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Benylin Cold & Flu Max Strength Capsules

Last Updated on eMC 10-Apr-2017 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 10-Apr-2017 and displayed until Current

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 10 - Date of revision of the text

Date of revision of text on the SPC: 23-Mar-2017

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:




 

4.2 Posology and method of administration

Posology

Adults and Children 12 years and over:

2 capsules every 4 hours as required to a maximum of four doses in any 24 hours.

Do not exceed eight capsules in any 24 hours.

Do not take continuously for more than 7 days without medical advice

This product is contraindicated in children under the age of 12 years (see section 4.3).

Method of administration

For oral use.

Swallow whole with water. Do not chew.Route of administration: Oral

Swallow whole with water. Do not chew.

For all indications:

Adults, the elderly and children aged 16 years and over:

Two capsules every 4 to 6 hours when necessary to a maximum of 8 capsules (4 doses) in 24 hours.

Leave at least 4 to 6 hours between doses.

Do not take more than 8 capsules (4 doses) in any 24 hours.

Dosage should not be continued for longer than 3 days without consulting a doctor.

Children under 16 years:

Not to be used unless recommended by a doctor.

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 non-cirrhotic alcoholic liver disease.

 

PL 12063/0066

 

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.CONTAINS PARACETAMOL

Do not take anything else containing paracetamol while taking this medicine.

Talk to a doctor at once if you take too much of this medicine, even if you feel well.

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.

 

The Label shall say:

Talk to a doctor at once if you take much of this medicine, even if you feel well.Immediate medical advice should be sought in the event of an overdose, even if you feel well.

The Leaflet shall say:

Talk to a 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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.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.

10 DATE OF REVISION OF THE TEXT

10/03/201623/01/2017




















Updated on 23-Jun-2016 and displayed until 10-Apr-2017

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 10-Mar-2016

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Text in green and underlined has been added, text in red and struck through has been removed

1                    NAME OF THE MEDICINAL PRODUCT

 

     Asda Max Strength Cold & Flu Capsules, hard

     Benylin Cold & Flu Max Strength Capsules, hard

     Galpharm Max Strength Cold & Flu Capsules, hard

     Lloyds pharmacy Max Strength Cold & Flu Capsules, hard

     Morrisons Max Strength Cold & Flu Capsules, hard

     Superdrug Max Strength Cold & Flu Capsules, hard

     Tesco Max Strength Cold & Flu Capsules, hard

            The co-operative Max Strength Cold & Flu Capsules

     Wilko Max Strength Cold & Flu Capsules, hard

            Boots Max Strength Cold & Flu Relief Capsules, hard

            Numark Max Strength Cold & Flu Capsules, hard

            Tesco Max Cold & Flu Relief Capsules, hard

     Sainsbury’s Healthcare Max Strength Cold & Flu Capsules, hard

 

     Health Essentials Max Strength Cold & Flu Capsules, hard

 

 

 

 

 

 

 

 

 



4.1    Therapeutic indications

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



4.2        Posology and method of administration

For oral use.

Posology

 

Swallow whole with water.  Do not chew.

 

     Adults and Children 12 years and over:

     2 capsules every 4 hours as required to a maximum of four doses in any 24 hours.

     Do not exceed eight capsules in any 24 hours.

      

 

Do not take continuously for more than 7 days without medical advice    

 

This product is contraindicated in children under the age of 12 years (see section 4.3).     

 

     Method of administration

     For oral use.

Swallow whole with water.  Do not chew.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


4.3     Contraindications

 

     Paracetamol:          Hypersensitivity to paracetamol or any of the other                             constituents.

 

Caffeine:                  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.

    

Not to be used in children under the age of 12 years.

Paracetamol:

Hypersensitivity to paracetamol or any of the other constituents.

Caffeine:

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.


4.5             Interaction with other medicinal products and other forms of interaction

Enzyme-inducing drugs may increase hepatic damage, as does excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

These interactions are considered to be of unlikely clinical significance in acute usage at the dosage regimen proposed.

Medical advice should be sought before taking paracetamol-caffeine-phenylephrine in combination with the following drugs:

 

 

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 sympathomimetics amines can increase the risk of cardiovascular side effects (see warnings and precautions).

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 (see contraindications).

Tricyclic antidepressants (eg amitriptyline)

May increase the risk of cardiovascular side effects with phenylephrine (see contraindications)

Digoxin and cardiac glycosides

Concomitant use of phenylephrine with digoxin or cardiac glycosides may increase the risk of irregular heartbeat or heart attack

Ergot alkaloids

(ergotamine and methylsergide) increased risk of ergotism

Warfarin and other coumarins

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with an increased risk of bleeding; occasional doses have no significant effect.

 

 

 

 

 


4.6     Fertility, Pregnancy and lactationLactation

PARACETAMOL

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

Caffeine

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

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.

 

 

 

 

 

 

 


4.8 Undesirable effects

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

 

The frequency of occurrence of undesirable effect is usually classified as follows:

Very common (> 1/10)

Common (> 1/100 to < 1/10)

Uncommon (> 1/1,000 to < 1/100)

Rare (> 1/10,000 to 1/1,000)

Very rare (< 1/10,000)

Not known (incidence cannot be assessed on the basis of the available data).

 

Adverse events of paracetamol 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.

 

Paracetamol

 

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, angiodema and Stevens Johnson syndrome, toxic epidermal necrolysis

 

Respiratory, thoracic and mediastinal disorders

 

Bromchospasm*

Hepatobiliary disorders

 

Hepatic dysfunction

* There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosiscases of bronchospasm with paracetamol, but these were not necessarily causally related to paracetamol.  are more likely in asthmatics sensitive to aspirin or other NSAIDs.

 

     Very rare cases of serious skin reactions have been reported.

CAFFEINE

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.Caffeine

Adverse reactions identified through post-marketing use with caffeine are listed below. The frequency of these reactions is unknown.

 

Central Nervous system

Nervousness and anxiety

Irritability, Restlessness and Excitability

 

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.

 

Phenylephrine

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

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.

 

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.

 

 

 


5.1       Pharmacodynamic properties

Pharmacotherapeutic Group:                 Other analgesics and antipyretics &

                                                            Other cold combination preparations

 

ATC code:                                           N02BE51

 

 

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 sensitisesensities pain receptors to mechanical or chemical stimulation.

 

Antipyretic:

Paracetamol probably produces antipyresis by acting on the hypothalamic heat-regulating 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

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 headacheheadaches 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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


6.5     Nature and contents of container

 

Pack size 8 or 16 capsules.

 

Blister packs comprising either:

 

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

 

OR

 

250 micron white opaque PVC/9 micron aluminium foil laminated to 35 g/m2 paper, contained in an outer cardboard carton.

35 g/m2 paper, contained in an outer cardboard carton.

 

 

 

 

 

 


10      DATE OF REVISION OF THE TEXT

 

  02 September 2015

10/03/2016


Updated on 03-Nov-2015 and displayed until 23-Jun-2016

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 02-Sep-2015

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 Add Text "Galpharm. The co-opertative Max Strength Cold & Flu Capsules. Boots Max Strength Cold & Flu Relief Capsules, hard. Numark Max Strength Cold & Flu Capsules, hard. Tesco Max Cold & Flu Relief Capsules, hard. Sainsbury's Healthcare Max Strength Cold & Flu Capsules, hard."

Section 1 Remove Text "Boots. Sainsbury's Max Strength Cold & Flu Capsules, hard"

Section 4.8 Add Text "Very rare cases of serious skin reactions have been reported. 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 Sceme at: www.mhra.gov.uk/yellowcard."

Section 10 Add Text "02 September 2015"

Updated on 13-May-2009 and displayed until 03-Nov-2015

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable Effects

Date of revision of text on the SPC: 01-Apr-2009

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update to Childrens Cough and Cold medicinal products as requested by the MHRA:

http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON038908

Updated on 09-Aug-2006 and displayed until 13-May-2009

Reasons for adding or updating:

  • New SPC for new product

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

caffeine, paracetamol, phenylephrine hydrochloride

Legal categories

GSL - General Sales List

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