DOLQUINE 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dolquine 300 mg Film-Coated Tablets

hydroxychloroquine, sulfate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Dolquine and what is it used for

This medicinal product belongs to a group of medicines called antimalarials. It is used in:

Adults

• Treatment of acute or chronic rheumatoid arthritis.
• Treatment of systemic and discoid lupus erythematosus.

Adolescents with a body weight over 46 kg

• Prevention and treatment of uncomplicated malaria (caused by sensitive species of Plasmodium) when other treatments are not suitable or not available.

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 disorders.
• 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 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 treated with this medicine 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

Consult your doctor or pharmacist before starting to take 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 vivax and Plasmodium ovale, primaquine should also be administered to prevent relapses,
• if you are being treated with this medicine 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 this medicine, 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 ultraviolet (UVA) lamps while using this medicine.

If you take this medicine for a long period, your doctor will probably perform periodic 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 about the signs and symptoms of low blood glucose levels. It may be necessary to check your blood glucose level.

Severe skin rashes 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 rashes 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 can cause skin irritation, liver or eye damage.
• Bupropion (used to treat depression).
• Leflunomide (antirheumatic).

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

This medicine 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

This medicine passes into breast milk. This medicine 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 whether this medicine 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 the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor or pharmacist again.

• The tablets are taken orally.
• Swallow the tablets whole without chewing during meals or with a glass of milk.
• The score line is only to help you break the tablet if you have difficulty swallowing it whole.

It is possible that this medicine may not be exactly suitable for the dose you need throughout your treatment. Consult your doctor about using other presentations of Dolquine suitable for each phase of treatment.

The recommended doses are:

Adults

• Treatment of rheumatoid arthritis
• • Initial dose: 400 to 600 mg per day, depending on the patient's response to the medicine. If side effects occur, the initial dose should be reduced and then gradually increased (5-10 days) later.
  • Maintenance dose: once an adequate response is achieved (usually 4-12 weeks), a maintenance dose of 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: 400 mg per day or 200 mg every 12 hours, depending on 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 ideal body weight.

Adolescents with a body weight over 46 kg

• Prevention and treatment of uncomplicated malaria

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

• Prevention of uncomplicated malaria:6.5 mg/kg ideal body weight once a week, not exceeding 400 mg once a 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 may 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:

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

Use in patients with liver or kidney problems:

Your doctor will decide whether 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 medicine than you should, 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 Toxicological 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 for advice on the dosing 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 Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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. The symptoms can include a general feeling of being unwell, 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 swollen lymph nodes. This could be a condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
  • blisters, widespread skin peeling, spots with pus, along with fever. This could be a condition called Acute Generalized Exanthematous Pustulosis (AGEP).
  • blisters or skin peeling around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever. This could be a condition called Stevens-Johnson Syndrome (SJS).
  • multiple skin lesions, itching, joint pains, fever, and a general feeling of being unwell. This could be a condition 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. This could be a condition called Sweet's Syndrome.

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

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

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

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

• Bone marrow failure (the tissue inside the bone that produces blood cells).
• Retinal disorders (a part of the eye) that can 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.
• Psoriasis (a skin disease).

Frequency Not Known(frequency cannot be estimated from the available data)

• Decrease in blood cell count (anemia, leucopenia, thrombocytopenia), dissolution of red blood cells (in individuals with glucose-6-phosphate dehydrogenase deficiency), and agranulocytosis (lack of white blood cells).
• Nightmares.
• Difficulty coordinating movements.
• Paralysis of the extraocular muscle.
• Sudden difficulty breathing (bronchospasm) and respiratory failure.
• Hives.
• Worsening or precipitation of porphyria (a hereditary metabolic disorder).
• 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.

If you notice any side effects not mentioned in this leaflet, or if any of the side effects become serious, tell your doctor or pharmacist.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide 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 expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content and Additional Information

Dolquine Composition

• 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 phosphate dihydrate, 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 Dolquineand Packaging Content

White, oblong, film-coated tablets with a score line on both sides.

It is 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

Manufacturer

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

Date of the Last Revision of this Prospectus: March 2024

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