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MANDANOL PLUS TABLETS

Active substance(s): CAFFEINE / PARACETAMOL / CAFFEINE / PARACETAMOL / CAFFEINE / PARACETAMOL

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Summary of Product Characteristics
1.

Trade name of the medicinal product
Mandanol Plus

2.

Qualitative and quantitative composition
Each tablet contains:
For excipients, see 6.1.

3.

Paracetamol 500 mg and Caffeine 65 mg.

Pharmaceutical form
Film-coated tablet.
White, capsule-shaped, film-coated “MANDA+” embossed on one side.

4

Clinical particulars

4.1.

Therapeutic indications
Mandanol Plus is a mild analgesic and antipyretic. It is indicated in the
treatment of most painful and febrile conditions, for example, headache,
including migraine, toothache, neuralgia, rheumatic pain, muscular aches and
pains, dysmenorrhoea, and relief of the symptoms of cold, influenza and sore
throat.

4.2

Posology and method of administration
Posology
Children aged 12-15 years:
1 tablet every 4-6 hours
Do not take more than 4 tablets in any 24-hour
period
Adults and children over 16 years of age:
One to two tablets every four to six hours.
Maximum of eight tablets daily.
Paediatric population
Not recommended for children under 12 years of
age.
Elderly:

One to two tablets every four to six hours.
Maximum of eight tablets daily.
Reduce dosage if renal or hepatic function is
impaired.
Method of administration
For oral administration.
Do not exceed the recommended dose.
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, because of the risk of delayed, serious liver damage.
As caffeine is found naturally in tea, coffee and chocolate, and in some
carbonated drinks there is the potential for users to take more than the
recommended 520 mg/day of caffeine (8 tablets) per day. Therefore
users should take account of dietary and other medicinal sources of
caffeine and ensure that they do not exceed the stated dose.
4.3

Contraindications
Hypersensitivity to paracetamol, caffeine and/or other constituents.
This medicine should not be used by people who have been diagnosed with
hypertension or who are receiving antihypertensive medication, or who have a
history of cardiac arrhythmia.
This medicine should not be used by patients recovering from chronic
alcoholism who are taking disulfiram.
This medicine should not be used if antidepressants (including lithium
carbonate), anxiolytics (including clozapine) and sedatives are being used, or
by persons with anxiety disorders.
This medicine should not be used by any persons who are also taking
ephedrine (see also section 4.5).
Caffeine shares the same metabolic pathway as theophylline and therefore this
medicine should not be used concurrently with theophylline.

4.4

Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe
renal or severe hepatic impairment. The hazard of overdose is greater in those
with non-cirrhotic alcoholic liver disease.
Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should
be avoided while taking this product.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become
persistent.

Patients should be advised not to take other paracetamol-containing products
concurrently.
If symptoms persist consult your doctor.
Keep out of the sight and reach of children.
The pack label will state:
• Contains paracetamol
• Do not take more medicine than the label tells you to. If you do not get

better talk to your doctor.
• Do not take anything else containing paracetamol while taking this

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

feel well.
The patient information leaflet will state:
• 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 metoclopromide 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.
Xanthine derivatives such as caffeine can weaken the vasodilating effect of
substances used for myocardial imaging such as adenosine and dipyridamole.
Therefore, caffeine should be avoided for 24 hours before myocardial imaging.
Caffeine, a CNS stimulant, has an antagonistic effect towards the action of sedatives
and tranquilizers.
Caffeine may enhance the tachycardic effect of phenylpropanolamine.
Caffeine exerts a competitive inhibition of the metabolism of clozapine. Therefore
clozapine and caffeine must not be used concurrently (see contraindications).
Caffeine can increase blood pressure and counters the hypotensive action of beta
blockers such as atenolol, metoprolol, oxprenolol and propranolol. This medicine
should not be used at the same time as beta blockers.
Disulfiram increases caffeine clearance by up to 50%. Concomitant use of disulfiram
and caffeine should be avoided (see contraindications).
Use of lithium carbonate and caffeine may cause a small to moderate rise in serum
lithium levels. Concomitant use should be avoided (see contraindications).
Monoamine oxidase inhibitors may increase the stimulant effects of caffeine.
Methoxsalen reduces clearance of caffeine and may increase the effects of caffeine.
Phenytoin doubles caffeine clearance, although caffeine does not affect the
metabolism of phenytoin.
Pipemidic acid reduces caffeine clearance, enhancing the effects of caffeine.
Theophylline and caffeine share the same metabolic pathway, leading to increased
clearance times for theophylline when used concurrently with caffeine. Concomitant
use should be avoided (see contraindications).

Levothyroxine, like caffeine can increase blood pressure, and therefore these two
active ingredients should not be used concurrently.
Ephedrine and caffeine interact to produce significant cardiovascular effects.
Therefore caffeine should be avoided when ephedrine is being taken.

4.6

Fertility, pregnancy and lactation
Epidemiological studies in human pregnancy have shown no ill effects due to
paracetamol used in the recommended dosage, but patients should follow the
advice of their doctor regarding its use. However, paracetamol-caffeine is not
recommended for use during pregnancy due to the possible increased risk of
lower birth weight and spontaneous abortion associated with caffeine
consumption.
Paracetamol is excreted in breast milk but not in a clinically significant
amount. Available published data on paracetamol do not contraindicate breast
feeding but caffeine in breast milk may potentially have a stimulating effect on
breast fed infants. Therefore, due to the caffeine content of this product it
should not be used if you are pregnant or breast feeding.

4.7.

Effects on ability to drive and use machines
None.

4.8

Undesirable effects
Adverse events from historical clinical trial data are both infrequent and from
small patient exposure. Accordingly, events reported from extensive postmarketing 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 post-marketing experience indicates that adverse reactions
to paracetamol are rare and serious reactions are very rare.
Post marketing data
Body System
Blood and lymphatic system
disorders

Immune system disorders

Undesirable effect
Thrombocytopenia
Agranulocytosis
Anaphylaxis
Cutaneous hypersensitivity reactions

including skin rashes, angioedema
and Stevens Johnson syndrome/toxic
epidermal necrolysis
Respiratory, thoracic and
mediastinal disorders

Bronchospasm*

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
Caffeine
Nervousness
Central Nervous System
Dizziness
At doses up to 520 mg per day undesirable effects are not normally observed
in healthy individuals. However some users who are caffeine naïve, have
abstained from caffeine for a period or who are more sensitive to caffeine
may experience effects more commonly seen at higher doses. These include
tremor, insomnia, nervousness, irritability, anxiety, headache, tinnitus,
arrhythmia, and tachycardia, diuresis, gastrointestinal disturbances, elevated
respiration, restlessness and palpitations. Individuals who experience these
effects must stop taking this medicine (and any others containing caffeine)
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
Paracetamol
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, phenobarbital,
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, 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 h from
ingestion should be discussed with the NPIS or a liver unit.
Caffeine
Symptoms
Overdose of caffeine may result in epigastric pain, vomiting, diuresis,
tachycardia, nervousness, facial flushing, “rambling” flow of thought and
speech or cardia arrhythmia, CNS stimulation (insomnia, restlessness,
excitement, agitation, jitteriness, muscle twitching, tremors and convulsions).
Management
Patients should receive general supportive care (e.g. hydration and
maintenance of vital signs). The administration of activated charcoal may be
beneficial when performed within one hour of the overdose, but can be
considered for up to four hours after the overdose. The CNS effects of
overdose may be treated with intravenous sedatives.

Summary
Treatment of overdose with Mandanol Plus Tablets requires assessment of
plasma paracetamol levels for antidote treatment, with signs and symptoms of
caffeine toxicity being managed symptomatically.
5

Pharmacological Properties

5.1.

Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics, ATC code: NO2B E51
The combination of paracetamol and caffeine is a well established analgesic
combination.

5.2

Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract with peak plasma levels occurring about 30 minutes to 2 hours
after ingestion.
It is relatively uniformly distributed throughout most body fluids and exhibits
variable protein binding. It is metabolised in the liver and excreted in the urine
mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted
unchanged.
The elimination half life of Paracetamol varies from about 1 to 4 hours.
Caffeine 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 1methyluric acid and 1-methylxanthine.

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 sections of the SPC.

6

Pharmaceutical particulars

6.1.

List of Excipient(s)
Maize starch
Silica, colloidal anhydrous
Sodium starch glycollate (Type A)
Povidone

Potassium sorbate
Magnesium stearate
Talc
Hypromellose (Pharmacoat 606)
Hypromellose (Pharmacoat 615)
Macrogol 4000

6.2.

Major incompatibilities
Not applicable.

6.3.

Shelf life
36 months

6.4.

Special precautions for storage
Do not store above 25°C. Store in the original container. Keep container in
outer carton.

6.5.

Nature and contents of container
Aluminium/PVC blister.
16 tablets per carton, in 2 blister packs of 8 tablets.

6.6.

Special precautions for disposal
Not applicable.

7.

Marketing authorisation holder
Name: M & A Pharmachem Ltd
Address:
Wigan Road, Westhoughton, Bolton BL5 2AL.
Country:
United Kingdom

8.

Marketing authorisation number
PL 04077/0180

9

Date of the first authorisation or renewal
29/09/2005

10

DATE OF REVISION OF THE TEXT
10/11/2016

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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