Pep
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PEP
or
Asda Energy Plus Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Caffeine Alkaloid 30.0 mg
Glucose Monohydrate 150.0 mg
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablets
White, circular flat bevelled-edge tablets with no markings.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of mental and muscular fatigue.
4.2 Posology and method of administration
Adults, the elderly and children over 12 years: Two tablets to be taken up to three times a day, as required. No more than 6 tablets should be taken in any 24 hour period.
Children under 12 years: Not recommended.
As caffeine and Glucose tablets contain a stimulant, patients should avoid taking them close to bedtime.
Route of administration: Oral
4.3 Contraindications
Hypersensitivity to caffeine, Glucose or any of the other ingredients
Caffeine and Glucose tablets should not be used by people who have been diagnosed with hypertension or who are receiving antihypertensive medication (see section 4.5) or who have a history of cardiac arrhythmia
Caffeine and Glucose tablets should not be used inpatients recovering from chronic alcoholism who are taking disulfiram (see section 4.5).
Caffeine and Glucose tablets should not be used if antidepressants (including lithium carbonate), anxiolytics (including clozapine) or sedatives are being used (see section 4.5).
Caffeine and Glucose tablets should not be used by any persons who are also taking sympathomimetics such as phenylpropanolamine, ephedrine and pseudoephedrine (see section 4.5)
Caffeine shares the same metabolic pathway as theophylline and therefore Caffeine and Glucose tablets should not be used concurrently with theophylline (see section 4.5).
Caffeine and Glucose tablets should not be taken in pregnancy or lactation (see section 4.6).
4.4 Special warnings and precautions for use
Caffeine should be used with caution in patients with a history of peptic ulceration.
Users are not recommended to take more than 400mg/day of caffeine (13 tablets). Caffeine is naturally found in tea, coffee, carbonated drinks and chocolate therefore the user should be careful not to take a total quantity of caffeine more than the recommended amount per day.
The amount of caffeine in a drink of coffee or tea depends on how they are made, and the table below can be used as a guide:
|
Food or Drink |
Amount |
Caffeine Content |
|
Filter Coffee |
100ml |
50 - 100 mg |
|
Instant Coffee |
100ml |
20 - 73 mg |
|
Tea |
100ml |
20 - 73 mg |
|
Cola Drink |
100ml |
Up to 20mg |
|
Chocolate |
100g |
5 - 20 mg |
|
This medicine |
1 tablet |
30 mg |
This product contains glucose. Patients with rare glucose-galactose malabsorption should not take this medicine.
Caffeine naive and caffeine sensitive individuals may be more prone to the undesirable effects of caffeine (see section 4.8).
4.5 Interaction with other medicinal products and other forms of interaction
Small doses of caffeine (5 to 10 mg/kg) appear to reduce the ED50 for aspirin, indomethacin and phenylbutazone by more than threefold.
Caffeine enhances the effects of ergot alkaloids in the treatment of migraine.
Smokers metabolise caffeine more rapidly than non-smokers.
Xanthine derivatives such as caffeine can weaken the vasodilation effects of substances used for myocardial imaging such as adenosine and dipyridamole. Caffeine should therefore be avoided for 24 hours before myocardial imaging.
Caffeine, a CNS stimulant, has an antagonistic effect towards the action of sedatives and tranquilizers (see section 4.3).
Caffeine may enhance the cardiovascular effects of sympathomimetics such as phenylpropanolamine, ephedrine and pseudoephedrine (see section 4.3).
Caffeine exerts a competitive inhibition of the metabolism of clozapine and therefore should not be used concurrently (see section 4.3).
Caffeine can increase blood pressure and counters the hypotensive action of antihypertensive medication including beta blockers such as atenolol, oxprenolol, metoprolol, propranolol. Caffeine and Glucose Tablets should not be used at the same time as beta blockers (see section 4.3).
Disulfiram increases caffeine clearance by up to 50%. Concomitant use of disulfiram and caffeine should be avoided (see section 4.3).
Use of caffeine and lithium carbonate may cause a small to moderate rise in the serum lithium levels. Concomitant use should be avoided (see section 4.3).
Monoamine oxidase inhibitors may increase the stimulant effect of caffeine.
Methoxsalen reduces the clearance of caffeine and increases its effects.
Phenytoin doubles caffeine clearance although caffeine does not affect the metabolism of phenytoin.
Pipemidic acid reduces caffeine clearance and enhances the effects of caffeine.
Levothyroxine, like caffeine, can increase blood pressure and therefore should not be used concomitantly.
Theophylline and caffeine use the same metabolic pathway, leading to increased clearance times for theophylline when used concurrently with caffeine. Concomitant use should be avoided (see section 4.3).
4.6 Pregnancy and lactation
At very high doses, caffeine has been shown to have some teratogenic activity in mammals, but no malformations have been associated with caffeine intake in humans.
Caffeine is found in breast milk. It is therefore advisable to limit exposure to caffeine during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
None stated
4.8 Undesirable effects
At doses up to 400mg per day undesirable effects are not normally observed in healthy individuals. However some users who are caffeine naive, have abstained from caffeine for a period or who are more sensitive to caffeine may experience effects more commonly seen at higher doses. The frequency of adverse effects is unknown for this product.
Adverse effects of caffeine may include:
Immune system disorders:
Anaphylactic reactions
Psychiatric disorders:
Insomnia
Nervousness
Restlessness
Anxiety
Caffeine use can result in clinical dependence similar to that seen by other psychoactive substances
Nervous system disorders:
Headache
Tremors
Hyperaesthesia
Ear and labyrinth disorders:
Tinnitus
Cardiac disorders:
Arrhythmia
Tachycardia
Respiratory thoracic and mediastinal disorders Tachypnoea
Gastrointestinal disorders:
Nausea
Gastrointestinal disturbance
Gastric secretions are increased and may cause gastric ulceration
Skin and subcutaneous tissue disorders:
Urticaria
Rashes
Renal and urinary disorders:
Diuresis
General disorders and administration site conditions:
Irritability
Individuals who experience these effects must stop taking caffeine and Glucose tablets and any other dietary caffeine.
Following regular use of caffeine, cessation of intake may lead to withdrawal symptoms which may last for up to a week and which include headache, tiredness and decreased alertness.
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.
4.9 Overdose
Symptoms
Large doses of caffeine (15 mg/kg bodyweight) may produce insomnia, restlessness, tinnitus, scintillating scotoma, muscle tremor, tachycardia and extrasystoles.
Other symptoms of overdose may include pallor, dilated pupils, rigidity, tonic posturing and convulsions, nervousness, irritability, headache, excitement, rapid speech, cardiac arrhythmias, systemic hypertension, gastrointestinal disturbances including vomiting and abdominal cramps, increased respiratory rate, diuresis and emesis leading to electrolyte imbalances.
The fatal dose is about 5 - 10 g.
Treatment
Treatment of overdosage consists of withdrawal of caffeine followed by close monitoring of plasma levels of caffeine and electrolytes. A caffeine plasma level of 1mg/ml should be considered toxic.
The benefit of gastric decontamination is uncertain. The treatment of overdosage may be initiated by activated charcoal only if the patient presents within 1 hour of ingestion of a potentially toxic amount. Alternatively consider gastric lavage in adults within 1 hour of a potentially life-threatening overdose, and restoration of electrolyte balance as necessary. Treatment of patients presenting later than 1 hour after ingestion should be based on the patient’s symptoms.
It is recommended that the pulse, blood pressure and cardiac rhythm are monitored. Supportive cardiovascular measures should be used as required. Consider the use of a 12 lead ECG and the measurement of urine output and electrolytes. Tachycardia with adequate cardiac output is best left untreated.
Fluid and electrolyte balance can be maintained by intravenous fluids and oxygen given as necessary. Hypokalaemia should be corrected cautiously. Haemoperfusion has also been used successfully to treat caffeine overdose.
Convulsions may be controlled by the intravenous administration of diazepam (5 or 10 mg) or lorazepam. Correct acid base and metabolic disturbances. Phenytoin may be useful if fits are unresponsive to above measures. Ventricular arrhythmias occurring in a patient who is having convulsions are best treated with amiodarone or disopyramide rather than lidocaine or mexiletine since the latter may exacerbate convulsions.
If the systolic blood pressure is greater than 220 and diastolic blood pressure greater than 140 mm Hg, in the absence of long-standing hypertension, diazepam should be administered. Persistent hypertension may respond to a beta-blocker. Beta blockers such as metoprolol or esmolol should be used in extreme cases (care in asthmatics). If hypertension is unresponsive to the above measures, discuss with your local poisons service.
If the patient is agitated, sedate with oral diazepam. Alternatively, give oral or parenteral haloperidol for adults.
Other measures as indicated by the patient’s clinical condition.
5.1 Pharmacodynamic properties
Caffeine is a methylxanthine which predominantly stimulates the CNS, although the cardiovascular system, smooth muscle and the kidneys are also affected. It produces wakefulness, increases mental activity, facilitates the performance of muscular work and increases the total work which can be performed by a muscle.
Glucose provides a rapidly available source of energy.
5.2 Pharmacokinetic properties
Caffeine is readily absorbed from the gastro-intestinal tract. It is widely distributed throughout all body compartments. About 36% of caffeine in the plasma is bound to proteins. The maximum plasma concentration is reached within 1 hour of an oral dose. The plasma half-life averages 4.9 hours
although it is shorter in smokers and longer in pregnant women. Caffeine crosses the placenta and has been detected in breast milk.
Caffeine is metabolised in the liver and excreted in the urine almost completely in the form of metabolites, principally 1-methyluric acid and l-methylxanthine. Only about 1% is excreted unchanged.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other section of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Dextrin
Maize Starch Magnesium Stearate
6.2 Incompatibilities
None stated
6.3 Shelf life
Three years
6.4 Special precautions for storage
Store below 25°C in a dry place. Protect from light.
6.5 Nature and contents of container
Al/PVC blister strips enclosed in a cardboard outer containing 8, 12, 20, 24, 36 & 48 tablets.
Polypropylene containers with polyethylene lids containing 60 tablets.
Amber glass bottles containing 100 tablets.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Galpharm Healthcare Limited
Wrafton
Braunton
Devon
EX33 2DL
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 16028/0117
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/06/1995 / 19/09/2005
10 DATE OF REVISION OF THE TEXT
16/08/2016