Hydroxychloroquine 300 mg film coated tablets

• are allergic (hypersensitive) to hydroxychloroquine sulfate or to any of the other ingredients in Hydroxychloroquine Sulfate 300 Tablets (listed in section 6, Contents of the pack and other information)
• are allergic (hypersensitive) to 4-aminoquinolone compounds (e.g. chloroquine, amodiaquine)
• suffer from maculopathy (a disease of the eye)

• this should be repeated at least once every year while you are taking this medicine
• the elderly, those with kidney or previous eye problems and those taking more than one tablet per day should have an eye test every year after starting this medicine.

Some people being treated with hydroxychloroquine sulfate can experience mental health problems such as irrational thoughts, anxiety, hallucinations, feeling confused or feeling depressed, including thoughts of self-harm or suicide, even those who have never had similar problems before. If you or others around you notice any of these side effects (see section 4) seek medical advice straight away.

Talk to your doctor before taking Hydroxychloroquine Sulfate 300 Tablets if you:

• suffer from liver or kidney disease
• suffer from severe problems with your gastrointestinal system or nervous system
• suffer from heart problems
• have an inactive chronic infection with hepatitis B virus
• suffer from severe problems with your blood or bone marrow
• suffer from porphyria (a disease of blood proteins that can affect the skin, gut and nervous system)
• have the inherited condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme deficiency which increases the risk of developing anaemia)
• were born with or have family history of prolonged QT interval, or you have acquired QT prolongation (seen on ECG, electrical recording of the heart)
• have heart disorders or have a history of heart attack (myocardial infarction), as hydroxychloroquine may cause heart rhythm disorders in some patients.
• experience palpitations or irregular heartbeat, you should inform your doctor immediately. The risk of heart problems may increase with increase of the dose. Therefore, the recommended dosage should be followed
• have salt imbalance in the blood (especially low level of potassium or magnesium, see section “Other medicines and Hydroxychloroquine Sulfate 300 Tablets”)
• suffer from psoriasis (a skin condition causing scaly skin patches over the body)
• have eye or eyesight problems
• are taking any medicines known to cause damage to the eyes (such as tamoxifen)
• are allergic to quinine (a medicine used to treat malaria).

Serious skin rashes have been reported with the use of hydroxychloroquine (see section 4 possible side effects). Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by flu-like symptoms such as fever, headache and body ache. The rash may progress to widespread blistering and peeling of the skin. If you develop these skin symptoms, stop taking hydroxychloroquine and contact your doctor immediately.

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are taking any of the following medicines:

• while you are taking this medicine your doctor may arrange for blood tests to monitor your response to treatment
• if you have been taking this medicine for more than 6 months for the treatment of rheumatoid arthritis and you do not feel that it is helping you, speak to your doctor as it may be decided to stop treatment with this medicine.

The following medicines may increase the chance of you getting side effects when taken with Hydroxychloroquine Sulfate 300 Tablets:

• Some antibiotics used for infections (such as azithromycin, clarithromycin, erythromycin, gentamicin, neomycin or tobramycin). Taking azithromycin, clarithromycin, or erythromycin at the same time as hydroxychloroquine may increase the chance of you getting side effects that affect your heart.
• medicines used to treat myasthenia gravis – a disease of the muscles and nerves (e.g. neostigmine and pyridostigmine)
• aminoglycoside antibiotics (used to treat bacterial infections)
• cimetidine (used to treat heartburn and stomach ulcers)
• medicines that affect the skin or the eyes (such as tamoxifen)
• medicines that may affect the kidney or liver.
• halofantrine, mefloquine (used to treat malaria)
• amiodarone (used to treat heart problems)
• moxifloxacin (used to treat infections)
• medicines used to treat epilepsy
• medicines used for psychiatric disorders (such as amisulpride, quetiapine, risperidone).

The following medicines can change the way Hydroxychloroquine Sulfate 300 Tablets work or Hydroxychloroquine Sulfate 300 Tablets may affect the way some of these medicines work:

• medicines used to treat diabetes (e.g. insulin and antidiabetic tablets)
• digoxin (used to treat abnormal heart rhythms and heart failure)
• rabies vaccine
• antacids (medicines used to treat indigestion) – you should wait at least four hours between taking antacids and Hydroxychloroquine Sulfate 300 Tablets.
• ciclosporin (used after organ transplant to help prevent rejection)
• praziquantel (used to treat worm infections)
• agalsidase (used to treat a rare condition called Fabry’s disease)

Hydroxychloroquine Sulfate 300 Tablets should be taken with a meal or a glass of milk.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you should take Hydroxychloroquine Sulfate 300 Tablets during this time.

When you first start treatment with Hydroxychloroquine Sulfate 300 Tablets you may get blurred vision. If this happens do not drive a car or operate machinery. If this continues or you get other visual problems see your doctor immediately. There is more information on this in section 4.

This medicine 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.

• swallow the tablets whole with a meal or a glass of milk
• the doctor will work out the dose depending on your body weight
• if you are being treated for a skin disease that is sensitive to sunlight light, then you should use this medicine during periods of high exposure to light

Adults (including older people)

• the usual dose is one tablet taken daily
• your doctor may alter your dose depending on your response to treatment.

Children and Adolescents

• one tablet each day
• this medicine is only suitable for children who weigh 60kg or more

It may be several weeks before you notice an improvement in your condition with this medicine.

The score line is only intended to facilitate ease of swallowing and not for breaking the tablet into equal doses.

If you (or anybody else), takes more Hydroxychloroquine Sulfate 300 Tablets than you should contact your nearest hospital casualty department or doctor immediately. Always take the blister pack of tablets and this leaflet with you.

Young children and babies are particularly at risk if they accidentally take Hydroxychloroquine Sulfate 300 Tablets. Take the child to hospital straight away.

Symptoms that could indicate someone has taken too much are headache, visual disturbances, breathing difficulties, problems with your heart leading to uneven heart beats, low blood pressure and fits.

If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

• 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. A check of the blood glucose level may be necessary
• 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.
• any visual disturbance including persistent blurring of vision, changes to your colour vision, or sensitivity to light
• any muscle weakness, particularly of the upper arms or legs, muscle spasms or cramps, or changes in sensation of your skin. If you take this medicine over a long time your doctor will occasionally check your muscles and tendons to ensure they are not affected
• you may bruise more easily than usual, this could be due to a blood problem called ‘thrombocytopenia’
• you feel tired, faint or dizzy and have pale skin, these could be symptoms of something called ‘anaemia’
• you feel weak, short of breath, bruise more easily than usual and get infections more easily than usual, these could be symptoms of something called ‘aplastic anaemia’
• weakening of the heart muscle (cardiomyopathy) resulting in difficulty breathing, chest pain, an irregular or abnormal heartbeat, feeling dizzy or tired, swelling of feet, ankles and legs.
• unexpected bleeding or bruising, tiredness and pale skin, or frequent signs of infection such as sore throat, mouth ulcers and fever
• stiffness, abnormal movements or shaking
• You notice yellowing of your skin or your eyes or your urine becomes darker in colour. This could be a liver problem, such as jaundice or hepatitis.

You should tell your doctor or pharmacist if you have any of the following side effects, or if you think Hydroxychloroquine Sulfate 300 Tablets are making you feel unwell in any other way.

Side effects reported with this medicine include:

Very Common (may affect more than 1 in 10 people):

stomach pains; feeling sick (nausea)

Common (may affect more than 1 in 100 people):

itchy raised rash; diarrhoea; being sick (vomiting); headache; loss of appetite; mood swings, visual disturbance

Uncommon (may affect more than 1 in 1000 people):

changes in the colour of skin or the inside of the nose or mouth; bleaching of hair / hair loss; dizziness; decreased reflexes; abnormal liver function seen on blood tests; vertigo; ringing in the ears; nervousness

Not Known (frequency cannot be estimated):

abnormal nerve conduction; liver failure; symptoms of a condition called Porphyria, which may include stomach pain, being sick, constipation, fits, rashes or blisters, itching, pain or weakness in back, arms and legs; problems with heart conduction system; psoriasis (red scaly patches on the skin usually affecting the knees, elbows and scalp); hearing loss; psychosis, anaemia, low white blood cells, low platelets, feeling depressed or having thoughts of self-harm or suicide, hallucinations, feeling nervous or anxious, feeling confused, agitated, difficulty sleeping, feeling elated or overexcited; chest pain and shortness of breath and irregular heartbeat (these could be signs of a condition called “Torsade de pointes”), or fast heartbeat (tachycardia).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can report side effects directly via www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.