Hydroxychloroquine Uxa 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Hydroxychloroquine Uxa 200 mg film-coated tablets EFG

Hydroxychloroquine sulfate

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Hydroxychloroquine Uxa is and what it is used for
2. What you need to know before taking Hydroxychloroquine Uxa
3. How to take Hydroxychloroquine Uxa
4. Possible adverse effects
5. How to store Hydroxychloroquine Uxa
6. Contents of the pack and other information

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

Adults

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

Children (≥ 6 years and ≥ 35 kg)

• Certain diseases characterized by skin problems and/or joint disorders (systemic and discoid lupus erythematosus)
• Treatment of acute attacks of uncomplicated malaria and prevention of malaria

2. What you need to know before taking Hidroxicloroquina Uxa

Do not take Hidroxicloroquina Uxa:

• if you are allergic to hydroxychloroquine sulfate, to 4-aminoquinoline compounds, or to any of the other ingredients of this medicine (listed in section 6).
• if you have an eye condition affecting the retina, the inside of the eye (maculopathy), or if you experience a change in eye color or any other eye problem.
• if you suffer from a certain type of muscle weakness (myasthenia gravis).
• if you weigh less than 35 kg.

Warnings and precautions

Talk to your doctor or pharmacist before starting hydroxychloroquine.

• If you have nervous system or brain disorders. Movement disorders (extrapyramidal symptoms) may occur (see possible side effects).
• Before starting this medicine, your doctor will examine your eyes to check for abnormalities. This eye examination should be repeated during prolonged use of this medicine. If you experience eye problems while using this medicine (for example, if you notice reduced sharpness of vision, color vision changes, or reduced field of vision), contact your doctor immediately.
• If you have a known blood disorder called porphyria, this condition may worsen. Your blood will be monitored regularly during long-term use.
• If you have an inactive chronic infection with hepatitis B virus.
• If you have liver (glucose-6-phosphate dehydrogenase deficiency) or kidney disease, your doctor will use this medicine with caution.
• If you have heart problems. Prolonged use may lead to cardiac arrhythmia (see section 4). In addition, heart failure has been observed after use of this medicine, in some cases with fatal outcomes. Symptoms of heart failure include fatigue, difficulty breathing, and swelling of legs and ankles. Contact your doctor if these symptoms occur.
• This medicine may cause a severe drop in blood sugar levels (hypoglycemia). If you notice any of the following symptoms (sweating, trembling, dizziness, irritability, headache, tiredness, hunger) or loss of consciousness, contact your doctor to check your blood sugar levels.
• If you take this medicine for a long time, the function of your muscles and tendons should be monitored periodically. If you experience weak muscles or tendons, consult your doctor.
• If you have a skin disease characterized by scaly red patches on the skin, usually affecting the knees, elbows, and scalp (psoriasis). Your doctor will use this medicine with caution. (See section 4).
• If you are hypersensitive to quinine. Inform your doctor if this applies to you.
• Hydroxychloroquine may cause disturbances in heart rhythm in some patients: caution is needed when using hydroxychloroquine if you were born with or have a family history of prolonged QT interval, if you have acquired QT prolongation (seen on ECG, the electrical recording of the heart), if you have heart disorders or a history of heart attack (myocardial infarction), or if you have an imbalance of salts in the blood (especially low levels of potassium or magnesium).

If you experience palpitations or irregular heartbeats during treatment, you must inform your doctor immediately. The risk of heart problems may increase with higher doses. 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 people around you notice any of these adverse effects (see section 4), consult a doctor immediately.
• Serious skin rashes have been reported with the use of hydroxychloroquine (see section 4, possible adverse effects). Often, the rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, inflamed eyes). These serious skin rashes are often preceded by flu-like symptoms such as fever, headache, and body aches. The skin rash may progress to widespread blisters and skin peeling. If you develop these skin symptoms, stop taking hydroxychloroquine and contact your doctor immediately.

Children

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

Taking Hidroxicloroquina Uxa with other medicines

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

• Hydroxychloroquine may increase blood levels of digoxin (used for heart problems) and could lead to digoxin overdose.
• Medicines for diabetes (such as insulin or metformin). Hydroxychloroquine may enhance the effect of these medicines on blood sugar, so your dose may need to be reduced.
• Hydroxychloroquine may reduce the effectiveness of the rabies vaccine.
• Certain medicines used to treat depression (monoamine oxidase inhibitors (MAOIs)) should not be combined with hydroxychloroquine.
• Hydroxychloroquine inhibits the CYP2D6 enzyme. Therefore, medicines that inhibit CYP2D6 (such as fluoxetine, quinidine, ritonavir, or sertraline) should not be taken simultaneously with hydroxychloroquine.
• Hydroxychloroquine may increase susceptibility to epileptic seizures. Other antimalarial medicines (such as mefloquine) should not be taken with hydroxychloroquine, as they may cause loss of consciousness with convulsions.
• The effectiveness of antiepileptic medicines may be affected if taken at the same time as hydroxychloroquine.
• Inform your doctor if you are taking any medicine known to affect your heart rhythm. This includes medicines used for abnormal heart rhythm (antiarrhythmics), for depression (tricyclic antidepressants), for psychiatric disorders (antipsychotics), for bacterial infections, or for malaria (e.g., halofantrine).

Taking Hidroxicloroquina Uxa with food and drinks

Hidroxicloroquina Uxa should be taken after meals.

Pregnancy and breastfeeding

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

Pregnancy

Hydroxychloroquine may be associated with a small increased risk of major birth defects and should not be used during pregnancy unless your doctor determines 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 take this medicine daily at high doses for a prolonged period, breastfeeding should be discontinued. It is known that young children are highly sensitive to the side effects of this medicine.

When taking this medicine once a week, as for malaria prevention, breastfeeding does not need to be interrupted because only a small amount of the medicine passes into breast milk. However, this amount is insufficient to prevent malaria in the infant.

Fertility

There is no information available on the effects of hydroxychloroquine on fertility in humans.

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

Driving and using machines

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

3. How to take Hydroxychloroquine Uxa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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 daily
Maintenance dose: 200 mg daily, and then your doctor may reduce your dose to 200 mg on alternate days.

Systemic and discoid lupus erythematosus

Initial dose: 400 mg to 600 mg daily
Maintenance dose: 200 mg to 400 mg daily.

Malaria prevention

400 mg once a week, taken on the same day each week.

When travelling to a malaria-affected area, you should start treatment one week before arriving in the malaria zone 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, administered over a maximum of three days.

Reduced liver or kidney function

If you have reduced liver or kidney 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 long-term treatment with this medicine, your doctor will prescribe the lowest possible dose.

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

Use in children

Your doctor will determine the dose according to body weight. The 200 mg tablet is not suitable for children under 6 years of age or with a body weight below 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.

An overdose is dangerous, especially for young children.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Hydroxychloroquine Uxa

If you forget to take a dose of Hydroxychloroquine Uxa, you may take it as soon as you remember, unless it is almost time for your next dose, in which case you should continue taking your medicine as prescribed. Do not take a double dose to make up for a missed dose.

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

If you stop taking Hydroxychloroquine Uxa

Always consult your doctor if you wish to stop taking Hydroxychloroquine Uxa. If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 condition called drug reaction with eosinophilia and systemic symptoms (DRESS).
• Blisters, widespread scaly skin, pus-filled spots along with fever. This could be a condition 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 condition called Stevens-Johnson syndrome (SJS).
• Multiple skin lesions, itchy skin, joint pain, fever, and general malaise. This could be a condition called toxic epidermal necrolysis (TEN).
• Skin reaction, including painful, raised plum-colored lesions, 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.
• Liver problems that may cause the eyes or skin to turn yellow (jaundice). Symptoms may include general malaise, 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 the color of your eye and vision problems such as blurred vision, light sensitivity, or changes in how you perceive color. If these problems are detected early, they are usually mild after stopping hydroxychloroquine treatment. If the problems are not detected until later, they may continue or even worsen after stopping treatment.
• Seizures
• Weakening of the heart muscle (cardiomyopathy), resulting in difficulty breathing, cough, high blood pressure, swelling, increased heart rate, low urine output
• Heart muscle disease (cardiomyopathy), which may be fatal with long-term high-dose use (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 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 skin rash with pustules, fever, and increased white blood cell count (acute generalized exanthematous pustulosis)

Not known (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 weakness, fatigue, dizziness, pale skin, shortness of breath, bruise more easily than usual, or get infections more easily than normal (anemia, aplastic anemia, thrombocytopenia, leucopenia, or agranulocytosis)
• Liver problems that may cause the eyes or skin to turn yellow (jaundice).
• Decreased blood sugar levels (hypoglycemia); you may feel nervousness, trembling, or sweating.

Other adverse effects associated 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 resolve after dose reduction or discontinuation of 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 (this usually resolves after dose reduction or discontinuation of treatment)
• Reduced bone marrow function (myelosuppression)

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

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

Not known (frequency cannot be estimated from available data)

• Worsening of a red blood cell disorder (porphyria).
• Drowsiness/dizziness (vertigo)
• Nervousness
• Marked changes in mood.
• 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 beside 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 visual field, and abnormal color perception.
• Corneal changes with clouding or fluid retention have been observed. Sometimes these changes cause no symptoms, but vision disturbances such as seeing colored halos, blurred vision, or photophobia may occur. These problems are temporary or improve after discontinuation of treatment.
• Blurred vision due to altered focusing of the eye. This problem is temporary and improves with dose reduction.
• Changes in heart rhythm (your doctor may monitor the electrical activity of your heart using an electrocardiogram).
• Enlargement of both heart chambers (biventricular hypertrophy).
• Severe skin itching (pruritus)
• Changes in skin color or inside the nose or mouth, hair loss, or loss of hair color (these symptoms usually resolve after dose reduction or discontinuation of treatment).
• Cases of blistering or bump-forming rashes.
• Increased sensitivity to light (photosensitivity).
• Skin inflammation with redness and peeling (exfoliative dermatitis).
• Recurrent skin condition accompanied by scaling, dry skin rash (psoriasis).
• A rare hypersensitivity reaction (DRESS syndrome) characterized by fever, rash, and increased white blood cell count associated with liver and lung disease.
• Musculoskeletal disorders. These may recover after discontinuation of this medicine, but recovery may take several months (myopathy).
• Muscle disorder affecting nerves as well, leading to weakness (neuromyopathy leading to progressive weakness).
• Loss of muscle tissue, reducing muscle strength (atrophy).
• Changes in sensory perception.
• Reduced tendon reflexes.
• Impaired limb control due to nerve problems.
• Breathing difficulties.
• Abnormal liver function tests.
• Severe liver failure.
• Allergic reactions, such as itchy rash and hives (urticaria). Abnormal heart rhythm, life-threatening irregular heartbeat (seen on ECG) (see section 2, "Warnings and precautions"). If you accidentally take more hydroxychloroquine than you should, contact 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of HidroxicloroquinaUxa

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

• The other components are:

• Core: maize starch, calcium hydrogen phosphate dihydrate, anhydrous colloidal silica, polysorbate 80, dehydrated maize starch, talc, magnesium stearate.

• Coating: hypromellose (15 cps), talc, titanium dioxide (E171), macrogol 6000, purified water.

Appearance of the product and contents of the pack

Hidroxicloroquina Uxa is presented as film-coated tablets. The tablets are round, biconvex, white in colour, with the inscription "200" on one side.

It is available in packs of 30 and 60 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent review of this leaflet: October 2023

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