DIFFLAM 3 MG LOZENGES MINT FLAVOUR

Active substance: BENZYDAMINE HYDROCHLORIDE

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1.

NAME OF THE MEDICINAL PRODUCT

Difflam 3mg Lozenges Mint flavour
Benzydamine Hydrochloride
2.

STATEMENT OF ACTIVE SUBSTANCE(S)

Each lozenge contains 3 mg benzydamine hydrochloride (equivalent to 2.68 mg benzydamine)
3.

LIST OF EXCIPIENTS

Isomalt (E 953), Acesulfame potassium, Citric acid monohydrate, Eucalyptus oil, Levomenthol,
Quinoline yellow (E 104), Indigotin dye (E 132)

4.

PHARMACEUTICAL FORM AND CONTENTS

Lozenges

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

Oropharyngeal use.
Read the package leaflet before use.

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

Difflam is indicated, in adults and children above 6 years of age, for symptomatic local treatment for
the relief of pain and irritation of mouth and throat.
Children 6-11 years of age: The medicinal product should be administered under adult supervision.
The pharmaceutical form “lozenges” is not suitable for use in children under the age of 6 years.
Relief of pain and irritation of mouth and throat

8.

EXPIRY DATE

Exp:

9.

SPECIAL STORAGE CONDITIONS

Do not store above 30°C. Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE

11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley,
Bishop’s Stortford, CM22 6PU, UK.

12.

MARKETING AUTHORISATION NUMBER(S)

PL 15142/0264

13.

BATCH NUMBER

Lot:

14.

GENERAL CLASSIFICATION FOR SUPPLY

P

15.

INSTRUCTIONS ON USE

Let one lozenge dissolve slowly in your mouth. Do not swallow.
Do not chew.
Take one lozenge 3 times a day. Allow to dissolve slowly in the mouth.
Do not use for more than 7 days at a time.

16.

INFORMATION IN BRAILLE

difflam 3 mg lozenges mint

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
WRAP

1.

NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Difflam 3mg Lozenges Mint flavour
Benzydamine Hydrochloride
Oropharyngeal use

2.

METHOD OF ADMINISTRATION

Let one lozenge dissolve slowly in your mouth. Do not swallow. Do not chew.

3.

EXPIRY DATE

Exp:

4.

BATCH NUMBER

Lot:

5.

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 Lozenges

6.

OTHER

MAH: Meda Pharmaceuticals Ltd
Skyway House, Parsonage Road, Takeley,
Bishop’s Stortford, CM22 6PU, UK.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Difflam 3 mg lozenges, mint flavour
Benzydamine Hydrochloride
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Difflam carefully to
get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact your doctor if your symptoms worsen or do not improve after 3 days.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1. What Difflam is and what it is used for
2. Before you take Difflam
3. How to take Difflam
4. Possible side effects
5. How to store Difflam
6. Further information

1. WHAT DIFFLAM IS AND WHAT IT IS USED FOR
Difflam contains benzydamine, which is used in adults and children above 6 years of age, for
symptomatic local treatment for the relief of pain and irritation of the mouth and throat.

2. BEFORE YOU TAKE DIFFLAM
Do not take Difflam :
-

If you have had an allergic (hypersensitivity) reaction to benzydamine or to any of the other
ingredients.

Take special care with Difflam :
-

You suffer from a condition known as phenylketonuria.
If you have a history of Asthma.
If you are allergic to acetylsalicylic acid or to other anti-inflammatory painkillers called
NSAIDs.
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.
If after using the lozenges the pain in your mouth or throat gets worse or does not improve
within 3 days, or you appear feverish or have other symptoms, you should speak to your doctor
or dentist.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Taking Difflam with food and drink
Food and drink have no influence.
Pregnancy and breast-feeding
You should tell your doctor or pharmacist if you are pregnant, planning to become pregnant or are
breastfeeding.
He/She will then decide whether you should take Difflam.
Driving and using machines
Difflam does not affect your ability to drive or use machines.
Important information about some of the ingredients of Difflam
This medicinal product contains Isomalt. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.
The medicinal product contains also Aspartame a source of phenylalanine. Maybe harmful for
people with phenylketonuria.
3. HOW TO TAKE DIFFLAM
Always take Difflam as your doctor has told you. You should check with your doctor or pharmacist
if you are not sure.
The usual dose is:
Adults and children over 6 years old: one lozenge 3 times a day. Do not take more than 3 lozenges
per day.
Children from 6 to 11 years old: this medicinal product should be administered under an adult
supervision.
The pharmaceutical form “lozenges” should not be given to children under the age of 6 years.
Difflam should not be used for more than 7 days.
Oropharyngeal use.
Let one lozenge dissolve slowly in the mouth.
Do not swallow.
Do not chew.

If you take more Difflam than you should
If you accidentally take too many lozenges, you should contact your pharmacist, doctor or nearest
hospital casualty department immediately. Always take the labelled medicine package with you,
whether there are any lozenges left or not.

Although very rarely, the symptoms of overdose reported in children are excitation, convulsions,
sweating, ataxia, tremor and vomiting after the oral administration of benzydamine dosages about
100 times higher than those of the lozenge.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Difflam may cause side-effects, although not everybody gets them.

Uncommon side effects (between 1 and 10 in every 1,000 people are likely to get these):
- Skin sensitivity to sunlight (causing a rash or sunburn).
Rare side effects (between 1 and 10 in every 10,000 people are likely to get these):
- Burning sensation or dryness of the mouth. If this happens to you, try sipping a glass of water to
reduce the effect.
- Allergic reaction, rash or itching especially if affecting the whole body (hypersensitivity
reaction).
Very rare side effects (less than 1 in every 10,000 people are likely to get these):
- sudden swelling in the mouth/throat and mucous membranes (angioedema).
- difficulty breathing (laryngospasm).
Not known (cannot be estimated from the available data):
- severe allergic reactions (anaphylactic reactions)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. HOW TO STORE DIFFLAM
Keep out of the reach and sight of children.
Do not use Difflam after the expiry date, which is stated on the label after EXP.
The expiry date refers to the last day of that month.
Do not store above 25C.
Store in the original package in order to protect from moisture.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Difflam contains:
-

Each lozenge contains 3 mg benzydamine hydrochloride (equivalent to 2.68 mg benzydamine).

Excipients: The other ingredients are Isomalt (E 953), Aspartame (E951), ,Levomenthol, Citric
acid monohydrate, Lemon flavour, Mint flavour, Quinoline yellow (E104), Indigotin dye
(E132).
What Difflam looks like and contents of the pack
This medicinal product is presented as green, square shaped lozenges with a central cavity,
wrapped in paper. Pack sizes of 20 lozenges and 30 lozenges.
Not all pack sizes may be marketed
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder
is Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishop’s Stortford, CM22 6PU
The Manufacturer is A.C.R.A.F. S.p.A.,
Via Vecchia del Pinocchio,22
60131 – Ancona, Italy

This medicinal product is authorised in the Member States of the EEA under the following
names:
Italy: Tantum Verde P, 3mg pastiglie gusto menta
®
Portugal: Tantum Verde , pastilhas, 3 mg, sabor a menta
Spain: Tantum Verde 3 mg pastillas para chupar sabor menta
Germany: Tantum Verde mit Minzgeschmack 3 mg Lutschtabletten
Denmark: Zyx mint 3mg sugetabletter
Sweden: Zyx Mint 3 mg sugtabletter
Ireland: Tantum Verde mint taste 3mg lozenges
UK: Difflam 3 mg Lozenges, mint flavour
France: Chlorydrate de Benzydamine A.C.R.A.F., 3mg arome menthe, pastille
Luxembourg:Tantum Verde P
Belgium: Tantum Verde, 3mg, pastilles goût menthe
Netherlands: Tantum Verde P Mintsmaak, zuigtabletten 3 mg

This leaflet was last approved in

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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