DUPLAXIL 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Duplaxil200mg film-coated tablets EFG

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 pack

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

1. What is Duplaxil and what is it used for

Duplaxil contains the active substance hydroxychloroquine sulfate.

It can be used for:

Adults

• Treatment of a chronic disease that causes inflammation of the joints, muscles, tendons, or ligaments (rheumatoid arthritis).
• Some diseases that manifest, among other symptoms, in the form of skin or joint problems (systemic and discoid lupus erythematosus).
• Treatment of skin problems with sensitivity to sunlight (photodermatosis).
• Treatment of acute episodes of malaria and to prevent malaria.

Children(6years or older and 31kg or more)

• Treatment of juvenile idiopathic arthritis in combination with other treatments.
• Some diseases that manifest, among other symptoms, in the form of skin or joint problems (systemic and discoid lupus erythematosus).
• Treatment of acute episodes of malaria and to prevent malaria.

2. What you need to know before you take Duplaxil

Do not take Hydroxychloroquine:

• If you are allergic to:
• • hydroxychloroquine sulfate or any of the other ingredients of this medicine (listed in section 6).
  • other similar medicines such as quinolones and quinine (other medicines used for malaria).
• If you have certain eye problems (maculopathy or retinitis pigmentosa).
• If you have a certain type of muscle weakness (myasthenia gravis).
• Hydroxychloroquine should not be used in children under 6 years of age and under 31 kg.

If any of the above applies to you, do not take this medicine. If you are not sure, consult your doctor or pharmacist before taking Hydroxychloroquine.

Warnings and precautions

Consult your doctor or pharmacist before taking Hydroxychloroquine:

• If you have liver or kidney problems.
• If you have serious stomach or intestinal problems.
• If you are taking a medicine called tamoxifen, used to treat breast cancer.
• If you have a blood disorder. You may need to have blood tests to check for this.
• If you have heart problems (such as difficulty breathing or chest pain) that may require monitoring.
• If you have any disorder of the nervous system or brain.
• If you have psoriasis (scaly red patches on the skin that usually affect the knees, elbows, and scalp).
• If you have had an adverse reaction to quinine in the past.
• If you have a genetic disorder called glucose-6-phosphate dehydrogenase deficiency.
• If you have a rare disease called porphyria that affects metabolism.
• If you have a chronic inactive hepatitis B virus infection.
• Hydroxychloroquine may lower your blood sugar levels. Ask your doctor to inform you about the symptoms and signs of low blood sugar levels. It may be necessary to check your blood sugar levels.
• If you have hearing loss.
• Severe skin reactions have been reported with the use of hydroxychloroquine (see section 4, possible side effects). These reactions often involve 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 reaction can progress to widespread blisters and skin peeling. If you experience these skin symptoms, stop taking hydroxychloroquine and contact your doctor immediately.

Before starting treatment with Duplaxil

• Before starting to take this medicine, your doctor will perform an eye examination to determine if there are any abnormalities. This eye examination will need to be repeated if this medicine is used for a long time, at least every 6 months while taking hydroxychloroquine. If you are over 65 years old, need to take a high dose (two tablets a day), or have kidney problems, this examination will need to be performed more frequently. If you experience problems while taking this medicine (such as a reduction in vision, color quality, or field of vision), contact your doctor immediately.
• Hydroxychloroquine may cause changes in heart rhythm in some patients: it is necessary to take this medicine with caution if you have a congenital prolongation of the QT interval or a family history, if you have an acquired prolongation of the QT interval (observed on the ECG, a record of the heart's electrical activity), if you have heart problems or a history of heart attack (myocardial infarction), if you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium, see "Other medicines and Duplaxil"). If you experience palpitations or irregular heartbeats during treatment, inform your doctor immediately. The risk of heart problems may increase with the increase in dose. Therefore, the recommended dose should be followed.
• If you take this medicine for a long time, you will need to have a muscle and tendon examination periodically. Consult your doctor if you start to notice muscle or tendon weakness.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking Duplaxil.

Some people treated with Duplaxil 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.

Children

Hydroxychloroquine should not be used in children under 6 years of age and under 31 kg. Young children are especially sensitive to the toxic effects of quinolones, so this medicine should be kept out of the reach of children.

Other medicines and Duplaxil

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Certain medicines for treating depression (monoamine oxidase inhibitors [MAOIs]) should not be combined with Hydroxychloroquine.
• Taking Hydroxychloroquine with digoxin (a heart medicine) may have a potent and undesirable effect on digoxin.
• Hydroxychloroquine may reduce the effect of the rabies vaccine.
• Hydroxychloroquine may increase the risk of epileptic seizures, especially if used with antimalarial medicines (such as mefloquine). Hydroxychloroquine may also reduce the effectiveness of antiepileptics.
• Hydroxychloroquine may increase the effect of certain diabetes medicines (such as insulin or metformin) on blood sugar levels. Therefore, it may be necessary to reduce the dose of insulin or other antidiabetics.
• Tell your doctor if you are taking any medicine that is known to affect heart rhythm, including medicines used to treat irregular heartbeats (antiarrhythmics), depression (tricyclic antidepressants), mental disorders (antipsychotics), bacterial infections, or malaria (e.g., halofantrine).

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. Your doctor will tell you if this medicine is suitable for you.

Pregnancy

Do not use Duplaxil during pregnancy in high daily doses unless your doctor tells you it is necessary because the risk of stopping treatment is greater than the possible risks to the fetus.

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

Breastfeeding

This medicine is excreted in breast milk. There is not enough data on the effects of hydroxychloroquine in newborns/infants. Depending on the disorder and duration of treatment, your doctor will decide if you can use this medicine during breastfeeding. When taking this medicine once a week, such as to prevent malaria, you do not need to stop breastfeeding. However, this amount is not sufficient to prevent malaria in the infant.

Driving and using machines

You may experience eye problems and dizziness while taking this medicine. If this happens, do not drive or use tools or machines and inform your doctor immediately.

Duplaxil contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Duplaxil

Follow exactly the administration instructions of the medicine given by your doctor or pharmacist. Your doctor will decide your daily dose. If you are not sure, ask your doctor or pharmacist.

How much to take

The recommended dose is:

Adults

Rheumatoid arthritis

Initial dose: 400 mg per day, in one single dose or divided into two doses once a day.

Maintenance dose: 200 mg per day, later possibly 200 mg every two days.

Systemic and discoid lupus erythematosus

Initial dose: from 400 mg (in one single dose or divided into two doses) to 600 mg (in one single dose or divided into two or three doses) per day.

Maintenance dose: from 200 mg to 400 mg (in one single dose or divided into two doses) per day.

Skin disorders caused by sunlight

Treatment is restricted to periods when you are exposed to a large amount of sunlight.

Adults: 400 mg per day, in one single dose or divided into two doses, are usually sufficient.

Malaria prevention

Adults: 400 mg per week on the same day each week. For the prevention of malaria, you should receive treatment for one week before arriving in the malaria area and continue it for four weeks after leaving the area.

Treatment of an acute episode of malaria

The dose in case of an acute episode of malaria depends on the nature of the infection. The total dose consists of a maximum of 2 g and is administered over a maximum period of three days.

Children

Your doctor will determine the dose based on body weight. The 200 mg tablet is not suitable for children with a body weight of less than 31 kg.

Renal and hepatic impairment

If you have kidney or liver problems, your doctor may prescribe a lower dose.

Duration of treatment

Follow your doctor's instructions regarding the duration of treatment. Your doctor will give you the lowest possible dose for as long as your treatment with this medicine continues. When treating joint disorders, the medicine requires a few weeks to achieve its optimal effect.

Taking this medicine

• Take the medicine by mouth.
• Swallow the tablets whole after a meal.
• If you take this medicine to treat skin problems sensitive to sunlight, do so only during periods of high sun exposure.
• Your doctor will calculate the dose based on your body weight. If you think the effect of the medicine is too weak or too strong, do not change the dose yourself, consult your doctor.
• If you have been taking this medicine to treat rheumatoid arthritis for a long time (more than 6 months) and feel it is not helping, go to your doctor, as it may be necessary to stop treatment.

If you take more Duplaxil than you should

• If you take more hydroxychloroquine than you should, contact your doctor immediately, the emergency department of the nearest hospital, or call the Toxicology Information Service, telephone 91 562 04 20. Bring the medicine with you and indicate the amount taken.
• In this way, the doctor will know what you have taken. The following side effects may occur: headache, vision problems, sudden drop in blood pressure, seizures, and heart problems followed by sudden severe respiratory problems and possibly a heart attack. Overdose of Hydroxychloroquine can be fatal.
• Young children and babies are especially at risk if they accidentally take Hydroxychloroquine. Take the child to the hospital immediately.

If you forget to take Duplaxil

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Duplaxil

Keep taking the medicine until your doctor tells you to stop. Do not stop taking this medicine just because you feel better. If you stop treatment, the disease may worsen.

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.

Stop taking the medicine and go immediately to a doctor or hospital ifyou suffer from any of the following adverse effects:

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

• Eye problems, including changes in eye color and vision problems such as blurred vision, sensitivity to light, or changes in color perception. If these effects are observed early, they usually decrease after discontinuing treatment with this medicine. If these problems are not detected until later, the problems may persist or even worsen after discontinuing treatment.
• Seizures
• Weakening of the heart muscle (heart failure) leading to breathing difficulties, cough, high blood pressure, swelling, increased heart rate, and low urine output.
• Heart muscle disorder (cardiomyopathy) that can be fatal in cases of prolonged use of high doses (see section 2, "Warnings and Precautions").

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

• Severe skin reactions such as blistering and generalized scaly skin along with high temperature (toxic epidermal necrolysis).
• Blistering or peeling of the skin around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever (Stevens-Johnson syndrome).
• Sudden onset of a rash with pimples, fever, and an increased number of white blood cells (acute generalized exanthematous pustulosis, AGEP).

Frequency not known (cannot be estimated from available data)

• Allergic reaction. Signs may include a red or nodular rash, difficulty swallowing or breathing, and swelling of the eyelids, lips, face, throat, or tongue (angioedema).
• Feeling of weakness, fatigue, fainting, dizziness, pale skin, shortness of breath, increased tendency to bruise, and easier than usual development of infections (anemia, aplastic anemia, thrombocytopenia, leukopenia, or agranulocytosis).
• Liver problems that can cause yellowing of the eyes or skin (jaundice).
• Decreased blood sugar levels (hypoglycemia), may feel nervousness, agitation, or sweating.
• Depression or thoughts of self-harm or suicide, hallucinations, nervousness or anxiety, confusion, agitation, difficulty sleeping, euphoria, or overexcitement.
• 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 disease called drug reaction with eosinophilia and systemic symptoms (DRESS).
• blistering, generalized scaly skin, and pus-filled spots along with fever. This could be a disease called acute generalized exanthematous pustulosis (AGEP).
• blistering or peeling of the skin around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever. This could be a disease called Stevens-Johnson syndrome (SJS).
• multiple skin lesions, itching, joint pain, fever, and general feeling of discomfort. This 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. This could be a disease called Sweet's syndrome.

• Liver problems. Symptoms may include 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 severe liver failure (including fatal cases) have been observed.

Other Adverse Effects Associated with Hydroxychloroquine Sulfate

Frequent adverse effects (may affect up to 1 in 10 people)

• Decreased appetite (anorexia).

Infrequent adverse effects (may affect up to 1 in 100 people)

• Nausea, diarrhea, and abdominal pain. These symptoms usually disappear after reducing the dose or discontinuing treatment.
• Skin rash.

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

• Mental problems (such as delirium, hallucinations, and mood changes).
• Vomiting (usually disappears after reducing the dose or discontinuing treatment).
• Decreased bone marrow effect (myelosuppression).

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

• Permanent hearing loss.
• Redness of the skin with irregular, raised spots (erythema multiforme).
• Long-term treatment with a structurally similar substance, chloroquine phosphate, may rarely result in reversible phospholipidosis (increased accumulation of intracellular phospholipids), including renal phospholipidosis. Due to structural similarity, this adverse effect may also occur with hydroxychloroquine. In these cases, renal failure may worsen.

Frequency not known (cannot be estimated from available data)

• Worsening of a red blood cell disorder (porphyria).
• Drowsiness/dizziness (vertigo).
• Nervousness.
• Exaggerated mood changes.
• Ringing in the ears (tinnitus).
• Headache.
• Movement disorders such as muscle tension and tremors.
• Retinal changes, visual field disorders that prevent perception of parts of the visual field (with paracentral rings, only the center of the visual field can be perceived, with pericentral rings, only the periphery of the visual field can be perceived), transient blind spots in the visual field, and perception of abnormal colors.
• Corneal changes with clouding or fluid retention. Some changes do not cause symptoms, but may also cause visual disturbances such as perceiving colored rings, blurred vision, or photophobia. These problems are temporary or decrease after discontinuing treatment.
• Blurred vision due to changes in eye focus. This change is temporary and decreases with dose reduction.
• Heart rhythm changes (your doctor may examine the heart's electrical activity with an electrocardiogram).
• Increased size of both heart chambers (biventricular hypertrophy).
• Intense itching of the skin (pruritus).
• Changes in skin color inside the nose or mouth, hair loss, or loss of hair color (these symptoms usually disappear after dose reduction or treatment discontinuation).
• Cases of rash with blisters or bumps.
• Hypersensitivity to light (photosensitivity).
• Skin inflammation with redness and peeling (exfoliative dermatitis).
• Recurring skin disorder with scaly, dry skin rash (psoriasis).
• A rare hypersensitivity reaction (DRESS syndrome) characterized by fever, skin rash, and increased white blood cell count associated with liver and lung disorders.
• Musculoskeletal disorders. They may reverse after discontinuing treatment with this medicine, but recovery may take several months (myopathy).
• Muscle disorder that also affects the nerves, leading to weakness (neuromyopathy leading to progressive weakness).
• Decrease in muscle tissue that reduces muscle strength (atrophy).
• Changes in sensory perception.
• Decreased tendon reflexes.
• Changes in limb control due to nerve problems.
• Breathing difficulties.
• Abnormal liver function test results.
• Severe liver failure.
• Allergic reactions such as itchy skin rash with bumps (urticaria).
• Abnormal heart rhythms, potentially life-threatening irregular heartbeats (detected on ECG; see section 2, "Warnings and Precautions"). If you accidentally take more hydroxychloroquine than you should, inform your doctor immediately. Heart problems that cause irregular heartbeats may occur.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed 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 Duplaxil

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

Do not use this medicine after the expiration date stated on the blister or carton after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the pharmacy's SIGRE point . Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Duplaxil Composition

• Each tablet contains 200 mg of the active ingredient, hydroxychloroquine sulfate.
• The other ingredients are lactose monohydrate, cornstarch, magnesium stearate (E470b), povidone (E1201), polyvinyl alcohol (E1203), talc (E553b), macrogol, and titanium dioxide (E171).

Product Appearance and Package Contents

Duplaxil 200 mg film-coated tablets are white or off-white, peanut-shaped, biconvex, and film-coated with the inscription "H11" on one side and smooth on the other.

The approximate dimensions are 12.80 ± 0.05 mm × 6.10 ± 0.05 mm.

They are supplied in blisters of 20, 30, 50, 60, 90, or 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo, 29

08022 Barcelona, Spain

Manufacturer

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona 08040, Spain

Date of Last Revision of this Leaflet:December 2023

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