Hydroxychloroquine Sulphate Tablets USP 400mg

1. Name of the medicinal product

Hydroxychloroquine Sulphate Tablets USP 200mg
Hydroxychloroquine Sulphate Tablets USP 400mg

2. Qualitative and quantitative composition

a) Hydroxychloroquine Sulphate Tablets USP 200mg
Each film-coated tablet contains:
Hydroxychloroquine Sulphate USP 200mg
Excipients: Q.S.

b) Hydroxychloroquine Sulphate Tablets USP 400mg
Each film-coated tablet contains:
Hydroxychloroquine Sulphate USP 400mg
Excipients: Q.S.

3. Pharmaceutical form

Film-coated tablet.

White, round, film-coated tablets marked

4. Clinical particulars

Therapeutic indications

Adults

Treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight.

Paediatric population

Treatment of juvenile idiopathic arthritis (in combination with other therapies), discoid and systemic lupus erythematosus.

• Posology and method of administration

Adults (including the elderly)

The minimum effective dose should be employed. This dose should not exceed 6.5mg/kg/day (calculated from ideal body weight and not actual body weight) and will be either 200mg or 400mg per day.

In patients able to receive 400mg daily:

Initially 400mg daily in divided doses. The dose can be reduced to 200mg when no further improvement is evident. The maintenance dose should be increased to 400mg daily if the response lessens.

Paediatric population

The minimum effective dose should be employed and should not exceed 6.5mg/kg/day based on ideal body weight. The 200mg tablet is therefore not suitable for use in children with an ideal body weight of less than 31kg.

Each dose should be taken with a meal or glass of milk.

Hydroxychloroquine is cumulative in action and will require several weeks to exert its beneficial effects, whereas minor side effects may occur relatively early. For rheumatic disease treatment should be discontinued if there is no improvement by 6 months. In light-sensitive diseases, treatment should only be given during periods of maximum exposure to light.

The tablets are for oral administration.

• Contraindications

• known hypersensitivity to 4-aminoquinoline compounds
• pre-existing maculopathy of the eye
• pregnancy (see section 4.6 Pregnancy and lactation).

Special warnings and precautions for use

General

• The occurrence of retinopathy is very uncommon if the recommended daily dose is not exceeded. The administration of doses in excess of the recommended maximum is likely to increase the risk of retinopathy, and accelerate its onset.
• All patients should have an ophthalmological examination before initiating treatment with Hydroxychloroquine Sulphate. Thereafter, ophthalmological examinations must be repeated at least every 12 months.

The examination should include testing visual acuity, careful ophthalmoscopy, fundoscopy, central visual field testing with a red target, and colour vision.

This examination should be more frequent and adapted to the patient in the following situations:

• daily dosage exceeds 6.5mg/kg lean body weight. Absolute body weight used as a guide to dosage could result in an overdosage in the obese.
• renal insufficiency
• visual acuity below 6/8
• age above 65 years
• cumulative dose more than 200 g.

Hydroxychloroquine Sulphate should be discontinued immediately in any patient who develops a pigmentary abnormality, visual field defect, or any other abnormality not explainable by difficulty in accommodation or presence of corneal opacities. Patients should continue to be observed for possible progression of the changes.

Patients should be advised to stop taking the drug immediately and seek the advice of their prescribing doctor if any disturbances of vision are noted, including abnormal colour vision.

Hydroxychloroquine Sulphate should be used with caution in patients taking medicines which may cause adverse ocular or skin reactions. Caution should also be applied when it is used in the following:

• patients with hepatic or renal disease, and in those taking drugs known to affect those organs. Estimation of plasma hydroxychloroquine levels should be undertaken in patients with severely compromised renal or hepatic function and dosage adjusted accordingly.
• patients with severe gastrointestinal, neurological or blood disorders.

Although the risk of bone marrow depression is low, periodic blood counts are advisable as anaemia, aplastic anaemia, agranulocytosis, a decrease in white blood cells, and thrombocytopenia have been reported. Hydroxychloroquine Sulphate should be discontinued if abnormalities develop.

Caution is also advised in patients with a sensitivity to quinine, those with glucose-6-phosphate dehydrogenase deficiency, those with porphyria cutanea tarda which can be exacerbated by hydroxychloroquine and in patients with psoriasis since it appears to increase the risk of skin reactions.

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 Sulphate out of the reach of children.

All patients on long-term therapy should undergo periodic examination of skeletal muscle function and tendon reflexes. If weakness occurs, the drug should be withdrawn.

Hydroxychloroquine has been shown to cause severe hypoglycaemia including loss of consciousness that could be life threatening in patients treated with and without antidiabetic medications. Patients treated with hydroxychloroquine should be warned about the risk of hypoglycaemia and the associated clinical signs and symptoms. Patients presenting with clinical symptoms suggestive of hypoglycaemia during treatment with hydroxychloroquine should have their blood glucose level checked and treatment reviewed as necessary.

• Interaction with other medicinal products and other forms of interaction

Hydroxychloroquine sulphate has been reported to increase plasma digoxin levels: serum digoxin levels should be closely monitored in patients receiving combined therapy.

Hydroxychloroquine sulphate may also be subject to several of the known interactions of chloroquine even though specific reports have not appeared. These include: 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; reduction of the antibody response to primary immunisation with intradermal human diploid-cell rabies vaccine.

As with chloroquine, antacids may reduce absorption of hydroxychloroquine so it is advised that a 4 hour interval be observed between Hydroxychloroquine Sulphate and antacid dosaging.

As hydroxychloroquine may enhance the effects of a hypoglycaemic treatment, a decrease in doses of insulin or antidiabetic drugs may be required.

• Pregnancy and lactation

Pregnancy:

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 Sulphate should not be used in pregnancy.

Lactation:

Careful consideration should be given to using hydroxychloroquine during lactation, since it has been shown to be excreted in small amounts in human breast milk, and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinolines.

• 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
• Ocular effects:

Retinopathy with changes in pigmentation and visual field defects can occur, but appears to be uncommon if the recommended daily dose is not exceeded. In its early form it appears reversible on discontinuation of Hydroxychloroquine Sulphate. If allowed to develop, 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 and abnormal colour vision.

Corneal changes including oedema and opacities have been reported. They are either symptomless or may cause disturbances such as haloes, blurring of vision or photophobia. They may be transient and are reversible on stopping treatment.

Blurring of vision due to a disturbance of accommodation which is dose dependent and reversible may also occur.

• Dermatologic effects:

Skin rashes sometimes occur; pruritus, pigmentary changes in skin and mucous membranes, bleaching of hair and alopecia have also been reported. These usually resolve readily on stopping treatment.

Bullous eruptions including very rare cases of erythema multiforme and Stevens-Johnson syndrome, photosensitivity and isolated cases of exfoliative dermatitis have been reported. Very rare cases of acute generalised exanthematous pustulosis (AGEP) has to be distinguished from psoriasis, although hydroxychloroquine may precipitate attacks of psoriasis. It may be associated with fever and hyperleukocytosis. Outcome is usually favourable after drug withdrawal.

• Gastrointestinal effects:

Gastrointestinal disturbances such as nausea, diarrhoea, anorexia, abdominal pain and, rarely, vomiting may occur. These symptoms usually resolve immediately on reducing the dose or on stopping treatment.

• CNS effects:

Less frequently, dizziness, vertigo, tinnitus, hearing loss, headache, nervousness, emotional lability, toxic psychosis and convulsions have been reported with this class of drugs.

• Neuromuscular effects:

Skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups have been noted. Myopathy may be reversible after drug discontinuation, but recovery may take many months.

Associated mild sensory changes, depression of tendon reflexes and abnormal nerve conduction may be observed.

• Cardio-vascular effects:

Cardiomyopathy has been rarely reported.

Chronic toxicity should be suspected when conduction disorders (bundle branch block/atrioventricular heart block) as well as biventricular hypertrophy are found. Drug withdrawal may lead to recovery.

• Hematologic effects:

Rarely, there have been reports of bone-marrow depression. Blood disorders such as anaemia, aplastic anaemia, agranulocytosis, a decrease in white blood cells and thrombocytopenia have been reported.

Hydroxychloroquine may precipitate or exacerbate porphyria.

• Liver effects:

Isolated cases of abnormal liver function tests have been reported; rare cases of fulminant hepatic failure have also been reported.

• Allergic reactions:

Urticaria, angioedema and bronchospasm have been reported.

• Metabolism and nutrition disorders:

Hypoglycaemia (see section 4.4). Frequency: unknown.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

• Overdose

Overdosage with the 4-aminoquinolines is dangerous particularly in infants, as little as 1-2g having proved fatal.

The symptoms of overdosage may include headache, visual disturbances, cardiovascular collapse, convulsions, hypokalaemia, and rhythm and conduction disorders, followed by sudden and early respiratory and cardiac arrest. Since these effects may appear soon after taking a massive dose, treatment should be prompt and symptomatic. The stomach should be immediately evacuated, either by emesis or by gastric lavage. Activated charcoal in a dose at least five times of the overdose may inhibit further absorption if introduced into the stomach by tube following lavage and within 30 minutes of ingestion of the overdose.

Consideration should be given to administration of parenteral diazepam in cases of overdosage; it has been shown to be beneficial in reversing chloroquine cardiotoxicity.

Respiratory support and shock management should be instituted as necessary.

5. Pharmacological properties
   • Pharmacodynamic properties

Antimalarial agents like chloroquine and hydroxychloroquine have several pharmacological actions which 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

Hydroxychloroquine has actions, pharmacokinetics and metabolism similar to those of chloroquine. Following oral administration, hydroxychloroquine is rapidly and almost completely absorbed. In one study, mean peak plasma hydroxychloroquine concentrations following a single dose of 400mg in healthy subjects ranged from 53-208ng/ml with a mean of 105ng/ml. The mean time to peak plasma concentration was 1.83 hours. The mean plasma elimination half-life varied, depending on the post-administration period, as follows: 5.9 hours at C_max-10 hours), 26.1 hours (at 10-48 hours) and 299 hours (at 48-504 hours). The parent compound and metabolites are widely distributed in the body and elimination is mainly via the urine, where 3% of the administered dose was recovered over 24 hours in one study.

• Preclinical safety data

There are no preclinical safety data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.

6. Pharmaceutical particulars
   • List of excipients

Lactose Monohydrate, Maize Starch, Magnesium Stearate, Polyvidone, Opadry OY-L-28900 (Containing Hypromellose, Macrogol 4000, Titanium Dioxide, Lactose.

• Incompatibilities

No incompatibilities are known.

• Shelf life

3 years

• Special precautions for storage

Store below 25?C.

• Nature and contents of container

Amber glass bottles with a tin plate screw cap containing 50, 100, 360 and 500 tablets. HDPE bottle with LDPE cap containing 50, 100, 360 and 500 tablets.

Each clear PVC aluminium foil blister pack containing 10, 15, 20, 30, 40, 50, 60, 80, or 100 tablets

Not all pack size may be marketed.

• Special precautions for disposal and other handling

None.

Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)

Hydroxychloroquine Sulphate Tablets USP 400mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hydroxychloroquine Sulphate 200mg Film-coated Tablets

Hydroxychloroquine Sulphate

Is this leaflet hard to see or read?

Read all of this leaflet carefully before you start taking this medicine

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

In this leaflet:

1. What Hydroxychloroquine Sulphate is and what it is used for
2. Before you take Hydroxychloroquine Sulphate
3. How to take Hydroxychloroquine Sulphate
4. Possible side effects
5. How to store Hydroxychloroquine Sulphate
6. Further information

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

Hydroxychloroquine Sulphate contains a medicine called Hydroxychloroquine Sulphate.

Hydroxychloroquine Sulphate 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:

• Rheumatoid arthritis (inflammation of the joints)
• Juvenile idiopathic arthritis (in children)
• Discoid and systemic lupus erythematosus (a disease of the skin or the internal organs)
• Skin problems which are sensitive to sunlight

2. Before you take Hydroxychloroquine Sulphate

Do not take this medicine and tell your doctor if:

• You are allergic (hypersensitive) to:
  • hydroxychloroquine
  • other similar medicines such as quinolones and quinine
  • any of the other ingredients of Hydroxychloroquine Sulphate (listed in Section 6 below)
    Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You have an eye problem which affects the retina, the inside of the eye (maculopathy) or you get a change in eye color or any other eye problem
• You are pregnant, might become pregnant or think you may be pregnant (see ?Pregnancy and breast-feeding? 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 Sulphate.

Take special care with Hydroxychloroquine Sulphate

Check with your doctor or pharmacist before taking your medicine if:

• You have liver or kidney problems
• You have serious stomach or gut problems
• You have any problems with your blood. You may have blood tests to check this
• You have any problems with your nervous system or brain
• You have psoriasis (red scaly patches on the skin usually affecting the knees, elbows and scalp)
• You have had a bad reaction to quinine in the past
• You have a genetic condition known as ?glucose-6-dehydrogenase deficiency?
• You have a rare illness called ?porphyria? which affects your metabolism

Before treatment with Hydroxychloroquine Sulphate

• Before you take this medicine you should have your eyes examined
• This testing should be repeated at least every 12 months whilst taking Hydroxychloroquine Sulphate
• If you are over 65, need to take a high dose (2 tablets a day) or have kidney problems then this examination should be performed more often
• Hydroxychloroquine 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

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Hydroxychloroquine Sulphate.

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 Sulphate can affect the way some other medicines work. Also, some medicines can affect the way Hydroxychloroquine Sulphate works.

In particular, tell your doctor if you are taking any of the following:

The following medicines may increase the chance of you getting side effects when taken with Hydroxychloroquine Sulphate:

• Some antibiotics used for infections (such as gentamicin, neomycin or tobramycin)
• Cimetidine – used for stomach ulcers
• Neostigmine and pyridostigmine ? used for muscle weakness (myasthenia gravis)
• Medicines that may affect the kidney or liver
• Medicines that affect the skin or the eyes

The following medicines can change the way Hydroxychloroquine Sulphate works or Hydroxychloroquine Sulphate may affect the way some of these medicines work:

• Digoxin – used for heart problems
• Medicines for diabetes (such as insulin or metformin)
• Antacids – used for heartburn or indigestion. You should leave a gap of at least 4 hours between taking these medicines and Hydroxychloroquine Sulphate
• Rabies vaccine

Pregnancy and breast-feeding

Do not take Hydroxychloroquine Sulphate if:

• You are pregnant, might become pregnant or think you may be pregnant
• You are breast-feeding or planning to breast-feed. This is because small amounts may pass into mothers? milk

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

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.

Important information about some of the ingredients of Hydroxychloroquine Sulphate

This medicine contains lactose. If you have been told by your doctor that you can not tolerate some sugars, talk to your doctor before taking Hydroxychloroquine Sulphate.

3. How to take Hydroxychloroquine Sulphate

Always take Hydroxychloroquine Sulphate 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 Sulphate 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 elderly

• One or two tablets each day

Children and Adolescents

• One tablet each day
• This medicine is only suitable for children who weigh more than 31kg (around 5 stones)

It may take several weeks before you notice the benefit of taking Hydroxychloroquine Sulphate.

If you take more Hydroxychloroquine Sulphate than you should

• If you take more Hydroxychloroquine Sulphate than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: headache, problems with your eyesight, fall in blood pressure, convulsions (fits), heart problems, followed by sudden severe breathing problems and possibly heart attack
• Young children and babies are particularly at risk if they accidentally take Hydroxychloroquine Sulphate. Take the child to a hospital straight away

If you forget to take Hydroxychloroquine Sulphate

If you forget a dose, take it as soon as you 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 stop taking Hydroxychloroquine Sulphate

Keep taking Hydroxychloroquine Sulphate until your doctor tells you to stop. Do not stop taking Hydroxychloroquine Sulphate just because you feel better. If you stop, your illness may get worse again.

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

4. Possible side effects

Like all medicines, Hydroxychloroquine Sulphate Taj Pharma can cause side effects, although not everybody gets them.

Stop taking Hydroxychloroquine Sulphate and see a doctor or go to a hospital straight away if:

• You have an allergic reaction. The signs may include: a red or lumpy rash, swallowing or breathing problems, swelling of your eyelids, lips, face, throat or tongue

Stop taking Hydroxychloroquine Sulphate and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

• You have any eye problems. This includes changes in the colour of your eye and problems with your eyesight such as blurring, sensitivity to light or the way you see colour
• You have any muscle weakness, cramps, stiffness or spasms or changes in sensation such as tingling
  If you take this medicine for a long time, your doctor will occasionally check your muscles and tendons to make sure they are working properly
• Severe skin reactions such as blistering, widespread scaly skin, pus-filled spots together with a high temperature
• 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
• You may get infections more easily than usual. This could be due to bone marrow depression or a blood disorder called ?agranulocytosis?
• You may bruise more easily than usual. This could be due to a blood problem called ?thrombocytopenia?
• You feel tired, faint or dizzy and have pale skin. These could be symptoms of something called ?anaemia?
• You feel weak, short of breath, bruise more easily than usual and get infections more easily than usual. These could be symptoms of something called ?aplastic anaemia?
• Liver problems that may cause the eyes or skin to go yellow (jaundice)
• Lowering of the blood glucose level (hypoglycaemia), frequency unknown. You may feel a sense of nervousness, shaky or sweaty

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

• Skin rashes, itching, changes in the colour of your skin or the inside of your nose or mouth
• Psoriasis (red scaly patches on the skin usually affecting the knees, elbows and scalp)
• Hair loss or loss of hair colour
• Feeling or being sick, diarrhoea, loss of appetite (anorexia) or stomach pain
• Feeling nervous, ringing in the ear (tinnitus), hearing loss, headache, fits, balance problems (vertigo) or feeling dizzy, mental problems (such as delusions, hallucinations or changes in mood)
• Weakening of the heart muscle (cardiomyopathy) resulting in difficulty in breathing, coughing, high blood pressure, swelling, increased heart rate, low amount of urine
• You may get infections more easily than usual. This could be due to bone marrow depression
• Symptoms of a condition called ?porphyria? which may include stomach pain, being sick, fits, blisters, itching

Blood Tests

• A blood test may show changes in the way the liver is working and occasionally the liver may stop working

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Hydroxychloroquine Sulphate

Keep out of the reach and sight of children. Store below 25?C.

Do not use Hydroxychloroquine Sulphate after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Hydroxychloroquine Sulphate contains

• Each tablet contains 200mg/400mg of the active substance, Hydroxychloroquine Sulphate
• The other ingredients are lactose monohydrate, maize starch, magnesium stearate, polypovidone, hypromellose, macrogol, and titanium dioxide

What Hydroxychloroquine Sulphate looks like and contents of the pack

Hydroxychloroquine Sulphate 200mg/400mg Film-coated Tablets are round white film-coated tablets

Pack Size:

Each pack contains 10, 15, 20, 25, 30, 40, 50, 60 and 80 or 100 tablets

Each box contains 30, 60, 120, 240, 360, 500 or 1000 tablets.

Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)

A patient information leaflet of Hydroxychloroquine Sulphate Tablets is a technical document included in every medicine package to offer written information about the medication