Summary of Product Characteristics (SmPC) - Bells Hot Blackcurrant Cold Relief powders
1 NAME OF THE MEDICINAL PRODUCT
Bell’s Hot Blackcurrant Cold Relief Powders
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 650 mg
For excipients see 6.1.
3. PHARMACEUTICAL FORM
Powder for oral solution.
Unit doses of purple powder contained in individual laminate sachets.
4.1 Therapeutic indications
For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, feverishness and feverish colds.
4.2. Posology and method of administration
Adults, the elderly and children over 12 years: one sachet every four hours to a maximum of 4 sachets in any 24 hour period.
Empty the contents of one sachet into a tumbler and fill with hot water. Stir till dissolved.
If symptoms persist for more than 3 days, consult your doctor.
4.3. Contra-indications
Hypersensitivity to paracetamol or any of the other constituents.
4.4 Special warnings and precautions for use
Contains Paracetamol. Do not use with any other paracetamol-containing products.
Underlying liver disease increases the risk or paracetamol related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.
Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis (refer also to section 4.9).
Use with caution in patients with glutathione depletion due to metabolic deficiencies.
If symptoms persist, medical advice must be sought.
Keep out of the sight and reach of children.
Pack Label:
Talk to a doctor at once if you take too much of this medicine even if you feel well.
Do not take anything else containing paracetamol while taking this medicine.
Patient Information Leaflet:
Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause 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.
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 risk factors (see section 4.4)
4.6 Fertility, pregnancy and lactation
Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy if clinically needed, however, as with any medicine it should be used at the lowest effective dose for the shortest possible time.
Paracetamol is excreted in breast milk but not in a clinically significant amount in recommended dosages. Available published data do not contraindicate breastfeeding. Available published data do not contraindicate breast feeding.
4.7. Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Adverse events of paracetamol 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 and frequency. The following convention has been utilised for the classification of the undesirable effects: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data). Adverse event frequencies have been estimated from spontaneous reports received through post-marketing data.
Post marketing data
| Body System | Undesirable effect | Frequency |
Blood and lymphatic system disorders | Thrombocytopenia Agranulocytosis | Very rare |
| Immune system disorders | Anaphylaxis Cutaneous hypersensitivity reactions including, among others, skin rashes, angioedema, Very rare cases of serious skin reactions have been reported. | Very rare |
Respiratory, thoracic and mediastinal disorders | Bronchospasm* | Very rare |
| Hepatobiliary disorders | Hepatic dysfunction | Very rare |
| Metabolism and nutrition disorders | High anion gap metabolic acidosis | Not known |
Description of selected adverse reactions
High anion gap metabolic acidosis:
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.
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
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.yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
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 not 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Mechanisms of Action/Effect
Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependant on the inhibition of prostaglandin synthesis. This inhibition appears, however to be on a selective basis.
Clinical Efficacy
In two dental pain studies, pain relief was observed at a median time of 15 minutes following administration of the 1000 mg dose of Paracetamol Tablets.
Paracetamol Tablets demonstrated superior pain relief at 1000 mg dose compared to placebo and to Paracetamol Tablets at 500 mg dose. Paracetamol Tablets at the 500 mg dose also demonstrated superior efficacy compared to placebo.
5.2 Pharmacokinetic properties
Absorption and Fate
Paracetamol is readily absorbed from the gastro-intestinal tract
The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half- life is 1 - 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 - 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation.
Paracetamol Tablets contain a disintegrant system which accelerates tablet dissolution compared to standard paracetamol tablets. Human scintigraphy data demonstrate that Paracetamol Tablets generally start to disintegrate by 5 minutes post dose in the stomach. There is also less between-subject and less within- subject variability (p<0.0001) in early absorption of paracetamol from Paracetamol Tablets compared to standard paracetamol tablets.
Human pharmacokinetic data demonstrate that the time taken to reach plasma paracetamol therapeutic threshold (4-7mcg/ml) is at least 37% faster with Paracetamol Tablets compared to standard paracetamol tablets (P<0.05).
Total extent of absorption of paracetamol from Paracetamol Tablets is equivalent to that from standard paracetamol tablets.
5.3 Preclinical safety data
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Ascorbic Acid
Sucrose
Sodium Citrate
Citric Acid Anhydrous
Tartaric Acid
Sodium Cyclamate
Spray Dried Blackcurrant Flavour
Blackcurrant Flavour
Blackcurrant Aroma
Starch (modified edible)
Anthocyanin E163.
6.2. Incompatibilities
None known.
6.3. Shelf life
Three years.
6.4. Special precautions for storage
Do not store above 25°C
Do not use this medicine after the ‘EXP’ date shown on the pack.
6.5. Nature and contents of container
A laminated sachet containing 5 g of powder. Pack size: 5, 8 or 10 sachets per carton. The laminate consists of an inner polyethylene layer, followed by aluminium foil, a second polyethylene layer and an outer paper coating.
6.6 Special precautions for disposal
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Bell Sons & Co (Druggists) Ltd
Gifford House
Slaidburn Crescent
Southport
Merseyside
PR9 9AL
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 03105/0070
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29 November 2000
10 DATE OF REVISION OF THE TEXT
30/01/2026