JAMP HYDROXYCHLOROQUINE SULFATE TABLET

Canada - English - Health Canada

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Active ingredient:
HYDROXYCHLOROQUINE SULFATE
Available from:
JAMP PHARMA CORPORATION
ATC code:
P01BA02
INN (International Name):
HYDROXYCHLOROQUINE
Dosage:
200MG
Pharmaceutical form:
TABLET
Composition:
HYDROXYCHLOROQUINE SULFATE 200MG
Administration route:
ORAL
Units in package:
1ML/5ML
Prescription type:
Prescription
Therapeutic area:
ANTIMALARIALS
Product summary:
Active ingredient group (AIG) number: 0107403001; AHFS: 08:30.08
Authorization status:
APPROVED
Authorization number:
02491427
Authorization date:
2019-08-09

Documents in other languages

Page 1 of 27

PRODUCT MONOGRAPH

INCLUDING PATIENT MEDICATION INFORMATION

Pr

JAMP HYDROXYCHLOROQUINE SULFATE

Hydroxychloroquine Sulfate Tablets, USP

Tablet 200 mg

Anti-Inflammatory – Antimalarial – Aminoquinolines

ATC Code: P01BA02

Jamp Pharma Corporation

1310 rue Nobel,

Boucherville, Québec

J4B 5H3

Date of Revision:

February 07, 2020

Submission Control No.: 234952

Page 2 of 27

PRODUCT MONOGRAPH

JAMP HYDROXYCHLOROQUINE SULFATE

Hydroxychloroquine Sulfate Tablets, USP

Tablet 200 mg

ACTIONS AND CLINICAL PHARMACOLOGY

Hydroxychloroquine belongs to the 4-aminoquinoline class. Hydroxychloroquine sulfate has been

beneficial for patients with rheumatoid arthritis and lupus erythematosus, especially chronic

discoid lupus. The exact mode of action in controlling these diseases is unknown. The action of

this compound against malarial parasites is similar to that of chloroquine phosphate.

INDICATIONS AND CLINICAL USE

JAMP HYDROXYCHLOROQUINE SULFATE (hydroxychloroquine sulfate) is indicated for

the treatment of rheumatoid arthritis, and discoid and systemic lupus erythematosus, in patients

who have not responded satisfactorily to drugs with less potential for serious side effects.

It is also indicated for the suppressive treatment and treatment of acute attacks of malaria due to

P.

vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. It is not active against

the exo-erythrocytic forms of P. vivax, P. malariae and P. ovale and therefore will neither

prevent infection due to these organisms when given prophylactically, nor prevent relapse of

infection due to these organisms. It is highly effective as a suppressive agent in patients with

vivax or malariae malaria in terminating acute attacks and significantly lengthening the interval

between treatment and relapse. In patients with falciparum malaria, it abolishes the acute attack

and effects complete cure of the infection, unless due to a resistant strain of P. falciparum.

Comparative Bioavailability

CLINICAL TRIALS

A open label, randomized, two-treatment, single-period, single oral dose (1 x 200 mg), parallel-

design comparative bioavailability study was conducted with JAMP HYDROXYCHLOROQUINE

SULFATE tablets 200 mg (JAMP Pharma Corporation, Canada) and

PLAQUENIL

tablets 200

mg (Covis Pharmaceuticals, Inc., Cary, NC, USA) in 110 normal, healthy, adult, human subjects

under fasting conditions. Data from 108 subjects who completed the study are presented in the

following table.

Page 3 of 27

SUMMARY TABLE OF THE COMPARATIVE BIOAVAILABILITY DATA

Hydroxychloroquine Sulfate

(1 x 200 mg)

Geometric Mean

Arithmetic Mean (CV %)

Parameter

Test

Reference

% Ratio of

Geometric

Means

% Confidence

Interval

0-72

4928.11

4943.50

99.69

90.97-109.24

(hr. ng/mL)

5159.84 (29.9)

240.17 (27.7)

229.38

231.33

99.16

90.05-109.18

(ng/mL)

241.42 (32.1)

5113.61 (29.0 )

4.33

4.33

(1.50-6.00)

(1.00-6.50)

Due to the study design, AUC

and T

cannot be estimated accurately.

JAMP HYDROXYCHLOROQUINE SULFATE tablets 200 mg (Jamp Pharma Corporation, Canada)

† Pr

PLAQUENIL

tablets 200 mg (Covis Pharmaceuticals, Inc., Cary, NC, USA)

Expressed as the median (range)

CONTRAINDICATIONS

JAMP HYDROXYCHLOROQUINE SULFATE is contraindicated in:

Patients with pre-existing retinopathy of the eye

patients with known hypersensitivity to 4-aminoquinoline compounds

children below 6 years of age (200 mg tablets not adapted for weight <35 kg)

(see

WARNINGS AND PRECAUTIONS, Special Populations – Pediatric Use).

WARNINGS AND PRECAUTIONS

General:

Observe caution in patients with gastrointestinal or neurological disorders, in those with

sensitivity to quinine, and in porphyria.

Effects on Ability to Drive and Use Machinery:

Patients should be warned about driving and operating machinery since JAMP

HYDROXYCHLOROQUINE SULFATE (hydroxychloroquine sulfate) can impair

accommodation and cause blurring of vision. If the condition is not self-limiting, dosage may

need to be temporarily reduced.

Malaria: Hydroxychloroquine is not effective against chloroquine-resistant strains of P.

falciparum and is not active against the exo-erythrocytic forms of P. vivax, P. ovale and P.

malarias and therefore will neither prevent infection due to these organisms when given

prophylactically, nor prevent relapse of infection due to these organisms.

Carcinogenesis and Mutagenesis:

Non-clinical studies showed a potential risk of chloroquine inducing gene mutations. Long term

studies in animals have not been conducted to evaluate the carcinogenic potential (see

TOXICOLOGY). In humans, there are insufficient data to rule out an increased risk of cancer in

Page 4 of 27

patients receiving-long term treatment.

Cardiovascular:

Cardiomyopathy:

Cases of cardiomyopathy resulting in cardiac failure, in some cases with a fatal outcome, have

been reported in patients treated with hydroxychloroquine sulfate. JAMP

HYDROXYCHLOROQUINE SULFATE should be discontinued if signs and symptoms of

cardiomyopathy develop. Chronic toxicity should be considered when conduction disorders

(bundle branch block/atrio-ventricular heart block) as well as biventricular hypertrophy is

diagnosed (see ADVERSE REACTIONS and SYMPTOMS AND TREATMENT OF

OVERDOSAGE).

Electrocardiogram (ECG) Changes and Potential for Cardiac Arrhythmias:

JAMP HYDROXYCHLOROQUINE SULFATE

can prolong the PR, QRS and QTc intervals,

especially in patients with underlying risk factors.

Serious adverse events, including fatal outcomes,

have been reported in patients taking

hydroxychloroquine sulfate

including ventricular arrhythmias,

heart blocks, ventricular fibrillation and torsade de pointes

(see WARNINGS AND

PRECAUTIONS, Monitoring and Laboratory Tests, ADVERSE REACTIONS, DRUG

INTERACTIONS and SYMPTOMS AND TREATMENT OF OVERDOSAGE).

QTc prolongation may lead to an increased risk of ventricular arrhythmias including torsade

de pointes. Torsade de pointes may be asymptomatic or experienced by the patient as

dizziness, palpitations, syncope, or seizures. If sustained, torsade de pointes can progress to

ventricular fibrillation and sudden cardiac death. Permanently discontinue JAMP

HYDROXYCHLOROQUINE SULFATE in patients who develop torsade de pointes or

polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia. If cardiac

complications due to JAMP HYDROXYCHLOROQUINE SULFATE are suspected, treatment

should be discontinued.

JAMP HYDROXYCHLOROQUINE SULFATE is not recommended for use in patients with

baseline QTc prolongation (e.g., congenital or acquired Long QT Syndrome), second-or third-

degree atrioventricular block. Electrolyte imbalances (e.g.

hypokalemia/hypomagnesemia/hypocalcemia) must be corrected prior to use. Use of JAMP

HYDROXYCHLOROQUINE SULFATE should be undertaken with extreme caution in patients

with other risk factors for torsade de pointes.

Risk factors for torsade de pointes in the general population include, but are not limited to, the

following: female gender; age ≥ 65 years; baseline prolongation of the QT/QTc interval;

presence of genetic variants affecting cardiac ion channels or regulatory proteins, especially

congenital long QT syndromes; family history of sudden cardiac death at <50 years of age;

cardiac disease (e.g., myocardial ischemia or infarction, congestive heart failure,

cardiomyopathy, conduction system disease); history of arrhythmias; electrolyte disturbances

or conditions leading to electrolyte disturbances (e.g., persistent vomiting, eating disorders);

bradycardia; acute neurological events (e.g., intracranial or subarachnoid haemorrhage, stroke,

intracranial trauma); diabetes mellitus; and autonomic neuropathy.

Concomitant use with other QTc, PR or QRS interval prolonging drugs should be avoided or

Page 5 of 27

undertaken with particular caution (see DRUG INTERACTIONS).

The magnitude of QT, PR or QRS prolongation with JAMP HYDROXYCHLOROQUINE

SULFATE may increase with increasing concentrations of the drug. Therefore, the

recommended dose should not be exceeded (see DOSAGE AND ADMINISTRATION).

Endocrine and Metabolism:

Hydroxychloroquine sulfate has been shown to cause severe hypoglycemia including loss of

consciousness that could be life threatening in patients treated with and without antidiabetic

medications. Patients treated with JAMP HYDROXYCHLOROQUINE SULFATE should be

warned about the risk of hypoglycemia and the associated clinical signs and symptoms. Patients

presenting with clinical symptoms suggestive of hypoglycemia during treatment with JAMP

HYDROXYCHLOROQUINE SULFATE should have their blood glucose level checked and the

need for JAMP HYDROXYCHLOROQUINE SULFATE treatment reviewed as necessary. In

cases of severe hypoglycemia, JAMP HYDROXYCHLOROQUINE SULFATE should be

discontinued and alternative therapy considered. If patients use JAMP

HYDROXYCHLOROQUINE SULFATE concomitantly with antidiabetic drugs, a decrease in

doses of insulin or antidiabetic drugs may be required as JAMP HYDROXYCHLOROQUINE

SULFATE may enhance the effects of hypoglycemic treatment (see DRUG INTERACTIONS

and ADVERSE REACTIONS).

Hematologic:

Periodic blood counts should be obtained in patients requiring prolonged therapy due to the risk

of bone marrow depression (see ADVERSE REACTIONS). If any severe blood disorder appears

that is not attributable to the disease under treatment, the drug should be discontinued.

Observe caution in patients with blood disorders or glucose-6-phosphate dehydrogenase

deficiency.

Hepatic/Biliary/Pancreatic:

JAMP HYDROXYCHLOROQUINE SULFATE should be used with caution in patients with hepatic

disease or alcoholism, in whom a reduction in dosage may be necessary, or in conjunction with known

hepatotoxic drugs.

Use of JAMP HYDROXYCHLOROQUINE SULFATE in patients with hepatic impairment as

well as with concomitant CYP2C8 or CYP3A4 inhibitors can result in elevation of

hydroxychloroquine plasma concentrations, with the magnitude of the effect depending on the

degree of hepatic impairment, as well as the enzyme inhibited and the potency of the inhibitor.

Isolated cases of abnormal liver function tests as well as fulminant hepatic failure have been

reported (see WARNINGS AND PRECAUTIONS, Cardiovascular, ADVERSE REACTIONS,

DRUG INTERACTIONS and DOSAGE AND ADMINISTRATION).

Musculoskeletal:

All patients on long term therapy with this preparation should be questioned and examined

periodically, including the examination of skeletal muscle function and tendon reflexes, testing

knee and ankle reflexes, to detect any evidence of muscular weakness. If weakness occurs,

discontinue the drug (see ADVERSE REACTIONS).

Page 6 of 27

Neurologic:

Extrapyramidal reactions have been reported in patients taking hydroxychloroquine sulfate (see

ADVERSE REACTIONS). Symptoms may persist in some patients after discontinuation of

therapy.

Ophthalmologic:

Irreversible retinal damage has been observed in some patients who had received long-term or

high-dosage 4-aminoquinoline therapy for discoid and systemic lupus erythematosus, or

rheumatoid arthritis. Before starting a long term treatment, both eyes should be examined by

careful ophthalmoscopy for visual acuity, central visual field and colour vision, and fundoscopy.

Then, the examination should be repeated at least annually.

Retinal toxicity is largely dose-related. The risk of retinal damages is small with daily doses of up

to 6.5 mg/kg ideal (lean) body weight. Exceeding the recommended daily dose sharply increases

the risk of retinal toxicity. Significant risk factors for toxic retinopathy reported during long-term

(≥5 years) treatment with hydroxychloroquine include daily doses greater than 6.5 mg/kg (5

mg/kg base) of actual body weight, subnormal glomerular filtration rate, durations of use longer

than five years, and concurrent treatment with tamoxifen citrate. Concomitant use of JAMP

HYDROXYCHLOROQUINE SULFATE with drugs known to induce retinal toxicity, such as

tamoxifen, is not recommended.

Careful ophthalmologic examination should be more frequent and adapted to the patient, in the

following situations:

daily doses exceeding 6.5 mg (salt form)/kg ideal (lean) body weight. Absolute body

weight used as a guide to dosage, could result in an overdosage in the obese;

renal insufficiency;

cumulative dose more than 200 g (salt form);

elderly;

impaired visual acuity.

If there is any indication of abnormality in the visual acuity, visual field, or retinal macular areas

(such as pigmentary changes, loss of foveal reflex), or any visual symptoms (such as light flashes

and streaks, abnormal colour vision) that are not fully explainable by difficulties of

accommodation or corneal opacities, the drug should be stopped immediately. The patient should

be closely observed for possible progression of the abnormality. Retinal changes (and visual

disturbances) may progress even after cessation of the therapy (see ADVERSE REACTIONS).

Methods recommended for early diagnosis of retinopathy consist of (1) funduscopic examination

of the macula for fine pigmentary disturbances or loss of the foveal reflex and (2) examination of

the central visual field with a small red test object for pericentral or paracentral scotoma or

determination of retinal thresholds to red. Any unexplained visual symptoms, such as light

flashes or streaks also should be regarded with suspicion as possible manifestations of

retinopathy.

Psychiatric:

Suicidal behaviour has been reported in patients treated with hydroxychloroquine sulfate (see

ADVERSE REACTIONS).

Page 7 of 27

Renal:

Observe caution in patients with renal disease, in whom a reduction in dosage may be necessary,

as well as in those taking medicines known to affect this organ. During treatment and after

discontinuation, monitoring for adverse reactions may be warranted in patients with severe renal

impairment or end-stage renal disease (ESRD), given the long half-life of hydroxychloroquine (see

WARNINGS AND PRECAUTIONS, Cardiovascular, DRUG INTERACTIONS and DOSAGE

AND ADMINISTRATION).

Skin:

Dermatological reactions to JAMP HYDROXYCHLOROQUINE SULFATE may occur. It is not

recommended for the treatment of psoriasis or porphyria as these conditions may be exacerbated

by its use. Observe caution in patients with psoriasis.

JAMP HYDROXYCHLOROQUINE SULFATE may cause acute generalized exanthematous

pustulosis (AGEP). AGEP has to be distinguished from psoriasis, although JAMP

HYDROXYCHLOROQUINE SULFATE may precipitate attacks of psoriasis. It may be

associated with fever and hyperleukocytosis. Outcome is usually favorable after discontinuation of

drug.

Sexual Health:

Fertility:

Animal

studies

showed

impairment

male

fertility

with

chloroquine

treatment

(see

TOXICOLOGY, Reproductive and development toxicity). There are no data in humans.

Special Populations

Pregnancy:

Hydroxychloroquine

crosses

placenta.

Data

limited

regarding

hydroxychloroquine sulfate during pregnancy. JAMP HYDROXYCHLOROQUINE SULFATE

should be avoided in pregnancy. It should be noted that the 4- aminoquinolines in therapeutic doses

have been associated with central nervous system damage, including ototoxicity (auditory and

vestibular toxicity, congenital deafness), retinal hemorrhages and abnormal retinal pigmentation to

the foetus.

Embryonic deaths and ocular malformations in the offspring have been reported when pregnant

rats received large doses of chloroquine (see TOXICOLOGY, Reproductive and development

toxicity).

Nursing Mothers:

Careful consideration should be given to using JAMP HYDROXYCHLOROQUINE SULFATE

during

breastfeeding, since it is excreted in small amounts (approximately 2% of the maternal dose

after bodyweight correction) in human breast milk and it is known that infants are extremely

sensitive to the toxic effects of 4-aminoquinolines. There are very limited data on the safety in the

breastfed infant during hydroxychloroquine long-term treatment. The prescriber should assess the

potential risks and benefits of use during breastfeeding, according to the indication and duration

of treatment.

Page 8 of 27

Although hydroxychloroquine is excreted in breast milk, the amount is insufficient to confer any

protection against malaria to the infant. Separate chemoprophylaxis for the infant is required.

Pediatric Use:

Safety

efficacy

been

established

rheumatoid

arthritis

systemic

lupus

erythematosus in children. Children are especially sensitive to the 4-aminoquinoline compounds.

The most reported fatalities follow the accidental ingestion of chloroquine, sometimes in small

doses. Patients should be strongly warned to keep these drugs out of the reach of children (see

CONTRAINDICATIONS).

Hepatic Impairment:

JAMP HYDROXYCHLOROQUINE SULFATE should be used with caution in patients with

hepatic disease or alcoholism, in whom a reduction in dosage may be necessary, or in conjunction

with known hepatotoxic drugs. Isolated cases of abnormal liver function tests as well as fulminant

hepatic

failure

have

been

reported

WARNINGS

PRECAUTIONS,

Hepatic/Biliary/Pancreatic, DOSAGE AND ADMINISTRATION, and DRUG INTERACTIONS).

Renal Impairment:

JAMP HYDROXYCHLOROQUINE SULFATE

should be used with

caution in patients with

renal disease, in whom a reduction in dosage

may be necessary, as well as in those taking

medicines known to affect this organ

(see WARNINGS AND PRECAUTIONS, Renal, and

DRUG INTERACTIONS).

Monitoring and Laboratory Tests

ECG assessments are recommended at baseline and periodically during treatment with JAMP

HYDROXYCHLOROQUINE SULFATE. More frequent monitoring is recommended if

JAMP HYDROXYCHLOROQUINE SULFATE is administered to patients with baseline

ECG abnormalities or who are being treated concomitantly with other QTc-, QRS-, or PR-

interval prolonging drugs. Monitor electrolytes regularly (see WARNINGS AND

PRECAUTIONS, Cardiovascular, and DRUG INTERACTIONS).

DRUG INTERACTIONS

Drugs that Prolong the PR, QRS and/or QTc Intervals:

JAMP HYDROXYCHLOROQUINE SULFATE has the potential to prolong the PR, QRS and/or

QTc intervals in a concentration-related manner (see WARNINGS AND PRECAUTIONS,

Cardiovascular). Caution is recommended if JAMP HYDROXYCHLOROQUINE SULFATE is

used concomitantly with other drugs that prolong the PR, QRS and QTc intervals. Current

information sources should be consulted for drugs that prolong the QTc interval, the QRS duration,

or the PR interval.

Drugs that Affect Electrolytes:

Caution is recommended if JAMP HYDROXYCHLOROQUINE SULFATE is used with drugs that

have the potential to decrease electrolytes levels. Current information sources should be consulted

for drugs that disrupt electrolytes.

Page 9 of 27

A table with potential drug interaction with JAMP HYDROXYCHLOROQUINE SULFATE

included

below.

This

list

possible

drug

interactions

exhaustive.

JAMP

HYDROXYCHLOROQUINE SULFATE

should also be used with

caution in patients taking

medicines

which

cause

adverse

ocular

skin

reactions

(see

WARNINGS AND

PRECAUTIONS).

Proper Name

Effect/clinical comment

Agalsidase

There is a theoretical risk of inhibition of intra-cellular α-

galactosidase

activity

when

JAMP

HYDROXYCHLOROQUINE SULFATE is co-administered

with agalsidase.

Aminoglycoside antibiotics

JAMP HYDROXYCHLOROQUINE SULFATE may also be

subject to several of the known interactions of chloroquine,

even

though

specific

reports

have not

appeared,

including

potentiation of its direct blocking action at the neuromuscular

junction by aminoglycoside antibiotics.

Antacids

As with chloroquine, antacids may reduce absorption of JAMP

HYDROXYCHLOROQUINE SULFATE so it is advised that

hour

interval

observed

between

JAMP

HYDROXYCHLOROQUINE SULFATE and antacid dosing.

Antidiabetic drugs

May enhance the effects of a hypoglycemic treatment, a

decrease in doses of antidiabetic drugs may be required.

Antiepileptic drugs

The activity of antiepileptic drugs might be impaired if

co- administered

with

JAMP

HYDROXYCHLOROQUINE SULFATE.

Antimalarials known

to lower the

convulsion threshold

JAMP HYDROXYCHLOROQUINE SULFATE can lower

the convulsive threshold. Co- administration of JAMP

HYDROXYCHLOROQUINE

SULFATE

with

other

antimalarials known to lower the convulsion threshold (e.g.

mefloquine) may increase the risk of convulsions.

Cimetidine

JAMP HYDROXYCHLOROQUINE SULFATE may also be

subject to several of the known interactions of chloroquine,

even though specific reports have not appeared, including

inhibition of its metabolism by cimetidine, which may increase

plasma concentration of the antimalarial.

Cyclosporine

An increased plasma cyclosporin level was reported when

ciclosporin

hydroxychloroquine

sulfate

were

administered.

CYP2C8 and CYP3A4

inhibitors

Co-administration of JAMP HYDROXYCHLOROQUINE

SULFATE with moderate and strong CYP2C8 and CYP3A4

inhibitors (such as, but not limited to, ketoconazole, itraconazole,

erythromycin, aprepitant, fluconazole, clopidogrel,

teriflunomide, letermovir) may result in increased plasma

concentrations of hydroxychloroquine.

Page 10 of 27

Proper Name

Effect/clinical comment

Digoxin

May result in increased serum digoxin levels; serum

digoxin levels should be closely monitored in

patients receiving concomitant treatment.

Drugs that prolong

the QRS and/or QT

interval and other

arrhythmogenic

drugs

JAMP HYDROXYCHLOROQUINE SULFATE prolongs

the QT interval and should not be administered with other

drugs that have the potential to induce cardiac arrhythmias.

There may be an increased risk of inducing ventricular

arrhythmias

JAMP

HYDROXYCHLOROQUINE

SULFATE is used

concomitantly with other drugs that

prolong the QT interval, including, but not limited to, Class

IC and

antiarrhythmics; certain antidepressants,

antipsychotics,

anti-infectives;

domperidone;

hydroxytryptamine (5-HT)3 receptor antagonists; kinase

inhibitors;

histone

deacetylase

inhibitors

beta-2

adrenoceptor

agonists

(see

WARNINGS

PRECAUTIONS, Cardiovascular, and SYMPTOMS AND

TREATMENT OF OVERDOSAGE).

Drugs that affect

electrolytes

Caution

recommended

JAMP

HYDROXYCHLOROQUINE

SULFATE

used

with

drugs that have the potential to decrease electrolytes levels,

including, but not limited to, loop, thiazide, and related

diuretics, laxatives and enemas, amphotericin B, high dose

corticosteroids,

proton

pump

inhibitors

(see

WARNINGS AND PRECAUTIONS, Cardiovascular, and

SYMPTOMS AND TREATMENT OF OVERDOSAGE).

Insulin

May enhance the effects of a hypoglycemic treatment, a

decrease in doses of insulin may be required.

Mefloquine

JAMP HYDROXYCHLOROQUINE SULFATE can lower

the convulsive threshold. Co-administration of JAMP

HYDROXYCHLOROQUINE

SULFATE

with

other

antimalarials known to lower the convulsion threshold (e.g.

mefloquine) may increase the risk of convulsions.

Neostigmine

JAMP HYDROXYCHLOROQUINE SULFATE may also be

subject to several of the known interactions of chloroquine

even though specific reports have not appeared including

antagonism of effect of neostigmine.

Praziquantel

Chloroquine has been reported to reduce the bioavailability of

praziquantel.

similarities

structure

pharmacokinetic parameters between hydroxychloroquine and

chloroquine, a similar effect may be expected for JAMP

HYDROXYCHLOROQUINE SULFATE.

Page 11 of 27

Proper Name

Effect/clinical comment

Pyridostigmine

JAMP HYDROXYCHLOROQUINE SULFATE may also

be subject to several of the known interactions of

chloroquine, even though specific reports have not

appeared, including antagonism of effect of pyridostigmine.

Tamoxifen/Drugs known

to induce retinal toxicity

An increased risk of toxic retinopathy was reported when

hydroxychloroquine sulfate

used

concurrently

with

tamoxifen

citrate.

Concomitant

JAMP

HYDROXYCHLOROQUINE SULFATE with drugs known

induce

retinal

toxicity,

such

tamoxifen,

recommended

(see

WARNINGS

PRECAUTIONS,

Ophthalmologic).

Vaccine: Human diploid cell

rabies vaccine

JAMP HYDROXYCHLOROQUINE SULFATE may also be

subject to several of the known interactions of chloroquine,

even though specific reports have not appeared, including

reduction of the antibody response to primary immunization

with intradermal human diploid cell rabies vaccine.

Food Interactions: Grapefruit products contain one or more components that strongly inhibit

CYP3A4 and can increase plasma concentrations of hydroxychloroquine. Consumption of

grapefruit or its juice should be avoided while taking JAMP HYDROXYCHLOROQUINE

SULFATE.

ADVERSE REACTIONS

The following Council for International Organizations of Medical Sciences

CIOMS) frequency

rating is used, when applicable: Very common

10 %; Common

1 and <10 %; Uncommon

0.1 and < 1 %; Rare

0.01 and <0.1 %; Very rare < 0.01 %; Not known (frequency cannot be

estimated from available data).

Blood and lymphatic system disorders

Not known: Bone marrow depression, anemia, aplastic anemia, agranulocytosis, leucopenia,

thrombocytopenia (see WARNINGS AND PRECAUTIONS, Hematologic).

Cardiac disorders

Not known: Cardiomyopathy, which may result in cardiac failure and in some cases a fatal

outcome.

Chronic toxicity should be considered when conduction disorders (bundle branch block/

atrioventricular heart block) as well as biventricular hypertrophy are found. Drug discontinuation

may lead to recovery (see WARNINGS AND PRECAUTIONS, Cardiovascular, DRUG

INTERACTIONS, and SYMPTOMS AND TREATMENT OF OVERDOSAGE).

Hydroxychloroquine sulfate prolongs the QT, PR and/or QRS intervals which may lead to an

arrhythmia. Ventricular arrhythmias and torsade de

pointes have been reported in patients taking

hydroxychloroquine sulfate (see WARNINGS AND PRECAUTIONS, Cardiovascular, DRUG

INTERACTIONS, and SYMPTOMS AND TREATMENT OF OVERDOSAGE).

Page 12 of 27

Ear and labyrinth disorders

Uncommon: Vertigo, tinnitus

Not known: Hearing loss, including cases of irreversible hearing loss.

Eye disorders

Common: Blurring of vision due to a disturbance of accommodation which is dose dependent

and reversible (see WARNINGS AND PRECAUTIONS, Ophthalmologic).

Uncommon: Maculopathies, which may be irreversible.

Retinopathy with changes in pigmentation and visual field defects (see WARNINGS AND

PRECAUTIONS, Ophthalmologic). In its early form it appears reversible upon discontinuation

of the drug. If allowed to develop however, there may be a risk of progression even after

treatment withdrawal.

Patients with retinal changes may be asymptomatic initially, or may have scotomatous vision with

paracentral, pericentral ring types, temporal scotomas, abnormal colour visions, reduction in

visual acuity, night blindness, difficulty reading and skipping words.

Corneal changes including edema and opacities. They are either symptomless or may cause

disturbances such as halos around lights especially at night, blurring of vision, vision disturbances,

or photophobia. They may be transient or are reversible upon discontinuation of therapy (see

WARNINGS AND PRECAUTIONS, Ophthalmologic).

Not known: Macular degeneration, which may be irreversible.

Gastrointestinal disorders

Very common: Abdominal pain, nausea

Common: Diarrhea, vomiting

These symptoms usually resolve immediately upon reducing the dose or upon stopping the

treatment.

Hepatobiliary disorders

Uncommon: Abnormal liver function tests.

Not known: Fulminant hepatic failure (see WARNINGS AND PRECAUTIONS,

Hepatic/Biliary/Pancreatic).

Immune system disorders

Not known: Urticaria, angioedema, bronchospasm.

Metabolism and nutrition disorders

Common: Anorexia (usually resolves immediately upon reducing the dose or upon stopping the

Page 13 of 27

treatment).

Not known: hypoglycemia (see WARNINGS AND PRECAUTIONS, Endocrine and

Metabolism).

JAMP HYDROXYCHLOROQUINE SULFATE may exacerbate porphyria (see WARNINGS

AND PRECAUTIONS, General).

Musculoskeletal and connective tissue disorders

Uncommon: Sensori motor disorders.

Not known: Skeletal muscle palsies or skeletal muscle myopathy or neuromyopathy leading to

progressive weakness and atrophy of proximal muscle groups. Depression of tendon reflexes,

abnormal results of nerve conduction tests. Myopathy may be reversible after drug

discontinuation, but recovery may take many months (see WARNINGS AND PRECAUTIONS,

Musculoskeletal).

Nervous system disorders

Common: Headache

Uncommon: Dizziness

Not known: Convulsions. Extrapyramidal reactions such as: akathisia, dystonia, dyskinesia, gait

disturbance, tremor.

Psychiatric disorders

Common: Affect lability

Uncommon: Nervousness

Not known: Psychosis, suicidal behavior.

Skin and subcutaneous tissue disorders

Common: Skin rash, pruritus

Uncommon: Pigmentary changes in skin and mucous membranes, bleaching of hair, alopecia.

These usually resolve readily upon cessation of therapy.

Not known: Bullous eruptions (including urticarial, morbilliform, lichenoid, maculopapular,

purpuric, erythema annulare centrifugum), toxic epidermal necrolysis, erythema multiforme,

Stevens-Johnson syndrome, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS

syndrome), photosensitivity, exfoliative dermatitis, acute generalized exanthematous pustulosis

(AGEP) (see WARNINGS AND PRECAUTIONS, Skin).

Page 14 of 27

DOSAGE AND ADMINISTRATION

Dosing Considerations:

Absolute body weight used as a guide to dosage could result in an overdosage; daily doses

should not exceed 6.5 mg (salt form)/kg ideal (lean) body weight. Exceeding the recommended

daily dose sharply increase the risk of retinal toxicity as well as cardiac arrhythmias (see

WARNINGS AND PRECAUTIONS, Cardiovascular).

The dosages cited below are stated in terms of hydroxychloroquine sulfate. Each dose

should

be taken with a meal or a glass of milk.

Recommended Dose and Dosage Adjustment:

Rheumatoid Arthritis:

The compound is cumulative in action and will require several weeks to exert its beneficial

therapeutic effects, whereas minor side effects may occur somewhat early. Several months of

therapy may be required before maximum effects can be obtained. If objective improvement

(such as reduced joint swelling, increased mobility) does not occur within six months, the drug

should be stopped. Safe use of the drug in the treatment of juvenile rheumatoid arthritis has

been established.

Initial dosage – In adults, from 400 to 600 mg daily. In a few patients, the side effects may

require temporary reduction of the initial dosage. Generally, after five to ten days the dose may

be gradually increased to the optimum response level, frequently, without return of side

effects

Maintenance dosage – When a good response is obtained (usually in four to twelve weeks),

dosage is reduced by 50 percent and continued at an acceptable maintenance level of 200 to

400 mg daily. The incidence of retinopathy has been reported to be higher when the

maintenance dose is exceeded.

If a relapse occurs after medication is withdrawn, therapy may be resumed or continued on an

intermittent schedule if there are no ocular contraindications.

Use in Combination Therapy: JAMP HYDROXYCHLOROQUINE SULFATE may be used

safely and effectively in combination with corticosteroids, salicylates, NSAIDS, and

methotrexate

and other second line therapeutic agents. Corticosteroids and salicylates can

generally be

decreased gradually in dosage or eliminated after the drug has been used for several

weeks. When gradual reduction of steroid dosage is suggested, it may be done by reducing

every four to

five days, the dose of cortisone by no more than 5 to 15 mg; of hydrocortisone

from 5 to 10 mg; of prednisolone and prednisone from 1 to 2.5 mg; of methylprednisolone and

triamcinolone from

1 to 2 mg and dexamethasone from 0.25 to 0.5 mg. Regimens of treatment

using other agents than

steroids and NSAIDS are under development. No definitive dose

combinations have been established.

Lupus Erythematosus:

Initially, the average adult dose is 400 mg once or twice daily. This may be continued for several

weeks or months, depending upon the response of the patient. For prolonged maintenance

therapy,

a smaller dose, from 200 to 400 mg daily will suffice. The incidence of retinopathy has been

Page 15 of 27

reported to be higher when this maintenance dose is exceeded.

Malaria:

Suppression – In adults, 400 mg on exactly the same day of each week. In children (6 years of

age and older), the weekly suppressive dose is 5 mg base/kg, but should not exceed the adult

dose regardless of body weight.

Suppressive therapy should begin two weeks before exposure. When not administered before

exposure, give an initial loading dose of 800 mg to adults, or 10 mg base/kg to children in two

divided doses, six hours apart. The suppressive therapy should be continued for eight weeks after

leaving the endemic area.

Treatment of the acute attack – In adults, an initial loading dose of 800 mg followed by 400 mg in

six to eight hours. This is followed by 400 mg on each of the next two days for a total of 2 g of

hydroxychloroquine sulfate or 1.55 g base. Alternatively, the administration of a single dose of 800

mg has also proved effective. The dosage for adults may also be calculated by body weight.

For children (6 years of age and older) – dosage calculated by body weight is preferred. A total

dose representing 25 mg of base/kg is administered over three days as follows:

First dose: 10 mg base/kg (not to exceed 620 mg base)

Second dose: 5 mg base/kg 6 hours after the first dose (not to exceed 310 mg base)

Third dose: 5 mg base/kg 18 hours after the second dose

Fourth dose: 5 mg base/kg 24 hours after the third dose

For radical cure of vivax and malariae malaria - concomitant therapy with an 8-aminoquinoline

compound is necessary.

Dosing in Special Populations:

Patients with Hepatic Impairment:

JAMP HYDROXYCHLOROQUINE SULFATE should be used with caution in patients with

hepatic impairment; a reduction in dosage may be necessary (see WARNINGS AND

PRECAUTIONS, Hepatic/Biliary/Pancreatic).

Patients with Renal Impairment:

JAMP HYDROXYCHLOROQUINE SULFATE should be used with caution in patients with renal

impairment; a reduction in dosage may be necessary (see WARNINGS AND PRECAUTIONS,

Renal).

SYMPTOMS AND TREATMENT OF OVERDOSAGE

Overdosage with the 4-aminoquinolines is dangerous particularly in infants, as little as 1-2 grams

having proved fatal.

Page 16 of 27

Symptoms:

The 4-aminoquinoline compounds are very rapidly and completely absorbed following ingestion

and in accidental overdosage toxic symptoms may occur within 30 minutes. These consist of

headache, drowsiness, visual disturbances, cardiovascular collapse, hypokalemia and

convulsions, rhythm and conduction disorders, including QT interval prolongation, torsade de

pointes, ventricular tachycardia, ventricular fibrillation, width-increased QRS complex, PR

interval prolongation, bradyarrhythmias, nodal rhythm, atrioventricular block, followed by

sudden potentially fatal respiratory and cardiac arrest. Immediate medical attention is required,

as these effects may appear shortly after overdose. In the event of acute overdose, the patient

should be carefully observed (e.g., ECG monitoring) and given symptomatic and supportive

treatment. The ECG may reveal atrial standstill, nodal rhythm, prolonged intraventricular

conduction time, and progressive bradycardia leading to ventricular fibrillation and/or arrest.

Treatment:

Treatment is symptomatic and must be prompt with immediate evacuation of the stomach by

emesis (at home, before transportation to the hospital), or gastric lavage until the stomach is

completely emptied. If finely powdered activated charcoal is introduced by the stomach tube,

after lavage and within 30 minutes after ingestion of the tablets, it may inhibit further intestinal

absorption of the drug. To be effective, the dose of activated charcoal should be at least five times

the estimated dose of ingested hydroxychloroquine. Convulsions, if present, should be controlled

before attempting gastric lavage. If due to cerebral stimulation, cautious administration of an

ultrashort-acting barbiturate may be tried but, if due to anoxia, convulsions should be corrected

by oxygen administration, artificial respiration or, in shock with hypotension, by vasopressor

therapy. Because of the importance of supporting respiration, tracheal intubation or

tracheostomy, followed by gastric lavage, has also been advised. Exchange transfusions have

been used to reduce the level of 4-aminoquiolines in the blood.

Consideration should be given to administering diazepam parenterally since studies have

reported it beneficial in reversing chloroquine cardiotoxicity.

A patient who survives the acute phase and is asymptomatic should be closely observed for at

least 6 hours. Fluids may be forced, and sufficient ammonium chloride may be administered for

a few days to acidify the urine to help promote urinary excretion.

If serious toxic symptoms occur from overdosage or sensitivity, it has been suggested that

ammonium

chloride

(8 g

daily

in divided doses

adults)

three

four days a

week be

administered for several months after therapy has been stopped, as acidification of the urine

increases renal excretion of the 4-aminoquinoline compounds by 20 to 90 percent. However,

caution must be exercised in patients with impaired renal function and/or metabolic acidosis.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

STORAGE AND STABILITY

Store at room temperature (

15°C -30°C

Page 17 of 27

Keep in a safe place out of reach and sight of children.

AVAILABILITY OF DOSAGE FORMS

JAMP HYDROXYCHLOROQUINE SULFATE (hydroxychloroquine sulfate tablets) is

available

as: White to off white, capsule shaped, biconvex, film coated tablets containing

200 mg

hydroxychloroquine sulfate, imprinted with ‘LA52’ in black ink on one side and

plain on the

other side. Bottles of 100 and 500 tablets.

The non-medicinal ingredients are ammonium hydroxide, crospovidone, hypromellose, iron

oxide, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, shellac glaze

and titanium dioxide.

TOXICOLOGY

Only limited preclinical data are available for hydroxychloroquine, therefore chloroquine data

are considered due to the similarity of structure and pharmacological properties between the

2 products.

Genotoxicity

There are limited data on hydroxychloroquine genotoxicity.

Chloroquine is reported in the literature to be a weak genotoxic agent which may elicit both gene

mutations and chromosomal/DNA breaks. Mechanisms may involve DNA intercalation or

induction of oxidative stress. Positive and negative results were observed in in vitro reverse gene

mutation assays using bacteria (Ames test) and in in vivo studies using rodents (mouse bone

marrow cell

sister chromatid exchange, mouse bone marrow cell chromosome abnormality, and

rat DNA strand-breaks in multiple organs when animals were dosed by intraperitoneal route).

Carcinogenicity

There are no data on hydroxychloroquine carcinogenicity from animal studies and insufficient

data on carcinogenicity is available for chloroquine. Both drugs are not classifiable as to their

carcinogenicity to humans.

Reproductive and developmental toxicity

There are limited data on hydroxychloroquine teratogenicity.

Supratherapeutic doses of chloroquine resulted in a fetal mortality rate of 25% and ocular

malformations in 45% of fetuses. Autoradiographic studies have shown that when administered

at the start or the end of gestation, chloroquine accumulates in the eyes and ears.

There are no data on hydroxychloroquine action on fertility.

A study in male rats after 30 days of oral treatment at 5 mg/day of chloroquine showed a

decrease in testosterone levels, weight of testes, epididymis, seminal vesicles and prostate, and

caused production of abnormal sperm.The fertility rate was also decreased in another rat study

after 14 days of intraperitoneal treatment at 10 mg/kg/day.

Page 18 of 27

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

PATIENT MEDICATION INFORMATION

JAMP HYDROXYCHLOROQUINE SULFATE

Hydroxychloroquine Sulfate Tablets, USP

Read this carefully before you start taking JAMP HYDROXYCHLOROQUINE SULFATE and

each time you get a refill. This leaflet is a summary and will not tell you everything about this drug.

Talk to your healthcare professional about your medical condition and treatment and ask if there is

any new information about JAMP HYDROXYCHLOROQUINE SULFATE.

What is JAMP HYDROXYCHLOROQUINE SULFATE used for?

JAMP HYDROXYCHLOROQUINE SULFATE is used to:

Treat Rheumatoid Arthritis (RA): a disease marked by stiffness, swelling and pain in your

joints.

Treat Systemic Lupus Erythematosus (SLE): a disease where your immune system attacks

healthy parts of your body by mistake. It can affect your skin, joints, kidneys, brain, and

other organs.

Treat Discoid Lupus Erythematosus (DLE): a disease similar to SLE. DLE only affects

your skin with red rash or scaly patches.

Prevent and treat certain forms of Malaria: an infection caused by parasites in your red

blood cells. Symptoms can include high fever, shaking, chills, and extreme sweating.

You can only get JAMP HYDROXYCHLOROQUINE SULFATE with a doctor’s prescription.

How does JAMP HYDROXYCHLOROQUINE SULFATE work?

It is not known how JAMP HYDROXYCHLOROQUINE SULFATE works in the body to treat RA,

SLE, and DLE. JAMP HYDROXYCHLOROQUINE SULFATE may take up to six months to take

effect. For malaria, JAMP HYDROXYCHLOROQUINE SULFATE works by killing the parasite

that causes the infection.

What are the ingredients in JAMP HYDROXYCHLOROQUINE SULFATE?

Medicinal ingredient:

hydroxychloroquine sulfate.

Non-medicinal ingredients: ammonium hydroxide, crospovidone, hypromellose, iron oxide,

lactose

monohydrate, magnesium stearate, polyethylene glycol, polysorbate, shellac glaze and titanium

dioxide.

JAMP HYDROXYCHLOROQUINE SULFATE comes in the following dosage form:

Tablets, 200 mg.

Do not use JAMP HYDROXYCHLOROQUINE SULFATE if:

you are allergic to

o hydroxychloroquine sulfate

o any of the other ingredients of JAMP HYDROXYCHLOROQUINE SULFATE

o any similar drugs such as chloroquine

Page 19 of 27

you have retinopathy. This is an eye problem affecting the retina at the back of your eye.

JAMP HYDROXYCHLOROQUINE SULFATE may cause irreversible damage to your

retina. You should tell your doctor right away if you have any Visual Problems.

you are a child below 6 years of age or weigh less than 35 kg.

To help avoid side effects and ensure proper use, talk to your healthcare professional before

you take JAMP HYDROXYCHLOROQUINE SULFATE. Talk about any health conditions or

problems you may have, including if you:

were born with, now have, or have a family history of long QT interval. JAMP

HYDROXYCHLOROQUINE SULFATE may cause Heart Rhythm Disorders in some

patients. These Heart Rhythm Disorders can be seen on an ECG, or an electrical

recording of the heart. Caution should be taken when taking JAMP

HYDROXYCHLOROQUINE SULFATE if you:

have heart disease, which can include heart failure, slow heartbeat, heart

palpitations or irregular heartbeat. The risk of heart problems may increase with

higher doses of JAMP HYDROXYCHLOROQUINE SULFATE.

have had a heart attack (myocardial infarction)

have a family history of sudden death from heart attack before the age of 50

take other drugs that can cause prolonged QT interval

have a low level of potassium, calcium or magnesium in your blood, or have a condition

that may affect the levels of those salts in the blood. Examples are an eating disorder or

prolonged vomiting.

are allergic or sensitive to a drug called to quinine.

are pregnant, or you are planning to get pregnant. JAMP HYDROXYCHLOROQUINE

SULFATE may be passed to your unborn baby. JAMP HYDROXYCHLOROQUINE

SULFATE may harm your unborn baby. Your doctor will evaluate the benefit and risk

of using JAMP HYDROXYCHLOROQUINE SULFATE during pregnancy.

are breastfeeding. JAMP HYDROXYCHLOROQUINE SULFATE passes into breast

milk in small amounts. Infants can be very sensitive to the toxic effects of drugs like

JAMP HYDROXYCHLOROQUINE SULFATE. There is not enough JAMP

HYDROXYCHLOROQUINE SULFATE in breast milk to protect an infant against

malaria. The infant should receive their own malaria treatment if necessary. Talk to your

doctor about the risks JAMP HYDROXYCHLOROQUINE SULFATE can have on your

baby. These risks depend on:

why you are taking

JAMP HYDROXYCHLOROQUINE SULFATE

how long you will be taking

JAMP HYDROXYCHLOROQUINE SULFATE

for.

have diabetes or symptoms of low blood sugar. JAMP HYDROXYCHLOROQUINE

SULFATE can cause low blood sugar, and sometimes, low blood sugar can be very

dangerous. You may pass out or need to go to the hospital.

Page 20 of 27

have liver or kidney disease.

have alcoholism.

have a blood disease, including a rare blood disease called porphyria. JAMP

HYDROXYCHLOROQUINE SULFATE can make this worse.

have nervous system disease.

have a skin disease called psoriasis.

have a genetic red blood cell disease known as “glucose-6-phosphate dehydrogenase

deficiency”.

have gastrointestinal disorders. These are problems in the intestines, stomach, or gut.

have decreased vision.

have weakness in your muscles.

have thoughts of suicide or depression.

are over 65 years old.

Other warnings you should know about:

JAMP HYDROXYCHLOROQUINE SULFATE

can cause long QT interval or torsade de pointes.

This is a dangerously fast heart rate. It can lead to cardiac arrest, sudden collapse and death.

Heart problems or failure, cardiomyopathy, an enlarged or weak heart can occur if you take

JAMP HYDROXYCHLOROQUINE SULFATE for long periods of time. These are serious and can

result in death. Your doctor will check your heart regularly.

When you go outside, protect your skin from the sun by:

- wearing appropriate clothing, and

- using sunscreen cream with a minimum SPF 30 rating.

It is unclear whether JAMP HYDROXYCHLOROQUINE SULFATE may affect male fertility. Talk

to your doctor if you would like to father a child in the future.

Driving and Using Machines: You may have blurry vision when taking

JAMP

HYDROXYCHLOROQUINE SULFATE

. Do not drive or do things that require you to be alert. Wait

until you know how you respond to

JAMP HYDROXYCHLOROQUINE SULFATE

and can see well.

If you continue to have difficulty, your doctor may reduce your dose.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins,

minerals, natural supplements or alternative medicines.

The following may interact with JAMP HYDROXYCHLOROQUINE SULFATE:

Drugs for depression (tricyclic antidepressants) and psychiatric disorders

(antipsychotics).

Page 21 of 27

Digoxin. If you are taking both JAMP HYDROXYCHLOROQUINE SULFATE and

digoxin, your doctor may decide to check the level of digoxin in your blood, as the dose

may need to be reduced.

Anti-diabetic drugs, including insulin. If you take JAMP HYDROXYCHLOROQUINE

SULFATE and a drug for diabetes or high blood sugar, there is a risk of having very low

blood sugar. This can be life-threatening. Your doctor may decide to reduce the doses of the

drug or insulin to control diabetes.

Antiepileptic drugs

Some antibiotics used for infections (e.g. aminoglycoside antibiotics, erythromycin)

Neostigmine and pyridostigmine (medicines used to treat muscle disorders)

Cimetidine (medicine used to treat heartburn)

Cyclosporine (an immunosuppressant medication)

Drugs known as CYP2C8 and CYP3A4 inhibitors (e.g. ketoconazole, itraconazole,

erythromycin, aprepitant, fluconazole, clopidogrel, teriflunomide, letermovir).

Medicines that are known to cause cardiac arrhythmias (irregular heartbeats).

Antacids. You should take antacids at least 4 hours before or 4 hours after taking JAMP

HYDROXYCHLOROQUINE SULFATE

Rabies vaccine

Medicines that may affect the liver, the kidney, the skin or the eye

Medicines that may increase the risk of convulsions (e.g. antimalarials (mefloquine)).

Medicines that decrease blood salt levels (e.g. water pills, laxatives, amphotericin B, high

dose corticosteroids, and proton pump inhibitors).

Agalsidase (a medicine used to treat a rare genetic disease called Fabry disease)

Medicines that may increase risk of retinal toxicity. An example is tamoxifen, which is used

to treat breast cancer. When taken alone, both JAMP HYDROXYCHLOROQUINE

SULFATE and tamoxifen can cause damage to your retina at in the eye. Taking both drugs

at the same time can increase your risk of retinal damage.

Praziquantel (a medicine used to treat some infestations).

Do NOT eat grapefruit or drink grapefruit juice while taking

JAMP HYDROXYCHLOROQUINE

SULFATE.

JAMP HYDROXYCHLOROQUINE SULFATE has been used safely with

salicylates (aspirin),

non-steroidal anti- inflammatory medications, methotrexate and

corticosteroids.

How to take JAMP HYDROXYCHLOROQUINE SULFATE:

Take JAMP HYDROXYCHLOROQUINE SULFATE exactly as your doctor told you to. Never

take more JAMP HYDROXYCHLOROQUINE SULFATE than your doctor has prescribed.

To help avoid an upset stomach, take JAMP HYDROXYCHLOROQUINE SULFATE with a meal

Page 22 of 27

or a glass of milk.

Usual dose:

Your doctor will decide on the best dose for you. It may be based on your weight, physical

health and other factors such as what other medications you are taking. The dose may need to be

stopped or temporarily reduced due to side effects. The dose may then be re-started or increased

to an optimum level by your doctor. Your dose will likely be lowered during treatment, after

your Initial Dose. You may take the lower dose for a lengthy amount of time. This is called a

Maintenance Dose.

Condition

Recommended dose

Number of

tablets a

day

Rheumatoid

Arthritis

Initial:

400 – 600 mg a day

200 - 400 mg a day

2 – 3

1 - 2

Maintenance:

Lupus

Erythematosus

Initial:

400 mg, once or twice a

2 - 4

Maintenance:

200 – 400 mg a day

1 - 2

Malaria (adults)

Prevention:

400 mg a week, on the

same day of each week,

starting 2 weeks before

exposure.

Treatment:

800 mg initially,

followed by 400 mg 6-8

hours later, and then 400

mg daily for the next two

days.

Malaria

(children)

Your dose will be calculated by your

doctor based on each child’s body

weight.

Should you have a serious change of health at any point while taking JAMP

HYDROXYCHLOROQUINE SULFATE, see your doctor.

For patients with RA, SLE or DLE, if JAMP HYDROXYCHLOROQUINE SULFATE makes your

symptoms completely better, talk to your doctor. They may want to bring down your daily dose.

Never change your dose without

talking with your doctor first.

Overdose:

If you think you have taken too much JAMP HYDROXYCHLOROQUINE SULFATE, contact

your healthcare professional, hospital emergency department or regional poison control centre

immediately, even if there are no symptoms.

Taking too much JAMP HYDROXYCHLOROQUINE SULFATE is dangerous and can lead to

death. You could have symptoms of overdose within 30 minutes after taking it.

Taking too much JAMP HYDROXYCHLOROQUINE SULFATE is also dangerous for

Page 23 of 27

children. Children have died by taking too

much hydroxychloroquine sulfate. If you think an

infant or small child has swallowed even one pill, immediately take them to the nearest hospital

emergency room or dial “911" on your telephone.

Symptoms of overdose include:.

- headache

- feeling drowsy

- vision problems, like seeing blurry or in double

- heart problems like uneven heartbeats or rapid heartbeats

- fainting

- muscle weakness

- convulsions

- serious trouble breathing

Missed Dose:

If you forget to take a dose, take it as soon as you remember. But if it’s within twelve hours of

your next dose, skip the one you missed and take only the regularly scheduled dose. Never take

a

double dose.

What are possible side effects from using JAMP HYDROXYCHLOROQUINE SULFATE

These are not all the possible side effects you may feel when taking JAMP

HYDROXYCHLOROQUINE SULFATE. If you experience

any side effects not listed here, contact

your healthcare professional.

Before and during your treatment with JAMP HYDROXYCHLOROQUINE SULFATE your

doctor may do some tests. These may include:

- blood tests

- an electrocardiogram (ECG)

- a periodic exam of your muscles and tendon reflexes

- complete eye exams

JAMP HYDROXYCHLOROQUINE SULFATE can cause permanent eye damage. To help

prevent this, you should have an eye exam

before you start taking JAMP

HYDROXYCHLOROQUINE SULFATE. You will need more eye exams while you are taking

JAMP HYDROXYCHLOROQUINE SULFATE.

Serious side effects and what to do about them

Symptom / effect

Talk to your healthcare

professional

Stop taking

drug and get

immediate

medical help

Only if

severe

In all cases

VERY COMMON

Nausea, stomach pain, stomach cramps

COMMON

Page 24 of 27

Serious side effects and what to do about them

Symptom / effect

Talk to your healthcare

professional

Stop taking

drug and get

immediate

medical help

Only if

severe

In all cases

Diarrhea

Vomiting

Anorexia: loss or lack of appetite

Visual problems and damage to the

retina of the eye: blurred vision, seeing

halos around lights, especially at night.

Seeing light flashes and streaks. Night

blindness with difficulty seeing at night or

in poor light. Visual field loss including

blind spots or blind areas in your vision.

Change in eye colour. Difficulty focusing

your eyes, or skipping words when

reading.

Headache

Rash, itchy rash with raised red bumps

Nervousness, quick changes in mood

(emotional lability)

RARE

Dizziness or vertigo: feel as if you or the

objects around you are moving when they

are not.

Change in colour of skin, mucous

membranes and hair: bleaching of

hair. Loss or increase in skin pigment

(bluish-black colour)

Alopecia: hair loss from your head

or any part of your body.

Hearing problems: Ringing in the ears.

Hearing loss.

Page 25 of 27

Serious side effects and what to do about them

Symptom / effect

Talk to your healthcare

professional

Stop taking drug

and get

immediate

medical help

Only if

severe

In all cases

Nerve and muscle problems: tingling,

numbness, burning pain, weakness,

cramps, spasms, restlessness, rigidity,

tremors, twitches, difficulty walking

UNKNOWN FREQUENCY

Allergic reaction or angioedema

rash,

hives, swelling of the face, lops, tongue or

throat, difficulty swallowing or breathing

Heart rhythm disorders including long

QT interval, torsade de pointes and

heart block: abnormal heartbeat, life-

threatening irregular heartbeat,

palpitations

Severe, life-threatening skin problems

including Toxic Epidermal Necrolysis,

Erythema Multiforme, Stevens-

Johnson syndrome, Drug Rash with

Eosinophilia and Systemic Symptoms

(DRESS syndrome): rash, red skin, red

or purple skin patches possibly with

blister or crust in the center. Pus filled

rash. Peeling skin, blisters on lips, eyes,

skin or in the mouth. Itching or burning.

Flu-like fever.

Severe breathing problems including

bronchospasm, angioedema: sudden

shortness of breath

Increased sensitivity to sunlight. Skin rash

due to sunlight can be reduced by

appropriate use of sunscreen creams

Muscle weakness

Permanent damage to vision

Fainting spells or loss of consciousness

Page 26 of 27

Serious side effects and what to do about them

Symptom / effect

Talk to your

healthcare

professional

Stop taking

drug and

immediate

medical

help

Only if

severe

In all cases

Heart problems or heart failure,

cardiomyopathy, an enlarged or weak

heart: shortness of breath with exercise or

even at rest. Swelling of the legs, ankles

and feet. Irregular heartbeats that feel

rapid or pounding. Chest pain, sudden

fainting or feeling tired, light-headed and

dizzy, You can have a seizure or fit.

Liver problems: unusual tiredness,

nausea, vomiting, abdominal pain, or

jaundice (yellow discoloration of the eyes

or skin),dark urine

Bone Marrow Depression or a decrease

in production of cells:

Low White Blood cells (leukocytes):

Fever and chills. Infections.

Anemia or low red blood cells

(erythrocytes): Fatigue, extreme tiredness

that doesn't get better with rest. Paleness

of skin, lips, and nail beds.

Low platelets used for blood clotting

(thrombocytes): Bleeding: nose bleeds,

gums, or mouth. Tiny red spots on the

skin

Convulsions, seizures or fits

Psychosis: hallucinations, loss of contact

with reality

Suicidal thoughts or actions

Hypoglycemia or low blood sugar : hunger

pains, sweating, shakiness, weakness,

dizziness, fast heartbeat, nausea, irritability,

blurred vision, confusion, loss of

consciousness

Muscle, nerve and tendon problems:

Long-lasting involuntary muscle contraction,

impairment of voluntary movements, tremor.

Decreased reflexes or feeling by nerves.

Page 27 of 27

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to

interfere with your daily activities, talk to your healthcare professional.

Storage:

Keep out of reach and sight of infants and small children.

Store at room temperature (15

C - 30

Do not use JAMP HYDROXYCHLOROQUINE SULFATE after the expiry date.

If you want more information about JAMP HYDROXYCHLOROQUINE SULFATE:

Talk to your healthcare professional

Find the full Product Monograph that is prepared for healthcare professionals and

includes this Patient Medication Information by visiting the Health Canada

website

(https://health-products.canada.ca/dpd-bdpp/index-eng.jsp

); the manufacturer’s

website (www.jamppharma.com), or by calling Jamp Pharma

Corporation, at 1-866-

399-9091.

This leaflet was prepared by

Jamp Pharma Corporation.

1310 rue Nobel

Boucherville, Québec

J4B 5H3

Date Revised: February 07, 2020

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health

Canada by:

Visiting

page

Adverse

Reaction

Reporting

(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-

canada/adverse-reaction-reporting.html) for

information on how to report online, by

mail or by fax; or

Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage

your side effects. The Canada Vigilance Program does not provide medical advice.

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