Prospecto:Information for the Patient

Hidroxicloroquina Teva-ratiopharm 200 mg Film-Coated Tablets

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctororpharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

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

2.What you need to knowbeforestarting totake Hidroxicloroquina Teva-ratiopharm

3.How to take Hidroxicloroquina Teva-ratiopharm

4.Possible adverse effects

5.Storage of Hidroxicloroquina Teva-ratiopharm

6.Contents of the package and additional information

Adults

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

Children (≥ 6 years and ≥ 35 kg)

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

Do not take Hidroxicloroquina 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 a retinal problem, maculopathy, or any other eye problem.
• if you have myasthenia gravis, a certain type of muscle weakness.
• 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 called 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 called 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). Your doctor will apply this medication with caution (see section 4 “Possible side effects”).
• 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 examination should be repeated with long-term use of this medication. If you experience problems while using this medication (for example, if you notice a reduction in visual acuity, color quality, or field of vision), contact your doctor immediately. The concomitant use of this medication with drugs known to be harmful to the retina (such as tamoxifen) is not recommended.

Hydroxychloroquine may cause cardiac rhythm disorders in some patients: caution should be exercised when using hydroxychloroquine,

• if you were born or have a family history of prolonged QT interval,
• if you have acquired a prolonged QT interval (observed on ECG, heart electrical recording),
• if you have heart problems or have had a heart attack (myocardial infarction),

• if you have a blood electrolyte imbalance (especially low potassium or magnesium levels)
• if you are taking medications that are known to affect your heart rhythm (see section “Taking Hidroxicloroquina Teva-ratiopharm with other medications”).

If you experience palpitations or irregular heartbeats during the treatment period, you must inform your doctor immediately. The risk of cardiac problems may increase with increasing doses. Therefore, follow the recommended dose.

Additionally, the appearance of heart failure has been observed after the use of 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 sugar levels.

If you use this medication for a long time, your doctor will periodically check the functioning of your muscles and tendons. If you experience muscle weakness or tendon weakness, consult your doctor. Your doctor may decide to interrupt treatment.

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

Some people receiving hydroxychloroquine treatment 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 those around you notice any of these side effects (see section 4 “Possible side effects”), seek medical attention immediately.

Severe skin eruptions have been reported with the use of hydroxychloroquine (see section 4, Possible side effects). Often, the rash may consist of mouth ulcers, throat, nose, genital, and conjunctivitis (red and inflamed eyes). These severe skin eruptions are often preceded by flu-like symptoms, such as fever, headache, and body aches. The skin rash may 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 reach and sight of children. Children are particularly sensitive to the potential harmful effects of this medication.

Taking Hidroxicloroquina Teva-ratiopharm with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. 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. moxifloxacino, azitromicina)
• HIV treatment (e.g. saquinavir)
• fungal infections (e.g. fluconazol)
• parasitic infections (e.g. pentamidina)
• or malaria (e.g. halofantrina)

• Diabetes medications (such as insulin or metformin). Hydroxychloroquine may increase the effect of these medications on blood sugar levels, and therefore your dose may need to be reduced.
• Rabies vaccine. Hydroxychloroquine may reduce the effect of the rabies vaccine. The vaccine should not be administered by injection into the skin when hydroxychloroquine is used. When the vaccine is administered in a muscle, the protection is sufficient.
• Certain medications for depression (monoamine oxidase inhibitors (MAO)) should not be combined with hydroxychloroquine.
• Malaria medications such as mefloquina (which may increase the risk of seizures)
• Seizure medications (convulsions), such as phenobarbital, phenytoin, carbamazepine. The effectiveness of antiepileptic medications may be affected if taken simultaneously with hydroxychloroquine.
• Antacids (for stomach acid) and kaolin: Take hydroxychloroquine at least 2 hours apart
• Cimetidine (used for stomach ulcers)
• Medications for bacterial infections (such as rifampicina, claritromicina)
• Medications for fungal infections (such as itraconazol)
• Medications for lipid disorders (such as gemfibrozilo, statins)
• Medications for HIV treatment (such as ritonavir)
• Medications for organ transplants or immune system disorders (such as ciclosporina)
• Medications for depression (fluoxetina, paroxetina)
• Medications for blood clots (such as dabigatrán, clopidogrel)
• Medications for heart disease (such as digoxina, flecainida, propafenona, quinidina, and metoprolol)
• St. John's Wort (a herbal treatment for depression).

Taking Hidroxicloroquina 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, or think you may be 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 increase in the risk of major malformations and should not be used during pregnancy unless your doctor considers that the benefits outweigh the risks.

Prevention and treatment of malaria

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

Prevention and treatment of malaria

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 reaches the baby through breast milk is insufficient to prevent malaria in the baby.

Rheumatoid arthritis and lupus erythematosus

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

Fertility

There is no information on the effects of hydroxychloroquine on human fertility.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of 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 per day

Maintenance dose: 200 mg per day and 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 an area affected by malaria, you should start treatment one week before arriving in the malaria area and continue for four to eight weeks after leaving that area.

Acute Uncomplicated Malaria Treatment

The dose depends on the nature of the infection. The total dose is up to 2 grams and is administered for 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.

Treatment Duration

Follow your doctor's instructions regarding treatment duration. In the case of prolonged treatment with this medication, your doctor will prescribe the lowest possible dose.

This medication requires several weeks to achieve the best effect for the treatment of joint disorders.

Use in Children

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

A 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 arrhythmias, and seizures, followed by sudden respiratory and cardiac arrest that 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 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 your next dose, in which case you should continue with your medication as prescribed. Do not take a double dose to compensate for missed doses.

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

If You Interrupt Treatment with 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Rare side effects (can 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, light sensitivity, or the way you see color. If these problems are detected early, they will usually be less severe after stopping treatment with hydroxychloroquine. If the problems are not detected until later, they may continue or even worsen after stopping treatment.
• Seizures
• Cardiac muscle weakness(cardiomyopathy) that can lead to heart failure, which can be fatal. Symptoms include fatigue, difficulty breathing, and swollen legs and ankles

Unknown frequency (frequency cannot be estimated from available data)

• Severe skin reactions(see section 2, Warnings and precautions) such as:
• • fever, skin rash, and systemic symptoms, such as an increase in lymph node size. It could be a disease called drug reaction with eosinophilia and systemic symptoms (DRESS).
  • blistering, generalized scaly skin, pus-filled spots with fever. It could be a disease called generalized acute pustular psoriasis (PEGA).
  • blistering or peeling of the skin around the lips, eyes, mouth, nose, and genitals, systemic symptoms, and fever. It could be a disease called Stevens-Johnson syndrome (SSJ).
  • multiple skin lesions, itching, joint pain, fever, and general feeling of discomfort. It could be a disease called toxic epidermal necrolysis (NET).
  • skin rash, including cherry-colored ulcers, elevated and painful, especially on the arms, hands, fingers, face, and neck, which may also be accompanied by fever. It could be a disease called Sweet syndrome.
• If you have anallergic reaction. The signs may include: red or hives rash, difficulty swallowing or breathing, swelling of the eyelids, lips, face, throat, or tongue (angioedema)
• If you havethoughts of self-harm or suicide(see section 2 “Warnings and precautions”)
• If you have aneye problemthat affects the retina, the inner eye (maculopathy)
• If you feelweakness, fatigue, dizziness, or fainting, have pale skin, shortness of breath, easy bruising, or contract infections such as fever, intense 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 fatal irregular heart rhythm(seen on ECG) (see section 2 “Warnings and precautions”)
• Low blood sugar levels(hypoglycemia). You may feel nervousness, trembling, or sweating.

Otherside effectsassociated with Hydroxychloroquine Teva-ratiopharm

Frequent side effects (can affect up to 1 in 10 people)

• Loss of appetite (anorexia).
• Exaggerated mood changes

Infrequent side effects (can affect up to 1 in 100 people)

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

Rare side effects (can affect up to 1 in 1,000 people)

• Reduced bone marrow function (myelosuppression)
• Severe mental illness in which control over one's behavior and actions is altered (psychosis)
• Vomiting. This usually disappears after reducing the dose or stopping treatment

Very rare side effects (can affect up to 1 in 10,000 people)

• Permanent hearing loss
• The long-term treatment with substances structurally related to chloroquine phosphate can very rarely lead to a reversible phospholipidosis (increased intracellular accumulation of phospholipids), including renal phospholipidosis. Due to structural similarity, this side effect can also occur with hydroxychloroquine. In this case, it can intensify an altered renal function.

Unknown frequency (frequency cannot be estimated from available data)

• Worsening of a red blood cell disorder (porphyria).
• Dizziness
• Feeling depressed, delirium, hallucinations, anxiety, confusion, agitation, difficulty sleeping, euphoria, or overexcitement
• Sensation of spinning (vertigo), ringing in the ears (tinnitus)
• Getting excited more quickly, headache
• Muscle 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 central visual field is visible, with pericentral rings only the center of the visual field is visible), temporal blind spots in the visual field, and abnormal color observations.
• Corneal changes with turbidity or fluid retention have been observed. Sometimes the changes do not cause complaints, but you may also have visual disturbances, such as seeing colored rings, blurred vision, or photophobia. These problems are temporary or decrease after stopping treatment.
• Blurred vision due to altered eye focus. 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, elevated patches (erythema multiforme)
• Itching (pruritus), changes in skin color or the inside of your nose or mouth, hair loss, or hair color loss. These symptoms usually disappear after reducing the dose or stopping treatment.
• Cases of blistering or bubbling eruptions.
• Sensitivity to light (photosensitivity).
• Inflammatory skin condition with redness and peeling (dermatitis exfoliativa).
• Recurring skin condition accompanied by peeling, dry skin rash (psoriasis).
• Urticaria, difficulty breathing
• Muscle diseases (skeletal muscle myopathy or neuromyopathy) that cause progressive weakness and muscle strength reduction (atrophy). This can be restored after stopping treatment with this medication, but recovery may take several months.

Reporting side effects

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

Keepthis medicationout of the sight and reach of children.

Store in the original packaging to protect it from light.

Do not usethis medicationafter the expiration date that appears onthe box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and

medicines that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacisthow to dispose ofthepackaging and themedicines that you no longerneed. By doing so, you will help protect the environment.

Composition of Teva-ratiopharm Hydroxychloroquine

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

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

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

Appearance of the product and contents of the package

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

Package sizes

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U..

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

28108 Alcobendas, Madrid

Spain

Responsible 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 medicinal product is authorized in the member states of the European Economic Area with the following names:

GermanyHydroxychloroquin-ratiopharm 200 mg Filmtabletten

SpainHidroxicloroquina Teva-ratiopharm 200 mg film-coated tablets EFG

NetherlandsHydroxychloroquinesulfaat Teva 200 mg, filmomhulde tabletten

Last review date of thisleaflet:December 2023

Other sources of information

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your 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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