This information is intended for use by health professionals

1. Name of the medicinal product

Hedex Extra or Solpadeine Headache Tablets

2. Qualitative and quantitative composition

Each tablet contains Paracetamol Ph.Eur. 500.0 mg and Caffeine Ph.Eur. 65.0 mg.

3. Pharmaceutical form

Tablet.

Hedex Extra/Solpadeine Headache Tablets are white film-coated, capsule shaped tablets.

4. Clinical particulars
4.1 Therapeutic indications

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

4.2 Posology and method of administration

Adults and children16 years and over:

Two tablets every 4-6 hours up to four times daily. Do not exceed 8 tablets in 24 hours.

Elderly:

As for adults.

Children and children aged 12 – 15 years:

One tablet every 4-6 hours up to four times daily. Do not exceed 4 tablets in 24 hours. Not recommended for children under 12 years.

Method of Administration:

Hedex Extra 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 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 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 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.

4.6 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 post-marketing 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

Bromchospasm*

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

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. Gastric lavage or 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. Antidotes such as N-acetylcysteine (NAC) and methionine protect the liver if administered within 12 hours of overdose. NAC is effective up to and possibly beyond 24 hours. General supportive measures must be available.

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.

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 gastro-intestinal 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 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 excipients

Starch pregelatinised, maize starch, polyvinyl pyrrolidone, potassium sorbate, purified talc, stearic acid, croscarmellose sodium, water, hypromellose (6CPS) and triacetin

6.2 Incompatibilities

None

6.3 Shelf life

60 months

6.4 Special precautions for storage

Store below 25°C

6.5 Nature and contents of container

Opaque PVC 250µm / aluminium foil 30µm blister strips packed into cardboard cartons, containing 8, 12, 16, 24, 30 or 32 tablets; or opaque PVC 250µm/aluminium foil 30µm blisters in a round, wallet style pack containing 12 tablets.

6.6 Special precautions for disposal and other handling

None

7. Marketing authorisation holder

Omega Pharma Ltd.

1st Floor

32 Vauxhall Bridge Road

LONDON, SW1V 2SA

United Kingdom

8. Marketing authorisation number(s)

PL 02855/0069

9. Date of first authorisation/renewal of the authorisation

26.05.88

10. Date of revision of the text

12/10/17