AUTOKILA 200 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Autokila, 200 mg, coated tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Autokila and what is it used for
4. Important information before taking Autokila
   1. When not to take Autokila
   2. Warnings and precautions
   3. Before starting treatment with Autokila, you should discuss it with your doctor or pharmacist if:
   4. Before starting treatment:
   5. Children
   6. Autokila and other medicines
   7. Autokila with food and drink
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Autokila contains lactose
5. How to take Autokila
   1. Dosage
   2. Taking Autokila
   3. Taking a higher dose of Autokila than recommended
   4. Missing a dose of Autokila
   5. Stopping treatment with Autokila
6. Possible side effects
   1. The patient should stop taking Autokila and immediately go to their doctor or hospital if:
   2. The patient should stop taking Autokila and immediately go to their doctor or hospital if they experience any of the following serious side effects - the patient may need urgent medical attention:
   3. Uncommon (less than 1 in 100 patients)
   4. Frequency not known (frequency cannot be estimated from the available data)
   5. The patient should tell their doctor or pharmacist if any of the following side effects get worse or last longer than a few days:
   6. Very common (more than 1 in 10 patients)
   7. Common (less than 1 in 10 patients)
   8. Uncommon (less than 1 in 100 patients)
   9. Frequency not known (frequency cannot be estimated from the available data)
   10. Blood tests
   11. Reporting side effects
7. How to store Autokila
8. Contents of the packaging and other information
   1. What Autokila contains
   2. What Autokila looks like and contents of the packaging
   3. Marketing authorization holder and manufacturer
   4. Date of approval of the leaflet:

Leaflet attached to the packaging: patient information

Autokila, 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.
• If you have 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 as yours.
• 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 Autokila and what is it used for
• 2. Important information before taking Autokila
• 3. How to take Autokila
• 4. Possible side effects
• 5. How to store Autokila
• 6. Contents of the packaging and other information

1. What is Autokila and what is it used for

Autokila contains the active substance hydroxychloroquine sulfate. The action of Autokila is to reduce inflammation in people with autoimmune diseases, in which the immune system mistakenly attacks and ultimately destroys its own tissues.
The medicine can be used to treat the following diseases:

• Rheumatoid arthritis
• Juvenile idiopathic arthritis
• Discoid and systemic lupus erythematosus
• Skin problems with hypersensitivity to sunlight.

2. Important information before taking Autokila

When not to take Autokila

• If the patient is allergic to:
• hydroxychloroquine or any of the other ingredients of this medicine (listed in section 6)
• other similar medicines, such as quinolones and quinine The symptoms of an allergic reaction include: rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
• If the patient has certain eye disorders (maculopathy, eye color changes or other eye problems).
• Autokila should not be used in children under 6 years of age or with a body weight below 35 kg. Do not take this medicine if any of the above points apply to you. If in doubt, consult a doctor or pharmacist before taking Autokila.

Warnings and precautions

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

• the patient has liver or kidney disease,
• the patient has severe stomach or intestinal diseases,
• 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 covering the knees, elbows and scalp),
• the patient has previously had an adverse reaction to quinine,
• 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,
• the patient has inactive chronic hepatitis B,
• 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,
• hydroxychloroquine may cause heart rhythm disturbances in some patients. Caution should be exercised when taking Autokila 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 [ECG]), if the patient has heart rhythm disorders or has had a heart attack (myocardial infarction), if the patient has electrolyte imbalance disorders (especially low potassium or magnesium levels), if the patient is taking medicines that affect heart rhythm (see section "Autokila and other medicines"). If the patient experiences palpitations or irregular heartbeat during treatment, they should stop taking the medicine and contact their doctor immediately. The risk of heart problems may be higher with increasing dose. Therefore, the recommended dose should be followed.
• serious skin rashes have been reported with hydroxychloroquine use (see section 4 "Possible side effects"). Often the rash can include mouth 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 widespread blisters and skin peeling. If such skin symptoms occur, the patient should stop taking hydroxychloroquine and contact their doctor immediately.
• some people taking Autokila may experience mental health problems, such as irrational thoughts, anxiety, hallucinations, disorientation or depression (including suicidal thoughts or self-harm), even in people who have not had such disorders before. If the patient or someone around them notices the occurrence of such side effects (see section 4), they should seek medical help immediately.
• extrapyramidal disorders may occur during hydroxychloroquine treatment. If the patient experiences symptoms such as involuntary movements causing bending and twisting of different parts of the body, they should contact their doctor.

Before starting treatment:

• Before starting treatment with this medicine, the patient's eyes should be examined,
• This examination should be repeated at least every 12 months during treatment with Autokila,
• If the patient is over 65 years old, is taking a high dose (2 tablets per day) or has kidney problems, this examination should be performed more frequently,
• In case of doubt as to whether any of the above situations apply to the patient, they should consult a doctor or pharmacist before taking Autokila

Children

Autokila should not be used in children under 6 years of age or with a body weight below 35 kg.
Young children are particularly sensitive to the toxic effects of quinolones, so this medicine should be kept out of their reach.

Autokila 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, including those available without a prescription. Especially about the following 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 (anti-arrhythmic medicines),
• depression (tricyclic antidepressants),
• psychiatric disorders (antipsychotic medicines),
• bacterial infections (e.g. moxifloxacin, azithromycin),
• HIV (e.g. saquinavir),
• fungal infections (e.g. fluconazole),
• parasitic infections (e.g. pentamidine),
• antimalarial medicines (e.g. halofantrine).
• Insulin or other antidiabetic medicines
• Antimalarial medicines, such as mefloquine (as it may increase the risk of seizures)
• Antiepileptic medicines, in particular phenobarbital, phenytoin, carbamazepine
• Medicines affecting the skin, blood or eyes
• Tamoxifen, used to treat breast cancer
• Agalsidase, used to treat a rare condition called Fabry's disease
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin and aminoglycosides, e.g. gentamicin, neomycin or tobramycin)
• Neostigmine and pyridostigmine, used to treat a condition called myasthenia gravis (muscle weakness)
• Rabies vaccine
• Medicines that may affect the kidneys or liver
• Antacids (for heartburn) and kaolin: Autokila should be taken at least 2 hours apart from these medicines
• Cimetidine, used to treat stomach ulcers
• Medicines used to treat fungal infections (such as itraconazole)
• Medicines used to treat lipid disorders (such as gemfibrozil, statins)
• Medicines used to treat HIV (such as ritonavir)
• Medicines used in organ transplantation and immune system disorders (such as cyclosporin)
• Anticoagulant medicines (such as dabigatran, clopidogrel)
• Medicines used to treat heart conditions (such as digoxin, flecainide, propafenone, quinidine and metoprolol)
• Praziquantel (an antiparasitic medicine)
• Medicines used to treat depression (such as fluoxetine, paroxetine)
• St. John's Wort (a herbal medicine used to treat depression).

Autokila with food and drink

The patient should avoid consuming grapefruit juice, as it may increase the risk of 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 a doctor or pharmacist before taking this medicine. The doctor will discuss with the patient whether Autokila is suitable for them.
Taking Autokila during pregnancy may be associated with a small increased risk of serious birth defects. This medicine should not be taken during pregnancy unless the doctor considers that the benefits of treatment for the mother outweigh the risks for the child.
During breastfeeding, Autokila should not be taken unless the doctor considers that the benefits outweigh the risks.

Driving and using machines

While taking this medicine, vision disturbances may occur. If this happens, the patient should not drive or operate any machinery and should contact their doctor immediately.

Autokila contains lactose

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

3. How to take Autokila

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. If in doubt, the patient should consult a doctor or pharmacist.

Dosage

Adults (including elderly patients)

• one or two tablets per day.

Children

• one tablet per day
• this medicine is only suitable for children with a body weight over 35 kg.

It may take several weeks before the patient notices the benefits of taking Autokila.

Taking Autokila

• The medicine should be taken orally.
• The tablets should be swallowed whole with food or a glass of milk. The tablets should not be crushed or chewed.
• If the patient is taking this medicine for skin problems related to hypersensitivity to sunlight, Autokila should only be taken during periods of high sun exposure.
• The doctor will determine the recommended dose based on the patient's body weight. If the patient feels that the effect of the medicine is too strong or too weak, they should not change the dose themselves and should consult a 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 a doctor. It may be necessary to stop the treatment.

Taking a higher dose of Autokila than recommended

• If the patient has taken a higher dose of Autokila 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 subsequently severe respiratory distress and possibly myocardial infarction. Overdose of Autokila can be fatal.
• There is a particular risk for young children and infants if they accidentally take Autokila. The child should be taken to the hospital immediately.

Missing a dose of Autokila

If a dose is missed, the patient should take it as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Autokila

The medicine should be taken until the doctor advises to stop the treatment. The patient should not stop taking Autokila because their condition has improved. If the treatment is stopped, the condition may worsen again.
If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking Autokila and immediately go to their doctor or hospital if:

• The patient has an allergic reaction. Symptoms may include: red rash or hives, swallowing or breathing problems, swelling of the eyelids, lips, face, throat or tongue (frequency not known: frequency cannot be estimated from the available data).

The patient should stop taking Autokila and immediately go to their doctor or hospital if they experience any of the following serious side effects - the patient may need urgent medical attention:

Uncommon (less than 1 in 100 patients)

• Eye disorders such as eye color changes and vision disturbances, such as blurred vision, sensitivity to light or changes in color vision.
• Any muscle weakness, pain, stiffness or cramps or changes in sensation, such as tingling. If the patient is taking this medicine for a long time, the doctor will check the muscles and tendons to make sure they are working properly.

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

• Thoughts of self-harm or suicide (see section 2 "Warnings and precautions").
• 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 skin peeling, pus-filled spots, occurring with fever. This may be a condition called acute generalized exanthematous pustulosis (AGEP).
• blisters or skin peeling 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 changes, itching, joint pain, fever and general malaise. This may be a condition 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 condition called Sweet's syndrome.
• Increased susceptibility to infections. This may be due to bone marrow depression or a blood disorder called agranulocytosis.
• Increased susceptibility to bruising. This may be due to a blood disorder called thrombocytopenia.
• Feeling tired, fainting or dizziness, pale skin. These may be symptoms of anemia.
• Feeling weak, shortness of breath, increased susceptibility to bruising and infections. These may be symptoms of aplastic anemia.
• Liver problems, which may be indicated by 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.
• Abnormal heart rhythm, irregular heart rhythm that can be life-threatening (observed on an ECG; see section 2 "Warnings and precautions").

The patient should tell their doctor or pharmacist if any of the following side effects get worse or last longer than a few days:

Very common (more than 1 in 10 patients)

• Abdominal pain, nausea.

Common (less than 1 in 10 patients)

• Skin rashes, itching.
• Diarrhea, vomiting, loss of appetite (anorexia).
• Mood changes.
• Headache.

Uncommon (less than 1 in 100 patients)

• Changes in skin or mouth color.
• Excessive hair loss or hair color loss.
• Nervousness or anxiety.
• Ringing in the ears (tinnitus), dizziness, balance disorders.

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

• Psoriasis (red scaly patches on the skin, usually covering the knees, elbows and scalp).
• Feeling depressed, disoriented, agitated, having difficulty sleeping, having delusions, hallucinations, feeling euphoric or over-stimulated (see section 2 "Warnings and precautions") (frequency not known: frequency cannot be estimated from the available data).
• Hearing loss.
• Seizures.
• Breathing difficulties, cough, high blood pressure, swelling, rapid heart rate, decreased urine output - these may be symptoms of heart muscle weakness (cardiomyopathy).
• Increased susceptibility to infections (this may be due to bone marrow depression).
• Symptoms of a condition called porphyria, which may include abdominal pain, vomiting, seizures, blisters, itching.
• Low blood sugar levels (hypoglycemia), which may cause nervousness, trembling or sweating.
• Tremors, muscle cramps or irregular, violent movements.

Blood tests

In patients treated with Autokila for a long time, periodic blood counts are recommended, and if abnormalities occur, Autokila should be discontinued.
Blood tests may show liver function disorders (uncommon: less than 1 in 100 patients).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist or nurse. Side effects can be reported 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
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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Autokila

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for the medicine.
Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
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 Autokila contains

• The active substance of the medicine is 200 mg of hydroxychloroquine sulfate, which corresponds to 154.80 mg of hydroxychloroquine.
• The other ingredients of the medicine are: corn starch, lactose monohydrate, magnesium stearate, Povidone K29-32 and Aqua Polish P Yellow 020.202 coating with the composition: hypromellose, 6 mPa; titanium dioxide (E171); talc; macrogol 6000; iron oxide, yellow (E172).

What Autokila looks like and contents of the packaging

The coated tablets are convex, round tablets with a light yellow color and a diameter of 9 mm.
The tablets are packaged in blisters. The packaging contains 28, 30, 56 or 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone: 22 811-18-14
In order to obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder.

Date of approval of the leaflet: