HYDROXYCHLOROQUINE RUBIO 200 mg FILM-COATED TABLETS

2. What you need to know before you take Hydroxychloroquine Rubió

Do not take Hydroxychloroquine Rubió:

• if you are allergic to hydroxychloroquine sulfate, 4-aminoquinoline compounds or any of the other ingredients of this medicine (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 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 you start taking Hydroxychloroquine Rubió.

• If you have problems with your nervous system or brain. Movement disorders (extrapyramidal symptoms) may occur (see possible side effects).
• Before starting this medicine, your doctor will examine your eyes to determine if there are any abnormalities. This eye examination should be repeated with prolonged use of this medicine. If you experience problems while using this medicine (for example, if you notice a reduction in vision clarity, 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 liver (glucose-6-phosphate dehydrogenase deficiency) or kidney disease, your doctor will use this medicine with caution.
• If you have heart problems. After prolonged use, cardiac arrhythmia may occur (see section 4). Additionally, heart failure has been observed after the use of this medicine, 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 you experience these symptoms.
• This medicine 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 medicine for a long time, your muscle and tendon function should be checked periodically. If you suffer from 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 use this medicine 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 disorders or have a history of heart attack (myocardial infarction), if you have a salt imbalance in the blood (especially low levels of potassium or magnesium).

If you experience palpitations or irregular heartbeats during the treatment period, you must 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 have a chronic inactive hepatitis B virus infection.

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

Other medicines and Hydroxychloroquine Rubió

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

• Hydroxychloroquine may increase the level of digoxin (used for heart problems) in the blood and could cause a digoxin overdose.
• Medicines for diabetes (such as insulin or metformin). Hydroxychloroquine may increase the effect these medicines have on blood sugar and, therefore, your dose may need to be reduced.
• Hydroxychloroquine may reduce the effect of the rabies vaccine.
• Certain medicines for treating 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 the susceptibility to epileptic seizures. Other anti-malarial medicines (such as mefloquine) should not be taken with hydroxychloroquine as they may cause loss of consciousness with convulsions.
• The effectiveness of anti-epileptic medicines may be affected if taken simultaneously with hydroxychloroquine.
• Tell your doctor if you are taking any medicine that is known to affect your heart rhythm. This includes medicines used for irregular heartbeats (anti-arrhythmics), for depression (tricyclic antidepressants), for psychiatric disorders (antipsychotics), for bacterial infections, or for malaria (e.g., halofantrine).

Taking Hydroxychloroquine Rubió with food and drinks

Hydroxychloroquine Rubió should be taken after meals.

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

Hydroxychloroquine Rubió may be associated with a small increased risk of important malformations and should not be used during pregnancy unless your doctor considers that the benefits outweigh the risks.

Breastfeeding

Hydroxychloroquine is excreted in breast milk. Hydroxychloroquine Rubió 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 if Hydroxychloroquine Rubió is suitable for you.

Fertility

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

Driving and using machines

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

3. How to take Hydroxychloroquine Rubió

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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 malaria 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 liver and 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 prolonged 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 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 Hydroxychloroquine Rubió than you should

If you take more Hydroxychloroquine Rubió than 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 convulsions, followed by sudden respiratory and cardiac arrest, which 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 medicine and the amount taken.

If you forget to take Hydroxychloroquine Rubió

If you forget to take a dose of Hydroxychloroquine Rubió, 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 medicine 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 Hydroxychloroquine Rubió

Always talk to your doctor if you want to stop taking Hydroxychloroquine Rubió. If you have any doubts about the use of this medicine, 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 Rubió and go to a doctor immediately if you notice any of the following serious adverse effects,you may need urgent medical treatment:

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

• Eye problems. This includes changes in the color of your eye and problems with your vision, such as blurring, sensitivity to light, or the way you see color. If these problems are detected early, they will generally be minor 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, low urine output
• Heart muscle disease (cardiomyopathy) that can be fatal in cases of high doses over a long period (see section 2, "Warnings and Precautions")

Frequency not known (cannot be estimated from available data)

• If you have an allergic reaction. The signs may include: red or lumpy rash, problems swallowing or breathing, swelling of the eyelids, lips, face, throat, or tongue (angioedema)
• If you feel weakness, tiredness, dizziness, pale skin, shortness of breath, bruise more easily than usual, and get infections more easily than usual (anemia, aplastic anemia, thrombocytopenia, leukopenia, or agranulocytosis)
• If you have liver problems. The 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.
• Decreased blood sugar level (hypoglycemia), you may feel a feeling of nervousness, trembling, or sweating.

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

• Multiple skin lesions, itching of the skin, joint pain, fever, and a general feeling of discomfort. This could be a disease called toxic epidermal necrolysis (TEN).
• 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)
• Blisters, widespread scaly skin, pus-filled spots along with fever and an increased number of white blood cells. This could be a disease called acute generalized exanthematous pustulosis (AGEP).
• Rash with fever and flu-like symptoms and enlargement of the lymph nodes. This could be a disease called drug reaction with eosinophilia and systemic symptoms (DRESS).
• 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.

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 after treatment is discontinued)
• Reduced effect of the bone marrow (myelosuppression).

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

• Hearing loss (permanent)
• 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 the structural similarity, this side effect may also occur with hydroxychloroquine. In this case, impaired renal function may be intensified.

Frequency not known (cannot be estimated from available data)

• Worsening of a red blood cell disorder (porphyria).
• Redness of the skin with irregular raised spots (erythema multiforme)
• Drowsiness/dizziness (vertigo)
• Nervousness
• Depression or thoughts of self-harm or suicide, hallucinations, nervousness or anxiety, confusion, agitation, difficulty sleeping, euphoria, or overexcitement.
• Exaggerated 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 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 disorders, 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 the color of your skin or inside your 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.
• Reduction of tendon reflexes.
• Changes in limb control due to nerve problems.
• Breathing difficulties.
• Abnormal liver function tests.
• Severe liver failure.
• Allergic reactions, such as 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 uneven heartbeats.

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 Rubió

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

Store in the original package to protect it from light.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Hydroxychloroquine Rubió

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

Tablet core: microcrystalline cellulose PH102, anhydrous calcium hydrogen phosphate, povidone 30, crospovidone, magnesium stearate.

Coating: opadry 03B28796 white (which contains hypromellose, titanium dioxide, and polyethylene glycol) and purified water.

Appearance of the Product and Package Contents

Hydroxychloroquine Rubió 200 mg film-coated tablets EFG are white, round tablets, approximately 9.7 mm in diameter.

Package Sizes

30 and 60 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Rubió, S.A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal

Barcelona – Spain

Date of the Last Revision of thisLeaflet:November 2023

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