HYDROQUENIN 200 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Hydroquenin, 200 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Hydroquenin and what is it used for
4. Important information before taking Hydroquenin
   1. When not to take Hydroquenin
   2. Warnings and precautions
   3. Children
   4. Hydroquenin and other medicines
   5. Hydroquenin with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
5. How to take Hydroquenin
   1. Use in children and adolescents
   2. Taking a higher dose of Hydroquenin than recommended
   3. Missing a dose of Hydroquenin
   4. Stopping Hydroquenin treatment
6. Possible side effects
   1. Other side effects
   2. Reporting side effects
7. How to store Hydroquenin
8. Package contents and other information
   1. What Hydroquenin contains
   2. What Hydroquenin looks like and what the package contains
   3. Marketing authorization holder
   4. Importer
   5. Date of the last leaflet update:

Leaflet attached to the packaging: patient information

Hydroquenin, 200 mg, film-coated tablets

Hydroxychloroquine sulfate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 Hydroquenin and what is it used for
• 2. Important information before taking Hydroquenin
• 3. How to take Hydroquenin
• 4. Possible side effects
• 5. How to store Hydroquenin
• 6. Package contents and other information

1. What is Hydroquenin and what is it used for

Hydroquenin contains the active substance hydroxychloroquine sulfate, is an antimalarial medicine and has anti-inflammatory and antirheumatic properties.
Hydroquenin is used in adults for:

• prevention and treatment of malaria,
• treatment of rheumatoid arthritis,
• treatment of skin diseases caused or exacerbated by sunlight (photodermatoses),
• treatment of connective tissue diseases (systemic and discoid lupus erythematosus).

Hydroquenin is used in children and adolescents for:

• treatment of juvenile idiopathic arthritis (in combination with other therapies),
• treatment of connective tissue diseases (systemic and discoid lupus erythematosus).

2. Important information before taking Hydroquenin

When not to take Hydroquenin

Hydroquenin should not be given to children with a body weight of less than 35 kg.

Warnings and precautions

Caution should be exercised before starting Hydroquenin and discussed with a doctor or pharmacist if the patient has:

• liver or kidney function disorders and if the patient is taking medicines that may affect the liver and/or kidneys (dose reduction may be necessary);
• severe gastrointestinal disorders;
• nervous system disorders;
• blood diseases;
• quinine hypersensitivity;
• heart conduction disorders;
• glucose-6-phosphate dehydrogenase deficiency (a hereditary disease);
• porphyria (a hereditary metabolic disease);
• inactive chronic hepatitis B virus infection.

While taking Hydroquenin, direct exposure to sunlight should be avoided.
Medicines containing gold salts or phenylbutazone (used in rheumatoid arthritis and gout) should not be taken at the same time.
Hydroxychloroquine may cause a decrease in blood glucose levels (hypoglycemia).
The doctor should inform the patient about the signs and symptoms of low blood sugar levels.
It may be necessary to monitor blood glucose levels and, if necessary, verify the treatment.
Hydroxychloroquine may cause severe heart rhythm disorders with rapid, irregular heartbeat (QTc interval prolongation).
Before starting Hydroquenin, the patient should discuss with their doctor:

In patients treated with hydroxychloroquine, cases of cardiomyopathy have been reported, some of which were fatal. The doctor will monitor the subjective and objective symptoms of cardiomyopathy.
Treatment with Hydroquenin should be discontinued if cardiomyopathy occurs. If the patient is diagnosed with heart conduction disorders (bundle branch block, atrioventricular block) and biventricular hypertrophy, chronic toxicity can be suspected.
The treatment duration should not exceed 3 years.
Before starting long-term treatment, a thorough eye examination should be performed, and every 12 months during treatment, the eyes should be examined.
If vision disorders occur, Hydroquenin should be discontinued and the doctor consulted.
Children should always be examined by an ophthalmologist before starting treatment.
Patients with visual acuity below 0.8, as well as patients over 65 years of age, should be examined by an ophthalmologist before starting treatment.
During long-term treatment, regular blood tests and muscle and tendon tests should be performed. If abnormalities occur (e.g., changes in blood or muscle weakness), the doctor will decide to discontinue Hydroquenin.
During treatment, movement disorders, involuntary movements, and/or tremors may occur (see section 4).
In some people taking Hydroquenin, 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.
Severe skin reactions have been reported with hydroxychloroquine use (see section 4 "Possible side effects"). Often, the rash can involve oral ulcers, throat, nose, genitals, and conjunctivitis (eye redness and swelling). The occurrence of such severe skin reactions is often preceded by flu-like symptoms, such as fever, headache, and body aches. The rash can transform into widespread blisters and skin peeling. If such skin symptoms occur, Hydroquenin should be discontinued and the doctor consulted immediately.

Children

Hydroquenin should not be given to children with a body weight of less than 35 kg.
Young children are very sensitive to the group of medicines to which Hydroquenin belongs. Special caution should be exercised, and Hydroquenin should be stored in a place inaccessible to children to avoid poisoning.

Hydroquenin 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 the patient plans to take.
Some medicines may interact with hydroxychloroquine.
The doctor should be informed if the patient is taking any of the following medicines that affect heart rhythm, such as:

• medicines used to treat heart rhythm disorders (antiarrhythmic medicines);
• medicines used to treat depression (tricyclic antidepressants);
• medicines used to treat mental disorders (antipsychotic medicines);
• medicines used to treat bacterial infections (e.g., moxifloxacin, azithromycin);
• medicines used to treat HIV infection (e.g., saquinavir);
• medicines used to treat fungal infections (e.g., fluconazole);
• medicines used to treat parasitic infections (e.g., pentamidine);
• medicines used to treat malaria (e.g., halofantrine).

The doctor should be informed if the patient is taking any of the following medicines:

• insulin or other antidiabetic medicines;
• medicines used to treat malaria, such as mefloquine (as it may increase the risk of seizures);
• antiepileptic medicines (used to treat epilepsy), especially phenobarbital, phenytoin, carbamazepine;
• medicines that affect the skin, blood, or eyes;
• tamoxifen - a medicine used to treat breast cancer;
• agalsidase - a medicine used to treat a rare disease called "Fabry's disease";
• medicines used to treat bacterial infections (such as rifampicin, clarithromycin);
• medicines that may affect kidney or liver function;
• antacids and medicines containing kaolin (white clay). A minimum of 2 hours should be allowed between taking Hydroquenin and these medicines;
• cimetidine - a medicine used to treat stomach ulcers;
• medicines used to treat fungal infections (itraconazole);
• medicines used to treat lipid disorders (gemfibrozil);
• medicines used to treat AIDS (ritonavir);
• medicines used after organ transplants or to treat immune system diseases (cyclosporine);
• anticoagulant medicines (dabigatran, clopidogrel);
• medicines used to treat heart diseases (digoxin, flecainide, propafenone, and metoprolol);
• a medicine used to treat parasitic infections (praziquantel);
• herbal medicines used to treat depression containing St. John's Wort.

Hydroquenin with food and drink

Grapefruit juice should not be consumed while taking Hydroquenin, as it may cause 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 their doctor or pharmacist before taking this medicine. The doctor will discuss with the patient whether Hydroquenin is suitable for them.
Pregnancy
Taking Hydroquenin may be associated with a small increased risk of serious birth defects and should not be taken during pregnancy unless the doctor considers that the benefits outweigh the risks.
Breastfeeding
Hydroquenin passes into breast milk.
Hydroquenin should not be taken during breastfeeding unless the doctor considers that the benefits outweigh the risks.

Driving and using machines

In some cases, the medicine may cause side effects that can affect the ability to drive and use machines. The medicine may cause vision disturbances and blurred vision.
It may be necessary to temporarily reduce the dose if the above side effects do not disappear on their own.

3. How to take Hydroquenin

This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist.
Recommended doses:
Malaria prophylaxis:
Adults: 400 mg (2 tablets) once a week. Prophylactic treatment should be started one week before arrival in the malaria area, continued during stay, and for 4 weeks after leaving the area.
The dose should be taken on the same day each week.
For other uses, the dose is determined by the doctor, who will adjust it individually for the patient, according to the following guidelines:
Malaria treatment:
Adults: initially 800 mg (4 tablets), after 6 hours 400 mg (2 tablets), then 400 mg (2 tablets) per day for 2 days, and for patients with a body weight over 60 kg for 3 days.
Photodermatoses:
Adults: 200 to 400 mg (1-2 tablets) per day, starting 14 days before expected sun exposure.
Discoid lupus erythematosus:
Adults: initially 400 to 800 mg (2-4 tablets), then 200 to 400 mg (1-2 tablets) per day.
Connective tissue diseases:
Adults: 200 to 400 mg (1-2 tablets) per day.

Use in children and adolescents

The dose of Hydroquenin is determined by the doctor. The smallest effective dose should be used, which should not exceed 6.5 mg per kg of body weight per day based on ideal body weight.
This medicine is not suitable for children with an ideal body weight below 31 kg.

Taking a higher dose of Hydroquenin than recommended

In case of taking a higher dose of Hydroquenin than recommended, the doctor, emergency services, or pharmacist should be contacted immediately.
In case of overdose, the following symptoms may occur: headache, vision disturbances, seizures, heart rhythm disorders with irregular pulse, affecting blood pressure and breathing, and subsequently, a heart attack may occur.
If such symptoms occur, the patient should go to the nearest hospital immediately and bring the medicine with them.

Missing a dose of Hydroquenin

If a dose is missed, the medicine should be taken as soon as possible, and then the regular dosing schedule should be resumed.
A double dose should not be taken to make up for the missed tablet.

Stopping Hydroquenin treatment

Hydroquenin treatment should only be stopped in agreement with the doctor.
If there are any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Hydroquenin can cause side effects, although not everybody gets them.
Hydroquenin should be stopped immediately and the doctor consulted if any of the following serious side effects occur - the patient may need urgent treatment:
Severe skin reactions(see section 2: "Warnings and precautions"), such as:

• rash with flu-like symptoms and fever, and swollen lymph nodes. These may be symptoms of a disease called drug reaction with eosinophilia and systemic symptoms (DRESS);
• blisters, widespread skin peeling, pus-filled spots, occurring with fever. These may be symptoms of a disease called acute generalized exanthematous pustulosis (AGEP);
• blisters or skin peeling around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever. These may be symptoms of a disease called Stevens-Johnson syndrome (SJS);
• widespread skin changes, itching, joint pain, fever, and general malaise. This may be a disease called toxic epidermal necrolysis (TEN);
• skin reactions (including purple, raised, painful sores, especially on the arms, hands, fingers, face, and neck) with possible fever. This may be a disease called Sweet's syndrome;
• fatigue, bleeding from the skin and mucous membranes, and infections and fever caused by bone marrow failure (bone marrow suppression);
• abnormal heart rhythm, severe heart arrhythmia with rapid, irregular heartbeat (QT interval prolongation);
• heart diseases (cardiomyopathy), which can cause heart failure, which in some cases can be fatal (see section 2: "Warnings and precautions");
• sudden liver failure;
• 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; rash (hives) and swelling (angioedema). If swelling of the face, lips, and tongue occurs, it can be life-threatening.

The most common side effects (occurring in 10-20% of patients) are gastrointestinal disorders, such as nausea, abdominal pain, diarrhea, and vomiting. Side effects may resolve on their own or after dose reduction.

Other side effects

Very common(occurring in more than 1 in 10 people):

• nausea;
• abdominal pain.

Common(occurring in 1 to 10 people in 100):

• anorexia (psychogenic loss of appetite);
• emotional instability;
• headache;
• blurred vision due to accommodation disorders (dose-dependent and resolves after treatment discontinuation);
• diarrhea, vomiting;
• rash and itching (occurring in about 40% of patients with lupus erythematosus).

Uncommon(occurring in 1 to 10 people in 1,000):

• nervousness;
• dizziness;
• retinal changes causing changes in the visual field, irregular retinal pigmentation, and abnormal color vision;
• corneal changes causing vision disturbances, such as halos, blurred vision, and increased sensitivity to light (may resolve after treatment discontinuation);
• tinnitus;
• abnormal liver function test results;
• hair loss;
• skin and mucous membrane discoloration;
• hair lightening;
• sensorimotor disorders, such as muscle weakness, cramps, stiffness, or sensory disturbances, e.g., tingling.

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

• blood changes, such as decreased white blood cell count (leukopenia and agranulocytosis), decreased platelet count (thrombocytopenia), and anemia (anemia and aplastic anemia);
• porphyria (a hereditary metabolic disease);
• in patients with psoriasis, exacerbation of the disease may occur;
• bronchospasm;
• cold sweat, hunger, confusion, loss of consciousness, and seizures caused by low blood sugar levels (hypoglycemia);
• increased skin sensitivity to light;
• hearing loss (irreversible);
• drug rash (drug eruption);
• skin inflammation with blisters (bullous rash);
• fever, rash on the face, hands, and feet (erythema multiforme);
• seizures;
• muscle tone disorders, spontaneous gestures, inability to sit still, tremors;
• sensory disturbances caused by nerve inflammation (neuropathy);
• muscle weakness (myopathy), which may resolve after treatment discontinuation;
• decreased tendon reflexes;
• maculopathy and macular degeneration, which may be irreversible;
• feeling of depression, suicidal thoughts, hallucinations, feeling of nervousness or anxiety, disorientation, agitation, sleep disturbances, feeling of elation or excessive excitement (see section 2 "Warnings and precautions").

Reporting side effects

If 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 the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Hydroquenin

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 (EXP). The expiry date refers to the last day of the month.
There are no special storage temperature requirements. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Hydroquenin contains

• The active substance of the medicine is hydroxychloroquine sulfate. Each film-coated tablet contains 200 mg of hydroxychloroquine sulfate.
• The other ingredients are: cornstarch, calcium hydrogen phosphate dihydrate, colloidal anhydrous silica, polysorbate 80, dried cornstarch, talc, magnesium stearate,

coating (hypromellose, type 2910, 15 cps, talc, titanium dioxide E171, macrogol 6000).

What Hydroquenin looks like and what the package contains

Hydroquenin is a film-coated tablet, round, 9.5 mm in diameter, biconvex, white, with the inscription "200" on one side, smooth on the other.
The package contains 30 film-coated tablets. The package is a blister pack of aluminum/PVC in a cardboard box with a leaflet.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151
95-200 Pabianice
phone: (42) 22-53-100

Importer

Aflofarm Farmacja Polska Sp. z o.o.
Szkolna 31
95-054 Ksawerów

Date of the last leaflet update: