SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Sootheze Six Plus Paracetamol 250mg / 5ml Oral Suspension

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Active Ingredient:    Each 5ml of Suspension contains:

Paracetamol: 250mg

Excipients with known effects Each 5ml of Suspension contains:-

Maltitol: 1.0ml

Sodium Methylparahydroxybenzoate (E219): 9.0mg Sodium Propylparahydroxybenzoate (E217): 1.0mg

For a full list of excipients: See section 6.1

3    PHARMACEUTICAL FORM

Uniform off-white Suspension With strawberry flavour

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Sootheze Six Plus Paracetamol Suspension is indicated    for the treatment of mild to

moderate pain. It is also used for the relief of the pain associated with feverish cold, and as an antipyretic.

4.2    Posology and method of administration

It is important to shake the bottle for at least 10 seconds before use

		hours)*
6 - 8 years	One 5 mL spoonful (large end)	4 times
8 - 10 years	One 5.0 mL spoonful (large end) and one 2.5 mL spoonful (small end)	4 times
10 - 12 years	Two 5 mL spoonfuls (large end)	4 times
•    Do not give more than 4 doses in any 24 hour period •    Leave at least 4 hours between doses •    Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist •    Do not give to children under the age of 6 years.

Children aged 12-16 years: Two - three 5mL spoonfuls (large end) up to 4 times a day

Adults and children over 16 years: Two - four 5mL spoonfuls (large end) up to 4 times a day.

4.3 Contraindications

Sootheze Six Plus Paracetamol Suspension is contra-indicated in patients with known hypersensitivity to Paracetamol, or any of the other components.

4.4. Special warnings and precautions for use

Sootheze Plus Paracetamol Suspension should be used with caution in moderate to severe renal impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

The label should contain the following statements:

•    Contains paracetamol.

•    Do not give this medicine with any other paracetamol-containing product.

•    For oral use only.

•    Never give more medicine than shown in the table.

•    Do not overfill the spoon.

•    Always use the spoon supplied with the pack.

•    Do not give more than 4 doses in any 24 hour period.

•    Leave at least 4 hours between doses.

•    Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

•    As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.

•    Do not store above 25°C. Store in the original package.

•    Keep out of the reach and sight of children.

• Immediate medical advice should be sought in the event of an overdose, even if the child seems well (label).

• Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage (leaflet).

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 use of Paracetamol with risk of bleeding; occasional does have no significant effect.

Patients who have taken barbiturates, tricyclic, antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol, the plasma half-life of which can be prolonged.

Alcohol can increase the hepatotoxicity of Paracetamol overdosage and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of Paracetamol.

Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first pass metabolism or clearance.

4.6    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 the doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7    Effects on ability to drive    and    use    machines

None known.

4.8    Undesirable effects

Paracetamol has been widely    used    and,    when taken at the usual recommended dosage,

side effects are mild and infrequent and reports of adverse reactions are rare. Skin rash and other allergic reactions occur rarely.

There have been reports of blood dyscrasias including thrombocytopenia and agranulocystosis but these were not necessarily causally related to Paracetamol.

Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of Paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of Paracetamol nor was the control of the disease improved after Paracetamol withdrawal.

Nephrotoxicity following therapeutic doses of Paracetamol is uncommon. Papillary necrosis has been reported after prolonged administration.

4.9 Overdose

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 24h from ingestion should be discussed with the NPIS or a liver unit.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

ATC Code:    NO2 BE01

Pharmacotherapeutic group:    Analgesic

Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has weak anti-inflammatory effects.

5.2    Pharmacokinetic properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma halflife is in the range of 1 to 3 hours after therapeutic doses. Drug is widely distributed throughout most body fluids. Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours almost entirely following hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected. Children have less capacity for glucuronidation of the drug than do adults. In overdosage these is increased N-hydroxylation followed by gluthathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.

5.3    Preclinical safety data

No data of relevant to the prescriber, which is additional to that already included in other section of the SPC.

6    PHARMACEUTICAL    PARTICULARS

6.1    List of excipients

Glycerol

Xanthan Gum

Avicel RC591 (microcrystalline cellulose and carboxycellulose sodium) Maltitol liquid (E965)

Polysorbate 80 Saccharin Sodium (E954)

Citric Acid Monohydrate

Sodium Methyl parahydroxybenzoate (E219)

Sodium Propyl parahydroxybenzoate (E217)

Strawberry flavour (containing propylene glycol)

Purified Water

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

2 years

6.4    Special precautions for storage

Do not store above 25°C.

6.5    Nature and contents of container Amber Glass Bottle & 28mm White Closure:

Amber glass bottle closed with a three piece plastic child resistant, tamper evident closure fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.

A double-ended spoon, made form high density polyethylene, with a 2.5ml and 5ml measure is supplied with all packs of this product.

Pack sizes available: 100ml

6.6    Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

Aspar Pharmaceuticals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale, London NW9 0EQ

8    MARKETING AUTHORISATION NUMBER(S)

PL 08977 / 0027

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28/09/2007

10    DATE OF REVISION OF THE TEXT

20/07/2012