Hydroxychloroquine-BP 200 Mg Film-coated Tablets Hydroxychloroquine Sulfate

MORE product information can be FOUND HERE

Read this entire leaflet carefully, before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to reread it.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. You don’t have to give it to other people. It can hurt them, even if they have the same signs of illness as you.
If you get any side effects, talk to your doctor or pharmacist. These include any possible side effects not listed in this leaflet. See section 4.

What you find in this leaflet:

What Hydroxychloroquine-BP is and what it is used for
What you need to know before you take Hydroxychloroquine-BP
How to take Hydroxychloroquine-BP
Possible side effects
How to store Hydroxychloroquine-BP
Package contents and other information

What Hydroxychloroquine-BP is and what it is used for

Hydroxychloroquine-BP contains an active substance called hydroxychloroquine sulfate.

Hydroxychloroquine-BP works by reducing inflammation in people with autoimmune diseases (conditions in which their own immune system accidentally attacks its body).

It can be indicated:

– Rheumatoid arthritis (inflammation of the joints)

– Juvenile idiopathic arthritis (in children)

– Systemic and discoid lupus erythematosus (a disease that affects the skin and internal organs)

– Skin conditions caused by sunlight

Hydroxychloroquine-BP is also recommended in:

– Prevention of malaria and treatment of acute malaria attacks caused by Plasmodium vivax, Plasmodium ovale and Plasmodium malariae or Plasmodium falciparum species.

What you need to know before you take Hydroxychloroquine-BP

Do not take Hydroxychloroquine-BP:

– If you are allergic to hydroxychloroquine sulfate, similar substances (quinolones or quinines) or any of the other ingredients of this medicine (listed in section 6).

– If you have eye problems that affect your retina (retinopathy) or inside the eyeball (maculopathy).

– If you are pregnant, you may be pregnant or breast-feeding.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist.

Children:

Hydroxychloroquine-BP should not be used in children under 6 years of age (weighing less than 35 kg)

Warnings and precautions

Talk to your doctor or pharmacist before using Hydroxychloroquine-BP

– If you have liver or kidney problems

– If you have severe stomach or bowel problems

– If you have nervous system disorders

– If you have blood disorders

– If you have a genetic condition called ‘glucose-6-phosphate dehydrogenase deficiency’ or porphyria (a rare disease that affects your metabolism)

– If you have psoriasis (a disease that affects your skin, manifested by red spots with scales, usually on the scalp, knees, elbows)

– If you have had an allergic reaction to quinine in the past.

Before taking Hydroxychloroquine-BP:

– Perform an eye check and repeat at least every 12 months during treatment with Hydroxychloroquine-BP

– If you are over 65, have a high dose of Hydroxychloroquine-BP (2 tablets daily) or have kidney problems, eye exams should be done more often.

If you are taking Hydroxychloroquine-BP and your eye color changes or you have any other eye problems, you should stop treatment and see your doctor.
The combination of hydroxychloroquine with other medicines known to have a possible risk of retinal damage, such as tamoxifen, is not recommended.
Hydroxychloroquine may lower blood glucose levels. Please ask your doctor to inform you of the signs and symptoms that may occur with low blood glucose levels. It may be necessary to perform a test to determine the concentration of glucose in the blood.
Hydroxychloroquine may cause heart rhythm disorders in some patients: precautions should be taken when using hydroxychloroquine and you were born with or have a family history of prolonged, acquired prolonged QT interval (observed on ECG, electrical activity recording heart disease), you have a heart condition or a history of heart attack (myocardial infarction), you have an imbalance in your blood salt levels (especially low levels of potassium or magnesium, see “Hydroxychloroquine-BP with other medicines “).
If you have an irregular heartbeat, you should tell your doctor immediately. The risk of heart problems may increase with increasing dose. As a result, you must follow the recommended dose.
If you are taking Hydroxychloroquine-BP there may be signs and symptoms of a serious disease affecting the heart muscle (cardiomyopathy), in some cases lethal (see section 4 and section 3 – “If you take more Hydroxychloroquine-BP than you should”), manifested by altered breathing, chest pain or discomfort, palpitations, swelling of the legs. If this disease occurs, your doctor will monitor the signs and symptoms of heart disease and stop treatment with Hydroxychloroquine-BP.
If the doctor diagnoses certain serious heart conditions (heart disorders), the chronic toxicity of the medicine must be taken into account (see section 4).
If you are taking long-term treatment with Hydroxychloroquine-BP, your doctor will recommend that you have a regular blood test, and if abnormal values occur, you should stop treatment (see section 4).
Also, during long-term treatment, it is necessary for your doctor to periodically check the functions of your skeletal muscles and tendon reflexes.
If muscle weakness occurs, treatment with Hydroxychloroquine-BP should be discontinued (see section 4).
If you take Hydroxychloroquine-BP, thoughts of self-harm or suicide may occur (see section 4). If such thoughts occur at any time during treatment, contact your doctor immediately.
If you take Hydroxychloroquine-BP, extrapyramidal disorders may occur (see section 4).

Hydroxychloroquine-BP with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking Hydroxychloroquine-BP in combination with other medicines, the effects of Hydroxychloroquine-BP or other medicines may change.

Please talk to your doctor if you are taking any of the following medicines:

The following medicines may affect the way Hydroxychloroquine-BP works:

– Neostigmine and pyridostigmine, used for muscle weakness (myasthenia gravis).

– Cimetidine, used to treat gastric ulcer.

– Some antibiotics for the treatment of infections, for example gentamicin, neomycin or tobramycin.

– Medicines that affect the kidneys or liver; medicines that affect the skin and eyes.

– Medications known to affect the heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmic), treatment of depression (tricyclic antidepressants), treatment of mental disorders (antipsychotics), bacterial or anti-malarial infections (for example, halofantrine).

Hydroxychloroquine-BP may influence the action of some drugs:

– Digoxin, used to treat some heart conditions.

– Some medicines for diabetes (insulin or metformin); your doctor may need to reduce the doses you use.

– Antacids, used to treat diseases of the stomach or intestines; you must observe a period of 4 hours between the administration of Hydroxychloroquine-BP and that of antacids.

Hydroxychloroquine-BP should not be administered concomitantly with:

– Halofantrine (used to treat malaria); the combination of hydroxychloroquine-BP with halofantrine may lead to heart rhythm disturbances.

– Cyclosporine (used in organ transplant therapy).

– Amiodarone and moxifloxacin, as heart rhythm disorders may occur.

– Antimalarial drugs (such as mefloquine).

– Medicines used to treat epilepsy.

– Praziquantel, used as an anthelmintic.

– Agalsidase, used to treat a rare disease (Fabry disease).

Rabies vaccination may be less effective in patients taking this medicine.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

This medicine should not be used during pregnancy. If you become pregnant during treatment with this medicine, you must tell your doctor immediately. He will be able to establish proper monitoring of your condition and treatment from the very beginning of pregnancy (especially in the case of malaria prevention or treatment).

Breastfeeding:

As hydroxychloroquine sulfate passes into breast milk, Hydroxychloroquine-BP should not be used during breast-feeding.

Driving and using machines:

At the beginning of treatment, Hydroxychloroquine-BP may cause blurred vision, caused by an accommodation disorder. If this happens, do not drive or use any machinery.

If your vision does not improve, talk to your doctor.

Hydroxychloroquine-BP contains lactose.

If you have intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Hydroxychloroquine-BP

Always take this medicine exactly as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.

This medicine is reserved for adults, adolescents and children over 6 years of age.

Administration method:

It is administered orally only. Do not break or chew the tablet. Each dose should be swallowed with food or a glass of milk.

Dosage

Adults

Rheumatic diseases

Hydroxychloroquine has a cumulative action and will take several weeks to exert its beneficial therapeutic effects, during which time minor side effects may occur relatively early. If no objective improvement occurs within the first 6 months, treatment should be discontinued.

– Rheumatoid arthritis: an initial dose of 400-600 mg of hydroxychloroquine sulfate per day is recommended. For maintenance treatment, the dose is 200-400 mg of hydroxychloroquine sulfate per day.

– Systemic or discoid lupus erythematosus: an initial dose of 400-600 mg of hydroxychloroquine sulfate per day is recommended. For maintenance treatment, the dose is 200-400 mg of hydroxychloroquine sulfate per day.

Dermatological conditions due to sun exposure

Treatment will be limited to periods of maximum sun exposure. In adults, doses of 400 mg of hydroxychloroquine sulfate per day may be sufficient.

Malaria

Malaria prophylaxis: 400 mg hydroxychloroquine sulfate once a week, always on the same day. If circumstances permit, prophylactic treatment should be initiated 2 weeks prior to exposure. Otherwise, adults may be given a double starting (loading) dose of 800 mg of hydroxychloroquine sulfate, divided into 2 doses, administered every 6 hours. Prophylactic treatment should be continued for another 8 weeks after leaving the endemic area.

Treatment of acute malaria attack

An initial dose of 800 mg of hydroxychloroquine sulfate, followed by 400 mg of hydroxychloroquine sulfate, after 6-8 hours on the first day, is continued with 400 mg of hydroxychloroquine sulfate per day for a further 2 days (a total of 2 g of hydroxychloroquine sulfate).

An alternative regimen, using a dose of 800 mg of hydroxychloroquine sulfate, has also been shown to be effective. Doses for adults can also be calculated based on body weight, similar to doses for children (see below).

Use in adolescents and children over 6 years of age

Rheumatic diseases

Treatment of juvenile idiopathic arthritis, systemic lupus erythematosus and discoid lupus: the minimum effective dose should be used and should not exceed 6.5 mg/kg/day, depending on the ideal body weight.

Malaria

Malaria prophylaxis:

The weekly prophylactic dose is 6.5 mg hydroxychloroquine sulfate/kg, but should not exceed the recommended dose for adults, regardless of weight.

If circumstances permit, prophylactic treatment should be initiated 2 weeks prior to exposure. However, a dose of 12.9 mg hydroxychloroquine sulfate/kg (but not exceeding 800 mg hydroxychloroquine sulfate) may be administered in 2 divided doses over 6 hours. Prophylactic treatment should be continued for another 8 weeks after leaving the endemic area.

Treatment of acute malaria attack:

In children, a total dose of 32 mg hydroxychloroquine sulfate/kg (but not exceeding 2 g hydroxychloroquine sulfate) is fractionated and administered over 3 days as follows:

– First dose: 12.9 mg hydroxychloroquine sulfate/kg (but not exceeding 800 mg hydroxychloroquine sulfate);

– Second dose: 6.5 mg hydroxychloroquine sulfate/kg (but not exceeding 400 mg hydroxychloroquine sulfate), 6 hours after the first dose;

– Third dose: 6.5 mg hydroxychloroquine sulfate/kg (but not exceeding 400 mg hydroxychloroquine sulfate), 18 hours after the second dose;

– Fourth dose: 6.5 mg hydroxychloroquine sulfate/kg (but not more than 400 mg hydroxychloroquine sulfate), 24 hours after the third dose.

In all cases, you must follow the doses and duration of treatment recommended by your doctor.

If you take more Hydroxychloroquine-BP than you should

Overdose with this medicine can be dangerous. If you accidentally take a high dose, contact your doctor immediately or go to the nearest hospital. Take the medicine pack with you so that the doctor knows what you have taken. The following effects may occur: heart problems – irregular heartbeat, headache, vision problems, low blood pressure, seizures, heart problems, followed by severe breathing disorders and rapid onset or cardiac arrest.

Young children are at increased risk of toxicity if they have accidentally swallowed Hydroxychloroquine-BP and need to be rushed to hospital.

If you forget to take Hydroxychloroquine-BP

If you forget to take a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Hydroxychloroquine-BP

Continue to take Hydroxychloroquine-BP until your doctor advises otherwise. Do not stop taking Hydroxychloroquine-BP just because you feel better. If you stop taking Hydroxychloroquine-BP, your illness may get worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Hydroxychloroquine-BP and consult a doctor immediately or go to the hospital immediately if: you notice any of the following side effects with an unknown frequency (frequency cannot be estimated from the available data).

– You have a severe allergic reaction, manifested by rash on the skin, red and embossed (hives), swelling of the face, lips, tongue and throat, difficulty swallowing or breathing (angioedema), and shortness of breath (bronchospasm).

– You have signs of low blood glucose levels (you are pale, sweaty, have a fast and strong pulse, high blood pressure, enlarged pupils, and high muscle tone).

– You have an abnormal heartbeat rhythm, an irregular heartbeat rhythm that is life-threatening (visible on the ECG recording) (see section “Warnings and precautions”).

Stop taking Hydroxychloroquine-BP and contact a doctor immediately if you notice any of the following serious side effects – you may need emergency medical treatment:

Common side effects (may affect up to 1 in 10 people)

– If you have blurred vision.

Uncommon side effects (may affect up to 1 in 100 people)

– If you have eye problems. These include changes in eye color, blurred vision, or how you perceive colors. Your doctor will recommend an eye exam before starting treatment and then every 12 months while using this medicine. If you are over 65 years of age, have kidney problems or poor vision, or take a daily dose of more than 6.5 mg hydroxychloroquine sulfate/kg, your doctor will recommend that you have more frequent medical check-ups.

– Abnormal values of liver function tests.

Sides effects with unknown frequency (frequency cannot be estimated from the available data)

– If you have thoughts of self-harm or suicide during treatment with Hydroxychloroquine-BP. If you notice such thoughts, contact your doctor immediately.
– If you have vision problems, such as blurred vision, sensitivity to light (photophobia) or distorted perception of the size and shape of objects.
– If you have muscle weakness, cramps, stiffness or muscle spasms, its changes in the way you perceive sensations, such as tingling. If you take this medicine for a long time, your doctor will check your muscles and tendons from time to time to make sure they are working properly.
– If you have severe skin reactions such as blisters, large areas of scaly skin, pustules, accompanied by high body temperature.
– If you have blisters or detachment of the upper layer of skin around the lips, eyes, mouth, nose and genitals, cold-like symptoms and fever. They can occur due to a condition called Steven-Johnson syndrome.
– If you have multiple skin lesions, itchy skin, joint pain, fever and poor general condition. They can occur due to a condition called toxic epidermal necrolysis.
– If you have a rash, fever, inflammation of the internal organs, lymphadenopathy, blood problems. These may be due to a severe reaction of your body to the administration of Hydroxychloroquine-BP (called DRESS syndrome).
– If you get infections more easily than usual. This can be caused by bone marrow depression or a blood condition called “agranulocytosis”.
– If you blame yourself easier than usual. It can be caused by a blood condition called “thrombocytopenia”.
– You feel tired, powerless or dizzy and your skin is pale. These can be symptoms of a disease called “anemia.”
– You feel weak, you feel short of breath, you become lighter than usual and you get infections more easily than usual. These can be symptoms of a condition called “aplastic anemia”.
– If you have severe liver problems, which can be manifested by yellowing of the skin or whites of the eyes (jaundice).

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts for several days.

Common side effects (may affect up to 1 in 10 people)

– Stomach pain, nausea, vomiting.

– Loss of appetite (anorexia), diarrhea.

– Headaches, dizziness.

– Rash, itching.

– Emotional lability.

Uncommon side effects (may affect up to 1 in 100 people)

– Changing the color of the skin or mucous membranes of the nose or mouth.

– Hair loss, hair discoloration.

– Psoriasis (red spots with scales on the skin, which generally appear on the knees, elbows and scalp).

– Noises in the ears (tinnitus), problems with balance (vertigo).

– Feeling nervous, mental problems (such as illusions, hallucinations or mood swings).

– Weakening of the heart muscle (cardiomyopathy), which leads to difficulty breathing, coughing, increased blood pressure, edema, increased heart rate, decreased urine output and, in some cases, death (see section 2 “Warnings and precautions”). .

– With prolonged use, heart rhythm disturbances (branch block, atrioventricular block) or increased heart muscle size (bilateral ventricular hypertrophy) may occur.

Sides effects with unknown frequency (frequency cannot be estimated from the available data)

– If you get infections more easily than usual. It can be caused by a blood condition called “leukopenia”.

– Seizures.

– Hearing loss.

– Worsening of the symptoms of a disease called “porphyria”, which may include stomach pain, malaise, seizures, blisters, itching.

– Extrapyramidal disorders, such as dystonia (movements that you cannot control), dyskinesia (slowing of movements), tremors (see section 2 “Warnings and precautions”).

Blood test

Blood tests may show changes in the way your liver works or a very serious damage to your liver (fulminant liver failure).

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. These include any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Hydroxychloroquine-BP

Keep this medicine out of the sight and reach of children.

Store in a place protected from light and below 25°C in the original package.

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.

Do not throw any medicine in the way of water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Package contents and other information

What Hydroxychloroquine-BP contains

– The active substance is hydroxychloroquine sulfate. Each film-coated tablet contains 200 mg of hydroxychloroquine sulfate.

– The other ingredients are: lactose monohydrate, Povidone K25, maize starch, magnesium stearate, copolymer of polyvinyl alcohol and polyethylene glycol, talc, titanium dioxide, mono and diglycerides of fatty acids, polyvinyl alcohol.

What Hydroxychloroquine-BP looks like and contents of the pack

Round, biconvex, white or off-white film-coated tablets.

Box of 1 or 3 PVC blisters with 10 film-coated tablets.

Holder of the registration certificate and the manufacturer

Holder of the registration certificate

SC ”Balkan Pharmaceuticals” SRL

str. N. Grădescu, 4, MD-2002, or. Chisinau, Republic of Moldova

The manufacturer