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1. Teva Max Strength Cold & Flu Day & Night Capsules Hard
2. Teva Max Strength Cold & Flu Day & Night Capsules Hard

3.    PHARMACEUTICAL FORM

Capsule, hard (capsule)

Red/yellow (Day) and dark blue/light blue (Night) hard gelatin capsules containing the drug products, which are off-white powders.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

DAY CAPSULE

For the relief of symptoms associated with the common cold and influenza, including relief of aches and pains, sore throat, headache, fatigue and drowsiness, nasal congestion and lowering of temperature.

NIGHT CAPSULE

For the relief of symptoms associated with the common cold and influenza, including relief of aches and pains, sore throat, headache, nasal congestion and lowering of temperature.

4.2    Posology and method of administration

For oral use.

Swallow whole with water. Do not chew.

Each blister contains 6 red/yellow Day capsules and 2 dark blue/light blue Night capsules.

Adults and Children over 12 years

2 red/yellow capsules every 4 - 6 hours during the day as required, followed by 2 dark blue/ light blue capsules at bedtime.

Leave at least 4 hours between doses.

Do not take more than 8 capsules in 24 hours.

Not recommended for children under 12 years of age.

Note: Does not contain a sleep aid

4.3 Contraindications

PARACETAMOL

Hypersensitivity to paracetamol or any of the other constituents.

CAFFEINE (Day capsules only):

Should be given with care to patients with a history of peptic ulcer.

PHENYLEPHRINE HYDROCHLORIDE

Severe coronary heart disease and cardiovascular disorders. Hypertension. Hyperthyroidism. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.

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 hazards of overdose are greater in those with noncirrhotic alcoholic liver disease.

Use with caution in patients with Raynaud’s Phenomenon and diabetes mellitus.

The following warnings will appear on the pack:-CONTAINS PARACETAMOL

-    If symptoms persist consult your doctor.

-    Do not exceed the stated dose.

-    Keep all medicines out of the reach and sight of children.

-    Do not take with any other paracetamol-containing products.

The Label shall say:

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

The Leaflet shall say:

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.

If you are pregnant or being prescribed medicine by your doctor, seek your doctor’s advice before taking this product.

4.5 Interaction with other medicinal products and other forms of interaction

PARACETAMOL

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 use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors because of a risk of hypertensive crisis.

PHENYLEPHRINE HYDROCHLORIDE

Phenylephrine may adversely interact with other sympathomimetics, vasodilators and beta blockers.

4.6 Pregnancy and lactation

PARACETAMOL

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.

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

CAFFEINE (Day capsules only)

Taken during pregnancy, it appears that the half-life of caffeine is prolonged. This is a possible contributing factor in hyperemesis gravidarum (morning sickness).

Caffeine appears in breast milk. Irritability and poor sleeping pattern in the infant have been reported.

PHENYLEPHRINE HYDROCHLORIDE

Due to the vasoconstrictive properties of phenylephrine the product should be used with caution in patients with a history of pre-eclampsia. Phenylephrine may reduce placental perfusion and the product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

PARACETAMOL

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.

There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Very rare cases of serious skin reactions have been reported.

CAFFEINE (Day capsules only)

Nausea and insomnia have been noted.

PHENYLEPHRINE HYDROCHLORIDE

Phenylephrine hydrochloride may elevate blood pressure with headache, vomiting and rarely palpitations; tachycardia or reflex bradycardia; tingling and coolness of the skin. There have been rare reports of allergic reactions.

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, phenobarbitone, 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 British National Formulary (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 hours from ingestion should be discussed with the National Poison Information Service (NPIS) or a liver unit.

CAFFEINE (Day capsules only)

Doses over 1g are probably necessary to induce toxicity, 2 - 5g to produce severe toxicity and 5 - 10g is likely to be lethal.

Symptoms include: epigastric pain, vomiting, diuresis, tachycardia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors, convulsions).

No specific antidote is available, reduce or stop dosage and avoid excessive intake of coffee or tea.

PHENYLEPHRINE HYDROCHLORIDE

Severe overdosage may produce hypertension and associated reflex bradycardia. Treatment measures include early gastric lavage and symptomatic and supportive measures. The hypertensive effects may be treated with an alpha-receptor blocking agent (such as phentolamine mesylate 6 - 10 mg) given intravenously, and the bradycardia treated with atropine, preferably only after the pressure has been controlled.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group:    Other analgesics and antipyretics &

Other cold combination preparations

NO2B E51

PARACETAMOL

Analgesic:

The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting a prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent through a peripheral action by blocking pain-impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.

Antipyretic:

Paracetamol probably produces antipyresis by acting on the hypothalamic heatregulating centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

CAFFEINE (Day capsules only)

Central nervous system stimulant - Caffeine stimulates all levels of the CNS, although its cortical effects are milder and of shorter duration than those of amfetamines.

Analgesia Adjunct:

Caffeine constricts cerebral vasculature with an accompanying decrease in cerebral blood flow and in the oxygen tension of the brain. It is believed that caffeine helps to relieve headache by providing a more rapid onset of action and/or enhanced pain relief with lower doses of analgesic. Recent studies with ergotamine indicate that the enhancement of effect by the addition of caffeine may also be due to improved gastrointestinal absorption of ergotamine when administered with caffeine.

PHENYLEPHRINE HYDROCHLORIDE

Sympathomimetic amines, such as phenylephrine, act on alpha-adrenergic receptors of the respiratory tract to produce vasoconstriction, which temporarily reduces the swelling associated with inflammation of the mucous membranes lining the nasal and sinus passages. This allows the free drainage of the sinusoidal fluid from the sinuses.

In addition to reducing mucosal lining swelling, decongestants also suppress the production of mucus, therefore preventing a build up of fluid within the cavities which could otherwise lead to pressure and pain.

5.2 Pharmacokinetic properties

PARACETAMOL

Absorption and Fate

Paracetamol is rapidly absorbed from the gastro-intestinal tract with peak plasma concentrations occurring between 10 and 120 minutes after oral administration. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 4 hours.

Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdose and cause liver damage.

CAFFEINE (Day capsules only)

Absorption and Fate

Caffeine is absorbed readily after oral administration and is widely distributed throughout the body. Caffeine is metabolised almost completely via oxidation, demethylation, and acetylation, and is excreted in the urine as 1-methyluric acid, 1-methylxanthine, 7-methylxanthine, 1,7-dimethylxanthine (paraxanthine), 5-acetylamino-6-formylamino-3-methyluracil (AFMU), and other metabolites with only about 1% unchanged.

PHENYLEPHRINE HYDROCHLORIDE Absorption and Fate

Phenylephrine has reduced bioavailability from the gastro-intestinal tract owing to irregular absorption and first-pass metabolism by monoamine oxidase in the gut and liver.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber additional to that already covered in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

DAY CAPSULE

Maize starch Croscarmellose sodium Sodium laurilsulfate Magnesium stearate

Talc

Gelatin

Titanium dioxide    E171

Quinoline yellow    E104

Patent blue V    E131

Erythrosine    E127

NIGHT CAPSULE

Maize starch Croscarmellose sodium Sodium laurilsulfate Magnesium stearate Talc Gelatin

Titanium dioxide    E171

Erythrosine    E127

Indigo carmine    E132

6.2    Incompatibilities

None known.

6.3    Shelf life

36 months.

6.4    Special precautions for storage

Do not store above 25°C.

6.5    Nature and contents of container

Blister packs of white opaque 250 micron PVC/30 micron hard temper pyramidal aluminium foil, heat-seal coated, contained in an outer cardboard carton.

Pack sizes:

16 capsules comprising two blisters each containing 6 red/yellow Day capsules and 2 light blue/dark blue Night capsules.

6.6    Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Limited

Wrafton

Braunton

North Devon

EX33 2DL

8    MARKETING AUTHORISATION NUMBER(S)

PL 12063/0073.

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/11/2007

10    DATE OF REVISION OF THE TEXT

24/02/2016