Summary of medicine characteristics - SYMPTOMED COMPLETE 500 MG / 200 MG / 10 MG POWDER FOR ORAL SOLUTION
1 NAME OF THE MEDICINAL PRODUCT
SymptoMed Complete 500 mg/200 mg/10 mg Powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet contains:
500 mg Paracetamol
200 mg Guaifenesin
10 mg Phenylephrine hydrochloride
Excipients with known effect:
Sucrose 2000 mg
Aspartame 6 mg
Sodium 157 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution
Off-white free flowing powder, with a characteristic citrus/menthol odour
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Short term symptomatic relief of symptoms of mild to moderate pain, fever, nasal congestion and chesty cough, associated with colds.
SymptoMed Complete is indicated in adults and children over 15 years old.
4.2 Posology and method of administration
Posology
Adults, the Elderly and children aged 15 years and over: One sachet
Repeat every four hours as required, but do not exceed four doses (sachets) in any 24 hours.
Do not give to patients with hepatic or severe renal impairment (see Section 4.3)
Seek medical advice if symptoms persist for more than 3 days
Paediatric population
SymptoMed Complete is contraindicated in children under 15 years.
Elderly: No special dosage modifications are required.
Method of administration
Dissolve the contents of one sachet in a standard mug of hot, but not boiling, water (approx. 250 ml). Allow to cool to a drinkable temperature.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Heart Disease
Hepatic or severe renal impairment
Hypertension
Hyperthyroidism
Diabetes
Narrow-angle glaucoma
Phaeochromocytoma
Porphyria
History of seizures
Children under 15 years
Breast-feeding mothers (see section 4.6)
Use in patients taking tricyclic antidepressants
Use in patients who are currently taking or have taken monoamine oxidase inhibitors (MAOIs) within the last 2 weeks (see section 4.5)
Use in patients taking beta-blocking drugs (see section 4.5)
Use in patients who are currently taking other sympathomimetic drugs (see section 4.5).
Use in patients taking other vasoconstrictors (due to urethra-prostatic disorders)
4.4 Special warnings and precautions for use
Long term use of the product is not recommended.
Patients should be advised not to take with other paracetamol-containing products or other products containing the same active ingredients as this preparation. They should also be advised not to take other cough, cold or decongestant products concurrently, or alcohol. The doctor or pharmacist should check that sympathomimetic-containing preparations are not simultaneously administered by several routes, i.e. orally and topically (nasal, aural and eye preparations).
This medicine should only be recommended if all symptoms (pain and/or fever, nasal congestion and chesty cough) are present.
The hazards of overdose are greater in patients with non-cirrhotic alcoholic liver disease.
Use with caution in patients receiving digitalis, beta-adrenergic blockers, methyldopa or other antihypertensive agents (see section 4.5).
Use with caution in patients with prostatic hypertrophy as they may be susceptible to urinary retention.
Use with caution in patients with Raynaud’s phenomenon.
Sympathomimetic-containing products should be used with great care in patients receiving phenothiazines.
Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Contains sucrose. The content of sucrose on a daily basis or four doses is 8.0g. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Contains sodium 157 mg per dose. To be taken into consideration by patients on a controlled sodium diet.
Contains aspartame (E951) a source of phenylalanine equivalent to 3mg/dosage unit. May be harmful for patients with phenylketonuria.
4.5 Interaction with other medicinal products and other forms of interaction The hepatotoxicity of paracetamol may be potentiated by excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.
Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage.
Isoniazid reduces paracetamol clearance, with possible potentiation of its action and/or toxicity, by inhibition of its metabolism in the liver.
Probenecid causes an almost 2-fold reduction in clearance of paracetamol by inhibiting its conjugation with glucuronic acid. A reduction in the paracetamol dose should be considered for concomitant treatment with probenecid.
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.
Regular use of Paracetamol possibly reduces metabolism of Zidovudine (increased risk of neutropenia).
Paracetamol may decrease the bioavailability of lamotrigine, with possible reduction of its effect, due to a possible induction of its metabolism in the liver.
Paracetamol may affect phosphotungstate uric acid tests and blood sugar tests.
If urine is collected within 24 hours of a dose of this product, a metabolite may cause a colour interference with laboratory determinations of 5 hydroxyindoleacetic acid (5-HIAA) and vanillymandelic acid (VMA).
Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors. Phenylephrine may adversely interact with sympathomimetic agents and may reduce the efficacy of beta-blocking drugs and other antihypertensive drugs (including debrisoquine, guanethidine, reserpine, methyldopa) and increase the risk of hypertension and other cardiovascular side effects (see section 4.4). Conditions where these drugs are used are contraindications for the product.
Tricyclic antidepressants (e.g. amitriptyline) may increase the risk of cardiovascular side effects with phenylephrine.
Pharmacological interactions involving paracetamol with a number of other drugs have been reported. These are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed.
There is a possibility that digitalis may sensitise the myocardium to effects of sympathomimetic drugs.
Use of phenylephrine with ergot alkaloids (ergotamine and methylsergide) may lead to increased risk of ergotism.
Digoxin and cardiac glycosides in association with phenylephrine increase the risk of irregular heartbeat or heart attack.
4.6 Fertility, pregnancy and lactation
Pregnancy
A large amount of data on pregnant women indicate no malformative nor feto/neonatal toxicity of Paracetamol. Paracetamol can be used during pregnancy if clinically needed however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Based on human experience phenylephrine hydrochloride causes congenital malformations when administered during pregnancy. It has also been shown to have possible associations with fetal hypoxia. Phenylephrine should not be used during pregnancy unless the clinical condition of the woman requires treatment.
The safety of guaifenesin in pregnancy has not been fully established. The product should only be used in pregnancy when considered essential by the doctor.
Breast-feeding
Paracetamol / metabolites are excreted in human milk, but at therapeutic doses of the product no effects on the breastfed newborns/infants are anticipated.
There are no data available on whether phenylephrine is released into breast milk and no reports on the effects of phenylephrine on the nursing infant. Until more data are available, use of phenylephrine should be avoided in lactating women, unless considered essential by the doctor.
The safety of guaifenesin during lactation has not been fully established. The product should only be used when considered essential by the doctor.
Fertility
There are no or limited data regarding the use of paracetamol, guaifenesin or phenylephrine hydrochloride and its impact on fertility.
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. When performing these activities, the possibility of adverse effects, such as dizziness and confusion should be taken into account.
4.8 Undesirable effects
The frequency of occurrence of undesirable effect is usually classified as follows:
Very common (> 1/10)
Common (> 1/100 to < 1/10)
Uncommon (> 1/1,000 to < 1/100)
Rare (> 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Not known (cannot be estimated from the available data).
| System Order Class | Adverse reaction |
| Cardiac disorders | Phenylephrine may rarely be associated with tachycardia (>1/10,000 to <1/1000). Palpitations – not known Myocardial infarction – not known |
| Blood and lymphatic system disorders | Very rarely (<1/10,000) blood dyscrasias e.g. thrombocytopenia, agranulocytosis, haemolytic anaemia, neutropenia, leucopenia, pancytopenia have been reported with paracetamol, but these were not necessarily causally related. |
| Nervous system disorders | As with other sympathomimetic amines insomnia, nervousness, tremor, anxiety, restlessness, confusion, irritability and headache may rarely occur (>1/10,000 to <1/1000). Headache and dizziness are also known to occur rarely with Guaifenesin (>1/10,000 to <1/1000). Haemorrhagic or ischemic stroke – not known Seizures (in children) and convulsions – not known |
| Gastrointestinal disorders | Anorexia, nausea and vomiting are common with sympathomimetics (>1/100 to <1/10) and may occur with phenylephrine. |
| System Order Class | Adverse reaction |
| Gastrointestinal discomfort, nausea, vomiting and diarrhoea are the most common side effects associated with guaifenesin but these occur rarely (>1/10,000 to <1/1000). Gastro-intestinal effects of paracetamol are very rare but there have been reports of acute pancreatitis after ingestion of above normal dosage. | |
| Renal and urinary disorders | Interstitial nephritis has been reported incidentally after prolonged use of high doses of paracetamol. Dysuria, urinary retention has been reported in patients taking phenylephrine. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy – not known |
| Skin and subcutaneous disorders | Hypersensitivity reactions including skin rash and urticaria may occur rarely (>1/10,000 to <1/1000). Very rare (< 1/10,000) cases of serious skin reactions including Stevens Johnson syndrome, toxic epidermal necrolysis have been reported with paracetamol. Angioedema has been reported in association with paracetamol and guaifenesin, but the frequency of this adverse event is not known. |
| Vascular disorders | High blood pressure with headache, vomiting and palpitations may occur rarely (>1/10,000 to <1/1000) with phenylephrine. Tachycardia may occur with not known frequency. |
| Immune system disorders | There are rare reports (>1/10,000 to <1/1000) of allergic or hypersensitivity reactions with both phenylephrine and paracetamol, including skin rashes, urticaria, anaphylaxis and bronchospasm. |
| Hepatobiliary disorders | Rarely (> 1/10,000 to < 1/1000) liver function test abnormal (increase in hepatic transaminases). Hepatic dysfunction has been reported in patients after paracetamol administration, but the frequency of this adverse event is not known. |
| Psychiatric disorders | Hallucination – not known, |
| Eye disorders | Phenylephrine may cause mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma – not known. |
| Respiratory, thoracic and mediastinal disorders | Allergic reactions, angioedema, anaphylactic reactions -not known. Dyspnoea in relation with guaifenesin and bronchospasm after paracetamol intake, which is more likely in asthmatics sensitive to aspirin or other NSAIDs with not known frequency. |
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
4.9 OverdosePARACETAMOL
There is a risk of poisoning, particularly in elderly patients, young children, in patients with liver disease, in case of chronic alcoholism, in patients with chronic malnutrition. Overdosing may be fatal in these cases.
Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g 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.
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 24h from ingestion should be discussed with the local National Poison Centre or a liver unit.
PHENYLEPHRINE HYDROCHLORIDE
Symptoms of phenylephrine overdose include irritability, headache, an increase in blood pressure and associated reflex bradycardia and arrhythmias.
Raised blood pressure should be treated with an alpha receptor antagonist such as intravenous phentolamine.
Reduction of blood pressure should, by reflex mechanism, increase the heart rate but, if necessary, this can be facilitated by the administration of atropine.
GUAIFENESIN
Mild to moderate overdose may cause dizziness and gastrointestinal disturbances. Very high doses may produce excitation, confusion and respiratory depression. Urinary calculi have been reported in patients consuming large quantities of preparations containing guaifenesin.
Treatment is symptomatic, involving gastric lavage and general supportive measures.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Anilides (Paracetamol combinations excluding psycholeptics), ATC code: N02BE51
Paracetamol has both analgesic and antipyretic activity which is mediated principally through its inhibition of prostaglandin synthesis in the central nervous system.
Guaifenesin has an expectorant action. Expectorants are believed to alleviate cough discomfort by stimulating receptors in the gastric mucosa that initiate a reflex secretion of respiratory tract fluid, thereby increasing the volume and decreasing the viscosity of bronchial secretions. This facilitates removal of mucus and reduces irritation to the bronchial tissue.
Phenylephrine hydrochloride mainly acts directly on adrenergic receptors. It has predominantly a-adrenergic activity and is without significant stimulating effects on the central nervous system at usual doses. It has recognised decongestant activity and acts by vasoconstriction to reduce oedema of the nasal mucosa.
The active ingredients are not known to cause sedation.
5.2 Pharmacokinetic properties
Absorption and distribution
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are attained 10–60 minutes following oral dosing.
Paracetamol is primarily metabolised in the liver via three pathways: glucuronidation, sulphation and oxidation.
Guaifenesin is rapidly absorbed from the gastrointestinal tract after oral administration with maximum blood levels occurring within 15 minutes of administration.
Phenylephrine hydrochloride is irregularly absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidase in the gut and liver; orally administered phenylephrine thus has reduced bioavailability.
Elimination
Paracetamol is excreted in the urine, mainly as the glucuronide and sulphate conjugates. The elimination half-life ranges from 1 to 3 hours. Salicylate/aspirin may prolong the elimination t1/2 of paracetamol.
Guaifenesin is rapidly metabolised in the kidneys by oxidation to P-(2 methyoxy-phenoxy) lactic acid, which is excreted in the urine. The elimination half life is one hour.
Phenylephrine hydrochloride is excreted in the urine almost entirely as the sulphate conjugate. Peak plasma levels occur between 1 and 2 hours and the plasma half life ranges from 2 to 3 hours.
5.3 Preclinical safety data
5.3 Preclinical safety dataPreclinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use in the product and which have not already been mentioned elsewhere in this Summary.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Citric Acid
Tartaric Acid
Sodium Cyclamate
Sodium Citrate
Aspartame (E951)
Acesulfame Potassium (E950)
Powdered Menthol
Lemon Flavour
Lemon Juice Flavour
Curcumin
6.2 Incompatibilities
None known
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
The sachet laminate comprises:
Ethylene/methacrylic copolymer (Surlyn)/aluminium foil/polyethylene/paper (outer layer).
A pack size of five and ten sachets is available.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalOral administration after dissolution in water.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Procter & Gamble (Health & Beauty Care) Limited
The Heights, Brooklands, Weybridge, Surrey
KT13 0XP
8 MARKETING AUTHORISATION NUMBER(S)
PL 00129/0363
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/04/2019