HYDROXYCHLOROQUINE TEVA-RATIOPHARM 200 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the patient

Hydroxychloroquine Teva-ratiopharm 200 mg film-coated tablets EFG

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 questions, 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 Teva-ratiopharm and what is it used for
2. What you need to know before taking Hydroxychloroquine Teva-ratiopharm
3. How to take Hydroxychloroquine Teva-ratiopharm
4. Possible side effects
5. Storage of Hydroxychloroquine Teva-ratiopharm
6. Package contents and additional information

1. What is Hydroxychloroquine Teva-ratiopharm 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 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 Teva-ratiopharm

Do not take Hydroxychloroquine Teva-ratiopharm

• 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 problem.
• 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.
• if you have gastrointestinal or blood disorders.
• if you have a condition known as porphyria. Hydroxychloroquine 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 or kidney problems.
• if you have a genetic disorder known as glucose-6-phosphate dehydrogenase deficiency.
• if you have a skin disease characterized by scaly red patches on the skin that usually affect the knees, elbows, and scalp (psoriasis) see section 4 “Possible side effects”). Your doctor will use this medication with caution.
• if you are hypersensitive to quinine.

Before starting to take 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 reduction in vision clarity, color quality, or your field of vision is reduced), contact your doctor immediately. Concomitant use with medications that are known to be harmful to the retina (such as tamoxifen) is not recommended.

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 on the ECG, electrical recording of the heart),
• if you have heart disorders 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 are taking medications that are known to affect your heart rhythm (see section “Taking Hydroxychloroquine Teva-ratiopharm with other medications”).

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

Additionally, heart failure has been observed after using 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 monitored. If you experience muscle or tendon weakness, consult your doctor. The doctor may decide to interrupt treatment.

Movement disorders (extrapyramidal symptoms) (see section 4 “Possible side effects”) may occur when using this medication.

Some people who receive treatment 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 “Possible side effects”), seek medical attention 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 peeling of the skin. 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 Hydroxychloroquine Teva-ratiopharm with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. This includes, in particular:

• Medications that are known to affect your heart rhythm. This includes medications used for
• • abnormal heart rhythm (antiarrhythmics)
  • depression (tricyclic antidepressants)
  • psychiatric disorders (antipsychotics)
  • bacterial infections (e.g., moxifloxacin, azithromycin)
  • HIV treatment (e.g., saquinavir)
  • fungal infections (e.g., fluconazole)
  • parasitic infections (e.g., pentamidine)
  • or malaria (e.g., halofantrine)

• 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.
• Rabies vaccines. Hydroxychloroquine may reduce the effect of the rabies vaccine. It is not recommended to administer the rabies vaccine via intradermal injection when using hydroxychloroquine. When the vaccine is administered in a muscle, the protection is sufficient.
• Certain medications for treating depression (monoamine oxidase inhibitors (MAOIs)) should not be combined with hydroxychloroquine.
• Medications for malaria, such as mefloquine (as it may increase the risk of seizures)
• Medications for epilepsy (seizures), such as phenobarbital, phenytoin, carbamazepine. The effectiveness of antiepileptic medications may be affected if taken simultaneously with hydroxychloroquine.
• Antacid medications (for stomach acidity) and kaolin: Take hydroxychloroquine at least 2 hours apart
• Cimetidine (used for stomach ulcers)
• Medications for bacterial infections (such as rifampicin, clarithromycin)
• Medications for fungal infections (such as itraconazole)
• Medications for lipid disorders (such as gemfibrozil, statins)
• Medications for HIV treatment (such as ritonavir)
• Medications for organ transplants or immune system disorders (such as cyclosporine)
• Medications for depression (fluoxetine, paroxetine)
• Medications for blood clots (such as dabigatran, clopidogrel)
• Medications for heart conditions (such as digoxin, flecainide, propafenone, quinidine, and metoprolol)
• St. John's Wort (a herbal treatment for depression).

Taking Hydroxychloroquine Teva-ratiopharm with food and drinks

Do not drink grapefruit juice, as it may increase the risk of side effects.

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. Your doctor will discuss with you whether hydroxychloroquine is suitable for you.

Pregnancy

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

Malaria prevention and treatment

If your doctor considers that the benefits outweigh the risks, hydroxychloroquine can be used for the prophylaxis and treatment of malaria infections, as the malaria infection itself is harmful to the fetus.

Breastfeeding

This medication is excreted in breast milk. It is known that small children are very sensitive to the side effects of this medication.

Malaria prevention and treatment

Depending on the disease and the duration of treatment, your doctor will decide whether you can use this medication during breastfeeding.

You do not need to stop breastfeeding if you take this medication to prevent malaria. However, the amount of hydroxychloroquine that passes into breast milk is insufficient to prevent malaria in the baby.

Rheumatoid arthritis and lupus erythematosus

If you take hydroxychloroquine in high doses for a long time, it is recommended that you stop breastfeeding.

Fertility

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

Driving and using machines

Hydroxychloroquine Teva-ratiopharm may cause blurred vision and dizziness. If you experience these symptoms, you should not drive or use machines.

3. How to take Hydroxychloroquine Teva-ratiopharm

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The hydroxychloroquine 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 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 Teva-ratiopharm than you should

If you take more Hydroxychloroquine Teva-ratiopharm 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), heart rhythm disorders, 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 Hydroxychloroquine Teva-ratiopharm

If you forget to take a dose of Hydroxychloroquine Teva-ratiopharm, 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 Hydroxychloroquine Teva-ratiopharm

Always consult your doctor if you want to stop taking Hydroxychloroquine Teva-ratiopharm. 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 and consult a doctor or go to a hospital immediately if you experience any of the following adverse effects:

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, 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 stopped.
• Seizures
• Weakening of the heart muscle(cardiomyopathy) that can result in heart failure that can be fatal. Symptoms include fatigue, difficulty breathing, and swollen legs and ankles

Frequency not known (frequency cannot be estimated from available data)

• Severe skin reactions(see section 2, Warnings and Precautions) such as:
• • rash with fever and flu-like symptoms and enlarged lymph nodes. This could be a disease called drug reaction with eosinophilia and systemic symptoms (DRESS).
  • blisters, 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 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.
• 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 have thoughts of self-harm or suicide(see section 2 "Warnings and Precautions")
• If you have an eye problemthat affects the retina, the inside of the eye (maculopathy)
• If you feel weakness, fatigue, fainting, or dizziness, have pale skin, are short of breath, bruise more easily than usual, or get infections such as fever, chills, sore throat, or mouth ulcers more easily than usual. These may be signs of blood disorders called anemia, aplastic anemia, thrombocytopenia, leukopenia, or agranulocytosis.
• Liver problems. 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
• Abnormal heart rhythm, potentially life-threatening irregular heart rhythm(seen on ECG) (see section 2 "Warnings and Precautions")
• Low blood sugar levels(hypoglycemia). You may feel nervous, shaky, or sweaty.

Otheradverse effectsassociated with Hydroxychloroquine Teva-ratiopharm

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

• Decreased appetite (anorexia).
• Exaggerated mood changes

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

• Nervousness
• 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)

• Reduced bone marrow function (myelosuppression)
• Serious mental illness in which control over one's own behavior and actions is impaired (psychosis)
• Vomiting. This usually disappears after the dose is reduced or after treatment is discontinued

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

• Permanent hearing loss
• 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 exacerbated.

Frequency not known (frequency cannot be estimated from available data)

• Worsening of a red blood cell disorder (porphyria).
• Dizziness
• Feeling depressed, delirious, hallucinations, anxiety, confusion, agitation, difficulty sleeping, euphoria, or overexcitement
• Feeling of spinning (vertigo), ringing in the ears (tinnitus)
• Becoming emotional more quickly, headache
• Movement disorders such as muscle tension disorders (dystonia), involuntary muscle movements (dyskinesia), 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 impaired. 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).
• Abnormal liver function tests
• Redness of the skin with irregular, raised spots (erythema multiforme)
• Itching (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 blistering rashes or bumps.
• Increased sensitivity to light (photosensitivity).
• Skin inflammation with redness and peeling (exfoliative dermatitis).
• Recurring skin condition accompanied by peeling, dry skin rash (psoriasis).
• Hives, difficulty breathing
• Muscle diseases (skeletal muscle myopathy or neuromyopathy) that cause progressive weakness and reduced muscle strength (atrophy). This can be restored after treatment with this medicine is discontinued, but recovery may take several months.

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 Teva-ratiopharm

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 that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in 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 Teva-ratiopharm

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

Core of the tablet: cornstarch, calcium phosphate dihydrate (E341), anhydrous colloidal silica (E551), polysorbate 80 (E433), dry cornstarch, talc (E553B), magnesium stearate (E470b).

Coating: hypromellose 15 cps (E464), talc (E553B), macrogol 6000, and titanium dioxide (E171)

Appearance of the Product and Package Contents

Hydroxychloroquine Teva-ratiopharm 200 mg film-coated tablets EFG are white, round, approximately 9.5 mm, biconvex, marked with "200" on one side of the tablet and smooth on the other.

Package Sizes

Hydroxychloroquine Teva-ratiopharm is available in packages containing 30 or 100 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid

Spain

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

2600 Dupnitsa

Bulgaria

or

Teva Pharma B.V.

Swensweg 5

2031GA Haarlem

Netherlands

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Hydroxychloroquin-ratiopharm 200 mg Filmtabletten

Spain Hidroxicloroquina Teva-ratiopharm 200 mg film-coated tablets EFG

Netherlands Hydroxychloroquinesulfaat Teva 200 mg, filmomhulde tabletten

Date of the Last Revision of thisLeaflet:December 2023

Other Sources of Information

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/)

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83938/P_83938.html

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