HYDROXYCHLOROQUINE DOC GENERICI

Package leaflet: Information for the user

HYDROXYCHLOROQUINE DOC 200 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What IDROSSICLOROCHINA DOC is and what it is used for
2. What you need to know before taking IDROSSICLOROCHINA DOC
3. How to take IDROSSICLOROCHINA DOC
4. Possible side effects
5. How to store IDROSSICLOROCHINA DOC
6. Contents of the pack and other information

1. What IDROSSICLOROCHINA DOC is and what it is used for

IDROSSICLOROCHINA DOC contains hydroxychloroquine sulfate, which works by reducing inflammation in people with autoimmune diseases (i.e. diseases in which the body's immune system mistakenly attacks itself).
This medicine is also used to prevent and treat acute attacks of malaria, an infectious disease caused by parasites in the red blood cells, which manifests with symptoms such as high fever, shivering, chills, and profuse sweating.
IDROSSICLOROCHINA DOC is used in adults for:

• treating chronic inflammation of joints, muscles, tendons, or muscle insertions (rheumatoid arthritis)
• treating acute attacks of malaria and for preventing malaria
• treating skin problems and/or joint disorders caused by systemic and discoid lupus erythematosus
• treating skin rashes caused by exposure to sunlight (photodermatoses).

IDROSSICLOROCHINA DOC is used in children for:

• treating juvenile arthritis in combination with other treatments
• treating skin problems and/or joint disorders caused by systemic and discoid lupus erythematosus
• treating acute attacks of malaria and for preventing malaria.

IDROSSICLOROCHINA DOC does not work against certain types of malaria (those resistant to chloroquine).

2. What you should know before taking IDROSSICLOROCHINA DOC

Do not take IDROSSICLOROCHINA DOC

• If you are allergic to hydroxychloroquine, to other medicines of similar structure such as quinolones and quinine, or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from an eye disease causing blurred or hazy vision (maculopathy).
• If you suffer from a type of muscle weakness (myasthenia gravis).
• If you suffer from a retinal disease with pigment formation (retinitis pigmentosa).
• If your body weight is less than 35 kg.

Warnings and precautions
Talk to your doctor before taking IDROSSICLOROCHINA DOC.
Inform your doctor if you have or have previously had any of the following conditions:

• You may experience movement disorders (extrapyramidal disorders) (see section 4 “Possible side effects”).
• Vision problems (for example blurred vision, sensation of narrowing of the visual field, or reduced ability to distinguish colors). Before starting treatment with this medicine, your doctor will examine your eyes to check for any problems. This eye examination should be repeated if this medicine is used for a prolonged period. Concomitant use of other medicines known to be harmful to the retina, including tamoxifen, is not recommended.
• Porphyria (a rare inherited blood disorder causing impaired formation of heme, a component of hemoglobin, the oxygen-carrying protein in red blood cells). This condition may worsen when using this medicine. Your blood will be monitored regularly if this medicine is used long-term.
• Chronic inactive hepatitis B virus infection.
• Liver or kidney problems. Your doctor will monitor you closely if you have a deficiency of a certain liver enzyme (glucose-6-phosphate dehydrogenase deficiency).
• Heart rhythm problems. IDROSSICLOROCHINA DOC may cause heart rhythm disturbances in some patients: IDROSSICLOROCHINA DOC must be used with caution if you were born with or have a family history of prolonged QT interval, if you have experienced QT interval prolongation (detectable by electrocardiogram, a recording of the heart's electrical activity), if you have heart problems or a history of heart attack (myocardial infarction), or if you have an imbalance of electrolytes in the blood (particularly low levels of potassium or magnesium, see section “Other medicines and IDROSSICLOROCHINA DOC”). If you experience palpitations or irregular heartbeat during treatment, inform your doctor immediately. The risk of heart problems increases with higher doses. Therefore, the recommended dose must be strictly observed. Cases of cardiac failure, which in rare cases may be fatal, have also been reported with use of this medicine. Symptoms of heart failure include fatigue, shortness of breath, and swelling of the legs and ankles. Contact your doctor if you experience any of these symptoms.
• Hypoglycemia (low blood sugar levels). This medicine causes a decrease in blood sugar levels. If you experience symptoms such as sweating, trembling, dizziness, sudden mood changes, difficulty concentrating, headache, fatigue, hunger, or loss of consciousness, contact your doctor to check your blood sugar levels.
• If you use this medicine for a prolonged period, your muscles and tendons should be monitored periodically. Contact your doctor if you develop muscle or tendon weakness; your doctor may decide to discontinue treatment.
• Some patients treated with IDROSSICLOROCHINA DOC may experience mental health problems such as irrational thoughts, anxiety, hallucinations, confusion, or depression, including thoughts of self-harm or suicide, even in individuals who have never had such problems before. If you or someone caring for you notices any of these side effects (see section 4), contact your doctor immediately.
• Psoriasis (a skin disease characterized by skin scaling). Your doctor will monitor you closely during treatment with this medicine (see section 4 “Possible side effects”).
• Serious skin rashes have been reported with hydroxychloroquine use (see section 4, “Possible side effects”). Often, the rash may involve mouth, throat, nose, genital ulcers, and conjunctivitis (red, swollen eyes). These serious skin reactions are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash may progress to widespread blistering and skin peeling. If you develop these skin symptoms, stop taking hydroxychloroquine and contact your doctor immediately.
• Inform your doctor if you are allergic to quinine.

Children and adolescents
Children are particularly sensitive to the toxic effects of this medicine; therefore,
IDROSSICLOROCHINA DOC must be kept out of the reach of children.

Other medicines and IDROSSICLOROCHINA DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those obtained without a prescription.
This includes in particular:

• Concomitant use of hydroxychloroquine and digoxin (a medicine used for heart conditions) may cause an undesirable increase in digoxin’s effects.
• Monoamine oxidase inhibitors (MAOIs), used as antidepressants. These medicines must not be used at the same time as hydroxychloroquine.
• Medicines used for depression (fluoxetine, paroxetine).
• Hydroxychloroquine may enhance the blood sugar-lowering effect. Therefore, the dose of insulin or other antidiabetic medicines may need to be reduced.
• Hydroxychloroquine inhibits an enzyme mainly produced in the liver, called CYP2D6. For this reason, other medicines that inhibit CYP2D6 should not be used concomitantly with hydroxychloroquine.
• Hydroxychloroquine may reduce the effectiveness of the rabies vaccine. Administration of the subcutaneous rabies vaccine is not recommended while taking IDROSSICLOROCHINA DOC. If the vaccine is administered intramuscularly, adequate protection levels are achieved.
• Hydroxychloroquine may increase susceptibility to epileptic seizures. Concomitant use of hydroxychloroquine and antimalarial medicines that also increase this susceptibility (such as mefloquine) may trigger loss of consciousness with muscle spasms (convulsions).
• The effectiveness of antiepileptic medicines may be affected by concomitant use of hydroxychloroquine.
• Medicines known to affect heart rhythm. These include medicines used for heart rhythm disorders (antiarrhythmics), depression (tricyclic antidepressants), psychiatric disorders (antipsychotics), bacterial infections (e.g., moxifloxacin, azithromycin), HIV treatment (e.g., saquinavir), fungal infections (e.g., fluconazole), parasitic infections (e.g., pentamidine), or malaria (e.g., halofantrine).
• Antacids (for heartburn) and kaolin. Take IDROSSICLOROCHINA DOC at least 2 hours apart from these.
• Some medicines may interfere with the effect of hydroxychloroquine when taken at the same time. These medicines may increase or decrease the effect of hydroxychloroquine, increasing the risk of side effects or reducing its effectiveness. These include medicines used for stomach ulcers (cimetidine), fungal infections (such as itraconazole), bacterial infections (such as rifampicin, clarithromycin), epilepsy (seizures) (such as phenobarbital, phenytoin, carbamazepine), lipid disorders (such as gemfibrozil, statins), HIV treatment (such as ritonavir) (HIV causes AIDS), organ transplants or immune system disorders (such as cyclosporine), blood clots (such as dabigatran, clopidogrel), heart diseases (such as digoxin, flecainide, propafenone, quinidine, and metoprolol), and the herbal remedy for depression: St. John’s wort.

IDROSSICLOROCHINA DOC with food
Avoid drinking grapefruit juice, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.

Pregnancy
IDROSSICLOROCHINA DOC may be associated with a small increased risk of major congenital malformations and should not be used during pregnancy unless your doctor considers that the benefits outweigh the risks.
This medicine may be used during pregnancy to prevent malaria, as low doses are required.

Breastfeeding
Hydroxychloroquine is excreted in breast milk. There is insufficient information on the effects of IDROSSICLOROCHINA DOC in infants. When this medicine is used at high doses for prolonged periods, breastfeeding must be discontinued.
When this medicine is used to prevent malaria, you do not need to stop breastfeeding. The amount absorbed through breastfeeding is not sufficient to prevent malaria in your baby.
Consult your doctor or pharmacist before taking any medicine during pregnancy or breastfeeding. Your doctor will discuss with you whether IDROSSICLOROCHINA DOC is suitable for you.

Fertility
There is no information available on the effects of IDROSSICLOROCHINA DOC on fertility in humans.

Driving and using machines
IDROSSICLOROCHINA DOC may cause blurred vision and dizziness. If you experience any of these side effects, you must not drive or operate machinery.

3. How to take HYDROXYCHLOROQUINE DOC

Take this medicine exactly as directed by your doctor or pharmacist. It is important that you follow these instructions for the entire duration prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

It is preferable to take HYDROXYCHLOROQUINE DOC tablets after a meal.

How much HYDROXYCHLOROQUINE DOC to take

The recommended dose in adults is:

• If you are being treated for rheumatoid arthritis
  Initial dose: 400 mg daily.
  Maintenance dose: 200 mg daily, and subsequently, if possible, 200 mg every other day.

• If you are being treated for systemic and discoid lupus erythematosus
  Initial dose: 400 mg to 600 mg daily.
  Maintenance dose: 200 mg to 400 mg daily.

• If you are being treated for photosensitivity (skin eruptions caused by exposure to sunlight)
  Treatment duration is limited to periods during which you are exposed to sunlight. For adults: 400 mg daily is usually sufficient.

• If you are being treated for malaria prophylaxis
  Adults: 400 mg once weekly, taken on the same day each week. To prevent malaria, treatment must begin one week before entering a malaria-endemic area and must continue for approximately four to eight weeks after leaving the area.

• If you are being treated for an acute attack of malaria

The dose for an acute attack of malaria depends on the type of infection.
The maximum total dose is 2 g, to be administered within a maximum period of three days.

Use in children

Your doctor will determine the dose based on body weight. The 200 mg tablets are not suitable for children weighing less than 31 kg.

Use in patients with renal or hepatic impairment

If you have kidney or liver problems, your doctor will prescribe a lower dose.

How long to take HYDROXYCHLOROQUINE DOC

Follow your doctor's instructions regarding the duration of treatment. For long-term treatment, your doctor will prescribe the lowest possible dose.

For the treatment of joint inflammation, this medicine may take several weeks to achieve its full effect.

If you take more HYDROXYCHLOROQUINE DOC than you should

If you take more HYDROXYCHLOROQUINE DOC than prescribed, inform your doctor immediately. Bring the medicine package with you.

Overdose is dangerous, especially for young children.

If you have taken more than the prescribed dose, you may experience the following effects: headache, blurred vision, fainting (due to suppression of heart function), heart problems that may cause irregular heartbeat and seizures, followed immediately by respiratory arrest and cardiac arrest, which may be fatal. Contact your doctor immediately if you experience any of these symptoms.

If you forget to take HYDROXYCHLOROQUINE DOC

• If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Then continue with your regular dosing schedule.
• Do not take a double dose to make up for a forgotten dose.
• If you have forgotten more than one dose, contact your doctor or pharmacist.

If you stop taking HYDROXYCHLOROQUINE DOC

Continue taking HYDROXYCHLOROQUINE DOC for as long as your doctor has instructed you to do so.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking IDROSSICLOROCHINA DOC and contact a doctor immediately if you notice any of the following serious side effects; you may need urgent medical treatment:

• Severe skin reactions (see section 2 Warnings and precautions), such as:
  • rash with fever and flu-like symptoms and swollen lymph nodes. This could be a condition called drug reaction with eosinophilia and systemic symptoms (DRESS)
  • rash with blisters, widespread peeling skin, pus-filled spots together with fever. This could be a condition called acute generalized exanthematous pustulosis (AGEP)
  • rash with blisters or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome (SJS)
• multiple skin lesions, sensation of skin itching, joint pain, fever and general feeling of malaise. This could be a condition called toxic epidermal necrolysis (TEN)
• skin reaction, including painful, raised, plum-colored lesions, particularly on arms, hands, fingers, face and neck, which may also be accompanied by fever. This could be a condition called Sweet's syndrome.
  • Liver problems. Symptoms may include a general feeling of being unwell, 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.

Side effects may occur with the following frequencies:
Common (may affect up to 1 in 10 people)

• Decreased appetite (anorexia).
• Feeling emotional.

Uncommon (may affect up to 1 in 100 people)

• Nausea, diarrhoea and abdominal pain. These symptoms usually disappear by reducing the dose or stopping treatment.
• Rash.
• Nervousness.

Rare (may affect up to 1 in 1,000 people)

• Decrease in blood cell production (reduced bone marrow function).
• Seizures (convulsions).
• Retinal changes. Sometimes you may barely notice them initially, but you might also notice spots or rings in your vision, changes in color perception, or notice that some parts of your visual field are not visible. If you notice these problems early, they usually improve by stopping treatment with IDROSSICLOROCHINA DOC. If you notice these changes too late, the problems may persist and worsen even after stopping treatment.
• Cases of macular degeneration have been reported and may be irreversible.
• Vomiting. Usually resolves by reducing the dose or stopping treatment.
• Heart muscle disease (cardiomyopathy) which, when the medicine is used at high doses and for a long time, can be fatal (see section 2 “Warnings and precautions”).

Very rare (may affect up to 1 in 10,000 people)

• Hearing loss (permanent).
• Erythema multiforme (skin redness with irregular (wet) spots).
• Severe hypersensitivity reaction which may present with high fever, red spots on the skin, joint pain and/or eye infection (Stevens-Johnson syndrome).
• Severe and sudden reaction (hypersensitivity) accompanied by fever, blisters on the skin and skin peeling (toxic epidermal necrolysis).
• A form of sudden rash with acne (acute generalized exanthematous pustulosis (AGEP)) which may cause fever and increased number of white blood cells in the blood (leukocytosis).

Not known (frequency cannot be estimated from the available data)

• Anaemia and aplastic anaemia.
• Very serious blood problems (lack of white blood cells in the blood) with sudden high fever, severe sore throat and mouth ulcers (agranulocytosis).
• Decrease in white blood cells in the blood (leukopenia).
• Blood disorder (lack of platelets in the blood) accompanied by bruising and bleeding (thrombocytopenia).
• Worsening of a blood pigment disorder (porphyria).
• Dizziness/vertigo.
• Psychosis (abnormal mental state characterized by “loss of contact with reality”. The person may experience personality changes and thought disturbances, which may be accompanied by unusual or strange behaviour, difficulty in social interaction, and difficulty in carrying out daily activities).
• Sensation of depression, thoughts of self-harm or suicide, hallucinations, nervousness or anxiety, feeling confused, agitation, difficulty sleeping, euphoria or hyperexcitability.
• Ringing in the ears (tinnitus).
• Headache.
• Retinal changes, visual field problems causing loss of part of the visual field, temporary blind spots in the visual field (scotoma), and changes in color perception.
• Corneal changes including fluid accumulation (edema) and loss of transparency (opacity).
• Blurred vision caused by problems with eye accommodation. This problem is temporary and improves by reducing the dose.
• Heart conduction problems. Abnormal heart rhythm, life-threatening irregular heart rhythm (visible on electrocardiogram) (see section 2 “Warnings and precautions”).
• Enlargement of both heart chambers (biventricular hypertrophy).
• Decrease in blood sugar levels (hypoglycaemia).
• Very serious liver problems (fulminant hepatic failure).
• Abnormal liver function test results.
• Itching, change in skin color, discoloration of mucous membranes or hair, hair loss (alopecia) (these symptoms usually resolve by reducing the dose or stopping treatment).
• Hypersensitivity to light (photosensitivity).
• Rash with redness and skin peeling (exfoliative dermatitis).
• Recurrent skin disorder accompanied by peeling and dry rash (psoriasis).
• Rare hypersensitivity reaction (DRESS syndrome) characterized by fever, rash and increased number of white blood cells in the blood, accompanied by liver and lung problems.
• Muscle problems affecting nerves as well, causing weakness (myopathy and neuromyopathy causing progressive weakness).
• Loss of muscle tissue causing reduced muscle strength (atrophy).
• Movement disorders (extrapyramidal disorders) such as stiffness (dystonia), abnormal movements (dyskinesia) or trembling (tremor) of body muscles (see also “Warnings and precautions”).
• Changes in sensory perception.
• Decreased tendon reflex.
• Nerve conduction problems detected by nerve conduction tests.
• Allergic reactions such as rash with intense itching or development of hives (irritative hives or urticaria) and swelling of the skin or mucous membranes with itching (angioedema).
• Breathing problems caused by contraction of the respiratory tract muscles (bronchospasm).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store HYDROXYCHLOROQUINE DOC

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and the carton after “Exp”. The expiry date refers to the last day of that month.
• Store in the original packaging to protect the medicine from light.
• Do not dispose of this medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What IDROSSICLOROCHINA DOC contains

• The active substance is hydroxychloroquine sulfate. Each tablet contains 200 mg of hydroxychloroquine sulfate.
• The other components are: Tablet core: maize starch, calcium hydrogen phosphate dihydrate (E341), anhydrous colloidal silica (E551), polysorbate 80 (E433), dried maize starch, talc (E553b), and magnesium stearate (E470b). Coating: hypromellose (E464), talc (E553b), titanium dioxide (E171), and macrogol 6000.

Description of the appearance of IDROSSICLOROCHINA DOC and package contents
IDROSSICLOROCHINA DOC tablets are white, round, biconvex, film-coated tablets (with a diameter of 9.5 mm), engraved on one side with the number "200" and smooth on the other side.
This medicine is available in a pack of 30 tablets in blister packs.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan - Italy.
Manufacturer:
PharmaS d.o.o. - Industrijska cesta 5, Potok - 44317 Popovaca - Croatia.

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: IDROSSICLOROCHINA DOC.
Netherlands: Hydroxychloroquinesulfaat DOC 200 mg, filmomhulde tabletten.