Methyldopa Tablets USP 500mg Taj Pharma

  1. NAME OF THE MEDICINAL PRODUCT

Methyldopa Tablets USP 125mg Taj Pharma
Methyldopa Tablets USP 250mg Taj Pharma
Methyldopa Tablets USP 500mg Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

a) Methyldopa Tablets USP 125mg Taj Pharma
Each film-coated tablet contains:
Methyldopa USP
Equivalent to Methyldopa Anhydrous 125mg

b) Methyldopa Tablets USP 250mg Taj Pharma
Each film-coated tablet contains:
Methyldopa USP
Equivalent to Methyldopa Anhydrous 250mg

c) Methyldopa Tablets USP 500mg Taj Pharma
Each film-coated tablet contains:
Methyldopa USP
Equivalent to Methyldopa Anhydrous 500mg

For a full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Film-coated Tablets.

  1. CLINICAL PARTICULARS
  • Therapeutic indications

In the treatment of hypertension and reducing blood pressure

  • Posology and method of administration

Posology

Use in adults:

Initial dosage: Usually 125mg or 250mg two or three times a day, for two days.

Adjustment: Usually adjusted at intervals of not less than two days, until an adequate response is obtained. The maximum recommended daily dosage is 500mg to 3g.

Many patients experience sedation for two or three days when therapy with ‘Methyldopa Taj Pharma’ is started or when the dose is increased. When increasing the dosage, therefore, it may be desirable to increase the evening dose first.

Withdrawal of ‘Methyldopa Taj Pharma’ is followed by return of hypertension, usually within 48 hours. This is not complicated generally by an overshoot of blood pressure.

Patients with renal impairment:

Methyldopa is largely excreted by the kidney, and patients with impaired renal function may respond to smaller doses.

Other antihypertensives:

Therapy with ‘Methyldopa Taj Pharma’ may be initiated in most patients already on treatment with other antihypertensive agents by terminating these antihypertensive medications gradually, as required. Following such previous antihypertensive therapy, ‘Methyldopa Taj Pharma’ should be limited to an initial dose of not more than 500mg daily and increased as required at intervals of not less than two days.

When Methyldopa Taj Pharma is given to patients on other antihypertensives the dose of these agents may need to be adjusted to effect a smooth transition.

When 500mg of ‘Methyldopa Taj Pharma’ is added to 50mg of hydrochlorothiazide, the two agents may be given together once daily.

Paediatric population:

Initial dosage is based on 10mg/kg of bodyweight daily in 2-4 oral doses. The daily dosage is then increased or decreased until an adequate response is achieved. The maximum dosage is 65mg/kg or 3.0 g daily, whichever is less.

Older people:

The initial dose in elderly patients should be kept as low as possible, not exceeding 250mg daily; an appropriate starting dose in the elderly would be 125mg b.d. increasing slowly as required, but not to exceed a maximum daily dosage of 2 g. Syncope in older patients may be related to an increased sensitivity and advanced arteriosclerotic vascular disease. This may be avoided by lower doses.

Method of administration

Oral.

  • Contraindications

‘Methyldopa Taj Pharma’ is contra-indicated in patients with:

  • active hepatic disease, such as acute hepatitis and active cirrhosis
  • hypersensitivity to the active substance (including hepatic disorders associated with previous Methyldopa Taj Pharma therapy), or to any of the excipients listed in section 6.1
  • depression
  • on therapy with monoamine oxidase inhibitors (MAOIs)
  • with a catecholamine-secreting tumour such as phaeochromocytoma or paraganglioma
  • with porphyria.
    • Special warnings and precautions for use

Acquired haemolytic anaemia has occurred rarely; should symptoms suggest anaemia, haemoglobin and/or haematocrit determinations should be made. If anaemia is confirmed, tests should be done for haemolysis. If haemolytic anaemia is present, ‘Methyldopa Taj Pharma’ should be discontinued. Stopping therapy, with or without giving a corticosteroid, has usually brought prompt remission. Rarely, however, deaths have occurred.

Some patients on continued therapy with Methyldopa Taj Pharma develop a positive Coombs test. From the reports of different investigators, the incidence averages between 10% and 20%. A positive Coombs test rarely develops in the first six months of therapy, and if it has not developed within 12 months, it is unlikely to do so later on continuing therapy. Development is also dose-related, the lowest incidence occurring in patients receiving 1 g or less of Methyldopa Taj Pharma per day. The test becomes negative usually within weeks or months of stopping Methyldopa Taj Pharma.

Prior knowledge of a positive Coombs reaction will aid in evaluating a cross-match for transfusion. If a patient with a positive Coombs reaction shows an incompatible minor cross-match, an indirect Coombs test should be performed. If this is negative, transfusion with blood compatible in the major cross-match may be carried out. If positive, the advisability of transfusion should be determined by a haematologist.

Reversible leukopenia, with primary effect on granulocytes has been reported rarely. The granulocyte count returned to normal on discontinuing therapy. Reversible thrombocytopenia has occurred rarely.

Occasionally, fever has occurred within the first three weeks of therapy, sometimes associated with eosinophilia or abnormalities in liver-function tests. Jaundice, with or without fever, may also occur. Its onset is usually within the first two or three months of therapy. In some patients the findings are consistent with those of cholestasis. Rare cases of fatal hepatic necrosis have been reported. Liver biopsy, performed in several patients with liver dysfunction, showed a microscopic focal necrosis compatible with drug hypersensitivity. Liver-function tests and a total and differential white blood-cell count are advisable before therapy and at intervals during the first six weeks to twelve weeks of therapy, or whenever an unexplained fever occurs.

Should fever, abnormality in liver function, or jaundice occur, therapy should be withdrawn. If related to Methyldopa Taj Pharma, the temperature and abnormalities in liver function will then return to normal. Methyldopa should not be used again in these patients. Methyldopa should be used with caution in patients with a history of previous liver disease or dysfunction.

Patients may require reduced doses of anaesthetics when on Methyldopa Taj Pharma. If hypotension does occur during anaesthesia, it can usually be controlled by vasopressors. The adrenergic receptors remain sensitive during treatment with Methyldopa Taj Pharma.

Dialysis removes Methyldopa Taj Pharma; therefore, hypertension may recur after this procedure.

Rarely, involuntary choreoathetotic movements have been observed during therapy with Methyldopa Taj Pharma in patients with severe bilateral cerebrovascular disease. Should these movements occur, therapy should be discontinued.

Interference with laboratory tests:

Methyldopa may interfere with the measurement of urinary uric acid by the phosphotungstate method, serum creatinine by the alkaline picrate method, and AST (SGOT) by colorimetric method. Interference with spectrophotometric methods for AST (SGOT) analysis has not been reported.

As Methyldopa Taj Pharma fluoresces at the same wavelengths as catecholamines, spuriously high amounts of urinary catecholamines may be reported interfering with a diagnosis of catecholamine-secreting tumours such as phaeochromocytoma or paraganglioma.

It is important to recognise this phenomenon before a patient with a possible phaeochromocytoma is subjected to surgery. Methyldopa does not interfere with measurements of VMA (vanillylmandelic acid) by those methods which convert VMA to vanillin. Methyldopa is contraindicated for the treatment of patients with a catecholamine-secreting tumour such as phaeochromocytoma or paraganglioma.

Rarely, when urine is exposed to air after voiding, it may darken because of breakdown of Methyldopa Taj Pharma or its metabolites.

  • Interaction with other medicinal products and other forms of interaction

Lithium:

When Methyldopa Taj Pharma and lithium are given concomitantly the patient should be monitored carefully for symptoms of lithium toxicity.

Other antihypertensive drugs:

When Methyldopa Taj Pharma is used with other antihypertensive drugs, potentiation of antihypertensive action may occur. The progress of patients should be carefully followed to detect side reactions or manifestations of drug idiosyncrasy.

Other classes of drug:

The antihypertensive effect of ‘Methyldopa Taj Pharma’ may be diminished by sympathomimetics, phenothiazines, tricyclic antidepressants and MAOIs (see 4.3 ‘Contra-indications’). In addition, phenothiazines may have additive hypotensive effects.

Iron:

Several studies demonstrate a decrease in the bioavailability of Methyldopa Taj Pharma when it is ingested with ferrous sulphate or ferrous gluconate. This may adversely affect blood pressure control in patients treated with Methyldopa Taj Pharma.

  • Pregnancy and lactation

Pregnancy

‘Methyldopa Taj Pharma’ has been used under close medical supervision for the treatment of hypertension during pregnancy. There was no clinical evidence that ‘Methyldopa Taj Pharma’ caused foetal abnormalities or affected the neonate.

Published reports of the use of Methyldopa Taj Pharma during all trimesters indicate that if this drug is used during pregnancy the possibility of foetal harm appears remote.

Methyldopa crosses the placental barrier and appears in cord blood.

Although no obvious teratogenic effects have been reported, the possibility of foetal injury cannot be excluded and the use of the drug in women who are, or may become pregnant requires that anticipated benefits be weighed against possible risks.

Breast-feeding

Methyldopa appears in breast milk. The use of the drug in breast-feeding mothers requires that anticipated benefits be weighed against possible risks.

  • Effects on ability to drive and use machines

‘Methyldopa Taj Pharma’ may cause sedation, usually transient, during the initial period of therapy or whenever the dose is increased. If affected, patients should not carry out activities where alertness is necessary, such as driving a car or operating machinery.

  • Undesirable effects

Sedation, usually transient, may occur during the initial period of therapy or whenever the dose is increased. If affected, patients should not attempt to drive, or operate machinery. Headache, asthenia or weakness may be noted as early and transient symptoms.

The following convention has been utilised for the classification of frequency: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).

System Organ Class Adverse event term Frequency
Infections and infestations Sialoadenitis Not known
Blood and lymphatic system disorders Haemolytic anaemia, bone-marrow failure, leukopenia, granulocytopenia, thrombocytopenia, eosinophilia Not known
Endocrine disorders Hyperprolactinaemia Not known
Psychiatric disorders Psychic disturbances including nightmares, reversible mild psychoses or depression, decreased libido Not known
Nervous system disorders Sedation (usually transient), headache, paraesthesia, Parkinsonism, VIIth nerve paralysis, choreoathetosis, mental impairment, carotid sinus syndrome, dizziness, symptoms of cerebrovascular insufficiency (may be due to lowering of blood pressure) Not known
Cardiac disorders Bradycardia, angina pectoris, myocarditis, pericarditis, atrioventricular block Not known
Vascular disorders Orthostatic hypotension (decrease daily dosage) Not known
Respiratory, thoracic and mediastinal disorders Nasal congestion Not known
Gastrointestinal disorders Nausea, vomiting, abdominal distension, constipation, flatulence, diarrhoea, colitis, dry mouth, glossodynia, tongue discolouration, pancreatitis Not known
Hepatobiliary disorders Liver disorders including hepatitis, jaundice Not known
Skin and subcutaneous tissue disorders Rash (eczema, lichenoid eruption), toxic epidermal necrolysis, angioedema, urticaria Not known
Musculoskeletal and connective tissue disorders Lupus-like syndrome, mild arthralgia with or without joint swelling, myalgia Not known
Reproductive system and breast disorders Breast enlargement, gynaecomastia, amenorrhoea, lactation disorder, erectile dysfunction, ejaculation failure Not known
General disorder and administration site conditions Asthenia, oedema (and weigh gain) usually relieved by use of a diuretic. (Discontinue Methyldopa Taj Pharma if oedema progresses or signs of heart failure appear). Pyrexia Not known
Investigations Positive Coombs test, positive tests for antinuclear antibody, LE cells, and rheumatoid factor, abnormal liver-function tests, increased blood urea Not known

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

Symptoms

Acute overdosage may produce acute hypotension with other responses attributable to brain and gastro-intestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, light-headedness, constipation, distension, flatus, diarrhoea, nausea, and vomiting).

Management

If ingestion is recent, emesis may be induced or gastric lavage performed. There is no specific antidote. Methyldopa is dialysable. Treatment is symptomatic. Infusions may be helpful to promote urinary excretion. Special attention should be directed towards cardiac rate and output, blood volume, electrolyte balance, paralytic ileus, urinary function and cerebral activity.

Administration of sympathomimetic agents may be indicated. When chronic overdosage is suspected, ‘Methyldopa Taj Pharma’ should be discontinued.

  1. Pharmacological properties
  • Pharmacodynamic properties

Pharmacotherapeutic group: antiadrenergic agents;

Mechanism of action

It appears that several mechanisms of action account for the clinically useful effects of Methyldopa Taj Pharma and the current generally accepted view is that its principal action is on the central nervous system. The antihypertensive effect of Methyldopa Taj Pharma is probably due to its metabolism to alpha-methylnoradrenaline, which lowers arterial pressure by stimulation of central inhibitory alpha-adrenergic receptors, false neurotransmission, and/or reduction of plasma renin activity. Methyldopa has been shown to cause a net reduction in the tissue concentration of serotonin, dopamine, epinephrine (adrenaline) and norepinephrine (noradrenaline).

  • Pharmacokinetic properties

Absorption

Absorption of oral Methyldopa Taj Pharma is variable and incomplete.

Distribution

Bioavailability after oral administration averages 25%.

Biotransformation

Peak concentrations in plasma occur at two to three hours, and elimination of the drug is biphasic regardless of the route of administration. Plasma half-life is 1.8 ± 0.2 hours.

Elimination

Renal excretion accounts for about two thirds of drug clearance from plasma.

  • Preclinical safety data

No relevant information.

  1. Pharmaceutical particulars
    • List of excipients

Tablet-core:

Powdered cellulose

Citric acid anhydrous

Collodial silicon dioxide

Ethylcellulose

Guar gum

Magnesium stearate

Edetate calcium disodium

Tablet-coating:

Propylene glycol

Citric acid monohydrate

Hypromellose

Quinoline yellow aluminium lake

Red iron oxide

Talc

Titanium dioxide

Carnauba wax

  • Incompatibilities

None known.

  • Shelf life

36 months.

  • Special precautions for storage

Keep containers well closed and store below 25°C, protected from light.

  • Nature and contents of container

White polyethylene bottle of 50, 100, 200, 250, 300, 360 and 500 tablets with turquoise polyethylene closure, or PVC aluminium blister packs of 50, 100, 200, 250, 300, 360 and 500 tablets in each box.

Not all pack size may be marketed.

  • Special precautions for disposal and other handling

None.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at: Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Methyldopa Tablets USP 500mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Methyldopa Tablets USP 125mg Taj Pharma

(Methyldopa)

Read all of this leaflet 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, ask your doctor or 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 side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet:

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

Methyldopa Taj Pharma contains the active substance called Methyldopa Taj Pharma. This belongs to a group of medicines called ‘antihypertensives’.

Methyldopa is changed inside your body to a natural substance that lowers blood pressure. Your doctor has prescribed Methyldopa Taj Pharma to treat high blood pressure (hypertension).

  1. What you need to know before you take Methyldopa Taj Pharma

Do not take Methyldopa Taj Pharma if you have:

  • ever had a bad reaction, such as an allergy to Methyldopa Taj Pharma, or to any of the other ingredients (listed in section 6)
  • ever had liver disease
  • ever had depression
  • high blood pressure due to a tumour near your kidney called ‘phaeochromocytoma’ or ‘paraganglioma’.
  • been taking a type of medicine called a ‘monoamine oxidase inhibitor’ (MAO inhibitor)
  • porphyria (a rare, inherited blood disorder)

Do not take Methyldopa Taj Pharma if any of the above applies to you. If you are not sure talk to your doctor or pharmacist before taking Methyldopa Taj Pharma.

Take special care with Methyldopa Taj Pharma

Talk to your doctor or pharmacist before taking Methyldopa Taj Pharma if you have:

  • a blood disorder called haemolytic anaemia
  • liver problems
  • jaundice (yellowing of the skin and eyes)
  • fever
  • any abnormal movements (involuntary)

Check with your doctor while taking this medicine if you are going to have:

  • dialysis
  • an operation
  • a blood transfusion.

Tests you may have while taking Methyldopa Taj Pharma

Your doctor may do blood tests to check how your liver is working during the first 6 – 12 weeks. He or she may use similar tests if you have a fever at any time while you are taking Methyldopa Taj Pharma. Tell your doctor you are taking Methyldopa Taj Pharma if you have a laboratory test where a urine or blood sample is taken. This is because Methyldopa Taj Pharma may affect the results of some types of tests.

Rarely, in patients taking Methyldopa Taj Pharma urine may darken when it is exposed to air after voiding.

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

Other medicines and Methyldopa Taj Pharma

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription as some drugs may affect each other’s action. This includes herbal medicines.

Do not take Methyldopa Taj Pharma if you are taking a type of medicine called a ‘monoamine oxidase inhibitor’ (MAO inhibitor) used to treat depression.

It is particularly important that you tell your doctor or pharmacist if you are taking any of the following before taking Methyldopa Taj Pharma

  • other medicines for high blood pressure (antihypertensives)
  • lithium – used to treat some types of depression
  • medicines called ‘phenothiazines’ such as chlorpromazine – used for mental illness and sometimes feeling and being sick
  • medicines called ‘tricyclic antidepressants’ – used to treat depression
  • cough and cold remedies that contain a decongestant
  • iron and supplements containing iron, such as multivitamins with minerals

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

Surgery

If you have to have surgery, including dental, that requires an anaesthetic, you must inform the dentist or hospital that you are taking Methyldopa Taj Pharma tablets.

Methyldopa Taj Pharma with alcohol

You are advised not to drink alcohol while taking Methyldopa Taj Pharma tablets. Discuss this with your doctor if you have any questions.

Pregnancy and breast-feeding

You should check with your doctor before taking Methyldopa Taj Pharma if you are or think you may be pregnant, if you are planning to become pregnant or if you are breast-feeding.

Driving and using machines

You may feel drowsy or light-headed while taking Methyldopa Taj Pharma. If this happens do not drive or use any tools or machines.

  1. How to take Methyldopa Taj Pharma

Always take Methyldopa Taj Pharma exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

You should take this medicine by mouth and exactly as advised by your doctor or pharmacist. The amount you take each day will depend upon your condition. It is very important to continue taking Methyldopa Taj Pharma for as long as your doctor has prescribed. Do not take more or less than your doctor has prescribed.

The usual doses of Methyldopa Taj Pharma are:

Adults

  • The usual starting dose for the first two days is 250mg two or three times a day.
  • Your doctor may then change your dose depending on how you respond.
  • You should not take more than 3000mg in a day.

The elderly

  • The usual starting dose will not be more than 250mg each day.
  • Your doctor may then slowly increase the dose.
  • You should not usually take more than 2000mg in a day.

Children

The doctor will work out the number of tablets. The dose is based on the weight of the child.

  • The usual starting dose is 10mg for each kg of body-weight each day.
  • This dose is taken in two to four doses during the day.
  • Your doctor may then change the dose, depending on how the child responds.
  • A child will not usually take more than 65mg for each kg (or 3000mg a day), whichever is less.

If you take more Methyldopa Taj Pharma than you should

If you take too many tablets by mistake, contact your doctor immediately or seek medical attention.

If you forget to take Methyldopa Taj Pharma

  • If you forget to take a dose, just carry on with the next dose as normal.
  • Do not take a double dose to make up for a forgotten dose.

If you stop taking Methyldopa Taj Pharma

Do not stop taking Methyldopa Taj Pharma without talking to your doctor.

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

  1. Possible side effects

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

Contact your doctor immediately if you have any of the following side effects as they are serious and require medical attention:

  • an allergic reaction – symptoms such as shortness of breath, skin rash or itching, hives, swelling of your lips, face or tongue, chills or
  • fever or painful joints
  • chest pain, slow heart rate, existing angina made worse, problems with the electrical current in the heart (AV block)
  • severe skin reactions (such as painful reddening, followed by blistering and peeling of layers of skin)
  • liver problems, including jaundice and hepatitis – signs include yellowing of your skin and eyes, sometimes with a fever, pale stools and dark urine
  • pain in the gut and diarrhoea caused by inflammation of the bowel (colitis)
  • severe pain in the gut and back caused by inflammation of the pancreas (pancreatitis).

The following reactions have also been reported:

Blood:

  • reduction in red blood cells (anaemia) – this can make your skin pale and make you weak or breathless
  • abnormal blood test causing symptoms such as pale skin, tiredness, fever and sore throat
  • bruising and prolonged bleeding after injury
  • your medicine may alter the numbers and types of your blood cells and cause a rise in urea in the blood

Nervous system:

  • feeling sleepy or tired – this may happen at the start of treatment or when the dose is increased, and usually goes away
  • headache or feeling weak – this may happen at the start of treatment and usually goes away
  • pins and needles
  • being unable to move part of your face (paralysis)
  • having movements you cannot control
  • Parkinsonism – with symptoms such as tremor, a decrease in body movements with an inability to move your muscles
  • confusion
  • frequent dizziness or fainting
  • dizziness due to low blood pressure and light-headedness (particularly when standing up quickly)

Nose and chest:

  • nasal stuffiness

Stomach and gut:

  • feeling sick
  • being sick
  • abdominal pain
  • feeling bloated
  • constipation
  • excess wind
  • diarrhoea
  • dry mouth
  • sore or black tongue

Skin and hair:

  • skin rash or peeling skin

Joints and muscles:

  • painful and/or swollen joints
  • muscle pains

Infections:

  • swelling of salivary glands

General:

  • water retention causing swelling and weight gain
  • fever

Sexual:

  • breast enlargement
  • breast development in men
  • loss of periods in women
  • abnormal production of milk
  • changes in sexual function such as impotence and not being able to ejaculate
  • decreased sex drive

Psychiatric:

  • mental changes, including nightmares or depression
  • delusions and paranoia – which will stop when you stop taking this medicine

Laboratory tests:

  • Your doctor may need to carry out simple blood tests during the first few months of therapy with Methyldopa Taj Pharma. Results could show:
    • a decrease in blood cell production
    • an increase in some white blood cells
    • abnormal levels of prolactin

Methyldopa Taj Pharma may also interfere with the interpretation of certain blood and urine tests.

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

  1. How to store Methyldopa Taj Pharma

Keep out of the reach and sight of children.

Do not use the medicine past the expiry date which is stated on the side of the carton after ‘Exp’. The expiry date refers to the last day of that month.

Do not store above 25°C.

Blisters: Store in the original package in order to protect from light.

Bottles: Keep the container tightly closed in order to protect from light.

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.

  1. Contents of the pack and other information

What Methyldopa Taj Pharma contains

Active substances

The active ingredient in Methyldopa Taj Pharma tablets is Methyldopa Taj Pharma.

Methyldopa Taj Pharma tablets are available in two different strengths containing Methyldopa Taj Pharma equivalent to either 250mg anhydrous Methyldopa Taj Pharma, or 500mg anhydrous Methyldopa Taj Pharma.

Other ingredients

Cellulose powder, anhydrous citric acid, colloidal anhydrous silica, ethylcellulose, guar gum, magnesium stearate, sodium calcium edetate, hypromellose, propylene glycol, quinoline yellow aluminium lake, red iron oxide, talc, titanium dioxide, citric acid monohydrate.

What Methyldopa Taj Pharma looks like and contents of the pack

Methyldopa Taj Pharma is available as film-coated tablets which come in three different strengths. They are yellow-coloured, round tablets containing Methyldopa Taj Pharma equivalent to either 125mg, 250mg anhydrous Methyldopa Taj Pharma, or 500mg anhydrous Methyldopa Taj Pharma.

White polyethylene bottle of 50, 100, 200, 250, 300, 360 and 500 tablets with turquoise polyethylene closure, or PVC aluminium blister packs of 50, 100, 200, 250, 300, 360 and 500 tablets in each box.

Not all pack size may be marketed.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at: Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

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