Plaquenil 200 mg, 60 tablets

Trade Name:

Plaquenil 200 mg

60 film-coated tablets

Composition:

Each tablet contains:

Hydroxychloroquine sulfate 200 mg

Inactive ingredients:

Lactose monohydrate, maize starch, magnesium, Piromellose, macrogol 4000, and titanium dioxide (E171) 

Properties:

Plaquenil contains a medicine called hydroxychloroquine sulfate.

Plaquenil works by reducing inflammation in people with autoimmune diseases (this is where the body’s immune system attacks itself by mistake).

Indications:

-Rheumatoid arthritis (inflammation of the joints)

-Juvenile idiopathic arthritis (inflammation of the joints)

-Discoid and systemic lupus erythematosus (a disease of the skin or internal organs)

-Skin problems which are sensitive to sunlight.

Dosage and administration:

Always take Plaquenil exactly as your doctor has told you. Your doctor will decide your daily dose. 

• Take this medicine by mouth
• Swallow the tablets whole with a meal or a glass of milk. Do not crush or chew.
• After six months of treatment, if your condition does not improve, ask your doctor. This is because the treatment may need to be stopped.

-Adults including the elderly: one or two tablets per day

-Children and adolescents

One tablet each day

• This medicine is only suitable for children who weigh more than 35 kg.
• It may take several weeks before you notice the benefit of taking Plaquenil.
• If you missed the dose, take it right when you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up tor a forgotten dose.

Side effects:

Stop taking Plaquenil and see a doctor or go to hospital straight away if:

-You have an allergic reaction. The signs may include: a red or lumpy rash, swallowing or breathing problems, swelling of your eyelids, lips, face, throat or Stop taking Plaquenil and see a doctor straight away if:

-You have any eye problems. This induces changes in the color of your eye and

problems with your eyesight such as blurring, sensitivity to light or the way you see.

-You have any muscle weakness, (ramps, stiffness or spasms or changes in thi ediin for a long time, your doctor will occasionally check your muscles and tendons to make sure they are working properly

• Severe skin reactions such as blistering, widespread scaly skin, pus-filled spots itering 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.

-Multiple skin lesions, itching of the skin, joint aches, fever and a general ill

feeling. This could be a condition called -Toxic Epidermal Necrolysis.

You may get infections more easily than usual. This could be due to bone marrow  or may bruise more easily than usual. This could be due to a blood problem called thrombocytopenia

-Liver problems that may cause the eyes or skin to go yellow (jaundice)

-Abnormal heart rhythm., lite-threatening irregular heart rhythm (seen on ECG)  (frequency cannot be estimated from the

Tell your dotor if any of the following side effects get serious or lasts longer than a few days:

• Skin rashes, itching, changes in the color of your skin or the inside of your nose.
• Psoriasis (red scaly patches on the skin usually affecting the knees, elboWs and

-Hair loss or loss of hair color

• Feeling or being sick, diarrhea, loss of appetite (anorexia) or stomach pain
• Feeling nervous, ringing in the ear (tinnitus), hearing loss, headache, fits, balance hallucinating elzy, mental problems (such as delusions
• Weakening of the heart muscle (cardiomyopathy) resulting in difficulty in breathing.
• Coughing, high blo0od pressure, swelling. increased heart rate, low amount of urine.

-You may get infections more easily than usual. This could be due to bone marrow depression.

Contraindications:

Do not take Plaquenil and tell your doctor if:

• You are allergic (hypersensitive) to:

-hydroxychloroquine

-other similar medicines such as quinolones and quinine

-any of the other ingredients of Plaquenil 

• You have an eye problem which affects the retina, the inside of the eye

(maculopathy) or you get a change in eye color or any other eye problem

• Used in children under 6 years of age or below 35kg.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Plaquenil if:

• You have liver or kidney problems;
• You have serious stomach and gut problems (You may have blood tests to check this);
• You have heart problems (signs include breathlessness and chest pain) which may require monitoring;

• You have any problems with your nervous system or brain;
• You have psoriasis;
• You have a genetic condition known as ‘glucose-6-dehydrogenase deficiency;
• You have a rare illness called ‘porphyria’ which affects your metabolism;
• Hydroxychloroquine can cause lowering of the blood glucose level. Please ask

your doctor to inform you of signs and symptoms of low blood glucose levels. 

• If you have heart disorders or have a

history of heart attack (myocardial infarction), if you have salt imbalance in the hydroxychloroquine”). lf you experience palpitations or irregular heart beat, you should inform your doctor immediately. The risk of heart problems may increase with an increase of the dose. •Before you take this medicine you should have your eyes examine

• This testing should be repeated at least every 12 months while taking Plaquenil.
• lf you are over 65, need to take a high dose (2 tablets a day) or have problems then this examination should be performed more often.
• Please tell your doctor or pharmacist if you are taking any other medicines, including ones obtained without a prescription.

-Medicines known to affect the rhythm of your heart. 

-Medicines for bacterial infections (eg. moxifloxacin, azithromycin)

-Medicines for parasitic infections (eg.. pentamidine) or against malaria (e.g, halofantrine).

-Medicines for malaria such as metloquine (as it may increase the risk of seizures)

-Medicines for epilepsy (seizures), in particular phenobarbital, phenytoin,

Caroaiaetthe skin, the blood or the eyes

• Tamoxifen, used to treat breast cancer
• Agalsidase
• Neostigmine and pyridostigmine- used for muscle weakness (myasthenia gravis) kait mm attert the kidney or liver

• Antacid medicines (for heartburn) and kaolin: Take Plaquenil at least 2 hours apart from those.

Modidin or fungal infections (such as itraconazole)

• Medicines for lipid disorders (such as gemfibrozil)
• Medicines tor HIV treatment (such as ritonavir)

Medicines for organ transplantation or immune system disorders 

• Medicines for blood dots (such as dabigatran, clopidogrel)

*Medicines for heart diseases (such as digoxin, flecainide, propafenone

• Praziquantel (an antiparasitic medicine) an herbal treatment for depression: St. John’s wort.

• Avoid taking grapefruit juice as it may increase the risk of side effects.
• Pregnancy and breast-feeding soua hot be used during pregnancy unless your doctor considers the benefits outweigh the risks.

Plaquenil should not be used during breast-feeding unless your doctor considers the benefits outweigh the risks.

• This medicine contains lactose. 

Storage:

Store at a temperature not exceeding 30°C, in a dry place.

Package:

Carton box contains 6 strips each of 10 film coated tablets, and paper instructions.