APO-HYDROXYCHLOROQUINE

APO-HYDROXYCHLOROQUINE

Active ingredient(s): Hydrochloroquine sulfate

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Consumer Medicine Information (CMI)

This leaflet provides important information about using APO-Hydroxychloroquine. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using APO-HYDROXYCHLOROQUINE.

Where to find information in this leaflet:

1. Why am I using APO-Hydroxychloroquine?
2. What should I know before I use APO-Hydroxychloroquine?
3. What if I am taking other medicines?
4. How do I use APO-Hydroxychloroquine?
5. What should I know while using APO-Hydroxychloroquine?
6. Are there any side effects?
7. Product details

1. Why am I using APO-HYDROXYCHLOROQUINE?

APO-Hydroxychloroquine contains the active ingredient hydroxychloroquine sulfate.

APO-Hydroxychloroquine is used for any of the following conditions:

Rheumatoid arthritis

Rheumatoid arthritis is a form of arthritis with inflammation of the joints, characterised by stiffness, swelling and pain. APO-Hydroxychloroquine may be used for short or long-term rheumatoid arthritis treatment.

In treating rheumatoid arthritis, APO-Hydroxychloroquine may slow down the process of joint damage and relieve the symptoms of the disease.

Systemic Lupus Erythematous (SLE)

SLE is a disease in which a person’s normal immunity is upset. The body produces an excess of blood proteins called antibodies and these antibodies may cause problems in any organ of the body.

These antibodies may end up, for example, in the skin causing a variety of skin rashes or deposit in the kidney, brain, lung and joints causing injury.

Discoid Lupus Erythematous (DLE)

DLE is similar to SLE except it only affects the skin and is characterised by a scaling, red rash.

Malaria (treatment and control of symptoms)

Malaria is an infectious disease caused by the presence of parasites in red blood cells.

The disease is characterised by chills, fever and sweats. In malaria, APO-Hydroxychloroquine destroys the harmful parasite which causes the illness.

Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why APO-Hydroxychloroquine has been prescribed for you.

APO-Hydroxychloroquine is not addictive. This medicine is available only with a doctor’s prescription.

2. What should I know before I use APO-HYDROXYCHLOROQUINE?

Warnings

Do not use APO-Hydroxychloroquine if:

• you are allergic to hydroxychloroquine, chloroquine or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• You have previously experienced changes in your eyesight when taking medicines for rheumatoid arthritis or malaria.
• You have a heart rhythm disorder.
• APO-Hydroxychloroquine should not be used in children under 6 years.
• APO-Hydroxychloroquine should not be used in children over 6 years for long periods.
• Do not take APO-Hydroxychloroquine after the expiry date printed on the bottle.
• Do not take APO-Hydroxychloroquine if the bottle is damaged or shows signs of tampering.
• Do not take APO-Hydroxychloroquine to treat any other complaint unless your doctor says it is safe. Do not give this medicine to anyone else.

Check with your doctor if you:

• are taking any other medicines for any medical condition.
• are allergic to quinine.
• have allergies to any ingredients listed under “Product Description” at the end of this leaflet.
• have any pre-existing eye disorders.
• have experienced low blood sugar levels (hypoglycaemia – a “hypo”). APO-Hydroxychloroquine may increase the risk of you having a hypo.
• have an inactive chronic infection with hepatitis B virus.
• have or have had any of these medical conditions:
  – Chloroquine-resistant malaria
  – Liver or kidney problems
  – Diabetes
  – Stomach, brain or blood disorders
  – Disease of the heart muscle
  – Skin diseases, in particular psoriasis which is a kind of itchy rash.
  – Glucose-6-phosphate dehydrogenase (G-6-PD) deficiency which is a lack of a chemical substance which causes the breakdown of sugar in the body.
  – Porphyria, which is a rare disease of blood pigments.
  – Porphyria Cutanea Tarda (PCT), which is a rare disorder of painful, blisters on the skin
  – Myasthenia (a disease with general muscle weakness including in some cases muscles used for breathing). You may notice aggravation of symptoms such as muscle weakness, difficulty in swallowing, double vision, etc.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

APO-Hydroxychloroquine should be avoided in pregnancy except when, in the judgement of the physician, the potential benefits outweigh the potential hazards.

When APO-Hydroxychloroquine is taken for long periods of time, there is an increased risk to the unborn child. It may cause problems with brain function, hearing, balance and vision.

There is very limited data on the safety in the breastfed infant during long-term treatment with APO-Hydroxychloroquine. The active ingredient (hydroxychloroquine) is excreted in breast milk and it is known that infants are extremely sensitive to the toxic effects.

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

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or think you may be pregnant or planning to have a baby or breast-feeding. Your doctor will discuss with you whether APO-Hydroxychloroquine is suitable for you.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with APO-Hydroxychloroquine and affect how it works, these include:

• Any medicine to treat depression, including the herbal product St John’s wort
• Digoxin, Flecainide, Propafenone, Quinidine – a medicine used to treat heart disease
• Medicines to treat diabetes
• Medicines used to suppress the immune system such as ciclosporin
• Antiarrythmic drugs such as amiodarone and moxifloxacin
• Other antimalarial drugs
• Medicines to treat epilepsy, such as carbamazepine and phenobarbital
• Tamoxifen (a medicine used to treat breast cancer)
• Anti-infective medicines
• Some antibiotics used for bacterial infections (such as moxifloxacin, azithromycin, clarithromycin, erythromycin, roxithromycin). Taking these antibiotics at the same time as hydroxychloroquine may increase the chance of you getting side effects that affect your heart which could be life-threatening.
• Medicines that may affect your blood
• Medicines that may affect your eyes
• Antacids containing magnesium or kaolin or cimetidine, used to neutralise stomach acid
• Itraconazole, an antifungal medication
• Grapefruit juice
• Anticoagulant drugs such as dabigatran and clopidogrel
• Medicines to treat high cholesterol, such as gemfibrozil, statins
• Ritonavir (a medicine used to treat HIV)

These medicines may be affected by APO-Hydroxychloroquine or affect the way APO-Hydroxychloroquine works.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect APO-Hydroxychloroquine.

4. How do I use APO-HYDROXYCHLOROQUINE?

How much to take

The usual doses are:

Rheumatoid arthritis

Adults

• 2-3 tablets daily. Your doctor may later reduce this to 1-2 tablets daily.

SLE and DLE

Adults

• 2-4 tablets daily. Your doctor may later reduce this to 1-2 tablets daily.

Control of Malaria Symptoms

Adults

• 2 tablets once a week. The tablets should be taken on exactly the same day of each week.
• For example, if your first dose is taken on a Monday, then each weekly dose should be taken on a Monday.

Treatment of malaria

Adults

• The starting dose is 4 tablets. Take another 2 tablets six to eight hours later and two further tablets on each of the next 2 days.

Always follow the instructions given to you by your doctor.

Dosages for children are calculated according to the child’s body weight.

Your doctor will work out the correct dose for you or your child.

APO-Hydroxychloroquine should not be used in children for long periods.

Your doctor may ask you to take a different dose. You should follow the instructions on the label.

If you are unsure what dose to take, ask your pharmacist or doctor.

When to take APO-Hydroxychloroquine

• Swallow tablets whole with a little water or other liquid.
• It is best to take APO-Hydroxychloroquine at meal times.
• The dosage will depend on why you are being treated with APO-Hydroxychloroquine.

If you forget to take APO-Hydroxychloroquine

If you are being given APO-Hydroxychloroquine for rheumatoid arthritis, SLE or DLE, do not take a double dose to make up for the dose missed. Just continue with the appropriate dose on the next day.

If you are being given APO-Hydroxychloroquine for suppression or treatment of malaria, you should take your tablets as soon as you remember, and go back to taking it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much APO-Hydroxychloroquine

If you think that you have taken too much APO-Hydroxychloroquine, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre in Australia by calling 13 11 26, or 0800 POISON or 0800 764766 in New Zealand, or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too many tablets you may experience headaches, drowsiness, visual disturbances or fits.

These symptoms may occur within 30 minutes of overdose.

5. What should I know while using APO-HYDROXYCHLOROQUINE?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you are using APO-Hydroxychloroquine.

Call your doctor straight away if you:

• Are about to start taking any new medicines, tell your doctor and pharmacist that you are taking APO-Hydroxychloroquine.
• Experience any of the following symptoms including; weakness, trembling or shaking, sweating, lightheadedness, headache, dizziness, lack of concentration, tearfulness or crying, irritability, hunger and numbness around the lips and fingers. These symptoms may be associated with hypoglycaemia.
• If you experience any of the symptoms of hypoglycaemia, you need to raise your blood glucose urgently. You can do this by taking one of the following:
  – 5-7 jelly beans
  – 3 teaspoons of sugar or honey
  – 1/2 can of ordinary (non-diet) soft drink
  – 2-3 concentrated glucose tablets
  – unless you are within 10 to 15 minutes of your next meal or snack, follow up with extra carbohydrates e.g. plain biscuits, fruit or milk – when over the initial symptoms. Taking this extra carbohydrate will prevent a second drop in your blood glucose level.
• Make sure you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia and know how to treat them.
• Your doctor will need to perform the following tests during treatment with APO-Hydroxychloroquine.

Eye Tests

• Your doctor will need to perform some eye tests every few months to check that your eyesight is not changing.
• In extremely rare cases, APO-Hydroxychloroquine has been associated with blindness. This can be avoided by having regular eye tests.
• It is recommended you wear sunglasses when out in the sun.

Blood Tests

• Your doctor will need to perform occasional blood tests to check for any blood reactions.
• Your doctor may monitor your blood sugar levels if you have experienced hypoglycaemia while taking APO-Hydroxychloroquine.

Serious skin reactions

• Serious skin reactions have been reported with the use of APO-Hydroxychloroquine.
• 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.

Mental health problems

• Some people being treated with APO-Hydroxychloroquine 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 Side effects) seek medical advice straight away, and stop your treatment if you have thoughts of self-harm or suicide.

Talk to your doctor if you have a rare illness called porphyria which affects your metabolism.

Muscle and Nerve disorders

Hydroxychloroquine may cause muscle and nerve disorders. Caution should be taken when you take this medicine for a long time, your doctor will occasionally check for muscle weakness, numbness and pain.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how APO-Hydroxychloroquine affects you.

APO-Hydroxychloroquine may cause dizziness in some people.

APO-Hydroxychloroquine may cause problems with the eyesight of some people. Make sure you know how you react to APO-Hydroxychloroquine before you drive a car, operate machinery, or do anything else that could be dangerous with blurred vision.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Keep your tablets in the bottle until it is time to take them.
• If you take the tablets out of the bottle they will not keep well.
• Keep it in a cool dry place where the temperature stays below 25°C.
• Heat and dampness can destroy some medicines. Do not leave APO-Hydroxychloroquine in the car on hot days.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Children are particularly sensitive to the unwanted effects of APO-Hydroxychloroquine.

When to discard your medicine

If your doctor tells you to stop taking the tablets, ask your pharmacist what to do with any tablets that are left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention. APO-Hydroxychloroquine helps most people with rheumatoid arthritis, SLE, DLE, treatment of malaria and the control of malaria symptoms, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
Stomach problems such as: Nausea Vomiting Diarrhoea Abdominal cramps Other problems such as: Loss of appetite Muscle weakness Dizziness Ringing in the ears Headache Nervousness Skin rash and itching Hair loss If you already have psoriasis, you are more likely to experience skin reactions than other people when taking APO-Hydroxychloroquine.	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Visual disturbances Any hearing loss Suicidal behaviour Having thoughts of self-harm or suicide Feeling depressed, feeling nervous or anxious, feeling confused, agitated, difficulty sleeping, delusions, hallucinations, changes in mood, feeling elated or overexcited, Frequent fevers, severe chills, bruising, sore throat or mouth ulcers (these may be signs of blood reactions) Changes in the way your heart Beats 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. Kidney problems due to accumulation of phospholipids More severe symptoms of hypoglycaemia, including: – disorientation – seizures, fits or convulsions – loss of consciousness 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, genitals, hands or feet, 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 reddish-purple color, 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’s syndrome.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

These are serious side effects. You may need urgent medical attention.

Serious side effects are rare.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What APO-Hydroxychloroquine contains

Active ingredient (main ingredient)	Contains 200 mg of hydroxychloroquine sulfate as the active ingredient
Other ingredients (inactive ingredients)	Calcium hydrogen phosphate Pregelatinised maize startch hypromellose magnesium stearate colloidal anhydrous silica polysorbate 80 Opadry II White 85F18422.

Do not take this medicine if you are allergic to any of these ingredients.

This medicine is gluten-free, lactose free and free of other azo dyes.

What APO-HYDROXYCHLOROQUINE looks like

White to off-white, capsule-shaped tablets, embossed “HCQS” on one side, plain on the other side. AUST R 186393.

Packaged in bottles of 100 tablets.

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au

This leaflet was prepared in February 2024.