Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.

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Difflam 3 mg Lozenge Lemon Flavour

What it is and what it is used for

Difflam contains the active substance benzydamine hydrochloride, which is a local anti-inflammatory agent.

Difflam 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.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

2.What you need to know before you take Difflam Lozenges

Do not take Difflam Lozenges:

— If you are allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6).

— If you suffer from a condition known as phenylketonuria.

— If you are allergic to salicylic acid or to other anti-inflammatory painkillers called NSAIDs (e.g. ibuprofen).

Warnings and precautions

Talk to your doctor before taking this medicine:

— If you have a history of Asthma.

— 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 pharmacist.

Taking other medicines and Difflam Lozenges

Tell your doctor or pharmacist if you are taking or have recently

taken or might take any other medicines, including medicines

obtained without a prescription.

Difflam Lozenges are not expected to affect other medicines, however if you are not sure, please ask your doctor or pharmacist about other medicines obtained without

a prescription.

Difflam Lozenges with food, drink Food and drink have no influence.

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VERSION N°: / DATE: /

DESIGN CODE: P VERSION N°: 01 BRAILLE REFERE BRAILLE TEXT:

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Pregnancy, breast-feeding

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 lozenges should not be used during pregnancy.

You should not use Difflam during pregnancy unless clearly necessary and advised by your doctor. If you need treatment the lowest dose for the shortest time possible

should be used. Difflam lozenges should not be

used during breast-feeding.

Driving and using machines Difflam Lozenges does not affect your ability to drive or use machines.

Difflam Lozenges contains

Isomalt (which is a type of sugar): If you have

been told by your doctor that you have an

intolerance to some sugars, contact your doctor

before taking this medicinal product.

Aspartame: This medicine contains 3.26 mg

aspartame in each lozenge which is equivalent

to 3.26 mg/ 3237 mg. Aspartame is a source

of phenylalanine. It may be harmful if you have

phenylketonuria (PKU), a rare genetic disorder in

which phenylalanine builds up because the body cannot remove it properly.

Mint Fragrance with Benzyl Alcohol, Citronellol,

d- Limonene, Eugenol, Geraniol, Linalool and Lemon Fragrance with Benzyl Alcohol, Citral, Citronellol, d-Limonene, Geraniol, Linalool.

These may cause allergic reactions.

Butylated hydroxyanisole which is a component of lemon fragrance: It may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

What you need to know before you take it

3. How to take Difflam Lozenges

How to take it

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and children over 6 years old: one lozenge 3 times a day. Do not take more than 3 lozenges per day.

Use in children

Children from 6 to 11 years old: this medicinal product should be administered under an adult supervision.

Children under the age of 6 years old should not be given Difflam Lozenges.

Let one lozenge dissolve slowly in your mouth up to three times a day.

Do not swallow.

Do not chew.

Difflam should not be used for more than 7 days.

If after using the lozenges your throat gets worse or does not feel better, speak to your pharmacist or doctor.

If you take more Difflam Lozenges 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.

4.Possible side effects

Like all medicines, this medicine can cause side-effects, although not everybody gets them.

Allergic reactions are rare, but can be serious. Tell your doctor immediately if you get any sudden swelling in

Firmato digitalmente Anceli _ da Maddalena snaetint Data 2026.07.07 17:08:32 +02'00'

6

DIE CUT/SUPPLIER: - UNIT OF MEASUREMENT: mm

SIZE: 160x250 mm REDUCTION SCALE: 1:1

NOTES:

ARTWORK CREATION READABILITY REQUIREMENT COLOR LIST HOLDER APPROVAL SIGNATURE PRODUCT NAME: PIL.DIFFLAM LEMON BLS UK MINIMUM FONT SIZE pt:/ 1.K

SX010346 SPACE BETWEEN LINE pt:/ PICTOGRAMS: NA

NT: NA NA

FRONT

NOTES:

This design is 'property' of Angelini Pharma

S.p.A and must not be delivered or exhibited to another person in original or in copy.

(for client out of DAM Sistem only)

the mouth/ throat, difficulty breathing, rash or itching especially if affecting the whole body.

Uncommon (may affect up to 1 in 100 people): ¢ Skin sensitivity to sunlight (causing a rash or sunburn)

Rare (may affect up to 1 in 1,000 people):

e Burning sensation or dryness of the mouth. If this happens to you, try sipping a glass of water to reduce the effect.

Very rare (may affect up to 1 in 10,000 people):

e Sudden swelling in the mouth/throat and mucous membranes (angioedema)

¢ Difficulty breathing (laryngospasm)

Not known (frequency cannot be estimated from the

available data):

¢ Local loss of sensitivity of the oral mucosa (Hypoaesthesia oral)

e Allergic reaction (Hypersensitivity)

e Serious allergic reaction (anaphylactic shock), signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, and which may be potentially lifethreatening.

Reporting of side effects

If you get any the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

the Yellow Card Scheme (www.mhra.go.uk/ yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

Possible side effects

5. How to store Difflam Lozenges

How to store it

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away you no longer use. These measures will help to protect the environment.

6.Contents of the pack and other information

What Difflam Lozenges contains:

e The active substance is benzydamine.

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

e The other ingredients are isomalt (E 953), aspartame (E951), citric acid monohydrate, lemon flavour, mint flavour, quinoline yellow (E104), indigotin dye (E132).

What Difflam Lozenges looks like and contents of the pack

Difflam Lozenges are yellow-green, square shaped lozenges with a central cavity. The lozenges can be pack- aged in PVC/PE/PVDC - ALU blister or wrapped in paraffined paper. Difflam Lozenges are provided in packs of 20 lozenges and 30 lozenges.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is Cooper Consumer Health B.V.,

Verrijn Stuartweg 60,

1112AX Diemen

The Netherlands.

The Manufacturers are: A.C.R.ALF. S.p.A.,

Via Vecchia del Pinocchio, 22 60131 — Ancona, Italy

'6 Angelini Pharma STANDARD INFO PANEL CODE: /

DESCRIPTION: /

DIE CUT/SUPPLIER: - SIZE: 160x250 mm

VERSION N°: /

DATE: /

UNIT OF MEASUREMENT: mm REDUCTION SCALE: 1:1

NOTES:

PIERRE FABRE MEDICAMENT PRODUCTION Site Diététique et Pharmacie

Zone Industrielle de la Coudette

32290 Aignan, France

This leaflet was last revised in April 2026

9013631 605396 03

Firmato digitalmente da 6 Angelini Maddalena Pharma Data: 2026.07.07 17:08:21 +02'00'

ARTWORK CREATION

PRODUCT NAME: PIL.DIFFLAM LEMON BLS UK DESIGN CODE: PSX010346

VERSION N°: 01

BRAILLE REFERENT: NA

BRAILLE TEXT: NA

READABILITY REQUIREMENT COLOR LIST

HOLDER APPROVAL SIGNATURE

MINIMUM FONT SIZE pt:/ 1.K SPACE BETWEEN LINE pt:/ PICTOGRAMS: NA

BACK

NOTES:

This design is 'property' of Angelini Pharma

S.p.A and must not be delivered or exhibited to another person in original or in copy.

(for client out of DAM Sistem only)

Frequently asked questions about Difflam 3 mg Lozenge Lemon Flavour

How do I take Difflam 3 mg Lozenge Lemon Flavour?

Difflam 3 mg Lozenge Lemon Flavour comes as medicine containing 3 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Difflam 3 mg Lozenge Lemon Flavour?

The active substance in Difflam 3 mg Lozenge Lemon Flavour is benzydamine hydrochloride.

Are there equivalent medicines to Difflam 3 mg Lozenge Lemon Flavour?

Medicines with the same active substance include: Benzydamine 0.15% w/v Mouthwash, Benzydamine 0.15%w/v Oromucosal Spray, Benzydamine Hydrochloride 0.15 % w/v Oromucosal Spray, Benzydamine Hydrochloride 0.15% w/v Oromucosal solution spray. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Difflam 3 mg Lozenge Lemon Flavour, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Difflam 3 mg Lozenge Lemon Flavour without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Benzydamine Hydrochloride (8 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Difflam is indicated in adults and children over 6 years of age, for symptomatic local treatment for the relief of pain and irritation of mouth and throat.

4.2. Posology and method of administration

Posology

Adults and children over 6 years of age: one lozenge 3 times a day.

The treatment must not exceed 7 days.

Paediatric population

Children 6-11 years of age:

The medicinal product should be administered under adult supervision.

Children below 6 years of age:

Due to the type of the pharmaceutical form, the administration should be restricted to children of more than 6 years of age.

Method of administration

For oropharingeal use.

Lozenge should be dissolved slowly in the mouth.

Do not swallow. Do not chew.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no clinical data from the use of Difflam during pregnancy.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy prolonged bleeding time in both mother and child may occur, and labour can be delayed.

It is not known if the systemic Difflam exposure reached after topical administration can be harmful to an embryo/fetus.

Therefore, Difflam should not be used during pregnancy unless clearly necessary. If used, the dose should be kept as low and duration of treatment as short as possible.

Breast-feeding

There is insufficient information on the excretion of benzydamine in human milk.

Difflam should not be used during breast-feeding.

4.7. Effects on ability to drive and use machines

Difflam has no or negligible influence on the ability to drive and use machines, when it is used at the recommended dose.

4.9. Overdose

Symptoms

No overdosage with the lozenge formulation has been reported. However, very rarely in children excitation, convulsions, sweating, ataxia, tremor and vomiting have been reported after the oral administration of benzydamine dosages about 100 times higher than those of the lozenge.

Management

In the event of acute overdosage only symptomatic treatment is possible; the stomach should be emptied by inducing vomiting or by gastric lavage, and the patient carefully observed and given supportive treatment. Adequate hydration must be maintained.

💬 Ask about this leaflet

Ask anything about Difflam 3 mg Lozenge Lemon Flavour. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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