ASPI 0.25 % Mouthwash

Зміст інструкції

1. ASPI GOLA 8.75 mg lozenges lemon and honey flavour
   1. What is ASPI GOLA and what is it used for
   2. What you need to know before taking ASPI GOLA
   3. How to take ASPI GOLA
   4. Possible side effects
   5. How to store ASPI GOLA
   6. Contents of the pack and other information
2. ASPI GOLA 0,25% mouthwash
   1. What is ASPI GOLA and what is it used for
   2. What you need to know before using ASPI GOLA
   3. How to use ASPI GOLA
   4. Possible side effects
   5. How to store ASPI GOLA
   6. Contents of the pack and other information
3. ASPI GOLA 0,25% spray per mucosa orale
   1. What is ASPI GOLA and what is it used for
   2. What you need to know before using ASPI GOLA
   3. How to use ASPI GOLA
   4. Possible side effects
   5. How to store ASPI GOLA
   6. Contents of the pack and other information

ASPI GOLA 8.75 mg lozenges lemon and honey flavour

Flurbiprofen

Read this leaflet carefully before 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 would like 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 3 days of treatment.

Contents of this leaflet:

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

1. What is ASPI GOLA and what is it used for

ASPI GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine that acts against inflammation and pain of the throat, mouth and gums.
ASPI GOLA lozenges are used in adultsand adolescents over 12 years of agein the
treatment of symptoms of pain and irritation of the gums, mouth and throat (e.g.
gingivitis, stomatitis, pharyngitis).
See a doctor if you do not feel better or if you feel worse after 3 days of treatment
(see section 3).

2. What you need to know before taking ASPI GOLA

Do not take ASPI GOLA

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid (a medicine against inflammation, pain, fever and heart disorders) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and ASPI GOLA”);
• if you have previously suffered from bleeding or perforation of the stomach or intestine related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
• if you suffer from chronic inflammatory diseases of the intestine (ulcerative colitis and Crohn's disease);
• if you frequently suffer from peptic ulcer (stomach lesion) or bleeding of the stomach or intestine (two or more distinct episodes of ulcer or bleeding);
• if you suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function) and severe kidney failure (reduced kidney function).
• if you are in the last three months of pregnancy (see section “Pregnancy, breastfeeding and fertility”).

Do not give ASPI GOLA lozenges to children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking ASPI GOLA.
Talk to your doctor or pharmacist if:

• you have an infection - refer to the “Infections” section below.

In particular, tell your doctor if:

• you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you may experience bronchospasm (narrowing of the bronchi which causes severe difficulty breathing due to reduced airflow);
• you have previously suffered from allergies;
• you are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
• you suffer from systemic lupus erythematosus or mixed connective tissue disease;
• you suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic insufficiency);
• you suffer from hypertension (high blood pressure);
• you are taking other pain relievers for a long time or without respecting the dosage, as headache (head pain) may occur;
• you have previously suffered from a peptic ulcer (stomach lesion) and other diseases of the stomach and intestine as this increases the risk that these diseases may recur. This risk increases especially with high doses of flurbiprofen, if you are elderly or if the peptic ulcer has been complicated by bleeding or perforation of the stomach and intestine (see section 4 “Possible side effects”);
• if you are elderly (because you are more likely to experience side effects);
• you have problems with the heart or blood vessels, as medicines like ASPI GOLA may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with high doses and prolonged treatments; do not exceed the dose of ASPI GOLA and do not take it for long periods. Tell your doctor if you have heart problems, a history of stroke or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke).

Report any unusual abdominal symptoms to your doctor.
The use of this medicine, especially if prolonged, may give rise to allergic or local irritation (see section 4 “Possible side effects”); in such cases, discontinue the treatment and consult your doctor who, if necessary, will carry out suitable therapy.
If you experience irritation of the mouth, discontinue treatment.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections such as fever and pain. This can delay appropriate treatment of the infection, which in turn can lead to an increased risk of complications. If you take this medicine during an infection and the symptoms of the infection persist or worsen, contact your doctor or pharmacist immediately.

Children and adolescents
Do not give this medicine to children under 12 years of age (see “Do not take ASPI GOLA”).

Other medicines and ASPI GOLA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines:

• medicines containing acetylsalicylic acid(a medicine against inflammation, pain, fever and heart disorders), as they may increase the side effects;
• antiplatelet agents(medicines that make the blood more fluid, such as low-dose daily acetylsalicylic acid), as this increases the risk of bleeding in the stomach and intestines;
• anticoagulants(medicines that slow down or inhibit the blood clotting process, such as warfarin), as their effect may be potentiated by NSAIDs;
• selective serotonin reuptake inhibitors(medicines used against depression), as this increases the risk of bleeding in the stomach and intestines;
• antihypertensive medicines(ACE inhibitors, angiotensin II receptor antagonists and diuretics), as NSAIDs may reduce the effect of diuretics or some antihypertensive medicines may increase renal toxicity;
• alcohol, as it may increase the risk of side effects, especially the risk of bleeding in the stomach and intestines;
• cardiac glycosides(medicines that affect heart function), as NSAIDs may worsen heart failure and increase the level of glycosides in the blood;

Pregnancy, breastfeeding and fertility
Oral formulations (e.g. tablets) of flurbiprofen can cause adverse effects in the unborn child.
It is not known whether the same risk applies to ASPI GOLA.
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take ASPI GOLA in the last three months of pregnancy.
Do not take ASPI GOLA in the first 6 months of pregnancyunless absolutely necessary and as directed by your doctor. If treatment is necessary during this period, you should take the minimum dose for the shortest possible time.

Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary and advised by your doctor.

Fertility
Flurbiprofen belongs to a group of medicines that can affect female fertility. This effect is reversible when taking the medicine is stopped. Occasional use of this medicine is unlikely to affect the ability to become pregnant. However, ask your doctor if you have fertility problems before taking the medicine.

Driving and using machines
This medicine does not interfere with the ability to drive vehicles and use machines.

ASPI GOLA contains glucose and sucrose
This medicine contains glucose and sucrose.
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take ASPI GOLA

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

HOW MUCH AND HOW
The minimum effective dose should be used for the shortest time necessary to relieve symptoms.
If you have an infection, consult your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to paragraph 2).
Warning: do not exceed the indicated doses without the advice of your doctor.

Adults and adolescents over 12 years of age
The recommended dose is 1 lozenge every 3-6 hours, as needed. Do not exceed the dose of 8 lozenges in 24 hours.
Dissolve the lozenge slowly in your mouth.

If you are elderly or have suffered in the past from an ulcer (stomach lesion)
If you are elderly or have suffered in the past from a peptic ulcer (stomach lesion), it is recommended to use the lowest recommended dose, as there is a greater risk of serious consequences in case of undesirable effects and the risk of developing an ulcer, bleeding or perforation of the stomach and intestines is greater (see paragraph 4 “Possible side effects”).

Use in children and adolescents
Do not give ASPI GOLA lozenges to children under 12 years of age.

Duration of treatment
Use ASPI GOLA only for short periods of treatment, not exceeding 7 days. If no appreciable results are observed after 3 days of treatment, the cause may be a different pathological condition, therefore consult your doctor.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics.

If you take more ASPI GOLA than you should
If you accidentally ingest/take an excessive dose of ASPI GOLA, inform your doctor immediately or go to the nearest hospital.
In the case of accidental ingestion/intake of significant amounts of flurbiprofen, you may experience symptoms such as: nausea, vomiting, irritation of the stomach or intestines, stomach pain or rarely diarrhea. Ringing in the ears, headache and bleeding of the stomach or intestines can also occur. In such cases, the doctor will adopt appropriate treatments.

If you forget to take ASPI GOLA
Do not take a double dose to make up for a missed dose.

If you stop taking ASPI GOLA
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 ASPI GOLA, STOPthe
treatment and immediatelyconsult your doctor:

allergic reactions (sensitization reactions):

• allergic reaction
• anaphylactic reactions (severe allergic reactions)
• angioedema (sudden swelling of the mouth/throat and mucous membranes)

local irritation

• sensations of heat or tingling in the mouth and throat
• respiratory phenomena: asthma, bronchospasm, shortness of breath or difficulty breathing
• various skin disorders: skin rashes of various types, itching, redness, swelling, skin loss, blisters, scaling or ulceration of the skin and mucous membranes.

If you experience the following side effects at the beginning of treatment with ASPI GOLA, consult

immediatelyyour doctor:

• abdominal pain
• peptic ulcer (stomach lesion)
• perforation and bleeding of the stomach or intestine.

These side effects can be fatal and you may experience them with or without warning symptoms.
These side effects are especially likely to occur if you are elderly or if you have
suffered in the past from stomach and intestinal diseases.
In addition, you may experience the following side effects:

Effects affecting the blood

• anemia (reduction in the number of red blood cells in the blood)
• thrombocytopenia (reduction in the number of platelets in the blood)
• aplastic anemia (reduction in the number of all types of blood cells, red blood cells, white blood cells, platelets)
• agranulocytosis (reduction in the number of granulocytes, a type of white blood cells, in the blood).

Effects affecting the nervous system

• dizziness,
• headache, migraine (chronic condition characterized by recurrent headaches)
• paresthesia (numbness of the limbs or other parts of the body)
• drowsiness
• cerebrovascular accidents (diseases caused by insufficient blood flow to an area of the brain)
• visual disturbances
• optic neuritis (severe inflammation of the optic nerve, which can lead to vision loss or blindness)
• confusion
• vertigo

Effects affecting the immune system

• anaphylactic reactions (severe allergic reaction)
• hypersensitivity
• angioedema (inflammatory reaction of the skin).

Effects affecting the eye:

• visual disturbances

Effects affecting the ear and labyrinth

• tinnitus (ringing in the ears)

Effects affecting the cardiovascular system

• heart failure
• swelling
• hypertension (high blood pressure)

Effects affecting the bronchi and lungs

• throat irritation
• asthma
• bronchospasm (narrowing of the bronchi that causes severe difficulty breathing due to reduced airflow)
• dyspnea (shortness of breath).

Effects affecting the mouth, stomach and intestines

• diarrhea
• constipation
• nausea
• vomiting
• lesions inside the mouth, blisters in the mouth or throat
• pain in the mouth and throat, numbness of the mouth or throat
• feeling of warmth or burning, tingling of the mouth
• dry mouth
• abdominal distension, abdominal pain
• difficulty digesting
• flatulence (emission of gas from the intestines)
• inflammation of the tongue, altered taste
• blood in the stool
• blood in the vomit
• colitis
• worsening of inflammatory diseases of the colon and intestines (Crohn's disease)
• gastritis (inflammation of the stomach)
• peptic ulcer, bleeding from the stomach and intestines, gastric perforation.

Effects affecting the skin and subcutaneous tissue

• skin rash
• itching
• urticaria (redness of the skin accompanied by itching)
• purpura (appearance of patches of skin of various sizes with a purplish color)
• bullous dermatoses (severe skin lesions characterized by erythema, blistering lesions with areas of skin detachment), including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis and Erythema multiforme.

Effects affecting the kidneys and urinary tract

• kidney toxicity
• tubulo-interstitial nephritis (inflammation of the kidneys)
• nephrotic syndrome (alteration of the renal glomeruli that causes a loss of proteins with the urine)
• renal failure (reduction in kidney function).

General effects and at the site of administration

• fever, pain, discomfort, fatigue.

Effects affecting the liver

• hepatitis (inflammation of the liver).

Effects affecting the psychiatric sphere

• insomnia
• depression, hallucination

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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this
medicine.

5. How to store ASPI GOLA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. 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 ASPI GOLA contains

• The active ingredient is flurbiprofen. One lozenge contains 8.75 mg of flurbiprofen.
• The other ingredients are: sucrose, glucose, macrogol, potassium hydroxide, lemon flavour, levomenthol, honey.

Description of the appearance of ASPI GOLA and contents of the pack
ASPI GOLAis available in the form of lozenges contained in blisters.
The pack contains 16 or 24 lozenges.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Bayer S.p.A. Viale Certosa 130 , 20156 Milano Italy

Manufacturer
Doppel Farmaceutici S.r.l.- Via Volturno, 48 - 20089 Quinto de’ Stampi- Rozzano (MI)
or
Lozy’s Pharmaceuticals S.l., Spain

ASPI GOLA 0,25% mouthwash

flurbiprofen

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 3 days of treatment.

Contents of this leaflet:

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

1. What is ASPI GOLA and what is it used for

ASPI GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain relieving) medicine that acts against inflammation and pain of the throat, mouth and gums.
ASPI GOLA Mouthwash is used in adultsand adolescents over the age of 12in the
treatment of symptoms of pain and irritation of the gums, mouth and throat (for example gingivitis, stomatitis, pharyngitis), even as a result of conservative or extraction dental therapy (e.g. cavity treatment or tooth extraction).
Consult a doctor if you do not feel better or if you feel worse after 3 days of treatment
(see section 3).

2. What you need to know before using ASPI GOLA

Do not use ASPI GOLA

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid (a medicine against inflammation, pain, fever and heart problems) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and ASPI GOLA”);
• if you have previously suffered from bleeding or perforation of the stomach or intestine related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
• if you suffer from chronic inflammatory diseases of the intestine (ulcerative colitis and Crohn's disease);
• if you frequently suffer from peptic ulcer (stomach lesion) or bleeding of the stomach or intestine (two or more distinct episodes of ulcer or bleeding);
• if you suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function) and severe kidney failure (reduced kidney function).
• if you are in the last three months of pregnancy (see section “Pregnancy, breastfeeding and fertility”). Donot give ASPI GOLA to children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using ASPI GOLA.
Consult your doctor or pharmacist if:

• you have an infection - refer to the “Infections” section below.

In particular, tell your doctor if:

• you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you may experience bronchospasm (narrowing of the bronchi causing severe breathing difficulties due to reduced airflow);
• you have previously suffered from allergies;
• you are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
• you suffer from systemic lupus erythematosus or mixed connective tissue disease;
• you suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic insufficiency);
• you suffer from hypertension (high blood pressure);
• you have been taking other pain relievers for a long time or without respecting the dosage, as headache (pain in the head) may occur;
• you have previously suffered from a peptic ulcer (stomach lesion) and other diseases of the stomach and intestine as this increases the risk that these diseases may recur. This risk increases, especially with high doses of flurbiprofen, if you are elderly or if the peptic ulcer has been complicated by bleeding or perforation of the stomach and intestine (see section 4 “Possible side effects”);
• you are elderly (as you are more likely to experience side effects);
• you have problems with the heart or blood vessels, as medicines like ASPI GOLA may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. The risk of experiencing side effects increases with high doses and prolonged treatments; do not exceed the dose of ASPI GOLA and do not use it for long periods. Tell your doctor if you have heart problems, a history of stroke or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke).

Report any unusual abdominal symptoms to your doctor.
The use of this medicine, especially if prolonged, may give rise to allergic or local irritation phenomena (see section 4 “Possible side effects”); in such cases, discontinue the
treatment and consult your doctor who, if necessary, will carry out appropriate therapy.
If you experience irritation of the mouth, discontinue treatment.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections such as fever and
pain. This can delay appropriate treatment of the infection, which in turn can lead to an
increased risk of complications. If you are taking this medicine during an infection and the symptoms
of the infection persist or worsen, consult your doctor or pharmacist immediately.

Children and adolescents
Donot give ASPI GOLA Mouthwash to children under 12 years of age.

Other medicines and ASPI GOLA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor if you are taking any of the following medicines:

• medicines containing acetylsalicylic acid(a medicine against inflammation, pain, fever and heart problems), as they may increase the side effects;
• antiplatelet agents(medicines that make the blood more fluid, such as low-dose daily acetylsalicylic acid), as this increases the risk of bleeding in the stomach and intestines;
• anticoagulants(medicines that slow down or inhibit the blood clotting process, such as warfarin), as their effect may be potentiated by NSAIDs;
• selective serotonin reuptake inhibitors(medicines used against depression), as this increases the risk of bleeding in the stomach and intestines;
• antihypertensive medicines(ACE inhibitors, angiotensin II antagonists and diuretics), as NSAIDs may reduce the effect of diuretics or some antihypertensive medicines may increase renal toxicity;
• alcohol, as it may increase the risk of side effects, especially the risk of bleeding in the stomach and intestines;
• cardiac glycosides(medicines that affect heart function), as NSAIDs may worsen heart failure and increase the level of glycosides in the blood;
• cyclosporine(a medicine that prevents rejection after organ transplantation), as it increases the risk of renal toxicity;
• corticosteroids(medicines used against inflammation/allergies), as they increase the risk of having lesions or bleeding in the stomach and intestines;
• lithium (a medicine used for behavioral disorders), as the level of lithium in the blood may increase;
• methotrexate (a medicine used for psoriasis, arthritis and tumors), as the level of methotrexate in the blood may increase;
• mifepristone(a medicine used to terminate a pregnancy): NSAIDs should not be used for 8 - 12 days after taking mifepristone, as they reduce its effect;
• oral antidiabetics(for treating diabetes);
• phenytoin(a medicine for treating epilepsy);
• agents to increase water elimination through the kidneys(diuretics, including potassium-sparing agents);
• agents against gout (probenecid, sulfinpyrazone);
• quinolone antibiotics(medicines used for bacterial infections), as NSAIDs may increase the risk of developing seizures;
• tacrolimus(an immunosuppressant medicine used after organ transplantation), as NSAIDs may increase the risk of renal toxicity;
• zidovudine(a medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
• Cox-2 inhibitors and other NSAIDs(medicines used against inflammation and pain), as it may increase the effect of these medicines and the risk of side effects.

Pregnancy, breastfeeding and fertility
Oral formulations (e.g. tablets) of flurbiprofen can cause adverse effects in the
newborn. It is not known whether the same risk applies to ASPI GOLA.
If you are pregnant or breastfeeding, if you suspect or are planning
a pregnancy, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Do not use ASPI GOLA in the last three months of pregnancy.
Do not use ASPI GOLA in the first 6 months of pregnancyunless absolutely necessary and on
doctor's advice. If treatment is necessary during this period, you should take the
minimum dose for the shortest possible time.

Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary
and advised by your doctor.

Fertility
Flurbiprofen belongs to a group of medicines that can affect female fertility.
This effect is reversible when taking the medicine is stopped. It is
unlikely that occasional use of this medicine will have an effect on the chances of
getting pregnant. However, ask your doctor if you have fertility problems before taking the
medicine.

Driving and operating machinery
This medicine does not interfere with the ability to drive vehicles and operate machinery.

ASPI GOLA Mouthwash contains para-hydroxybenzoates, hydrogenated castor oil-40
polyoxyethylene,
This medicine contains para-hydroxybenzoates which may cause allergic reactions
(even delayed).
This medicine contains hydrogenated castor oil-40 polyoxyethylene which may cause
localized skin reactions.

3. How to use ASPI GOLA

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

HOW MUCH AND HOW
The minimum effective dose should be used for the shortest time necessary to relieve
symptoms.
If you have an infection, consult your doctor or pharmacist immediately if symptoms (such as
fever and pain) persist or worsen (see section 2).
Caution: do not exceed the indicated doses without your doctor's advice.

Adults and adolescents over 12 years of age
The recommended dose is 2-3 rinses or gargles per day (hold in mouth for up to 1 minute).
You can use the mouthwash undiluted (without diluting it with water) using 10 ml (1 measuring cap) of mouthwash
or diluted by pouring 10 ml (1 measuring cap) of mouthwash into half a glass of water.
At the recommended doses, occasional ingestion does not cause any harm,
although it is advisable not to ingest the product.

If you are elderly or have suffered from ulcers (stomach lesions) in the past
If you are elderly or have suffered from peptic ulcer (stomach lesion) in the past, it is recommended to use
the lowest recommended dose, as there is a greater risk of serious consequences in
the event of side effects and the risk of developing ulcers, bleeding or perforation of the
stomach and intestines is greater (see section 4 “Possible side effects”).

Use in children and adolescents
Donot give ASPI GOLA Mouthwash to children under 12 years of age.

Duration of treatment
Use ASPI GOLA only for short periods of treatment, not exceeding 7 days. If you do not notice
appreciable results after 3 days of treatment, the cause may be a different condition,
therefore consult your doctor.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any
recent change in its characteristics.

If you use more ASPI GOLA than you should
If you accidentally ingest/take an excessive dose of ASPI GOLA, warn
your doctor immediately or go to the nearest hospital.
In the event of accidental ingestion of significant amounts of flurbiprofen, you may
experience symptoms such as: nausea, vomiting, irritation of the stomach or intestines, stomach
pain or rarely diarrhea. Ringing in the ears, headache and bleeding of the
stomach or intestines may also occur. In such cases, the doctor will adopt appropriate treatments.

If you forget to use ASPI GOLA
Do not use a double dose to make up for a missed dose.

If you stop using ASPI GOLA
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 ASPI GOLA, STOPthe
treatment and immediatelyconsult your doctor:

allergic reactions (sensitization reactions):

• allergic reaction
• anaphylactic reactions (severe allergic reactions)
• angioedema (sudden swelling of the mouth/throat and mucous membranes)

local irritation

• respiratory phenomena: asthma, bronchospasm, shortness of breath or difficulty breathing
• various skin disorders: rashes of various types, itching, redness, swelling, skin loss, blisters, scaling or ulceration of the skin and mucous membranes.

If you experience the following side effects at the beginning of treatment with ASPI GOLA, consult

immediatelyyour doctor:

• abdominal pain
• peptic ulcer (stomach lesion)
• perforation and bleeding of the stomach or intestine.These side effects can be fatal and you may experience them with or without warning symptoms. These side effects occur especially if you are elderly or if you have suffered from stomach and intestinal diseases in the past.

In addition, you may experience the following side effects:

Effects affecting the blood

• anemia (reduction in the number of red blood cells in the blood)
• thrombocytopenia (reduction in the number of platelets in the blood)
• aplastic anemia (reduction in the number of all types of blood cells, red blood cells, white blood cells, platelets)
• agranulocytosis (reduction in the number of granulocytes, a type of white blood cells, in the blood).

Effects affecting the nervous system

• dizziness
• headache, migraine (chronic disease characterized by recurrent headaches)
• paresthesia (numbness of the limbs or other parts of the body)
• drowsiness
• cerebrovascular accidents (diseases caused by insufficient blood flow to an area of the brain)
• visual disturbances
• optic neuritis (severe inflammation of the optic nerve, which can lead to vision loss up to blindness)
• confusion
• vertigo

Effects affecting the immune system

• anaphylactic reactions (severe allergic reaction)
• hypersensitivity
• angioedema (inflammatory reaction of the skin).

Effects affecting the eye:

• visual disturbances.

Effects affecting the ear and labyrinth

• tinnitus (ringing in the ears).

Effects affecting the cardiovascular system

• heart failure
• swelling
• hypertension (high blood pressure)

Effects affecting the bronchi and lungs

• throat irritation
• asthma
• bronchospasm (narrowing of the bronchi that causes severe breathing difficulties due to reduced airflow)
• dyspnea (shortness of breath).

Effects affecting the mouth, stomach and intestines

• diarrhea
• constipation
• nausea
• vomiting
• lesions inside the mouth, blisters in the mouth or throat
• pain in the mouth and throat, numbness of the mouth or throat
• dry mouth
• abdominal distension, abdominal pain
• difficulty digesting
• flatulence (emission of gas from the intestine)
• inflammation of the tongue, altered taste
• blood in the stool
• blood in the vomit
• colitis
• worsening of inflammatory diseases of the colon and intestine (Crohn's disease)
• gastritis (inflammation of the stomach)
• peptic ulcer, bleeding from the stomach and intestines, gastric perforation.

Effects affecting the skin and underlying tissue

• skin rash
• itching
• urticaria (redness of the skin accompanied by itching)
• purpura (appearance of patches of skin of various sizes with a purplish color)
• bullous dermatoses (severe skin lesions characterized by erythema, blistering lesions with areas of skin detachment), including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis and Erythema multiforme

Effects affecting the kidneys and urinary tract

• kidney toxicity
• tubulo-interstitial nephritis (inflammation of the kidneys)
• nephrotic syndrome (alteration of the renal glomeruli that causes a loss of proteins with the urine)
• renal failure (reduction of kidney function).

General effects and at the site of administration

• fever, pain, discomfort, fatigue.

Effects affecting the liver

• hepatitis (inflammation of the liver).

Effects affecting the psychiatric sphere

• insomnia
• depression, hallucination

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult 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 ASPI GOLA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging.
The expiry date refers to the last day of that month.
Once the bottle is opened, use within 9 weeks.
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 ASPI GOLA contains

• The active ingredient is flurbiprofen. 100 ml of solution contains 250 mg of flurbiprofen.
• The other ingredients are: glycerol (98%), ethanol, non-crystallizing liquid sorbitol, hydrogenated castor oil-40 polyoxyethylene, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavour, Patent Blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of ASPI GOLA and contents of the pack
Pack containing a bottle with dosing measuring cup and safety cap of 160 ml.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Bayer S.p.A. Viale Certosa 130, 20156 Milan

Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1- 29016 Cortemaggiore (PC) Italy

ASPI GOLA 0,25% spray per mucosa orale

Flurbiprofene

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 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 3 days of treatment.

Contents of this leaflet:

• 1. What ASPI GOLA is and what it is used for
• 2. What you need to know before you use ASPI GOLA
• 3. How to use ASPI GOLA
• 4. Possible side effects
• 5. How to store ASPI GOLA
• 6. Contents of the pack and other information

2. What is ASPI GOLA and what is it used for

ASPI GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic
(pain relieving) medicine that acts against inflammation and pain of the throat, mouth and gums.
ASPI GOLA Oral mucosa spray is used in adultsand adolescents over the age of
12 yearsin the treatment of symptoms of pain and irritation 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).
See a doctor if you do not feel better or if you feel worse after 3 days of treatment
(see section 3).

2. What you need to know before using ASPI GOLA

Do not use ASPI GOLA

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid (a medicine against inflammation, pain, fever and heart disorders) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and ASPI GOLA”);
• if you have previously suffered from bleeding or perforation of the stomach or intestine related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
• if you suffer from chronic inflammatory diseases of the intestine (ulcerative colitis and Crohn's disease);
• if you frequently suffer from peptic ulcer (lesion of the stomach) or bleeding of the stomach or intestine (two or more distinct episodes of ulcer or bleeding);
• if you suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function) and severe kidney failure (reduced kidney function).
• - if you are in the last three months of pregnancy (see section “Pregnancy, breastfeeding and fertility”). Do notgive ASPI GOLA Spray to children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using ASPI GOLA.
Consult your doctor or pharmacist if:

• you have an infection - refer to the section “Infections” below.

In particular, tell your doctor if:

• you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you may experience bronchospasm (narrowing of the bronchi causing severe breathing difficulties due to reduced airflow);
• you have previously suffered from allergies;
• you are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
• you suffer from systemic lupus erythematosus or mixed connective tissue disease;
• you suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic insufficiency);
• you suffer from hypertension (high blood pressure);
• you have been taking other painkillers for a long time or without respecting the dosage, as headache (headache) may occur;
• you have previously suffered from a peptic ulcer (lesion of the stomach) and other diseases of the stomach and intestine as this increases the risk that these diseases may recur. This risk increases, especially with high doses of flurbiprofen, if you are elderly or if the peptic ulcer has been complicated by bleeding or perforation of the stomach and intestine (see section 4 “Possible side effects”);
• if you are elderly (as you are more likely to experience side effects);
• you have problems with the heart or blood vessels, as medicines like ASPI GOLA may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. The risk of adverse effects increases with high doses and prolonged treatments; do not exceed the dose of ASPI GOLA and do not use it for long periods. Tell your doctor if you have heart problems, a history of stroke or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke).

Report any unusual abdominal symptoms to your doctor.
The use of this medicine, especially if prolonged, can give rise to allergic or local irritation phenomena (see section 4 “Possible side effects”); in such cases discontinue the
treatment and consult your doctor who, if necessary, will carry out suitable therapy.
If you experience irritation of the mouth, discontinue treatment.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections such as fever and
pain. This can delay appropriate treatment of the infection, which in turn can lead to an
increased risk of complications. If you take this medicine during an infection and the symptoms
of the infection persist or worsen, consult your doctor or pharmacist immediately.

Children and adolescents
Do not give ASPI GOLA Spray to children under 12 years of age.

Other medicines and ASPI GOLA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor if you are taking any of the following medicines:

• medicines containing acetylsalicylic acid(a medicine against inflammation, pain, fever and heart disorders), as they may increase the side effects;
• antiplatelet agents(medicines that make the blood more fluid, such as low-dose daily acetylsalicylic acid), as this increases the risk of bleeding in the stomach and intestines;
• anticoagulant agents(medicines that slow down or inhibit the blood clotting process, such as warfarin), as their effect may be potentiated by NSAIDs;
• selective serotonin reuptake inhibitors(medicines used against depression), as this increases the risk of bleeding in the stomach and intestines;
• antihypertensive medicines(ACE inhibitors, angiotensin II antagonists and diuretics), as NSAIDs may reduce the effect of diuretics or some antihypertensive medicines may increase renal toxicity;
• alcohol, as it may increase the risk of side effects, especially the risk of bleeding in the stomach and intestines;
• cardiac glycosides(medicines that affect heart function), as NSAIDs may worsen heart failure and increase the level of glycosides in the blood;
• cyclosporine(a medicine that prevents organ rejection after transplantation), as it increases the risk of renal toxicity;
• corticosteroids(medicines used against inflammation/allergies), as they increase the risk of having lesions or bleeding in the stomach and intestines;
• lithium (a medicine used for behavioral disorders), as the level of lithium in the blood may increase;
• methotrexate(a medicine used for psoriasis, arthritis and tumors), as the level of methotrexate in the blood may increase;
• mifepristone(a medicine used to terminate a pregnancy): NSAIDs should not be used for 8-12 days after taking mifepristone, as they reduce its effect;
• oral antidiabetics(for treating diabetes);
• phenytoin(a medicine for treating epilepsy);
• agents to increase water elimination through the kidneys(diuretics, including potassium-sparing agents);
• agents against gout (probenecid, sulfinpyrazone);
• quinolone antibiotics(medicines used for bacterial infections), as NSAIDs may increase the risk of developing seizures;
• tacrolimus(an immunosuppressant medicine used after organ transplantation), as NSAIDs may increase the risk of renal toxicity;
• zidovudine(a medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
• Cox-2 inhibitors and other NSAIDs(medicines used against inflammation and pain), as it may increase the effect of these medicines and the risk of side effects.

Pregnancy, breastfeeding and fertility
Oral formulations (e.g. tablets) of flurbiprofen can cause adverse effects in the
unborn child. It is not known whether the same risk applies to ASPI GOLA.
If you are pregnant or breastfeeding, if you suspect or are planning
a pregnancy, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Do not use ASPI GOLA in the last three months of pregnancy.
Do not use ASPI GOLA in the first 6 months of pregnancyunless absolutely necessary and
under the guidance of a doctor. If treatment is necessary during this period, you should take
the minimum dose for the shortest possible time.

Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary
and advised by your doctor.

Fertility
Flurbiprofen belongs to a group of medicines that can affect female fertility.
This effect is reversible when taking the medicine is stopped. It is
unlikely that occasional use of this medicine will affect the chances of
getting pregnant. However, ask your doctor if you have fertility problems before taking
the medicine.

Driving and operating machinery
This medicine does not interfere with the ability to drive vehicles and operate machinery.

ASPI GOLA Spray contains para-hydroxybenzoates, hydrogenated castor oil-40
polyoxyethylene
This medicine contains para-hydroxybenzoates which may cause allergic reactions
(even delayed).
This medicine contains hydrogenated castor oil-40 polyoxyethylene which may cause
localized skin reactions.

3. How to use ASPI GOLA

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.

HOW MUCH AND HOW
The minimum effective dose should be used for the shortest time necessary to relieve
symptoms.
If you have an infection, consult your doctor or pharmacist immediately if symptoms (such as
fever and pain) persist or worsen (refer to paragraph 2).
Caution: do not exceed the indicated doses without your doctor's advice.

Adults and adolescents over 12 years of age
The recommended dose is 2 sprays, 3 times a day.
Spray the solution, directing it directly onto the affected area (mouth, throat). Each
spray corresponds to 0.2 ml of solution, equivalent to 0.5 mg of flurbiprofen.

If you are elderly or have suffered from ulcers (stomach lesions) in the past
If you are elderly or have suffered from peptic ulcer (stomach lesion) in the past, it is recommended to use
the lowest recommended dose, as there is a greater risk of serious consequences in
the event of side effects and the risk of developing ulcers, bleeding or perforation of the
stomach and intestines is greater (see paragraph 4 “Possible side effects”).

Use in children and adolescents
Do not give ASPI GOLA Spray to children under 12 years of age.

Duration of treatment
Use ASPI GOLA only for short periods of treatment, not exceeding 7 days. If you do not notice
appreciable results after 3 days of treatment, the cause may be a different medical
condition, therefore consult your doctor.
Consult your doctor if the disorder recurs or if you have noticed any recent
change in its characteristics.

If you use more ASPI GOLA than you should
If you accidentally ingest/take an excessive dose of ASPI GOLA, immediately notify
your doctor or go to the nearest hospital.
In the event of accidental ingestion/intake of significant amounts of flurbiprofen, you may
experience symptoms such as: nausea, vomiting, irritation of the stomach or intestines, stomach
pain or, rarely, diarrhea. Ringing in the ears, headache and bleeding of the
stomach or intestines may also occur. In such cases, the doctor will adopt appropriate treatments.

If you forget to use ASPI GOLA
Do not use a double dose to make up for a missed dose.

If you stop treatment with ASPI GOLA
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 ASPI GOLA, STOPthe
treatment and contact your doctor immediately:

allergic reactions (sensitization reactions):

• allergic reaction
• anaphylactic reactions (severe allergic reactions)
• angioedema (sudden swelling of the mouth/throat and mucous membranes).

local irritation
respiratory phenomena: asthma, bronchospasm, wheezing or shortness of breath

various skin disorders: skin rashes of various types, itching, redness, swelling, skin loss, blisters, scaling or ulceration of the skin and mucous membranes.
If you experience the following side effects at the beginning of treatment with ASPI GOLA, contact your doctor

immediately:

• abdominal pain
• peptic ulcer (lesion of the stomach)
• perforation and bleeding of the stomach or intestine.These side effects can be fatal and you may experience them with or without warning symptoms. These side effects occur especially if you are elderly or if you have previously suffered from stomach and intestinal diseases.

In addition, you may experience the following side effects:

Effects affecting the blood

• anemia (reduction in the number of red blood cells in the blood)
• thrombocytopenia (reduction in the number of platelets in the blood)
• aplastic anemia (reduction in the number of all types of blood cells, red blood cells, white blood cells, platelets)
• agranulocytosis (reduction in the number of granulocytes, a type of white blood cells, in the blood).

Effects affecting the nervous system

• dizziness
• headache, migraine (chronic condition characterized by recurrent headaches)
• paresthesia (numbness of the limbs or other parts of the body)
• drowsiness
• cerebrovascular accidents (diseases caused by insufficient blood flow to an area of the brain)
• visual disturbances
• optic neuritis (severe inflammation of the optic nerve, which can lead to vision loss up to blindness)
• confusion
• vertigo.

Effects affecting the immune system

• anaphylactic reactions (severe allergic reaction)
• hypersensitivity
• angioedema (inflammatory reaction of the skin).

Effects affecting the eye:

• visual disturbances.

Effects affecting the ear and labyrinth

• tinnitus (ringing in the ears).

Effects affecting the cardiovascular system

• heart failure
• swelling
• hypertension (high blood pressure).

Effects affecting the bronchi and lungs

• sore throat irritation
• asthma
• bronchospasm (narrowing of the bronchi that causes severe difficulty breathing due to reduced airflow)
• dyspnea (shortness of breath).

Effects affecting the mouth, stomach and intestines

• diarrhea
• constipation
• nausea
• vomiting
• lesions inside the mouth, blisters in the mouth or throat
• pain in the mouth and throat, numbness of the mouth or throat
• dry mouth
• abdominal distension, abdominal pain
• difficulty digesting
• flatulence (emission of gas from the intestine)
• inflammation of the tongue, altered taste
• blood in the stool
• blood in the vomit
• colitis
• worsening of inflammatory diseases of the colon and intestines (Crohn's disease)
• gastritis (inflammation of the stomach)
• peptic ulcer, bleeding from the stomach and intestines, gastric perforation.

Effects affecting the skin and subcutaneous tissue

• skin rash
• itching
• urticaria (reddening of the skin accompanied by itching)
• purpura (appearance of skin patches of various sizes with a purplish color)
• bullous dermatoses (severe skin lesions characterized by erythema, blister lesions with areas of skin detachment), including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis and Erythema multiforme.

Effects affecting the kidneys and urinary tract

• kidney toxicity
• tubulo-interstitial nephritis (inflammation of the kidneys)
• nephrotic syndrome (alteration of the renal glomeruli which involves a loss of proteins with the urine)
• renal failure (reduction of kidney function).

General effects and at the site of administration

• fever, pain, discomfort, fatigue.

Effects affecting the liver

• hepatitis (inflammation of the liver).

Effects affecting the psychiatric sphere

• insomnia
• depression, hallucination.

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 ASPI GOLA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging
The expiry date refers to the last day of that month.
Once opened, use within 21 weeks.
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 ASPI GOLA contains
The active ingredient is flurbiprofen. 100 ml of solution contains 250 mg of flurbiprofen.

• The other ingredients are: glycerol (98%), ethanol, non-crystallizing liquid sorbitol, hydrogenated castor oil-40 polyoxyethylene, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint aroma, Patent Blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of ASPI GOLA and contents of the pack
Pack containing a bottle with a dosing pump and applicator of 15 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Bayer S.p.A. Viale Certosa 130, 20156 Milano

Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1- 29016 Cortemaggiore (PC) Italy