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Chloroquine Phosphate Tablets Bp 250mg

Document: leaflet MAH GENERIC_PL 17907-0487 change

Patient Information Leaflet

CHLOROQUINE PHOSPHATE TABLETS BP 250 MG

Please read this leaflet carefully before you start to take your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. Keep this leaflet in a safe place, you may need to read it again.

WHAT ARE CHLOROQUINE PHOSPHATE TABLETS BP 250 MG?

These tablets are white, round biconvex tablets with a breakline on one face. The active ingredient is Chloroquine Phosphate BP 250 mg. Each tablet also contains the inactive ingredients Lactose BP, Starch BP, Sodium Starch Glycollate BP, Magnesium Stearate BP and Stearic Acid BP. The tablets are available in blister packs in a variety of sizes.

Marketing Authorization Holder:

Bristol Laboratories Limited

Unit-3, Canalside, Northbridge Road, Berkhamsted, HP4 1EG Manufacturer:

Norbrook Laboratories Limited, Newry, Co. Down, Northern Ireland.

WHAT ARE CHLOROQUINE PHOSPHATE TABLETS BP 250 MG USED FOR?

Chloroquine Phosphate is one of a group of medicines called anti malarials, which are used in the prevention and suppression of malaria. (When prescribed by a doctor it may also be used to treat malaria).

When used to prevent malaria, official guidelines and local information on prevalence or resistance to anti malarial drugs should be taken into consideration.

WHEN MUST CHLOROQUINE PHOSPHATE TABLETS BP 250 MG NOT BE TAKEN?

You should not take these tablets if:

•    You are allergic to Chloroquine Phosphate or any of the other ingredients in the tablet.

•    You are pregnant or planning to be.

•    You have a rare hereditary problem of galactose intolerance, the Lapp lactase deficiency or glucose-galactase malabsorption.

•    You are currently taking amiodaraone for treatment of irregular heart beats

You should consult your doctor before taking these tablets if:

•    You suffer from Porphyria.

•    You suffer from kidney disorders.

•    You suffer from liver disorders, particularly cirrhosis.

•    You suffer from Psoriasis.

•    You suffer from convulsions or other nervous disorders.

•    You suffer from gastro-intestinal disorders.

Chloroquine can cause lowering of the 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.

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

You should inform your doctor if you are taking any medication. The following table lists some of the drugs with which Chloroquine interacts:

Type of Drug

Example

Heart Treatment

Amiodarone

Anti-epileptic

Carbemazapine

Immunosuppressant

Ciclosporin

Parasympathomimetic

Neostigmine, Pyridostigmine

Ulcer healing

Cimetidine

Rabies Vaccine

Aventis Pasteur

Anti Malarial

Mefloquine

Antacids should not be taken at the same time as this medicine as they may reduce its effectiveness

HOW SHOULD CHLOROQUINE PHOSPHATE TABLETS BP 250 MG BE TAKEN?

For adults, the elderly and children over 12 years old, the usual dose is:

2 tablets as a single weekly dose, taken on the same day each week during exposure. The dose should be started 1-2 weeks before entering an endemic area and continued for 4 weeks after leaving the area.

The product should only be given to children younger than 12 years old under the supervision of a doctor.

The product should only be used to treat malaria under medical supervision.

If you have missed a dose, do not double up on a dose to make up for the one you have missed.

If you take too much medicine or someone else accidentally takes your medicine, contact your doctor, pharmacist or local hospitalstraight away.

WHAT ARE THE POSSIBLE UNWANTED EFFECTS OF CHLOROQUINE PHOSPHATE TABLETS BP 250 MG?

Like all medicines, Chloroquine Phosphate can cause side effects in some patients. However, adverse effects are rare at normal dosages and are usually reversible. They include:

•    Gastrointestinal disturbances, nausea, vomiting, diarrhoea and abdominal cramps.

•    Skin disorders including urticaria, pruritis or after prolonged use, skin discolouration.

•    Muscular damage.

•    Low blood pressure or changes in heart rate.

•    Hearing disorders, such as reduced hearing or tinnitus.

•    Effects on the central nervous system such as convulsions, psychotic reactions including hallucinations (rarely), anxiety and personality changes.

•    Irreversible retinal damage can occur if high doses are used for prolonged periods. If you take weekly doses to prevent malaria over long periods of time (3 years or more), you should visit your doctor for eye examinations, preferably before the start of treatment and then at 3 - 6 month intervals thereafter.

•    Blood disorders can also occur with prolonged use and full blood counts should be carried out during extended treatment.

•    Not known (frequency cannot be estimated from the available data) - Lowering of the blood glucose level.

If you are concerned about these or if you notice any side effects not mentioned in this

leaflet, please inform your doctor or pharmacist.

HOW SHOULD CHLOROQUINE PHOSPHATE TABLETS BP 250 MG BE STORED?

•    The tablets should be stored in a dry place and protected from light

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

•    This medicine must not be used after the expiry date printed on the pack. Return any left over medicine to your pharmacist.

FURTHER INFORMATION: You can get more information on Chloroquine

Phosphate BP 250 mg from your doctor or pharmacist.

PL 17907/0487

This leaflet was last revised in October 2014

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