Product Index

For the use of a Registered Medical Practitioner only

Qualitative and Quantitative Composition

IMULAST Tablets 200 mg

Each film-coated tablet contains:

Hydroxychloroquine Sulfate IP….. 200 mg

Excipients:………………………….q.s.

Colour: Titanium Dioxide IP

IMULAST Tablets 400 mg

Each film-coated tablet contains:

Hydroxychloroquine Sulfate IP….. 400 mg

Excipients:………………………….q.s.

Colour: Titanium Dioxide IP

Dosage Form(S) And Strength(S)

Film-coated tablets 200 mg/400 mg

Clinical Particulars

Therapeutic Indications

IMULAST Tablets are indicated for the treatment of systemic lupus erythematosus and rheumatoid arthritis in adults.

Posology and Method of Administration

Do not crush or divide IMULAST Tablets. Take IMULAST Tablets with a meal or a glass of milk.

Systemic Lupus Erythematosus: The recommended adult dosage is 200 to 400 mg daily, administered as a single daily dose or in two divided doses. Doses above 400 mg a day are not recommended. The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded.

Rheumatoid Arthritis: The action of hydroxychloroquine is cumulative and may require weeks to months to achieve the maximum therapeutic effect.

• Initial Adult Dosage: 400 mg to 600 mg daily, administered as a single daily dose or in two divided doses. In a small percentage of patients, side effects may require temporary reduction of the initial dosage.
• Maintenance Adult Dosage: When a good response is obtained, the dosage may be reduced by 50% and continued at a maintenance level of 200 mg to 400 mg daily, administered as a single daily dose or in two divided doses.
• Do not exceed 600 mg or 6.5 mg/kg per day, whichever is lower, as the incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded.

Corticosteroids and salicylates may be used in conjunction with IMULAST Tablets and they can, generally, be decreased gradually in dosage or eliminated after a maintenance dose of IMULAST Tablets has been achieved.

Contraindications

Use of IMULAST Tablets is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds, pre-existing maculopathy of the eye, and pregnancy.

Special Warnings and Precautions for Use

Ocular: Irreversible retinal damage has been observed in some patients who had received hydroxychloroquine sulfate. Significant risk factors for retinal damage include daily doses of hydroxychloroquine sulfate greater than 6.5 mg/kg (5 mg/kg base) of actual body weight, durations of use greater than five years, subnormal glomerular filtration, use of some concomitant drug products such as tamoxifen citrate and concurrent macular disease.

A baseline ocular examination is recommended within the first year of starting IMULAST Tablets. The baseline exam should include: best corrected distance visual acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees (with retesting if an abnormality is noted), and spectral domain ocular coherence tomography (SD-OCT).

For individuals with significant risk factors (daily dose of hydroxychloroquine sulfate greater than 5.0 mg/kg base of actual body weight, subnormal glomerular filtration, use of tamoxifen citrate or concurrent macular disease) monitoring should include annual examinations, which include BCVA, VF and SD-OCT. For individuals without significant risk factors, annual exams can usually be deferred until 5 years of treatment.

In individuals of Asian descent, retinal toxicity may first be noticed outside the macula. In patients of Asian descent, it is recommended that visual field testing be performed in the central 24 degrees instead of the central 10 degrees.

It is recommended that hydroxychloroquine be discontinued if ocular toxicity is suspected and the patient should be closely observed given that retinal changes (and visual disturbances) may progress even after cessation of therapy.

Cardiac Effects, including Cardiomyopathy and QT prolongation: Postmarketing cases of life-threatening and fatal cardiomyopathy have been reported with use of hydroxychloroquine sulfate as well as with use of chloroquine. Patients may present with atrioventricular block, pulmonary hypertension, sick sinus syndrome or with cardiac complications. ECG findings may include atrioventricular, right or left bundle branch block. Signs or symptoms of cardiac compromise have appeared during acute and chronic treatment. Clinical monitoring for signs and symptoms of cardiomyopathy is advised, including use of appropriate diagnostic tools such as ECG to monitor patients for cardiomyopathy during IMULAST Tablets therapy. Chronic toxicity should be considered when conduction disorders (bundle branch block/atrio-ventricular heart block) or biventricular hypertrophy are diagnosed. If cardiotoxicity is suspected, prompt discontinuation of IMULAST Tablets may prevent life-threatening complications.

Hydroxychloroquine sulfate prolong the QT interval. Ventricular arrhythmias and torsades de pointes have been reported in patients taking hydroxychloroquine sulfate (see Overdose). Therefore, IMULAST Tablets should not be administered with other drugs that have the potential to prolong the QT interval (see Drug interactions).

Worsening of Psoriasis and Porphyria: Use of IMULAST Tablets in patients with psoriasis may precipitate a severe attack of psoriasis. When used in patients with porphyria the condition may be exacerbated. The preparation should not be used in these conditions unless in the judgment of the physician the benefit to the patient outweighs the possible hazard.

Proximal Myopathy and Neuropathy: Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes and abnormal nerve conduction has been reported. Muscle and nerve biopsies have been associated with curvilinear bodies and muscle fiber atrophy with vacuolar changes. Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy with IMULAST Tablets.

Neuropsychiatric Events, Including Suicidality: Suicidal behavior has been rarely reported in patients treated with hydroxychloroquine sulfate.

Hypoglycemia: Hydroxychloroquine sulfate has been shown to cause severe hypoglycemia including loss of consciousness that could be life threatening in patients treated with or without antidiabetic medications (see Drug Interactions and Undesirable Effects). Patients treated with IMULAST Tablets 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 IMULAST Tablets should have their blood glucose checked and treatment reviewed as necessary.

General: Use with caution in patients with gastrointestinal, neurological or blood disorders, and in those with a sensitivity to quinine.

IMULAST Tablets should be administered with caution in patients having glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Small children are particularly sensitive to the toxic effects of 4-aminoquinolines; therefore patients should be warned to keep hydroxychloroquine sulfate out of the reach of children.

Hematologic Effects/Laboratory Tests: Hydroxychloroquine sulfate should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs. Periodic blood cell counts should be performed if patients are given prolonged therapy. If any severe blood disorder such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia appears, which is not attributable to the disease under treatment, consider discontinuation of IMULAST Tablets.

Dermatologic Effects: Dermatologic reactions to IMULAST Tablets may occur and, therefore, proper care should be exercised when it is administered to any patient receiving a drug with a significant tendency to produce dermatitis.

Drug Interactions

Digoxin: Concomitant IMULAST Tablets and digoxin therapy may result in increased serum digoxin levels: serum digoxin levels should be closely monitored in patients receiving combined therapy.

Insulin or Antidiabetic Drugs: As IMULAST Tablets may enhance the effects of a hypoglycemic treatment, a decrease in doses of insulin or antidiabetic drugs may be required.

Drugs That Prolong QT Interval and Other Arrhythmogenic Drugs: IMULAST Tablets prolongs the QT interval and should not be administered with other drugs that have the potential to induce cardiac arrhythmias. Also, there may be an increased risk of inducing ventricular arrhythmias if IMULAST Tablets are used concomitantly with other arrhythmogenic drugs. Halofantrine prolongs the QT interval and should not be administered with other drugs that have the potential to induce cardiac arrhythmias, including hydroxychloroquine. Also, there may be an increased risk of inducing ventricular arrhythmias if hydroxychloroquine is used concomitantly with other arrhythmogenic drugs, such as amiodarone and moxifloxacin.

Hydroxychloroquine sulfate may also be subject to several of the known interactions of chloroquine even though specific reports have not appeared. These include the following: potentiation of its direct blocking action at the neuromuscular junction by aminoglycoside antibiotics; inhibition of its metabolism by cimetidine, which may increase plasma concentration of the antimalarial; antagonism of effect of neostigmine and pyridostigmine; and, reduction of the antibody response to primary immunisation with intradermal human diploid-cell rabies vaccine.

Mefloquine and Other Drugs Known to Lower the Convulsive Threshold: IMULAST Tablets can lower the convulsive threshold. Co-administration of IMULAST Tablets with other antimalarials known to lower the convulsion threshold (e.g., mefloquine) may increase the risk of convulsions.

Antiepileptics: The activity of antiepileptic drugs might be impaired if co-administered with IMULAST Tablets.

Methotrexate: Combined use of methotrexate with IMULAST Tablets has not been studied and may increase the incidence of adverse effects.

Cyclosporin: An increased plasma cyclosporin level was reported when cyclosporin and hydroxychloroquine sulfate were co-administered.

The following interactions have been observed on treatment with the structurally related substance chloroquine phosphate and, therefore, cannot be ruled out for hydroxychloroquine.

Praziquantel: Chloroquine has been reported to reduce the bioavailability of praziquantel.

Antacids and Kaolin: Antacids and kaolin can reduce absorption of chloroquine; an interval of at least 4 hours between intake of these agents and chloroquine should be observed.

Ampicillin: In a study of healthy volunteers, chloroquine significantly reduced the bioavailability of ampicillin.

Cimetidine: Cimetidine can inhibit the metabolism of chloroquine, increasing its plasma level. Concomitant use of cimetidine should be avoided.

There is a theoretical risk of inhibition of intra-cellular α-galactosidase activity when hydroxychloroquine is co-administered with agalsidase.

Use in Special Populations

Patients with Hepatic/Renal Impairment: Hydroxychloroquine sulfate should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs. A reduction in dosage may be necessary in patients with hepatic or renal disease, as well as in those taking medicines known to affect these organs.

Pregnant Women Hydroxychloroquine crosses the placenta. Data are limited regarding the use of hydroxychloroquine during pregnancy. It should be noted that 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. Therefore hydroxychloroquine sulfate should not be used in pregnancy.

Lactating Women

Caution should be exercised when administering IMULAST Tablets to nursing mothers. It has been demonstrated that hydroxychloroquine administered to nursing mothers is excreted in human milk and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinolines.

Pediatric Patients

Safety and efficacy have not been established in the use of IMULAST Tablets in pediatric patients.

Geriatric Patients

Clinical studies of hydroxychloroquine sulfate did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. However, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.

Effects on Ability to Drive and Use Machines

Impaired visual accommodation soon after the start of treatment has been reported and patients should be warned regarding driving or operating machinery. If the condition is not self-limiting, it will resolve on reducing the dose or stopping treatment.

Undesirable Effects

The following adverse reactions have been identified during post-approval use of IMULAST Tablets or other 4-aminoqunoline compounds. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Blood and Lymphatic System Disorders: Bone marrow failure, anemia, aplastic anemia, agranulocytosis, leukopenia, and thrombocytopenia. Hemolysis reported in individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
• Cardiac Disorders: Cardiomyopathy, which may result in cardiac failure and, in some cases, a fatal outcome (see Special Warnings and Precautions for Use and Overdose). IMULAST Tablets prolongs the QT interval. Ventricular arrhythmias and torsades de pointes have been reported in patients taking IMULAST (see Overdose and Drug Interactions).
• Ear and Labyrinth Disorders: Vertigo, tinnitus, nystagmus, nerve deafness, deafness.
• Eye Disorders: Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance), visual field defects (paracentral scotomas) and visual disturbances (visual acuity), maculopathies (macular degeneration), decreased dark adaptation, color vision abnormalities, corneal changes (edema and opacities), including corneal deposition of drug with or without accompanying symptoms (halo around lights, photophobia, blurred vision).
• Gastrointestinal Disorders: Nausea, vomiting, diarrhea, and abdominal pain.
• General Disorders and Administration Site Conditions: Fatigue.
• Hepatobiliary Disorders: Liver function tests abnormal, hepatic failure acute.
• Immune System Disorders: Urticaria, angioedema, bronchospasm.
• Metabolism and Nutrition Disorders: Decreased appetite, hypoglycemia, porphyria, weight decreased.
• Musculoskeletal and Connective Tissue Disorders: Sensorimotor disorder, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction.
• Nervous System Disorders: Headache, dizziness, seizure, ataxia and extrapyramidal disorders such as dystonia, dyskinesia, and tremor have been reported with this class of drugs.
• Psychiatric Disorders: Affect/emotional lability, nervousness, irritability, nightmares, psychosis, suicidal behavior.
• Skin and Subcutaneous Tissue Disorders: Rash, pruritus, pigmentation disorders in skin and mucous membranes, hair color changes, alopecia. Dermatitis bullous eruptions including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity, dermatitis exfoliative, acute generalized exanthematous pustulosis (AGEP). AGEP has to be distinguished from psoriasis, although IMULAST Tablets may precipitate attacks of psoriasis. It may be associated with pyrexia and hyperleukocytosis.

If you experience any side effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the National Pharmacovigilance Programme of India by calling on 1800 267 7779 (Cipla number) from within India and on +91 821-6643551 from outside India (except the USA and EU).

Overdose

The 4-aminoquinoline compounds are very rapidly and completely absorbed after ingestion, and in accidental overdosage, or rarely with lower doses in hypersensitive patients, toxic symptoms may occur within 30 minutes. The symptoms of overdosage may include headache, drowsiness, visual disturbances, cardiovascular collapse, convulsions, hypokalemia, rhythm and conduction disorders (including QT prolongation, torsades de pointes, ventricular tachycardia and ventricular fibrillation, followed by sudden potentially fatal respiratory and cardiac arrest).

Treatment is symptomatic and must be prompt. Immediate gastric lavage until the stomach is completely emptied is indicated. After lavage, activated charcoal is introduced by the stomach tube within 30 minutes of ingestion of the drug may inhibit further intestinal absorption. To be effective, the dose of activated charcoal should be at least five times the estimated dose of hydroxychloroquine ingested.

Consideration should be given to administering diazepam parenterally since studies suggest that it may be beneficial in reversing chloroquine and hydroxychloroquine cardiotoxicity.

Respiratory support and shock management should be instituted as necessary.

Exchange transfusions are used to reduce the level of 4-aminoquinoline drug in the blood.

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 (8 g daily in divided doses for adults) may be administered for a few days to acidify the urine. This will promote urinary excretion in cases of both overdosage and sensitivity. However, caution must be exercised in patients with impaired renal function and/or metabolic acidosis.

Pharmacological Properties

Mechanism of Action

The mechanisms underlying the anti-inflammatory and immunomodulatory effects of IMULAST Tablets are unknown.

Pharmacodynamic Properties

Antimalarial agents such as chloroquine and hydroxychloroquine have several pharmacological actions that may be involved in their therapeutic effect in the treatment of rheumatic disease, but the role of each is not known. These include interaction with sulphydryl groups, interference with enzyme activity (including phospholipase, NADH—cytochrome C reductase, cholinesterase, proteases and hydrolases), DNA-binding, stabilisation of lysosomal membranes, inhibition of prostaglandin formation, inhibition of polymorphonuclear cell chemotaxis and phagocytosis, possible interference with interleukin 1 production from monocytes, and inhibition of neutrophil superoxide release.

Pharmacokinetic Properties

Following a single 200 mg oral dose of IMULAST Tablets to healthy males, the mean peak blood concentration of hydroxychloroquine was 129.6 ng/mL, reached in 3.26 hours with a half-life of 537 hours (22.4 days). In the same study, the plasma peak concentration was 50.3 ng/mL reached in 3.74 hours with a half-life of 2,963 hours (123.5 days). Urine hydroxychloroquine levels were still detectable after 3 months with approximately 10% of the dose excreted as the parent drug. Results following a single dose of a 200 mg tablet versus intravenous infusion (155 mg), demonstrated a half-life of about 40 days and a large volume of distribution. Peak blood concentrations of metabolites were observed at the same time as peak levels of hydroxychloroquine. The mean fraction of the dose absorbed was 0.74. After administration of single 155 mg and 310 mg intravenous doses, peak blood concentrations ranged from 1161 ng/mL to 2,436 ng/mL (mean 1918 ng/mL) following the 155 mg infusion and 6 months following the 310 mg infusion. Pharmacokinetic parameters were not significantly different over the therapeutic dose range of 155 mg and 310 mg, indicating linear kinetics.

Following chronic oral administration of hydroxychloroquine, significant levels of three metabolites, desethylhydroxychloroquine (DHCQ), desethylchloroquine (DCQ), and bidesethylhydroxychloroquine (BDCQ) have been found in plasma and blood, with DHCQ being the major metabolite. The absorption half-life was approximately 3 to 4 hours and the terminal half-life ranged from 40 to 50 days. The long half-life can be attributed to extensive tissue uptake rather than through decreased excretion. Peak plasma levels of hydroxychloroquine were seen in about 3 to 4 hours. Renal clearance in rheumatoid arthritis patients taking IMULAST Tablets for at least six months seemed to be similar to that of the single dose studies in volunteers, suggesting that no change occurs with chronic dosing. Range for renal clearance of unchanged drug was approximately 16 to 30% and did not correlate with creatinine clearance; therefore, a dosage adjustment is not required for patients with renal impairment. In rheumatoid arthritis patients, there was large variability as to the fraction of the dose absorbed (i.e., 30 to 100%), and mean hydroxychloroquine levels were significantly higher in patients with less disease activity. Cellular levels of patients on daily hydroxychloroquine have been shown to be higher in mononuclear cells than polymorphonuclear leucocytes.

Non-Clinical Properties

Animal Toxicology or Pharmacology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of IMULAST Tablets.

The mutagenic potential of hydroxychloroquine was not evaluated. However, chloroquine has been shown to be a catalytic inhibitor of DNA repair enzymes (topoisomerase II) and to produce weak genotoxic effects through this mode of action.

Description

IMULAST Tablets (hydroxychloroquine sulfate) is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. The chemical name for hydroxychloroquine sulfate is 2-pentyl] ethylamino]ethanol sulfate (1:1). Its structural formula is as below:

The molecular weight of hydroxychloroquine sulfate is 433.95, and molecular formula is C₁₈H₂₆ClN₃O.H₂SO₄.

IMULAST Tablets 200 mg/400 mg (hydroxychloroquine sulfate) tablets contain 200 mg and 400 mg hydroxychloroquine sulfate, respectively, and are for oral administration.

Pharmaceutical Particulars

Incompatibilities

No incompatibilities are known.

Shelf-Life

As on the pack.

Packaging Information

IMULAST Tablets 200 mg/400 mg are available in blister packs of 10 tablets each.

Storage and Handling Instructions

Store at a temperature not exceeding 30°C. Protect from light and moisture.

Patient Counselling Information

Read this whole section carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this section:

1. What Hydroxychloroquine Sulfate Tablets is and what it is used for
2. What you need to know before you take Hydroxychloroquine Sulfate Tablets
3. How to take Hydroxychloroquine Sulfate Tablets
4. Possible side effects
5. How to store Hydroxychloroquine Sulfate Tablets
6. Contents of the pack and other information

1. What Hydroxychloroquine Sulphate Tablets is and what it used for?

Hydroxychloroquine sulfate works by reducing inflammation in people with autoimmune diseases (this is where the body’s immune system attacks itself by mistake).

It can be used for the following:

• Rheumatoid arthritis (inflammation of the joints)
• Systemic lupus erythematosus (a disease of the skin or the internal organs)

2. What you need to know before you take Hydroxychloroquine Sulfate Tablets

Do not take this medicine and tell your doctor in case of the following:

• You are allergic (hypersensitive) to hydroxychloroquine and/or other similar medicines such as quinolones and quinine.
• You see signs of allergic reaction, including a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You have an eye problem that affects the retina, the inside of the eye (maculopathy) or you get a change in eye colour or any other eye problem.

• You are pregnant, might become pregnant or think you may be pregnant (see Pregnancy and breastfeeding below).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking hydroxychloroquine sulfate.

Take special care with hydroxychloroquine sulfate) in case of the following and check with your doctor or pharmacist before taking your medicine:

• You have liver or kidney problems
• You have serious stomach or gut problems
• You have heart problems
• You have a genetic condition known as glucose-6-dehydrogenase deficiency
• You have a rare illness called porphyria, which affects your metabolism

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because hydroxychloroquine sulfate can affect the way some other medicines work. Also some medicines can affect the way hydroxychloroquine sulfate works.

Pregnancy and breastfeeding

Do not take hydroxychloroquine sulfate if:

• you are pregnant, might become pregnant or think you may be pregnant; or,
• you are breastfeeding or planning to breastfeed. This is because small amounts may pass into the breast milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.

Driving and using machines

You may get eye problems while taking this medicine. If this happens, do not drive or use any tools or machines, and tell your doctor straight away.

3. How to take hydroxychloroquine sulfate Tablets

Always take hydroxychloroquine sulfate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

 Taking this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a meal or a glass of milk. Do not crush or chew your tablets.
• If you are taking this medicine for skin problems that are sensitive to sunlight, only take hydroxychloroquine sulfate during periods of high exposure to light.
• The doctor will work out the dose depending on your body weight. If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
• If you have been taking this medicine for rheumatoid arthritis for a long time (more than 6 months) and you do not feel that it is helping you, see your doctor. This is because the treatment may need to be stopped.

How much to take

• Adults, including the elderlySystemic lupus erythematosus: 200 to 400 mg daily, administered as a single daily dose or in two divided doses. Doses above 400 mg a day are not recommended.
• Rheumatoid arthritis:

• Initial Adult Dosage: 400 mg to 600 mg daily, administered as a single daily dose or in two divided doses.
• Maintenance Adult Dosage: 200 mg to 400 mg daily, administered as a single daily dose or in two divided doses.
• Do not exceed 600 mg or 6.5 mg/kg per day.

It may take several weeks before you notice the benefit of taking hydroxychloroquine sulfate.

If you forget to take hydroxychloroquine sulfate Tablets

If you forget a dose, take it as soon as your remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects of hydroxychloroquine sulfate tablets 200 mg/400 mg?

Like all medicines, hydroxychloroquine sulfate can cause side effects, although not everybody gets them.

Stop taking hydroxychloroquine sulfate and see a doctor or go to a hospital straightaway in case of the following:

Side effects (frequency unknown)

• You have an allergic reaction. The signs may include a red or lumpy rash, swallowing or breathing problems, swelling of the eyelids, lips, face, throat or tongue.
• Severe skin reactions such as blistering, widespread scaly skin, pus-filled spots together with a high temperature, reddening and being more sensitive to the sun.
• Blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome.

If you experience any side effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the National Pharmacovigilance Programme of India by calling on 1800 267 7779 (Cipla number) from within India and on +91 821-6643551 from outside India (except the USA and EU).

5.  How should IMULAST Tablets 200 mg/400 mg be stored?

Store at a temperature not exceeding 30°С. Protect from light and moisture.

Do not take this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month after EXP.

Keep out of the reach and sight of children.

6. What are the ingredients of IMULAST Tablets 200 mg/400 mg and contents of the pack?

IMULAST Tablets 200 mg

Each film-coated tablet contains:

Hydroxychloroquine Sulfate IP….. 200 mg

Excipients: …………………………q.s.

Colour: Titanium Dioxide IP

IMULAST Tablets 400 mg

Each film-coated tablet contains:

Hydroxychloroquine Sulfate IP….. 400 mg

Excipients:…………………………..q.s.

Colour: Titanium Dioxide IP

Details of The Manufacturer

INNOVA CAPTAB LTD.

1281/1, Hilltop Industrial Estate,

Near EPIP Phase-1

Jharmajri, Baddi-173205,

(H.P.) India

Details of Permission or Licence Number with Date

Licence No. MNB/16/970 dated 10.03.2017

Date of Revision

Sept 2019