Hidroxihloroquine Adamed

Leaflet accompanying the packaging:

Information for the user

Hydroxychloroquine Adamed, 200 mg, film-coated tablets

Hydroxychloroquine sulfate

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

• You should keep this leaflet, so you can read it again if you need to.
• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

• 1. What is Hydroxychloroquine Adamed and what is it used for
• 2. Important information before taking Hydroxychloroquine Adamed
• 3. How to take Hydroxychloroquine Adamed
• 4. Possible side effects
• 5. How to store Hydroxychloroquine Adamed
• 6. Contents of the pack and other information

1. What is Hydroxychloroquine Adamed and what is it used for

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

• treatment of chronic inflammatory joint disease (rheumatoid arthritis),
• treatment of certain diseases with symptoms including skin problems and/or joint pain (systemic and discoid lupus erythematosus),
• treatment of skin problems with sensitivity to sunlight (photodermatoses),
• treatment of acute attacks of uncomplicated malaria and prevention of malaria.

Children and adolescents (≥6 years and body weight ≥31 kg)

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

2. Important information before taking Hydroxychloroquine Adamed

When not to take Hydroxychloroquine Adamed

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other similar medicines, such as quinolones and quinine (other medicines used for malaria)
• If you have certain eye disorders (maculopathy or retinal pigmentary degeneration).
• Hydroxychloroquine Adamed should not be used in children under 6 years of age and with a body weight below 31 kg.

Warnings and precautions

Before starting treatment with Hydroxychloroquine Adamed, you should discuss it with your doctor or pharmacist if:

• you have liver or kidney disease,
• you have severe stomach or intestinal disease,
• you are taking tamoxifen, used to treat breast cancer,
• you have blood diseases. You may need to have a blood test to check this condition,
• you have heart disease (symptoms include shortness of breath and chest pain), which may require monitoring,
• you have nervous system or brain disorders,
• you have psoriasis (red, scaly patches on the skin, usually on the elbows, knees, and scalp),
• you have had an adverse reaction to quinine in the past,
• you have a genetic disorder known as glucose-6-phosphate dehydrogenase deficiency,
• you have a rare disease known as porphyria, which affects metabolism,
• you have inactive chronic hepatitis B virus infection,
• hydroxychloroquine may cause a decrease in blood glucose levels. You should ask your doctor to explain the subjective and objective symptoms of low blood glucose levels. It may be necessary to perform a blood glucose test.
• you have hearing loss.

In some people taking Hydroxychloroquine Adamed, mental health problems may occur, such as irrational thoughts, hallucinations, feelings of disorientation or depression, including suicidal thoughts or behaviors, even in people who have not had such disorders before. If you or someone around you notices the occurrence of such side effects (see section 4), you should seek medical help immediately.
Severe skin rashes have been reported with the use of hydroxychloroquine (see section 4 "Possible side effects"). Often, the rash can involve ulcers of the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes). The occurrence of such severe skin rashes is often preceded by flu-like symptoms, such as fever, headache, and body aches. The rash can transform into widespread blisters and peeling of the skin. If such skin symptoms occur, you should stop taking hydroxychloroquine and contact your doctor immediately.

Before taking Hydroxychloroquine Adamed

• Before starting treatment with this medicine, your doctor will perform an eye examination to check for any abnormalities. In the case of long-term use of this medicine, the eye examination should be repeated at least every 12 months during treatment with Hydroxychloroquine Adamed. If you are over 65 years old, you are taking a high dose (2 tablets per day) or have kidney problems, this examination should be performed more frequently. If you experience problems (e.g., noticing a decrease in visual acuity, color vision, or visual field) during treatment with this medicine, you should contact your doctor immediately.

Hydroxychloroquine Adamed may cause heart rhythm disturbances in some patients. You should be cautious when taking Hydroxychloroquine Adamed if you have congenital QT interval prolongation or if a family member has QT interval prolongation, if you have had QT interval prolongation (visible on an electrocardiogram [EKG]), if you have heart rhythm disorders or have had a heart attack (myocardial infarction), if you have electrolyte imbalance in the blood (especially low potassium or magnesium levels, see "Hydroxychloroquine Adamed and other medicines"). If you experience palpitations or irregular heartbeat during treatment, you should tell your doctor immediately. The risk of heart problems may be higher with increasing dose. Therefore, you should follow the recommended dose.

• If you are taking this medicine for a long time, periodic muscle and tendon examinations are necessary. If you experience muscle or tendon weakness, you should tell your doctor.

In case of doubt whether any of the above situations apply to you, you should consult your doctor or pharmacist before taking Hydroxychloroquine Adamed.

Children

Small children are particularly sensitive to the toxic effects of 4-aminoquinoline derivatives, to which hydroxychloroquine belongs. For this reason, Hydroxychloroquine Adamed should be kept out of the reach of children.

Hydroxychloroquine Adamed and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• Certain medicines used to treat depression (monoamine oxidase inhibitors [MAOIs]) should not be combined with Hydroxychloroquine Adamed.
• Taking Hydroxychloroquine Adamed with digoxin (a heart medicine) may increase the effect of digoxin.
• Hydroxychloroquine Adamed may reduce the effectiveness of the rabies vaccine.
• Hydroxychloroquine Adamed may increase the risk of seizures, especially if Hydroxychloroquine Adamed is used with antimalarial medicines (e.g., mefloquine). Additionally, Hydroxychloroquine Adamed may reduce the effectiveness of antiepileptic medicines.
• Hydroxychloroquine Adamed may increase the effect 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.
• You should inform your doctor if you are taking medicines known to affect heart rhythm. These include medicines used to treat heart rhythm disorders (antiarrhythmic medicines), depression (tricyclic antidepressants), mental disorders (antipsychotic medicines), bacterial infections (e.g., macrolides, including azithromycin), or antimalarial medicines (e.g., halofantrine).
• Hydroxychloroquine Adamed may reduce the effectiveness of agalsidase alfa, a medicine used to treat a rare condition called Fabry's disease.
• Hydroxychloroquine Adamed should not be used with dapsone (an antibiotic).
• Hydroxychloroquine Adamed may reduce the effectiveness of Remdesivir (an antiviral medicine). You should avoid concurrent use.
• Hydroxychloroquine Adamed may increase the blood levels of cyclosporine (a medicine used after organ transplantation to prevent rejection).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will discuss with you whether Hydroxychloroquine Adamed is suitable for you.
Pregnancy
Hydroxychloroquine Adamed may be associated with a small increased risk of serious birth defects and should not be used during pregnancy unless your doctor considers that the benefits outweigh the risks.
Breastfeeding
The medicine passes into human milk.
Hydroxychloroquine Adamed should not be used during breastfeeding unless your doctor considers that the benefits outweigh the risks.

Driving and using machines

This medicine may cause blurred vision and dizziness. If you experience either of these side effects, do not drive or operate any tools or machines.

Hydroxychloroquine Adamed contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Hydroxychloroquine Adamed

This medicine should always be taken exactly as your doctor or pharmacist has told you. Your doctor will decide on the daily dose of the medicine. If you are unsure, ask your doctor or pharmacist.

Dosage of Hydroxychloroquine Adamed

The recommended dose is:
Rheumatoid diseases
Adults (including elderly patients): 200 mg to 400 mg per day in a single daily dose or in 2 divided doses.
Photodermatoses
Adults: 400 mg per day in a single dose. It should only be used during periods of high sun exposure.
Malaria prevention
Adults: A dose of 400 mg per week taken on the same day each week. Malaria prophylaxis should be started one week before arrival in the area where malaria is present and continued for four weeks after leaving the area.
Treatment of acute uncomplicated malaria
Adults: The dose used for acute malaria depends on the nature of the infection. The total dose is up to 2 grams and is given for a maximum of three days.
Children and adolescents
Your doctor will decide on the dose based on the patient's body weight. The 200 mg tablet is not suitable for children with a body weight below 31 kg.
Impaired renal and hepatic function
In patients with impaired renal or hepatic function, your doctor may prescribe a lower dose.

Taking Hydroxychloroquine Adamed

• The medicine should be taken orally.
• Tablets should be swallowed whole after a meal.
• If you are taking this medicine due to sensitivity to sunlight, Hydroxychloroquine Adamed should only be taken during periods of high sun exposure.
• Your doctor will determine the recommended dose based on the patient's body weight. If you feel that the effect of the medicine is too strong or too weak, do not change the dose yourself and consult your doctor.
• If you are taking this medicine for rheumatoid arthritis for a long time (more than 6 months) and do not notice an improvement, you should consult your doctor. It may be necessary to discontinue treatment.

How long to take Hydroxychloroquine Adamed

You should follow your doctor's advice regarding the duration of treatment. In the case of long-term treatment, your doctor will prescribe the lowest possible dose of the medicine. In the treatment of joint disorders, the medicine will start working only after a few weeks of use.

Taking a higher dose of Hydroxychloroquine Adamed than recommended

• If you have taken more than the recommended dose of Hydroxychloroquine Adamed, you should immediately tell your doctor or go to the hospital emergency department. You should take the medicine with you. This will allow the doctor to assess what you have taken. The following symptoms may occur: headache, vision problems, decreased blood pressure, seizures, heart rhythm disturbances, and subsequently severe respiratory disturbances and possibly myocardial infarction. Overdose of Hydroxychloroquine Adamed can be fatal.
• There is a particular risk for small children and infants if they accidentally take Hydroxychloroquine Adamed. You should immediately take the child to the hospital.

Missing a dose of Hydroxychloroquine Adamed

If you miss a dose, you should take it as soon as possible. However, if it is almost time for the next dose, you should skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Hydroxychloroquine Adamed

You should take the medicine for as long as your doctor recommends. Do not stop taking Hydroxychloroquine Adamed due to improvement in your condition. If you stop taking the medicine, your condition may worsen.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

You should stop taking Hydroxychloroquine Adamed and seek medical help immediately if you experience any of the following serious side effects - you may need urgent medical attention:

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 vision. If these problems are detected early, they usually improve after stopping treatment with Hydroxychloroquine Adamed. If the problems are not detected early enough, they may persist or even worsen after stopping treatment.
• Seizures (convulsions),
• Difficulty breathing, coughing, 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 (see section 2, "Warnings and precautions").

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

• Allergic reaction. Symptoms may include: red rash or rash with bumps, swallowing or breathing problems, swelling of the eyelids, lips, face, throat, or tongue (angioedema).
• Flu-like symptoms with rash, fever, and swollen lymph nodes - these may be symptoms of a hypersensitivity reaction called drug reaction with eosinophilia and systemic symptoms (DRESS).
• Feeling weak, tired, faint, dizzy, pale skin, shortness of breath, increased tendency to bruise and infections (anemia, aplastic anemia, thrombocytopenia, leukopenia, or agranulocytosis).
• Feeling depressed (depression) or having suicidal thoughts or behaviors, hallucinations, feeling nervous or anxious, feeling disoriented, agitation, difficulty sleeping, feeling elated or overexcited.
• Liver problems. Symptoms may include general 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.
• Low blood sugar (hypoglycemia) may cause nervousness, shakiness, or sweating.
• 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 mouth, eyes, lips, 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 (plum-colored, 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.

Other side effects associated with hydroxychloroquine sulfate treatment

Common side effects (less than 1 in 10 treated patients)

• Decreased appetite (anorexia).

Uncommon side effects (less than 1 in 100 treated 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 treated patients)

• Vomiting (usually resolves after reducing the dose or stopping treatment).
• Decreased bone marrow function (bone marrow suppression).

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

• Hearing loss (irreversible).
• 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 (frequency cannot be estimated from the available data)

• Worsening of porphyria (a disease of red blood cells).
• Drowsiness and/or dizziness (of vestibular origin).
• Ringing in the ears (tinnitus).
• Headache.
• Transient blind spots in the visual field and abnormal color vision; transient, blurred vision or sensitivity to light.
• Skin disorders, such as severe itching, skin rash with blisters or bumps, sensitivity to light, redness and peeling, dry, scaly skin rash, changes in skin color or mucous membranes, hair loss or hair color loss. Erythema multiforme, with raised, red spots, sometimes with blisters (erythema multiforme).
• 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 test results.
• Severe liver failure.
• Allergic reactions, such as skin rash with severe itching and hives (urticaria).
• Abnormal heart rhythm, life-threatening irregular heart rhythm (observed in EKG; see section 2, "Warnings and precautions"). If you take more than the recommended dose of hydroxychloroquine, you should immediately tell your doctor. Heart rhythm disturbances leading to irregular heartbeat may occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring 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

5. How to store Hydroxychloroquine Adamed

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 storage temperature.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Hydroxychloroquine Adamed contains

• The active substance is hydroxychloroquine sulfate. Each tablet contains 200 mg of hydroxychloroquine sulfate.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, maize starch, povidone K25, crospovidone type A, magnesium stearate, and AquaPolish P yellow 024.138, which consists of: hypromellose, hydroxypropyl cellulose, medium-chain triglycerides, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Hydroxychloroquine Adamed looks like and contents of the pack

Hydroxychloroquine Adamed is a yellow, biconvex, round film-coated tablet with a diameter of 10.50 mm.
The medicine is available in PVC/PVDC/Aluminum blisters in a cardboard box.
The pack contains 20, 30, 50, 60, 90, or 100 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: