BENZIDAMINA 3% Cream

Зміст інструкції

1. BENZIDAMINA ACRAF 1,5 mg/ml oral mucosa solution
   1. What is BENZIDAMINA ACRAF 1.5 mg/ml oral mucosa solution and what it is used for
   2. What you need to know before using BENZIDAMINA ACRAF 1,5 mg/ml oral mucosal solution
   3. How to use BENZIDAMINA ACRAF 1.5 mg/ml oral mucosa solution
   4. Possible side effects
   5. How to store BENZIDAMINA ACRAF 1,5 mg/ml oral mucosa solution
   6. Package contents and other information
2. BENZIDAMINA ACRAF 5 mg/g oral mucosal gel
   1. What is BENZIDAMINA ACRAF 5 mg/g oral mucosal gel and what is it used for
   2. What you need to know before using BENZIDAMINA ACRAF 5 mg/g oral mucosal gel
   3. How to use BENZIDAMINA ACRAF 5 mg/g oral mucosal gel
   4. Possible side effects
   5. How to store Benzidamina ACRAF 5 mg/g oral mucosa gel
   6. Package Contents and Other Information
3. BENZIDAMINA ACRAF 5 mg/g toothpaste
   1. What is BENZIDAMINA ACRAF 5 mg/g dental paste and what is it used for
   2. What you need to know before using BENZIDAMINA ACRAF 5 mg/g dental paste
   3. How to use BENZIDAMINA ACRAF 5 mg/g toothpaste
   4. Possible side effects
   5. How to store BENZIDAMINA ACRAF toothpaste
   6. Contents of the pack and other information
4. BENZIDAMINA ACRAF 30 mg/g cream
   1. What is BENZIDAMINA ACRAF 30 mg/g cream and what is it used for
   2. What you need to know before using BENZIDAMINA ACRAF 30 mg/g cream
   3. How to use BENZIDAMINA ACRAF 30 mg/g cream
   4. Possible side effects
   5. How to store BENZIDAMINA ACRAF cream
   6. Contents of the pack and other information
5. BENZIDAMINA ACRAF 3 mg/ml spray for oral mucosa
   1. What is BENZIDAMINA ACRAF 3 mg/ml oral mucosa spray and what it is used for
   2. What you need to know before using BENZIDAMINA ACRAF 3 mg/ml oral mucosa spray
   3. How to use BENZIDAMINA ACRAF 3 mg/ml oral mucosa spray
   4. Possible side effects
   5. How to store BENZIDAMINA ACRAF 3 mg/ml oral mucosa spray
   6. Contents of the pack and other information
6. BENZIDAMINA ACRAF 3 mg tablets
   1. What is BENZIDAMINA ACRAF 3 mg lozenges and what is it used for
   2. What you need to know before taking BENZIDAMINA ACRAF 3 mg tablets
   3. How to take BENZIDAMINA ACRAF 3 mg tablets
   4. Possible side effects
   5. How to store BENZIDAMINA ACRAF 3 mg lozenges
   6. Contents of the pack and other information

BENZIDAMINA ACRAF 1,5 mg/ml oral mucosa solution

Benzydamine hydrochloride

Read this leaflet carefully before using/giving this medicine to your child as it
contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

• 1. What BENZIDAMINA ACRAF 1,5 mg/ml oral mucosa solution is and what it is used for
• 2. What you need to know before using BENZIDAMINA ACRAF 1,5 mg/ml oral mucosa solution
• 3. How to use BENZIDAMINA ACRAF 1,5 mg/ml oral mucosa solution
• 4. Possible side effects
• 5. How to store BENZIDAMINA ACRAF 1,5 mg/ml oral mucosa solution
• 6. Contents of the pack and other information

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

BENZIDAMINA ACRAF oral mucosa solution is a non-steroidal anti-inflammatory drug
with analgesic properties, meaning a drug that acts against pain and inflammation of the throat,
mouth and gums. BENZIDAMINA ACRAF oral mucosa solution also exhibits
disinfectant properties and a moderate superficial anesthetic action.
BENZIDAMINA ACRAF oral mucosa solution is used for the symptomatic local treatment of
pain and irritation of the throat, mouth and gums (e.g. gingivitis, stomatitis, pharyngitis),
also as a result of conservative or extraction dental therapy (e.g. caries treatment or extraction
of the tooth).
BENZIDAMINA ACRAF oral mucosa solution is particularly indicated for patients unable
to gargle.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after a
short period of treatment.

2. What you need to know before using BENZIDAMINA ACRAF 1,5 mg/ml oral mucosal solution

oral
Do not use BENZIDAMINA ACRAF oral mucosal solution

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

Warnings and precautions
Consult 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 a sign of
more serious illnesses.
In particular, inform your doctor:

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

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

Children and adolescents
In children from 6 to 12 years of age, the product may only be used on the advice of a doctor.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice 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 necessary, it should
be used at the lowest dose for the shortest possible time.

Driving and operating machinery
The use of BENZIDAMINA ACRAF oral mucosal solution, at the recommended doses ,does notalter
the ability to drive vehicles and operate machinery.

BENZIDAMINA ACRAForal mucosal solution contains methyl parahydroxybenzoate and mint
flavor
Methyl parahydroxybenzoate may cause allergic reactions (even delayed).
This medicine contains mint flavor 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 following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and adolescents (age 12 years and over)
The recommended dose is 4-8 sprays, 2-6 times a day (each spray delivers 0.17 ml of
solution).

Use in children (up to 12 years)
In children from 6 to 12 years, the product may only be used on the advice of a doctor and at the dosages
established by him/her.
Caution: do not exceed the indicated doses without the advice of a doctor.

Instructions for use:

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

Important note: at the first use of the product, press the pump button several times into the air,
until a regular spray is initiated.

If you use more BENZIDAMINA ACRAForal mucosa solution than you should
If you take an excessive amount of medicine or accidentally ingest large quantities,
consult 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 missed dose.

If you stop using BENZIDAMINA ACRAF oral mucosa solution
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 gets them.
If you experience the following side effects during treatment with BENZIDAMINA ACRAF oral mucosa solution, STOP the treatment 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 reaction)
• burning 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 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
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 BENZIDAMINA ACRAF 1,5 mg/ml oral mucosa 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 which is stated on the pack after SCAD. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 contains

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

Description of the appearance of BENZIDAMINA ACRAFand package contents
BENZIDAMINA ACRAF oral mucosa solution is presented as a spray solution for oral mucosa
in a 30 ml spray bottle.

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

NDES
Certain environmental conditions, such as lowering or fluctuations in temperature, increased humidity, etc., can cause inflammation of the upper respiratory tract (mouth, nose, throat),
because they favour attack by germs that can cause infections (pathogenic germs).
The characteristic symptoms of inflammation of the upper respiratory tract (mouth, nose, throat)
include, among other things, a burning sensation and pain in the throat with difficulty swallowing.
To avoid worsening these symptoms, it is useful to avoid some further irritating factors such as smoke, dry air, smog, crowded places, etc.
The gums can also be a site of inflammation. The latter could even be
a sign of dental problems in the early stages: in this case, a check-up
with the dentist may be useful.

BENZIDAMINA ACRAF 5 mg/g oral mucosal gel

Benzydamine hydrochloride

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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

• 1. What BENZIDAMINA ACRAF 5 mg/g oral mucosal gel is and what it is used for
• 2. What you need to know before using BENZIDAMINA ACRAF 5 mg/g oral mucosal gel
• 3. How to use BENZIDAMINA ACRAF 5 mg/g oral mucosal gel
• 4. Possible side effects
• 5. How to store BENZIDAMINA ACRAF 5 mg/g oral mucosal gel
• 6. Contents of the pack and other information

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

BENZIDAMINA ACRAF gel is a medicine based on benzydamine 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 accompanied by inflammation of the mouth and gums.
See 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 5 mg/g oral mucosal gel

Do not use BENZIDAMINA ACRAF gel
If you are allergic to benzidamine or 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 athletes
BENZIDAMINA ACRAF gel contains ethyl alcohol: the use of medicines containing ethyl alcohol may
result in positive doping tests in relation to the blood alcohol concentration limits indicated
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, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use BENZIDAMINA ACRAF gel during pregnancy unless it is clearly necessary
and as directed by your doctor. If treatment is necessary, the lowest dose should be used
for the shortest possible time.

Driving and operating machinery
The use of BENZIDAMINA ACRAF gel, at the recommended doses ,does notalter the ability to drive vehicles and
operate machinery.

BENZIDAMINA ACRAF gel contains methyl parahydroxybenzoatewhich may cause allergic reactions
(including delayed reactions).

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

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Instructions for use:
Spread BENZIDAMINA ACRAF gel onto your toothbrush,

• gently massage the gums and teeth,
• rinse your mouth keeping the gel in your mouth. Repeat applications 3 times a day, after meals

Caution: do not exceed the indicated doses without the advice of your doctor.
Caution: use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.

If you use more BENZIDAMINA ACRAF gel than you should
If you take an excessive amount of medicine or accidentally ingest large quantities, consult your doctor or pharmacist immediately.

If you forget to use BENZIDAMINA ACRAF gel
Do not use a double dose to make up for a missed dose.

If you stop using BENZIDAMINA ACRAF gel
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 gets them.
If you experience the following side effects during treatment with Benzidamina ACRAF,
STOP the treatment and contact your doctor immediately:

• allergic reactions(sensitization reactions).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system 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 Benzidamina ACRAF 5 mg/g oral mucosa gel

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 ingredient is: benzydamine hydrochloride 0.5 g (equivalent to 0.447 g of benzydamine).
The other ingredients are: sodium saccharin; sodium monofluorophosphate; sodium lauryl sulfate; methyl
parahydroxybenzoate(see paragraph “Benzidamina ACRAF gel contains methyl
parahydroxybenzoate”); citric acid; 95% ethanol; hydroxyethylcellulose; mint aroma; licorice
aroma; purified water.

Description of the appearance of Benzidamina ACRAF gel and package contents
Benzidamina ACRAF gel is presented as a gel for oral use.
The package contains a tube of 20 g.

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

BENZIDAMINA ACRAF 5 mg/g toothpaste

Benzydamine hydrochloride

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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

• 1. What is BENZIDAMINA ACRAF 5 mg/g toothpaste and what it is used for
• 2. What you need to know before using BENZIDAMINA ACRAF 5 mg/g toothpaste
• 3. How to use BENZIDAMINA ACRAF 5 mg/g toothpaste
• 4. Possible side effects
• 5. How to store BENZIDAMINA ACRAF 5 mg/g toothpaste
• 6. Contents of the pack and other information

1. What is BENZIDAMINA ACRAF 5 mg/g dental paste and what is it used for

BENZIDAMINA ACRAF dental paste is a medicine based on 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 that accompanies
inflammation of the mouth and gums.
See 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 5 mg/g dental paste

Do not use BENZIDAMINA ACRAF dental paste

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

Warnings and precautions
Consult your doctor or pharmacist before using BENZIDAMINA ACRAF dental paste.
Tell your doctor if you are allergic to acetylsalicylic acid or other anti-inflammatory drugs.
Use of BENZIDAMINA ACRAF dental paste, especially if prolonged, may lead to sensitization (allergic reactions). In this case, stop treatment and contact your doctor.

Other medicines and BENZIDAMINA ACRAF dental paste
Tell 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, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use BENZIDAMINA ACRAF dental paste during pregnancy unless it is
clearly necessary and as directed by your doctor. If treatment is necessary, it should be
used at the lowest dose for the shortest possible time.

Driving and operating machinery
Use of BENZIDAMINA ACRAF dental paste, at the recommended doses ,does notimpair the ability to drive
vehicles and operate machinery.

BENZIDAMINA ACRAF dental paste contains methyl and propyl parahydroxybenzoate and mint
flavor
Methyl and propyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).
This medicine contains mint flavor which in turn contains anisil alcohol, benzyl alcohol,
cinnamal, cinnamyl alcohol, citronellol, d-Limonene, eugenol, farnesol, geraniol,
isoeugenol, linalool.
Anisil 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 described 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 your toothbrush,

• gently and repeatedly massage the gums and teeth,
• rinse your mouth while keeping the toothpaste in your mouth. Repeat applications 3 times a day, after meals.

Caution: do not exceed the indicated doses without the advice of your doctor.
Caution: use only for short periods of treatment

If you use more BENZIDAMINA ACRAF toothpaste than you shouldIf you take an excessive amount of medicine or accidentally ingest a large quantity, consult your doctor or pharmacist immediately.

If you forget to use BENZIDAMINA ACRAF toothpaste
Do not use a double dose to make up for a missed dose.

If you stop using BENZIDAMINA ACRAF toothpaste
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 everyone will experience them.
If you experience the following side effects during treatment with BENZIDAMINA ACRAF dental paste, STOP the
treatment and contact your doctor immediately:

• hypersensitivity reactions(allergic reaction), generally transient.
• anaphylactic reactions(severe allergic reactions)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
inform your doctor or pharmacist. You can also report side effects directly through
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 BENZIDAMINA 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 which is stated on the pack after SCAD. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 toothpaste contains

• The active ingredient is: benzydamine hydrochloride 0.5 g (equivalent to 0.447 g of benzydamine).
• The other components are: dibasic calcium phosphate dihydrate, glycerol, sodium carboxymethylcellulose, sodium lauryl sulfate, precipitated silica, sodium saccharin, methyl parahydroxybenzoate, propylparahydroxybenzoate,mint flavour(see paragraph “BENZIDAMINA ACRAF toothpaste contains methyl and propyl parahydroxybenzoate and mint flavour”), quinoline yellow (E 104), Patent Blue V (E131), purified water.

Description of the appearance of BENZIDAMINA ACRAF toothpaste and contents of the pack
BENZIDAMINA ACRAF toothpaste is presented as a green toothpaste to be used
in the mouth.
The pack contains a tube of 120 g.

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

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

BENZIDAMINA ACRAF 30 mg/g cream

Benzydamine hydrochloride

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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

• 1. What BENZIDAMINA ACRAF 30 mg/g cream is and what it is used for
• 2. What you need to know before using BENZIDAMINA ACRAF 30 mg/g cream
• 3. How to use BENZIDAMINA ACRAF 30 mg/g cream
• 4. Possible side effects
• 5. How to store BENZIDAMINA ACRAF 30 mg/g cream
• 6. Contents of the pack and other information

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

BENZIDAMINA ACRAF cream is a non-steroidal anti-inflammatory drug with analgesic properties, meaning a drug that 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, sports medicine;
• of muscle and joint pain, for example in case of:
• myalgias (pain of one or more muscles),
• tendinitis (inflammation of tendons, the structures that connect muscles to bones),
• bursitis (inflammation of bursae, sac-like structures found in joints),
• contusions (injuries after trauma),
• muscle strains (muscle tears),
• sprains.

See 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 benzidamine or 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 wounds that are still
open.
Avoid exposing the treated skin area to direct sunlight.
Tell your doctor if you are allergic to acetylsalicylic acid or other anti-inflammatory drugs.
The use of BENZIDAMINA ACRAF cream, especially if prolonged, may lead to sensitization (allergic reactions).

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use BENZIDAMINA ACRAF cream during pregnancy unless it is clearly
necessary and as directed by your doctor. If treatment is necessary, the lowest dose should be used for the shortest possible time.

Driving and operating machinery
The use of BENZIDAMINA ACRAF cream, at the recommended doses, does notalter the ability to drive vehicles and
operate machinery.

BENZIDAMINA ACRAF cream contains Cetyl alcohol, Methyl and propyl parahydroxybenzoate,
Propylene glycol and crematest fragrance:
Cetyl alcohol may cause localized skin reactions (e.g., contact dermatitis).
Methyl and propyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).
This medicine contains 5g of propylene glycol per 100g 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, and 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 instructed 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 corresponding to the pain/lesion and rub gently until
complete absorption.
Caution: do not exceed the indicated doses without the advice of your doctor.
Caution: use this medicine only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any change
in its characteristics.

If you use more BENZIDAMINA ACRAF cream than you should
Local use of benzidamine has never caused effects due to excessive use.

If you forget to use BENZIDAMINA ACRAF cream
Do not use a double dose to make up for a missed dose.

If you stop using BENZIDAMINA ACRAF cream
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 gets them.
If you experience the following side effects during treatment with BENZIDAMINA ACRAF cream,
STOP the treatment and consult your doctor immediately:
rare (may affect up to 1 in 1,000 people):

• hypersensitivity reactions (allergic reaction);
• itching
• 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 based on available data):

• anaphylactic reactions (severe allergic reactions)

It is also possible for skin irritation to occur, due to the presence of propylene glycol in the
cream.

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

5. How to store BENZIDAMINA ACRAF cream

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the package after SCAD. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 cream contains

• The active ingredient is: benzydamine hydrochloride (100 g of cream contains 3g of benzydamine hydrochloride)
• The other ingredients are: glycerides of fatty acids, decyl oleate, propylene glycol(see paragraph “BENZIDAMINA ACRAF cream contains cetyl alcohol, parabens and propylene glycol”), polyglycol ethers of fatty acids, cetyl alcohol(see paragraph “BENZIDAMINA ACRAF cream contains cetyl alcohol, parabens and propylene glycol”), crematest fragrance, methyl parahydroxybenzoate, propyl parahydroxybenzoate(see paragraph “BENZIDAMINA ACRAF cream contains cetyl alcohol, parabens and propylene glycol”), purified water.

Description of the appearance of BENZIDAMINA ACRAF cream and contents of the pack
BENZIDAMINA ACRAF cream is presented as a soft, white cream. The cream is
packaged in aluminum tubes of 20 g or 50 g.
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

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

BENZIDAMINA ACRAF 3 mg/ml spray for oral mucosa

Benzydamine hydrochloride

Read this leaflet carefully before you start 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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment.

Contents of this leaflet:

• 1. What is BENZIDAMINA ACRAF 3 mg/ml spray for oral mucosa and what it is used for
• 2. What you need to know before you use BENZIDAMINA ACRAF 3 mg/ml spray for oral mucosa
• 3. How to use BENZIDAMINA ACRAF 3 mg/ml spray for oral mucosa
• 4. Possible side effects
• 5. How to store BENZIDAMINA ACRAF 3 mg/ml spray for oral mucosa
• 6. Contents of the pack and other information

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

BENZIDAMINA ACRAF spray is a non-steroidal anti-inflammatory drug with analgesic properties,
that is, a drug that acts against pain and inflammation of the throat, mouth and gums.
BENZIDAMINA ACRAF spray also exhibits disinfectant properties and a moderate superficial
anesthetic action.
BENZIDAMINA ACRAF spray is used for the treatment of symptoms of inflammation and irritation, also associated with pain, of the gums, mouth and throat (e.g. gingivitis, stomatitis,
pharyngitis), even as a result of conservative or extraction dental therapy (e.g. caries treatment or
tooth extraction).
BENZIDAMINA ACRAF spray is particularly indicated for patients unable to gargle.
See a 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 3 mg/ml oral mucosa spray

Do not use BENZIDAMINA ACRAF spray

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

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

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not use BENZIDAMINA ACRAF spray during pregnancy unless it is clearly
necessary and as directed by your doctor. If treatment is necessary, the lowest dose should be used
for the shortest possible time.

Driving and operating machinery
The use of BENZIDAMINA ACRAF spray, at the recommended doses ,does notalter the ability to drive vehicles and
operate machinery.

BENZIDAMINA ACRAF spray contains hydrogenated castor oil polyoxyethylene, peppermint aroma and
methyl parahydroxybenzoate:

• hydrogenated castor oil polyoxyethylene may cause localized skin reactions
• methyl parahydroxybenzoate may cause allergic reactions (even delayed).

This medicine contains peppermint aroma which in turn contains benzyl alcohol, citronellol, d-
Limonene, eugenol, geraniol and linolool.
Benzyl alcohol, citronellol, d-Limonene, eugenol, geraniol and linolool may cause allergic
reactions.

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

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Adults
The recommended dose is 2-4 sprays, 2-6 times a day (each spray delivers 0.17 ml of solution).
Caution: do not exceed the indicated doses without consulting your doctor.

Instructions for use:

• Lift the spray nozzle.
• Insert the nozzle into your mouth and direct the spray towards the inflamed area or towards the throat in case of throat pain and inflammation. Press firmly with your finger on the knurled area of the button.

Important note: for the first use of the product, press the pump button several times into the air, until a regular spray is initiated.

If you use more BENZIDAMINA ACRAF spray than you should
If you take an excessive amount of medicine or accidentally ingest a large quantity, consult your doctor or pharmacist immediately.

If you forget to use BENZIDAMINA ACRAF spray
Do not use a double dose to make up for a missed dose.

If you stop using BENZIDAMINA ACRAF spray
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 during treatment with BENZIDAMINA ACRAF spray you experience the following side effects,
STOP the treatment 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 reaction)
• burning 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 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
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 BENZIDAMINA 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 which is stated on the pack after EXP. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in 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 ingredient is benzydamine hydrochloride (100 ml of solution contains 0.30 g of benzydamine
hydrochloride equivalent to 0.268 g of benzydamine).
The other ingredients are: ethanol (96%), glycerol, hydrogenated castor oil polyoxyl 35 castor oil, mint aroma,methyl parahydroxybenzoate(see paragraph “BENZIDAMINA ACRAF spray contains hydrogenated castor oil polyoxyl 35 castor oil, mint aroma and methyl parahydroxybenzoate”), sodium saccharin,
purified water.

Description of the appearance of BENZIDAMINA ACRAF spray and contents of the pack
BENZIDAMINA ACRAF spray is presented as a solution for oral mucosal spray in a 15 ml spray bottle.

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

NDES
Certain environmental conditions, such as lowering or fluctuations in temperature, increased humidity levels, etc., can cause inflammation of the upper respiratory tract (mouth, nose, throat),
because they promote 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 other things, a burning sensation and pain in the throat with difficulty swallowing.
To avoid worsening these symptoms, it is useful to avoid some further irritating factors such as smoke, dry air, smog, crowded places, etc.
The gums can also be a site of inflammation. The latter could even be
a sign of early dental problems: in this case, a dental check-up may be useful.

BENZIDAMINA ACRAF 3 mg tablets

Benzidamine hydrochloride

Read this leaflet carefully before you start taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if you feel worse after 7 days of treatment.

Contents of this leaflet:

• 1. What BENZIDAMINA ACRAF 3 mg tablets is and what it is used for
• 2. What you need to know before you take BENZIDAMINA ACRAF 3 mg tablets
• 3. How to take BENZIDAMINA ACRAF 3 mg tablets
• 4. Possible side effects
• 5. How to store BENZIDAMINA ACRAF 3 mg tablets
• 6. Contents of the pack and other information

1. What is BENZIDAMINA ACRAF 3 mg lozenges and what is it used for

BENZIDAMINA ACRAF lozenges is a medicine that acts against irritation of the mouth and throat. BENZIDAMINA ACRAF lozenges also exhibits a moderate surface anesthetic action. BENZIDAMINA ACRAF lozenges is used for the symptomatic local treatment of pain and irritation of the mouth and throat (which manifest with burning, redness, a feeling of swelling, difficulty 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 any of the other ingredients of this medicine (listed in section 6)
• if you suffer from phenylketonuria (a metabolic disorder resulting from a hereditary deficiency of the enzyme that transforms the amino acid phenylalanine into tyrosine), as the product contains aspartame (see section “BENZIDAMINA ACRAF tablets contains 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, oro-pharyngeal ulcerations may be a sign of more serious
conditions. Therefore, if symptoms persist, the patient should consult their
doctor or dentist as needed.
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 of age, it is recommended to take the product under the supervision
of an adult.

Other medicines and BENZIDAMINA ACRAF tablets
Tell 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, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not use BENZIDAMINA ACRAF tablets during pregnancy unless clearly
necessary and as directed by your doctor. If treatment is necessary, the
lowest dose should be used for the shortest possible time.

Driving and operating machinery
The use of BENZIDAMINA ACRAF tablets, at the recommended doses ,does notimpair the ability to drive
vehicles and operate machinery.

BENZIDAMINA ACRAFtabletscontains 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 described in this leaflet or as instructed
by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet 3 times a day.
Caution: do not exceed the indicated doses without your doctor's advice.

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

Instructions for use:
Take the medicine as needed, at any time of the day.
Dissolve the tablet slowly in your mouth.
If you do not feel better after 7 days of treatment, consult your doctor or dentist as needed.
Sore throat disorders can in fact be a sign of more serious illnesses.

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 (inducing vomiting, gastric lavage, hydration).

If you forget to take BENZIDAMINA ACRAF tablets
Do not take a double dose to make up for a missed dose.

If you stop taking 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 gets them.
During the intake of BENZIDAMINA ACRAF tablets, the following side effects may be observed:

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

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through 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 BENZIDAMINA ACRAF 3 mg lozenges

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 tablets contain

• the active ingredient is: benzydamine hydrochloride (each tablet contains 3 mg of benzydamine hydrochloride, equivalent to 2.68 mg of benzydamine).
• The other ingredients are: isomalt, aspartame(see section “BENZIDAMINA ACRAF tablets contains aspartame”), menthol, citric acid, lemon flavour, mint flavour, quinoline yellow (E 104), indigotine (E 132).

Description of the appearance of BENZIDAMINA ACRAF tablets and contents of the pack
BENZIDAMINA ACRAF is presented in the form of translucent, green, square-shaped tablets with a
central groove.
Each tablet is wrapped in food-grade paper and packaged in strips of 10 tablets. Each
pack may contain 20 tablets (2 strips of 10 tablets) or 30 tablets (3 strips of 10 tablets).
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

Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona
September 2025
Health Education Notes
Certain environmental conditions, such as lowering or fluctuations in temperature, increased humidity rates, etc., can cause irritation of the upper respiratory tract, as they promote
attack by pathogenic germs.
The characteristic symptoms include, among others, burning, sore throat, difficulty swallowing.
To avoid worsening these symptoms, it is useful to avoid some further irritating factors such as smoking, dry air, crowded places, etc.