Ibugesic Plus (Generic Ibuprofen and Paracetamol Tablets)

Ibugesic Plus (Ibuprofen and Paracetamol Tablets)
© The Swiss Pharmacy

Ibugesic Plus contains 2 ingredients: Ibuprofen And
Acetaminophen (Paracetamol). This medicine is used for the
management of mild to moderate pain and inflammation in
conditions such as dysmenorrhoea, headache, including
migraine, post-operative pain, dental pain, musculoskeletal and
joint disorders, peri-articular disorders and soft tissue disorders
(sprains and strains).This combination product works by
blocking your body's production of certain natural substances
that cause inflammation. This effect helps to decrease swelling,
pain, or fever.

Ibugesic Plus is manufactured by Cipla
Limited, India in the strengths of 725 mg
(400 mg of Ibuprofen, IP and 325 mg of
Paracetamol, IP).

Chemical Structure - Ibuprofen

Chemical Structure - Paracetamol

The active pharmaceutical ingredients
present in Ibugesic Plus tablets are
Ibuprofen and Paracetamol
(Acetaminophen). Each uncoated Ibugesic
Plus tablet contains 400 mg of Ibuprofen, IP
and 325 mg of Paracetamol, IP.
Active Ingredients

The dosage of
Ibugesic Plus (Ibuprofen and Paracetamol Tablets) is
given below.
Ibugesic Plus must not be used for more than 3 days at a
time. The dosage varies as per the condition being
treated. If Ibugesic Plus tablets are required in adults for
more than 3 days in the case of fever or for more than 4
days for the treatment of pain or if the symptoms worsen
the patient is advised to consult a physician.
Recommended Adult Dosage

Ibugesic Plus (Generic Ibuprofen and Paracetamol
Tablets) Dosage:
Adults and adolescents weighing from 40 kg body weight (aged 12
years and above):
Initial dose, 1 tablet of Ibugesic Plus. If necessary, additional doses of
Ibugesic Plus tablet can be taken. The respective dosing interval should
be chosen in line with the observed symptoms and the maximum
recommended daily dose. It should not be below 6 hours. A total dose of
3 tablets of Ibugesic Plus should not be exceeded in any 24-hour period.
This medicine has to be used for short-term use only.
Recommended Adult Dosage

Contraindications
Ibugesic Plus Tablets are contraindicated in patients with the
following conditions:
➔Hypersensitivity to Paracetamol, Ibuprofen, or any inactive
component of this medication.
➔Ibugesic Plus should not be given to patients who have experienced
asthma, urticaria, or allergic-type reactions after taking Aspirin or
other NSAIDs.
➔Ibugesic Plus is contraindicated for the treatment of peri-operative
pain in the setting of coronary artery bypass graft (CABG) surgery.

Contraindications
Ibugesic Plus Tablets are contraindicated in patients with the following
conditions:
➔Ibugesic Plus is also contraindicated in patients with a history of
gastrointestinal bleeding or perforation, related to previous NSAID
therapy. Ibugesic Plus should not be used in patients with active, or history
of, recurrent peptic ulcer or gastrointestinal haemorrhage (two or more
distinct episodes of proven ulceration or bleeding).
➔Ibugesic Plus should not be given to patients with conditions involving an
increased tendency to bleeding.
➔Ibugesic Plus is contraindicated in patients with severe heart failure
(NYHA Class IV), hepatic failure and renal failure.

Contraindications
Ibugesic Plus Tablets are contraindicated in patients with the following
conditions:
➔Ibugesic Plus is contraindicated in cerebrovascular or other active bleeding
➔Ibugesic Plus should not be given to Adolescents under 40 kg body weight
and children below 12 years of age.
➔Patients with severe dehydration (caused by vomiting, diarrhoea or
insufficient fluid intake).
➔In patients with active alcoholism as chronic excessive alcohol ingestion
may predispose patients to hepatotoxicity (due to the paracetamol
component).
➔Ibugesic Plus is contraindicated during the last trimester of pregnancy.

Side Effects of Ibugesic Plus Tablets
The common side effects of Ibuprofen are nausea, epigastric pain,
heartburn, diarrhea, abdominal distress, nausea and vomiting,
indigestion, constipation, abdominal cramps or pain, fullness of GI tract
(bloating and flatulence), dizziness, headache, nervousness, rash
(including maculopapular type), pruritus, tinnitus, decreased appetite,
edema, and fluid retention.
The most common side effects in patients treated with Paracetamol
(Acetaminophen) were nausea, vomiting, headache, and insomnia in
adult patients and nausea, vomiting, constipation, pruritus, agitation, and
atelectasis in pediatric patients.

The rare side effects of Ibuprofen include Gastic or duodenal ulcer
with bleeding and/or perforation, gastrointestinal hemorrhage,
melena, gastritis, hepatitis, jaundice, abnormal liver function tests;
pancreatitis, Depression, insomina, confusion, emotional lability,
somnolence, aseptic meningitis with fever and coma, vesiculobullous
eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome,
alopecia, hearing loss, amblyopia (blurred and/or diminished vision,
scotomata and/or changes in color vision).

The rare side effects of Ibuprofen include neutropenia,
agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs
Positive), thrombocytopenia with or without purpura, eosinophilia,
decreases in hemoglobin and hematocrit, congestive heart failure in
patients with marginal cardiac function, elevated blood pressure,
palpitations, Syndrome of abdominal pain, fever, chills, nausea and
vomiting; anaphylaxis; bronchospasm, acute renal failure, decreased
creatinine clearance, polyuria, azotemia, cystitis, hematuria, dry eyes
and mouth, gingival ulcer and rhinitis.

Warnings And Precautions
➔
Cardiovascular Thrombotic Events: Increased risk of serious
cardiovascular (CV) thrombotic events, myocardial infarction, and stroke,
which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may
have a similar risk.
➔
Hypertension: NSAIDs, including Ibuprofen, can lead to onset of new
hypertension or worsening of preexisting hypertension, either of which
may contribute to the increased incidence of cardiovascular events.
➔
Congestive Heart Failure and Edema: Fluid retention and edema have
been observed in some patients taking NSAIDs. Ibuprofen should be used
with caution in patients with fluid retention or heart failure.

➔
Gastrointestinal Effects: NSAIDs, including Ibuprofen and
Paracetamol (Ibugesic Plus tablets), can cause serious
gastrointestinal (GI) adverse events including inflammation,
bleeding, ulceration, and perforation of the stomach, small
intestine, or large intestine, which can be fatal.
➔
Renal Effects: Long-term administration of NSAIDs has resulted
in renal papillary necrosis and other renal injury.
➔
Advanced Renal Disease: Treatment with Ibuprofen and
Paracetamol tablets is not recommended in these patients with
advanced renal disease.

➔
Anaphylactic/Anaphylactoid Reactions: As with other NSAIDs, anaphylactic /
anaphylactoid reactions may occur in patients without known prior exposure to
Ibuprofen. Ibuprofen should not be given to patients with the Aspirin triad. This
symptom complex typically occurs in asthmatic patients who experience rhinitis with
or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after
taking aspirin or other NSAIDs.
➔
Skin Reactions: NSAIDs, including Ibuprofen, can cause serious skin adverse
events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic
epidermal necrolysis (TEN), which can be fatal. These serious events may occur
without warning. Patients should be informed about the signs and symptoms of
serious skin manifestations and use of the drug should be discontinued at the first
appearance of skin rash or any other sign of hypersensitivity.

➔
Infections and infestations: Exacerbation of skin infection-related
inflammations (e.g. development of necrotising fasciitis) coinciding
with the use of NSAIDs has been described. If signs of an infection
occur or get worse during use of Ibuprofen and Paracetamol tablets,
the patient is therefore recommended to go to a doctor without delay.
➔
Pregnancy: In late pregnancy, as with other NSAIDs, Ibugesic plus
tablets should be avoided because it may cause premature closure of
the ductus arteriosus.

➔
Infections and infestations: Exacerbation of skin infection-related
inflammations (e.g. development of necrotising fasciitis) coinciding with the
use of NSAIDs has been described. If signs of an infection occur or get worse
during use of Ibuprofen tablets the patient is therefore recommended to go to a
doctor without delay.
➔
Respiratory disorder: Caution is required if Ibuprofen is administered to
patients suffering from, or with a previous history of bronchial asthma, chronic
rhinitis or allergic diseases since Ibuprofen has been reported to cause
bronchospasm, urticarial or angioedema in such patients.
➔
Ophthalmological effects: Adverse ophthalmological effects have been
observed with NSAIDs; accordingly, patients who develop visual
disturbances during treatment with Ibuprofen should have an
ophthalmological examination.

➔
Maximum Dosage: The maximum daily dose of this medicine is 3 tablets
in any 24 hour period. Severe liver damage could occur if you take
more than 4,000 mg of Acetaminophen in 24 hours. Do not administer
this medicine with other drugs containing Acetaminophen
(Paracetamol)
➔
Alcohol Intake: Do not consume 3 or more alcoholic drinks every day
while using this product.You should not use this medicine if you have
severe liver disease.

Effects On Ability To Drive And Use Machines
Following treatment with Ibugesic Plus Tablets (Generic
Ibuprofen and Paracetamol), the reaction time of patients
may be affected.
Care should be taken when driving or operating machinery
as the activity may be affected by dizziness, drowsiness,
fatigue and visual disturbance. This applies to a greater
extent in combination with alcohol.

Ibugesic Plus Tablets Overdose Symptoms
The symptoms of Ibuprofen overdose has included nausea,
vomiting, abdominal pain, drowsiness, nystagmus, diplopia,
headache, tinnitus, impaired renal function, coma and hypotension
lethargy, central nervous system depression, seizures, metabolic
acidosis, coma, rhabdomyolysis, hypothermia, fulminant hepatic
failure, apnea (primarily in very young children), cardiovascular
toxicity including bradycardia, tachycardia and atrial fibrillation.a,
tachycardia and atrial fibrillation.

Ibugesic Plus Tablets Overdose Symptoms
Symptoms of Paracetamol overdose in the first 24 hours are pallor,
nausea, vomiting, anorexia and abdominal pain. Liver damage may
become apparent 12 to 48 hours after ingestion. Abnormalities of
glucose metabolism and metabolic acidosis may occur.
In severe poisoning, hepatic failure may proceed to encephalopathy,
coma and death. Acute renal failure with acute tubular necrosis
may develop in the absence of severe liver damage. Cardiac
arrhythmias have been reported.

Treatment of Ibugesic Plus Tablets Overdose
Appropriate interventions to decontaminate the gastrointestinal tract
may be beneficial within the first four hours after ingestion. Routine
symptomatic and supportive treatment is then recommended.
In cases of acute overdose of Ibuprofen , the stomach should be
emptied by vomiting or lavage, although little of the drug will be likely
to be recovered if it is more than an hour since ingestion.
Since the medication is acidic and excreted in the urine, it is
theoretically beneficial to administer alkali and induce diuresis. In
addition to supportive measures, the use of oral activated charcoal may
help reduce the absorption and reabsorption of Ibuprofen.

Treatment of Ibugesic Plus Tablets Overdose
Immediate treatment is essential in the management of
Paracetamol overdose. Despite a lack of significant early
symptoms, patients should be referred to a hospital urgently
for immediate medical attention. Symptoms may be limited
to nausea or vomiting and may not reflect the severity of
overdose or the risk of organ damage. Management should
be in accordance with established treatment guidelines.

Ibugesic Plus Tablets During Pregnancy
Ibuprofen has been classified by the US FDA as Pregnancy Category C ,
Category D at 30 weeks or greater of gestation, due to the potential for
premature closure of the ductus arteriosus.
Reproductive studies conducted in rats and rabbits have not demonstrated
evidence of developmental abnormalities. However, animal reproduction
studies are not always predictive of human response. There are no
adequate and well-controlled studies in pregnant women.
Because of the known effects of NSAIDs on the fetal cardiovascular system
(closure of ductus arteriosus), use during late pregnancy should be
avoided.

Ibugesic Plus Tablets During Pregnancy
Paracetamol (also known as Acetaminophen or APAP) is classified by
the US FDA as Pregnancy Category C. Use of this medicine during
pregnancy should be avoided unless advised by a doctor. This includes
maternal use during labor because of the potential of respiratory
depression in the neonate.
The safety of Paracetamol during pregnancy has not been established
relative to possible adverse effects on foetal development.
Ibugesic Plus should be used in pregnancy only if the potential benefit
justifies the potential risk to the fetus. Do not use this medicine without
the advice of your doctor if you are pregnant.

Ibugesic Plus Tablets manufactured by
Cipla Limited, India
For more information click here

Ibugesic Plus (Generic Ibuprofen and Paracetamol Tablets)

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