What is Plaquenil and when should it be used?

On doctor's prescription.

Plaquenil is a medicine used as a basic treatment for certain inflammatory joint conditions (chronic polyarthritis). It can slow down the course of the disease and reduce the duration and intensity of acute seizures. These effects usually only appear after several months of treatment.

It is also used in a skin disease called lupus erythematosus (facial erythema in the form of "butterfly wing") and as protection in case of solar allergies (photodermatosis).

Plaquenil can also be used for the curative treatment and prevention of malaria. Malaria is a tropical disease caused by the parasite Plasmodium, transmitted by mosquito bites. In some regions this parasite can be resistant to the action of Plaquenil. Your doctor will decide if Plaquenil is right for you.

What should be taken into account outside of treatment?

Regarding malaria, it is important to protect yourself from mosquito bites (without considering that this protection against bites replaces prophylaxis).

This medicine has been prescribed by your doctor to treat the disease you are currently suffering from (or to prevent malaria). Do not use Plaquenil on your own initiative to treat other diseases.

When should Plaquenil not be used?

Plaquenil should not be taken:

- hypersensitivity to the active substance hydroxychloroquine or chloroquine
- by patients with certain acquired or congenital metabolic disorders (porphyria and glucose-6-phosphate-dehydrogenase deficiency).
- if you suffer from psoriasis
- if you have an eye condition affecting the retina or reduced visual field or - if you have myasthenia gravis (muscle disease).

Plaquenil should not be given to infants and children below 6 years and/or below 35 kg; in children, treatment will not exceed 6 months.

What precautions should be observed when using Plaquenil?

Pre-existing diseases:

It is important to tell your doctor before starting treatment if you suffer:

- severe kidney or liver disease,
- diseases of the organs responsible for the formation of blood (bone marrow),
- neurological, gastrointestinal or blood diseases - hypersensitivity to quinine (medicine for the treatment of malaria)
- or alcoholism.

Especially in case of prolonged treatment, the doctor will regularly check the blood formula as well as the function of the muscles and tendon reflexes.

Eye:

Before and during treatment with Plaquenil, a thorough eye check will be performed, as a rule, every 3 to 6 months. The ophthalmological checks prescribed by the doctor must be absolutely adhered to. If visual disturbance occurs (visual acuity, flicker, color vision etc.), you should immediately notify your doctor.

The use of Plaquenil with medicinal products that may cause retinal toxicity (e.g. tamoxifen) should be avoided.

Epilepsy:

Close medical monitoring is recommended in patients with epilepsy because of the possibility of an attack trigger on Plaquenil. Taking Plaquenil may decrease the activity of certain medications that treat epilepsy. As a result the number of seizures may increase.

Hypoglycemia and diabetes:

Severe hypoglycaemia (decreased blood sugar concentration) including loss of consciousness may occur. In case of symptoms of hypoglycemia, such as sweating, high heart rate, hunger, restlessness, anxiety, fatigue, irritability, headache, loss of concentration, drowsiness, mental confusion, coordination disorders, temporary visual or speech disorders, or even seizures, please contact your doctor immediately.

Since Plaquenil may increase the effect of hypoglycaemic therapy, a reduction in the dose of insulin or other antidiabetic drugs (blood sugar lowering drugs) may be necessary.

Heart

Plaquenil can lead to the development of cardiomyopathy. Regular medical checks are therefore recommended and Plaquenil should be discontinued if cardiomyopathy develops (see "What side effects can Plaquenil cause?»).

Heart rhythm disturbances may also appear with taking Plaquenil.

Plaquenil should not be given with other medicines that may interfere with heart function (e.g. amiodarone, moxifloxacin, halofantrine) (see "other medicines and Plaquenil").

Before starting treatment with Plaquenil, tell your doctor if you have heart disease (e.g. heart weakness, myocardial infarction), heart rhythm disturbances, a congenital or acquired cardiac conduction disorder called QT interval prolongation or a salt imbalance (including low potassium or magnesium). The risk of heart problems may increase depending on the dose. Therefore, always adhere to the dosage prescribed by your doctor.

If you experience palpitations or an irregular heartbeat, you should inform your doctor immediately.

Other:

A small number of patients treated with Plaquenil had thoughts of self-harm or suicide. Contact your doctor immediately if you notice at any time that you have this type of thoughts.

Involuntary movements in the head or neck (e.g. facial spasms, jaw contractions) may occur during treatment. Tell your doctor immediately if you develop such symptoms.

This medicine may affect reactions, ability to drive and ability to use tools or machines.

Other medicines and Plaquenil:

Concomitant use of Plaquenil and other medicinal products / substances may lead to interactions (aggravation of side effects, influence on the effectiveness of the combination drug). Please tell your doctor if you are taking other medicines at the same time, including the following medicines/substances:

- Antiepileptic Drugs
- Antidiabetic agents or insulins
- Other medicines for malaria (e.g. pyrimethamine, sulfadoxin, mefloquine, halofantrin)
- hepatotoxic drugs or substances (drugs causing liver toxicity, including alcohol consumption. Your doctor can help you identify them).
- monoamine oxidase inhibitor (depression drug).
- Substances causing sensitisation or dermatitis, e.g. phenylbutazone or gold salts, should be avoided if possible.
- Medicines that may interfere with heart function, e.g. medicines used for heart rhythm disorders (antiarrhythmic drugs, e.g. amiodarone), depression (tricyclic antidepressants), psychiatric disorders (antipsychotics), bacterial infections (e.g. moxifloxacin) or malaria (e.g. halofantrine)
- Digoxin (heart medicine; careful monitoring of serum levels is necessary)
- Corticosteroids
- Some antibiotics (aminoglycosides, ampicillin)
- Cimetidine (gastrointestinal ulcer medicine)
- Methotrexate (a medicine for certain cancers and for the treatment of chronic polyarthritis or severe psoriasis)
- Tamoxifen (a medicine used to treat breast cancer)
- Indomethacin
- Probenecid
- Ciclosporin (to prevent transplant rejection)
- Drugs against gastric hyperacidity may reduce the absorption of Plaquenil and should be taken 4 hours before or after taking Plaquenil

Please inform your doctor or pharmacist, if:

- you suffer from another disease,
- you are allergic,
– you are already taking other medicines for internal or external use (even self-medication)!

Can Plaquenil be used during pregnancy or lactation?

Plaquenil should not usually be given during pregnancy.

Before starting treatment with Plaquenil, it must be established, that you are not pregnant.

You must follow effective contraceptive measures throughout the course of treatment and again for 3 months after stopping treatment.

If you discover that you are pregnant during treatment with Plaquenil, tell your doctor to adjust the treatment.

Exception malaria:

Plaquenil can be used during pregnancy to prevent or treat malaria, if in the opinion of your doctor the potential benefits outweigh the possible risks because malaria itself causes malformations in an unborn child.

Hydroxychloroquine passes into breast milk at a low dose. Infants are particularly sensitive to the side effects of this drug (see section How to use Plaquenil?). Your doctor will discuss with you the need to stop breast-feeding during treatment with Plaquenil or to postpone taking Plaquenil until the end of breast-feeding.

Although hydroxychloroquin is excreted in breast milk, its quantity is insufficient to provide any protection against malaria to the infant. Separate chemoprophylaxis for the infant is required.

How to use Plaquenil?

Dosage and duration of use differ depending on the indication and are determined by the doctor.

Film-coated tablets should be taken with sufficient liquid during meals.

Chronic polyarthritis, lupus erythematosus or photodermatosis

Adult:

Unless otherwise indicated, the usual dosage is, at the beginning of treatment, 1 film-coated tablet of Plaquenil 2-3 times a day. Then and on the recommendation of the doctor, the dosage can be reduced to 1 film-coated tablet 1-2 times a day. Film-coated tablets should be taken with sufficient liquid during meals.

Children > 6 years (>35 kg)

The usual dosage is 5-7 mg/kg body weight per day.

Children should not be treated for more than 6 months.

This medicine should not be given to children under 6 years of age and/or with a body weight below 35 kg as 200 mg film-coated tablets are not suitable.

Malaria treatment

If Plaquenil is taken to treat malaria, follow your doctor's instructions for use.

Malaria prophylaxis

Prophylactic treatment should begin 2 weeks before arrival in a risk area and continue for 8 weeks after return.

Adults: 2 film-coated tablets once a week, always on the same day of the week.

Children: 6.5 mg / kg body weight once a week, always on the same day of the week. The dosage should not exceed 400 mg or 2 film-coated tablets.

Contact your doctor immediately if you have inadvertently taken more Plaquenil than you should, due to the increased risk of serious side effects especially from the heart. Plaquenil is especially dangerous for children. In case a child has inadvertently ingested Plaquenil, take the child immediately to the nearest hospital or doctor.

Do not change the prescribed dosage on your own. Talk to your doctor or pharmacist if you feel that the effectiveness of the drug is too low or on the contrary too strong.

What side effects can Plaquenil cause?

Taking Plaquenil can cause side effects, but they do not occur systematically in everyone.

The frequency of side effects associated with the use of Plaquenil is given below.

Very common side effects (affecting more than 1 in 10 people): nausea, abdominal pain.

Common side effects (affecting less than 1 in 10 people):

- loss of appetite, vomiting, diarrhea,
- nervousness, emotional lability
- headache,
- transient visual disturbances such as flickering or difficulty distinguishing colours (see also " What precautions should be taken when using Plaquenil?»),
- pruritus, rash.

Occasional side effects (affecting less than 1 in 100 people):

- dizziness, ringing in the ears,
– confusion,
- rashes on the skin( redness), extensive rash,
- blood pressure drop,
- hair loss or discoloration,
- tingling, sensory-motor disorders, disorders affecting the senses and motor activity,
- retinal damage resulting in decreased vision and requiring discontinuation of treatment (see also "What precautions should be observed when using Plaquenil?»).

Isolated cases:

– hypoglycemia,
- hearing loss,
- seizures, mental disorders, suicidal thoughts (see also " What precautions should be observed when using Plaquenil?»),
- permanent eye damage,
- cardiomyopathy,
- abnormal heart rhythm,
- life-threatening irregular heartbeat (seen on the electrocardiogram). If you experience palpitations or an irregular heartbeat, you should inform your doctor immediately (see " What precautions should be observed when using Plaquenil?».
- contractions of the musculature of the skeleton, tremors, involuntary movements, myopathies (significant muscle weakness),
- Significant peeling of the skin, severe skin reactions with bubble eruptions and peeling of the skin that can spread throughout the body and potentially accompanied by fever. In these cases, you should stop treatment with Plaquenil and immediately notify your doctor,
- allergic reactions (hives, sudden swelling of the face and neck, difficulty breathing),
- changes in blood formula (e.g. anaemia),

- liver damage (hepatitis) which may result in fatigue, malaise, lack of appetite, nausea, vomiting, yellowing of the eyes or skin (jaundice) or discolouration of the stool. Tell your doctor immediately if you develop such symptoms.

Some side effects usually disappear quickly, if the dosage is lowered or treatment is stopped.

If you notice any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned here.

What else should we pay attention to?

This medicinal product should not be used beyond the date after the words "EXP" on the container.

Store the medicine in its closed original packaging, at room temperature (15-25 °C) and out of the reach of children. At the end of the treatment, report the medicine with the rest of its contents to your doctor or pharmacist who will take care of destroying it according to the rules.

For more information, consult your doctor or pharmacist. The latter have all the detailed information for professionals.

What does Plaquenil contain?

1 film-coated tablet contains 200 mg of hydroxychloroquine sulfate and excipients used for the manufacture of tablets. Contains lactose.

Where do you get Plaquenil? What packaging is available on the market?

You get Plaquenil in pharmacies, by doctor's prescription.

There are packages of 30 film-coated tablets.

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