HYDROXYCHLOROQUINE UXA 200 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the patient

HydroxychloroquineUxa200 mg film-coated tablets EFG

Hydroxychloroquine sulfate

Read the entire leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Hydroxychloroquine Uxaand what is it used for
2. What you need to know before taking Hydroxychloroquine Uxa
3. How to take Hydroxychloroquine Uxa
4. Possible side effects
5. Storage of Hydroxychloroquine Uxa
6. Package contents and additional information

1. What is Hydroxychloroquine Uxa and what is it used for

Adults

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

Children (≥ 6 years and ≥ 35 kg)

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

2. What you need to know before taking Hydroxychloroquine Uxa

Do not take HydroxychloroquineUxa:

• if you are allergic to hydroxychloroquine sulfate, 4-aminoquinoline compounds, or any of the other ingredients 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 your eye color changes or you have any other eye problems.
• if you suffer from 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. Movement disorders (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 exam should be repeated with prolonged use of this medication. If you experience problems while using this medication (e.g., if you notice a decrease in vision clarity, color quality, or if your field of vision decreases), contact your doctor immediately.
• If you have a blood disorder known as porphyria, it may worsen this condition. Your blood will be regularly checked with long-term use.
• If you have a chronic inactive hepatitis B virus infection.
• If you have liver (glucose-6-phosphate dehydrogenase deficiency) or kidney disease, your doctor will use this medication with caution.
• If you have heart problems. After prolonged use, cardiac arrhythmia may occur (see section 4). Additionally, heart failure has been observed after taking this medication, in some cases with fatal outcomes. The 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, trembling, dizziness, irritability, headache, fatigue, hunger) or loss of consciousness, contact your doctor to check your blood levels.
• If you use this medication for a long time, your muscle and tendon function should be periodically checked. If you experience muscle or tendon weakness, 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 use this medication with caution. (See section 4).
• If you are hypersensitive to quinine. If this is the case, inform your doctor.
• Hydroxychloroquine may cause heart rhythm disorders in some patients: caution should be exercised when using hydroxychloroquine if you were born with or have a family history of prolonged QT interval, if you have acquired a prolonged QT interval (observed in the ECG, heart's electrical record), if you have heart problems or have a history of heart attack (myocardial infarction), if you have an electrolyte imbalance in the blood (especially low potassium or magnesium levels).

If you experience palpitations or irregular heartbeats during treatment, inform your doctor immediately. The risk of heart problems may increase with the dose. Therefore, the recommended dose should be followed.

• 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 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.
• 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.

Children

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

Taking HydroxychloroquineUxawithother medications

Inform your doctor or pharmacist if you are taking, have recently taken, or might 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 these medications have on blood sugar, and therefore, the dose may need to be reduced.
• Hydroxychloroquine may reduce the effect of the rabies vaccine.
• Certain medications for treating depression (monoamine oxidase inhibitors (MAOIs)) 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 epileptic seizures. Other antimalarial medications (such as mefloquine) should not be taken with hydroxychloroquine as they may cause seizures with loss of consciousness.
• The effectiveness of antiepileptic medications may be affected if taken simultaneously with hydroxychloroquine.
• Inform your doctor if you are taking any medication known to affect 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 (e.g., halofantrine).

Taking HydroxychloroquineUxawith food and drinks

Hydroxychloroquine Uxashould be taken after meals.

Pregnancy and breastfeeding

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

Pregnancy

Hydroxychloroquine may be associated with a small increased risk of major birth defects and should not be used during pregnancy unless your doctor indicates that it is necessary because the risk of stopping 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, breastfeeding should be discontinued. It is known that small children are very sensitive to the side effects of this medication.

When taking this medication once a week, such as to prevent malaria, you do not need to interrupt 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 fertility in humans.

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 using machines

Hydroxychloroquine Uxamay cause blurred vision and dizziness. If you experience these symptoms, do not drive or use machines.

3. How to take Hydroxychloroquine Uxa

Follow exactly the administration instructions of this medication 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 then 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 a malaria-affected area, you should start treatment one week before arriving in the area and continue for four to eight weeks after leaving the area.

Treatment of an acute attack of uncomplicated malaria

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

Reduced hepatic and renal function

If you have reduced renal or hepatic function, your doctor may prescribe a lower dose.

Duration of treatment

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.

For the treatment of joint disorders, this medication requires several weeks to achieve its best effect.

Use in children

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

If you take more HydroxychloroquineUxathan you should

If you take more Hydroxychloroquine Uxathan you should, talk to your doctor or pharmacist immediately.

An 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), cardiac arrhythmias, and seizures, followed by sudden respiratory and cardiac arrest, which can be fatal. Contact your doctor immediately if these symptoms occur.

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 HydroxychloroquineUxa

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 the next dose, in which case you should continue with your medication as prescribed. Do not take a double dose to make up for forgotten doses.

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

If you stop taking HydroxychloroquineUxa

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.

4. Possible Adverse Effects

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

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

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).
• Blisters, widespread scaly skin, spots with pus along with fever. This 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. This could be a disease called Stevens-Johnson syndrome (SJS).
• Multiple skin lesions, itching, joint pain, fever, and a 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 can also be accompanied by fever. This could be a disease called Sweet's syndrome.
• Liver problems that can cause the eyes or skin to turn yellow (jaundice). 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.

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

• Eye problems. This includes changes in eye color and vision problems, such as blurred vision, sensitivity to light, or changes in color vision. If these problems are detected early, they are usually mild after treatment with hydroxychloroquine is discontinued. If the problems are not detected until later, they may continue or even worsen after treatment is discontinued.
• Seizures
• Weakening of the heart muscle (cardiomyopathy) resulting in difficulty breathing, coughing, high blood pressure, swelling, increased heart rate, and low urine output
• Heart muscle disease (cardiomyopathy) that can be fatal in cases of long-term high-dose treatment (see section 2, "Warnings and Precautions")

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

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

Unknown frequency (cannot be estimated from available data)

• If you have an allergic reaction. Signs may include: red or lumpy 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, bruise more easily than usual, and get infections more easily than usual (anemia, aplastic anemia, thrombocytopenia, leukopenia, or agranulocytosis)
• Liver problems that can cause the eyes or skin to turn yellow (jaundice).
• Low blood sugar levels (hypoglycemia), you may feel nervous, shaky, or sweaty.

Otheradverse effectsassociated with hydroxychloroquine sulfate

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

• Decreased appetite (anorexia).

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

• Nausea, diarrhea, and abdominal pain. These symptoms usually disappear after the dose is reduced or treatment is discontinued.
• Skin rash

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

• Mental problems (such as delirium, hallucinations, and mood changes)
• Vomiting (this usually disappears after the dose is reduced or treatment is discontinued)
• Reduced bone marrow effect (myelosuppression).

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

• Hearing loss (permanent)
• Redness of the skin with irregular, raised spots (erythema multiforme)
• Long-term treatment with structurally related substances to chloroquine phosphate can very rarely lead to reversible phospholipidosis (increased accumulation of intracellular phospholipids), including renal phospholipidosis. Due to the structural similarity, this side effect may also occur with hydroxychloroquine. In this case, impaired renal function may be exacerbated.

Unknown frequency (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, movement disturbances, and tremors.
• Changes in the retina, visual field disorders, in which parts of the visual field cannot be seen (with paracentral rings, everything on the side of the center of the visual field is visible, with pericentral rings, only the center of the visual field is visible), temporary blind spots in the field of vision, and abnormal color observations.
• Changes in the cornea with clouding or fluid retention have been observed. Sometimes the changes do not cause complaints, but you may also have vision disturbances, such as seeing colored rings, blurred vision, or photophobia. These problems are temporary or decrease after treatment is discontinued.
• Blurred vision because the focus of your eye is altered. This problem is temporary and decreases if the dose is reduced.
• Changes in heart rate (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 inside the nose or mouth, hair loss, or loss of hair color (these symptoms usually disappear after the dose is reduced or after treatment is discontinued).
• Cases of eruptions with blisters or bumps.
• Hypersensitivity to light (photosensitivity).
• Skin inflammation with redness and peeling (exfoliative dermatitis).
• A recurring skin condition accompanied by peeling, dry skin rash (psoriasis).
• A rare hypersensitivity reaction (DRESS syndrome) characterized by fever, skin rash, and an increased number of white blood cells associated with liver and lung diseases.
• Musculoskeletal disorders. This can be restored after discontinuation of treatment with this medicine, but recovery may take several months (myopathy).
• Muscle disorder, in which the nerves are also affected, leading to weakness (neuromyopathy leading to progressive weakness).
• Decrease in muscle tissue, reducing muscle strength (atrophy).
• Changes in sensory perception.
• Decrease in tendon reflexes.
• Changes in limb control due to nerve problems.
• Breathing difficulties.
• Abnormal liver function tests.
• Severe liver failure.
• Allergic reactions, such as itchy skin rash with severe itching and bump formation (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 a doctor immediately. The following effects may occur: heart problems leading to irregular heartbeats.
• Depression or thoughts of self-harm or suicide, hallucinations, nervousness or anxiety, confusion, agitation, difficulty sleeping, euphoria, or overexcitement.

Reporting of Adverse Effects

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

5. Storage of Hydroxychloroquine Uxa

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

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Hydroxychloroquine Uxa

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

• Other ingredients:

• Core: cornstarch, calcium hydrogen phosphate dihydrate, colloidal anhydrous silica, polysorbate 80, cornstarch, talc, magnesium stearate.
• Coating: hypromellose (15 cps), talc, titanium dioxide (E171), macrogol 6000, purified water.

Appearance of the Product and Package Contents

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

It is presented in packages of 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

UXAfarma S.A.

Avda. San Francisco Javier 24

41018 Sevilla, Spain

Manufacturer

Laboratorio Fundación DAU

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

08040 Barcelona, Spain

Date of the Last Revision of this Leaflet:October 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/)