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IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200 MG/6.1 MG TABLETS

Active substance(s): IBUPROFEN / PHENYLEPHRINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ibuprofen and Phenylephrine Hydrochloride 200mg/6.1mg Tablets
Galpharm Pain Relief & Decongestant 200mg/6.1mg Tablets
Sudafed Congestion & Headache Relief Dual Action 200mg/6.1mg Tablets
Sudafed Sinus Pain Relief 200mg/6.1mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200 mg
Phenylephrine hydrochloride 6.1 mg
Sucrose 31.66 mg per tablet
Tartrazine 0.274 mg per tablet
For full list of excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Film-coated tablets (Tablets)
Green, round bi-convex sugar coated tablet.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

For the relief of symptoms of cold and 'flu with associated congestion, including
aches and pains, headache, fever, sore throat, blocked nose and sinuses.

4.2

Posology and method of administration
For oral administration and short-term use only.
Adults, the elderly and children between 12 and 18 years:
Undesirable effects may be minimised by using the lowest effective dose for the
shortest duration necessary to control symptoms (see section 4.4).
If in children between 12 and 18 years this medicinal product is required for more
than 3 days, or if symptoms worsen a doctor should be consulted.
If in adults the product is required for more than 10 days, or if the symptoms worsen
the patient should consult a doctor.
Two tablets every 8 hours, preferably with or after food. Leave at least 4 hours
between doses and do not exceed six tablets in any 24 hour period.
Not to be given to children under 12 years.

4.3

Contraindications

Hypersensitivity to ibuprofen, phenylephrine hydrochloride or any of the excipients in
the product.
Hypertension and severe coronary heart disease.
Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis,
angioedema or urticaria) in response to aspirin or other non-steroidal antiinflammatory drugs (NSAIDs).
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes
or proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to previous NSAIDs
therapy.
Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see Section
4.4).
Pregnancy (see section 4.6).
Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors (see
Section 4.5).

Patients being treated with monoamine oxidase inhibitors or within 14 days of ceasing
such treatment (see section 4.5).
Patients with diabetes mellitus.
Patients with closed angle glaucoma.
Patients with hyperthyroidism.
Patients suffering from prostatic enlargement.
Patients suffering with phaeochromocytoma.

4.4

Special warnings and precautions for use

Ibuprofen
Undesirable effects may be minimised by using the lowest effective dose for the
shortest duration necessary to control symptoms (see gastrointestinal and
cardiovascular risks below).
The elderly are at increased risk of consequence of adverse reactions to NSAIDs,
especially gastrointestinal bleeding and perforation which may be fatal.
Respiratory: Bronchospasm may be precipitated in patients suffering from or with a
previous history of bronchial asthma or allergic disease.
Other NSAIDs: The use of this product with concomitant NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided (see Section 4.5).
SLE and mixed connective tissue disease: Systemic lupus erythematosus and mixed
connective tissue disease - increased risk of aseptic meningitis (see Section 4.8).
Renal: Renal impairment as renal function may further deteriorate (see Sections 4.3
and 4.8).
There is a risk of renal impairment in dehydrated children aged between 12 and 18
years.
Hepatic: Hepatic dysfunction (see Sections 4.3 and 4.8).
Cardiovascular and cerebrovascular effects: Caution (discussion with doctor or
pharmacist) is required prior to starting treatment in patients with a history of
hypertension and/or heart failure as fluid retention, hypertension and oedema have
been reported in association with NSAID therapy.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400
mg/day) may be associated with a small increased risk of arterial thrombotic events
(for example myocardial infarction or stroke). Overall, epidemiological studies do not
suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased
risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III),
established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular
disease should only be treated with ibuprofen after careful consideration and high
doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term treatment of
patients with risk factors for cardiovascular events (e.g. hypertension,
hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen
(2400 mg/day) are required.
Impaired female fertility: There is limited evidence that drugs which inhibit
cyclooxygenase/ prostaglandin synthesis may cause impairment of female fertility by
an effect on ovulation. This is reversible on withdrawal of treatment.
Gastrointestinal: NSAIDs should be given with care to patients with a history of
gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be
exacerbated (see Section 4.8).
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all
NSAIDs at any time during treatment, with or without warning symptoms or a
previous history of serious GI events. The risk of GI bleeding, ulceration or
perforation is higher with increasing NSAID doses, in patients with a history of ulcer,
particularly if complicated with haemorrhage or perforation (see Section 4.3), and in
the elderly. These patients should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly the elderly, should report any
unusual abdominal symptoms (especially GI bleeding), particularly in the initial
stages of treatment.
Caution should be advised in patients receiving concomitant medications which could
increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants
such as warfarin, selective serotonin-reuptake inhibitors or anti-platelets agents such
as aspirin (see Section 4.5).
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment
should be withdrawn.
Dermatological: Serious skin reactions, some of them fatal, including exfoliating
dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, have been
reported very rarely in association with the use of NSAIDs (see Section 4.8). Patients
appear to be at highest risk of these reactions early in the course of therapy: the onset
of the reaction occurring in the majority of cases within the first month of treatment.
This product should be discontinued at the first appearance of skin rash, mucosal
lesions or any other sign of hypersensitivity.

Phenylephrine Hydrochloride
Vascular disorders: Phenylephrine hydrochloride should be used with caution in
patients with occlusive vascular disease including Raynaud's Phenomenon.
Phenylephrine should be used with care in patients with hyperthyroidism,
cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic
enlargement and hypertension.
General
This product contains sucrose. Patients with rare hereditary problems of fructose
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
should not take this medicine.
4.5
Interaction with other medicinal products and other forms of interaction
Ibuprofen
Ibuprofen should not be used in combination with:

Acetylsalicylic acid
Concomitant administration of ibuprofen and acetylsalicylic acid is not generally
recommended because of the potential of increased adverse effects.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low
dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly.
Although there are uncertainties regarding extrapolation of these data to the clinical
situation, the possibility that regular, long-term use of ibuprofen may reduce the
cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No
clinically relevant effect is considered to be likely for occasional ibuprofen use (see
section 5.1).
Other NSAIDs including cyclo-oxygenase-2 selective inhibitors: Avoid concomitant
use of two or more NSAIDs as this may increase the risk of adverse reactions (see
Section 4.4).
Ibuprofen should be used with caution in combination with:
Anti-coagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin
(see Section 4.4).
Antihypertensives and diuretics: NSAIDs may diminish the effect of these drugs.
Diuretics can increase the risk of nephrotoxicity.
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see Section
4.4).

Anti-platelet agents and selective serotonin-reuptake inhibitors (SSRIs): Increased
risk of gastrointestinal bleeding (see Section 4.4).
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and
increase plasma glycoside levels.
Lithium: There is evidence for potential increase in plasma levels of lithium.
Methotrexate: There is potential for an increase in plasma methotrexate.
Ciclosporin: Increased risk of nephrotoxicity.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone
administration as NSAIDs can reduce the effect of mifepristone.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with
tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with
zidovudine. There is evidence of an increased risk of haemarthroses and haematoma
in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and
ibuprofen.
Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of
convulsions associated with quinolone antibiotics. Patients taking NSAIDs and
quinolones may have an increased risk of developing convulsions.
Phenylephrine Hydrochloride
Phenylephrine Hydrochloride should not be used in combination with:
Monoamine Oxidase Inhibitors (MAOIs): Phenylephrine hydrochloride is not
recommended for patients currently receiving or within two weeks of stopping
therapy with monoamine oxidase inhibitors (MAOIs) (See section 4.3).
Phenylephrine Hydrochloride should be used with caution in combination with:
Sympathomimetic Amines: Phenylephrine hydrochloride may enhance
cardiovascular effects of other sympathomimetic amines (e.g. decongestants).

the

Beta-blockers and other Vasodilators: Phenylephrine hydrochloride may adversely
interact with other vasodilators and beta-blockers.
Anticholinergic Drugs: Phenylephrine hydrochloride may enhance the effects of
anticholinergic drugs such as tricyclic antidepressants.
Cardiac Glycosides: Phenylephrine hydrochloride may increase the possibility of
arrhythmias in digitalised patients.
4.6
Fertility, pregnancy and lactation

Ibuprofen
Whilst no teratogenic effects have been demonstrated to ibuprofen in animal
experiments, the use of ibuprofen should, if possible, be avoided during the first
six months of pregnancy.
During the third trimester, ibuprofen is contraindicated as there is a risk of
premature closure of the fetal ductus arteriosus with possible persistent pulmonary
hypertension. The onset of labour may be delayed and the duration increased with
an increased bleeding tendency in both mother and child (see Section 4.3).
In limited studies, ibuprofen appears in the breast milk in very low concentrations
and is unlikely to affect the breast-fed infant adversely.
See Section 4.4 regarding female fertility.
Phenylephrine Hydrochloride
The safety of phenylephrine hydrochloride during pregnancy and lactation has not
been established but in view of a possible association of foetal abnormalities with
first trimester exposure to phenylephrine hydrochloride, use during pregnancy
should be avoided.
Due to the vasoconstrictive properties of phenylephrine hydrochloride, it should
be used in caution in patients with a history of pre-eclampsia.
Phenylephrine hydrochloride may reduce placental perfusion and so should be
used in pregnancy only if the benefits outweigh this risk.
There is no data available on the use of phenylephrine in lactation.
Ibuprofen and Phenylephrine Hydrochloride Combination
The safety of the combination during pregnancy has not been established.
In view of the possible association of foetal abnormalities with first trimester
exposure to phenylephrine hydrochloride and the contraindication of ibuprofen in
the last trimester of pregnancy due to the risks of premature closure of the fetal
ductus arteriosus with possible persistent pulmonary hypertension the
combination product should not be used in pregnancy.
There is no data available on the use of the product during breastfeeding.

4.7

Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been
performed.

4.8

Undesirable effects

Ibuprofen
Hypersensitivity reactions have been reported following treatment with ibuprofen and
these may consist of:
(a) Non-specific allergic reaction and anaphylaxis.
(b) Respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm or
dyspnoea.
(c) Various skin reactions, e.g. pruritis, urticaria, angioedema and, more rarely,
exfoliative and bullous dermatoses (including epidermal necrolysis and erythema
multiforme).
The following list of adverse effects relates to those experienced with ibuprofen at
OTC doses, for short-term use. In the treatment of chronic conditions, under longterm treatment, additional adverse effects may occur.
Blood and Lymphatic System Disorders:
Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia,
pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth
ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Immune System Disorders:
Non-specific allergic reactions.
Respiratory tract reactivity (e.g. asthma, aggravated asthma and bronchospasm).
Various skin reactions including exfoliative and bullous dermatoses (including
epidermal necrolysis and erythema multiforme).
Uncommon: Hypersensitivity reactions with urticaria and pruritus.
Very rare: Severe hypersensitivity reactions. Symptoms could include: facial, tongue
and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema
or severe shock).
In patients with existing auto-immune disorders (such as systemic lupus
erythematosus, mixed connective tissue disease) during treatment with ibuprofen,
single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea,
vomiting, fever or disorientation have been observed (see section 4.4 Special
Warnings and Precautions for Use).
Nervous System Disorders:
Uncommon: Headache.
Vary rare: Aseptic Meningitis – single cases have been reported very rarely.
Cardiac Disorders and Vascular Disorders:
Oedema, hypertension and cardiac failure have been reported in association with
NSAID treatment.
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400
mg/day) may be associated with a small increased risk of arterial thrombotic events
(for example myocardial infarction or stroke) (see section 4.4).
Gastrointestinal Disorders:
The most commonly observed side effects of ibuprofen are gastrointestinal in nature.

Uncommon: Abdominal pain, nausea and dyspepsia.
Rare: Diarrhoea, flatulence, constipation and vomiting.
Very rare: Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena,
haematemesis, sometimes fatal, particularly in the elderly, ulcerative stomatitis,
gastritis.
Exacerbation of ulcerative colitis and Crohn’s disease (see section 4.4 Special
Warnings and Precautions for Use).
Hepatobiliary Disorders:
Very rare: Liver disorders.
Skin and Subcutaneous Tissue Disorders:
Uncommon: Various skin rashes.
Very rare: Severe forms of skin reactions such as bullous reactions, including Stevens
Johnson syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
Renal and Urinary Disorders:
Very rare: Acute renal failure, papillary necrosis, especially in long-term use,
associated with increased serum urea and oedema.
Phenylephrine Hydrochloride
Immune System Disorders:
Rare: Non-specific allergic reactions.
Nervous System Disorders:
Uncommon: Headache.
Cardiac Disorders and Vascular Disorders:
Tachycardia, cardiac arrhythmias, palpitations, hypertension,
Gastrointestinal Disorders:
Rare: Nausea and vomiting.
Renal and Urinary Disorders:
Very rare: urinary retention in males.
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 at: www.mhra.gov.uk/yellowcard.
4.9
Overdose
In children, ingestion of more than 400 mg/kg ibuprofen may cause symptoms. In
adults, the dose response rate effect is less clear cut. The half-life in overdose is 1.5-3
hours.
Symptoms:

Patients who have ingested clinically important amounts of NSAIDs will develop no
more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus,
headache and gastrointestinal bleeding are also possible. In more serious poisoning,
toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally
excitation and disorientation or coma. Occasionally patients develop convulsions. In
serious poisoning metabolic acidosis may occur and prothrombin time/INR may be
prolonged, probably due to interference with the actions of circulating clotting
factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is
possible in asthmatics.
Features of severe overdosage of phenylephrine include haemodynamic changes and
cardiovascular collapse with respiratory depression.
Management:
Management of overdose should be symptomatic and supportive and include the
maintenance of a clear airway and monitoring of cardiac and vital signs until stable.
Consider gastric lavage or oral administration of activated charcoal if the patient
presents within 1 hour of ingestion of a potentially toxic amount. If frequent or
prolonged, convulsions should be treated with intravenous diazepam or lorazepam.
Give bronchodilators for asthma. The hypertensive effects of phenylephrine
hydrochloride may be treated with an intravenous alpha-receptor blocking agent.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

M01AE51 - Ibuprofen, combinations.
Ibuprofen
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by
inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain,
swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.
The therapeutic effect of ibuprofen in symptoms relating to the common cold and
influenza has a duration of up to 8 hours.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low
dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly.
Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg
were taken within 8 h before or within 30 min after immediate release acetylsalicylic
acid dosing (81 mg), a decreased effect of acetylsalicylic acid on the formation of
thromboxane or platelet aggregation occurred. Although there are uncertainties
regarding extrapolation of these data to the clinical situation, the possibility that
regular, long-term use of ibuprofen may reduce the cardioprotective effect of lowdose acetylsalicylic acid cannot be excluded. No clinically relevant effect is
considered to be likely for occasional ibuprofen use (see section 4.5).

Phenylephrine Hydrochloride
Phenylephrine Hydrochloride is a post-synaptic alpha-receptor agonist with low
cardioselective beta-receptor affinity and minimal central stimulant activity. It is a
recognised decongestant and acts by vasoconstriction to reduce oedema and nasal
swelling.
5.2
Pharmacokinetic properties
Ibuprofen
Ibuprofen is rapidly absorbed following administration and is rapidly distributed
throughout the whole body. The excretion is rapid and complete via the kidneys.
Maximum plasma concentrations are reached 45 minutes after ingestion if taken on
an empty stomach. When taken with food, peak levels are observed after 1-2 hours.
These times may vary with different dosage forms.
The half-life of ibuprofen is about 2 hours.
In limited studies, ibuprofen appears in the breast milk in very low concentrations
Phenylephrine Hydrochloride
Phenylephrine Hydrochloride is absorbed from the gastrointestinal tract, but has
reduced bioavailability by the oral route due to first-pass metabolism.
It retains activity as a nasal decongestant when given orally, the drug distributing
through the systemic circulation to the vascular bed of the nasal mucosa.
When taken by mouth as a nasal decongestant, phenylephrine is usually given at
intervals of 4-6 hours.
Ibuprofen and Phenylephrine Hydrochloride Combination:
The ibuprofen component of this fixed combination (ibuprofen 200 mg plus
phenylephrine hydrochloride 6.1 mg) is absorbed faster than standard ibuprofen 200
mg tablets, with therapeutic levels being reached in 26.4 minutes (from the fixed
combination) as opposed to 55.2 minutes (for standard ibuprofen).

5.3

Preclinical safety data
There are no findings of relevance to the prescriber other than those already
mentioned elsewhere in the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Core Excipients:
Calcium Hydrogen Phosphate Dihydrate
Croscarmellose Sodium
Cellulose, Powdered
Talc
Simeticone
Silica, Colloidal Anhydrous
Coating Excipients:
Talc
Sucrose
Povidone K90
Calcium Carbonate
Macrogol 6000
Macrogol 4000
Green Spruce Food Colourant* 630004 [Containing Sodium Sulphate (E514),
Tartrazine (E102), Brilliant Blue (E133)]
Titanium Dioxide
Shellac
Theobroma Oil

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
24 Months

6.4

Special precautions for storage
Do not store above 25°C.
Store in the original package in order to protect from light.

6.5

Nature and contents of container

PVC/PVdC thermoformed blisters with Aluminium lidding foil.
Pack size of 16 tablets.

6.6

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

7

MARKETING AUTHORISATION HOLDER
Galpharm Healthcare Limited
Wrafton
Braunton
Devon
EX33 2DL
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 16028/0149

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26/06/2014

10

DATE OF REVISION OF THE TEXT
10/02/2016

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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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