Hydroxychloroquine Teva-Ratiopharm 200 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Hydroxychloroquine Teva-ratiopharm 200 mg film-coated tablets EFG

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

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Hydroxychloroquine Teva-ratiopharm is and what it is 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. How to store Hydroxychloroquine Teva-ratiopharm
6. Contents of the pack and other information

1. What Hidroxicloroquina Teva-ratiopharm is and what it is used for

Adults

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

Children (≥ 6 years and ≥ 35 kg)

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

2. What you need to know before taking Hidroxicloroquina Teva-ratiopharm

Do not take Hidroxicloroquina Teva-ratiopharm

• 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 problems.
• if you suffer from a certain form of muscle weakness (myasthenia gravis).
• if you weigh less than 35 kg.

Warnings and precautions

Talk to your doctor or pharmacist before taking hydroxychloroquine if:

• you have problems with your nervous system.
• you suffer from gastrointestinal or blood disorders.
• you have a known disorder called porphyria. Hydroxychloroquine may worsen this condition. Your blood will be monitored regularly during long-term use.
• you have a chronic inactive infection with hepatitis B virus.
• you have liver or kidney problems.
• you have a genetic disorder known as glucose-6-phosphate dehydrogenase deficiency.
• 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 medicine with caution.
• you are hypersensitive to quinine.

Before starting this medicine, your doctor will examine your eyes to check for any abnormalities. This eye examination should be repeated during prolonged use of this medicine. If you experience vision problems while taking this medicine (for example, if you notice reduced visual clarity, changes in color vision, or a narrowed field of vision), contact your doctor immediately. Concomitant use with medicines known to be harmful to the retina (such as tamoxifen) is not recommended.

Hydroxychloroquine may cause heart rhythm disturbances in some patients. Use hydroxychloroquine with caution:

• 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),
• if you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium),
• if you are taking medicines known to affect your heart rhythm (see section “Taking Hidroxicloroquina Teva-ratiopharm with other medicines”).

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

In addition, heart failure has been observed after using this medicine, 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 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.

Hydroxychloroquine may cause cardiac, renal, or muscular disorders. Consult your doctor for information about the signs and symptoms of drug-induced phospholipidosis. It may be necessary to discontinue hydroxychloroquine.

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

Some people receiving 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 in individuals who have never had similar problems before. If you or people around you notice any of these adverse 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 may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, inflamed eyes). These severe 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 Teva-ratiopharm with other medicines

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

• Medicines known to affect your heart rhythm. This includes medicines used for:

  • abnormal heart rhythm (antiarrhythmics)
  • depression (tricyclic antidepressants)
  • psychiatric disorders (antipsychotics)
  • bacterial infections (e.g., moxifloxacin, macrolides including azithromycin, roxithromycin, spiramycin)
  • HIV treatment (e.g., saquinavir)
  • fungal infections (e.g., fluconazole)
  • parasitic infections (e.g., pentamidine)
  • or for malaria (e.g., halofantrine)

• Medicines for diabetes (such as insulin or metformin). Hydroxychloroquine may enhance the effect of these medicines on blood sugar levels, and therefore your dose may need to be reduced.

• Rabies vaccines. Hydroxychloroquine may reduce the effectiveness of the rabies vaccine. Administration of the rabies vaccine via skin injection is not recommended when using hydroxychloroquine. When the vaccine is administered intramuscularly, protection is sufficient.

• Certain medicines for treating depression (monoamine oxidase inhibitors (MAOIs)) must not be combined with hydroxychloroquine.

• Medicines for malaria such as mefloquine (as it may increase the risk of seizures)

• Medicines for epilepsy (seizures), such as phenobarbital, phenytoin, carbamazepine. The effectiveness of antiepileptic medicines may be affected if taken simultaneously with hydroxychloroquine.

• Antacids (for stomach acidity) and kaolin: Take hydroxychloroquine at least 2 hours apart.

• Cimetidine (used for stomach ulcers)

• Medicines for bacterial infections (such as rifampicin, clarithromycin)

• Medicines for fungal infections (such as itraconazole)

• Medicines for lipid disorders (such as gemfibrozil, statins)

• Medicines for HIV treatment (such as ritonavir)

• Medicines for organ transplants or immune system disorders (such as cyclosporine)

• Medicines for depression (fluoxetine, paroxetine)

• Medicines for blood clots (such as dabigatran, clopidogrel)

• Medicines for heart conditions (such as digoxin, flecainide, propafenone, quinidine, and metoprolol)

• St. John’s wort (a herbal remedy for depression).

Taking Hidroxicloroquina Teva-ratiopharm with food and drinks

Do not drink grapefruit juice, as it may increase the risk of adverse 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 medicine. Your doctor will discuss 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 may be used for the prevention and treatment of malaria infections, as the malaria infection itself is harmful to the fetus.

Breastfeeding

This medicine is excreted in breast milk. It is known that young children are highly sensitive to the side effects of this medicine.

Malaria prevention and treatment

Depending on the condition and duration of treatment, your doctor will decide whether you can use this medicine while breastfeeding.

You do not need to stop breastfeeding if you are taking this medicine for malaria prevention. However, the amount of hydroxychloroquine passed through breast milk is insufficient to prevent malaria in the infant.

Rheumatoid arthritis and systemic lupus erythematosus

If you are taking hydroxychloroquine at high doses for a prolonged period, it is recommended that you stop breastfeeding.

Fertility

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

Driving and using machines

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

3. How to take Hydroxychloroquine Teva-ratiopharm

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Hydroxychloroquine tablets should be taken after meals.

The recommended dose is:

Adults

Rheumatoid arthritis

Initial dose: 400 mg daily
Maintenance dose: 200 mg daily; later your doctor may reduce the 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.

Prevention of malaria

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 entering the malaria zone and continue for four to eight weeks after leaving the area.

Treatment of an acute uncomplicated malaria attack

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. For 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 based on 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 Teva-ratiopharm than you should

If you take more Hydroxychloroquine Teva-ratiopharm than you should, speak to 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 heart 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. Telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Hydroxychloroquine Teva-ratiopharm

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

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 wish to stop taking Hydroxychloroquine Teva-ratiopharm. If you have any doubts 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 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, light sensitivity, or changes in how you perceive color. If these problems are detected early, they usually improve 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), which can lead to heart failure that may be fatal. Symptoms include fatigue, shortness of breath, 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 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 raised, painful, plum-colored ulcers, 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.
• If you have an allergic reaction. Signs may include: red or blotchy 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 problem affecting 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, severe chills, sore throat, or mouth ulcers more easily than normal. These may be signs of blood disorders called anemia, aplastic anemia, thrombocytopenia, leucopenia, or agranulocytosis.
• Liver problems. Symptoms may include a general feeling of being unwell, 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 reported.
• Abnormal heart rhythm, potentially life-threatening irregular heart rhythm (seen on ECG) (see section 2 “Warnings and precautions”)
• Decreased blood sugar level (hypoglycemia). You may feel nervous, shaky, or sweaty.

Other adverse effects associated with Hydroxychloroquine Teva-ratiopharm

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

• Decreased appetite (anorexia)
• Exaggerated changes in mood

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

• Nervousness
• Nausea, diarrhea, and abdominal pain. These symptoms usually resolve after reducing the dose or stopping treatment.
• Skin rash

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

• Reduced bone marrow function (myelosuppression)
• Severe mental illness in which control over one's own behavior and actions is impaired (psychosis)
• Vomiting. This usually resolves after dose reduction or discontinuation of treatment.

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

• Hearing loss (permanent)

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

• Worsening of a red blood cell disorder (porphyria)
• Accumulation of a type of fat in tissues causing damage (phospholipidosis; see section 2 “Warnings and precautions”). Your doctor may decide to discontinue hydroxychloroquine treatment.
• Dizziness
• Feeling depressed, delusions, hallucinations, anxiety, confusion, agitation, difficulty sleeping, euphoria, or overexcitement
• Sensation of spinning (vertigo), ringing in the ears (tinnitus)
• Becoming excited more easily, 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 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 you may also experience vision disturbances such as seeing colored halos, blurred vision, or photophobia. These problems are temporary or improve after stopping treatment.
• Blurred vision due to impaired focusing of your eye. This problem is temporary and improves if the dose is reduced.
• Changes in heart rhythm (your doctor may monitor the electrical activity of your heart using an electrocardiogram)
• Enlargement of both heart chambers (biventricular hypertrophy)
• Abnormal liver function tests
• Skin redness with irregular raised spots (erythema multiforme)
• Itching (pruritus), changes in the color of your skin or inside your 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 nodular rashes
• Increased sensitivity to light (photosensitivity)
• Skin inflammation with redness and peeling (exfoliative dermatitis)
• Recurrent skin condition accompanied by scaling, dry skin rash (psoriasis)
• Hives, difficulty breathing
• Muscle diseases (myopathy of skeletal muscles or neuromyopathy) causing progressive weakness and reduced muscle strength (atrophy). This may be restored after discontinuation of this medicine, but recovery may take several months.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 packaging to protect from light.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidroxicloroquina Teva-ratiopharm

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

Tablet core: maize starch, calcium hydrogen phosphate dihydrate (E341), colloidal anhydrous silica (E551), polysorbate 80 (E433), dried maize starch, talc (E553B), magnesium stearate (E470b).

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

Appearance of the product and contents of the pack

Hidroxicloroquina Teva-ratiopharm 200 mg film-coated tablets EFG are white, round, approximately 9.5 mm in diameter, biconvex tablets, marked with “200” on one side and smooth on the other.

Pack sizes

Hidroxicloroquina Teva-ratiopharm is available in packs containing 30 or 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

2600 Dupnitsa

Bulgaria

or

Teva Pharma B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany Hydroxychloroquin-ratiopharm 200 mg Filmtabletten

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

The Netherlands Hydroxychloroquinesulfaat Teva 200 mg, filmomhulde tabletten

Date of the most recent review of this summary: December 2025

Other sources of information

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. 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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