COLD RELIEF CAPSULES (P) - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Cold Relief Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:

Paracetamol 300 mg

Caffeine 25 mg

Phenylephrine Hydrochloride 5 mg

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsule hard

Green cap with yellow body size one hard gelatin capsule filled with a white powder

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Symptomatic relief of symptoms of influenza, feverishness, chills and colds including feverish colds.

The symptomatic relief of nasal congestion and difficult breathing arising from this, sinusitis and its associated pain, acute nasal catarrh

4.2 Posology and method of administration

Posology:

Two capsules every 4 – 6 hours as required. 12 capsules in any 24 hours.

Do not take continuously for more than 7 days without medical advice.

Do not exceed the stated dose.

Use the lowest amount needed to achieve benefit for the shortest duration of treatment.

Two capsules every 4 – 6 hours when necessary to a maximum of 4 doses in 24 hours. Do not exceed 8 capsules in any 24 hours.

LemoCalm Plus Cold and Flu Capsules are not recommended for children under the age 12.

Method of administration:

For oral administration

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1;

Concomitant use of other sympathomimetic decongestants;

Hepatic or severe renal impairment, cardiovascular disease, hypertension, diabetes mellitus, hyperthyroidism, phaeochromocytoma, closed angle glaucoma;

Patients taking tricyclic antidepressants, or beta blocking drugs and those who are taking or who have taken within the last two weeks monoamine oxidase inhibitors (see section 4.5).

4.4 Special warnings and precautions for use

Contains paracetamol. Patients should be advised not to take other paracetamolcon­taining products concurrently. 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. Concomitant use of other decongestants or cold and flu medicines should be avoided.

The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Underlying liver disease increases the risk of paracetamol-related liver damage.

Medical advice should be sought before using this product in patients with these conditions:

Medical advice should be sought before taking this medicine in patients with: glutathione depletion due to metabolic deficiencies.

An enlargement of the prostate gland;

Occlusive vascular disease (e.g. Raynaud's phe­nomenon);

Cardiovascular disease.

This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) (see interactions).

Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.

Keep out of the sight and reach of children.Do not exceed the stated dose

If symptoms persist consult your doctor

If you are under the care of your doctor or receiving prescribed medicines consult your doctor before taking this product.

Special Label Warnings

Contains paracetamol.

Do not take anything else containing paracetamol while taking this medicine Do not take with other flu, cold or decongestant products.Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

Talk to a doctor at once if you take too much of this medicine, even if you feel well.

Special Leaflet Warnings

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

Enzyme-inducing drugs may increase hepatic damage, as does excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. These interactions are considered to be of unlikely clinical significance in acute usage at the dosage regimen proposed.

Medical advice should be sought before taking paracetamol-caffeine phenylephrine in combination with the following drugs:

4.6 Fertility, pregnancy and lactationPregnancy

This product is not recommended for use in pregnancy due to the phenylephrine and caffeine content. There is a potential increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption during pregnancy. Pregnant women should seek medical advice before taking paracetamol.

This product should not be used while breast-feeding without medical advice. Avoid the use of the product during lactation, unless the benefits to the mother outweigh the risks to the infant. If used, the lowest effective dose and shortest duration of treatment should be considered.

Paracetamol is excreted in breast milk but not in a clinically significant amount at recommended dosages.

Caffeine in breast milk may have a stimulating effect on breast-fed infants but significant toxicity has not been observed.

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

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. The frequency of these adverse events is not known (cannot be estimated from available data).

(i) Paracetamol

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

(ii) Caffeine

Adverse reactions identified through post-marketing use with caffeine are listed below. The frequency of these reactions is unknown.

When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects

(iii) Phenylephrine hydrochloride

The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown.

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(i) Paracetamol

Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.

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 and signs

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. Treatment

Immediate treatment is essential in the management of paracetamol overdose.

Despite a lack of significant early symptoms, patients should be refered 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 one 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 NPIS or a liver unit. Acute pancreatitis has been observed, usually with hepatic dysfunction and liver toxicity.

(ii) Caffeine

Symptoms and signs

Overdose of caffeine may result in epigastric pain, vomiting, diurese, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).

It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity.

Treatment No specific antidote is available, but supportive measures such as beta adrenoceptor antagonists to reverse the cardiotoxic effects may be used.

(iii) Phenylephrine

Symptoms and signs

Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include, irritability, restlessness, hypertension, and possibly reflex bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than that required to cause paracetamol-related liver toxicity.

Treatment Treatment should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking drugs such as phentolamine.

If overdose is confirmed or suspected, seek immediate advice from your Poison Centre and refer patient to nearest Emergency Medical Centre for management and expert treatment. This should happen even in patients without symptoms or signs of overdose due to the risk of delayed liver damage.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Paracetamol: An analgesic and antipyretic.

Caffeine: A mild stimulant.

Phenylephrine hydrochloride: A sympathomimetic decongestant.

The active ingredients are not known to cause sedation.

5.2 Pharmacokinetic properties

Paracetamol: It is readily absorbed from the gastro-intestinal tract.

It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates.

Caffeine: It is absorbed readily after oral administration maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65–80% of administered caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine.

Phenylephrine hydrochloride: It has reduced bioavailability from the gastrointestinal tract owing to first pass metabolism by monoamine oxidase in the gut and liver. It is excreted in the urine almost entirely as the sulphate conjugate.

5.3 Preclinical safety data

Pre-clinical 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 of the product and which have not already been mentioned elsewhere in this Summary.

The toxicity of paracetamol has been extensively studied in numerous animal species. Pre-clinical studies in rats and mice have indicated single dose oral LD50 values of 3.7 g/kg and 338 mg/kg, respectively. Chronic toxicity in these species at large multiples of the human therapeutic dose, occurs as degeneration and necrosis of hepatic, renal and lymphoid tissue, and blood count changes. The metabolites believed responsible for these effects have also been demonstrated in man. Paracetamol should not, therefore, be taken for long periods of time, and in excessive doses. At normal therapeutic doses, paracetamol is not associated with genotoxic or carcinogenic risk. There is no evidence of embryo-or foetus-toxicity from paracetamol in animal studies.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Modified maize starch;

Colloidal anhydrous silica;

Magnesium stearate ;

Patent blue V (E131);

Titanium dioxide (E171);

Quinoline yellow (E 104);

Ferric oxide (E 172).

6.2 Incompatibilities

Not applicable

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

PVC/aluminium blisters.

Pack sizes: 8, 12, 16, 24 and 32.

6.6 Special precautions for disposal

Not applicable

7 MARKETING AUTHORISATION HOLDER

BRISTOL LABORATORIES,

UNIT 3, CANALSIDE,

NORTHBRIDGE ROAD,

BERKHAMSTED HERTFORDSHIRE HP4 1EG, UNITED KINGDOM