Hydroxychloroquine adamed

Package leaflet:

Information for the user
Hydroxychloroquine Adamed, 200 mg, film-coated tablets
Hydroxychloroquini sulfas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

• Treatment of chronic conditions involving inflammation of joints, muscles, tendons or ligaments (rheumatoid arthritis),
• Treatment of certain diseases whose symptoms include, among others, skin problems and (or) joint pain (systemic and discoid lupus erythematosus),
• Treatment of skin disorders associated with photosensitivity (photodermatoses),
• Treatment of acute attacks of uncomplicated malaria and prevention of malaria.

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

• Treatment of juvenile rheumatism in combination with other treatment methods (juvenile idiopathic arthritis),
• Treatment of certain diseases whose symptoms include, among others, 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 using Hydroxychloroquine Adamed

When not to use Hydroxychloroquine Adamed

• If the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to other similar medicines, such as quinolones and quinine (other medicines used in malaria).
• If the patient has certain eye disorders (maculopathy or retinal pigmentary degeneration).
• Hydroxychloroquine Adamed must not be used in children under 6 years of age and weighing less than 31 kg.

Warnings and precautions
Before starting treatment with Hydroxychloroquine Adamed, discuss with your doctor or
pharmacist if:

• the patient has liver or kidney disease,
• the patient has severe stomach or intestinal disorders,
• the patient is taking tamoxifen, a medicine used in the treatment of breast cancer,
• the patient has blood disorders. A blood test may be performed to check this condition,
• the patient has heart disease (symptoms include shortness of breath and chest pain), which may require monitoring,
• the patient has neurological or brain disorders,
• the patient has psoriasis (red, scaly patches on the skin, usually affecting knees, elbows and scalp),
• the patient previously experienced an adverse reaction to quinine,
• the patient has a genetic disorder known as glucose-6-phosphate dehydrogenase deficiency,
• the patient has a rare condition known as porphyria, which affects metabolism,
• the patient has inactive chronic hepatitis B virus infection,
• hydroxychloroquine may reduce blood glucose levels. The patient should ask the doctor to explain subjective and objective symptoms of low blood glucose levels. Blood glucose testing may be necessary.
• the patient has hearing loss.

In some individuals treated with Hydroxychloroquine Adamed, psychiatric symptoms may occur, such as irrational thoughts, hallucinations, feelings of disorientation or depression, including self-harming or suicidal thoughts, even in people who have not previously experienced such disorders. If the patient or someone close to them notices such adverse reactions (see section 4), immediate medical help should be sought.
Serious skin rashes have been reported with the use of hydroxychloroquine (see section 4 "Possible side effects"). Often, these rashes may involve ulceration of the mouth, throat, nose, genital organs 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 may progress to extensive blistering and peeling of the skin. If such skin symptoms occur, hydroxychloroquine must be discontinued immediately and the patient should contact a doctor without delay.

Before using Hydroxychloroquine Adamed

• Before starting this medicine, the doctor will perform an eye examination to check for any abnormalities. For long-term use of this medicine, eye examinations should be repeated at least every 12 months during treatment with Hydroxychloroquine Adamed. If the patient is over 65 years old, is taking a high dose (2 tablets per day), or has kidney problems, these examinations should be performed more frequently. If any problems occur (e.g. noticing worsening of visual acuity, colour vision quality or visual field limitations) during treatment with this medicine, the patient should contact the doctor immediately.

• Hydroxychloroquine Adamed may cause heart rhythm disturbances in some patients. Caution should be exercised when using Hydroxychloroine Adamed if the patient has congenital QT interval prolongation or if a family member has QT prolongation, if the patient has developed QT prolongation (visible on electrocardiogram [ECG]), if the patient has heart disorders or has previously had a heart attack (myocardial infarction), or if the patient has electrolyte imbalances in the blood (particularly low potassium or magnesium levels, see section "Hydroxychloroquine Adamed and other medicines"). If palpitations or irregular heartbeat occur during treatment, the patient must inform the doctor immediately. The risk of heart problems may increase with higher doses. Therefore, the recommended dose must be strictly followed.

• If the patient uses this medicine for a long time, periodic muscle and tendon examinations are necessary. If muscle or tendon weakness develops, the patient should inform the doctor.

If in doubt whether any of the above situations apply, the patient should consult a doctor or pharmacist before using Hydroxychloroquine Adamed.

Children
Young children are particularly sensitive to the toxic effects of 4-aminoquinoline derivatives, including hydroxychloroquine. Therefore, Hydroxychloroquine Adamed must be stored out of reach of children.

Hydroxychloroquine Adamed and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

• 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 when used together with antimalarial medicines (e.g. mefloquine). Additionally, Hydroxychloroquine Adamed may reduce the effectiveness of antiepileptic medicines.
• Hydroxychloroquine Adamed may enhance the effect of certain antidiabetic medicines (such as insulin or metformin) on blood glucose levels. It may be necessary to reduce the dose of insulin or other antidiabetic medicines.
• The patient should inform the doctor if taking medicines known to affect heart rhythm. This includes medicines used to treat heart rhythm disorders (antiarrhythmic medicines), depression (tricyclic antidepressants), psychiatric disorders (antipsychotics), bacterial infections (e.g. antibiotics in a group called 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 disease.
• Hydroxychloroquine Adamed should not be used with dapsone (an antibiotic).
• Hydroxychloroquine Adamed may reduce the effectiveness of remdesivir (an antiviral medicine). Concomitant use should be avoided.
• Hydroxychloroquine Adamed may increase blood levels of cyclosporine (a medicine used after organ transplantation to prevent rejection).

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 her doctor or pharmacist before using this medicine.
The doctor will discuss with the patient whether Hydroxychloroquine Adamed is suitable for her.

Pregnancy
Hydroxychloroquine Adamed may be associated with a small increased risk of serious developmental abnormalities and should not be used during pregnancy unless the doctor considers that the benefits outweigh the risks.

Breastfeeding
This medicine passes into human milk.
Hydroxychloroquine Adamed should not be used during breastfeeding unless the doctor considers that the benefits outweigh the risks.

Driving and operating machinery
This medicine may cause blurred vision and dizziness. If either of these side effects occurs, the patient should not drive or operate any tools or machinery.

Hydroxychloroquine Adamed contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to use Hydroxychloroquine Adamed

This medicine must always be taken exactly as directed by your doctor or pharmacist. Your doctor will determine the daily dose. If in doubt, consult your doctor or pharmacist.
Dosage of Hydroxychloroquine Adamed
Recommended dose:
Rheumatoid disorders
Adults (including elderly patients): 200 mg to 400 mg once daily or in two divided doses.
Photosensitivity disorders
Adults: 400 mg once daily. Use only during periods of high exposure to sunlight.
Prevention of malaria
Adults: A dose of 400 mg once weekly, taken on the same day each week. Malaria prophylaxis should begin one week before entering a malaria-risk area and continue for four weeks after leaving the area.
Treatment of acute uncomplicated malaria
Adults: The dose used in acute malaria attacks depends on the nature of the infection. The total dose should not exceed 2 grams and should be administered over a maximum of three days.
Children and adolescents
The doctor will determine the dose based on the patient's body weight. The 200 mg tablet is not suitable for children weighing less than 31 kg.
Impaired kidney or liver function
In patients with impaired kidney or liver function, the doctor may prescribe a lower dose.
Administration of Hydroxychloroquine Adamed

• This medicine should be taken orally.
• Tablets should be swallowed whole with food.
• When used for conditions related to photosensitivity, Hydroxychloroquine Adamed should be taken only during periods of high exposure to sunlight.
• The doctor will determine the recommended dose based on the patient's body weight. If you feel the effect of the medicine is too strong or too weak, do not adjust the dose yourself; consult your doctor.
• If a patient with rheumatoid arthritis has been taking this medicine for a long time (over 6 months) without noticing improvement, they should consult their doctor. It may be necessary to discontinue treatment.

How long to use Hydroxychloroquine Adamed
Follow your doctor's instructions regarding the duration of treatment. For long-term treatment, the doctor will prescribe the lowest effective dose. When treating joint disorders, the medicine may take several weeks to become effective.
Accidental overdose of Hydroxychloroquine Adamed

• If a patient takes more than the recommended dose of Hydroxychloroquine Adamed, contact a doctor immediately or go to the nearest hospital emergency department. Bring the medicine with you so the doctor can identify what was taken. Symptoms may include headache, visual disturbances, low blood pressure, seizures, cardiac arrhythmias, followed by sudden severe respiratory depression and possibly myocardial infarction. Overdose with Hydroxychloroquine Adamed can be fatal.
• Particular risk applies to young children and infants who accidentally ingest Hydroxychloroquine Adamed. Immediate hospitalization is required.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment with Hydroxychloroquine Adamed must be discontinued and the patient should immediately seek
medical attention from a doctor or go to hospital if any of the following serious adverse
effects occur – the patient may require urgent medical assistance:
Rare (occurring in no more than 1 in 1,000 patients)

• Eye disorders. These include changes in eye colour and vision problems such as blurred vision, light sensitivity, or changes in how colours are perceived. If such problems are detected early, they usually improve after stopping treatment with Hydroxychloroine Adamed. If problems are not detected early enough, they may persist or even worsen after discontinuation of treatment.
• Seizures,
• Breathing difficulties, cough, high blood pressure, swelling, rapid heartbeat, reduced urine output – these may be symptoms of heart muscle weakness (cardiomyopathy or heart failure) which may lead to death (see section 2, "Warnings and precautions").

Frequency unknown (frequency cannot be estimated from available data)

• Allergic reaction. Symptoms may include red rash or nodular rash, difficulty swallowing or breathing, 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 known as drug reaction with eosinophilia and systemic symptoms (DRESS).
• Feeling weak, tired, faint, dizzy, pale skin, shortness of breath, increased tendency to bruising and infections (anaemia, aplastic anaemia, thrombocytopenia, leukopenia or agranulocytosis).
• Feelings of depression or suicidal thoughts or self-harming thoughts, hallucinations, nervousness or anxiety, disorientation, agitation, difficulty sleeping, feelings of elation or excessive excitement.
• Liver problems. Symptoms may include general malaise, with or without jaundice (yellowing of the skin and eyes), dark-coloured urine, nausea, vomiting and (or) abdominal pain. Rare cases of liver failure (including fatal cases) have been observed.
• Low blood sugar (hypoglycaemia) may cause nervousness, trembling 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 generalised 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, itchy 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.

Other adverse effects associated with hydroxychloroquine sulphate treatment
Common adverse effects (occurring in no more than 1 in 10 treated patients)

• Decreased appetite (anorexia).

Uncommon adverse effects (occurring in no more than 1 in 100 treated patients)

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

Rare adverse effects (occurring in no more than 1 in 1,000 treated patients)

• Vomiting (usually resolves after dose reduction or discontinuation of treatment).
• Reduced bone marrow function (bone marrow suppression).

Very rare adverse effects (occurring in no more than 1 in 10,000 treated patients)

• Hearing loss (irreversible).
• Long-term hydroxychloroquine therapy may lead to increased accumulation of phospholipids in tissues, including the kidneys. In such cases, worsening of kidney function may occur.

Frequency unknown (frequency cannot be estimated from available data)

• Worsening of porphyria (a red blood cell disorder).
• Drowsiness and (or) dizziness (of labyrinthine origin).
• 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, 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. Erythematous-edematous lesions, appearing as raised spots, sometimes with vesicles (erythema multiforme).
• Movement disorders, such as muscle tension.
• Muscle disease causing muscle weakness.
• Sensory perception disturbances or impaired limb control, reduced tendon reflexes.
• Breathing difficulties.
• Abnormal liver function test results.
• Severe liver failure.
• Allergic reactions manifesting as skin rash with intense itching and appearance of nodules (urticaria).
• Irregular heart rhythm, life-threatening arrhythmia (observed on ECG; see section 2 "Warnings and precautions"). If a dose of hydroxychloroquine higher than recommended is taken, inform the doctor immediately. Heart function disturbances may occur, leading to irregular heartbeat.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

5. How to store Hydroxychloroquine Adamed

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or carton after EXP. The expiry date refers to the last day of the mentioned month.
There are no special requirements regarding the storage temperature of the medicinal product.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging 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 gelatinized, povidone K25, crospovidone type A, magnesium stearate, and AquaPolish P yellow 024.138 coating containing: hypromellose, hydroxypropylcellulose, medium chain triglycerides, talc, titanium dioxide (E 171), and yellow iron oxide (E 172).

What Hydroxychloroquine Adamed looks like and contents of the pack
Hydroxychloroquine Adamed is a yellow, biconvex, round coated tablet with a diameter of 10.50 mm.
The medicine is available in PVC/PVDC/Aluminium blisters packed in a cardboard box.
Pack sizes contain 20, 30, 50, 60, 90 or 100 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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