30 mg/kg ideal body weight, not exceeding the recommended adult dose.

Use in patients with liver or kidney problems

Your doctor will decide if it is necessary to adjust the dose if you have liver or kidney problems.

If you take more Dolquine than you should

If you take more Dolquine than your doctor has told you, you may experience headache, drowsiness, visual disturbances, circulatory collapse, convulsions, and cardiorespiratory arrest.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Dolquine

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Dolquine

Consult your doctor before stopping treatment.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Adverse effects can occur with certain frequencies, which are defined as follows:

Frequent(may affect between 1 and 10 out of 100 patients)

• Headache.
• Corneal problems (a part of the eye) that can 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 out of 1,000 patients)

• Emotional changes, feeling nervous, seeing, feeling, or hearing things that are not real are symptoms of psychosis.
• Seizure, uncontrolled eye movement.
• Deafness, ringing in the ears, and a sensation that everything is spinning (vertigo).
• Skin rashes of various types.
• Changes in skin and mucous membrane color.
• Itching.
• Changes in hair color (graying).
• Hair loss (alopecia).
• Skin rash with exposure to sunlight.
• Muscle disease.

Rare(may affect between 1 and 10 out of 10,000 patients)

• Bone marrow failure (tissue inside the bone that generates blood cells).
• Retinal diseases (a part of the eye) that can lead to vision loss.
• Heart muscle disease.
• Muscle weakness.

Very Rare(may affect less than 1 in 10,000 patients)

• Abnormal liver function and liver failure.
• Psoriasis (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), and agranulocytosis (lack of white blood cells).
• Nightmares.
• Inability to coordinate movements.
• Paralysis of the extraocular muscle.
• Sudden sensation of difficult breathing (bronchospasm) and respiratory failure.
• Hives.
• Worsening or precipitation of porphyria (a familial metabolic disease).
• Irritability and fatigue.
• Loss of the foveal reflex (affecting the retina, a part of the eye).
• Decrease in blood glucose levels.
• Depression or thoughts of self-harm or suicide.
• Hallucinations.
• 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 adverse 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 failure (including fatal cases) have been observed.

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

• rash with fever and flu-like symptoms and enlarged lymph nodes. It could be a disease called drug reaction with eosinophilia and systemic symptoms (DRESS).

• blisters, widespread scaly skin, spots with pus along with fever. It could be a disease called acute generalized exanthematous pustulosis (AGEP).

• blisters or peeling of the skin around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever. It could be a disease called Stevens-Johnson syndrome (SJS).

• multiple skin lesions, skin itching, joint pain, fever, and general feeling of discomfort. It could be a disease called toxic epidermal necrolysis (TEN).

• skin reaction, including purple-colored, raised, and painful ulcers, especially on the arms, hands, fingers, face, and neck, which may also be accompanied by fever. It could be a disease called Sweet's syndrome.

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

Adverse Effect Reporting

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

5. Storage of Dolquine

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

Do not use this medicine 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.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Dolquine Composition

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

Product Appearance and Package Contents

White, oblong, scored coated tablets.

Available in packages of 30 and 60 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

Manufacturer

LABORATORIOS RUBIÓ, S.A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal

Barcelona- Spain

Date of the Last Revision of this Leaflet:

October 2023

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