200 mg film-coated tablet
hydroxychloroquine sulfate
What Plaquenil is and what it is used for
Plaquenil contains hydroxychloroquine which is effective in inflammatory conditions such as rheumatic diseases. The exact mechanism of action is not known.
Plaquenil is used in the treatment of certain inflammatory diseases such as chronic rheumatoid arthritis, rheumatism without a known cause in children and adolescents ( juvenile idiopathic arthritis ), chronic rheumatic disease of the skin and various organs of the body (discoid and systemic lupus erythematosus) and also certain forms of light-induced skin rash.
What you need to know before taking Plaquenil
Do not take Plaquenil:
- If you are allergic to hydroxychloroquine or any of the other ingredients of this medicine (listed in section 6).
- If you have porphyria (increased secretion of certain blood dyes) or psoriasis.
- If you have certain visual or hearing impairments.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Plaquenil:
- Contact your doctor if you develop symptoms of cardiomyopathy (cardiovascular disease) during treatment with Plaquenil, such as shortness of breath, difficulty breathing, fatigue, bone swelling, palpitations, and chest pain. In cardiomyopathy, treatment should be discontinued (the condition may be life-threatening).
- If you have liver or kidney disease, nerve disease, blood disease, or are hypersensitive to quinine.
- Severe rash has been reported with the use of hydroxychloroquine (see section 4 Possible side effects ). Skin rashes often include sores in the mouth, throat, nose, genitals, and red and swollen eyes ( conjunctivitis ). These severe skin rashes are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash can develop into widespread blisters and flaky skin. Stop taking hydroxychloroquine and contact a doctor immediately if you get these skin symptoms.
- Before long-term treatment, the eyes should be examined. Thereafter, eye examinations are performed regularly. If you notice any changes in vision / visual disturbances, contact a doctor immediately as treatment will probably need to be stopped. Concomitant use of Plaquenil with medicinal products that may cause eye side effects (retinal detachment), such as tamoxifen used in breast cancer, is not recommended.
- Plaquenil can impair the eye’s ability to see at different distances (accommodation) and thus impair vision.
- Some patients treated with Plaquenil may experience problems with their mental health, such as irrational thoughts, anxiety, hallucinations, confusion, or depression, including thoughts of harming themselves or committing suicide. This also applies to people who have never had similar problems before. If you or your surroundings notice any of these side effects (see section 4), consult a doctor immediately.
- If you notice muscle weakness and reflexes, consult a doctor (treatment may need to be stopped).
- Hydroxychloroquine can cause low blood sugar. Ask your doctor to tell you about the signs and symptoms of low blood sugar. Blood sugar control may be necessary.
- Hydroxychloroquine can cause cardiac arrhythmias in some patients: and should be used with caution if you were born with a prolonged QT interval or have extended QT intervals in the family if you have acquired QT prolongation (see ECG, recording of the electrical activity of the heart) if you have heart disease or have previously had a heart attack (heart attack) if you have a salt imbalance in your blood (especially low potassium or magnesium levels) if you are taking medicines that can affect your heart rhythm (see section “Other medicines and Plaquenil”). If you experience palpitations or irregular heartbeats, tell your doctor immediately. The risk of heart problems may increase with increasing dose and therefore the dose recommendation should be followed.
- Extrapyramidal symptoms such as convulsions, involuntary movements, and tremors may occur with the use of Plaquenil (see also section 4 Possible side effects ).
Children
- Toddlers are very sensitive to the group of medicines to which Plaquenil belongs. Therefore, great care should be taken to avoid the risk of poisoning and to ensure that Plaquenil is kept out of the reach and sight of children. Children under 6 years of age or 35 kg should not be treated with Plaquenil due to the risk of accidental overdose. The tablet has no breaking point and is therefore not useful for lower body weight.
Other medicines and Plaquenil
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
This is especially true:
- drugs that affect the heart rhythm. This includes drugs used
- against abnormal heart rhythm ( antiarrhythmics ),
- against depression ( tricyclic antidepressants ),
- against mental illness (antipsychotics),
- against bacterial infections (eg moxifloxacin, azithromycin),
- for the treatment of HIV (eg saquinavir),
- against fungal infections (eg fluconazole ),
- against parasitic infections (eg pentamidine),
- or against malaria (eg halofantrine).
- antacids (for heartburn) and kaolin. Take Plaquenil at least 2 hours before or after these medicines.
- agalsidase (in Fabry disease)
- antidiabetic drugs
- cimetidine (for stomach ulcers )
- antifungal drugs (such as itraconazole)
- drugs against bacterial infections (such as rifampicin, clarithromycin)
- antiepileptic drugs (seizures) (such as phenobarbital, phenytoin, carbamazepine)
- lipid-disrupting drugs (such as gemfibrozil)
- drugs for the treatment of HIV (such as ritonavir)
- drugs used in organ transplantation or disorders of the immune system (such as cyclosporine)
- anticoagulants (such as dabigatran, clopidogrel)
- medicines for heart disease (such as digoxin, flecainide, propafenone, and metoprolol )
- (traditional) herbal medicines containing St. John’s wort (used for mild depression and mild anxiety).
Plaquenil may lower the seizure threshold and the risk of seizures may increase, especially if Plaquenil is taken at the same time as other medicines that lower the seizure threshold such as mefloquine (malaria medicine).
Plaquenil with food and drink
Avoid drinking grapefruit juice as it may increase the risk of side effects.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy: Plaquenil should not be used during pregnancy unless your doctor thinks the benefits outweigh the risks.
Breast-feeding: Plaquenil is excreted in human milk and should not be used by breastfeeding women unless directed to do so by a doctor.
Driving and using machines
During treatment with Plaquenil, the eye’s accommodation can be affected and this can cause blurred vision, which you should keep in mind when driving and precision work. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist
Plaquenil contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Plaquenil
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you. It may take time before the full treatment effect has been achieved. E.g. rheumatoid arthritis can take 4-12 weeks.
Use for children
Please note that children under 6 years of age or 35 kg should not be treated with Plaquenil due to the risk of accidental overdose. The tablet has no breaking point and is therefore not useful for lower body weight.
If you take more Plaquenil than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Symptoms from the nervous system such as headaches and nausea can occur and in the case of severe overdose, serious symptoms such as seizures and pronounced heart effects with uneven beats and drops in blood pressure can also occur.
Toddlers are very sensitive to the group of medicines to which Plaquenil belongs. Therefore, see also the section “Warnings and Precautions.” above.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Plaquenil and contact your doctor immediately if you get any of the following symptoms
Angioedema (frequency unknown)
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing
Stop taking Plaquenil and contact a doctor immediately if you get any of the following serious side effects – you may need urgent medical attention:
Serious skin side effects (see section 2 Warnings and precautions) such as:
- rash with fever and flu-like symptoms and enlarged lymph nodes. This can be a condition called a drug reaction with eosinophilia and systemic symptoms (DRESS).
- blistering, widespread scaly skin, swollen spots along with fever. This can be a condition called acute generalized exanthematous pustulosis (AGEP).
- blistering or flaky skin around lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever. This can be a condition called Steven-Johnson Syndrome (SJS).
- widespread skin damage, itching, joint pain, fever, and general malaise. This can be a condition called toxic epidermal necrolysis (TEN)
- skin reaction with purple, raised, painful sores, especially on your arms, hands, fingers, face, and neck which may also be accompanied by fever. This can be a condition called Sweet’s syndrome
Plaquenil can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general condition or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication.
Very common (may affect more than 1 user in 10):
- Nausea, bloating, abdominal cramps, abdominal pain
Common (may affect up to 1 in 10 people):
- Fatigue, headache, dizziness,
- Loss of appetite
- Irritability, anxiety
- Blurred vision due to problems with adjusting visual acuity at different distances (accommodation disturbances)
- Diarrhea, vomiting
- Skin rash, itching
Uncommon (may affect up to 1 in 100 people):
- Nervousness
- Retinal changes and impaired visual field (after long-term treatment)
- Tinnitus _ _
- Abnormal liver function tests
- Allergic skin reactions, pigment changes in the skin and mucous membranes, hair bleaching, graying of hair, hair loss (which goes back).
- Disorder of the nerve pathways for sensation and muscle function
Rare (may affect up to 1 in 1,000 people):
- Epilepsy
- Abnormal color vision, weakness in the eye’s movement muscles
- Hearing damage after long-term treatment
- Liver effects
Has been reported (occurs in an unknown number of users):
- Inhibition of blood production, blood changes
- Hives
- Cramps in the trachea
- Low blood sugar
- Exacerbation of porphyria (metabolic disorder)
- Depression or thoughts of self-harm or suicide, hallucinations, anxiety, confusion, anxiety, difficulty sleeping, elation, or excessive arousal. Psychosis (changed perception of reality).
- Cramps
- Changes in the yellow spot of the eye have been reported
- Hearing loss
- Cardiomyopathy, (in some cases life-threatening). Cardiac arrhythmias, life-threatening irregular heartbeat (as seen on ECG ) (see section 2, Warnings and precautions)
- Sudden liver failure
- Blisters and photosensitive skin, skin and mucous membrane changes (sometimes severe), severe widespread skin damage (skin detachment). Severe drug reaction in the skin where the outermost layer of the skin dies and is rejected ( toxic epidermal necrolysis ). Severe skin reactions also cause symptoms such as fever and blood clots. Plaquenil can trigger psoriasis attacks (and psoriasis patients appear to be more susceptible to severe skin reactions).
- Impaired nerve or muscle function, muscle weakness
- Extrapyramidal symptoms such as cramps, involuntary movements, and tremors.
With continuous treatment, uptake of the medicine into the cornea of the eye can cause symptoms in the form of rings around light sources (halos), blurred vision, or photosensitivity. The problems disappear completely if you stop or take a break from the medication. However, never change the prescribed dose yourself. With long-term treatment with a higher dose, changes in the retina that cause visual impairment may occur. This can be detected in time at eye examinations and the treatment is then stopped immediately.
How to store Plaquenil
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is hydroxychloroquine sulfate 1 tablet contains 200 mg of hydroxychloroquine sulfate.
- The other ingredients are lactose monohydrate, povidone, maize starch, magnesium stearate, hypromellose, macrogol, and titanium dioxide (E 171).
What the medicine looks like and the contents of the pack
The tablets are white, cupped, film-coated, and marked with HCQ on one side and 200 on the other side.
Blister pack of PVC and aluminum
Pack size: 100 tablets
Marketing Authorisation Holder
Sanofi AB
Box 30052
104 25 Stockholm
Tel: (+46) 08-634 50 00