QUININE SULFATE 300 MG

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986

The dispensing of this medicine requires a doctor's prescription

Read this package insert carefully in its entirety

before using this medicine

The format of this leaflet was determined by the Ministry of Health

and its content was checked and approved by it in November 2010

QUININE SULFATE

Tablets

Composition:

Each tablet contains: Quinine Sulfate 300 mg

Inactive Ingredients: Avicel, Maize Starch, Talc, Magnesium Stearate, Aerosil,

Sucrose, Gelatin, AC-Di-Sol, Carboxymethyl Cellulose Sodium

Therapeutic group:

Antimalarial.

Therapeutic activity:

For treatment of malaria.

When should the preparation not be used?

Do not use this medicine if you have a deficiency of the enzyme G6PD

(sensitivity to fava beans). Do not use this medicine if there is a known

sensitivity to any of its ingredients, or hypersensitivity to quinine. Do not take

this medicine if there is a known sensitivity to quinidine or other antimalarials.

If you suffer from muscle weakness disease (myasthenia gravis).

Do not take this medicine without consulting a doctor before

starting treatment:

If you are pregnant, intend to become pregnant or are breastfeeding.

If you are suffering, or have suffered in the past, from impaired function of:

the heart and/or vascular system, the eyes - optic nerve inflammation, the

blood system (thrombocytopenia), if you have ever had blackwater fever, if

you have hypoglycemia, asthma or ringing in the ears (tinnitus).

Warnings:

Use of this medicine may cause blurring of vision.

If you are sensitive to any type of food or medicine, inform your doctor before

commencing treatment with this medicine.

Drug interactions:

If you are taking another drug concomitantly or if you have just finished

treatment with another medicine, inform the attending doctor, in order

to prevent hazards or lack of efficacy arising from drug interactions. This

is especially important for medicines belonging to the following groups:

anticoagulants (such as warfarin), digoxin/digitoxin, quinidine, cyclosporine,

medicines for treatment of diabetes, additional medicines for the treatment

of malaria, (such as Lariam), rifampin, protease inhibitors.

Side effects:

In addition to the desired effect of the medicine, adverse reactions may occur

during the course of taking this medicine, for example: diarrhea, nausea, severe

abdominal pain, buzzing in the ears. These side effects usually disappear

within a short time following the period of adaptation to the medicine, but

if they persist or are bothersome, refer to the doctor.

Pay special attention to the warning signs of decreased levels of blood

platelets (thrombocytopenia), such as easy bruising, severe nose bleeds,

blood in the urine or stool, bleeding gums, and the appearance of unusual

purple, brown, or red spots on the skin. In case these signs appear, refer to

the attending doctor immediately. Patients are encouraged to read the patient

package insert given to them at the pharmacy before starting treatment with

Quinine Sulfate and each time of the prescription renewal.

Side effects that require special attention:

Sore throat and fever, chills, pain in the chest, back or abdomen, unusual bruises

(rare): stop treatment and refer to the doctor immediately. Loss of appetite,

pallor, unusual tiredness or weakness (rare): stop treatment and refer to the

doctor immediately. Bleeding, anxiety, cold, increased hunger, dizziness (rare):

stop treatment and refer to the doctor immediately. Blushing, nervousness,

sweating, irregular pulse, yellowing of the skin and eyes (rare): stop treatment

and refer to the doctor immediately. Symptoms of hypersensitivity: itching,

redness, skin rash and tingling, swelling or tingling of the face, hands, mouth

or throat, tightness in the chest, shortness of breath or difficulty breathing

(rare): stop treatment and refer to the doctor immediately.

Blurred vision, vomiting, severe abdominal pain (rare): stop treatment and

refer to the doctor immediately.

In the event that you experience side effects not mentioned in this leaflet, or if

there is a change in your general health, consult your doctor immediately.

Adverse reactions and drug interactions in children and infants:

Parents must inform the attending doctor about any side effects, as well as

any additional medicine being taken by the child.

See above for details of special side effects and drug interactions.

Dosage:

Dosage is according to doctor's instructions only. Do not exceed the

recommended dosage. If you forget to take this medicine at the specified time,

take the dose as soon as you remember, but never take a double dose.

Directions for use:

This medicine can be taken with food or milk.

The tablet can be halved/crushed.

How can you contribute to the success of the treatment?

Complete the full course of treatment as instructed by the doctor.

Avoid poisoning!

This medicine, and all other medicines, must be stored

in a safe place out of the reach of children and/or infants, to avoid poisoning.

If you have taken an overdose, or if a child has accidentally swallowed the

medicine, proceed immediately to a hospital emergency room and bring the

package of the medicine with you. Do not induce vomiting unless explicitly

instructed to do so by a doctor! This medicine has been prescribed for the

treatment of your ailment; in another patient it may cause harm. Do not give

this medicine to your relatives, neighbors or acquaintances.

Do not take medicines in the dark! Check the label and the dose each time

you take your medicine. Wear glasses if you need them.

Storage:

Store in a dark and dry place at a temperature below 25°C.

Even if kept in their original container and stored as recommended, medicines

may be kept for a limited period only. Please note the expiry date of the

medicine! In case of doubt, consult the pharmacist who dispensed the medicine

to you. Do not store different medications in the same package.

License number:

118102217600

Manufacturer:

Rekah Pharmaceutical Prod. Ltd., 30 Hamelacha St., Holon.