Consumer medicine information

Quinate

Quinine sulfate dihydrate

BRAND INFORMATION

Brand name

Quinate

Active ingredient

Quinine sulfate dihydrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Quinate.

What is in this leaflet

This leaflet answers some common questions about Quinate. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking Quinate against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Quinate is used for

Quinate contains quinine (as quinine sulfate) as the active ingredient.

Quinate is used to treat malaria, an infectious disease spread by female mosquitoes. It belongs to a group of medicines called antimalarials.

This medicine works by stopping the growth of the organisms which cause malaria.

Ask your doctor if you have any questions about why Quinate has been prescribed for you. Your doctor may have prescribed it for another purpose

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

There is no evidence that it is addictive.

Before you take it

When you must not take it

Do not take Quinate if you have ever had an allergic reaction to:

  • quinine sulfate
  • tonic water or bitter lemon drinks which contain quinine
  • Any of the tablet ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include shortness of breath, wheezing, or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.

Do not take Quinate if you have had a reaction to it before.

Highly sensitive reactions to quinine can include bleeding or bruising more easily than normal, bloody diarrhoea and stomach pains.

Do not take Quinate if you have:

  • myasthenia gravis, a disease of the muscles.
  • Glucose-6-phosphate dehydrogenase, a genetic disorder mainly affecting red blood cells
  • Tinnitus, ringing in the ears
  • Optic neuritis, an inflammation of the optic nerve
  • A history of blackwater fever, a form of malaria characterized by kidney damage resulting in dark urine
  • a disorder affecting the red blood cells (haemolysis).
  • a rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption.

Do not take Quinate after the expiry date (EXP) printed on the label.

If you take this medicine after the expiry date has passed, it may not work as well.

Do not take it if the bottle shows signs of tampering, or if the tablets don't look quite right.

Before you start to take it

Tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • Heart problems.
  • Blood problems including anaemia and haemophilia.
  • Nervous system disorder.

Do not take Quinate if you are pregnant or plan to become pregnant unless you and your doctor have discussed the risks and benefits involved. Quinine sulphate should not be used during pregnancy to treat leg cramps.

Do not take it if you are breast feeding or plan to breast feed. It is not recommended for use while breastfeeding as it is found in breast milk.

If you have not told your doctor about any of these things, tell them before you take Quinate.

You should not take more than the prescribed dose as a condition called ‘cinchonism’ may occur, even with normal doses. Symptoms of cinchonism include abdominal pain, diarrhoea, disturbed vision (blurred vision, changes in colour perception or field of vision, total blindness), headache, feeling or being sick, ringing in the ears or impaired hearing, rashes, loss of consciousness, fits, shock due to heart problems, irregular heartbeats, death. Tell your doctor if you experience any of them.

Taking other medicines

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

Some medicines may interfere with Quinate. These include:

  • glycosides (e.g. digoxin and digitoxin), medicines used to heart failure.
    It is recommended that regular bold tests be performed when glycosides and Quinate are taken at the same time.
  • antacids containing aluminium
  • warfarin, a medicine used to prevent blood clots
  • pancuronium, succinylcholine, and tubocurarine, medicines used for anaesthesia
  • mefloquine, a medicine used for treating malaria
  • cimetidine, a medicine used for ulcers
  • muscle relaxant drugs
  • flecainide, quinidine or amiodarone (used to treat irregular heartbeats)
  • ciclosporin (used as an immunosuppressant medication)
  • urinary alkalinisers (e.g. sodium bicarbonate and acetazolamide), medicines used for bladder infections
  • quinine-containing beverages eg. tonic water, bitter lemon.
  • barbiturates, carbamazepine or phenytoin (medicines to treat epilepsy)
  • amantadine (to treat Parkinsons Disease or some viral infections)
  • medicines to treat diabetes
  • moxifloxacin, rifampicin or antifungals (used to treat infections)
  • astemizole or terfenadine (for allergic reactions)
  • pimozide or thioridazine (used to treat some mental disorders)
  • levacetylmethadol (a pain killer).

These medicines may be affected by Quinate or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist has a more complete list of medicines to be careful with or avoid while taking Quinate.

How to take it

How much to take

Your doctor will tell you how much Quinate to take.

The dose will depend on the condition being treated and your response to the treatment.

Follow all directions given to you by your doctor carefully. These directions may differ from the information contained in this leaflet.

How to take it

Swallow the tablet whole with a full glass of water.

Do not chew the tablets. Quinate has a special coating to mask the bitter taste of the tablet.

How long to take it

Continue taking Quinate for as long as your doctor tells you.

Do not stop taking it, or lower the dosage, even if you are feeling better, without first checking with your doctor.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much Quinate. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include:

  • tinnitus (ringing in the ears)
  • deafness
  • disturbed vision
  • Dizziness
  • Skin rash
  • Intestinal cramping and Vomiting
  • Headache
  • Fever
  • apprehension and confusion
  • Convulsions

While you are taking it

Things you must do

Take Quinate exactly as your doctor has prescribed.

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Quinate, especially if you are being started on any new medicine.

Tell your doctor, surgeon or dentist that you are taking Quinate if you are about to undergo surgery or an operation requiring a general anaesthetic.

Tell your doctor immediately if you become pregnant while taking Quinate.

Things you must not do

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not take Quinate to treat any other complaints unless your doctor tells you to.

Do not stop taking it, or lower the dosage, even if you are feeling better, without first checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how Quinate affects you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Quinate.

Like other medicines, Quinate may cause some unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or Pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following side effects and they worry you:

  • tinnitus (ringing in the ears)
  • headache
  • nausea
  • Slightly disturbed vision

These side effects are usually mild and short-lived.

Tell your doctor immediately if you notice any of the following:

  • severely disturbed vision
  • chest pain
  • changes in the way your heart beats for example if you notice it beating faster.
  • hypersensitivity, for example, flushing or rash of the skin, itching, fever, and swelling.
  • shortness of breath, difficulty in breathing
  • diarrhoea or cramps
  • distinct reduction in the amount of urine or a reddish colour in the urine.
  • bruising or bleeding more easily than normal
  • symptoms of liver disease with yellowing of the eyes or skin (jaundice) and dark urine.
  • confusion
  • loss of consciousness, coma, death.

Stop taking Quinate and tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any unexplained signs of bruising or swelling.

Some side effects can only be detected by your doctor. So it is important to visit your doctor for regular check-ups.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Some people may get other side effects while taking Quinate.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After taking it

Storage

Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep as well.

Keep your tablets in a cool dry place, protected from light, where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car on hot days or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Quinate or you find that the expiry date has passed, ask your pharmacist what to do with any tablets that are left over.

Product description

What it looks like

Quinate tablets are plain white, round, biconvex and film coated.

Available in bottles of 50 tablets.

Ingredients

Active ingredient:

Each tablet contains 300 mg of quinine sulfate dihydrate.

Inactive ingredients:

  • Lactose monohydrate
  • magnesium stearate
  • maize starch
  • Povidone
  • sodium starch glycollate
  • Opadry complete film coating system White Y-1-7000

Quinate tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.

Contains sugars as lactose.

Sponsor

Arrow Pharma Pty Ltd
15 – 17 Chapel Street
Cremorne, VIC 3121

Australian Registration Number:
AUST R 50707

This leaflet was prepared in October 2023.

Published by MIMS December 2023

BRAND INFORMATION

Brand name

Quinate

Active ingredient

Quinine sulfate dihydrate

Schedule

S4

 

1 Name of Medicine

Quinine sulfate dihydrate.

2 Qualitative and Quantitative Composition

Quinate tablets contain 300 mg of quinine sulfate dihydrate.
Excipients with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Quinate tablets are white, round, biconvex film coated tablets.

4 Clinical Particulars

4.9 Overdose

The most common signs and symptoms of overdosage are tinnitus, deafness, visual disturbances, dizziness, skin rash and gastrointestinal disturbances (intestinal cramping). With higher doses, cardiovascular and CNS effects may occur, including headache, fever, vomiting, apprehension, confusion and convulsions. Abortion, low blood pressure and renal failure are also possible results of overdosage. Other effects are listed in Section 4.8 Adverse Effects (Undesirable Effects).
Fatalities have been reported from a single dose of 2-8 g of quinine and a single fatality reported with a 1.5 g dose (which may reflect an idiosyncratic effect). Several cases of blindness following large overdoses of quinine, with partial recovery of vision in each instance, have been reported. Tinnitus and impaired hearing may occur at plasma quinine concentration of over 10 microgram/mL. This level would not be normally attained with the dose of 1-2 quinine tablets a day, but in hypersensitive patients, as little as 0.3 g of quinine may produce tinnitus.
Treatment for overdosage with Quinate should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient together with careful monitoring of ECG, respiratory status and central nervous system toxicity. There is no specific antidote for overdose with Quinate. Administration of activated charcoal may also be used to aid in removal of unabsorbed drug.
Patients should be warned of possible blindness but reassured that some recovery of sight frequently occurs. Stellate block has been used effectively for quinine associated blindness. Residual visual impairment occasionally yields to vasodilators.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Quinine sulfate is the sulfate of an alkaloid obtained from the bark of species of Cinchona. It contains not less than 99.0 per cent and not more than 101.0 per cent of total alkaloid salt, calculated as (C20H24N2O2)2.H2SO4, on the anhydrous basis. It is a white or almost white or colourless, fine, crystalline solid.
Chemical structure. Quinine sulfate dihydrate has the following structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSQUINSD.gif Molecular weight: 783.0.
CAS number. CAS Registry Number: 6119-70-6.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/QUINATST.gif