Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Difflam Sore Throat Rinse contains the active substance benzydamine hydrochloride and belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDS.
&K
Difflam Sore Throat Rinse works by stopping pain and swelling (inflammation). It is used to treat many painful conditions of the throat including:
e Sore throat.
Do not use Difflam Sore Throat Rinse if
e you are allergic to benzydamine hydrochloride
e you are allergic to any of the other ingredients of Difflam Sore Throat Rinse (see section 6).
If either of these applies to you, talk to
your doctor, dentist or pharmacist.
Warnings and precautions:
Talk to your doctor, pharmacist or nurse
before using Difflam Sore Throat Rinse:
e If you have a history of asthma
e If you are allergic to acetylsalicylic acid or other non-steroidal
anti-inflammatory (NSAID) drugs
If any of these apply, talk to your
doctor, dentist or pharmacist.
Other medicines and Difflam Sore Throat Rinse
Tell your doctor or pharmacist if
you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
IIf 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.
You should not use Difflam Sore Throat Rinse 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 sore throat rinse contains: This medicine contains less than
1 mmol sodium (23 mg) per 15 ml dose, that is to say essentially 'sodium-free'. Methyl-para-hydroxy benzoate may cause allergic reactions (possibly delayed)
This medicine contains 1126 mg of alcohol (ethanol) in each 15 ml dose. The amount in 15 ml of this medicine is equivalent to less than 30 ml beer or 12 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effects.
This medicine contains 0.025 mg benzyl alcohol in each 175 microlitre dose which is equivalent to 0.14 mg/ml. Benzyl alcohol may cause allergic reactions and mild local irritation.
This medicinal product contains mint flavour with benzyl alcohol, cinnamy! alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, limonene and linalool. These substances may cause allergic reactions.
Important:
Always use Difflam Sore Throat Rinse exactly as your pharmacist has told you. You should check with your doctor, dentist or pharmacist if you are not sure.
If you get Difflam Sore Throat Rinse in your eyes
Do not use Difflam Sore Throat Rinse in or near your eyes. If any Sore Throat Rinse gets in your eyes, wash them immediately with cold water.
How much Difflam Sore Throat
Rinse to use
e Adults, adolescents and elderly: The usual dose is 15 ml of solution to be used every 1% to 3 hours. Use the measuring cup provided to measure the dose.
e Children: This medicine is not suitable for children aged 12 years or under.
How to use the Sore Throat Rinse
The solution should be rinsed around the mouth or used as a gargle for 20 to 30 seconds and then spat out.
If your symptoms worsen or do not improve contact your doctor or dentist.
If you use more Difflam Sore Throat Rinse than you should
If you take too much or you accidentally swallow large quantities of your medicine, contact immediately your doctor or pharmacist for advice.
If you forget to use Difflam Sore Throat Rinse
Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
Like all medicines Difflam Sore Throat Rinse 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:
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 life-threatening.
Other side effects include the following, if they get serious, please tell your doctor:
Uncommon
(affects 1 in 1,000 people):
e Numbness and/or stinging in the mouth and/or throat.
Very rare
(affects less than 1 in 10,000 people): e Difficulty breathing and wheezing e Itching
e Skin rash.
Not known: (frequency cannot be estimated from the available data) e Skin redness or swelling
e Allergic reaction (Hypersensitivity).
If this solution stings your mouth, the next dose can be diluted with some water to reduce this effect.
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.
Reporting of side effects
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.
Keep out of the sight and reach of children.
Do not use Difflam Sore Throat Rinse after the expiry date on the bottle.
The expiry date refers to the last day of that month.
If you store the product without the original carton, make sure it is kept out of the direct sunlight.
Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
What Difflam Sore Throat Rinse contains
The active substance is benzydamine hydrochloride. Each 15 ml contains 22.5 mg benzydamine hydrochloride.
The other ingredients are ethanol, glycerol, saccharin, sodium hydrogen carbonate, mouthwash flavour
52 503/T, polysorbate 20, methyl parahydroxybenzoate, quinoline yellow (E104) and patent blue V (E131), purified water. For advice on what to do if you are allergic to any of these ingredients see section 2.
What Difflam Sore Throat Rinse looks like
Difflam Sore Throat Rinse is a clear, green coloured gargle solution.
Difflam 0.15% w/v Sore Throat Rinse comes as medicine containing 0.15%. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Difflam 0.15% w/v Sore Throat Rinse is benzydamine hydrochloride.
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.
This leaflet reproduces the patient information leaflet approved for Difflam 0.15% w/v Sore Throat Rinse, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Benzydamine Sore Throat Rinse is a locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions of the throat including:
Traumatic conditions: Pharyngitis following tonsillectomy or the use of a naso-gastric tube.
Inflammatory conditions: Pharyngitis, aphthous ulcers and oral ulceration due to radiation therapy.
Dentistry: For use after dental operations.
Posology
| Adults: | Rinse or gargle with 15ml (using measuring cup provided) every 1½ to 3 hours as required for pain relief. |
| Children: | Not suitable for children aged 12 years or under. |
| Elderly: | No special dosage recommendations are made for elderly patients. |
Method of administration
Rinse or gargle.
The solution should be expelled from the mouth after use.
Benzydamine Sore Throat Rinse should generally be used undiluted, but if 'stinging' occurs the rinse may be diluted with water.
Uninterrupted treatment should not exceed seven days, except under medical supervision.
Difflam Sore Throat Rinse is contra-indicated in patients with:
Hypersensitivity to the active ingredient, benzydamine hydrochloride or to any of the excipients listed in section 6.1.
None known.
Pregnancy
There are no clinical data from the use of Benzydamine Sore Throat Rinse 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 Benzydamine Sore Throat Rinse exposure reached after topical administration can be harmful to an embryo/fetus.
Therefore, Benzydamine Sore Throat Rinse 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
Benzydamine Sore Throat Rinse should not be used during lactation unless considered essential by the physician.
Not applicable.
Intoxication is only to be expected if large quantities of Difflam Oral Rinse/ Difflam Sore Throat Rinse are swallowed (> 300mg).
Symptoms associated with ingested overdose of benzydamine are mainly gastrointestinal symptoms and symptoms of the central nervous system. Most frequent gastrointestinal symptoms are nausea, vomiting, abdominal pain, and esophageal irritation. Symptoms of the central nervous system include dizziness, hallucinations, agitation, anxiety, and irritability.
In acute overdose only symptomatic treatment is possible. Patients should be kept under close observation and supportive treatment should be given. Adequate hydration must be maintained.
Ask anything about Difflam 0.15% w/v Sore Throat Rinse. 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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