1. Name of the medicinal product

Atenolol/Chlorthalidone Tablets 50mg/25mg Taj Pharma
Atenolol/Chlorthalidone Tablets 100/25mg Taj Pharma

  1. Qualitative and quantitative composition

a) Atenolol/Chlorthalidone Tablets 50mg/25mg Taj Pharma
Each film-coated Tablets contains:
Atenolol USP 50mg
Chlortalidone USP 25mg
Excipients: Q.S.

b) Atenolol/Chlorthalidone Tablets 100mg/25mg Taj Pharma
Each film-coated Tablets contains:
Atenolol USP 100mg
Chlortalidone USP 25mg
Excipients: Q.S.

For excipients, see 6.1

  1. Pharmaceutical form

Film-coated tablet

Round, white, half scored, film-coated tablets.

  1. Clinical particulars
  • Therapeutic indications

For the management of hypertension.

  • Posology and method of administration

For oral administration.

Adults: One tablet daily.

Most patients should have a satisfactory response to one tablet daily. There is little or no further fall in blood pressure with increase in dose and therefore where control of hypertension is not achieved, the addition of a low dose of a third drug eg. a vasodilator, can be used.

Elderly: Dose requirements are normally lower in the elderly.

Children: There is no paediatric experience with Co-Tenidone tablets, therefore this preparation is not recommended for children.

Patients with impaired renal function:

Due to the properties of the chlortalidone component, Co-Tenidone tablets has reduced efficacy in the presence of renal insufficiency. This fixed dose combination should thus not be administrated to patients with severe renal impairment (see section 4.3).

  • Contraindications

Hypersensitivity to atenolol, chlortalidone or any of the other tablet ingredients.

Patients with bradycardia; second or third degree heart block; cardiogenic shock; hypotension; severe peripheral arterial disease; sick sinus syndrome; phaeochromocytoma (unless used concomitantly with an alpha-blocker); metabolic acidosis or uncontrolled heart failure.

During pregnancy and lactation.

Refractory hypokalaemia, hyponatraemia or hypercalcaemia.

Symptomatic hyperuricaemia.

Addison’s disease.

Severe renal failure.

  • Special warnings and precautions for use

Due to the active ingredient, atenolol:

May be used with caution in patients with heart failure which has been controlled (contra-indicated in uncontrolled heart failure, see Section 4.3).

Caution must be exercised in patients whose cardiac reserve is poor.

Extreme caution is required in patients with Prinzmetal’s angina as the number and duration of attacks may increase due to unopposed alpha receptor mediated coronary artery vasoconstriction. Atenolol is a beta1-selective beta-blocker; consequently the use of Co-Tenidone tablets may be considered although utmost caution must be exercised.

May aggravate less severe peripheral arterial disease (contra-indicated in severe peripheral arterial disease, see Section 4.3).

Caution is required when given to patients with first degree heart block.

In patients with portal hypertension, there is a risk of deterioration in liver function when administered beta-blockers.

Beta-blockers may unmask myasthenia gravis or potentiate a myasthenic condition.

May mask the symptoms of hypoglycaemia and hyperthyroidism. May modify warning signs of hypoglycaemia as tachycardia, palpitation and sweating.

May mask the cardiovascular signs of thyrotoxicosis.

On rare occasions atenolol may reduce the heart rate; should this occur the dose may need to be reduced.

Do not discontinue suddenly in patients suffering from ischaemic heart disease.

May cause a more severe reaction to a variety of allergens, when given to patients with a history of anaphylactic reaction to such allergens. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions. May cause a hypersensitivity reaction including angioedema and urticaria.

Due to its negative effect on conduction time, caution must be exercised if it is given to patients with first-degree heart block.

Cardioselective (beta1) beta-adrenoceptor blocking drugs such as atenolol may have less effect on lung function than non-selective beta-adrenoceptor blocking drugs, however, as with all beta-adrenoceptor blocking drugs Atenolol/Chlorthalidone Taj Pharma should be avoided in patients with reversible obstructive airways disease, unless there are compelling clinical reasons for its use. Where such reasons exist Atenolol/Chlorthalidone Taj Pharma may be used with caution. Occasionally some increase in airways resistance may occur in asthmatic patients however, and this may usually be reversed by commonly used dosage of bronchodilators such as salbutamol or isoprenaline.

Systemic effects of oral beta-blockers may be potentiated when used concomitantly with ophthalmic beta-blockers.

In patients with phaeochromocytoma must be administered only after alfa-receptor blockade. Blood pressure should be monitored closely.

Caution must be exercised when using anaesthetic agents with Co-Tenidone. The anaesthetist should be informed and the choice of anaesthetic should be an agent with as little negative inotropic activity as possible. Use of beta-blockers with anaesthetic drugs may result in attenuation of the reflex tachycardia and increase the risk of hypotension. Anaesthetic agents causing myocardial depression are best avoided.

The patient information leaflet for this product states the following warning:

“If you have ever had asthma or wheezing, you should not take this medicine unless you have discussed these symptoms with the prescribing doctor.”

Due to the active ingredient, Chlortalidone:

Caution is required in patients with renal impairment (see Section 4.2) or patients with severe hepatic impairment.

Plasma electrolyte should be periodically determined in appropriate intervals to detect possible electrolyte imbalance especially hypokalaemia and hyponatraemia.

Hyperuricaemia may occur although this is normally only a minor increase in the serum uric acid level. Should a prolonged increase occur the administration of a uricosuric drug at the same time might be appropriate to reverse the hyperuricaemia.

As hypokalaemia may occur blood potassium levels may need to be monitored, particularly in the following patients: the elderly, those taking a low potassium diet, those receiving treatment with digitalis preparations for cardiac failure or if suffering from gastrointestinal problems. In patients receiving digitalis, hypokalaemia may predispose to arrhythmias.

In patients with impaired hepatic function or progressive liver disease, minor alterations in fluid and electrolyte balance may precipitate hepatic coma.

Hyperuricaemia may occur. Only a minor increase in serum uric acid usually occurs but in cases of prolonged elevation, the concurrent use of a uricosuric agent will reverse the hyperuricaemia.

Impaired glucose tolerance may occur and diabetic patients should be aware of the potential for increased glucose levels. Close monitoring of glycaemia is recommended in the initial phase of therapy and in prolonged therapy test for glucosuria should be carried out at regular intervals.

Caution is required in patients with a known pre-disposition to diabetes mellitus, as glucose intolerance may occur.

  • Interaction with other medicinal products and other forms of interaction

Calcium channel blockers with negative inotropic effects e.g. verapamil, diltiazem: combined use with beta-adrenoceptor blocking drugs can enhance these effects especially in patients with impaired ventricular function and/or sino-atrial or atrio-ventricular conduction abnormalities. Severe hypotension, bradycardia and cardiac failure may occur. Neither the beta-adrenoceptor blocking drugs nor the calcium channel blocker should be administered intravenously within 48 hours of discontinuing the other.

Class 1 antiarrhythmic agents (e.g. disopyramide) and amiodarone may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.

Clonidine: beta-adrenoceptor blocking drugs may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are co-administered, the beta-adrenoceptor blocking drug should be withdrawn several days before discontinuing clonidine. If replacing clonidine by beta-adrenoceptor blocking drug therapy, the introduction of beta-adrenoceptor blocking drugs should be delayed for several days after clonidine administration has stopped.

Dihydropyridines e.g. nifedipine: concomitant treatment may increase the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency.

Concomitant use of baclofen may increase the antihypertensive effect making dose adjustments necessary.

Digitalis glycosides: may increase AV block and bradycardia if given with beta-adrenoceptor blocking drugs.

Insulin and oral antidiabetic drugs: concomitant use may lead to an enhanced hypoglycaemic effect.

Prostaglandin synthetase inhibiting drugs eg. ibuprofen and indometacin: concomitant use may decrease the antihypertensive effects of beta-adrenoceptor blocking drugs.

Preparations containing lithium should not be given with diuretics because they may reduce its renal clearance.

Sympathomimetic agents, eg. adrenaline: concomitant use may cause severe hypertension; counteracts the effect of beta-adrenoceptor blocking drugs.

Caution must be exercised when using anaesthetic agents with Atenolol/Chlorthalidone Taj Pharma tablets (see section 4.4)

  • Pregnancy and lactation

Do not give during pregnancy and lactation.

  • Effects on ability to drive and use machines

It is unlikely that any impairment in the ability of patients to drive or operate machinery will occur, however occasionally dizziness or fatigue may occur.

  • Undesirable effects

Atenolol/Chlorthalidone Taj Pharma is normally well-tolerated. In clinical studies, the undesired events reported are usually attributable to the pharmacological actions of its components.

The following undesirable effects, listed by body system, have been reported with the following frequencies: Very common (≥ 10%), common (1-9.9%), uncommon (0.1-0.9%), rare (0.01-0.09%), very rare (<0.01%), not known (cannot be estimated from the available data):

Blood and the lymphatic system disorders:

Rare: leucopenia (related to chlortalidone); purpura; thrombocytopenia.

Psychiatric disorders:

Uncommon: sleep disturbances of the type noted with other beta blockers.

Rare: confusion; mood changes; nightmares; psychoses and hallucinations.

Nervous system disorders:

Rare: dizziness; headache; paraesthesia.

Eye disorders:

Rare: disturbances in vision; dry eyes.

Cardiac disorders:

Common: bradycardia.

Rare: deterioration of heart failure; precipitation of heart block;

Vascular disorders:

Common: cold extremities.

Rare: postural hypotension which may be associated with syncope; intermittent claudication may be increased if already present; Raynaud’s phenomenon in susceptible patients.

Respiratory, thoracic and mediastinal disorders:

Rare: bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints.

Gastrointestinal disorders:

Common: gastrointestinal disturbances (including nausea related to chlortalidone).

Rare: dry mouth.

Not known: constipation.

Hepato-biliary disorders:

Rare: hepatic toxicity including intrahepatic cholestasis; pancreatitis (related to chlortalidone).

Skin and subcutaneous tissue disorders:

Rare: alopecia; psoriasiform skin reactions; exacerbation of psoriasis; skin rashes.

Not known: Hypersensitivity reactions, including angioedema and urticaria.

Reproductive system and breast disorders:

Rare: impotence.

General disorders and administration site conditions:

Common: fatigue.

Investigations:

Common: Related to chlortalidone: Hyperuricaemia, hyponatraemia, hypokalaemia, impaired glucose tolerance.

Uncommon: elevation of transaminase levels.

Very rare: an increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear.

Discontinuance of “Atenolol/Chlorthalidone Taj Pharma” should be considered if, according to clinical judgement, the well being of the patient is adversely affected by any of the above reactions.

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

The symptoms of overdosage may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm.

Treatment should include close monitoring, treatment in an intensive care unit, gastric lavage, activated charcoal and a laxative to prevent absorption of any drug still present in the gastrointestinal tract. Plasma or plasma substitutes may be used to treat hypotension and shock. Haemodialysis or haemoperfusion may be considered.

Excessive bradycardia may be treated with atropine (1- 2mg) intravenously and/or a cardiac pacemaker, followed if necessary by a bolus dose of glucagon (10mg) intravenously. If required this may be repeated or followed by an intravenous infusion of glucagon (1-10mg/hour) depending on the response. If the patient is unresponsive to glucagon or this is not available, a beta-adrenoceptor stimulant such as an intravenous infusion of dobutamine (2.5 to 10 µg/kg/minute) may be given.

Dobutamine, because of its positive inotropic effect, could also be used to treat hypotension and acute cardiac insufficiency. It is likely that these doses would be inadequate to reverse the cardiac effects of beta-blocker blockade if a large overdose has been taken. The dose of dobutamine should therefore be increased if necessary to achieve the required response according to the clinical condition of the patient

Should bronchospasm occur this can usually be reversed by bronchodilators and excessive diuresis should be prevented by maintaining normal fluid and electrolyte balance.

  1. Pharmacological properties
    • Pharmacodynamic properties

Atenolol is a cardioselective beta blocker. It has great affinity for beta1-adrenergic receptors in the heart although selectivity decreases with increases in dose. Atenolol does not possess intrinsic sympathomimetic and membrane stabilizing activities and as with other beta-adrenoceptor blocking drugs, has negative inotropic effects (therefore contra-indicated in uncontrolled heart failure). As with other beta-adrenoceptor blocking drugs, the method of action in the treatment of hypertension is unclear. It is unlikely that any additional ancillary properties possessed by S (-) atenolol, in comparison with the racemic mixture, will give rise to different therapeutic effects.

Chlortalidone, a monosulfonamyl diuretic, increases excretion of sodium and chloride. Natriuresis is accompanied by some loss of potassium. The mechanism by which Chlortalidone reduces blood pressure is not fully known but may be related to the excretion and redistribution of body sodium.

Atenolol is effective and well-tolerated in most ethnic populations. Black patients respond better to the combination of atenolol and Chlortalidone, than to atenolol alone.

The combination of atenolol with thiazide-like diuretics has been shown to be compatible and generally more effective than either drug used alone.

  • Pharmacokinetic properties

Following oral administration approximately 40-50% of atenolol is absorped with peak plasma concentrations reached 2-4 hours after dosing. The atenolol blood levels are consistent and subject to little variability. There is little or no hepatic metabolism of atenolol and more than 90% of that absorbed reaches the systemic circulation unaltered. The plasma half life is about 6-7 hours but this may rise in severe renal impairment since the kidney is the major route of elimination. Atenolol has low lipid solubility and only small concentrations are reported in brain tissue. Atenolol crosses the placenta and is distributed into breast milk where concentrations are higher than in maternal plasma have been reported. Plasma binding is low (approximately 3%).

Absorption of chlortalidone following oral dosing is consistent but incomplete (approximately 60%) with peak plasma concentrations occurring about 12 hours after dosing. The chlortalidone blood levels are consistent and subject to little variability. The plasma half-life is about 50 hours and the kidney is the major route of elimination. Plasma protein binding is high (approximately 75%).

Co-administration of Chlortalidone and atenolol has little effect on the pharmacokinetics of either.

A single dose of Atenolol/Chlorthalidone Taj Pharma 50/12.5mg is effective for at least 24 hours.

  • Preclinical safety data

No data of relevance which is additional to that already included in other sections of the SPC.

  1. Pharmaceutical particulars
    • List of excipients

Magnesium Carbonate, Heavy

Maize Starch

Sodium Laurilsulfate

Gelatin

Magnesium Stearate

Coating:

Hypromellose

Titanium Dioxide

Ethylcellulose

Diethyl phthalate

  • Incompatibilities

None known.

  • Shelf life

4 years.

  • Special precautions for storage

Do not store above 25°C. Store in the original package.

  • Nature and contents of container

Al/PVC blister containing 28, 56, 84, 112, 140, 168, 196, 224, 252, 280, 360 or 500 tablets enclosed within a carton.

Not all pack sizes may be marketed.

  • Special precautions for disposal and other handling

Not applicable.

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

Atenolol/Chlorthalidone Tablets USP 100mg/25mg Taj Pharma

Package leaflet: Information for the patient

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

1.What Atenolol/Chlorthalidone Taj Pharma is and what it is used for

Atenolol/Chlorthalidone Taj Pharma is used to treat high blood pressure (hypertension). It contains two different medicines: atenolol and chlortalidone. These medicines work together to lower your blood pressure.

  • Atenolol belongs to a group of medicines called beta-blockers. It works by making your heart beat more slowly and with less force.
  • Chlortalidone belongs to a group of medicines called diuretics. It works by increasing the amount of urine produced by your kidneys.
  1. What you need to know before you take Atenolol/Chlorthalidone Taj Pharma

Do not take Atenolol/Chlorthalidone Taj Pharma:

  • If you are allergic to Atenolol/Chlorthalidone Taj Pharma, Tenoret, Tenormin, atenolol, chlortalidone or any of the other ingredients of this medicine (listed in section 6).
  • If you have ever had any of the following heart problems:
    • heart failure which is not under control (this usually makes you breathless and causes your ankles to swell)
    • second- or third-degree heart block (a condition which may be treated by a pacemaker)
    • very slow or very uneven heart beats, very low blood pressure or very poor circulation.
  • If you have problems with your kidneys.
  • If you have a tumour called phaeochromocytoma that is not being treated. This is usually near your kidney and can cause high blood pressure.
  • If you have been told that you have higher than normal levels of acid in your blood (metabolic acidosis).
  • If you are pregnant, are trying to become pregnant or are breast-feeding.

Do not take Atenolol/Chlorthalidone Taj Pharma if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Atenolol/Chlorthalidone Taj Pharma.

Warning and precautions

Talk to your doctor or pharmacist before taking Atenolol/Chlorthalidone Taj Pharma:

If you have asthma, wheezing or any other similar breathing problems, or you get allergic reactions, for example to insect stings. If you have ever had asthma or wheezing, do not take this medicine without first checking with your doctor.

  • If you have a type of chest pain (angina) called Prinzmetal’s angina.
  • If you have poor blood circulation or controlled heart failure.
  • If you have first-degree heart block.
  • If you have diabetes. Your medicine may change how you respond to having low blood sugar. You may feel your heart beating faster.
  • If you have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine may hide the symptoms of thyrotoxicosis.
  • If you have problems with your adrenal glands.
  • If you have liver problems.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Atenolol/Chlorthalidone Taj Pharma.

Children

This medicine is not for use in children.

Other medicines and Atenolol/Chlorthalidone Taj Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Atenolol/Chlorthalidone Taj Pharma can affect the way some other medicines work and some medicines can have an effect on Atenolol/Chlorthalidone Taj Pharma.

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

  • Clonidine (for high blood pressure or migraine). If you are taking clonidine and Atenolol/Chlorthalidone Taj Pharma together, do not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine, your doctor will give you careful instructions about how to do it.
  • Verapamil, diltiazem and nifedipine (for high blood pressure or chest pain).
  • Disopyramide or amiodarone (for an uneven heart beat).
  • Digoxin (for heart problems).
  • Adrenaline, also known as epinephrine (a medicine that stimulates the heart).
  • Baclofen (a medicine used for muscle relaxation).
  • Ibuprofen or indometacin (for pain and inflammation).
  • Insulin or medicines that you take by mouth for diabetes.
  • Lithium (for certain mental illnesses).
  • Medicines to treat nose or sinus congestion or other cold remedies (including those you can buy in the pharmacy).
  • Betaxolol, carteolol, levobunolol and timolol (eye drops for glaucoma).

Operations

If you go into hospital to have an operation, tell the anaesthetist or medical staff that you are taking Atenolol/Chlorthalidone Taj Pharma. This is because you can get low blood pressure (hypotension) if you are given certain anaesthetics while you are taking Atenolol/Chlorthalidone Taj Pharma.

Pregnancy and breast-feeding

  • Do not take Atenolol/Chlorthalidone Taj Pharma if you are pregnant or trying to get pregnant, ask your doctor for advice before using this medicine.
  • Do not take Atenolol/Chlorthalidone Taj Pharma if you are breast-feeding, ask your doctor for advice before using this medicine.

Driving and using machines

  • Your medicine is not likely to affect you being able to drive or use any tools or machines. However, it is best to wait to see how your medicine affects you before trying these activities.
  • If you feel dizzy or tired when taking this medicine, ask your doctor for advice.
  1. How to take Atenolol/Chlorthalidone Taj Pharma

The score line is not intended for breaking the tablet.

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

  • Your doctor will tell you how many tablets to take each day and when to take them. Read the label on the carton to remind you what the doctor said.
  • Swallow your Atenolol/Chlorthalidone Taj Pharma tablet with a drink of water.

Adults

The recommended dose for an adult is one tablet each day.

Children

Your medicine must not be given to children.

If you take more Atenolol/Chlorthalidone Taj Pharma than you should

If you take more Atenolol/Chlorthalidone Taj Pharma than prescribed by your doctor, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so that the tablets can be identified.

If you forget to take Atenolol/Chlorthalidone Taj Pharma

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

If you stop taking Atenolol/Chlorthalidone Taj Pharma

Do not stop taking Atenolol/Chlorthalidone Taj Pharma without talking to your doctor. In some cases, you may need to stop taking it gradually.

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

  1. Possible side effects

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

Allergic reactions:

If you have an allergic reaction, see a doctor straight away. The signs may include raised lumps on your skin (weals) or swelling of your face, lips, mouth, tongue or throat.

Other possible side effects:

Common (may affect up to 1 in 10 people)

  • Cold hands and feet.
  • You may notice that your pulse rate becomes slower while you are taking the tablets. This is normal, but if you are concerned please tell your doctor about it.
  • Feeling sick (nausea).
  • Feeling tired.
  • Changes in the amount of certain substances in your blood. It can cause:
    • higher levels of sugar (glucose) than normal,
    • low levels of sodium, which may cause weakness, being sick (vomiting) and cramps,
    • low levels of potassium,
    • an increase in the amount of uric acid.

Your doctor may take blood samples every so often to check on these levels.

Uncommon (may affect up to 1 in 100 people)

  • Disturbed sleep.

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

  • Heart block (which can cause an abnormal heart beat, dizziness, tiredness or fainting).
  • Numbness and spasm in your fingers which is followed by warmth and pain (Raynaud’s disease).
  • Dizziness (particularly when standing up).
  • Feeling confused.
  • Changes in personality (psychoses) or hallucinations.
  • Mood changes.
  • Dry mouth.
  • Thinning of your hair.
  • Dry eyes.
  • Skin rash.
  • Tingling of your hands.
  • Disturbances of vision.
  • Bruising more easily or purplish marks on your skin.
  • Being unable to get an erection (impotence).
  • Jaundice (causing yellowing of your skin or the whites of your eyes).
  • Pancreatitis (inflammation of a large gland behind the stomach).
  • A reduced number of white blood cells.

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

  • Changes to some of the cells or other parts of your blood. Your doctor may take blood samples every so often to check whether Atenolol/Chlorthalidone Taj Pharma has had any effect on your blood.

Not known (frequency cannot be estimated from the available data)

  • Lupus-like syndrome (a disease where the immune system produces antibodies that attacks mainly skin and joints).

Conditions that may get worse

If you have any of the following conditions, they may get worse when you start to take your medicine. This happens rarely affecting less than 1 in 1,000 people:

  • Psoriasis (a skin condition).
  • Being short of breath or having swollen ankles (if you have heart failure).
  • Asthma or breathing problems.
  • Poor circulation.

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.

  1. How to store Atenolol/Chlorthalidone Taj Pharma
  • Keep this medicine out of the sight and reach of children. Your medicine could harm them.
  • Do not use your tablets after the expiry date which is stated on the blister strip and carton. The expiry date refers to the last day of that month.
  • Do not store above 25°C. Store your tablets in the original package. Keep the blister strip in the carton. This will protect your medicine from light and moisture.

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

  1. Contents of the pack and other information

What Atenolol/Chlorthalidone Taj Pharma contains

The active substances are atenolol and chlortalidone.

Each tablet contains 50mg (milligrams) of atenolol and 25mg of chlortalidone.

Each tablet contains 100mg (milligrams) of atenolol and 25mg of chlortalidone.

The other ingredients are gelatin, glycerol, magnesium carbonate, magnesium stearate, methylhydroxypropylcellulose, sodium laurilsulfate, titanium dioxide and maize starch.

What Atenolol/Chlorthalidone Taj Pharma looks like and contents of the pack

Atenolol/Chlorthalidone Taj Pharma tablets are white, round biconvex, film-coated tablets

Pack Size:

Al/PVC blister containing 28, 56, 84, 112, 140, 168, 196, 224, 252, 280, 360 or 500 tablets enclosed within a carton.

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