Package Insert:Information for the Patient

HydroxychloroquineUxa200 mg Film-Coated Tablets

Hydroxychloroquine Sulfate

Read this package insert carefully before taking this medication,because it contains important information for you.

• Keep this package insert, as you may need to read 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.

Adults

• Rheumatoid Arthritis (inflammation of the joints)
• Treatment of uncomplicated acute malaria attacks and to prevent malaria
• Systemic and discoid lupus erythematosus (a skin or internal organ disease)

Children (≥ 6 years and ≥ 35 kg)

• Certain diseases that manifest as skin problems and/or joint disorders (systemic and discoid lupus erythematosus)
• Treatment of uncomplicated acute malaria attacks and to prevent malaria

Do not take HydroxychloroquineUxa:

• if you are allergic to hydroxychloroquine sulfate, 4-aminoquinoline compounds, or any of the other components of this medication (listed in section 6).
• if you have an eye problem that affects the retina, the inside of the eye (maculopathy), or if you change the color of your eye or any other eye problem.
• if you have a certain type of muscle weakness (myasthenia gravis).
• if you weigh less than 35 kg.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take hydroxychloroquine.

• If you have problems with your nervous system or brain. Abnormal movements (extrapyramidal symptoms) may occur (see possible side effects).
• Before starting this medication, your doctor will examine your eyes to determine if there are any abnormalities. This eye examination should be repeated with prolonged use of this medication. If you experience problems while using this medication (for example, if you notice a reduction in visual acuity, color quality, or if your field of vision is reduced), contact your doctor immediately.
• If you have a blood disorder known as porphyria, it may worsen this condition. Your blood will be checked regularly with long-term use.
• If you have a chronic inactive infection with the hepatitis B virus.
• If you have liver disease (glucose-6-phosphate dehydrogenase deficiency) or kidney disease, your doctor will apply this medication with caution.
• If you have heart problems. After prolonged use, arrhythmia (see section 4) may occur. Additionally, heart failure has been observed after the use of this medication, in some cases with fatal outcomes. Symptoms of heart failure include fatigue, difficulty breathing, and swelling of the legs and ankles. Contact your doctor if these symptoms occur.
• This medication may cause a severe decrease in blood sugar levels (hypoglycemia). If you notice any of the following symptoms (sweating, tremors, dizziness, irritability, headache, fatigue, hunger) or loss of consciousness, contact your doctor to verify your blood sugar levels.
• If you use this medication for a long time, your muscle and tendon function should be checked periodically. If you have weak muscles or tendons, consult your doctor.
• If you have a skin disease characterized by scaly red patches on the skin that usually affect the knees, elbows, and scalp (psoriasis). Your doctor will apply this medication with caution (see section 4).
• If you are hypersensitive to quinine. If this is the case, inform your doctor.
• Hydroxychloroquine may cause cardiac rhythm disorders in some patients: caution should be exercised when using hydroxychloroquine if you were born or have a family history of prolonged QT interval, if you have acquired a prolonged QT (observed on ECG, heart electrical recording), if you have heart problems or have a history of heart attack (myocardial infarction), if you have a blood electrolyte imbalance (especially low potassium or magnesium levels).

If you experience palpitations or irregular heartbeats during treatment, you must inform your doctor immediately. The risk of cardiac problems may increase with increasing doses. Therefore, follow the recommended dose.

• Some people treated with hydroxychloroquine 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 others around you notice any of these adverse effects (see section 4), consult a doctor immediately.
• Severe skin eruptions have been reported with the use of hydroxychloroquine (see section 4 possible side effects). Often, the rash may 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 may progress to generalized blisters and skin peeling. If you experience these skin symptoms, stop taking hydroxychloroquine and contact your doctor immediately.

Children

Keep this medication out of the sight and reach of children. Children are particularly sensitive to the potential harmful effects of this medication.

Hydroxychloroquine Uxa with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• Hydroxychloroquine may increase the level of digoxin (used for heart problems) in the blood and could cause a digoxin overdose.
• Medications for diabetes (such as insulin or metformin). Hydroxychloroquine may increase the effect that these medications have on blood sugar levels and, therefore, your dose may need to be reduced.
• Hydroxychloroquine may reduce the effect of the rabies vaccine.
• Certain medications for depression (monoamine oxidase inhibitors (MAO)) should not be combined with hydroxychloroquine.
• Hydroxychloroquine inhibits the CYP2D6 enzyme. Therefore, medications that inhibit CYP2D6 (such as fluoxetine, quinidine, ritonavir, or sertraline) should not be taken simultaneously with hydroxychloroquine.
• Hydroxychloroquine may increase the susceptibility to seizures. Other medications for malaria (such as mefloquine) should not be taken with hydroxychloroquine as they may cause loss of consciousness with seizures.
• The effectiveness of antiepileptic medications may be affected if taken simultaneously with hydroxychloroquine.
• Inform your doctor if you are taking any medication that affects your heart rhythm. This includes medications used for abnormal heart rhythm (antiarrhythmics), for depression (tricyclic antidepressants), for psychiatric disorders (antipsychotics), for bacterial infections, or for malaria (for example, halofantrina).

Hydroxychloroquine Uxa with food and drinks

Hydroxychloroquine Uxa should be taken after meals.

Pregnancy and breastfeeding

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

Pregnancy

Hydroxychloroquine may be associated with a small increase in the risk of major birth defects and should not be used during pregnancy, unless your doctor tells you it is necessary because the risk of interrupting treatment is greater than the potential risk to the fetus.

Breastfeeding

Hydroxychloroquine should not be used during breastfeeding, unless your doctor considers that the benefits outweigh the risks.

Hydroxychloroquine is excreted in small amounts in breast milk. If you use this medication daily in high doses for a prolonged period, it is recommended to stop breastfeeding. It is known that young children are very sensitive to the side effects of this medication.

When taking this medication once a week, as for malaria prevention, you do not need to stop breastfeeding because only a small amount of this medication reaches the baby through breast milk. However, this amount is insufficient to prevent malaria in the baby.

Fertility

There is no information on the effects of hydroxychloroquine on human fertility.

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

Driving and operating machinery

Hydroxychloroquine Uxa may cause blurred vision and dizziness. If you experience these symptoms, you should not drive or operate machinery.

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

The tablets should be taken after meals.

The recommended dose is:

Adults

Rheumatoid Arthritis

Initial dose: 400 mg per day

Maintenance dose: 200 mg per day and your doctor may reduce the dose to 200 mg every other day.

Systemic and Discoid Lupus Erythematosus

Initial dose: 400 mg to 600 mg per day

Maintenance dose: 200 mg to 400 mg per day.

Malaria Prevention

400 mg per week, taken on the same day each week.

When traveling to an area affected by malaria, you should start treatment one week before arriving in the malaria area and continue for four to eight weeks after leaving that area.

Acute Uncomplicated Malaria Treatment

The dose depends on the nature of the infection. The total dose is up to 2 grams and is administered for a maximum of three days.

Reduced Liver and Kidney Function

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

Treatment Duration

Follow your doctor's instructions regarding the duration of treatment. In the case of prolonged treatment with this medication, your doctor will prescribe the lowest possible dose.

This medication requires several weeks to achieve the best effect for the treatment of joint disorders.

Use in Children

Your doctor will determine the dose based on your body weight. The 200 mg tablet is not suitable for children under 6 years or with a body weight less than 35 kg.

If You Take More Hydroxychloroquine Uxa Than You Should

If you take more Hydroxychloroquine Uxa than you should, speak with your doctor or pharmacist immediately.

A overdose is dangerous, especially for small children.

If you take more than the prescribed amount, you may experience headaches, blurred vision, fainting (caused by heart failure), heart arrhythmias, and seizures, followed by sudden respiratory and cardiac arrest that can be fatal. Contact your doctor immediately if you experience these symptoms.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Hydroxychloroquine Uxa

If you forget to take a dose of Hydroxychloroquine Uxa, you can take it as soon as you remember, unless it is almost time for your next dose, in which case you should continue with your medication as prescribed. Do not take a double dose to compensate for missed doses.

If you have forgotten more than one dose, contact your doctor or pharmacist.

If You Interrupt Treatment with Hydroxychloroquine Uxa

Always consult your doctor if you want to stop taking Hydroxychloroquine Uxa. If you have any doubts about the use of this medication, consult your doctor or pharmacist.

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

Stop taking hydroxychloroquine sulfate and consult a doctor or go to the hospital immediately if you experience any of the following side effects:

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

• fever, symptoms of a cold, and swollen lymph nodes. It could be a disease called drug reaction with eosinophilia and systemic symptoms (DRESS).
• blistering, generalized scaly skin, pus-filled spots with fever. It could be a disease called generalized acute pustular psoriasis (PEGA).
• blistering or peeling of the skin around the lips, eyes, mouth, nose, and genitals, symptoms of a cold, and fever. It could be a disease called Stevens-Johnson syndrome (SSJ).
• multiple skin lesions, itching, joint pain, fever, and general feeling of discomfort. It could be a disease called toxic epidermal necrolysis (NET).
• skin reaction, including purple-colored, elevated, and painful ulcers, especially on the arms, hands, fingers, face, and neck, which can also be accompanied by fever. It could be a disease called Sweet syndrome.
• liver problems that can turn your eyes or skin yellow (jaundice). Symptoms can include a general feeling of discomfort, with or without jaundice (yellow discoloration of the skin and eyes), dark urine, nausea, vomiting, and/or abdominal pain. Rare cases of liver failure (including fatal cases) have been observed.

Rare side effects (can affect up to 1 in 1,000 people)

• Eye problems. This includes changes in the color of your eye and problems with vision, such as blurred vision, light sensitivity, or the way you see colors. If these problems are detected early, they will usually be minor after stopping treatment with hydroxychloroquine. If the problems are not detected until later, they may continue or even worsen after stopping treatment.
• Seizures
• weakening of the heart muscle (cardiomyopathy) that results in difficulty breathing, coughing, high blood pressure, swelling, increased heart rate, low urine output
• heart muscle disease (cardiomyopathy) that can be fatal in high doses over a long period (see Section 2, "Warnings and Precautions")

Very rare side effects (can affect up to 1 in 10,000 people)

• Severe skin reactions, such as blisters, generalized scaly skin, along with a high temperature (toxic epidermal necrolysis)
• blistering or peeling of the skin around the lips, eyes, mouth, nose, and genitals, symptoms of a cold, and fever (Stevens-Johnson syndrome)
• sudden skin rash with pimples, fever, and increased white blood cell count (generalized acute pustular psoriasis)

Not known (frequency cannot be estimated from available data)

• If you have an allergic reaction. Signs can include: red or hives rash, difficulty swallowing or breathing, swelling of the eyelids, lips, face, throat, or tongue (angioedema)
• If you feel weak, tired, dizzy, pale skin, shortness of breath, easy bruising, and more frequent infections than usual (anemia, aplastic anemia, thrombocytopenia, leucopenia, or agranulocytosis)
• liver problems that can turn your eyes or skin yellow (jaundice).
• low blood sugar (hypoglycemia), you may feel nervousness, tremors, or sweating.

Other side effects associated with hydroxychloroquine sulfate

Frequent side effects (can affect up to 1 in 10 people)

• Loss of appetite (anorexia).

Uncommon side effects (can affect up to 1 in 100 people)

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

Rare side effects (can affect up to 1 in 1,000 people)

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

Very rare side effects (can affect up to 1 in 10,000 people)

• Permanent hearing loss
• Redness of the skin with irregular, elevated patches (erythema multiforme)
• The long-term treatment with substances structurally related to chloroquine phosphate can very rarely lead to a reversible phospholipidosis (increased intracellular accumulation of phospholipids), including renal phospholipidosis. Due to the structural similarity, this side effect can also occur with hydroxychloroquine. In this case, it can intensify an altered renal function.

Not known (frequency cannot be estimated from available data)

• Worsening of a blood disorder (porphyria).
• Dizziness/dizziness (vertigo)
• Nervousness
• Exaggerated mood changes.
• Ringing in the ears (tinnitus)
• Headache
• Musculoskeletal disorders, such as muscle tension, movement disorders, and tremors.
• Changes in the retina, visual disorders, in which parts of the visual field cannot be seen (with paracentral rings, everything on the side of the central visual field is visible, with pericentral rings only the center of the visual field is visible), temporal visual field defects, and abnormal color observations.
• Corneal changes with turbidity or fluid retention. Sometimes the changes do not cause complaints, but you may also have vision problems, such as seeing colored rings, blurred vision, or photophobia. These problems are temporary or decrease after stopping treatment.
• Blurred vision due to altered eye focus. This problem is temporary and decreases if the dose is reduced.
• Changes in heart rhythm (your doctor may observe the electrical activity of your heart using an electrocardiogram).
• Enlargement of both heart chambers (biventricular hypertrophy).
• Severe itching of the skin (pruritus)
• Changes in skin color or in the interior of your nose or mouth, hair loss, or loss of hair color (these symptoms usually disappear after reducing the dose or stopping treatment).
• Blistering or pustular eruptions.
• Sensitivity to light (photosensitivity).
• Inflammatory skin condition with redness and peeling (dermatitis exfoliativa).
• Recurrent skin condition accompanied by peeling, dry skin rash (psoriasis).
• Rare hypersensitivity reaction (DRESS syndrome) characterized by fever, skin rash, and increased white blood cell count associated with liver and lung diseases.
• Musculoskeletal disorders. This can be restored after stopping treatment with this medication, but recovery may take several months (myopathy).
• Muscle disorder, in which nerves are also affected, leading to weakness (neuromyopathy leading to progressive weakness).
• Muscle atrophy, reducing muscle strength
• Changes in sensory perception.
• Reduced tendon reflexes.
• Problems with controlling your limbs due to nervous system problems.
• Respiratory difficulties.
• Abnormal liver function tests.
• Severe liver failure.
• Allergic reactions, such as severe itching rash and blistering (urticaria). Abnormal heart rhythm, life-threatening irregular heart rhythm (seen on ECG) (see Section 2, "Warnings and Precautions"). If you accidentally take more hydroxychloroquine than you should, inform your doctor immediately. The following effects may occur: heart problems leading to irregular heartbeats.
• Depression or suicidal thoughts, hallucinations, nervousness, anxiety, confusion, agitation, difficulty sleeping, euphoria, or overexcitement.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Pharmacovigilance of Medicines for Human Use: https://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 store at a temperature above 25°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and the

medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medicines you no longer need. By doing so, you will help protect the environment.

Composition of Hydroxychloroquine Uxa

• The active ingredient is hydroxychloroquine sulfate. Each film-coated tablet contains 200 mg of hydroxychloroquine sulfate.

• Other components:

• Nucleus: cornstarch, calcium dihydrogen phosphate, anhydrous colloidal silica, polisorbate 80, dehydrated cornstarch, talc, magnesium stearate.
• Coating: hypromellose (15 cps), talc, titanium dioxide (E171), macrogol 6000, purified water.

Appearance of the product and contents of the packaging

Hydroxychloroquine Uxa is presented in the form of film-coated tablets. The tablets are round, biconvex, white in color, and have the inscription 200 on one of the faces.

It is presented in packaging of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing.

Holder of the marketing authorization

UXAfarma S.A.

Avda. San Francisco Javier 24

41018 Sevilla, Spain

Responsible for manufacturing

Laboratorio Fundación DAU

C/ de la Lletra C, 12-14 Pol. Ind. Zona Franca

08040 Barcelona, Spain

Last review date of this prospectus: October 2023

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