Label: information for the user

Dolquine 300 mg coated tablets

hydroxychloroquine, sulfate

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

• Keep this label, 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 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 label. See section 4.

Contents of the label:

1. What Dolquine is and for what it is used
2. What you need to know before starting to take Dolquine
3. How to take Dolquine
4. Possible adverse effects
5. Storage of Dolquine
6. Contents of the package and additional information

This medication belongs to a group of medications called antimalarials. It is used for:

Adults

Adolescents with a body weight of more than 46 kg

Do not take Dolquine

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

Some people treated with this medication may experience 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 (an autoimmune disease that causes muscle weakness and fatigue),
• alcoholism.

• if the malaria parasites are Plasmodium vivax and Plasmodium ovale, primaquine must also be administered to prevent recurrences,
• if you are being treated with this medication and have porphyria (a hereditary metabolic disorder), it may worsen the condition,
• if you have neurological alterations (epilepsy),
• if you are an elderly patient, you must be particularly 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 prolonged treatment with this medication, 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 with the hepatitis B virus.

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

If you take this medication for a long period, your doctor will likely perform periodic reviews. You must inform your doctor of any new or unusual symptoms and circumstances whenever you visit.

Hydroxychloroquine may 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 blood glucose levels.

Severe skin eruptions have been reported with the use of hydroxychloroquine (see section 4 possible adverse effects). The eruption often consists 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 eruption 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.

Take note that 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.
• Antihelmintics (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 (non-steroidal anti-inflammatory).
• Hepatotoxic medications.
• Medications that may cause skin irritation, damage the liver or eyes.
• Bupropion (used to treat depression).
• Leflunomide (anti-inflammatory).

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

This medication 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

This medication passes into breast milk. This medication 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 this medication is suitable for you.

Driving and Operating Machinery

Do not drive or operate machinery 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.

• The tablets are administered orally.
• Swallow the tablets whole without chewing during meals or with a glass of milk.
• The groove is only for breaking the tablet if it is difficult to swallow it whole.

This medication may not exactly match the dose you need throughout your entire treatment. Consult with your doctor about the use of other Dolquine presentations suitable for each phase of treatment.

Recommended doses are:

Adults

• Treatment ofrheumatoid arthritis
• • Initial dose: 400 to 600 mg per day according to the patient's response to the medication. If adverse effects appear, the initial dose should be reduced and then increased gradually over 5-10 days.
  • Maintenance dose: Once an adequate response has been obtained (usually 4-12 weeks), continue with a maintenance dose of 200-400 mg per day.

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

• Treatment ofsystemic lupus erythematosus
• • Initial dose: 400 mg per day or 200 mg every 12 hours, according to the patient's response.
  • Maintenance dose: 200 to 400 mg per day.

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

Adolescents with a body weight greater than 46 kg

• 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:6.5 mg/kg of ideal body weight once a week, not exceeding 400 mg once a 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 can be administered in two separate doses 6 hours apart and continued as indicated above until eight weeks after leaving the endemic area.

• Treatment of acute uncomplicated malaria:

First dose: 13 mg/kg, not exceeding 800 mg.

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

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

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

The total maximum dose for complete treatment will not exceed 30 mg/kg of ideal body weight, not 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 medication than you should, you may feel headache, drowsiness, visual disturbances, circulatory collapse, convulsions, 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 dosing schedule to follow until you reach your maintenance dose.

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

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

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 failure (including fatal cases) have been observed.

• Severe skin reactions (see section 2, Warnings and precautions) such as:
• • fever and flu-like symptoms with rash and swollen lymph nodes. This could be a condition called drug reaction with eosinophilia and systemic symptoms (DRESS).
  • blistering, widespread scaly skin, pus-filled spots with fever. This could be a condition called generalized acute pustular psoriasis (PEGA).
  • blistering or peeling of the skin around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever. This could be a condition called Stevens-Johnson syndrome (SSJ).
  • multiple skin lesions, itching, joint pain, fever, and general feeling of discomfort. This could be a condition called toxic epidermal necrolysis (NET).
  • skin rash, including purple-colored ulcers, elevated and painful, especially on the arms, hands, fingers, face, and neck, which may also be accompanied by fever. This could be a condition called Sweet's syndrome.

Side effects may occur with certain frequencies, which are defined as follows:

Frequent(may affect up to 1 in 10 people)

• Headache.
• Eye problems (a part of the eye) that may cause blurred vision, seeing halos, eye discomfort, and loss of visual acuity.
• Nausea, diarrhea, abdominal pain, loss of appetite, and vomiting.
• Weight loss.

Occasional(may affect up to 1 in 100 people)

• Mood changes, feeling nervous, seeing, feeling, or hearing things that are not real are symptoms of psychosis.
• Convulsions, uncontrolled eye movements.
• Deafness, ringing in the ears, and feeling like everything is spinning (dizziness).
• Various types of skin eruptions.
• Changes in skin and mucous color.
• Itching.
• Change in hair color (graying).
• Hair loss (alopecia).
• Sunlight-induced skin eruption.
• Muscle disease.

Rare(may affect up to 1 in 1,000 people)

• 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 vision loss.
• Heart muscle disease.
• Muscle weakness.

Very rare(may affect up to 1 in 10,000 people)

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

Frequency unknown(the frequency cannot be estimated from available data)

• Decreased number of blood cells (anemia, leukopenia, thrombocytopenia), hemolysis (breakdown 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 feeling of difficulty breathing (bronchospasm) and respiratory failure.
• Hives.
• Exacerbation or precipitation of porphyria (a genetic metabolic disorder).
• Irritability and fatigue.
• Loss of foveal reflex (retinal disease).
• Decreased blood glucose level.
• Depression or suicidal thoughts or behavior.
• Hallucinations.
• Anxiety or nervousness.
• Confusion.
• Agitation.
• Difficulty sleeping.
• Euphoria or overexcitement.

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

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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.

This medication does not require special storage conditions.

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 300 mg of hydroxychloroquine sulfate (equivalent to 232 mg of hydroxychloroquine base).
• The other components are:
• • Core: microcrystalline cellulose (E 460i), calcium dihydrogen phosphate, crospovidone,

and magnesium stearate (E 470b).

Appearance of Dolquine and content of the packaging

Oblong coated tablets, white in color, and scored on both faces.

Presented in packs of 30 tablets.

Marketing Authorization Holder

PRODUCTS AND TECHNOLOGY, S.L

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

Local Representative

LABORATORIOS RUBIÓ, S.A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal

Barcelona- Spain

Last review date of this leaflet: March 2024

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