Summary of Product Characteristics (SmPC) - Paracetamol, Phenylephrine Hydrochloride 600 mg/10 mg, powder for oral solution
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol, Phenylephrine Hydrochloride 600mg/10mg, Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Constituents mg / 6 g powder
Paracetamol 600.00
Phenylephrine Hydrochloride 10.00
Excipients
Vitamin C (Ascorbic Acid) 40.00
Sucrose 3802
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Oral Solution.
Off-white to beige, free-flowing, heterogeneous powder with an odour of honey, lemon and menthol.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The relief of symptoms of influenza, feverishness, chills and feverish colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated pain, and acute nasal catarrh.
4.2 Posology and method of administration
For Oral use
Directions for use
Empty contents of sachet into beaker. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired.
Recommended Dose and Dosage Schedule
Adults (including elderly) and children aged 16 years and over:
One sachet to be taken every four hours, if necessary, up to a maximum of six sachets in any 24 hours.
The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.
Do not take continuously for more than 7 days without medical advice.
Not to be given to children under 16 years of age except on medical advice.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Concomitant use of other sympathomimetic decongestants.
Phaeochromocytoma.
Closed angle glaucoma.
An enlargement of the prostate gland
Hypertensive patients or those taking of have taken in the last two weeks monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers (see section 4.5).
Hepatic or renal impairment, diabetes, hyperthyroidism and cardiovascular disease.
4.4 Special warnings and precautions for use
Contains paracetamol. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The concomitant use with other products containing paracetamol may lead to an overdose.
The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Medical advice should be sought before taking this product in patients with these conditions:
- Occlusive Vascular disease (e.g. Raynaud's Phenomenon)
- Glutathione depletion due to metabolic deficiencies
Use with caution in patients taking the following medications (see interactions).
- digoxin and cardiac glycosides
- ergot alkaloids (e.g. ergotamine and methysergide)
Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition or other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Contains 3.8 g sucrose per dose. This should be taken into account in patients with diabetes.
This medicinal product contains 135 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.
This product contains a source of phenylalanine. May be harmful for people with phenylketonuria.
Do not exceed the stated dose.
Patients should be advised not to take other paracetamol-containing or any other cold, flu or decongestant products concurrently.
Medical advice should be sought after if symptoms worse, persist for more than 7 days, or are accompanied by high fever, skin rash or persistent headache.
Keep out of the reach and sight of children.
Special label warnings
Do not take with other flu, cold or decongestant products. Do not take with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Special leaflet warnings
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.
4.5 Interaction with other medicinal products and other forms of
interaction
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 daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.
Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported.
| Monoamine oxidase inhibitors (including moclobemide) | Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications). |
| Sympathomimetic amines | Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects. |
| Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa) | Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased. |
| Tricyclic antidepressants (e.g. amitriptyline) | May increase the risk of cardiovascular side effects with phenylephrine. |
| Ergot alkaloids | (ergotamine and methylsergide) increased risk of ergotism |
| Digoxin and cardiac glycosides | Increase the risk of irregular heartbeat or heart attack |
Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors (see section 4.4).
4.6 Fertility, Pregnancy and lactation
Due to the phenylephrine content this product should not be used in pregnancy or whilst breast-feeding without medical advice. This product should not be used during pregnancy or lactation unless the expected benefit to the mother justifies the potential risk to the foetus or newborn. The lowest effective dose and shortest duration of treatment should be considered. Phenylephrine may be excreted in breast milk.
4.7 Effects on ability to drive and use machines
Patients should be advised not to drive or operate machinery if affected by dizziness.
4.8 Undesirable effects
Undesirable effects Paracetamol Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
| Body System | Undesirable effect |
| Blood and lymphatic system disorders | Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol |
| Immune system disorders | Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/ toxic epidermal necrolysis |
| Respiratory, thoracic and mediastinal disorders | Bronchospasm* |
| Hepatobiliary disorders | Hepatic dysfunction |
| Metabolic and nutrition disorders | High anion gap metabolic acidosis** |
Description of selected adverse reactions
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
** Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol (see section 4.4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
Phenylephrine
The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.
| Body System | Undesirable effect |
| Psychiatric disorders | Nervousness, irritability, restlessness, and excitability |
| Nervous system disorders | Headache, dizziness, insomnia |
| Cardiac disorders | Increased blood pressure |
| Gastrointestinal disorders | Nausea, Vomiting. |
Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.
| Eye disorders | Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma |
| Cardiac disorders | Tachycardia, palpitations |
| Skin and subcutaneous disorders | Allergic reactions (e.g. rash, urticaria, allergic dermatitis). Hypersensitivity reactions – including that cross-sensitivity may occur with other sympathomimetics |
Renal and urinary disorders Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
4.9 Overdose
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, phenobarbitone, 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, 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 N-acetylcysteine, 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 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Phenylephrine Hydrochloride
Symptoms and signs:
Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related toxicity.
Treatment
Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: N02BE51
Paracetamol provides the analgesic and antipyretic actions.
Phenylephrine Hydrochloride is a sympathomimetic agent and provides relief from nasal congestion due to its vasoconstrictor action.
5.2 Pharmacokinetic properties
Paracetamol - Is readily absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as glucuronide and sulphate conjugates.
Phenylephrine Hydrochloride - Due to irregular absorption and first pass metabolism by monoamine oxidase in the gut and liver, phenylephrine has reduced bioavailability from the gastrointestinal tract. It is excreted in the urine almost entirely as the sulphate conjugate.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ascorbic acid, Sucrose, Sodium citrate, Citric acid anhydrous, Maize starch, Menthol powder E41580, Honey flavour, Honey Flavour F7624/P, Lemon flavour, Caramel colour 626 E150A, aspartame (E 951), saccharin sodium.
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Store below 25°C
6.5 Nature and contents of container
The product is packed in laminate sachets comprising paper / polythene / aluminium foil / ethylene-methyacyrlic acid copolymer (EMAA). Five or ten sachets may be contained in a box board carton.
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
Thornton & Ross Ltd.,
Linthwaite,
Huddersfield,
HD7 5QH,
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00240/0585
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/11/2022
10 DATE OF REVISION OF THE TEXT
25/04/2025