Hidroxihloroquine sulfate Edest

Leaflet accompanying the packaging:

Information for the user

Hydroxychloroquine sulfate Edest, 200 mg, coated tablets

Hydroxychloroquine sulfate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Hydroxychloroquine sulfate Edest and what is it used for
• 2. Important information before using Hydroxychloroquine sulfate Edest
• 3. How to use Hydroxychloroquine sulfate Edest
• 4. Possible side effects
• 5. How to store Hydroxychloroquine sulfate Edest
• 6. Contents of the packaging and other information

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

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

• treatment of chronic conditions involving inflammation of the joints, muscles, tendons or ligaments (rheumatoid arthritis),
• treatment of certain diseases whose symptoms include skin problems and/or joint pain (systemic and discoid lupus erythematosus),
• treatment of skin problems with hypersensitivity to sunlight (photodermatoses),
• treatment of acute malaria attacks and prevention of malaria.

Children (aged 6 and above and weighing 31 kg and above)

• for the treatment of juvenile rheumatoid arthritis in combination with other treatment methods (juvenile idiopathic arthritis)
• treatment of certain diseases whose symptoms include skin problems and/or joint pain (systemic and discoid lupus erythematosus),
• treatment of acute malaria attacks and prevention of malaria.

2. Important information before using Hydroxychloroquine sulfate Edest

When not to use Hydroxychloroquine sulfate Edest:

• If the patient is allergic to:
• hydroxychloroquine sulfate or any of the other ingredients of this medicine (listed in section 6).
• other similar medicines, such as quinolones and quinine (other medicines used to treat malaria).
• The patient has certain eye diseases (maculopathy or retinal pigmentary degeneration).
• The patient suffers from a certain form of muscle weakness (myasthenia gravis).
• Hydroxychloroquine sulfate Edest should not be used in children under 6 years of age and weighing less than 31 kg. The medicine should not be taken if any of the above symptoms have occurred. In case of doubts, the patient should consult a doctor or pharmacist before starting treatment with Hydroxychloroquine sulfate Edest.

Warnings and precautions

Before starting treatment with Hydroxychloroquine sulfate Edest, the patient should discuss with their doctor or pharmacist if they have:

• liver or kidney disease,
• severe stomach or intestinal disease,
• the patient is taking tamoxifen, used to treat breast cancer,
• the patient has blood diseases. The patient may have a blood test to check this condition.
• the patient has heart disease (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 has had an adverse reaction to quinine in the past,
• the patient has a genetic disease known as glucose-6-phosphate dehydrogenase deficiency,
• the patient has a rare disease known as porphyria, which affects metabolism,
• hydroxychloroquine may cause a decrease in blood glucose levels. The patient should ask their doctor to explain the subjective and objective symptoms of low blood glucose levels. A blood glucose test may be necessary.
• the patient has hearing loss.

In some people treated with Hydroxychloroquine sulfate Edest, mental health problems may occur, such as irrational thoughts, hallucinations, disorientation or depression, including suicidal thoughts, even in people who have not had such problems before. If the patient or someone around them notices the occurrence of such side effects (see section 4), they should seek medical help immediately.
In connection with the use of hydroxychloroquine, serious skin rashes have been reported (see section 4 "Possible side effects"). Often, the rash can include oral 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 skin peeling. If such skin symptoms occur, the patient should stop taking hydroxychloroquine and contact their doctor immediately.

Before using Hydroxychloroquine sulfate Edest

• Before starting treatment with this medicine, the doctor will perform an eye examination on the patient to check for any abnormalities. In the case of long-term use of this medicine, the eye examination should be repeated at least every 6 months during treatment with Hydroxychloroquine sulfate Edest. If the patient is over 65 years old, they must take a high dose (2 tablets per day) or have kidney problems, then this examination should be performed more frequently. In case of problems during treatment with this

medicine (e.g., in case of worsening vision, color perception, or visual field), the patient should contact their doctor immediately.

• Hydroxychloroquine sulfate Edest may cause heart rhythm disturbances in some patients. Caution should be exercised when using Hydroxychloroquine sulfate Edest if the patient has congenital QT interval prolongation or a family member has QT interval prolongation, if the patient has had QT interval prolongation (visible on an electrocardiogram [EKG]), if the patient has heart rhythm disorders or has had a heart attack (myocardial infarction), if the patient has electrolyte imbalance in the blood (especially low potassium or magnesium levels, see "Hydroxychloroquine sulfate Edest and other medicines"). If heart palpitations or irregular heartbeat occur during treatment, the patient should tell their doctor immediately. The risk of heart problems may be higher with increasing dose. Therefore, the recommended dose should be followed.
• If the patient is taking this medicine for a long time, periodic muscle and tendon examinations are necessary. In case of muscle or tendon weakness, the patient should tell their doctor.

In case of doubts about whether any of the above symptoms apply to the patient, they should consult a doctor or pharmacist before using Hydroxychloroquine sulfate Edest.

Children

Hydroxychloroquine sulfate Edest should 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. For this reason, Hydroxychloroquine sulfate Edest should be kept out of the reach of children.

Hydroxychloroquine sulfate Edest and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Certain medicines used to treat depression (monoamine oxidase inhibitors [MAOIs]) should not be combined with Hydroxychloroquine sulfate Edest.
• Taking Hydroxychloroquine sulfate Edest with digoxin (a heart medicine) may lead to increased digoxin activity.
• Hydroxychloroquine sulfate Edest may reduce the effectiveness of the rabies vaccine.
• Hydroxychloroquine sulfate Edest may increase the risk of seizures, especially if used with antimalarial medicines (e.g., mefloquine). Additionally, Hydroxychloroquine sulfate Edest may reduce the effectiveness of antiepileptic medicines.
• Hydroxychloroquine sulfate Edest may enhance the effects of certain antidiabetic medicines (such as insulin or metformin) on blood sugar levels. It may be necessary to reduce the dose of insulin or other antidiabetic medicines.
• The patient should inform their doctor if they are taking medicines known to affect heart rhythm. This includes medicines used to treat heart rhythm disorders (antiarrhythmic medicines), depression (tricyclic antidepressants), mental disorders (antipsychotic medicines), bacterial infections, or antimalarial medicines (e.g., halofantrine).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Hydroxychloroquine sulfate Edest should not be used during pregnancy in high daily doses, unless the doctor considers it necessary, as the risk of stopping treatment is greater than the potential risk to the fetus.
This medicine may 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 on newborns and infants. Depending on the disease and duration of treatment, the doctor will decide whether the medicine can be used during breastfeeding. If the patient is taking this medicine once a week, e.g., for malaria prophylaxis, they do not need to stop breastfeeding. However, this amount of medicine is not sufficient to prevent malaria in the infant.

Driving and using machines

While taking this medicine, the patient may experience eye problems and dizziness. If such symptoms occur, the patient should not drive, use tools, or operate machines and should contact their doctor immediately.

Hydroxychloroquine sulfate Edest contains lactose

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

3. How to use Hydroxychloroquine sulfate Edest

This medicine should always be taken according to the doctor's or pharmacist's instructions. The doctor will determine the daily dose of the medicine. In case of doubts, the patient should consult their doctor or pharmacist.

What dose to take

The recommended dose is:
Adults
Rheumatoid arthritis
Initial dose: 400 mg per day, in a single dose or in two divided doses per day.
Maintenance dose: 200 mg per day, and then possibly 200 mg every other day.
Systemic and discoid lupus erythematosus
Initial dose: from 400 mg (in a single dose or in two divided doses) to 600 mg (in a single dose or in two or three divided doses) per day (for several weeks, if necessary).
Maintenance dose: from 200 mg to 400 mg in a single dose or in two divided doses per day.
Skin diseases related to sun exposure
Treatment is limited to periods of high sun exposure.
Adults: Usually, a dose of 400 mg per day is sufficient, in a single dose or in two divided doses.
Malaria prophylaxis
Adults: A dose of 400 mg per week, taken on the same day each week. Malaria prophylaxis should be started one week before arriving in an area where malaria is present and continued for four weeks after leaving the area.
Treatment of acute malaria attack
The dose used in the case of an acute malaria attack depends on the nature of the infection. The total dose is a maximum of 2 grams and is used for a maximum of three days.
Children
The doctor will determine the dose based on the patient's weight. A 200 mg tablet is not suitable for children weighing less than 31 kg.
Impaired kidney and liver function
In patients with impaired kidney or liver function, the doctor may prescribe a lower dose.
Duration of treatment
The patient should follow the doctor's instructions regarding the duration of treatment. In the case of long-term treatment, the doctor will prescribe the smallest possible dose of the medicine. In the case of joint disorders, the medicine will start working only after several weeks of treatment.

Taking this medicine

• The medicine should be taken orally.
• The tablets should be swallowed whole after a meal.
• In the case of taking this medicine for hypersensitivity to sunlight, Hydroxychloroquine sulfate Edest should be taken only during periods of high sun exposure.
• The doctor will determine the recommended dose based on the patient's weight. In case of feeling that the effect of the medicine is too strong or too weak, the patient should not change the dose themselves and should consult their doctor.
• If the patient is taking this medicine for rheumatoid arthritis for a long time (more than 6 months) and does not notice an improvement, they should consult their doctor. It may be necessary to stop the treatment.

Taking a higher dose of Hydroxychloroquine sulfate Edest than recommended

• If the patient has taken a higher dose of Hydroxychloroquine sulfate Edest than recommended, they should immediately tell their doctor or go to the hospital emergency department. They should take the medicine with them.
• This will allow the doctor to assess what the patient has taken. The following symptoms may occur: headache, vision problems, decreased blood pressure, seizures, heart rhythm disorders, and then sudden severe breathing difficulties and possibly a heart attack. Overdose of Hydroxychloroquine sulfate Edest can be fatal.
• There is a particular risk for young children and infants if they accidentally take Hydroxychloroquine sulfate Edest. The child should be taken to the hospital immediately.

Missing a dose of Hydroxychloroquine sulfate Edest

In case of missing a dose, the patient should take it as soon as possible. However, if it is almost time for the next dose, the patient should skip the missed dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Hydroxychloroquine sulfate Edest

The medicine should be taken until the doctor advises to stop treatment. The patient should not stop taking Hydroxychloroquine sulfate Edest due to improvement in their condition. If the patient stops taking the medicine, their condition may worsen.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should stop taking Hydroxychloroquine sulfate Edest and seek medical help immediately if they experience any of the following symptoms:

Rare (less than 1 in 1000 patients)

• Eye disorders. These include changes in eye color and vision problems, such as blurred vision, sensitivity to light, or changes in color perception. If these problems are detected early, they usually improve after stopping treatment with Hydroxychloroquine sulfate Edest. If the problems are not detected early, they may persist or worsen after stopping treatment.
• Seizures (convulsions),
• Muscle weakness (heart failure) causing breathing difficulties, cough, high blood pressure, swelling, rapid heartbeat, and low urine output,
• Heart disease (cardiomyopathy), which can be fatal in case of long-term use of high doses (see section 2, "Warnings and precautions").

Very rare (less than 1 in 10,000 patients)

• Severe skin reactions, such as blistering, widespread skin peeling, and high fever (toxic epidermal necrolysis).
• Blisters or skin peeling around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever (Stevens-Johnson syndrome).
• Sudden skin rash with blisters, fever, and increased white blood cell count (acute generalized exanthematous pustulosis - AGEP).

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

• Allergic reaction. Symptoms may include: red rash or hives, swallowing or breathing problems, swelling of the eyelids, lips, face, throat, or tongue (angioedema).
• Feeling weak, tired, faint, dizzy, pale skin, shortness of breath, increased susceptibility to bruising and infections (anemia, aplastic anemia, thrombocytopenia, leukopenia, or agranulocytosis).
• Liver problems, which can cause yellowing of the eyes or skin (jaundice).
• Low blood sugar levels (hypoglycemia) can cause nervousness, tremors, or sweating.
• Feeling depressed (depression) or having suicidal thoughts, hallucinations, nervousness, or anxiety, disorientation, excitement, difficulty sleeping, or feeling elated or overly excited
• 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 known as drug reaction with eosinophilia and systemic symptoms (DRESS).
• blisters or skin peeling, punctate lesions, occurring with fever. This may be a condition known as 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 known as Stevens-Johnson syndrome (SJS).
• multiple skin lesions, itching, joint pain, fever, and general malaise. This may be a condition known as toxic epidermal necrolysis (TEN).

Other side effects associated with hydroxychloroquine sulfate treatment

Common side effects (less than 1 in 10 patients)

• Decreased appetite (anorexia).

Uncommon side effects (less than 1 in 100 patients)

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

Rare side effects (less than 1 in 1000 patients)

• Mental problems (such as delusions, hallucinations, and mood changes).
• Vomiting (usually resolves after reducing the dose or stopping treatment).
• Decreased bone marrow activity (bone marrow suppression).

Very rare side effects (less than 1 in 10,000 patients)

• Irreversible hearing loss.
• Redness of the skin with raised irregular patches (erythema multiforme).
• Long-term treatment with a structurally related substance, which is chloroquine phosphate, may very rarely lead to reversible phospholipidosis (increased accumulation of intracellular phospholipids), including renal phospholipidosis. Due to the similar chemical structure, these side effects may also occur during hydroxychloroquine treatment. In such cases, kidney function disorders may worsen.

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

• Worsening of porphyria (a disease of red blood cells).
• Drowsiness and/or dizziness (of vestibular origin).
• Nervousness.
• Mood swings.
• Tinnitus.
• Headache.
• Movement disorders, such as muscle tension and tremors.
• Changes in the retina, visual field disorders, causing limited vision in part of the visual field (in the case of central rings, everything is visible except the center of the visual field, in the case of peripheral rings, only the center of the visual field is visible), transient blind spots in the visual field, and abnormal color perception.
• Corneal changes, including clouding and retention (retention) of fluids. Sometimes, these changes do not cause symptoms, but they can also cause vision problems, such as seeing colored rings, blurred vision, or photophobia. These problems are temporary or improve after stopping treatment.
• Blurred vision due to accommodation disorders (focusing) of the eye. This problem is temporary and improves after reducing the dose.
• Changes in heart rhythm (the doctor may check the heart's electrical activity using an electrocardiogram).
• Enlargement of both heart ventricles (biventricular hypertrophy).
• Severe itching of the skin (pruritus).
• Changes in skin color or mucous membranes, hair loss, or loss of hair color (these symptoms usually resolve after reducing the dose or stopping treatment).
• Cases of blistering or skin peeling.
• Sensitivity to light.
• Skin inflammation with redness and peeling (exfoliative dermatitis).
• Relapse of skin disease with peeling, dryness, and rash, accompanied by fever and general malaise. This may be a condition known as psoriasis.
• Rarely occurring hypersensitivity reaction characterized by fever, skin rash, and increased white blood cell count, associated with liver and lung diseases (DRESS syndrome).
• Musculoskeletal disorders. These may resolve after stopping treatment with this medicine, but recovery may take several months (myopathy).
• Muscle disorders that also affect the nerves, leading to weakness (neuromyopathy leading to progressive weakness).
• Muscle mass loss, muscle weakness (atrophy).
• Changes in sensory perception (reception of sensations)
• Decreased tendon reflexes (muscle contraction in response to tendon tapping; unconditioned reflex).
• Changes in limb control due to nerve disorders.
• Breathing difficulties.
• Abnormal liver test results.
• Severe liver failure.
• Allergic reactions manifesting as skin rash with severe itching and hives (urticaria).
• Abnormal heart rhythm, irregular heart rhythm that is life-threatening (observed in EKG; see section 2, "Warnings and precautions"). If the patient takes a higher dose of hydroxychloroquine than recommended, they should immediately tell their doctor. The following effects may occur: heart rhythm disorders - leading to irregular heartbeat.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Hydroxychloroquine sulfate Edest

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after EXP. The expiry date refers to the last day of the month.
There are no special precautions for the storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Hydroxychloroquine sulfate Edest contains

• Each tablet contains 200 mg of the active substance hydroxychloroquine sulfate.
• The other ingredients are: lactose monohydrate, cornstarch, magnesium stearate, povidone K30, polyvinyl alcohol, macrogol 4000, and titanium dioxide (E 171).

What Hydroxychloroquine sulfate Edest looks like and contents of the pack

Hydroxychloroquine sulfate Edest, 200 mg, coated tablets are white or off-white, peanut-shaped, biconvex, coated tablets with the letter "H11" embossed on one side and no markings on the other side.
The approximate dimensions are 12.80 ± 0.05 mm × 6.10 ± 0.05 mm.
The tablets are available in blisters containing 20, 30, 50, 60, 90, or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Intas Third Party Sales 2005, S.L.
World Trade Center, Moll Barcelona s/n, Edifici Est, 6th Floor,
08039 Barcelona, Spain

Manufacturer/Importer

Laboratori Fundació Dau
C/c 12-14 Poligon Industrial Zona Franca
08040 Barcelona
Spain
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Poland
Pharmadox Healthcare Ltd.
KW20A Corradino Industrial Estate
PLA 3000 Paola
Malta

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

Date of last revision of the leaflet March 2022