HYDROXYCHLOROQUINE 200 mg Tablets

Contents of the leaflet

1. What is Hydroxychloroquine sulfate Accord and what is it used for
2. Important information before taking Hydroxychloroquine sulfate Accord
   1. When not to take Hydroxychloroquine sulfate Accord
   2. Warnings and precautions
   3. Before taking Hydroxychloroquine sulfate Accord
   4. Children
   5. Hydroxychloroquine sulfate Accord and other medicines
   6. Taking Hydroxychloroquine sulfate Accord with food and drink
   7. Pregnancy and breastfeeding
   8. Driving and operating machinery
   9. Hydroxychloroquine sulfate Accord contains lactose
3. How to take Hydroxychloroquine sulfate Accord
   1. Dosage
   2. Taking the medicine
   3. Taking a higher dose of Hydroxychloroquine sulfate Accord than recommended
   4. Missing a dose of Hydroxychloroquine sulfate Accord
   5. Stopping treatment with Hydroxychloroquine sulfate Accord
4. Possible side effects
   1. Stop taking Hydroxychloroquine sulfate Accord and seek medical help immediately if any of the following side effects occur:
   2. If any of the following serious side effects are noticed, stop taking Hydroxychloroquine sulfate Accord and seek medical help immediately - urgent treatment may be necessary:
   3. Other side effects associated with hydroxychloroquine sulfate
   4. Reporting side effects
5. How to store Hydroxychloroquine sulfate Accord
6. Package contents and other information
   1. What Hydroxychloroquine sulfate Accord contains
   2. What Hydroxychloroquine sulfate Accord looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: November 2023

1. What is Hydroxychloroquine sulfate Accord and what is it used for

Hydroxychloroquine sulfate Accord contains the active substance hydroxychloroquine sulfate.
The medicine can be used in:
Adults

• Treatment of chronic inflammatory conditions of the joints, muscles, tendons, or ligaments (rheumatoid arthritis).
• Treatment of certain diseases whose symptoms include, among others, skin disorders and/or joint complaints (systemic lupus erythematosus).
• Treatment of skin disorders sensitive to sunlight (photodermatoses).
• Treatment of acute malaria attacks and prevention of malaria.

Children (aged 6 and over and weighing 31 kg or more)

• Treatment of juvenile idiopathic arthritis in combination with other treatment methods.
• Treatment of certain diseases that manifest with skin and/or joint complaints (systemic lupus erythematosus).
• Treatment of acute malaria attacks and prevention of malaria.

2. Important information before taking Hydroxychloroquine sulfate Accord

When not to take Hydroxychloroquine sulfate Accord

• If the patient is allergic to:
• hydroxychloroquine sulfate or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• other similar medicines, such as quinolones and quinine (other medicines used for malaria).
• If the patient has an eye disease affecting the retina or the inside of the eye (maculopathy), if there has been a change in eye color or any other eye disease.
• If the patient has pigmentary retinopathy.
• If the patient has a certain form of muscle weakness (myasthenia).
• Hydroxychloroquine sulfate Accord should not be used in children under 6 years of age and weighing less than 31 kg.

Do not take this medicine if any of the above points apply to the patient.
In case of doubts, consult a doctor or pharmacist before taking Hydroxychloroquine sulfate Accord.

Warnings and precautions

Before starting treatment with Hydroxychloroquine sulfate Accord, consult a doctor or pharmacist if:

• the patient has kidney or liver function disorders,
• the patient has severe stomach or intestinal disorders,
• the patient has blood disorders. Blood tests may be performed to check this,
• the patient has heart disorders (symptoms include shortness of breath and chest pain), which may require monitoring,
• the patient has nervous system or brain disorders,
• the patient has psoriasis (red, scaly patches on the skin, usually on the elbows, knees, and scalp),
• the patient has a history of abnormal reaction to quinine,
• the patient has a genetic disorder known as "glucose-6-phosphate dehydrogenase deficiency",
• the patient has a rare disease called "porphyria", which affects metabolism,
• the patient has inactive chronic hepatitis B infection
• hydroxychloroquine may cause a decrease in blood glucose levels. The doctor should be asked about the symptoms of low blood glucose levels. It may be necessary to check this level.
• in some people taking Hydroxychloroquine sulfate Accord, mental health problems may occur, such as irrational thoughts, anxiety, hallucinations, disorientation, or depression, including suicidal thoughts, even in people who have not had such disorders before. If the patient or someone around them notices the occurrence of such side effects (see section 4), they should seek medical help immediately.
• serious skin rashes have been reported with hydroxychloroquine (see section 4 "Possible side effects"). Often, the rash can include mouth ulcers, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes). The occurrence of such serious skin rashes is often preceded by flu-like symptoms, such as fever, headache, and body aches. The rash can transform into extensive blisters and peeling of the skin. If such skin symptoms occur, hydroxychloroquine should be discontinued and a doctor should be consulted immediately.
• Hydroxychloroquine sulfate Accord may cause heart rhythm disorders in some patients. Caution should be exercised when taking Hydroxychloroquine sulfate Accord if the patient has congenital QT interval prolongation or such prolongation in their family, if the patient has acquired QT interval prolongation (visible in an ECG, which is an electrical record of heart activity), if the patient has heart disorders or has had a heart attack in the past, if the patient has electrolyte balance disorders in the blood (especially low potassium or magnesium levels, see "Hydroxychloroquine sulfate Accord and other medicines"). If palpitations or irregular heartbeat occur during treatment, the doctor should be informed immediately.
  The risk of heart disorders may increase with increasing dose. Therefore, the recommended dose should be followed.

  Before taking Hydroxychloroquine sulfate Accord

  • Before starting treatment with this medicine, the doctor will examine the eyes to determine if there are any abnormalities. In case of prolonged treatment, the vision test should be repeated at least every 6 months while taking Hydroxychloroquine sulfate Accord.
  • If the patient is over 65 years old, must take a high dose (2 tablets per day) of the medicine, or has kidney function disorders, this test should be performed more frequently.

  If the patient is unsure whether any of the above warnings apply to them, they should consult a doctor or pharmacist before taking Hydroxychloroquine sulfate Accord.

  Children

  Hydroxychloroquine sulfate Accord should not be used in children under 6 years of age and weighing less than 31 kg. Small children are particularly sensitive to the toxic effects of quinolones, so Hydroxychloroquine sulfate Accord should be kept out of their reach.

  Hydroxychloroquine sulfate Accord and other medicines

  The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take, including those available without a prescription. Especially about the medicines listed below:

  • Insulin or other diabetes medicines
  • Malaria medicines, such as mefloquine and halofantrine (as they may increase the risk of seizures)
  • Seizure medicines (such as phenobarbital, phenytoin, carbamazepine)
  • Medicines that affect the skin, blood, or eyes
  • Tamoxifen, used in the treatment of breast cancer
  • Agalsidase, used in the treatment of a rare disease called Fabry's disease
  • Medicines used in bacterial infections (such as rifampicin, clarithromycin, moxifloxacin, or azithromycin, and medicines called aminoglycosides, such as gentamicin, neomycin, or tobramycin)
  • Cimetidine, used in the treatment of stomach ulcers
  • Neostigmine and pyridostigmine, medicines used in the treatment of a disease called myasthenia gravis (muscle fatigue)
  • Rabies vaccine
  • Medicines that may affect the kidneys or liver
  • Medicines that neutralize stomach acid (for heartburn) and kaolin. Hydroxychloroquine sulfate Accord should be taken at least 2 hours apart from these medicines.
  • Medicines used in fungal infections (such as itraconazole, fluconazole)
  • Medicines used in lipid metabolism disorders (such as gemfibrozil)
  • Medicines used in HIV treatment (such as saquinavir, ritonavir)
  • Medicines used after organ transplantation or in immune system disorders (such as cyclosporine)
  • Anticoagulant medicines (such as dabigatran and clopidogrel)
  • Medicines used in heart diseases (such as digoxin, flecainide, propafenone, and metoprolol)
  • Praziquantel, pentamidine (antiparasitic medicines)
  • Medicines for depression (fluoxetine, paroxetine)
  • Herbal medicine for depression (St. John's wort)

  Taking Hydroxychloroquine sulfate Accord with food and drink

  Grapefruit juice should be avoided, as it may increase the risk of side effects.

  Pregnancy and breastfeeding

  If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. The doctor will decide with the patient whether Hydroxychloroquine sulfate Accord is suitable for them.
  Pregnancy
  Taking Hydroxychloroquine sulfate Accord during pregnancy may be associated with a slight increase in the risk of serious birth defects and therefore should not be used in high daily doses unless the doctor considers it necessary, as the risk of discontinuing treatment is greater than the risk posed by the medicine to the fetus.
  This medicine can be used during pregnancy to prevent malaria, as only small doses are required.
  Breastfeeding
  The medicine passes into breast milk. There is not enough information about the effects of hydroxychloroquine in newborns and infants. Depending on the patient's condition and the duration of treatment, the doctor will decide whether the medicine can be used during breastfeeding. If the patient takes the medicine once a week, e.g., to prevent malaria, it is not necessary to stop breastfeeding. However, this amount is not sufficient to prevent malaria in the infant.

  Driving and operating machinery

  While taking this medicine, eye disorders and dizziness may occur. If this happens, the patient should not drive or operate any devices or machines and should immediately inform their doctor.

  Hydroxychloroquine sulfate Accord contains lactose

  If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Hydroxychloroquine sulfate Accord

This medicine should always be taken according to the doctor's or pharmacist's instructions. The doctor will decide on the daily dose. In case of doubts, the doctor or pharmacist should be consulted.

Dosage

The recommended dose is:
In adults
Rheumatoid arthritis
Initial dose: 2 tablets per day.
Maintenance dose: 1 tablet per day, then possibly 1 tablet every other day.
Systemic lupus erythematosus
Initial dose: 2 or 3 tablets per day.
Maintenance dose: 1 or 2 tablets per day.
Skin reactions caused by sunlight
Treatment is limited to periods when the patient is exposed to a large amount of sunlight.
In adults: usually, 2 tablets per day are sufficient.
Malaria prevention
Adults: 2 tablets per week, on the same day each week. In malaria prevention, the medicine should be taken for one week before arriving in a malaria-endemic area and continued for four weeks after leaving the area.
Malaria treatment
The dose in case of an acute malaria attack depends on the nature of the infection. The total dose is a maximum of 2 grams (10 tablets) and is given over a maximum of three days.
In children
The doctor determines the dose based on body weight. A 200 mg tablet is not suitable for children weighing less than 31 kg.
Reduced kidney and liver function
If the patient has kidney or liver function disorders, the doctor may prescribe a lower dose.
Duration of treatment
The patient should follow the doctor's instructions regarding the duration of treatment. The doctor will use the lowest possible dose during long-term treatment with this medicine. In the treatment of joint disorders, it may take several weeks to achieve the best effect of the medicine.

Taking the medicine

• The medicine should be taken orally.
• Tablets should be swallowed whole during a meal or with a glass of milk. Do not crush or chew the tablets.
• Tablets can be taken once a day or the total daily dose can be divided into two or three doses.
• In the case of skin disorders related to hypersensitivity to sunlight, Hydroxychloroquine sulfate Accord should be taken only during periods of high sun exposure.
• The doctor determines the dose based on body weight. If the patient thinks the effect of the medicine is too weak or too strong, they should not change the dose themselves but should ask their doctor.
• If the patient has been taking the medicine for a long time (more than 6 months) due to rheumatoid arthritis and thinks the medicine is not helping, they should contact their doctor. It may be necessary to discontinue treatment.

Taking a higher dose of Hydroxychloroquine sulfate Accord than recommended

• In case of taking a higher dose of Hydroxychloroquine sulfate Accord than recommended, the doctor or hospital emergency department should be informed immediately. The medicine should be taken along.
  This will allow the doctor to know what the patient has taken. The following symptoms may occur: headache, vision disorders, decreased blood pressure, seizures, heart rhythm disorders leading to irregular heartbeat, and then sudden and severe breathing difficulties, as well as a heart attack. Overdose of Hydroxychloroquine sulfate Accord can be fatal.
• Small children and infants are particularly at risk if they accidentally take Hydroxychloroquine sulfate Accord. In such a case, the child should be taken to the hospital immediately.

Missing a dose of Hydroxychloroquine sulfate Accord

In case of missing a dose, it should be taken as soon as possible. However, if the next dose is approaching, the missed dose should not be taken. Do nottake a double dose to make up for the missed dose.

Stopping treatment with Hydroxychloroquine sulfate Accord

Treatment with Hydroxychloroquine sulfate Accord should be continued until the doctor recommends stopping it. The patient should not stop taking Hydroxychloroquine sulfate Accord just because they feel better. If the patient stops treatment, the disease may worsen again.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Hydroxychloroquine sulfate Accord can cause side effects, although not everybody gets them.

Stop taking Hydroxychloroquine sulfate Accord and seek medical help immediately if any of the following side effects occur:

• An allergic reaction. Symptoms may include: red or lumpy rash, difficulty swallowing or breathing, swelling of the eyelids, lips, face, throat, or tongue.

If any of the following serious side effects are noticed, stop taking Hydroxychloroquine sulfate Accord and seek medical help immediately - urgent treatment may be necessary:

• Suicidal thoughts or behaviors (see section 2 Warnings and precautions) (Frequency not known: frequency cannot be estimated from the available data).
• Any eye disorders. These include changes in eye color and vision disorders, such as blurred vision, sensitivity to light, or changes in color perception.
• Any muscle weakness, cramps, stiffness, or sensory disturbances, such as tingling.
• If the patient has been taking the medicine for a long time, the doctor will occasionally perform muscle and tendon tests to ensure they are functioning properly.
• Severe skin reactions (see section 2 Warnings and precautions), such as:
• rash with flu-like symptoms and fever, and swollen lymph nodes. This may be a condition called drug reaction with eosinophilia and systemic symptoms (DRESS).
• blisters, widespread skin peeling, pus-filled spots, occurring with fever. This may be a condition called acute generalized exanthematous pustulosis (AGEP).
• blisters or skin peeling around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever. This may be a condition called Stevens-Johnson syndrome (SJS).
• multiple skin lesions, itching, joint pain, fever, and general malaise. This may be a condition called toxic epidermal necrolysis (TEN).
• skin reactions, including (purple, raised, painful sores, especially on the arms, hands, fingers, face, and neck), which may occur with fever. This may be a condition called Sweet's syndrome.
• Increased susceptibility to infections. This may be due to bone marrow suppression or a blood disorder called agranulocytosis.
• Easier bruising than usual. This may be due to a blood disorder called thrombocytopenia.
• Feeling weak, tired, faint, dizzy, pale skin, shortness of breath, easier bruising than usual, and increased susceptibility to infections. These may be symptoms of anemia.
• Feeling weak, shortness of breath, easier bruising than usual, and increased susceptibility to infections. These may be symptoms of aplastic anemia.
• Liver disorders. Symptoms may include feeling 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, life-threatening heart rhythm disorders (visible in an ECG) (see section 2 Warnings and precautions) (Frequency not known: frequency cannot be estimated from the available data).

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

• Eye disorders, such as changes in eye color and vision disorders, for example, blurred vision, sensitivity to light, or changes in color perception. If these disorders are noticed early, they usually decrease if Hydroxychloroquine sulfate Accord is discontinued. If they are noticed later, they may persist or worsen after treatment is stopped.
• Seizures.
• Difficulty breathing, cough, high blood pressure, swelling, rapid heart rate, decreased urine output - these may be symptoms of heart muscle weakness (cardiomyopathy or heart failure) leading to death.

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

• Red or lumpy rash, difficulty swallowing or breathing, swelling of the eyelids, lips, face, throat, or tongue - these may be symptoms of angioedema.
• Feeling weak, tired, faint, dizzy, pale skin, shortness of breath, easier bruising than usual, and increased susceptibility to infections - these may be symptoms of blood disorders.
• Feeling nervous, trembling, or sweating, dizziness, rapid heartbeat - these may be symptoms of low blood sugar (hypoglycemia), which in severe cases can lead to seizures and loss of consciousness, potentially life-threatening.
• Feeling depressed or having suicidal thoughts, hallucinations, feeling nervous or anxious, disorientation, agitation, difficulty sleeping, feeling elated or overly excited.

Other side effects associated with hydroxychloroquine sulfate

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

• Decreased appetite (anorexia).

Uncommon side 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 side effects (may affect up to 1 in 1,000 people)

• Vomiting (usually disappears after the dose is reduced or treatment is discontinued).

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

• Permanent hearing loss.
• Redness of the skin with raised, irregular spots (erythema multiforme).
• Long-term therapy with hydroxychloroquine may lead to increased accumulation of phospholipids in tissues, including the kidneys. In such cases, kidney function disorders may worsen.

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

• Porphyria exacerbation.
• Drowsiness/dizziness.
• Ringing in the ears (tinnitus).
• Headache.
• Transient blind spots in the field of vision and abnormal color vision; transient blurred vision or sensitivity to light.
• Skin disorders, such as severe itching, rash with blisters or nodules, sensitivity to light, redness, and peeling, dry, scaly rash, changes in skin color or the inside of the nose or mouth, hair loss or hair color loss.
• Movement disorders, such as muscle tension.
• Muscle disease causing muscle weakness.
• Changes in sensory perception or limb control, decreased tendon reflexes.
• Breathing difficulties.
• Abnormal liver function test results.
• Severe liver failure.
• Allergic reactions, such as rash with severe itching and blistering (hives).
• Heart disorders.
• Abnormal heart rhythm (visible in an ECG) (see section 2, "Before taking Hydroxychloroquine sulfate Accord").
• Psychiatric disorders (such as delusions, hallucinations, and mood changes).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Hydroxychloroquine sulfate Accord

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month stated.
This medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Hydroxychloroquine sulfate Accord contains

• Each tablet contains 200 mg of the active substance, hydroxychloroquine sulfate.
• The other ingredients are: lactose monohydrate, cornstarch, magnesium stearate, povidone K 30, polyvinyl alcohol, talc, macrogol 3350, and titanium dioxide (E 171).

What Hydroxychloroquine sulfate Accord looks like and what the package contains

Hydroxychloroquine sulfate Accord, 200 mg, film-coated tablets are white or almost white, biconvex, peanut-shaped tablets with the inscription "H11" on one side and smooth on the other.
The approximate dimensions are: 12.80 ± 0.05 mm × 6.10 ± 0.05 mm.
They are packaged in blisters of 20, 30, 50, 60, 90, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Tel: + 48 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50 Street
95-200 Pabianice

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

Date of last revision of the leaflet: November 2023