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Benylin Chesty Cough & Cold Tablets

Last Updated on eMC 17-Mar-2016 View document  | McNeil Products Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 17-Mar-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 02-Mar-2016

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.3 Removed text “Hypertension, hyperthyroidism, diabetes, serious heart disease or those patients receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.”

 

Added text “Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease or those taking tricyclic antidepressants or beta-blocking drugs and those patients who are taking or have taken, within the last two weeks, monoamine oxidase inhibitors (see section 4.5).” and “Phaeochromocytoma. Closed angle glaucoma.”

 

Section 4.4 Added text “Patients suffering from chronic cough or asthma should consult a physician before taking this product.

Patients should stop using the product and consult a health care professional if cough lasts for more than 5 days or comes back, or is accompanied by a fever, rash or persistent headache.

Do not take with a cough suppressant.

Medical advice should be sought before taking this product in patients with these conditions:

An enlargement of the prostate gland

Occlusive vascular disease (e.g. Raynaud's Phenomenon)

Cardiovascular disease

This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).

Concomitant use of other paracetamol-containing products should be avoided. If symptoms persist consult your doctor.”

Section 4.5 Added text “The hepato-toxicity of paracetamol may be potentiated by excessive intake of alcohol. Pharmacological interactions involving paracetamol with a number of other drugs have been reported. These are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed.”

“Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported: Monoamine oxidase inhibitors (including moclobemide)

Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications).

Sympathomimetic amines

Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.

Beta-blockers and other antihypertensives (including

debrisoquine, guanethidine, reserpine, methyldopa)

Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of

hypertension and other cardiovascular side effects may be increased.

Tricyclic antidepressants (e.g. amitriptyline)

May increase the risk of cardiovascular side effects with phenylephrine.

Ergot alkaloids (ergotamine and methylsergide)

Increased risk of ergotism

Digoxin and cardiac glycosides

Increase the risk of irregular heartbeat or heart attack”

“If urine is collected within 24 hours of a dose of this product, a metabolite may cause a colour interference with laboratory determinations of 5 hydroxyindoleacetic acid (5-HIAA) and vanillymandelic acid (VMA).”

 

Section 4.6 Replaced “P” in “Pregnancy” with “p”

Added text “This product should not be used during pregnancy without medical advice.”

Removed Text “Available published data do not contraindicate breast feeding.”

Added text “This product should not be used whilst breast feeding without medical advice.”

“The safety of phenylephrine during pregnancy has not been established.

Phenylephrine is excreted in breast milk but not in a clinically significant amount. This product should not be used whilst breast feeding without medical advice.”

 

Section 4.7 Added text “Patients should be advised not to drive or operate machinery if affected by dizziness.”

 

Section 4.8 Removed text “Adverse effects of paracetamol are rare but hypersensitivity including skin rashes may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

The active ingredients are usually well tolerated in normal use.”

 

Added text “Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ 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.”

“Body System

Undesirable effect

Blood and lymphatic system disorders

Thrombocytopenia

Agranulocytosis

These are not necessarily causally related to paracetamol

Immune system disorders

Anaphylaxis

Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome, toxic epidermal necrolysis

Respiratory, thoracic and mediastinal disorders

Bronchospasm*

Hepatobiliary disorders

Hepatic dysfunction

Gastrointestinal disorders

Acute pancreatitis”

“* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.”

 

Removed Text “Gastrointestinal discomfort has occasionally been reported with guaifenesin.”

 

Added Text “The frequency of these events is unknown but considered likely to be rare.”

“Body System

Undesirable effect

Immune system disorders

Allergic reactions, angioedema, anaphylactic reactions

Respiratory, thoracic and mediastinal disorders

Dyspnoea*

Gastrointestinal disorders

Nausea, vomiting, abdominal discomfort,

Skin and subcutaneous disorders

Rash, urticarial”

Removed Text “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.”

 

Added text “The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.”

“Body System

Undesirable effect

Psychiatric disorders

Nervousness, irritability, restlessness, and excitability

Nervous system disorders

Headache, dizziness, insomnia

Cardiac disorders

Increased blood pressure

Gastrointestinal disorders

Nausea, Vomiting, diarrhoea”

"Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.”

"Eye disorders

Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma

Cardiac disorders

Tachycardia, palpitations

Skin and subcutaneous disorders

Allergic reactions (e.g. rash, urticaria, allergic dermatitis).

Hypersensitivity reactions including cross-sensitivity with other

sympathomimetics may occur.

Renal and urinary disorders

 

Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy. "

Section 4.9 Removed text “Gastrointestinal discomfort has occasionally been reported with Guaifenesin.”

 

Added Text “Symptoms and signs

Very large doses of guaifenesin cause nausea and vomiting.

Treatment

Vomiting would be treated by fluid replacement and monitoring of electrolytes if indicated.”

 

Removed text “Phenylephrine hydrochloride may elevate blood pressure with headache, vomiting and rarely palpitations, tachycardia or reflex bradycardia, tingling and coolness of the skin.”

 

Added text “Symptoms and signs

Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related toxicity.”

“Treatment

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.”

 

Section 10 Date replaced with “02/03/2016”

 

 

Updated on 26-Oct-2015 and displayed until 17-Mar-2016

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 14-Oct-2015

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 Add text "Do not take more medicine than the label tells you to."

Section 4.4 Add text "Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Keep out of the sight and reach of children. Do not take anything else containing paracetamol while taking this medicine. Talk to your doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage."  

Section 4.8 Add text "Very rare cases of serious skin reactions have been reported. Reporting of suspected adverse reaction. 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."

Section 10 Add text "14 October 2015"

Updated on 06-Aug-2014 and displayed until 26-Oct-2015

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:GSL

Black Triangle (CHM): NO

Company contact details

McNeil Products Ltd

Company image
Address

Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG

Medical Information e-mail
Medical Information Direct Line

01344 864042

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

guaifenesin, paracetamol, phenylephrine hydrochloride

Legal categories

GSL - General Sales List

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