Benzidamine Acraf: detailed information

Package leaflet: Information for the user

BENZIDAMINA ACRAF 1.5 mg/ml oral mucosa solution

Benzidamine hydrochloride
Please read this leaflet carefully before using/administering this medicine to your child because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if symptoms worsen after a short period of treatment.

Contents of this leaflet:

What BENZIDAMINA ACRAF 1.5 mg/ml oral mucosa solution is and what it is used for
What you need to know before using BENZIDAMINA ACRAF 1.5 mg/ml oral mucosa solution
How to use BENZIDAMINA ACRAF 1.5 mg/ml oral mucosa solution
Possible side effects
How to store BENZIDAMINA ACRAF 1.5 mg/ml oral mucosa solution
Contents of the pack and other information

1. What BENZIDAMINA ACRAF 1.5 mg/ml oral mucosa solution is and what it is used for

BENZIDAMINA ACRAF oral mucosa solution is a non-steroidal anti-inflammatory drug
with analgesic properties, i.e. a medication that acts against pain and inflammation of the throat,
mouth, and gums. BENZIDAMINA ACRAF oral mucosa solution also has
disinfectant properties and a moderate local surface anesthetic effect.
BENZIDAMINA ACRAF oral mucosa solution is used for the local symptomatic treatment of
pain and irritation in the throat, mouth, and gums (e.g. gingivitis, stomatitis, pharyngitis),
including conditions arising from conservative or surgical dental treatments (e.g. dental caries treatment or tooth extraction).
BENZIDAMINA ACRAF oral mucosa solution is particularly indicated for patients unable
to perform gargling.
Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment.

2. What you should know before using BENZIDAMINA ACRAF 1.5 mg/ml oral mucosal solution

Do not use BENZIDAMINA ACRAF oral mucosal solution

if you are allergic to benzidamine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using BENZIDAMINA ACRAF oral mucosal solution.
In a limited number of patients, internal lesions of the mouth and throat may be signs of more serious diseases.
In particular, inform your doctor:

if you are allergic to acetylsalicylic acid or to other anti-inflammatory medicines; if you have previously suffered from breathing disorders, such as asthma.

The use of BENZIDAMINA ACRAF oral mucosal solution, especially if prolonged, may lead to sensitization phenomena (allergic reactions). In such case, discontinue treatment and contact your doctor.

Children and adolescents
In children aged 6 to 12 years, this product should be used only on medical advice.

Other medicines and BENZIDAMINA ACRAF oral mucosal solution
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No negative interactions with other medicines have been observed.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use BENZIDAMINA ACRAF oral mucosal solution during pregnancy unless clearly necessary and as directed by your doctor. If treatment is required, the lowest effective dose for the shortest possible duration should be used.

Driving and using machines
The use of BENZIDAMINA ACRAF oral mucosal solution, at the recommended doses, does not impair the ability to drive or operate machinery.

BENZIDAMINA ACRAF oral mucosal solution contains methyl parahydroxybenzoate and mint flavour
Methyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).
This medicine contains mint flavour, which in turn contains benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol, and d-Limonene.
Benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol, and d-Limonene may cause allergic reactions.

3. How to use BENZIDAMINA ACRAF 1.5 mg/ml oral mucosa solution

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents (aged 12 years and older)
The recommended dose is 4-8 sprays, 2-6 times daily (each spray delivers 0.17 ml of solution).
Use in children (up to 12 years of age)
In children aged 6 to 12 years, this product should only be used on medical advice and at doses prescribed by the doctor.
Caution: Do not exceed the recommended doses without medical advice.
Instructions for use:

Lift the nozzle that delivers the spray.
Insert the nozzle into the mouth and direct the spray towards the inflamed area or towards the throat in case of sore throat. Press firmly with your finger on the ribbed area of the spray button.

Important note: At first use, press the pump button several times without spraying (into the air) until a regular spray is obtained.
If you use more BENZIDAMINA ACRAF oral mucosa solution than you should
If you take too much of this medicine or accidentally swallow large amounts, contact your doctor or pharmacist immediately.
If you forget to use BENZIDAMINA ACRAF oral mucosa solution
Do not use a double dose to make up for a forgotten dose.
If you stop using BENZIDAMINA ACRAF oral mucosa solution
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects while using BENZIDAMINE ACRAF oral mucosal solution, STOP the treatment immediately and contact your doctor right away:

Uncommon (may affect up to 1 in 100 people):

photosensitivity (skin sensitivity to light);

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

hypersensitivity reactions (allergic reaction)
burning sensation and dryness of the mouth.

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

laryngospasm (difficulty breathing)
angioedema (sudden swelling of the mouth/throat and mucous membranes causing difficulty in swallowing and/or breathing)
pruritus
urticaria
skin rash

Not known (frequency cannot be estimated from the available data):

anaphylactic reactions (severe allergic reactions)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BENZIDAMINE ACRAF 1.5 mg/ml oral mucosal solution

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What BENZIDAMINA ACRAF contains

The active substance is benzidamine hydrochloride (100 ml of solution contain 0.15 g of benzidamine hydrochloride, equivalent to 0.134 g of benzidamine).
The other components are: glycerol, saccharin, sodium bicarbonate, 96% ethanol, methyl parahydroxybenzoate, peppermint flavour (see section “BENZIDAMINA ACRAF oral mucosa solution contains methyl parahydroxybenzoate and peppermint flavour”), polysorbate 20, purified water.

Description of the appearance of BENZIDAMINA ACRAF and package contents
BENZIDAMINA ACRAF oral mucosa solution is a spray solution for oral mucosa supplied in a 30 ml spray bottle.
Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome
Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona
N D E S
Certain environmental conditions, such as lowering or sudden changes in temperature, increased humidity, etc., may cause inflammation of the upper respiratory tract (mouth, nose, throat), as they favour the attack by germs that can cause infections (pathogenic germs).
The characteristic symptoms of inflammation of the upper respiratory tract (mouth, nose, throat) include, among others, a burning sensation and sore throat with difficulty swallowing.
To avoid worsening these symptoms, it is advisable to avoid further irritating factors such as smoking, dry air, smog, crowded places, etc.
Gums may also become inflamed. This inflammation could even be an early sign of dental problems: in such cases, a dental check-up may be helpful.

Package leaflet: information for the user

BENZIDAMINA ACRAF 5 mg/g oral mucosa gel

Benzidamine hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

What BENZIDAMINA ACRAF 5 mg/g oral mucosa gel is and what it is used for
What you need to know before using BENZIDAMINA ACRAF 5 mg/g oral mucosa gel
How to use BENZIDAMINA ACRAF 5 mg/g oral mucosa gel
Possible side effects
How to store BENZIDAMINA ACRAF 5 mg/g oral mucosa gel
Package contents and other information

1. What BENZIDAMINA ACRAF 5 mg/g oral mucosa gel is and what it is used for

BENZIDAMINA ACRAF gel is a medicinal product containing benzidamine hydrochloride, a non-steroidal anti-inflammatory drug with analgesic properties, meaning it acts against pain and inflammation.
BENZIDAMINA ACRAF gel is indicated for the local treatment of pain associated with inflammation of the mouth and gums.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you should know before using BENZIDAMINA ACRAF 5 mg/g oral mucosa gel

Do not use BENZIDAMINA ACRAF gel
If you are allergic to benzidamine or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using BENZIDAMINA ACRAF gel.
The use of BENZIDAMINA ACRAF gel, especially if prolonged, may lead to sensitization phenomena (allergic reactions).

For those engaged in sports activities
BENZIDAMINA ACRAF gel contains ethyl alcohol: the use of medicines containing ethyl alcohol may result in a positive anti-doping test, depending on the blood alcohol concentration limits set by certain sports federations.

Other medicines and BENZIDAMINA ACRAF gel
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, suspect you may be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before using this medicine.
Do not use BENZIDAMINA ACRAF gel during pregnancy unless clearly necessary and as directed by your doctor. If treatment is required, the lowest effective dose for the shortest possible duration should be used.

Driving and using machines
The use of BENZIDAMINA ACRAF gel at the recommended doses does not affect the ability to drive or operate machinery.

BENZIDAMINA ACRAF gel contains methyl 4-hydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).

3. How to use BENZIDAMINA ACRAF 5 mg/g oral mucosa gel

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Instructions for use:
Apply BENZIDAMINA ACRAF gel to the toothbrush,

thoroughly massage the gums and teeth,
rinse the oral cavity, keeping the gel in the mouth. Repeat applications 3 times daily, after meals.

Caution: do not exceed the recommended doses without medical advice.
Caution: use only for short-term treatment periods.
Consult your doctor if symptoms recur frequently or if you notice any recent changes in their characteristics.
If you use more BENZIDAMINA ACRAF gel than you should
If you take an excessive amount of the medicine or accidentally swallow large quantities, contact your doctor or pharmacist immediately.
If you forget to use BENZIDAMINA ACRAF gel
Do not use a double dose to make up for the missed dose.
If you stop using BENZIDAMINA ACRAF gel
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If you experience any of the following adverse reactions while being treated with Benzidamina ACRAF,
STOP the treatment immediately and contact your doctor without delay:

allergic reactions (sensitization phenomena).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report adverse reactions directly through the national reporting system: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Benzidamina ACRAF 5 mg/g oral mucosa gel

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Benzidamina ACRAF gel contains
The active substance is: benzidamine hydrochloride 0.5 g (equivalent to 0.447 g of benzidamine).
The other components are: sodium saccharin; sodium monofluorophosphate; sodium lauryl sulfate; methyl
parahydroxybenzoate (see section "Benzidamina ACRAF gel contains methyl
parahydroxybenzoate"); citric acid; 95% ethanol; hydroxyethylcellulose; mint flavour; liquorice flavour; purified water.
Description of the appearance of Benzidamina ACRAF gel and contents of the pack
Benzidamina ACRAF gel is a gel for oral use.
The pack contains one 20 g tube.
Marketing Authorisation Holder
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO – A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome
Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona
September 2025

Package leaflet: information for the user

BENZIDAMINE ACRAF 5 mg/g dental paste

Hydrochloride benzidamine
Please read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

What BENZIDAMINE ACRAF 5 mg/g dental paste is and what it is used for
What you need to know before using BENZIDAMINE ACRAF 5 mg/g dental paste
How to use BENZIDAMINE ACRAF 5 mg/g dental paste
Possible side effects
How to store BENZIDAMINE ACRAF 5 mg/g dental paste
Package contents and other information

1. What BENZIDAMINA ACRAF 5 mg/g Dental Paste is and what it is used for

BENZIDAMINA ACRAF dental paste is a medicine containing Benzidamine hydrochloride, a non-steroidal anti-inflammatory drug with analgesic properties, meaning it acts against pain and inflammation.
BENZIDAMINA ACRAF dental paste is indicated for the local treatment of pain associated with inflammation of the mouth and gums.
Consult your doctor if you do not feel better or feel worse after a short period of treatment.

2. What you need to know before using BENZIDAMINA ACRAF 5 mg/g dental paste

Do not use BENZIDAMINA ACRAF dental paste

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

Warnings and precautions
Talk to your doctor or pharmacist before using BENZIDAMINA ACRAF dental paste.
Inform your doctor if you are allergic to acetylsalicylic acid or to other anti-inflammatory drugs.
The use of BENZIDAMINA ACRAF dental paste, especially if prolonged, may lead to sensitization reactions (allergic phenomena). In such case, stop treatment and contact your doctor.
Other medicines and BENZIDAMINA ACRAF dental paste
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use BENZIDAMINA ACRAF dental paste during pregnancy unless clearly necessary and under medical advice. If treatment is required, the lowest possible dose for the shortest possible time should be used.
Driving and using machines
The use of BENZIDAMINA ACRAF dental paste at the recommended doses does not impair the ability to drive or operate machinery.
BENZIDAMINA ACRAF dental paste contains methyl and propyl parahydroxybenzoate and mint flavour
Methyl and propyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).
This medicine contains mint flavour, which in turn contains anisyl alcohol, benzyl alcohol, cinnamal, cinnamyl alcohol, citronellol, d-Limonene, eugenol, farnesol, geraniol, isoeugenol, linalool.
Anisyl alcohol, benzyl alcohol, cinnamal, cinnamyl alcohol, citronellol, d-Limonene, eugenol, farnesol, geraniol, isoeugenol and linalool may cause allergic reactions.

3. How to use BENZIDAMINA ACRAF 5 mg/g toothpaste

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Instructions for use:
Apply BENZIDAMINA ACRAF toothpaste to the toothbrush,

thoroughly and repeatedly massage the gums and teeth,
rinse the oral cavity, keeping the toothpaste in the mouth. Repeat applications 3 times daily, after meals.

Caution: Do not exceed the recommended doses without medical advice.
Caution: Use only for short-term treatment periods.
If you use more BENZIDAMINA ACRAF toothpaste than you should
If you take an excessive amount of this medicine or accidentally ingest large quantities, consult your doctor or pharmacist immediately.
If you forget to use BENZIDAMINA ACRAF toothpaste
Do not use a double dose to make up for the missed dose.
If you stop treatment with BENZIDAMINA ACRAF toothpaste
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If you experience any of the following adverse reactions during treatment with BENZIDAMINE ACRAF DENTAL PASTE, STOP the treatment immediately and contact your doctor:

Hypersensitivity reactions (allergic reaction), usually transient.
Anaphylactic reactions (severe allergic reactions)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store BENZIDAMINE ACRAF toothpaste

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What BENZIDAMINA ACRAF toothpaste contains

The active substance is: benzidamine hydrochloride 0.5 g (equivalent to 0.447 g of benzidamine).
The other components are: dibasic calcium phosphate dihydrate, glycerol, sodium carmellose, sodium lauryl sulfate, precipitated silica, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, peppermint flavour (see section “BENZIDAMINA ACRAF toothpaste contains methyl and propyl parahydroxybenzoate and peppermint flavour"), quinoline yellow (E 104), patent blue V (E 131), purified water.

Description of the appearance of BENZIDAMINA ACRAF toothpaste and contents of the pack
BENZIDAMINA ACRAF toothpaste is a green toothpaste for oral use.
The pack contains one 120 g tube.

Marketing Authorization Holder
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO – A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome, Italy

Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy

Patient Information Leaflet: Information for the User

BENZIDAMINE ACRAF 30 mg/g cream

Benzidamine hydrochloride
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you would like more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

What BENZIDAMINE ACRAF 30 mg/g cream is and what it is used for
What you need to know before using BENZIDAMINE ACRAF 30 mg/g cream
How to use BENZIDAMINE ACRAF 30 mg/g cream
Possible side effects
How to store BENZIDAMINE ACRAF 30 mg/g cream
Package contents and other information

1. What BENZIDAMINA ACRAF 30 mg/g cream is and what it is used for

BENZIDAMINA ACRAF cream is a non-steroidal anti-inflammatory drug with analgesic properties, that is, a medication which acts against pain and inflammation of muscles, bones, and joints.
BENZIDAMINA ACRAF cream is indicated for local treatment of:

pain and inflammation of muscles, bones, and joints in surgery, traumatology, and sports medicine;
muscle and joint pain, for example in cases of:
- myalgia (pain in one or more muscles),
- tendinitis (inflammation of tendons, the structures connecting muscles to bones),
- bursitis (inflammation of bursae, sac-like structures located in the joints),
- contusions (injuries following trauma),
- muscle strains (muscle tears),
- sprains.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using BENZIDAMINA ACRAF 30 mg/g cream

Do not use BENZIDAMINA ACRAF cream

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

Warnings and precautions
Talk to your doctor or pharmacist before using BENZIDAMINA ACRAF cream.
Avoid applying this medicine to areas of skin that have lacerations and/or open wounds.
Avoid exposing the treated skin area to direct sunlight.
Inform your doctor if you are allergic to acetylsalicylic acid or to other anti-inflammatory medicines.
The use of BENZIDAMINA ACRAF cream, especially if prolonged, may lead to sensitization (allergic reactions).

Other medicines and BENZIDAMINA ACRAF cream
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No negative interactions with other medicines have been observed.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before using this medicine.
Do not use BENZIDAMINA ACRAF cream during pregnancy unless clearly necessary and as directed by your doctor. If treatment is required, the lowest possible dose for the shortest possible time should be used.

Driving and operating machinery
The use of BENZIDAMINA ACRAF cream at the recommended doses does not impair the ability to drive vehicles or operate machinery.

BENZIDAMINA ACRAF cream contains Cetyl Alcohol, Methyl and Propyl parahydroxybenzoates, Propylene Glycol and Crematest fragrance:
Cetyl alcohol may cause localized skin reactions (e.g. contact dermatitis).
Methyl and propyl parahydroxybenzoates may cause allergic reactions (including delayed reactions).
This medicine contains 5 g of propylene glycol per 100 g of product. It may cause skin irritation.
This medicine contains Crematest fragrance, which in turn contains D-limonene, geraniol, hydroxycitronellal, citronellol, benzyl alcohol, citral, 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, benzyl benzoate, coumarin, farnesol, linalool, eugenol, isoeugenol.
D-limonene, geraniol, hydroxycitronellal, citronellol, benzyl alcohol, citral, 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, benzyl benzoate, coumarin, farnesol, linalool, eugenol and isoeugenol may cause allergic reactions.

3. How to use BENZIDAMINA ACRAF 30 mg/g cream

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2-3 applications per day.
Instructions for use:
Apply the cream to the skin over the painful/affected area and gently rub in until completely absorbed.
Caution: Do not exceed the recommended doses without medical advice.
Caution: Use this medicine only for short-term treatment.
Consult your doctor if the condition recurs or if you have noticed any recent changes in its characteristics.
If you use more BENZIDAMINA ACRAF cream than you should
Topical use of benzidamine has never caused effects due to overdose.
If you forget to use BENZIDAMINA ACRAF cream
Do not apply a double dose to compensate for a forgotten dose.
If you stop using BENZIDAMINA ACRAF cream
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects during treatment with BENZIDAMINE ACRAF cream,
STOP the treatment immediately and contact your doctor:
Rare (may affect up to 1 in 1,000 people):

hypersensitivity reactions (allergic reaction);
pruritus
erythema
dry skin
burning sensation
very rare (may affect up to 1 in 10,000 people):
photosensitivity (skin sensitivity to light);

Not known (frequency cannot be estimated from the available data):

anaphylactic reactions (severe allergic reactions)

Skin irritation may also occur due to the presence of propylene glycol in the cream.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BENZIDAMINE ACRAF cream

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BENZIDAMINA ACRAF cream contains

The active substance is: benzidamine hydrochloride (100 g of cream contain 3 g of benzidamine hydrochloride).
The other components are: fatty acid glycerides, decyl oleate, propylene glycol (see section “BENZIDAMINA ACRAF cream contains cetyl alcohol, parahydroxybenzoates and propylene glycol”), polyglycol ether of fatty acids, cetyl alcohol (see section “BENZIDAMINA ACRAF cream contains cetyl alcohol, parahydroxybenzoates and propylene glycol”), Crematest fragrance, methyl parahydroxybenzoate, propyl parahydroxybenzoate (see section “BENZIDAMINA ACRAF cream contains cetyl alcohol, parahydroxybenzoates and propylene glycol”), purified water.

Description of the appearance of BENZIDAMINA ACRAF cream and contents of the pack
BENZIDAMINA ACRAF cream is a soft white cream.
The cream is packed in aluminium tubes of 20 g or 50 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO – A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome, Italy

Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy

INSTRUCTIONS FOR USE

Patient Information Leaflet: Information for the User

BENZIDAMINE ACRAF 3 mg/ml oral mucosa spray

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

What BENZIDAMINE ACRAF 3 mg/ml oral mucosa spray is and what it is used for
What you need to know before using BENZIDAMINE ACRAF 3 mg/ml oral mucosa spray
How to use BENZIDAMINE ACRAF 3 mg/ml oral mucosa spray
Possible side effects
How to store BENZIDAMINE ACRAF 3 mg/ml oral mucosa spray
Contents of the pack and other information

1. What BENZIDAMINA ACRAF 3 mg/ml oral mucosa spray is and what it is used for

BENZIDAMINA ACRAF spray is a non-steroidal anti-inflammatory drug with analgesic properties,
i.e. a drug that acts against pain and inflammation of the throat, mouth and gums.
BENZIDAMINA ACRAF spray also exhibits disinfectant properties and a moderate surface
anaesthetic effect.
BENZIDAMINA ACRAF spray is used to treat symptoms of inflammation and irritation, even when
associated with pain, affecting the gums, mouth and throat (e.g. gingivitis, stomatitis,
pharyngitis), including conditions arising from conservative or extraction dental treatments (e.g.
treatment of caries or tooth extraction).
BENZIDAMINA ACRAF spray is particularly indicated for patients unable to perform gargling.
Consult your doctor if you do not feel better or feel worse after a short period of treatment.

2. What you need to know before using BENZIDAMINA ACRAF 3 mg/ml oral mucosa spray

Do not use BENZIDAMINA ACRAF spray

if you are allergic to benzidamine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using BENZIDAMINA ACRAF spray.
In a limited number of patients, internal lesions of the mouth and throat may be signs of more serious diseases. Therefore, if symptoms persist, you should consult your doctor or dentist as appropriate.
Inform your doctor if you are allergic to acetylsalicylic acid or to other anti-inflammatory medicines, or if you have previously suffered from breathing problems, such as asthma.
The use of BENZIDAMINA ACRAF spray, especially if prolonged, may lead to hypersensitivity reactions (allergic reactions).

Other medicines and BENZIDAMINA ACRAF spray
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No negative interactions with other medicines have been observed.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use BENZIDAMINA ACRAF spray during pregnancy unless clearly necessary and on medical advice. If treatment is required, the lowest effective dose for the shortest possible duration should be used.

Driving and using machines
The use of BENZIDAMINA ACRAF spray at the recommended doses does not impair the ability to drive or operate machinery.

BENZIDAMINA ACRAF spray contains hydrogenated polyoxyl castor oil, mint flavouring, and
methyl parahydroxybenzoate:

hydrogenated polyoxyl castor oil may cause localized skin reactions
methyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).

This medicine contains mint flavouring, which in turn contains benzyl alcohol, citronellol, d-Limonene, eugenol, geraniol and linool.
Benzyl alcohol, citronellol, d-Limonene, eugenol, geraniol and linool may cause allergic reactions.

3. How to use BENZIDAMINA ACRAF 3 mg/ml oral mucosa spray

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 2-4 sprays, 2-6 times daily (each spray delivers 0.17 ml of solution).
Caution: Do not exceed the recommended doses without medical advice.
Instructions for use:

Lift the nozzle that delivers the spray.
Insert the nozzle into the mouth and direct the spray towards the inflamed area or towards the throat in case of sore throat and inflammation. Press firmly with your finger on the ribbed area of the spray button.

Important note: At first use, press the spray button several times without spraying, until a regular mist is produced.
If you use more BENZIDAMINA ACRAF spray than you should
If you take too much of this medicine or accidentally swallow large amounts, contact your doctor or pharmacist immediately.
If you forget to use BENZIDAMINA ACRAF spray
Do not use a double dose to make up for a forgotten dose.
If you stop using BENZIDAMINA ACRAF spray
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone experiences them.
If you experience any of the following side effects during treatment with BENZIDAMINE ACRAF spray,
STOP the treatment immediately and contact your doctor immediately:

Uncommon (may affect up to 1 in 100 people):

photosensitivity (skin sensitivity to light);

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

hypersensitivity reactions (allergic reactions)
burning sensation at the application site due to the alcoholic component of the medicine
dry mouth.

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

laryngospasm (difficulty breathing)
angioedema (sudden swelling of the mouth/throat and mucous membranes causing difficulty in swallowing and/or breathing)
itching
urticaria
skin rash

Not known (frequency cannot be estimated from available data):

anaphylactic reactions (severe allergic reactions)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BENZIDAMINE ACRAF 3 mg/ml oral mucosa spray

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BENZIDAMINA ACRAF spray contains
The active substance is benzidamine hydrochloride (100 ml of solution contain 0.30 g of benzidamine
hydrochloride, equivalent to 0.268 g of benzidamine).
The other components are: ethanol (96%), glycerol, hydrogenated polyoxyl castor oil, peppermint flavour,
methyl parahydroxybenzoate (see section “BENZIDAMINA ACRAF spray contains hydrogenated polyoxyl
castor oil, peppermint flavour and methyl parahydroxybenzoate”), sodium saccharin, purified water.
Description of the appearance of BENZIDAMINA ACRAF spray and contents of the pack
BENZIDAMINA ACRAF spray is a spray solution for oral mucosa supplied in a 15 ml spray bottle.
Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome
Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona
P I D S
Certain environmental conditions, such as lowering or sudden changes in temperature, increased
humidity, etc., may cause inflammation of the upper respiratory tract (mouth, nose, throat), as they
favour the attack by germs that can cause infections (pathogenic germs).
Characteristic symptoms of inflammation of the upper respiratory tract (mouth, nose, throat) include,
among others, a burning sensation and sore throat with difficulty in swallowing.
To avoid worsening these symptoms, it is advisable to avoid further irritating factors such as smoking,
dry air, smog, crowded places, etc.
The gums may also become inflamed. This inflammation could even be a sign of early-stage dental
problems: in such cases, a dental check-up may be helpful.

Package leaflet: information for the user

BENZIDAMINE ACRAF 3 mg tablets

Benzidamine hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you would like more information or advice, please consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days of treatment.

Contents of this leaflet:

What BENZIDAMINE ACRAF 3 mg tablets are and what they are used for
What you need to know before taking BENZIDAMINE ACRAF 3 mg tablets
How to take BENZIDAMINE ACRAF 3 mg tablets
Possible side effects
How to store BENZIDAMINE ACRAF 3 mg tablets
Contents of the pack and other information

1. What BENZIDAMINA ACRAF 3 mg tablets are and what they are used for

BENZIDAMINA ACRAF tablets are a medicine that acts against irritations of the mouth and throat. BENZIDAMINA ACRAF tablets also exert a mild local anaesthetic effect.
BENZIDAMINA ACRAF tablets are used for the local symptomatic treatment of pain and irritations of the mouth and throat (manifested by burning, redness, sensation of swelling, and difficulty in swallowing).
Consult your doctor if you do not feel better or if you feel worse after 7 days of treatment.

2. What you need to know before taking BENZIDAMINA ACRAF 3 mg tablets

Do not take BENZIDAMINA ACRAF tablets

if you are allergic to benzidamine or to any of the other ingredients of this medicine (listed in section 6)
if you suffer from phenylketonuria (a metabolic disorder caused by inherited deficiency of the enzyme that converts the amino acid phenylalanine into tyrosine), as the product contains aspartame (see section “BENZIDAMINA ACRAF tablets contain aspartame”).

Warnings and precautions
Talk to your doctor or pharmacist before taking BENZIDAMINA ACRAF tablets.
The use of BENZIDAMINA ACRAF tablets, especially if prolonged, may lead to sensitization (allergic reactions).
In a limited number of patients, oral-pharyngeal ulcerations may be a sign of more serious diseases. Therefore, if symptoms persist, the patient should consult their doctor or dentist as appropriate.
Avoid using this medicine if you are allergic to salicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
The tablets are sugar-free.

Children and adolescents
Due to the pharmaceutical form, administration should be limited to children over 6 years of age. In children under 12 years, it is recommended that the product be taken under the supervision of an adult.

Other medicines and BENZIDAMINA ACRAF tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use BENZIDAMINA ACRAF tablets during pregnancy unless clearly necessary and on medical advice. If treatment is required, the lowest effective dose for the shortest possible duration should be used.

Driving and using machines
The use of BENZIDAMINA ACRAF tablets at the recommended doses does not impair the ability to drive vehicles or operate machinery.

BENZIDAMINA ACRAF tablets contain aspartame
This medicine contains a source of phenylalanine. It may be harmful if you have phenylketonuria.

3. How to take BENZIDAMINA ACRAF 3 mg tablets

Take this medicine exactly as stated in this leaflet or according to the instructions provided by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet three times a day.
Warning: Do not exceed the recommended dose without medical advice.
Children
Due to the pharmaceutical form, administration should be limited to children above 6 years of age. In children under 12 years, it is recommended that the product be taken under the supervision of an adult.

Instructions for use:

Take the medicine as needed, at any time of the day.
Allow the tablet to dissolve slowly in the mouth.
If you do not feel better after 7 days of treatment, consult your doctor or dentist, as appropriate.
In fact, throat disorders may be signs of more serious diseases.
If you take more BENZIDAMINA ACRAF tablets than you should
If you accidentally take an excessive dose of BENZIDAMINA ACRAF tablets, inform your doctor immediately or go to the nearest hospital.
The doctor will carry out appropriate treatment (induction of vomiting, gastric lavage, hydration).
If you forget to take BENZIDAMINA ACRAF tablets
Do not take a double dose to make up for the missed dose.
If you stop using BENZIDAMINA ACRAF tablets
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur during treatment with BENZIDAMINE ACRAF tablets:

Hypersensitivity reactions (allergic reaction).
Burning sensation and dryness of the mouth.

Photosensitivity (skin sensitivity to light) has very rarely been observed following systemic use of benzidamine.
Exceptionally, following the use of solutions containing benzidamine (mouthwashes), cases of laryngospasm (a respiratory complication with contraction of throat muscles) and angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat) have been reported.
Very rarely, photosensitivity (skin sensitivity to light) has been observed following systemic use of benzidamine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BENZIDAMINE ACRAF 3 mg tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BENZIDAMINA ACRAF tablets contain

The active substance is: benzidamine hydrochloride (each tablet contains 3 mg of benzidamine hydrochloride, equivalent to 2.68 mg of benzidamine).
The other components are: isomalt, aspartame (see section “BENZIDAMINA ACRAF contains aspartame”), menthol, citric acid, lemon flavor, mint flavor, quinoline yellow (E 104), indigotine (E 132).

Description of the appearance of BENZIDAMINA ACRAF tablets and package contents
BENZIDAMINA ACRAF is presented as translucent green, square-shaped tablets with a central indentation.
Each tablet is wrapped in food-grade paper and packaged in sticks of 10 tablets. Each carton may contain 20 tablets (2 sticks of 10 tablets) or 30 tablets (3 sticks of 10 tablets).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome, Italy

Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy
September 2025

Health Education Notes
Certain environmental conditions, such as drops or fluctuations in temperature, increased humidity, etc., may cause irritation of the upper respiratory tract, as they favor infection by pathogenic germs.
Characteristic symptoms include, among others, burning sensation, sore throat, and difficulty swallowing.
To avoid worsening these symptoms, it is advisable to avoid additional irritating factors such as smoking, dry air, crowded places, etc.