Summary of medicine characteristics - BEECHAMS WARMERS BLACKCURRANT, BEECHAMS COLD & FLU HOT BLACKCURRANT, BEECHAMS HOT BLACKCURRANT
1 NAME OF THE MEDICINAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCTBeechams Hot Blackcurrant
or
Beechams Warmers Blackcurrant
or
Beechams Cold & Flu Hot Blackcurrant
2) Qualitative and Quantitative Composition
Active Constituents
mg / 6 g powder
Paracetamol
600.00
Phenylephrine Hydrochloride
10.00
Sucrose
Natural Grapeskin E 163 (contains sulfur dioxide)
Sodium
3 PHARMACEUTICAL FORM
Powder
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
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 paracetamol or any of the other constituents.
Concomitant use of other sympathomimetic decongestants Phaeochromocytoma
Closed angle glaucoma
An enlargement of the prostate gland
Hypertensive patients or those who are taking, or have taken in the last two weeks, monoamine oxidase inhibitors, tricyclic antidepressants or betablockers (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 renal or hepatic impairment. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. 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)
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 4g sucrose per dose. This should be taken into account in patients with diabetes.
This medicinal product contains 193 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.
Do not exceed the stated dose.
Patients should be advised not to take other paracetamol-containing or other cold, flu or decongestant products concurrently.
Medical advice should sought, if symptoms worsen, 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 betablocking 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 |
4.6 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
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 postmarketing 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, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis Very rare cases of serious skin reactions have been reported. |
| Respiratory, thoracic and mediastinal disorders | Bromchospasm |
| Hepatobiliary disorders | Hepatic dysfunction |
There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
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
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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
None stated
6.1 List of Excipients
Ascorbic acid, Sucrose, Sodium citrate, Citric acid, Sodium cyclamate, Saccharin sodium, Blackcurrant Juice, Blackcurrant Polvaromas, Blackcurrant Flavour, Natural Grapeskin E163(contains sulfur dioxide).
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 either laminate sachets comprising paper / polythene / aluminium foil / polythene or child resistant laminate composed of polyethylene terephthalate/polyethylene/Aluminium foil/ethylene-methacrylic acid copolymer. Five or ten sachets may be contained in a box board carton.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNone
7 MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited 980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44673/0011
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/11/1991 / 16/03/2009