PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER (PDF download)
QUININE INJECTION
• Read all this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again before, during or after use of this medicine.
• If you have any further questions, ask your health care provider.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please inform your health care provider
In this leaflet:
1. What Quinine 600mg injection is and what it is used for
2. What you need to know before you are given Quinine 600mg injection 3. How to take Quinine 600mg injection
4. Possible side effects
5. How to store Quinine 600mg injection
6. Contents of the pack and other information
1. WHAT QUININE 600MG INJECTION IS AND WHAT IT IS USED FOR
Quinine is a prescription drug used as an antimalarial drug indicated only for the treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN QUININE 600MG INJECTION.
You must not be given Quinine injections if you have an allergy to quinine or quinidine. Some of the symptoms of an allergic reaction may include:
• Shortness of breath
• Wheezing or difficulty breathing
• Swelling of the face, lips, tongue or other parts of the body
• Rash, intense itching, flushing or hives on the skin
• Ringing in the ears
• Changes in vision
• Fever
• Stomach pain or upset.
You must not be given Quinine injections if you have any of the following medical conditions:
• Glucose-6-phosphate-dehydrogenase deficiency (an inherited condition) • A history of blackwater fever
• Haemolysis (destruction of red blood cells)
• Tinnitus (buzzing, whistling, ringing or other persistent noises in the ear) • Inflammation of the optic nerve
• Diabetes
You should not be given this medicine if you are also taking medicine used to prevent blood clots such as Warfarin. You should not be given this medicine if the solution is discoloured, cloudy, turbid, or particles or a precipitate is present. The solution is normally a clear and colourless to light yellow solution. You should not be given this medicine if, when diluted with another solution, it causes the solution to precipitate, become cloudy, turbid, discolour, or particles are visible.
You should not be given this medicine after the expiry date printed on the pack, or if the packaging is torn or shows signs of tampering. If you are given this medicine after the expiry date has passed, it may not work as well.
Before you are given it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you have or have had any of the following medical conditions: • Irregular heartbeat
• Liver disease and/or hepatitis
• Kidney disease.
Taking other medicines with Quinine 600mg injection
Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket, health food shop, herbalist or naturopath. Some medicines and Quinine injections may interfere with each other. These include:
• Medicines used to treat the symptoms of urinary tract infections such as • Ammonium chloride, acetazolamide, sodium bicarbonate
• Cimetidine a medicine often used to treat reflux and ulcers
• Digoxin, a medicine used for heart conditions
• Medicines used to prevent blood clots such as warfarin, coumarin, or indanedione derivatives
• Other medicines used to treat malaria such as pyrimethamine, mefloquinine and quinidine
• Lithium, a medicine used to treat a mental illness: bipolar disorder
• Medicines used to treat myasthenia gravis
• Medicines that help relax the muscles during the use of general anaesthetics called neuromuscular blocking agents such as tubocurarine chloride and doxacurium chloride • Medicines which increase the effects of neuromuscular blocking agents when taken at the same time such as:
• Magnesium salts
• Salbutamol
• Some general anaesthetics
• Ganglion blockers such as trimethaphan
• Calcium channel blockers such as nifedipine and verapamil
• Antibacterials such as vancomycin
• Diuretics such as frusemide and mannitol
• Antiarrhythmics such as lignocaine and verapamil
• Anticholinesterases such as neostigmine
• Antineoplastics such as tamoxifen.
These medicines may be affected by Quinine dihydrochloride for injections or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.
Pregnancy
Quinine should not be withheld from pregnant women with life-threatening malaria if other less hazardous agents are unavailable or inappropriate. Pregnant women seem to be particularly prone to quinine-induced hyperinsulinemia and hypoglycemia. Excessive doses may induce abortion, and congenital malformation of the optic and auditory nerves have been reported after failure to induce abortion with quinine. When administered intravenously to pregnant patients, the infusion rate should not exceed 10 mg/kg every eight hours
Breast-feeding
You should not take Quinine Injection if you are breast-feeding. This is because small amounts may pass into mothers’ milk. This can be harmful to your baby. If you are breast feeding or planning to breastfeed, talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
You may feel drowsy, dizzy or confused while taking this medicine or in the morning after taking this medicine. If this happens, do not drive or use any tools or machines.
3. HOW TO TAKE QUININE
Your medicine will normally be given to you by a doctor or nurse. This is because it needs to be given by a deep injection into a muscle. Quinine injection must only be given by a doctor or nurse. Quinine injection is a concentrated solution and must be
diluted before use. It will be infused slowly into a vein only after dilution into an intravenous (IV) solution. If Quinine injection cannot be infused into a vein, it may be injected into a muscle. Your doctor will decide what dose of Quinine injection you will receive and for how long you will receive it. This depends on your medical condition and other factors including your weight.
If you are given too much (overdose)
Quinine injections is given by a doctor or nurse so an overdose is not likely to occur. Immediately contact your doctor or go to the Emergency Department at the nearest hospital if you notice the symptoms of an overdose. Symptoms of an overdose are similar to the symptoms of the side effects experienced with this medicine and are listed under Side Effects section.
Dosage and directions of use
In severe or complicated malaria, when the patient is unable to take oral
medication, a slow intravenous infusion of quinine is used. In severely ill adults, a loading dose of 20 mg quinine per kg may be administered by slow, constant rate intravenous infusion diluted in either isotonic fluid or 5% glucose solution (5-10 mL per kg bodyweight depending on the patient’s overall fluid balance) over four hours provided that the patient has not received quinine, quinidine or mefloquin during the previous twelve to twenty-four hours, and reliable hospital facilities are available, including cardiac monitoring.
What happens if I miss a dose?
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will be monitoring your progress and checking the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine. The following effects may happen: In children: Excitation, moving unsteadily or stumbling, uncontrolled writhing movements especially of the hands or feet, hallucinations, fits (seizures), loss of consciousness, uneven heartbeat and breathing difficulties. In adults: Feeling sleepy or drowsy, fits, loss of consciousness, uneven heartbeat and breathing difficulties.
If you miss a dose of Quinine Injection
Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However if you do think you have missed a dose, tell your doctor or nurse. If you have any further questions on the use of this product, ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Quinine injections. This medicine 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. Do not be alarmed by the following list of side effects. You may not experience any of them. Tell your doctor or nurse if you notice any of the following and they worry you: • Ringing in the ears or difficulty hearing
• Headache, confusion
• Disturbed vision
• Nausea, vomiting, diarrhoea, stomach pain
• Dizziness.
• Skin rash, itching, swelling of the face, flushing of the skin
• Wheezing, difficulty breathing
• Irregular heartbeat, chest pain
• Symptoms of liver disease such as yellowing of the eyes and skin • Reduced or no urine produced or discoloured urine
• Increase in bruising or bleeding
• Muscle weakness
• Fainting.
5. HOW TO STORE QUININE 600MG INJECTION
• Keep this medicine out of the sight and reach of children.
• Store below 30°C
• Do not use Quinine Tablet after the expiry date which is stated on the carton and label after ‘EXP’. The expiry date refers to the last day of that month.
6. FURTHER INFORMATION
What Quinine contains
• Each 2ml ampoule contains 600mg of the active substance, Quinine
What Quinine Injection looks like and contents of the pack
2ml X 10 ampoules placed in an inner carton with insert.
SUPPLIER AND MANUFACTURER
Fidson Healthcare Plc,
Km.38, Lagos-Abeokuta Expressway,
Sango-Ota, Ogun State, Nigeria
234-(0)60077008888
Customercare@fidson.com