NAME OF THE MEDICINAL PRODUCT

Solpadeine Headache Soluble Tablets SolpaPain 500mg/65mg Effervescent Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains Paracetamol 500 mg and Caffeine 65 mg

For excipients, see 6.1.

3 PHARMACEUTICAL FORM

Effervescent Tablet

White bevel-edged scored tablets, one inch in diameter.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Solpadeine Headache Soluble Tablets are a mild analgesic and antipyretic formulated to give extra pain relief. The soluble tablets are recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, backache, toothache, colds and influenza, sore throat, rheumatic pain and dysmenorrhoea.

4.2 Posology and method of administration

Solpadeine Headache Soluble Tablets should be dissolved in at least half a tumblerful of water.

Adults:

Two tablets up to four times daily.

Do not exceed 8 tablets in 24 hours.

Elderly:

As for adults.

Children:

Not recommended for children under 12 years. Method of Administration

Solpadeine Headache Soluble Tablets are for oral administration only.

4.3 Contraindications

Hypersensitivity to paracetamol, caffeine or any of the other constituents.

4.4 Special warnings and precautions for use

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with noncirrhotic 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.

Each 2 tablet dose contains 854 mg of sodium and should not be taken by patients on a low sodium diet.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Pack label

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Do not take with any other paracetamol-containing products.

Patient Information Leaflet

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 cholestyramine. 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.

4.6 Fertility, Pregnancy and lactation

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.

Caffeine in breast milk may potentially have a stimulating effect on breast fed infants.

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	Undesirable effect
Blood and lymphatic system disorders	Thrombocytopenia Agranulocytosis
Immune system disorders	Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema 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
Central Nervous system		Nervousness Dizziness

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 such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.

4.9 Overdose

Symptoms of paracetamol overdose 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

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 and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

Overdose of caffeine may result in epigastric pain, vomitting, diuresis, tachycardia or cardia 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 toxicity.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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. It is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal, in the form of conjugated metabolites.

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 1-methyluric acid and 1-methylxanthine.

5.3 Preclinical safety data

There are no preclinical 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 excipients

Sodium hydrogen carbonate

Sorbitol

Saccharin sodium Sodium laurilsulfate Citric acid anhydrous Sodium carbonate anhydrous Povidone Dimeticone

6.2 Incompatibilities

None known.

6.3    Shelf life

48 months.

6.4    Special precautions for storage

Do not store above 30°C.

6.5    Nature and contents of container

PPFP laminate sachets in cardboard carton outers containing 4, 6, 12, 16, 18, 24, 30, 48 or 60 tablets.

6.6 Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

Omega Pharma Ltd.

1^st Floor

32 Vauxhall Bridge Road LONDON, SW1V 2SA United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 02855/0079

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/03/2001

10 DATE OF REVISION OF THE TEXT

17/03/2015