Patient leaflet - Hydroxychloroquine Sulfate 200 mg film-coated tablets

1. What Hydroxychloroquine sulfate is and what it is used for

Hydroxychloroquine sulfate contains an active substance called hydroxychloroquine sulfate. Hydroxychloroquine sulfate works by reducing inﬂammation in people with autoimmune diseases (this is where the body’s immune system attacks itself by mistake). It can be used for:

Rheumatoid arthritis (inﬂammation of the joints)
Juvenile idiopathic arthritis (in children)
Discoid and systemic lupus erythematosus (a disease of the skin or the internal organs)
Skin problems which are sensitive to sunlight

2. What you need to know before you take Hydroxychloroquine sulfate

Do not take Hydroxychloroquine sulfate and tell your doctor if:

are allergic (hypersensitive) to
- Hydroxychloroquine
- Other similar medicines such as quinolones and quinine
- Any of the other ingredients of Hydroxychloroquine sulfate (listed in Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
have an eye problem which aﬀects the retina, the inside of the eye (maculopathy) or you
get a change in eye colour or any other eye problem.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor

or pharmacist before taking Hydroxychloroquine sulfate.

Warnings and precautions

Talk to your doctor or pharmacist before taking Hydroxychloroquine sulfate if:

have liver or kidney problems;
have serious stomach or gut problems;
have heart problems;
have any problems with your blood. You may have blood tests to check this.
have any problems with your nervous system or brain;
have psoriasis (red scaly patches on the skin usually aﬀecting the knees, elbows and scalp);
have had a bad reaction to quinine in the past.
have a genetic condition known as ‘glucose-6-dehydrogenase deﬁciency’.
have a rare illness called ‘porphyria’ which aﬀects your metabolism
have an inactive chronic infection with hepatitis B virus
are taking any medicines known to cause damage to the eyes (such as tamoxifen).
were born with or have family history of prolonged QT interval oryou 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 heart beat, 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.

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.

Before treatment with Hydroxychloroquine sulfate:

Before you take this medicine you should have your eyes examined.
This testing should be repeated at least every 12 months whilst taking Hydroxychloroquine sulfate
If you are over 65, need to take a high dose (2 tablets a day) or have kidney problems then
this
examination should be performed more often.
Hydroxychloroquine can cause lowering of 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.
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. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Hydroxychloroquine sulfate.
Other medicines and Hydroxychloroquine sulfate
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other Medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because hydroxychloroquine sulfate can aﬀect the way some other medicines work. Also some medicines can aﬀect the way hydroxychloroquine sulfate works. In particular, tell your doctor if you are taking any of the following:
The following medicines may increase the chance of you getting side eﬀects when taken with hydroxychloroquine sulfate
- 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.
- Cimetidine – used for stomach ulcers.
- Neostigmine and pyridostigmine – used for muscle weakness (myasthenia gravis).
- Medicines that may aﬀect the kidneys or liver.
- Medicines that aﬀect the skin.
- Medicines that aﬀect the eyes (suchas tamoxifen)
- Halofantrine, meﬂoquine – used for malaria.
- Medicines used for heart problems (such as amiodarone).
- Moxiﬂoxacin – used to treat infections.
- Medicines used for epilepsy.
- Medicines used for psychiatric disorders (such as amisulpride, quetiapine, risperidone). The following medicines can change the way hydroxychloroquine sulfate works or hydroxychloroquine sulfate may aﬀect the way some of these medicines work:
- Digoxin – used for heart problems.
- Medicines for diabetes (such as insulin or metformin).
- Antacids – used for heartburn or indigestion. You should leave a gap of at least 4 hours
  between taking these medicines and hydroxychloroquine sulfate.
- Rabies vaccine.
- Ciclosporin – used after an organ transplantation to help prevent rejection.
- Praziquantel – used to treat worm infections.
- Agalsidase – used to treat a rare condition called Fabry’s disease.

Pregnancy and breast-feeding

Hydroxychloroquine sulfate may be associated with a small increased risk of major malformations and should not be used during pregnancy unless your doctor considers the beneﬁts outweigh the risks.

If you discover that you are pregnant or are planning to have a baby, consult your doctor right

away to re-assess the need for treatment. Hydroxychloroquine should not be used during breast-feeding unless your doctor considers the beneﬁts outweigh the risks. This is because small amounts may pass into mother’s milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Your doctor will discuss with you whether hydroxychloroquine is suitable for you Driving and using machines

You may get eye problems while taking this medicine. If this happens, do not drive or use any tools or machines and tell your doctor straight away.

3. How to take Hydroxychloroquine sulfate

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine:

Take this medicine by mouth. Swallow the tablets whole with a meal or a glass of milk. Do not crush or chew your tablets.
If you are taking this medicine for skin problems that are sensitive to sunlight, only take
Hydroxychloroquine sulfate during periods of high exposure to light.
The doctor will work out the dose depending on your body weight. If you feel the eﬀect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.

If you have been taking this medicine for rheumatoid arthritis for a long time (more than 6 months) and you do not feel that it is helping you, see your doctor. This is because the treatment may need to be stopped.

How much to take

Adults (including the elderly)

One or two tablets each day

Children and adolescents

One tablet each day
This medicine is only suitable for children who weigh more than 31kg(around 5 stones) It may take several weeks before you notice the beneﬁt of taking hydroxychloroquine sulfate. If you take more Hydroxychloroquine sulfate than you should

If you take more hydroxychloroquine sulfate tell your doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following eﬀects may happen: headache, problems with your eyesight, fall in blood pressure, convulsions (ﬁts), heart problems, followed by sudden severe breathing problems and possibly heart attack.

Young children and babies are particularly at risk if they accidentally take hydroxychloroquine sulfate. Take the child to hospital straight away.

400 mm

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Size: 400 x 180 mm

10 mm

15 mm

If you forget to take Hydroxychloroquine sulfate If you forget a dose, take it as soon as your remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Hydroxychloroquine sulfate

Keep taking hydroxychloroquine sulfate until your doctor tells you to stop. Do not stop taking hydroxychloroquine sulfate just because you feel better. If you stop, your illness may get worse again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side eﬀects

Like all medicines, this medicine can cause side eﬀects, although not everybody gets them. Stop taking Hydroxychloroquine sulfate and see a doctor or go to a hospital straight away if:

Not known (the frequency cannot be established from the available data)

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 tongue. Stop taking Hydroxychloroquine sulfate and see a doctor straight away if you notice any of the following serious side eﬀects - you may need urgent medical treatment:

Severe skin reactions (see section 2 Warnings and precautions) such as:

Rash with a fever and ﬂu-like symptoms and enlarged lymph nodes. This could be a
condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Blistering, widespread scaly skin, pus-ﬁlled spots together with fever. This could be a
condition called Acute Generalized Exanthematous Pustulosis (AGEP).
Blistering 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 syndrome (SJS)
Multiple skin lesions, itching of the skin, joint aches, fever and a general ill feeling. This
could be a condition called Toxic Epidermal Necrolysis (TEN)
Skin reaction including plum-colored, raised, painful sores, particularly on your arms,
hands, ﬁngers, face and neck, which may also be accompanied by fever. This could be a condition called Sweet syndrome.

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.

Common (may aﬀect less than 1 in 10 people)

You have any eye problems. This includes problems with your eyesight such as blurring sensitivity to light or the way you see colour.

Uncommon (may aﬀect less than 1 in 100 people)

You have any muscle weakness, cramps, stiﬀness or spasms or changes in sensation such as
tingling. If you take this medicine for a long time, your doctor will occasionally check your muscles and tendons to make sure they are working properly.
Not known (frequency cannot be estimated from available data)
- You have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called ‘leucopenia’ or ‘agranulocytosis’.
- 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,
  coughing, high
  blood pressure, swelling, increased heart rate,low amount of urine.
- Low blood sugar levels (hypoglycaemia).You may feel a sense of nervousness, shaky or
  sweaty.
- You notice yellowing of your skin or your eyesor your urine becomes darker in colour. This
  could be a liver problem, such as jaundice or hepatitis.
- Fits.
- Lack of movement, stiﬀness, shaking or abnormal movements in the mouth and tongue.
- Feeling depressed or having thoughts of self harm or suicide, hallucinations, feeling
  nervous or anxious, feeling confused, agitated, diﬃculty sleeping, feeling elated or overexcited.

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

Very common side eﬀects (may aﬀect more than 1 in 10 people)

Stomach pain
Feeling sick

Common side eﬀects (may aﬀect less than 1 in 10 people)

Skin rashes, itching
Being sick, diarrhoea
Loss of appetite (anorexia)
Headache
Changes in mood with uncontrollable laughing or crying.

Uncommon side eﬀects (may aﬀect less than 1 in 100 people)

Changes in the colour of your skin or the inside of your nose or mouth
Hair loss or loss of hair colour
Feeling nervous
Ringing in the ear (tinnitus)
Balance problems (vertigo) or feeling dizzy
Liver problems shown by blood tests

Not known

Psoriasis (red scaly patches on the skin usually aﬀecting the knees, elbows and scalp)
- Hearing loss
- Mental problems (such as delusions, hallucinations and changes in mood)
- Symptoms of a condition called ‘porphyria’ which may include stomach pain, being sick,
  ﬁts, blisters, itching
- Chest pain and shortness of breath and irregular heartbeat( these could be signs of a condition called “Torsade de pointes”), or fast heartbeat (tachycardia)” Tests

Your doctor may monitor:

Your heart’s electrical activity using an ECG(electrocardiogram) machine.
Your muscle function and tendon reﬂexes.
The levels of speciﬁc cells in your blood using occasional blood tests. A blood test may alsoshow changes in the way the liver is working and occasionally the liver may stop working.

Reporting of side eﬀects

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 also report side eﬀects directly via the Yellow Card Scheme at: 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.

5. How to store Hydroxychloroquine sulfate

Keep this medicine out of sight and reach of the children.

Store in original package in order to protect from light.

Do not use Hydroxychloroquine sulfate after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Hydroxychloroquine sulfate contains

The active substance is hydroxychloroquine sulfate. Each tablet contains 200 mg of hydroxychloroquine sulfate.
The other ingredients are: Maize starch, Calcium hydrogen phosphate dihydrate, Silica
Colloidal
Anhydrous, Polysorbate 80, Talc, Magnesium stearate, Hypromellose, Titanium dioxide, Macrogol 6000.

What Hydroxychloroquine sulfate looks like and contents of the pack

Hydroxychloroquine sulfate 200 mg ﬁlm-coated tablets are white, approximately 9.5 mm circular, biconvex, ﬁlm-coated tablets debossed with 200 on one side and plain on the other side.

They are supplied in transparent PVC/Aluminium blister of 10 tablets. Pack size: 30 and 60 tablets.

Marketing Authorisation Holder and Manufacturer

Ipca Laboratories UK Ltd

Unit 97-98, Silverbriar, Sunderland Enterprise Park East, Sunderland, SR5 2TQ

United Kingdom

Manufacturer

Elara Pharmaservices Limited

Iron Farm

7 Grimes Gates,Diseworth,

DE74 2QD,UK

Misom Labs Ltd

Malta Life Sciences Park,

LS2.01.06. Industrial Estate,

San Gwann, SGN 3000,

Malta

This leaﬂet was last revised in 08/2025