The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 33271/0018.
Hydroxychloroquine 300 mg film coated tablets
Hydroxychloroquine Sulfate 300mg Film-Coated Tablets
(referred to as Hydroxychloroquine Sulfate 300 Tablets in the remainder of the leaflet)
1. What Hydroxychloroquine Sulfate 300 Tablets are and what they are used for
2. What you need to know before you take Hydroxychloroquine Sulfate 300 Tablets
3. How to take Hydroxychloroquine Sulfate 300 Tablets
4. Possible side effects
5. How to store Hydroxychloroquine Sulfate 300 Tablets
6. Contents of the pack and other information
The name of your medicine is Hydroxychloroquine Sulfate 300mg Film-Coated Tablets; the active ingredient is hydroxychloroquine sulfate. These tablets are used in the treatment of inflammatory diseases such as rheumatoid arthritis and juvenile idiopathic arthritis.
They are also used to treat discoid and systemic lupus erythematosus (a disease where the immune system attacks the body causing tissue damage and inflammation) and also in problems with the skin that are triggered or worsened by sunlight.
Your doctor should arrange for you to have a thorough eye test within 12 months of 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:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are taking any of the following medicines:
The following medicines may increase the chance of you getting side effects when taken with Hydroxychloroquine Sulfate 300 Tablets:
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:
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.
Always take Hydroxychloroquine Sulfate 300 Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide the right dose for you; this will be on the pharmacist’s label. Check this carefully, it will tell you how many tablets to take and how often to take them.
Adults (including older people)
Children and Adolescents
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, 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Hydroxychloroquine Sulfate 300 Tablets can cause side effects, although not everybody gets them.
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; 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.
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.
Keep this medicine out of the sight and reach of children.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help protect the environment.
The active ingredient is: 300mg hydroxychloroquine sulfate.
The other ingredients are: lactose monohydrate, maize starch, hypromellose, croscarmellose sodium, magnesium stearate, talc, titanium dioxide, macrogol 6000 and polysorbate 80.
Hydroxychloroquine Sulfate 300 Tablets are white capsule shaped film-coated tablets (caplets), with a score line on one side. They are supplied in blister strips of 10 tablets, with an outer cardboard carton, and are available in pack sizes of 30 or 60 tablets. Not all pack sizes may be marketed.
Product Licence Number: PLGB 33271/0018
Leaflet Prepared: November 2022