Aspirin Tablets 75mg, 150mg Taj Pharma SMPC

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Leaflets, PIL.
ASPIRIN TABLETS 75MG/150MG - Secondary prevention of transient

ENTERIC COATED ischaemic attacks (TIA) and ischaemic
cerebrovascular accidents (CVA), provided
TAJ PHARMA
intracerebral haemorrhages have been ruled
out.
1. NAME OF THE MEDICINAL - Acute Myocardial infarction
PRODUCT
4.2 Posology and method of administration
Aspirin Tablets 75mg Enteric Coated Taj Adults
Pharma
Secondary prevention of myocardial
Aspirin Tablets 150mg Enteric Coated Taj infarction:
Pharma
The recommended dose is 75-160 mg once
2. QUALITATIVE AND daily.
QUANTITATIVE COMPOSITION
Prevention of cardiovascular morbidity in
a) Each enteric coated tablet contains: patients suffering from stable angina
pectoris:
Aspirin BP 75mg
The recommended dose is 75-160 mg once
Excipients q.s. daily.
b) Each enteric coated tablet contains: History of unstable angina pectoris, except
Aspirin BP 150mg during the acute phase:
Excipients q.s. The recommended dose is 75-160 mg once
daily.
For the full list of excipients, see section 6.1.
Prevention of graft occlusion after Coronary
3. PHARMACEUTICAL FORM Artery Bypass Grafting (CABG):
Enteric coated tablet. The recommended dose is 75-160 mg once
4. CLINICAL PARTICULARS daily.
4.1 Therapeutic indications Coronary angioplasty, except during the
- Secondary prevention of myocardial acute phase:
infarction. The recommended dose is 75-160 mg once
- Prevention of cardiovascular morbidity in daily.
patients suffering from stable angina Secondary prevention of transient ischaemic
pectoris. attacks (TIA) and ischaemic cerebrovascular
- History of unstable angina pectoris, except accidents (CVA), provided intracerebral
during the acute phase. haemorrhages have been ruled out:
- Prevention of graft occlusion after Coronary The recommended dose is 75-325 mg once
Artery Bypass Grafting (CABG). daily.
- Coronary angioplasty, except during the Acute myocardial infarction
acute phase.
Aspirin Tablets 75mg/150mg Enteric Coated Taj Pharma 100mg Tablets Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Aspirin Tablets 75mg/150mg Enteric Coated Taj Pharma Dosage & Rx Info | Aspirin
Leaflets, PIL.
The recommended loading dose is 150-450 - Methotrexate used at doses >15mg/week

mg. The loading dose is administered as soon (see section 4.5).
as possible after onset of symptoms.
4.4 Special warnings and precautions for
Elderly use
Aspirin Tablets is not suitable for use as an
In general, acetylsalicylic acids should be
anti-inflammatory/analgesic/antipyretic.
used with caution in elderly patients who are
more prone to adverse events. The usual adult Recommended for use in adults and
dose is recommended in the absence of adolescents from 16 years of age. This
severe renal or hepatic insufficiency (see medicinal product is not recommended for
sections 4.3 and 4.4). Treatment should be use in adolescents/children under 16 years
reviewed at regular intervals. unless the expected benefits outweigh the
risks. Acetylsalicylic acid may be a
Paediatric population
contributory factor in the causation of Reye's
Acetylsalicylic acid should not be Syndrome in some children.
administered to children and adolescents
There is an increased risk of haemorrhage
younger than 16 years, except on medical
particularly during or after operative
advice where the benefit outweighs the risk
procedures (even in cases of minor
(see section 4.4).
procedures, e.g. tooth extraction). Use with
Method of administration caution before surgery, including tooth
extraction. Temporary discontinuation of
For oral use.
treatment may be necessary.
4.3 Contraindications Aspirin Tablets is not recommended during
- Hypersensitivity to salicylic acid
menorrhagia where it may increase menstrual
compounds or prostaglandin synthetase
bleeding.
inhibitors (e.g. certain asthma patients who
may suffer an attack or faint) or to any of the Aspirin Tablets is to be used with caution in
excipients listed in section 6.1; cases of hypertension and when patients have
a past history of gastric or duodenal ulcer or
- Active, or history of recurrent peptic ulcer
haemorrhagic episodes or are undergoing
and/or gastric/intestinal haemorrhage, or
therapy with anticoagulants.
other kinds of bleeding such as
cerebrovascular haemorrhages; Patients should report any unusual bleeding
symptoms to their physician. If
- Haemorrhagic diathesis; coagulation
gastrointestinal bleeding or ulceration occurs
disorders such as haemophilia and
the treatment should be withdrawn.
thrombocytopenia;
Acetylsalicylic acid should be used with
- Severe hepatic impairment;
caution in patients with moderately impaired
- Severe renal impairment; renal or hepatic function (contraindicated if
severe), or in patients who are dehydrated
- Gout; since the use of NSAIDs may result in
- Doses >100 mg/day during the third deterioration of renal function. Liver function
trimester of pregnancy (see section 4.6); tests should be performed regularly in
Leaflets, PIL.
patients presenting slight or moderate hepatic Acetylsalicylic acid should be avoided in late
insufficiency. pregnancy and generally during breast
feeding (see section 4.6).
Acetylsalicylic acid may promote
bronchospasm and asthma attacks or other Acetylsalicylic acid in low doses reduces uric
hypersensitivity reactions. Risk factors are acid excretion. Due to this fact, patients who
existing asthma, hay fever, nasal polyps or tend to have reduced uric acid excretion may
chronic respiratory diseases. The same experience gout attacks (see section 4.5).
applies for patients who also show allergic
The risk of hypoglycaemic effect with
reaction to other substances (e.g. with skin
sulfonylureas and insulins may be potentiated
reactions, itching or urticaria).
with Aspirin Tablets taken at over dosage
Serious skin reactions, including Steven- (see section 4.5).
Johnsons syndrome, have rarely been
4.5 Interaction with other medicinal
reported in association with the use of
products and other forms of interaction
acetylsalicylic acid (see section 4.8). Aspirin
Contraindicated combinations
Tablets should be discontinued at the first
appearance of skin rash, mucosal lesions, or Methotrexate (used at doses >15 mg/week):
any other sign of hypersensitivity.
The combined drugs, methotrexate and
Elderly patients are particularly susceptible acetylsalicylic acid, enhance haematological
to the adverse effects of NSAIDs, including toxicity of methotrexate due to the decreased
acetylsalicylic acid especially renal clearance of methotrexate by
gastrointestinal bleeding and perforation acetylsalicylic acid. Therefore, the
which may be fatal (see section 4.2). Where concomitant use of methotrexate (at doses
prolonged therapy is required, patients >15 mg/week) with Aspirin Tablets is
should be reviewed regularly. contraindicated (see section 4.3).
Concomitant treatment with Aspirin Tablets Not recommended combinations
and other drugs that alter haemostasis (i.e.
Uricosuric agents, e.g. probenecid
anticoagulants such as warfarin, thrombolytic
and antiplatelet agents, anti-inflammatory Salicylates reverse the effect of probenecid.
drugs and selective serotonin reuptake The combination should be avoided.
inhibitors) is not recommended, unless
strictly indicated, because they may enhance Combinations requiring precautions for use
the risk of haemorrhage (see section 4.5). If or to be taken into account
the combination cannot be avoided, close Anticoagulants e.g. coumarin, heparin,
observation for signs of bleeding is warfarin
recommended.
Increased risk of bleeding due to inhibited
Caution should be advised in patients thrombocyte function, injury of the duodenal
receiving concomitant medications which mucosa and displacement of oral
could increase the risk of ulceration, such as anticoagulants from their plasma protein
oral corticosteroids, selective serotonin- binding sites. The bleeding time should be
reuptake inhibitors and deferasirox (see monitored (see section 4.4).
section 4.5).
Anti-platelet agents (e.g clopidogrel and
dipyridamole) and selective serotonin
Leaflets, PIL.
reuptake inhibitors (SSRIs; such as sertraline The combined drugs, methotrexate and
or paroxetine) acetylsalicylic acid, may increase
haematological toxicity of methotrexate due
Increased risk of gastrointestinal bleeding
to decreased renal clearance of methotrexate
(see section 4.4).
by acetylsalicylic acid. Weekly blood count
Antidiabetics, e.g. sulfonylureas checks should be done during the first weeks
of the combination. Enhanced monitoring
Salicylics may increase the hypoglycaemic
should take place in the presence of even
effect of sulfonylureas.
mildly impaired renal function, as well, as in
Digoxin and lithium elderly.
Acetylsalicylic acid impairs the renal Other NSAIDs
excretion of digoxin and lithium, resulting in
Increased risk of ulcerations and
increased plasma concentrations. Monitoring
gastrointestinal bleeding due to synergistic
of plasma concentrations of digoxin and
effects.
lithium is recommended when initiating and
terminating treatment with acetylsalicylic Ibuprofen
acid. Dose adjustment may be necessary
Experimental data suggest that ibuprofen
Diuretics and antihypertensives may inhibit the effect of low dose
acetylsalicylic acid on platelet aggregation
NSAIDs may decrease the antihypertensive
when they are dosed concomitantly.
effects of diuretics and other antihypertensive
However, the limitations of these data and the
agents. As for other NSAIDs concomitant
uncertainties regarding extrapolation of ex
administration with ACE-inhibitors increases
vivo data to the clinical situation imply that
the risk of acute renal insufficiency.
no firm conclusions can be made for regular
Diuretics: Risk of acute renal failure due to ibuprofen use, and no clinically relevant
the decreased glomerual filtration via effect is considered to be likely for occasional
decreased renal prostaglandin synthesis. ibuprofen use (see section 5.1).
Hydrating the patient and monitoring renal
Ciclosporin, tacrolimus
function at the start of the treatment is
recommended. Concomitant use of NSAIDs and ciclospoin
or tacrolimus may increase the nephrotoxic
Carbonic anhydrase inhibitors
effect of ciclosporin and tacrolimus. The
(acetazolamide)
renal function should be monitored in case of
May result in severe acidosis and increased concomitant use of these agents and
central nervous system toxicity acetylsalicylic acid.
Systemic corticosteroids Antacids
The risk of gastrointestinal ulceration and The excretion of acetylsalicylic acid is
bleeding may be increased when increased by alkaline urine, which can occur
acetylsalicylic acid and corticosteroids are with some antacids.
co-administered (see section 4.4).
Alcohol
Methotrexate (used at doses <15 mg/week):
Leaflets, PIL.
Concomitant administration of alcohol and acid is used by a woman attempting to

acetylsalicylic acid increases the risk of conceive, or during the first and second
gastrointestinal bleeding. trimester of pregnancy, the dose should be
kept as low and duration of treatment as short
4.6 Fertility, pregnancy and lactation
as possible.
Pregnancy
During the third trimester of pregnancy, all
Low doses (up to 100 mg/day):
prostaglandin synthesis inhibitors may
Clinical studies indicate that doses up to 100 expose
mg/day for restricted obstetrical use, which
the foetus to:
require specialised monitoring, appear safe.
- cardiopulmonary toxicity (with premature
Doses of 100- 500 mg/day:
closure of the ductus arteriosus and
There is insufficient clinical experience pulmonary hypertension);
regarding the use of doses above 100 mg/day
- renal dysfunction, which may progress to
up to 500 mg/day. Therefore, the
renal failure with oligo- hydroamniosis;
recommendations below for doses of 500
mg/day and above apply also for this dose the mother and the neonate, at the end of
range. pregnancy, to:
Doses of 500 mg/day and above: - possible prolongation of bleeding time, an
anti-aggregating effect which may occur
Inhibition of prostaglandin synthesis may
even at very low doses.
adversely affect the pregnancy and/or the
embryo/foetal development. Data from - inhibition of uterine contractions resulting
epidemiological studies suggest an increased in delayed or prolonged labour.
risk of miscarriage and of cardiac
Consequently, acetylsalicylic acid at doses of
malformation and gastroschisis after use of a
100 mg/day and higher is contraindicated
prostaglandin synthesis inhibitor in early
during the third trimester of pregnancy.
pregnancy. The absolute risk for
cardiovascular malformation was increased Breastfeeding
from less than 1%, up to approximately 1.5
Low quantities of salicylates and of their
%. The risk is believed to increase with dose
metabolites are excreted into the breast milk.
and duration of therapy. In animals,
Since adverse effects for the infant have not
administration of a prostaglandin synthesis
been reported up to now, short-term use of
inhibitor has been shown to result in
the recommended dose does not require
increased pre- and post-implantation loss and
suspending lactation. In cases of long-term
embryo-foetal lethality. In addition,
use and/or administration of higher doses,
increased incidences of various
breastfeeding should be discontinued.
malformations, including cardiovascular,
have been reported in animals given a 4.7 Effects on ability to drive and use
prostaglandin synthesis inhibitor during the machines
organogenetic period. During the first and No studies on the effects on the ability to
second trimester of pregnancy, drive and use machines have been performed
acetylsalicylic acid should not be given with Aspirin 75mg/100mg/150mg Tablets.
unless clearly necessary. If acetylsalicylic
Leaflets, PIL.
Based on the pharmacodynamic properties Metabolism Not known:

and the side effects of acetylsalicylic acid, no and digestive Hyperuricemia.
influence on the reactivity and the ability to system
drive or use machines is expected. disorders
4.8 Undesirable effects Nervous system Rare:
Side effects are grouped on the basis of disorders Intracranial haemorrhage.
System Organ Class. Within each system Not known:
organ class the frequencies are defined as: Headache, vertigo.
very common (≥1/10), common (≥1/100 to Ear and Not known:
<1/10), uncommon (≥1/1,000 to <1/100), labyrinth Reduced hearing ability;
rare (≥1/10,000 to <1/1,000), very rare disorders tinnitus.
(<1/10,000) and not known (cannot be
Vascular Rare:
estimated from the available data)
disorders Hemorrhagic vasculitis.
Blood and Common: Respiratory, Uncommon:
lymphatic Increased bleeding thoracic and Rhinitis, dyspnoea.
system tendencies. mediastinal Rare:
disorders Rare: disorders Bronchospasm, asthma
Thrombocytopenia, attacks.
granulocytosis, aplastic Reproductive Rare: Menorrhagia.
anaemia. systemand
Not known: mammary
Cases of bleeding with disorders
prolonged bleeding time
such as epistaxis, gingival Gastrointestinal Common:
bleeding. Symptoms may disorders Dyspepsia.
persist for a period of 4–8 Rare:
days after acetylsalicylic Severe gastrointestinal
acid discontinuation. As a haemorrhage, nausea,
result there may be an vomiting.
increased risk of bleeding Not known:
during surgical procedures. Gastric or duodenal ulcers
Existing (haematemesis, and perforation.
melaena) or occult Hepatobiliary Not known:
gastrointestinal bleeding, disorders Hepatic insufficiency.
which may lead to iron Skin and Uncommon:
deficiency anaemia (more subcutaneous Urticaria.
common at higher doses). tissue disorders Rare:
Immune system Rare: Steven-Johnsons
disorders Hypersensitivity reactions, syndrome, Lyells
angio-oedema, allergic syndrome, purpura,
oedema, anaphylactic erythema nodosum,
reactions including shock. erythema multiforme.
Leaflets, PIL.
Renal and Not known: Impaired renal Furthermore, the following symptoms may
urinary tract function, salt and water occur: hyperthermia and perspiration,
disorders retention. resulting in dehydration: feelings of
restlessness, convulsions, hallucinations and
hypoglycaemia. Depression of the nervous
Reporting of suspected adverse reactions system may lead to coma, cardiovascular
Reporting suspected adverse reactions after collapse or respiratory arrest.
authorisation of the medicinal product is Treatment of overdose
important.
If a toxic dose has been ingested, hospital
4.9 Overdose admission is required. In the event of
Although considerable inter-individual moderate intoxication, inducing the patient to
variations are involved, it can be considered vomit should be attempted.
that the toxic dose is about 200 mg/kg in
adults and 100 mg/kg in children. The lethal If this fails, gastric lavage may be attempted
dose of acetylsalicylic acid is 25-30 grams. during the first hour after ingestion of a
Plasma salicylate concentrations above 300 substantial amount of the medicine.
mg/l indicate intoxication. Plasma Afterwards, administer activated carbon
concentrations above 500 mg/l in adults and (adsorbent) and sodium sulfate (laxative).
300 mg/l in children generally cause severe Activated charcoal may be given as a single
toxicity. dose (50 g for an adult, 1 g/kg body weight
Overdose may be harmful for elderly patients for a child up to 12 years).
and particularly for small children Alkalisation of the urine (250 mmol
(therapeutic overdose or frequent accidental NaHCO3, for three hours) whilst checking
intoxications may be fatal). urine pH levels. In the event of severe
Symptoms of moderate intoxications intoxication, haemodialysis is to be preferred.
Other symptoms to be treated
Tinnitus, hearing disorders, headache, symptomatically.
vertigo, confusion and gastrointestinal
symptoms (nausea, vomiting and abdominal 5. PHARMACOLOGICAL
pain). PROPERTIES
Symptoms of severe intoxications 5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic
Symptoms are related to severe disruption of agents: platelet aggregation inhibitors excl.
the acid-base balance. In the first instance heparin,
hyperventilation occurs, which results in
respiratory alkalosis. Respiratory acidosis Acetylsalicylic acid inhibits the platelet
ensues due to suppression of the respiratory activation: blocking the platelet
centre. In addition, metabolic acidosis occurs cyclooxygenase by acetylation, it inhibits
as a result of the presence of salicylate. thromboxane A2 synthesis, a physiological
activating substance released by the platelets
Since younger children are often not seen and which would play a role in the
until they have reached a late stage of complications of the atheromatosic lesions.
intoxication, they are usually in the stage of
acidosis.
Leaflets, PIL.
Inhibition of TXA2-synthesis is irreversible, After oral administration, acetylsalicylic acid

because thrombocytes, which have no is rapidly absorbed from the gastrointestinal
nucleus, are not capable (due to lack of tract. However, a significant portion of the
protein synthesis capability) to synthesise dosage is already hydrolysed to salicylic acid
new cyclooxygenase, which had been in the intestinal wall during the absorption
acetylated by acetylsalicylic acid. process.
The repeated doses from 20 to 325 mg Distribution
involve an inhibition of the enzymatic
Acetylsalicylic acid as well as the main
activity from 30 to 95%.
metabolite salicylic acid, are extensively
Due to the irreversible nature of the binding, bound to plasma proteins, primarily albumin,
the effect persists for the lifespan of a and distributed rapidly into all parts of the
thrombocyte (7-10 days). The inhibiting body. Maximum plasma concentration is
effect does not exhaust during prolonged reached after 0.3 - 2 hours (total salicylate).
treatments and the enzymatic activity The volume of distribution of acetylsalicylic
gradually begins again upon renewal of the acid is ca. 0.16 l/kg of body weight.
platelets 24 to 48 hours after treatment
Biotransformation
interruption.
Acetylsalicylic acid is rapidly metabolised to
Acetylsalicylic acid extends bleeding time on
salicylic acid, with a half-life of 15-30
average by approximately 50 to 100%, but
minutes. Salicylic acid is subsequently
individual variations can be observed.
predominantly converted into glycine and
Experimental data suggest that ibuprofen glucuronic acid conjugates.
may inhibit the effect of low dose
Elimination kinetics of salicylic acid is dose-
acetylsalicylic acid on platelet aggregation
dependent, because the metabolism is limited
when they are dosed concomitantly.
by liver enzyme capacity. Thus, elimination
In one study, when a single dose of ibuprofen half-time varies and is 2-3 hours after low
400 mg was taken within 8 h before or within doses (75 mg – 160 mg).
30 min after immediate release
Excretion
acetylsalicylic acid dosing (81 mg), a
decreased effect of acetylsalicylic acid on the Salicylic acid and its metabolites are
formation of thromboxane or platelet predominantly excreted via the kidneys.
aggregation occurred. However, the
limitations of these data and the uncertainties 5.3 Preclinical safety data
The nonclinical safety profile of
regarding extrapolation of ex vivo data to the
acetylsalicylic acid is well documented.
clinical situation imply that no firm
conclusions can be made for regular In experimental animal studies, salicylates
ibuprofen use, and no clinically relevant have shown no other organ injury than renal
effect is considered to be likely for occasional damage. In rat studies, fetotoxicity and
ibuprofen use. teratogenic effects were observed with
acetylsalicylic acid at maternotoxic doses.
5.2 Pharmacokinetic properties
Clinical relevance is unknown as the doses
Absorption
used in non-clinical studies are much higher
(7 times at least) than the maximal
Leaflets, PIL.
recommended doses in targeted 7. MANUFACTURED IN INDIA BY:

cardiovascular indications. Acetylsalicylic
acid was extensively investigated with regard
TAJ PHARMACEUTICALS LTD.
to mutagenic and carcinogenic effects. The
Mumbai, India
results as a whole show no relevant signs for
Unit No. 214.Old Bake House,
any mutagenic or carcinogenic effects in
Maharashtra chambers of Commerce Lane,
mice and rat studies.
Fort, Mumbai - 400001
6. PHARMACEUTICAL at:Gujarat, INDIA.
PARTICULARS Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-
a) Each enteric coated tablet contains:
800-222-825)
Aspirin BP 75mg Monday through Saturday 9:00 a.m. to 7:00
p.m. EST
Excipients q.s. E-mail: tajgroup@tajpharma.com
b) Each enteric coated tablet contains:
Aspirin BP 150mg
Excipients q.s.
6.1 List of excipients
Microcrystalline cellulose
Maize starch
Silica, colloidal anhydrous
Stearic acid
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
PVC/PVDC/Al blisters.
Pack sizes: Blisters: 7, 14, 28, 30, 50, 90, 100
and 500mg modified-release tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and
other handling
No special requirements.

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Aspirin Tablets 75mg/150mg Enteric Coated Taj Pharma 100mg Tablets Taj Pharma : Uses, Side Effects, Interactions,

ASPIRIN TABLETS 75MG/150MG - Secondary prevention of transient

The recommended loading dose is 150-450 - Methotrexate used at doses >15mg/week

Concomitant administration of alcohol and acid is used by a woman attempting to

Based on the pharmacodynamic properties Metabolism Not known:

Symptoms of severe intoxications 5.1 Pharmacodynamic properties

Inhibition of TXA2-synthesis is irreversible, After oral administration, acetylsalicylic acid

recommended doses in targeted 7. MANUFACTURED IN INDIA BY:

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