VicksSinexCapsules - Medicines and Healthcare products

PL 16028/0140

UKPAR Galpharm Healthcare Ltd,Vicks Sinex Decongestant Capsules

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Public Assessment Report

Vicks Sinex Decongestant Capsules

Paracetamol Dense Powder Phenylephrine Hydrochloride

PL 16208/0140

Galpharm Healthcare Ltd

Table of Contents Page Lay Summary 2 Scientific Discussion 3 Overall Conclusion And Risk Benefit/Analysis 6 Steps Taken During Assessment 7 Steps Taken After Assessment 8 Summary of Product Characteristics 9 Labels and Leaflet 16

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Lay Summary The MHRA granted a marketing authorisation for the medicinal product Vicks Sinex Decongestant Capsules (PL 16208/0140) to Galpharm Healthcare Ltd on 21/08/2009. The application was for a duplicate of the licence PL 12063/0031 (Extra Strength Cold and Flu Capsules with Decongestant) also held by the applicant. The licence for Extra Strength Cold and Flu Capsules with Decongestant was granted in October 1996. Vicks Sinex Decongestant Capsules are for relief of symptoms of colds and influenza, including aches and pains, headache, nasal congestion sinus pain and feverishness.

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Scientific Discussion

INTRODUCTION The MHRA granted a marketing authorisation for the medicinal product Vicks Sinex Decongestant Capsules (PL 16208/0140) to Galpharm Healthcare Ltd on 21/08/2009. This was a simple abridged application under Article 10.c of Directive 2001/83/EC. The application was for a duplicate of the licence PL 12063/0031 (Extra Strength Cold and Flu Capsules with Decongestant) also held by the applicant. The licence for Extra Strength Cold and Flu Capsules with Decongestant was granted in October 1996. Confirmation that the manufacturer is prepared to manufacture the product on the applicant’s behalf was provided. The applicant has also provided satisfactory written confirmation that they have access to all the data supporting the application and that the data are in their possession. Vicks Sinex Decongestant Capsules are for relief of symptoms of colds and influenza, including aches and pains, headache, nasal congestion sinus pain and feverishness. The product is available without medical prescription.

PHARMACEUTICAL ASSESSMENT DRUG SUBSTANCE The active ingredients in this product are identical to those in the reference product. Satisfactory letters of access have been provided. Drug substance specifications are identical to the reference product. DRUG PRODUCT Other Ingredients The other ingredients in the drug product are, Colloidal Anhydrous Silica, Sodium Starch Glycollate, Magnesium Stearate. The capsule shell contains: Gelatin, Titanium Dioxide (E171), Patent Blue V (E131), Yellow Iron Oxide (E172). These are identical to the reference product. The manufacturing process and finished product specifications are identical to that of the reference product. The proposed compositions and references to Pharmacopoeial standards are identical to those registered for the reference products. The product is contained in a blister of polyvinylchloride with a child-resistant aluminium closure.

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The product has a shelf-life of 2 years with the following storage conditions “Store below 25°C” and “Store in a dry place”. Product literature A satisfactory Summary of Product Characteristics which was consistent with the reference product was provided. Satisfactory Patient Information Leaflet and labels were provided

ASSESSOR’S OVERALL CONCLUSIONS ON QUALITY AND ADVICE A Marketing Authorisation was granted.

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PRE-CLINICAL AND MEDICAL ASSESSMENT

No clinical data or pre-clinical data were submitted with this application and none were required.

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Overall Conclusion and Risk/Benefit Analysis

Quality The quality aspects of the product were confirmed to be identical to the cross-reference product. Pre-Clinical No new preclinical data were submitted and none are required for applications of this type.

Clinical The clinical aspects of the product were confirmed to be identical to the cross-reference product.

Risk/Benefit Analysis The product was demonstrated to be identical to the cross-reference product which has already been found to have a positive risk/benefit ratio.

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Steps Taken During Assessment 1

The MHRA received the application on 16/04/2009.

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Following standard checks and communication with the applicant the MHRA considered the application valid on 21/04/2009.

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Following assessment of the application the MHRA requested further information from the applicant regarding the quality assessment on 08/07/2009.

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The applicant provided further information in regard to the quality assessment on 21/08/2009.

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The application was determined on 21/08/2009.

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Steps Taken after Assessment No non-confidential changes have been made to the market authorisation.

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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Vicks Sinex Decongestant Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Paracetamol 500mg Phenylephrine Hydrochloride 12.18mg For excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsule Green and white hard gelatin capsule containing white powder.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For relief of symptoms of colds and influenza, including aches and pains, headache, nasal congestion sinus pain and feverishness.

4.2 Posology and method of administration

For oral administration. Adults and children over 12 years of age: 1 capsule to be taken every 4-6 hours as required. Doses should not be repeated more frequently than every 4 hours. Maximum of 4 capsules in any 24 hours. Children under 12 years: Not recommended.

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4.3 Contraindications

Patients with known hypersensitivity to Paracetamol, Phenylephrine or any of the other ingredients. Also contra-indicated during pregnancy and in those taking monoamine oxidase inhibitors or tricyclic anti-depressant drugs.

4.4 Special warnings and precautions for use

Paracetamol should be used with care in patients with severe renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. 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. Do not take with any other paracetamol-containing products. Phenylephrine should be used with care in patients with hyperthyroidism, cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic enlargement and hypertension. Do not exceed the stated dose. If symptoms persist consult your doctor. Keep out of the reach and sight of children.

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 anti-coagulant 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. With phenylephrine there is a possibility that an increased risk of' arrhythmias may occur in patients receiving cardiac glycosides or tri-cyclic anti-depressants. Phenylephrine interacts with monoamine oxidase inhibitors; it should not therefore, be taken by patients receiving monoamine oxidase inhibitors or within 14 days of stopping such medication.

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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 their doctor regarding its use. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contra-indicate breast feeding. Phenylephrine should not be taken during pregnancy as it has been reported to cause fetal hypoxia. Excretion in breast milk is reported to be minimal.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Undesirable effects with paracetamol are rare however, hypersensitivity including skin rashes may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol. Phenylephrine can cause the adverse effects typical of sympathomimetics including, dizziness, hypertension and tachycardia.

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, 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

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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. The principal features of phenylephrine overdosage are a rise in blood pressure and associated reflex bradycardia. A severe hypertensive response can be countered by administration of an alpha-antagonist and any reflex bradycardia by atropine (but preferably only after the pressure has been controlled by alpha-adrenergic blockade).

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code: N02BE Paracetamol has analgesic and antipyretic actions probably due to the inhibition of prostaglandin biosynthesis. Phenylephrine hydrochloride is a sympathomimetic agent with mainly direct effect on adrenergic receptors. It has predominantly alpha-adrenergic

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activity and is without significant stimulating effects on the central nervous system at usual doses. It may be given orally to relieve nasal congestion.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastro-intestinal tract and peak plasma concentrations usually occur 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and largely excreted in the urine as sulphate and glucuronide conjugates. Less than 5% is excreted unchanged. The elimination half-life varies from about 1 to 4 hours. Phenylephrine is readily absorbed after oral administration but is subject to extensive presystemic metabolism. Peak plasma concentrations are achieved in 1 to 2 hours. Phenylephrine is biotransformed in the liver and is excreted along with its metabolites in the urine, with less than 20% as unchanged drug.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Colloidal Anhydrous Silica, Sodium Starch Glycollate, Magnesium Stearate. The capsule shell contains: Gelatin, Titanium Dioxide (E171), Patent Blue V (E131), Yellow Iron Oxide (E172).

6.2 Incompatibilities

None.

6.3 Shelf life

3 years.

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6.4 Special precautions for storage Store below 25°C in a dry place.

6.5 Nature and contents of container

Blister strips comprised of 30 micron hard temper Aluminium lidding foil with 250 – 300 micron PVC base material. or Blister strips comprised of 30 micron hard temper Aluminium lidding foil with 250 micron PVC/PVdC (40- 90 gsm) base material. or Blister strips comprised of 20 micron Aluminium /15micron PVC lidding foil with 250-300 micron PVC base material. or Blister strips comprised of 20 micron Aluminium/ 15micron PVC lidding foil with 250 micron PVC/PVdC (40 – 90gsm) base material. or Blister strips comprised of 35-41gsm Glassine paper/9micron Aluminium lidding foil with 250 – 300micron PVC base material. or Blister strips comprised of 35-41gsm Glassine paper/9micron Aluminium lidding foil with 250micron PVC/PVdC (40-90gsm) base material. Blister pack sizes of 8, 10, 12 or 16 capsules.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Dodworth Business Park Dodworth South Yorkshire S75 3SP

8 MARKETING AUTHORISATION NUMBER(S)

PL 16028/0140

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9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 21/08/2009 10 DATE OF REVISION OF THE TEXT

21/08/2009

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Labels and Leaflets

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Documents

VicksSinexCapsules - Medicines and Healthcare products