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NON-DROWSY SINUTAB

Active substance(s): PARACETAMOL / PSEUDOEPHEDRINE HYDROCHLORIDE / PARACETAMOL / PSEUDOEPHEDRINE HYDROCHLORIDE / PARACETAMOL / PSEUDOEPHEDRINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Non-Drowsy Sinutab

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Non-drowsy Sinutab tablets contain 30mg EP Pseudoephedrine Hydrochloride
and 500mg Paracetamol Ph Eur.

3

PHARMACEUTICAL FORM
Tablets

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Non-Drowsy Sinutab is indicated for the symptomatic relief of conditions
where congestion of the mucous membranes of the upper respiratory tract,
especially nasal mucosa and sinuses, is accompanied by mild to moderate pain
or pyrexia, e.g.: the common cold and influenza, sinusitis, nasopharyngitis,
allergic rhinitis and vasomotor rhinitis.

4.2

Posology and method of administration
Adults and children aged 16 years and over:
Oral. Two tablets every four to six hours, up to four times a day. Maximum daily dose:
8 tablets (i.e. 240 mg pseudoephedrine hydrochloride, 4 g paracetamol).
Children aged 12 years to 15 years
Oral. One tablet every four to six hours, up to four times a day. Maximum daily dose: 4
tablets (i.e. 120 mg pseudoephedrine hydrochloride, 2 g paracetamol).
Children under 12 years:
NON-DROWSY SINUTAB is contraindicated in children under the age of 12 years
(see section 4.3).

The Elderly:
There have been no specific studies of NON-DROWSY SINUTAB in the elderly.
Experience has indicated that normal adult dosage is appropriate.
In the elderly the rate and extent of paracetamol absorption is normal but plasma half
life is longer and paracetamol clearance is lower than in young adults.
Hepatic dysfunction

Caution should be exercised when administering NON-DROWSY SINUTAB to
patients with severe hepatic impairment.
Renal dysfunction:
Caution should be exercised when administering NON-DROWSY SINUTAB to
patients with moderate to severe renal impairment.
Do not exceed the stated dose.
Keep out of the reach and sight of children.

4.3

Contraindications
Non-Drowsy Sinutab is contraindicated in individuals with known
hypersensitivity to the product or any of its components.
Non-Drowsy Sinutab is contraindicated in patients with severe hypertension or
coronary artery disease.
Non-Drowsy Sinutab is contraindicated in patients who are taking or have
taken monoamine oxidase inhibitors within the preceding two weeks. The
concomitant use of pseudoephedrine and this type of product may occasionally
cause a rise in blood pressure.
Not to be used in children under the age of 12 years.

4.4

Special warnings and precautions for use
Although pseudoephedrine has virtually no pressor effects in normotensive
patients, Non-Drowsy Sinutab should be used with caution in patients
suffering from mild to moderate hypertension.
As with other sympathomimetic agents Non-Drowsy Sinutab should be used
with caution in patients with hypertension, heart disease, diabetes,
hyperthyroidism, elevated intraocular pressure and prostatic enlargement.
Care is advised in the administration of paracetamol to patients with severe
renal or severe hepatic impairment. The hazards of overdose are greater in
those with alcoholic liver disease.
The following statements will appear on packs of this product.
Do not store above 25ºC. Store in the original packaging.
Warning: Do not exceed the recommended dose.
Keep out of the reach and sight of children.
If symptoms persist consult your doctor.
Contains paracetamol.
Causes no drowsiness.
‘Immediate medical advice should be sought in the event of an overdose, even
if you feel well. (label).
Immediate medical advice should be sought in the event of an overdose, even
if you feel well, because of the risk of delayed, serious liver damage.’ (leaflet)
Do not take with any other paracetamol-containing products.’

As with all medicines, if you are pregnant or currently taking any other
medicine, consult your doctor or pharmacist before taking this product.

4.5

Interaction with other medicinal products and other forms of interaction
Concomitant use of Non-Drowsy Sinutab with tricyclic antidepressants,
sympathomimetic agents (such as decongestants, appetite suppressants and
amphetamine-like psychostimulants) or with monoamine oxidase inhibitors,
which interferes with the catabolism of sympathomimetic amines, may
occasionally cause a rise in blood pressure, [See Contra-indications].
Because of the pseudoephedrine content, Non-Drowsy Sinutab may partially
reverse the hypotensive action of drugs which interfere with sympathetic
activity including bretylium, betanidine, guanethedine, debrisoquine,
methyldopa, alpha- and beta-adrenergic blocking agents, [See Special
Warnings and Special Precautions for Use].
Patients who have taken barbiturates, tricyclic antidepressants and alcohol
may show diminished ability to metabolise large doses of paracetamol, the
plasma half-life of which can be prolonged. Alcohol can increase the
hepatotoxicity of paracetamol overdose and may have contributed to the acute
pancreatitis reported in one patient who had taken an overdose of paracetamol.
Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver
enzymes and may prevent attainment of therapeutic paracetamol levels by
increasing first pass metabolism or clearance.
The speed of absorption of paracetamol may be increased by metoclopramide
or domperidone and absorption reduced by colestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by
prolonged regular use of paracetamol with increased risk of bleeding;
occasional doses have no significant effect.

4.6

Pregnancy and lactation
Pseudoephedrine
Although pseudoephedrine has been in widespread use for many years without
apparent ill consequence, there are no specific data on its use during
pregnancy. Caution should therefore be exercised by balancing the potential
benefit of treatment to the mother against any possible hazards to the
developing foetus.
Systemic administration of pseudoephedrine, up to 50 times the human daily
dosage in rats and up to 35 times the human daily dosage in rabbits, did not
produce teratogenic effects.
Pseudoephedrine is excreted in breast milk in small amounts but the effect of
this on breast-fed infants is not known. It has been estimated that 0.5 to 0.7%
of a single dose of pseudoephedrine ingested by a mother will be excreted in
the breast milk over 24 hours.
No studies have been conducted in animals to determine whether
pseudoephedrine has the potential to impair fertility. There is no information
of the effect of Non-Drowsy Sinutab on fertility.

Paracetamol
Epidemiological studies in human pregnancy have shown no ill effects due to
paracetamol used in the recommended dosage. but patients should follow the
advice of their doctor regarding its use.
Paracetamol is excreted in breast milk but not in a clinically significant
amount. Available published data do not contraindicate breast feeding.

4.7

Effects on ability to drive and use machines
None known

4.8

Undesirable effects
Pseudoephedrine
Serious side effects associated with the use of pseudoephedrine are rare.
Symptoms of central nervous system excitation may occur, including sleep
disturbance and, rarely, hallucinations.
Skin rashes, with or without irritation, have occasionally been reported with
pseudoephedrine.
Urinary retention has been reported occasionally in men receiving
pseudoephedrine: prostatic enlargement could have been an important
predisposing factor.
Paracetamol
Paracetamol has been widely used and, when taken at the usual recommended
dosage, side effects are mild and infrequent and reports of adverse reactions are
rare. Skin rash and other allergic reactions occur rarely.
Most reports of adverse reactions to paracetamol relate to overdose with the
drug.
There have been reports of blood dyscrasias including thrombocytopenia and
agranulocytosis, but these were not necessarily causality related to paracetamol.
Chronic hepatic necrosis has been reported in a patient who took daily
therapeutic dosages of paracetamol for about a year and liver damage has been
reported after daily ingestion of excessive amounts for shorter periods. A
review of a group of patients with chronic active hepatitis failed to reveal
differences in the abnormalities of liver function in those who were long-term
users of paracetamol nor was the control of their disease improved after
paracetamol withdrawal.
Nephrotoxic effects following therapeutic dosages of paracetamol are
uncommon. Papillary necrosis has been reported after prolonged
administration.
Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard

4.9

Overdose
Pseudoephedrine
As with other sympathomimetic agents, symptoms and signs of
pseudoephedrine overdosage include irritability, restlessness, tremor,
convulsions, palpitations, hypertension and difficulty with micturition
Measures should be taken to maintain and support respiration and control
convulsions. Gastric lavage should be performed if indicated. Catheterisation
of the bladder may be necessary. If desired, the elimination of
pseudoephedrine can be accelerated by acid diuresis or by dialysis.
Paracetamol
Liver damage is possible in adults who have taken 10g or more of
paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage
if the patient has risk factors (see below).
Risk Factors:
If the patient
A. Is on long term treatment with carbamazepine, phenobarbital, phenytoin,
primidone, rifampicin, St John’s Wort or other drugs that induce liver
enzymes.
Or
B. Regularly consumes ethanol in excess of recommended amounts.
Or
C. Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis,
HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage 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
progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema,
coma and death. Acute renal failure with acute tubular necrosis, strongly
suggested by loin pain, haematuria and proteinuria, may develop even in the
absence of severe liver damage. Cardiac arrhythmias and pancreatitis have
been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose.
Despite a lack of significant early symptoms, patients should be referred to
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, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has
been taken within 1 hour. Plasma paracetamol concentration should be
measured at 4 hours or later after ingestion (earlier concentrations are
unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after
ingestion of paracetamol, however, the maximum protective effect is obtained
up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply
after this time. If required the patient should be given intravenous Nacetylcysteine, in line with the established dosage schedule. If vomiting is not
a problem, oral methionine may be a suitable alternative for remote areas,
outside hospital. Management of patients who present with serious hepatic
dysfunction beyond 24h from ingestion should be discussed with the NPIS or
a liver unit.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pseudoephedrine
Pseudoephedrine has direct and indirect sympathomimetic activity and is an
effective upper respiratory tract decongestant. Pseudoephedrine is
substantially less potent than ephedrine in producing both tachycardia and
elevation of systolic blood pressure and considerably less potent in causing
stimulation of the central nervous system.
Paracetamol
Paracetamol has analgesic and antipyretic actions but only weak antiinflammatory properties. This may be explained by presence of cellular
peroxides at sites of inflammation which prevent inhibition of cyclooxygenase by paracetamol. At other sites associated with low levels of cellular
perioxides, e.g. pain, fever, paracetamol can successfully inhibit prostaglandin
biosynthesis.

5.2

Pharmacokinetic properties
Pseudoephedrine
Pseudoephedrine is partly metabolised in the liver by N-demethylation to
norpseudoephedrine, an active metabolite. Pseudoephedrine and its metabolite
are excreted in the urine: 55% to 75% of a dose is excreted unchanged. The
rate of urinary excretion of pseudoephedrine is accelerated when the urine is
acidified. Conversely as the urine pH increases, the rate of urinary excretion is
slowed.
Paracetamol
Peak plasma paracetamol concentration usually occurs between 30 and 90
minutes after oral ingestion. Paracetamol is distributed uniformly throughout
most body fluids and is only 15 to 25 per cent bound to plasma proteins. The
plasma half life of paracetamol after therapeutic doses is in the range of 1 to 3
hours.

5.3

Preclinical safety data
The active ingredients of Non-Drowsy Sinutab are well known constituents of
medicinal products and their safety profile is well documented. The results of
pre-clinical studies do not add anything of relevance for therapeutic purposes.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
(Contained in compressible Paracetamol 90%)
Pregelatinised Maize Starch
Crospovidone
Povidone K30
Stearic Acid
Other ingredients
Microcrystalline Cellulose
Sodium Starch Glycollate
Magnesium Stearate

6.2

Incompatibilities
None known

6.3

Shelf life
3 years

6.4

Special precautions for storage
Do not store above 25ºC
Store in the original packaging

6.5

Nature and contents of container
Carton containing 4, 12, 15 or 24 tablets
Each blister strip consists of a white, opaque PVC/PVdC film and
paper/aluminium foil child resistant blister lidding

6.6

Special precautions for disposal
Any unused product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 15513/0027

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/03/1997

10

/

23/02/2011

DATE OF REVISION OF THE TEXT
22/11/2016

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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