1.NAME OF THE MEDICINAL PRODUCT
a) Salbutamol Tablets USP 2mg Taj Pharma

b) Salbutamol Tablets USP 4mg Taj Pharma

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
a) Each tablet contains

Salbutamol sulfate USP 8mg
equivalent to 4mg salbutamol.

b) Each tablet contains
Salbutamol sulfate USP
equivalent to 2mg salbutamol.

For the full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM
Tablets for oral administration.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Salbutamol Tablets are indicated in adults, adolescents and children aged 2 to 12 years.
1. For the relief of bronchospasm in bronchial asthmas of all types.
2. Chronic bronchitis.
3. Emphysema.

4.2  Posology and method of administration
Posology

Adults:
The usual effective dose is 4mg three or four times per day. If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 8mg. However, it has been established that some patients obtain adequate relief with 2mg three or four times daily. In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate treatment with 2mg three or four times per day.

Children:
The following doses should be administered three or four times daily.
2-6 years: 1-2mg
6-12 years: 2mg
Over 12 years: 2-4mg

The product is not recommended for children under 2 years of age. The drug is well tolerated by children so that, if necessary, these doses may be cautiously increased.

Method of administration
For oral use.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Salbutamol should not be used for threatened abortion during the first or second trimester of pregnancy.

Salbutamol and beta-blocking drugs such as propranolol should not usually be prescribed together.

 4.4 Special Warnings and precautions for use
Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma.

Increasing use of bronchodilators in particular short-acting inhaled beta2-agonists to relieve symptoms indicates deterioration of asthma control. If patients find that short acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.

Salbutamol causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac output.

Hyperthyroidism
Salbutamol should only be administered cautiously to patients suffering from thyrotoxicosis after careful evaluation of the benefits and risks of treatment.

Constant monitoring of potassium levels in patients with severe asthma is essential, potentially serious hypokalaemia may result from beta-2 agonist therapy.

In common with other β-adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels.

Diabetes
Administration of beta agonists is associated with a rise of blood glucose. Therefore blood glucose and lactate levels should be monitored in diabetics and diabetic treatment adjusted accordingly to meet the needs of the diabetic during tocolysis (see section 4.5). Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported.

Concurrent administration of corticosteroids can exaggerate this effect.
Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with beta agonists.

Respiratory indications
Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.

Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose – galactose malabsorption should not take this medicine.

Salbutamol tablets contain carmoisine (E122) which may cause allergic reactions

4.5 Interaction with other medicinal products and other forms of interaction
The effects of salbutamol may be altered by guanethidine, reserpine, methyldopa, tricyclic antidepressants and monoamine oxidase inhibitors.

There is an increased risk of hypokalaemia if high doses of theophylline or high doses of corticosteroids are given with higher doses of salbutamol.

Halogenated anaesthetics
Owing to the additional antihypertensive effect, there is increased uterine inertia with risk of haemorrhage; in addition, serious ventricular rhythm disorders due to increased cardiac reactivity, have been reported on interaction with halogenated anaesthetics. Treatment should be discontinued, whenever possible, at least 6 hours before any scheduled anaesthesia with halogenated anaesthetics.

Anti-diabetics
The administration of beta-agonists is associated with a rise of blood glucose, which can be interpreted as an attenuation of anti-diabetic therapy; therefore individual anti-diabetic therapy may need to be adjusted (see section 4.4).

Potassium depleting agents
Owing to the hypokalaemic effect of beta-agonists, concurrent administration of serum potassium depleting agents known to exacerbate the risk of hypokalaemia, such as diuretics, digoxin, methyl xanthines and corticosteroids, should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia (see section 4.4).

4.6 Fertility, Pregnancy and lactation
Pregnancy
Salbutamol should only be used during pregnancy if it is considered essential by the physician.

Breast-feeding
As salbutamol is probably secreted in breast milk its use in nursing mothers requires careful consideration.

It is not known whether salbutamol has a harmful effect on the neonate, and so its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.

4.7 Effects on ability to drive and use machines
None known.

4.8 Undesirable Effects
The frequencies of adverse reactions are ranked according to the following MedDRA convention: Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).

System organ classCommonUncommonRareVery rareNot known
Immune system disordersHypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse
Metabolism and nutrition disordersLactic acidosis

Hypokalaemia

Nervous system disordersHeadaches

Myoclonus

Cardiac disordersPeripheral vasodilation and compensatory increase in heart rate*

Cardiac arrhythmias

Myocardial ischemia**

Respiratory, thoracic and mediastinal disordersPulmonary oedema
Musculoskeletal and connective tissue disordersSkeletal muscle tremor***

Tense feeling****

* With doses of salbutamol higher than those recommended or in patients who are unusually sensitive to beta-adrenergic stimulants.

** There have been spontaneously reports of myocardial ischemia in post-marketing experience (frequency unknown, see section 4.4).

*** A fine tremor, which occurs in some patients, usually the hands and the effects are dose related.

**** Due to the effects on skeletal muscle and not to direct CNS stimulation.

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.

 4.9 Overdose
The preferred antidote for overdosage with salbutamol is a cardioselective beta blocking agent, but beta blocking drugs should be used with caution in patients with a history of bronchospasm.

Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Selective beta-2-adrenoreceptor agonists

Salbutamol is a selective beta-2-adrenergic agonist administered for the symptomatic relief of bronchospasm associated with chronic or acute asthma, brochitis or other obstructive pulmonary diseases. Because of its relative specificity for β2 receptors, salbutamol relaxes smooth muscle of the bronchi, uterus and vascular supply to the skeletal muscle, but generally has much less stimulant action on the heart than does isoproterenol which has powerful action on all beta receptors.

 5.2 Pharmacokinetic properties
Absorption
Salbutamol is readily absorbed from the gastrointestinal tract. Its effects occur within 15 minutes and last for about 14 hours.

The peak plasma concentration of salbutamol and its metabolites is 5.1-11.7μg% at 2.5-3 hours after an oral dose of 4mg. Salbutamol does not cross the blood brain barrier to a significant extent, but it crosses the placental barrier.

Elimination
The drug is excreted in urine in about 24 hours, 50% of the drug being excreted within 4 hours.

5.3 Preclinical safety data
None stated.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
The tablets also contain: maize starch, lactose monohydrate, dispersed pink (erythrosine (E127), carmoisine (E122), titanium dioxide (E171)), sodium starch glycollate, talc, magnesium stearate.

6.2 Incompatibilities
None known.

6.3  Shelf life
3 years.

6.4 Special precautions for storage
Store below 25°C in a dry place.

6.5 Nature and contents of container
Polypropylene tubes with low density polyethylene caps. Packing material: high density polyethylene film.
28s, 30s, 56s, 60s, 84s, 100s, 250s, 500s, 1000s
Polyethylene container with a polypropylene lid.
28s

6.6 Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. 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

Salbutamol Tablets USP 2mg Taj Pharma

Package leaflet: Information for the patient

a) Salbutamol Tablets USP 2mg Taj Pharma
b) Salbutamol Tablets USP 4mg Taj Pharma

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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet
1. What  Salbutamol is and what it is used for
2. Before you are given Salbutamol
3. How you will be given  Salbutamol
4. Possible side effects
5. How Salbutamol is stored
6. Further Information

1. What Salbutamol is and what it is used for
Salbutamol tablets belong to a group of medicines called selective beta-2-adrenergic agonists, which can be used to relax the muscles of the airways and womb. Salbutamol tablets may be used in:
· asthma, to relieve the narrowing of the airways
· chronic bronchitis
· emphysema

2. Before you are given Salbutamol
Do not take Salbutamol tablets and tell your doctor if you:
· are allergic to salbutamol or any of the other ingredients of this medicine (listed in section 6)
· have threatened abortion (potential miscarriage) during the first six months of pregnancy
· are taking beta-blockers such as propranolol

Warnings and precautions
Talk to your doctor or pharmacist before taking Salbutamol tablets if you have:
· an overactive thyroid gland (thyrotoxicosis).
· diabetes.
· a history of heart disease, irregular heart rhythm or angina.
Although it is not known exactly how often this happens, some people occasionally experience chest pain (due to heart problems such as angina) or difficulty breathing. Tell your doctor/midwife if you develop these symptoms whilst receiving treatment with salbutamol, but do not stop using this medicine unless told to do so.

Other medicines and Salbutamol tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Especially:
· diuretics, guanethidine, reserpine or methyldopa (to treat high blood pressure)
· monoamine oxidase inhibitors e.g. tranylcypromine (for depression)
·  tricyclic antidepressants e.g. amitriptyline (for depression)
·  beta-blockers such as propranolol
·  corticosteroids
·  theophylline (for breathing problems).
·  inhaled anaesthetics (advise your doctor or dentist if you are undergoing any dentistry or surgery)
· digoxin (for heart problems)
· xanthines such as theophylline, aminophylline (for asthma)
· medicines for diabetes

Pregnancy and breast-feeding
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.

Salbutamol tablets contain lactose
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a sugar called lactose.

Salbutamol tablets contain carmoisine (E122)
Salbutamol tablets contain carmoisine (E122) which may cause allergic reactions.

Tests
If you have severe asthma, your doctor may monitor you more closely by carrying out certain tests.

3. How you will be given Salbutamol
Always take Salbutamol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets with water

If you notice the tablets are not working as well as before, contact your doctor for advice.

  • Adults:
    The recommended dose is 4mg three or four times a day. Your doctor may increase this gradually up to a maximum of 8mg three or four times a day. Some patients may be treated successfully with 2mg three or four times a day.
  • Elderly or patients known to be sensitive to this product or other similar drugs:
    The recommended dose is initially 2mg three or four times a day.
  • Children 2-6 years:
    The recommended dose is 1-2mg three or four times a day.
  • Children 6-12 years:
    The recommended dose is 2mg three or four times a day.
  • Children over 12 years:
    The recommended dose is 2-4mg three or four times a day.
  • Children under 2 years:
    Not recommended.

If you take more than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include low levels of potassium in the blood which may cause muscle twitching or weakness and an irregular heart beat.

If you forget to take the tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

4. Possible Side Effects
Like all medicines, Salbutamol tablets can cause side effects, although not everybody gets them.

Stop taking and contact your doctor immediately if you experience
· an allergic reaction such as swelling of the face, lips, throat or tongue, pale or red irregular raised patches with severe itching (hives), difficulty breathing, low blood pressure, collapse

Contact your doctor immediately if you experience:
· chest, jaw or shoulder pain (which may be accompanied with shortness of· breath, feeling or being sick)

Tell your doctor if you notice any of the following effects or if you notice any not listed: Not known (frequency cannot be estimated from the available data)
· increased lactic acid in the body: rapid breathing, being sick, stomach pain.
· low blood potassium: muscle twitching or weakness, an irregular heart beat.
· other: headaches, increased blood sugar levels, slight shaking (usually of the hands),· a tense feeling, widening of blood vessels which can cause an increase in heart function and heart rate, an irregular heart beat, chest pain (due to heart problems such as angina), muscle spasm, fluid on the lungs. An increase in the amount of acid in the body (ketoacidosis) may occur in diabetics.

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 Salbutamol is stored
Keep this medicine out of the sight and reach of children.
Store below 25°C in a dry place.
Do not use Salbutamol tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.
Do not throw away 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.

6. Further information

What Salbutamol contains
The active substance (the ingredient that makes the tablets work) is salbutamol sulfate.
a) Each tablet contains
Salbutamol sulfate USP
equivalent to 2mg salbutamol.

b) Each tablet contains
Salbutamol sulfate USP 8mg
equivalent to 4mg salbutamol.

The other ingredients are maize starch, lactose monohydrate, dispersed pink (erythrosine (E127), carmoisine (E122), titanium dioxide (E171), sodium starch glycollate, talc, magnesium stearate.

What Salbutamol looks like and contents of the pack
Salbutamol tablets are pink, circular, flat bevelled edge, uncoated tablets.
Pack size is 28.

7. 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