Difflam 3% cream

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Benzydamine hydrochloride
Available from:
Mawdsley-Brooks & Company Ltd
ATC code:
M02AA05
INN (International Name):
Benzydamine hydrochloride
Dosage:
30mg/1gram
Pharmaceutical form:
Cream
Administration route:
Cutaneous
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 10030200

PACKAGE LEAFLET: INFORMATION FOR THE USER

Difflam-P 3% Cream or

Difflam 3% Cream

Read all of this leaflet carefully before you start taking this medicine because

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or

nurse have told you.

This medicine is available without prescription. However, you still need to use it carefully to get the

best results.

Keep this leaflet. You may need to read it again.

Ask your doctor or pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Difflam-P 3 % Cream or Difflam 3 % Cream is and what it is used for

2. What you need to know before you use Difflam-P 3 % Cream or Difflam 3 % Cream

3. How to use Difflam-P 3 % Cream or Difflam3 % Cream

4. Possible side effects

5. How to store Difflam-P 3 % Cream or Difflam 3 % Cream

6. Contents of the pack and other information.

1.

What Difflam-P 3 % Cream or Difflam 3 % Cream is and what it is used for

Difflam-P

Cream

Difflam

Cream

contains

active

substance

benzydamine

hydrochloride and belongs to a group of medicines called nonsteroidal anti-inflammatory drugs or

NSAIDS. Difflam-P 3 % Cream or Difflam 3 % Cream works by stopping pain and swelling

(inflammation). When rubbed into the skin of the affected area it is used to treat aches and pains

including:

Sprains

Strains

Bruises

Sore muscles

Stiff joints.

2.

What you need to know before you use Difflam-P 3 % Cream or Difflam 3 % Cream

Do not use Difflam-P 3 % Cream or Difflam 3 % Cream if

you are allergic to benzydamine hydrochloride.

you are allergic to any of the other ingredients of Difflam-P 3 % Cream or Difflam 3 % Cream (see

section 6).

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before using Difflam-P 3% Cream or Difflam 3% Cream:

If you have a history of asthma

If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory

(NSAID) drugs

If any of these apply to you, talk to your doctor, dentist or pharmacist.

Do not smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc)

that has been in contact with this product burns more easily and is a serious fire hazard. Washing

clothing and bedding may reduce product build-up but not totally remove it.

Other medicines and Difflam-P 3 % Cream or Difflam 3 % Cream

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

Medicines.

Pregnancy, breast feeding and fertility.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

Difflam Cream contains

Cetyl alcohol which may cause local skin reactions (e.g. contact dermatitis)

Propylene glycol which may cause skin irritation.

3.

How to use Difflam-P 3 % Cream or Difflam 3 % Cream

Important:

Always use Difflam-P 3 % Cream or Difflam 3 % Cream exactly as your pharmacist has told you.

You should check with your doctor or pharmacist if you are not sure.

If you get Difflam-P 3% Cream or Difflam 3% Cream in your eyes, mouth, nose or around

your genitals or anus.

Do not use Difflam-P 3 % Cream or Difflam 3 % Cream in or near your eyes, mouth, nose or around

your genitals or anus. If any cream does get in or onto these parts of your body, wash them

immediately with cold water.

How much Difflam-P 3% Cream or Difflam 3% Cream to use

The amount of cream used will depend on the size of the area to be treated.

The normal length of cream to be squeezed out of the tube is between a half and a full finger length

(35-85 mm).

How to use the cream

Rub the cream gently into the affected area until it seems to disappear.

The cream should be used three times each day for no more than 10 days. Your doctor may tell you to

use it more often.

Please wash your hands after applying the cream (unless your hands are being treated).

Contact your doctor if your symptoms worsen or they do not improve.

If you use more Difflam-P 3% Cream or Difflam 3% Cream than you should

It should not cause you any problems if you use more of your medicine than you should.

If you have any concerns, contact your doctor or pharmacist.

If you forget to use Difflam-P 3% Cream or Difflam 3% Cream

Do not apply a double dose to make up for a missed dose. Simply apply the next dose as planned.

If you accidentally swallow Difflam-P 3% Cream or Difflam 3% Cream

It should not cause you any problems if you accidentally swallow some of your medicine.

If you have any concerns, contact your doctor or pharmacist.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines Difflam-P 3 % Cream or Difflam 3 % Cream can cause side effects, although not

everybody gets them.

Some side effects could be serious. If you have any of the side effects listed below, seek

immediate medical help:

severe allergic reaction (anaphylaxis) seen as swelling of throat and mouth, difficulty in swallowing

or speaking, alterations in heart rate, severe asthma, collapse and unconsciousness

Other side effects include the following, if they get serious, please tell your doctor:

The frequency of these side effects cannot be estimated from the available data:

Increased sensitivity to sunlight

Itching

Skin rash

Skin redness or swelling

Difficulty breathing and wheezing.

Some people may react after using the product with a severe allergic reaction experiencing symptoms

as described above (a so called anaphylactic reaction) which may be potentially life-threatening. In

this case you should seek immediate medical assistance.

Some people become more sensitive to the effects of sunlight after using this Cream. This means that

the skin may become red and painful after only a few minutes in the sun. The increased sensitivity to

sunlight should disappear if you stop using the cream.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also report side effects directly via the Yellow

Card Scheme at: www.mhra.gov.uk/yellowcard

search for MHRA Yellow Card in the Google Play

or Apple App Store By reporting side effects you can help provide more information on the safety of

this medicine.

5. How to store Difflam-P 3 % Cream or Difflam 3 % Cream

Keep out of the sight and reach of children.

Do not use Difflam-P 3 % Cream or Difflam 3 % Cream after the expiry date on the tube. The expiry

date refers to the last day of that month.

Do not store above 30 °C. Do not store in the refrigerator or freezer.

Medicines should not be disposed of via wastewater or household waste.

Return any medicine you no longer need to your pharmacist.

6. Contents of the pack and other information

What Difflam-P 3% Cream or Difflam 3% Cream contains

The active substance is 3 % w/w benzydamine hydrochloride.

The other ingredients are glycerol monostearate40 – 55, cetyl alcohol, decyl oleate, eumulgin B1,

propylene glycol, perfume, methyl hydroxy-benzoate, propyl hydroxybenzoate and purified water.

For advice on what to do if you are allergic to any of these ingredients see section 2.

What Difflam-P 3% Cream or Difflam 3% Cream looks like

Difflam-P 3 % Cream or Difflam 3 % Cream is a white cream. It comes in a 35 g, 50 g or 100 g tube.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer

3M Health Care Limited

3M House

Morley Street

Loughborough

Leicestershire

LE11 1EP

This leaflet was last revised in 05/2019.

If this leaflet is difficult to see or read or you would like it in a different format, please contact

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Difflam Cream

Difflam 3% P Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tube of Difflam 3% Cream/ Difflam-P 3% Cream contains Benzydamine

Hydrochloride 3% w/w.

Contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl

alcohol and propylene glycol

For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Cream for topical application to skin.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Difflam 3% Cream/ Difflam-P 3% Cream is a topical analgesic and non-steroidal

anti-inflammatory agent.

It is recommended as a short-term treatment for the relief of symptoms associated

with painful inflammatory conditions of the musculo-skeletal system, including:

Acute inflammatory disorders such as myalgia and bursitis.

Traumatic conditions such as sprains, strains, contusions and the after-effects of

fractures.

Difflam 3% Cream/ Difflam-P 3% Cream is well absorbed through the skin and has

been shown to have anti-inflammatory and local anaesthetic actions.

4.2

Posology and method of administration

Difflam Cream/ Difflam 3% P Cream should be massaged lightly into the

affected area. Depending on the size of the site to be treated, 35 - 85 mm (1 -

2 g) should be applied three times daily and at the discretion of the doctor, up

to six times daily in more severe conditions. It is recommended that treatment

be limited to not more than ten days.

ELDERLY:

No special dosage recommendations are made for elderly patients.

4.3

Contraindications

Difflam 3% Cream/ Difflam-P 3% Cream is contraindicated in patients with known

hypersensitivity to the active substance benzydamine hydrochloride or to any of the

excipients listed in section 6.1.

4.4 Special warnings and precautions for use

To avoid possible irritation, Difflam 3% Cream/ Difflam-P 3% Cream should

be kept away from eyes and mucosal surfaces.

Cetyl alcohol may cause local skin reactions (e.g. dermatitis). Propylene

glycol may cause skin irritation.

Benzydamine use is not advisable in patients with hypersensitivity to

acetylsalicylic acid or other NSAIDs.

Bronchospasm may be precipitated in patients suffering from or with a

previous history of bronchial asthma. Caution should be exercised in these

patients.

Cetyl alcohol may cause local skin reactions (e.g. dermatitis). Propylene

glycol may cause skin irritation.

Methyl hydroxybenzoate and propyl hydroxybenzoate may cause allergic

reactions (possibly delayed).

Instruct patients not to smoke or go near naked flames - risk of severe burns.

Fabric (clothing, bedding, dressings etc) that has been in contact with this

product burns more easily and is a serious fire hazard. Washing clothing and

bedding may reduce product build-up but not totally remove it.

4.5

Interaction with other medicinal products and other forms of interaction

None.

4.6

Fertility, Pregnancy and lactation

Pregnancy

Difflam 3% Cream/ Difflam-P 3% Cream should not be used in pregnancy unless

considered essential by the physician. There is no evidence of a teratogenic effect

in animal studies.

Breast-feeding

Difflam

3% Cream/ Difflam-P 3% Cream

should not be used in lactation unless

considered essential by the physician.

4.7

Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Within each frequency grouping, undesirable effects are presented in order of

decreasing seriousness

The following rate values have been used: 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) and

Very rare

(<1/10,000), not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders

Frequency not known: Photosensitivity reactions have been reported and local

skin reactions which have varied from erythema to papular eruption. The skin

returned to normal on stopping treatment.

Immune system disorders

Frequency not known: Anaphylactic reaction which can be potentially life-

threatening.

Methyl hydroxybenzoate and propyl hydroxybenzoate may cause allergic

reactions (possibly delayed).

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 or search for MHRA Yellow Card in the Google

Play or Apple App Store.

4.9

Overdose

Difflam 3% Cream/ Difflam-P 3% Cream is unlikely to cause adverse systemic

effects, even if accidental ingestion should occur. No special measures are

required.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Other anti-inflammatory and antrheumatic agents,

non-steroids /Anti-inflammatory preparations, non-steroids for topical use,

ATC code: M01AX07/M02AA05

Mechanism of action

The indazole analogue benzydamine has physicochemical properties and

pharmacological activities which differ from those of the aspirin-like NSAIDs.

Unlike aspirin-like NSAIDs which are acids or metabolised to acids,

benzydamine is a weak base. In further contrast, benzydamine is a weak

inhibitor of the prostaglandin synthesis. Only at concentration of 1mM and

above benzydamine effectively inhibits cyclooxygenase and lipooxygenase

enzyme activity. It mostly exerts its effects through inhibition of the synthesis

of proinflammatory cytokines including tumour necrosis factor-alpha (TNF-

and Interleukin-1

(IL-1

) without significantly affecting other pro-

inflammatory (IL-6 and 8) or anti-inflammatory cytokines (IL-10, IL-1

receptor antagonist). Further mechanisms of action are hypothesised including

the inhibition of the oxidative burst of neutrophils as well as membrane

stabilisation as demonstrated by the inhibition of granule release from

neutrophils and the stabilization of lysosomes. The local anaesthetic activity of

the compound has been related to an interaction with cationic channels

Pharmacodynamic effects

Benzydamine specifically acts on the local mechanisms of inflammation such

as pain, oedema or granuloma. Benzydamine topically applied demonstrates

anti-inflammatory activity reducing oedema as well as exudate and granuloma

formation. Further, it exhibits analgesic properties if pain is caused by an

inflammatory condition and local anaesthetic activity. Hyperthermia, which is

indicative of systemic functional involvement, is poorly affected by

benzydamine

Clinical efficacy and safety

In a clinical study in 24 patients with pharyngitis following tonsillectomy

rinsing with Difflam 0.15% 5 times a day for 6 days significantly better and

more rapidly relieved throat pain, difficulty in swallowing and improved

clinical signs including hyperaemia and oedema versus placebo on day 7.

Similar results were found in other studies in patients with tonsillitis or

pharyngitis or following dental surgery. The gargling with 30 ml 0.075%

benzydamine prior to the induction of anaesthesia in 58 adults undergoing

general anaesthesia with endotracheal tube intubation significantly reduced

postoperative sore throat versus water control for the first 24 hours whereas

aspirin gargles reduced it for 4 hours.

In a clinical study with 48 patients rinsing four times daily with 0.15%

benzydamine during a 3 to 5 week radiotherapy of oral cancer provided

significant pain relief and reduction of size and severity of mucositis in the

oropharynx. Similar effects were seen in a study in patients undergoing

chemotherapy for oral cancer. In a study in 67 patients with severe

oropharyngeal mucositis following radiotherapy who rinsed with benzydamine

solution pain with swallowing, hyperaemia and severity of mucositis were

significantly reduced compared to placebo treatment within the first three

treatment days.

A higher incidence of transient numbness and stinging was noted among the

patients using benzydamine that was attributed to the medication’s local

anaesthetic effect.

The topical application of Difflam cream 3% 3 times daily for 6 days in 50

patients with soft tissue injuries significantly better relieved pain, tenderness,

erythema, functional impairment and swelling compared to placebo on day 6.

Overall, benzydamine was well tolerated in clinical trials.

5.2

Pharmacokinetic properties

Following topical administration, benzydamine is absorbed through intact skin

and reaches peak levels between 24 - 32 hours, amounting to about 20 - 25%

of the plasma levels obtained after the oral administration of the same dose.

About half of the benzydamine is excreted unchanged via the kidney at a rate

of 10% of the dose within the first 24 hours. The remainder is metabolised,

mostly to N-oxide.

5.3

Preclinical safety data

Non-Clinical Data reveal no special hazards for humans based on conventional

studies of safety pharmacology, repeated toxicity, genotoxicity, cardiogenic

potential, and toxicity to reproduction.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Glycerol stearate ‘Cutina’

Cetyl Alcohol USNF

Decyl oleate ‘Cetiol V’

Macrogol cetostearyl ether ‘Eumulgin B1’

Propylene Glycol Ph Eur

Perfume, ‘Crematest’ 0/064060’

Methyl Hydroxybenzoate Ph Eur

Propyl Hydroxybenzoate Ph Eur

Purified Water Ph Eur

6.2

Incompatibilities

None known.

6.3

Shelf life

3 years.

6.4

Special precautions for storage

Store between 5 - 30°C. Do not freeze.

6.5

Nature and contents of container

Collapsible Aluminium tube closed with plastic screwcap

Laminate tube closed with plastic screwcap.

Contents: 35 g, 50 g or 100 g

6.6

Special precautions for disposal

Not applicable.

7

MARKETING AUTHORISATION HOLDER

Mylan Products Ltd.,

Station Close,

Potters Bar,

Herts,

EN6 1TL,

United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)

PL 46302/0158

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

06/03/1980 / 06/09/2002

10

DATE OF REVISION OF THE TEXT

26/06/2019

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