Hydroxychloroquine sulfate accord

Package leaflet: Information for the user

Hydroxychloroquine sulfate Accord, 200 mg, film-coated tablets
Hydroxychloroquini sulfas
Please read all of this leaflet carefully before 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 others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Hydroxychloroquine sulfate Accord is and what it is used for
2. What you need to know before taking Hydroxychloroquine sulfate Accord
3. How to take Hydroxychloroquine sulfate Accord
4. Possible side effects
5. How to store Hydroxychloroquine sulfate Accord
6. Contents of the pack and other information

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

Hydroxychloroquine sulfate Accord contains the active substance hydroxychloroquine sulfate.
This medicine may 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 problems (discoid and systemic lupus erythematosus).
• Treatment of skin disorders that are sensitive to sunlight (photodermatoses).
• Treatment of acute attacks of malaria and prevention of malaria.

Children (aged 6 years and older and weighing 31 kg or more)

• Treatment of juvenile rheumatism, in combination with other treatments (juvenile idiopathic arthritis).
• Treatment of certain diseases whose symptoms include, among others, skin disorders and/or joint problems (discoid and systemic lupus erythematosus).
• Treatment of acute attacks of malaria and prevention of malaria.

2. Important information before using Hydroxychloroquine sulfate Accord

When not to use 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 to treat malaria).
  • If the patient has an eye disease affecting the retina or inside of the eye (maculopathy), if there has been a change in eye colour, or any other eye disease.
  • If the patient has pigmentary retinopathy (pigmentary degeneration of the retina).
  • If the patient has a certain form of muscle weakness (myasthenia).
  • Hydroxychloroquine sulfate Accord must 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 apply to the patient.
If in doubt, talk to a doctor or pharmacist before taking Hydroxychloroquine sulfate Accord.
Warnings and precautions
Before starting treatment with Hydroxychloroquine sulfate Accord, talk to a doctor or pharmacist if:

• the patient has impaired kidney or liver function,
• the patient has serious stomach or intestinal disorders,
• the patient has blood disorders. Blood tests may be performed to check this,
• the patient has heart problems (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 knees, elbows and scalp),
• the patient previously had an abnormal reaction to quinine,
• the patient has a genetic condition known as glucose-6-phosphate dehydrogenase deficiency,
• the patient has a rare condition called "porphyria", which affects metabolism,
• the patient has inactive chronic hepatitis B virus infection,
• hydroxychloroquine may lower blood glucose levels. Ask the doctor about symptoms of low blood glucose. Monitoring may be necessary.
• in some people treated with Hydroxychloroquine sulfate Accord, psychiatric symptoms may occur, such as irrational thoughts, anxiety, hallucinations, feelings of disorientation or depression, including self-destructive or suicidal thoughts, even in individuals who have not previously experienced such disorders. If the patient or someone close to them notices such adverse effects (see section 4), seek immediate medical help.
• serious skin rashes have been reported with the use of hydroxychloroquine (see section 4 "Possible side effects"). Often, the rash may involve ulceration of the mouth, throat, nose, genital organs and conjunctivitis (redness and swelling of the eyes). Such serious skin rashes are often preceded by flu-like symptoms such as fever, headache and body aches. The rash may progress to extensive blistering and peeling of the skin. If such skin symptoms occur, stop taking hydroxychloroquine and contact a doctor immediately.
• Hydroxychloroquine sulfate Accord may cause heart rhythm disturbances in some patients. Exercise caution when using Hydroxychloroquine sulfate Accord if the patient has congenital QT prolongation or a family history of QT prolongation, if the patient has acquired QT prolongation (seen on ECG, which is an electrical recording of heart activity), if the patient has heart disorders or has previously had a heart attack, or if the patient has electrolyte imbalances in the blood (especially low potassium or magnesium levels, see section "Hydroxychloroquine sulfate Accord and other medicines"). If during treatment

palpitations or irregular heartbeat occur, inform the doctor immediately.
The risk of heart problems may increase with higher doses. Therefore, the recommended dose must be strictly followed.
Before using Hydroxychloroquine sulfate Accord

• Before starting treatment with this medicine, the doctor will examine the eyes to determine whether there are any abnormalities. If long-term treatment is required, eye examinations should be repeated at least every 6 months during treatment with Hydroxychloroquine sulfate Accord.
• If the patient is over 65 years of age, needs to take a high dose (2 tablets per day) of the medicine, or has impaired kidney function, these eye examinations should be performed more frequently.

If the patient is unsure whether any of the above warnings apply, talk to a doctor or pharmacist before taking Hydroxychloroquine sulfate Accord.
Children
Hydroxychloroquine sulfate Accord must not be used in children under 6 years of age and weighing less than 31 kg. Young children are particularly sensitive to the toxic effects of quinolones; therefore, Hydroxychloroquine sulfate Accord should be stored out of the reach of children.
Hydroxychloroquine sulfate Accord and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription. Especially mention the following medicines:

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

Taking Hydroxychloroquine sulfate Accord with food and drink
Avoid drinking grapefruit juice, as it may increase the risk of side effects.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether Hydroxychloroquine sulfate Accord is suitable for her.
Pregnancy
Taking Hydroxychloroquine sulfate Accord during pregnancy may be associated with a slightly increased risk of serious developmental defects, and therefore high daily doses should not be used unless the doctor determines it is necessary because the risk of stopping treatment is greater than the risk the medicine poses to the unborn child.
This medicine may be used during pregnancy to prevent malaria, as only low doses are required.
Breastfeeding
This medicine passes into breast milk. There is insufficient information on the effects of hydroxychloroquine in newborns and infants. Depending on the patient's condition and duration of treatment, the doctor will decide whether this medicine can be used during breastfeeding. If the patient takes this medicine once a week, e.g. to prevent malaria, it is not necessary to interrupt breastfeeding. However, this amount is insufficient to prevent malaria in the infant.
Driving and using machines
While taking this medicine, eye disturbances and dizziness may occur. If this happens, do not drive or operate any vehicles or machinery, and inform the doctor immediately.
Hydroxychloroquine sulfate Accord contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to use Hydroxychloroquine sulfate Accord

This medicine should always be taken exactly as directed by your doctor or pharmacist. Your doctor will decide the daily dose. If in doubt, consult your doctor or pharmacist.
Dosage
Recommended doses:
For adults
Rheumatoid arthritis
Initial dose: 2 tablets per day.
Maintenance dose: 1 tablet per day, later possibly 1 tablet every other day.
Discoid and systemic lupus erythematosus
Initial dose: 2 or 3 tablets per day.
Maintenance dose: 1 or 2 tablets per day.
Skin reactions caused by sunlight exposure
Treatment is limited to periods when the patient is exposed to high levels of sunlight.
For adults: usually 2 tablets per day are sufficient.
Malaria prophylaxis
Adults: 2 tablets weekly, on the same day each week. For malaria prevention, the medicine should be taken for one week before entering a malaria-endemic area and continued for four weeks after leaving the area.
Treatment of malaria
The dose during an acute malaria attack depends on the type of infection. The total dose is up to 2 grams (10 tablets) and is administered over a maximum of three days.
For children
The doctor will determine the dose based on body weight. The 200 mg tablet is not suitable for children weighing less than 31 kg.
Reduced kidney or liver function
If the patient has impaired kidney or liver function, the doctor may prescribe a lower dose.
Duration of treatment
Follow your doctor's instructions regarding the duration of treatment. Your doctor will prescribe the lowest possible dose for long-term treatment with this medicine. When treating joint disorders, several weeks may be needed to achieve the full therapeutic effect of this medicine.
Taking the medicine

• This medicine should be taken orally.
• Tablets should be swallowed whole with food or a glass of milk. Do not crush or chew the tablets.
• Tablets may be taken once daily or the total daily dose may be divided into two or three doses.
• For skin disorders related to photosensitivity, Hydroxychloroquine sulfate Accord should only be taken during periods of high sunlight exposure.
• The dose is determined by the doctor according to body weight. If the patient feels the medicine's effect is too weak or too strong, do not adjust the dose independently; consult the doctor.
• If the patient has been taking this medicine for a long time (over 6 months) for rheumatoid arthritis and feels the medicine is no longer effective, contact the doctor. Discontinuation of treatment may be necessary.

Taking more Hydroxychloroquine sulfate Accord than recommended

• If more than the recommended dose of Hydroxychloroquine sulfate Accord is taken, inform your doctor immediately or go to the nearest hospital emergency department. Take the medicine with you.
• This will allow the doctor to know what has been taken. The following symptoms may occur: headache, visual disturbances, decreased blood pressure, convulsions, heart disturbances leading to irregular heartbeat, followed by sudden and severe breathing difficulties, and heart attack may also occur. Overdose of Hydroxychloroquine sulfate Accord can lead to death.
• Small children and infants are particularly at risk if they accidentally take Hydroxychloroquine sulfate Accord. In such a case, take the child to hospital immediately.

Missed dose of Hydroxychloroquine sulfate Accord
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for a missed dose.
Stopping Hydroxychloroquine sulfate Accord
Continue taking the medicine until your doctor advises otherwise. Do not stop taking Hydroxychloroquine sulfate Accord just because you feel better. If you stop treatment, the disease may flare up again.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking Hydroxychloroquine sulfate Accord and go immediately to a
doctor or hospital if any of the following adverse reactions occur:

• If the patient experiences 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 adverse reactions are observed, you must stop taking
Hydroxychloroine sulfate Accord and contact a doctor immediately – urgent treatment may be required:

• Thoughts of self-harm or suicide (see section 2 Warnings and precautions) (Frequency unknown: frequency cannot be determined from available data).
• Any eye disorders. These include changes in eye colour and vision disturbances such as blurred vision, light sensitivity, or changes in colour perception.
• Any muscle weakness, cramps, stiffness, or sensory disturbances such as tingling.
• If the patient takes this medicine for a prolonged period, the doctor will occasionally perform muscle and tendon examinations 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 peeling of the skin, pus-filled spots, occurring with fever. This may be a condition called acute generalized exanthematous pustulosis (AGEP).
  • Blisters or peeling of the skin around the lips, eyes, mouth, nose and genital organs, flu-like symptoms and fever. This may be a condition called Stevens-Johnson syndrome (SJS).
  • Numerous skin lesions, itching of the skin, joint pain, fever and general malaise. This may be a disease called toxic epidermal necrolysis (TEN).
  • Skin reactions, including (plum-coloured, raised, painful lesions, particularly on arms, hands, fingers, face and neck), possibly accompanied by fever. This may be a condition called Sweet's syndrome.
• Greater than usual susceptibility to infections. This may be due to bone marrow suppression or a blood disorder called agranulocytosis.
• Easier than usual bruising. This may be due to a blood disorder called thrombocytopenia.
• Feeling of fatigue, fainting or dizziness and pale skin. These may be symptoms of anaemia.
• Feeling of weakness, shortness of breath, easier than usual bruising and greater than usual susceptibility to infections. These may be symptoms of so-called aplastic anaemia.
• Liver disorders. Symptoms may include malaise, 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.
• Irregular heartbeat, life-threatening heart rhythm disorders (visible on ECG) (see section Warnings and precautions) (frequency cannot be determined from available data).

Rare adverse reactions (may affect less than 1 in 1,000 people)

• Eye disorders such as changes in eye colour and vision disturbances, for example blurred vision, light sensitivity or changes in colour perception. If these disorders are detected early, they usually improve after stopping treatment with Hydroxychloroquine sulfate Accord. If detected later, they may persist or even worsen after discontinuation of treatment.
• Seizures.
• Breathing difficulties, cough, high blood pressure, swelling, rapid heartbeat, passing small amounts of urine – these may be symptoms of heart muscle weakness (cardiomyopathy or heart failure) leading to death.

Frequency unknown (cannot be determined from 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 of weakness, fatigue, fainting, dizziness, pale skin, shortness of breath, easier than usual bruising and greater than usual 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 (hypoglycaemia), which in severe cases may lead to seizures and loss of consciousness, which may be life-threatening.
• Feeling depressed, suicidal or self-destructive thoughts, hallucinations, feeling nervous or anxious, feeling disoriented, agitation, difficulty sleeping, feeling of euphoria or excessive excitement.

Other adverse reactions associated with hydroxychloroquine sulfate
Common adverse reactions (may affect less than 1 in 10 people)

• Decreased appetite (anorexia).

Uncommon adverse reactions (may affect less than 1 in 100 people)

• Nausea, diarrhoea and abdominal pain. These symptoms usually resolve after dose reduction or discontinuation of treatment.
• Skin rash.

Rare adverse reactions (may affect less than 1 in 1,000 people)

• Vomiting (usually resolves after dose reduction or after stopping treatment).

Very rare adverse reactions (may affect less than 1 in 10,000 people)

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

Frequency unknown (cannot be determined from available data)

• Worsening of red blood cell disorders (porphyria).
• Drowsiness/dizziness (systemic).
• Ringing in the ears (tinnitus).
• Headache.
• Transient blind spots in the visual field and abnormal colour vision; transient blurred vision or light sensitivity.
• Skin disorders such as severe itching of the skin, skin rash with blisters or nodules, photosensitivity, redness and peeling, scaly dry skin rash, changes in skin colour or inside the nose or mouth, hair loss or loss of hair colour.
• Movement disorders such as muscle tension.
• Muscle disease causing muscle weakness.
• Changes in sensory perception or limb control, reduced tendon reflexes.
• Breathing difficulties.
• Abnormal liver function test results.
• Severe liver failure.
• Allergic reactions such as skin rash with severe itching and blistering (urticaria).
• Heart disorders.
• Irregular heartbeat (visible on ECG) (see section 2, "Before taking Hydroxychloroquine sulfate Accord").
• Psychiatric disorders (such as delusions, hallucinations and mood changes).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Hydroxychloroine sulfate Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP.
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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, maize starch, magnesium stearate, povidone K 30, polyvinyl alcohol, talc, macrogol 3350 and titanium dioxide (E 171).

What Hydroxychloroquine sulfate Accord looks like and contents of the pack
Hydroxychloroquine sulfate Accord 200 mg film-coated tablets are white or almost white,
biconvex, peanut-shaped tablets, embossed with "H11" on one side and smooth on the other.
Approximate dimensions: 12.80 ± 0.05 mm × 6.10 ± 0.05 mm.
They are packed in blisters of 20, 30, 50, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 577 28 00
Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice

This medicine is authorised for marketing in the European Economic Area Member States under the following names: