1. Name of the medicinal product

Hydralazine Hydrochloride Tablets USP 25mg Taj Pharma
Hydralazine Hydrochloride Tablets USP 50mg Taj Pharma

  1. Qualitative and quantitative composition

a) Hydralazine Hydrochloride Tablets USP 25mg Taj Pharma
Each film coated tablet contains:
Hydralazine Hydrochloride USP
Equivalent to hydrazinophthalazine HCl Tablets 25mg
Colours: Titanium Dioxide

b) Hydralazine Hydrochloride Tablets USP 50mg Taj Pharma
Each film coated tablet contains:
Hydralazine Hydrochloride USP
Equivalent to hydrazinophthalazine HCl Tablets 50mg
Colours: Titanium Dioxide

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablets, Titanium Dioxide

4. Clinical particulars

  • Therapeutic indications

Indicated for:

  • Moderate to severe hypertension as an adjunct to other antihypertensive agents.
  • Moderate to severe chronic congestive heart failure along with long acting nitrates in patients whose optimal doses of diuretics and cardiac glycosides have proved insufficient and ACE inhibitors are unsuitable.

Posology and method of administration

Posology

The dosage should be adjusted to the individual requirements of the patient. Treatment should commence with low doses which, depending on the patient’s response, should be increased stepwise to achieve optimal therapeutic effect, whilst minimizing unwanted effects.

Due to the complementary mechanism of action, the combination of Hydralazine Taj Pharma with beta-blockers and diuretics may enable antihypertensive efficacy at lower dose levels and counteract accompanying Hydralazine Taj Pharma effects such as reflex tachycardia and oedema.

Adults

Hypertension: the initial dose is 25mg twice daily. This may be increased gradually to a maximum dose of 200mg daily. The patient’s acetylator status must be checked prior to increasing the daily dose beyond 100mg.

Chronic congestive heart failure: Doses vary greatly between individual patients and are generally higher than those used to treat hypertension. Treatment should be initiated in hospital where the patient’s individual haemodynamic values can be determined with the help of invasive monitoring. Treatment should continue in hospital until the patient has been established on the required maintenance dose. After progressive titration (initially 25mg three or four times daily, increasing every second day) maintenance dosage averages 50-75mg four times daily.

Pediatric population

Hydralazine Taj Pharma is not recommended.

Elderly

There is no special dosage requirement. Systemic clearance and blood concentration of Hydralazine Taj Pharma are not affected by advanced age, though renal elimination may be affected due to diminished kidney function with age. The elderly may also be more sensitive to the hypotensive effects of Hydralazine Taj Pharma.

Method of administration

For oral administration only. Swallow the tablets with a glass of water.

  • Contraindications

Hydralazine Taj Pharma is contraindicated in patients with:

  • Hypersensitivity to the active substance, diHydralazine Taj Pharma or to any of the excipients listed in section 6.1
  • Idiopathic systemic lupus erythematosus (SLE) and related diseases
  • Severe tachycardia
  • High output cardiac failure (e.g. in thyrotoxicosis)
  • Myocardial insufficiency due to mechanical obstruction (eg. in the presence of mitral or aortic stenosis or constrictive pericarditis)
  • Cor pulmonale
  • Dissecting aortic aneurysm
  • Porphyria

Special warnings and precautions for use

The “Hyperdynamic” state of the circulation induced by Hydralazine Taj Pharma may accentuate certain clinical conditions. Myocardial stimulation may provoke or aggravate angina pectoris. Patients with suspected or confirmed coronary artery disease should be given Hydralazine Taj Pharma only under cover of a beta-blocker or in combination with other suitable sympatholytic agents. Beta-blocker medication should be started a few days prior to commencing treatment with Hydralazine Taj Pharma.

Patients who have survived a myocardial infarction should not receive Hydralazine Taj Pharma until a post-infarction stabilisation phase has been achieved.

Prolonged treatment with Hydralazine Taj Pharma (ie. usually for more than 6 months) may provoke a systemic lupus erythematosus (SLE) like syndrome, especially with doses exceeding 100mg daily. Initial symptoms are likely to be similar to rheumatoid arthritis (arthralgia, sometimes associated with rash, anaemia, leucopenia, thrombocytopenia and fever) and are reversible upon withdrawal of the drug. In its more severe form it resembles acute SLE (similar manifestations as the milder form plus pleurisy, pleural effusions and pericarditis), and in rare cases renal and ocular involvement have been reported. Early detection and a timely diagnosis with appropriate therapy (i.e. treatment discontinuation and possibly long-term treatment with corticosteroids may be required to reverse these changes) are of utmost importance in this life- threatening illness to prevent more severe complications, which may sometimes be fatal.

Since such reactions tend to occur more frequently with higher doses and longer duration of treatment and since they are also more common in slow acetylators, the lowest effective dose should be used for maintenance therapy. If 100mg daily fails to elicit an adequate response, the patient’s acetylator status should be evaluated. Slow acetylators and women are at greater risk of developing the SLE-like syndrome and every effort should therefore be made to keep the dosage below 100mg daily. The patient should be watched for signs and symptoms of the syndrome and if such symptoms develop, the drug should be gradually withdrawn. Rapid acetylators often respond inadequately even to doses of 100mg daily and therefore the dose may be raised with only a slightly increased risk of an SLE-like syndrome.

During long-term treatment with Hydralazine Taj Pharma, it is advisable to determine the antinuclear factors and conduct urine analysis at intervals of approximately 6 months. Microhaematuria and /or proteinuria, in particular along with positive ANF titres, may be initial signs of immune-complex glomerulonephritis associated with the SLE-like syndrome. If overt clinical signs or symptoms develop, Hydralazine Taj Pharma should be withdrawn immediately.

Skin rash, febrile reactions and change in blood count occur rarely and the drug should be withdrawn. Peripheral neuritis in the form of paraesthesia has been reported and may respond to pyridoxine administration or withdrawal of the drug.

Hydralazine Taj Pharma dose or interval between doses should be adjusted according to clinical response in patients with hepatic dysfunction or renal impairment (creatinine clearance < 30 ml/ min or serum creatinine > 2.5mg/ 100 ml) in order to avoid accumulation of the drug.

Hydralazine Taj Pharma should be used with caution in patients with coronary artery disease (since it may increase angina) or cerebrovascular disease.

Patients on Hydralazine Taj Pharma who undergo surgery, may show a fall in blood pressure. Adrenaline should not be used to correct the hypotension since it enhances the cardiac-accelerating effects of Hydralazine Taj Pharma.

When initiating therapy in heart failure, particular caution should be exercised and the patient monitored for early detection of postural hypotension or tachycardia. Where discontinuation of therapy in heart failure is necessary, Hydralazine Taj Pharma should be withdrawn gradually (except in serious situations such as SLE- like syndrome or blood dyscrasias) in order to avoid precipitation and /or exacerbation of heart failure.

Interaction with other medicinal products and other forms of interaction

The following drugs enhance the hypotensive effects of Hydralazine Taj Pharma:

– Other antihypertensives (diuretics, ACE inhibitors, calcium channel blockers, vasodilators*)

  • Anaesthetics
  • Tricyclic antidepressants
  • Major tranquillisers
  • Nitrates or drugs exerting central depressant actions (including alcohol)

*Administration of Hydralazine Taj Pharma within an hour or two of diazoxide may give rise to marked hypotension.

The following drugs antagonise the effects of Hydralazine Taj Pharma:

  • Non-steroidal anti-inflammatory agents (especially indometacin)
  • Corticosteroids
  • Carbenoxolone
  • Oestrogens and combined oral contraceptives

Concurrent administration of Hydralazine Taj Pharma and beta-blockers which are subject to significant first-pass metabolism (e.g. propranolol) may result in increased bioavailability of the beta-blocker. Dosage reduction of the beta-blocker may be necessary in such cases.

MAOI’s should be used with caution in patients receiving Hydralazine Taj Pharma.

Fertility, pregnancy and lactation

Pregnancy

Hydralazine Taj Pharma readily crosses the placenta with serum concentrations in the foetus being equal to or greater than those in the mother. Animal studies have shown reproductive toxicity (see section 5.3). No serious adverse effects in human pregnancy have been reported with Hydralazine Taj Pharma use during the third trimester. Thrombocytopenia, leucopenia, petechial bleeding and haematomas have been reported in new-borns whose mother took Hydralazine Taj Pharma, though these symptoms resolved spontaneously in one to three weeks.

Hydralazine Taj Pharma should be avoided during the first and second trimesters of pregnancy, but may be used later in pregnancy if the mother or foetus is at risk (eg pre-eclampsia, eclampsia) or if no safer alternative is available.

Breast-feeding

Hydralazine Taj Pharma passes into breast milk but reports to date have not indicated adverse effects on the infant. Breast-fed infants of mothers taking Hydralazine Taj Pharma should be observed for possible adverse effects.

Effects on ability to drive and use machines

Hydralazine Taj Pharma may cause headache and difficulty in concentration, especially at the start of treatment, which can impair the patient’s reactions. If symptoms are severe, the patient should not drive or operate machinery.

Undesirable effects

Some side effects of Hydralazine Taj Pharma such as palpitations, tachycardia, angina symptoms, flushing, headaches, dizziness, gastrointestinal disturbances and nasal congestion are commonly seen at the start of therapy especially if the dose is raised quickly but generally subside as treatment continues.

Adverse reactions are categorised by frequencies as follows: very common (≥1/10), common (≥1/100 to <1/10), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).

Blood and lymphatic system disorders:

Rare: leucopenia, neutropenia, thrombocytopenia with or without purpura, anaemia

Very rare: haemolytic anaemia, lymphadenopathy, leucocytosis, pancytopenia, splenomegaly and agranulocytosis

Immune system disorders:

Rare: hypersensitivity reactions such as urticaria, pruritus, vasculitis, eosinophilia, hepatitis

Psychiatric disorders:

Rare: anorexia, agitation, anxiety

Very rare: depression, hallucinations

Nervous system disorders:

Very common: headache

Common: dizziness

Very rare: peripheral neuritis, polyneuritis and paraesthesia (which may be reversed by administering pyridoxine)

Cardiac disorders:

Very common: palpitations and tachycardia

Common: angina symptoms

Rare: heart failure

Very rare: paradoxical pressor responses

Vascular disorders:

Common: hypotension, flushing

Respiratory, thoracic and mediastinal disorders:

Common: nasal congestion

Rare: dyspnoea and pleural pain

Eye disorders:

Rare: increased lacrimation, conjunctivitis

Very rare: exophthalmos

Gastrointestinal disorders:

Common: gastrointestinal disturbances, diarrhoea, nausea and vomiting

Very rare: paralytic ileus

Hepatobiliary disorders:

Rare: jaundice, hepatomegaly, abnormal liver function sometimes in association with hepatitis

Skin and subcutaneous tissue disorders:

Rare: skin rash

Musculoskeletal and connective tissue disorders:

Common: arthralgia, myalgia, joint swelling, SLE-like syndrome (sometimes resulting in a fatal outcome, see section 4.4)

Renal and urinary disorders:

Rare: proteinuria, haematuria sometimes associated with glomerulonephritis

Very rare: acute renal failure and urinary retention

General disorders and administration site conditions:

Rare: fever, weight loss, malaise, oedema

Investigations:

Rare: increased plasma creatinine

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

The signs and symptoms of Hydralazine Taj Pharma overdose include hypotension, tachycardia, headache and generalised skin flushing. Complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmias, profound shock and coma.

Management

There is no specific antidote. Gastric lavage should be instituted as soon as possible, taking adequate precautions against aspiration and for protection of the airway. An activated charcoal slurry may be instilled if conditions permit. These procedures may have to be omitted or carried out after cardiovascular status has been stabilised since they might precipitate cardiac arrhythmias or increase the depth of shock.

Support of the cardiovascular system is of primary importance. Shock should be treated with plasma expanders if possible, rather than vasopressors. Supportive measures including intravenous fluids are also indicated. If hypotension is present, an attempt should be made to raise the blood pressure without increasing the tachycardia. If a vasopressor is used, one should be chosen that is least likely to precipitate or aggravate cardiac arrhythmia. Tachycardia responds to beta-blockers. Digitalisation may be necessary. Fluid and electrolyte status and renal function should be monitored.

5. Pharmacological properties

Pharmacodynamic properties

Pharmacotherapeutic group: Arteriolar smooth muscle, agents acting on; hydrazinophthalazine derivatives,

Mechanism of action

Hydralazine Taj Pharma is a direct acting vasodilator which exerts its effects primarily on the arterioles, with little effect on veins. Its exact mechanism of action is unknown. Administration of Hydralazine Taj Pharma decreases peripheral resistance and arterial blood pressure, producing a reflex increase in heart rate and cardiac output. These reflex effects can be reduced by concomitant administration of a beta-blocker, thus enhancing the antihypertensive effect. Increased plasma renin activity and sodium and water retention, producing oedema and reduced urinary volume, may also occur with Hydralazine Taj Pharma administration attenuating its antihypertensive action. These effects can be prevented by concomitant administration of a diuretic.

Pharmacokinetic properties

Absorption

Hydralazine Taj Pharma is well absorbed (up to 90%) after oral administration, but is subject to a dose-dependent first- pass effect. Systemic bioavailability ranges from 26-55% and is dependent on individual acetylator status.

Food may enhance the bioavailability of Hydralazine Taj Pharma by reducing first-pass metabolism in the gut wall.

Peak plasma concentrations are reached after 0.5 – 1.5 hours.

Distribution

Hydralazine Taj Pharma is rapidly distributed in the body and displays a particular affinity for the blood vessel walls.

It is highly protein bound (≈ 90%) in the plasma. Within 24 hours after an oral dose, the quantity recovered in the urine averages 80% of the dose.

Elimination

Hydralazine Taj Pharma appears in the plasma chiefly in the form of a readily hydrolysable conjugate with pyruvic acid. Its plasma half-life averages 2-3 hours, but is prolonged up to 16 hours in severe renal failure (creatinine clearance < 20 ml/ min) and shortened to approximately 45 minutes in rapid acetylators.

The bulk of the dose excreted as acetylated and hydroxylated metabolites, some of which are conjugated with glucuronic acid.

Preclinical safety data

Studies in animals found Hydralazine Taj Pharma to be teratogenic in mice at oral doses ranging from 20 – 120mg/kg (20-30 times the maximum human daily dose). Teratogenic effects included cleft palate and malformations of facial and cranial bones. Hydralazine Taj Pharma was not found to be teratogenic in rats or rabbits.

In high (cyto-) toxic concentrations, Hydralazine Taj Pharma induces gene mutations in single cell organisms and in mammalian cells in vitro. No unequivocally mutagenic effects have been detected in-vivo in a great number of test systems.

In lifetime carcinogenicity studies, Hydralazine Taj Pharma, towards the end of the experiments, caused small but statistically significant increase in lung tumours in mice and hepatic and testicular tumours in rats. These tumours also occur spontaneously with fairly high frequency in aged rodents.

With due consideration of these toxicological findings, Hydralazine Taj Pharma in therapeutic doses does not appear to bear a risk that would necessitate a limitation of its administration.

Years of clinical experience have not suggested that the use of Hydralazine Taj Pharma is associated with any risk of cancer in humans.

6. Pharmaceutical particulars

List of excipients

Tablet core

Cellulose, microcrystalline,Maize starch, pregelatinised, Silica, Colloidal anhydrous, Disodium edetate, Talc, Magnesium stearate, Tablet coat, Hypromellose, Diethyl phthalate, Titanium dioxide , Quinoline yellow, Hydroxypropylcellulose, Ethylcellulose, Iron oxide red , Carnauba wax.

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light.

Nature and contents of container

Each pack type is available in pack sizes of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250 and 500 tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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

Hydralazine Hydrochloride Tablets USP 25mg Taj Pharma
Film-coated Tablets

Package leaflet: Information for the patient

Hydralazine Taj Pharma hydrochloride

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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Hydralazine Taj Pharma is and what it is used for

Hydralazine Taj Pharma belongs to a group of medicines called antihypertensives.

Hydralazine Taj Pharma can be used along with other medicines:

  • To reduce high blood pressure (hypertension)
  • To treat moderate and serious heart failure.

Anti-hypertensives work by lowering blood pressure. High blood pressure increases the workload of the heart and arteries (blood vessels) and if left untreated, can lead to damage of the blood vessels of the brain, heart and kidneys.

2. What you need to know before you take Hydralazine Taj Pharma
Do not take Hydralazine Taj Pharma:

  • if you are allergic to Hydralazine Taj Pharma hydrochloride or diHydralazine Taj Pharma, or any of the other ingredients of this medicine (listed in section 6)
  • if you suffer from the condition systemic lupus erythematosus (SLE) or a related disease
  • if you suffer from an unusually fast heart beat
  • if you have heart failure, heart valve problems (aortic or mitral stenosis) or inflammation of the
  • heart (constrictive pericarditis)
  • if you have an aortic aneurysm (swelling in the wall of the aorta which can cause sweating, a
  • fast heartbeat, and abdominal or back pain)
  • if you have an enlarged heart often caused by lung disease (cor pulmonale)
  • If there is a family history of the rare condition porphyria.

Warnings and precautions

Talk to your doctor or pharmacist before taking Hydralazine Taj Pharma:

  • if you have liver or kidney problems.
  • if you suffer from hardened arteries (coronary artery disease), chest pain (angina) or are at risk of having a stroke.
  • if you are recovering from a heart attack.
  • if you need surgery.

Other medicines and Hydralazine Taj Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription, herbal medicines or any of the following:

  • other antihypertensives including medicines used to widen the blood vessels such as diazoxide
  • or nitrates, beta-blockers (e.g. propranolol), ACE inhibitors (e.g. captopril), “water” tablets
  • (diuretics e.g. furosemide ) and medicines known as “calcium channel blockers” (e.g.
  • verapamil)
  • medicines used to treat depression e.g. tricyclic antidepressants such as dosulepin, monoamine
  • oxidase inhibitors (MAOIs) such as phenelzine or to treat a mental illness (eg. Chlorpromazine)
  • medicines used to treat anxiety such as tranquillisers (e.g. diazepam)
  • anti-inflammatory painkillers (NSAIDs) e.g. indometacin
  • corticosteroids e.g. prednisolone
  • medicines which slow down the nervous system (CNS depressants)
  • carbenoxolone, used to treat stomach ulcers
  • anaesthetics
  • medicines containing oestrogens e.g. HRT, or the combined oral contraceptive pill.

Ask your doctor or pharmacist for advice before taking any medicine.

Hydralazine Taj Pharma with alcohol

Alcohol may increase the effects of Hydralazine Taj Pharma causing side effects such as dizziness.

Pregnancy and breast-feeding

Hydralazine Taj Pharma should only be used in the last few months of pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Do not drive or use machines if you suffer from headaches or have difficulty concentrating while taking this medicine. Speak to your doctor or pharmacist for advice.

Hydralazine Taj Pharma contains lactose

The 50 mg strength tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.

Hydralazine Taj Pharma contains Sunset yellow

The 50 mg tablets also contain the colouring Sunset yellow which may cause allergic reactions in some people.

3. How to take Hydralazine Taj Pharma

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you are taking Hydralazine Taj Pharma for a long time, your doctor may wish to test your urine and blood every six months.

Your doctor will start you on a low dose of Hydralazine Taj Pharma and gradually increase the dose depending on your condition.

The recommended dose is:

Adults

Hypertension

The recommended starting dose is 25 mg of Hydralazine Taj Pharma twice a day, increasing to a maximum total dose of 200 mg of Hydralazine Taj Pharma a day.

Heart failure

Treatment is started in hospital with a dose of 25 mg of Hydralazine Taj Pharma three or four times a day; if necessary, increasing to 50-75 mg of Hydralazine Taj Pharma four times a day.

A small group of patients can break down Hydralazine Taj Pharma in their body at a different rate to the majority of patients. This can lead to unwanted effects. Your doctor will check for this possibility, and if this occurs, will change your dose of Hydralazine Taj Pharma as needed. You should carry on taking your medicine as long as your doctor or pharmacist tells you to, even if you feel better.

Use in children and adolescents

Hydralazine Taj Pharma should not be given to children or adolescents.

Method of administration

Swallow the tablets with a glass of water.

If you take more Hydralazine Taj Pharma than you should

The signs and symptoms of Hydralazine Taj Pharma overdose include low blood pressure, a racing heart beat, headache and generalised skin flushing. If you take more Hydralazine Taj Pharma than you should contact your doctor or hospital emergency department immediately.

If you forget to take Hydralazine Taj Pharma

If you forget to take a dose of Hydralazine Taj Pharma take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Hydralazine Taj Pharma

Do not stop taking Hydralazine Taj Pharma without talking to your doctor, even if you feel better, because it may make your illness worse.

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

4. Possible side effects

Like all medicines, Hydralazine Taj Pharma can cause side effects, although not everybody gets them. If any of the following happen, stop taking this medicine and see your doctor straight away or go to the nearest hospital immediately.

Common (may affect up to 1 in 10 people)

  • systemic lupus erythematosus (SLE) or a related disease with signs such as joint pain (similar to rheumatoid arthritis), fever, change in blood count and skin rash

Rare (may affect up to 1 in 1,000 people)

  • swelling of the hands and lower legs, breathlessness, tightness of the chest, sharp chest pain which is worse when breathing in, feeling dizzy
  • allergic reactions such as itchy red and swollen skin, red skin rash on cheeks and other parts of the body, skin rashes which may be severe
  • signs of reduced numbers of different blood cells, which may cause unusual bruising or bleeding of the skin (reduced number of platelets), frequent infections, fever, chills, sore throat or mouth ulcers (reduced number of white blood cells)
  • liver problems, which can cause yellowing of the skin or whites of the eyes, dark urine and pale stools
  • blood in the urine (the urine may look red or pink)
  • Very rare (may affect up to 1 in 10,000 people)
  • illness resulting from the destruction of red blood cells with signs such as looking pale, feeling tired, breathlessness, yellowing of the skin and/or eyes
  • a reduction in all types of blood cells, which may cause frequent infections, unusual bruising or bleeding of the skin or you to feel tired and breathless
  • changes in how much you urinate, difficulty or pain when passing urine, lower back pain, fever, nausea and vomiting – these may be signs of kidney problems
  • severe pain in the stomach with bloating, cramps constipation and vomiting
  • protruding eyes

Other possible side effects

Very common (may affect more than 1 in 10 people)

  • fast or irregular heart beat
  • headache

Common (may affect up to 1 in 10 people)

  • low blood pressure
  • muscle or joint pain
  • swelling of the joints
  • feeling or being sick
  • diarrhoea, upset stomach
  • chest pain
  • flushing
  • dizziness
  • blocked nose

Rare (may affect up to 1 in 1,000 people)

  • protein in the urine which would be seen in a urine test
  • increased levels of creatinine in the blood which would be seen in a blood test
  • loss of appetite, weight loss
  • feeling generally unwell
  • feeling anxious or agitated
  • itchy, red, infected eyes (conjunctivitis), watery or swollen eyes.
  • abdominal swelling caused by enlarged liver or fluid retention in the body
  • swelling of blood vessels. Signs include fever, general aches and pain, loss of appetite, weight loss and tiredness
  • pinkish, itchy swellings on the skin, also called hives or nettle rash
  • increase in some white blood cells which may be seen in a blood test
  • decrease in some red blood cells which may be seen in a blood test

Very rare (may affect up to 1 in 10,000 people)

  • an increase in blood pressure
  • inflammation of the nerves, which may causes tingling or numbness especially in the hands, arms, feet or legs
  • painful swelling in the arms or legs
  • swollen (lymph) glands in the armpits, neck or groins
  • feeling depressed
  • seeing, feeling or hearing things that are not there (hallucinations)
  • abnormal swelling of the spleen (splenomegaly). You may notice signs such as being unable to eat a large meal, feeling discomfort, fullness, or pain on the upper left side of the abdomen; this pain may spread to your left shoulder

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Hydralazine Taj Pharma

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

Do not use this medicine after the expiry date which is stated on the label or container after “EXP”.

The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Hydralazine Taj Pharma contains

The active substance is Hydralazine Taj Pharma hydrochloride.

Each 25 mg tablet contains 25 mg of Hydralazine Taj Pharma hydrochloride.

Each 50 mg tablet contains 50 mg of Hydralazine Taj Pharma hydrochloride.

The other ingredients are microcrystalline cellulose, pregelatinised maize starch, colloidal anhydrous silica, sodium starch glycolate (in 50 mg strength only), disodium edetate, talc and magnesium stearate. .

The coating for the 25 mg strength tablets contains diethyl phthalate, hydroxypropylcellulose, ethylcellulose, carnauba wax, red iron oxide hypromellose, titanium dioxide and Quinoline yellow

The coating for the 50 mg strength tablets contains titanium dioxide lactose (see section 2 “Hydralazine Taj Pharma contains lactose”), hypromellose, macrogol, indigo carmine sunset yellow (see section 2 “Hydralazine Taj Pharma contains sunset yellow iron oxide yellow and erythrosine

What Hydralazine Taj Pharma looks like and contents of the pack

Hydralazine Taj Pharma Tablets 25 mg and 50 mg are available in glass or plastic containers and blisters of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250 and 500 tablets.

Not all pack sizes 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