Zerinomed for sore throat: detailed information

Package leaflet: Information for the user

ZERINOMED GOLA 2.5 mg/ml mouthwash

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

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 3 days of treatment.

Contents of this leaflet:

What ZERINOMED GOLA is and what it is used for
What you need to know before using ZERINOMED GOLA
How to use ZERINOMED GOLA
Possible side effects
How to store ZERINOMED GOLA
Contents of the pack and other information

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

ZERINOMED GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine that acts against inflammation and pain in the throat, mouth, and gums.
ZERINOMED GOLA is used in adults and adolescents over 12 years of age for the treatment of symptoms of pain and irritation affecting the gums, mouth, and throat (e.g. gingivitis, stomatitis, pharyngitis), including cases following conservative or extraction dental procedures (e.g. dental caries treatment or tooth extraction).
Consult your 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 ZERINOMED GOLA

Do not use ZERINOMED GOLA

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

Do not give ZERINOMED GOLA to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using ZERINOMED GOLA.
In particular, inform your doctor if:

you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you may develop bronchospasm (narrowing of the airways causing severe breathing difficulties due to reduced airflow);
you have previously suffered from allergies;
you are currently 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 following the recommended dosage, as this may cause headache;
you have previously suffered from peptic ulcer (stomach lesion) or other stomach or intestinal diseases, as this increases the risk that these conditions may recur. This risk increases especially with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer was complicated by gastrointestinal bleeding or perforation (see section 4 “Possible side effects”);
you are elderly (as you are more likely to experience side effects);
you have heart or blood vessel problems, as medicines like ZERINOMED GOLA may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with higher doses and prolonged treatment; do not exceed the recommended dose of ZERINOMED GOLA and do not use it for long periods. Inform 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, high cholesterol, or smoke);
you have an infection – refer to the section “Infections” below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain.
This could delay appropriate treatment of the infection, thereby increasing the risk of complications.
If you use this medicine during an infection and infection symptoms persist or worsen, consult your
doctor or pharmacist immediately.
Inform your doctor of any unusual abdominal symptoms.
The use of this medicine, especially if prolonged, may cause allergic reactions or local irritation (see section 4 “Possible side effects”); in such cases, stop treatment and consult your doctor, who will, if necessary, initiate appropriate therapy.
If you experience mouth irritation, discontinue treatment.
Children and adolescents
Do not give ZERINOMED GOLA to children under 12 years of age.
Other medicines and ZERINOMED GOLA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking any of the following medicines:

medicines containing acetylsalicylic acid (medicines for inflammation, pain, fever, and heart conditions), as they may increase side effects;
antiplatelet agents (medicines that make the blood thinner, such as low-dose daily acetylsalicylic acid), as they increase the risk of gastrointestinal bleeding;
anticoagulants (medicines that slow down or inhibit blood clotting, such as warfarin), as their effect may be enhanced by NSAIDs;
selective serotonin reuptake inhibitors (medicines used for depression), as they increase the risk of gastrointestinal bleeding;
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 stomach and intestinal bleeding;
cardiac glycosides (medicines that affect heart function), as NSAIDs may worsen heart failure and increase blood levels of cardiac glycosides;
cyclosporine (a medicine used to prevent organ transplant rejection), as it increases the risk of kidney toxicity;
corticosteroids (medicines used for inflammation/allergies), as they increase the risk of stomach or intestinal lesions or bleeding;
lithium (a medicine used for behavioral disorders), as blood levels of lithium may increase;
methotrexate (a medicine used for psoriasis, arthritis, and tumors), as blood levels of methotrexate may increase;
mifepristone (a medicine used to terminate pregnancy): NSAIDs should not be used for 8–12 days after taking mifepristone, as they reduce its effectiveness;
quinolone antibiotics (medicines used for bacterial infections), as NSAIDs may increase the risk of seizures;
tacrolimus (an immunosuppressant medicine used after organ transplantation), as NSAIDs may increase the risk of kidney toxicity;
zidovudine (a medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
Cox-2 inhibitors and other NSAIDs (medicines used for inflammation and pain), as this may enhance the effect of these medicines and increase the risk of side effects.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Oral formulations (e.g., tablets) of flurbiprofen may cause adverse effects in the newborn.
It is not known whether the same risk applies to ZERINOMED GOLA.
Do not use ZERINOMED GOLA during the last three months of pregnancy. Do not use ZERINOMED GOLA during the first 6 months of pregnancy unless strictly necessary and on medical advice.
If treatment is needed during this period, use the lowest effective dose for the shortest possible time.
Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary and advised by a doctor.
Fertility
Flurbiprofen belongs to a group of medicines that may affect female fertility.
This effect is reversible when the medicine is discontinued. Occasional use of this medicine is unlikely to affect the ability to become pregnant.
However, consult your doctor if you have fertility problems before using this medicine.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
ZERINOMED GOLA contains parahydroxybenzoates, hydrogenated castor oil-40 polyoxylated, and ethanol
Parahydroxybenzoates: may cause allergic reactions (including delayed reactions).
Hydrogenated castor oil-40 polyoxylated: may cause localized skin reactions.
This medicine contains 86.4 mg of alcohol (ethanol) per ml. It may cause a burning sensation on damaged skin.

3. How to use ZERINOMED GOLA

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
HOW MUCH AND HOW TO USE
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2).
Warning: Do not exceed the recommended doses without medical advice.
Adults and adolescents over 12 years of age
The recommended dose is 2–3 mouth rinses or gargles per day (hold in the mouth for up to 1 minute).
You may use the mouthwash undiluted (without mixing with water), using 10 ml (1 measuring cup) of mouthwash, or diluted, by pouring 10 ml (1 measuring cup) of mouthwash into half a glass of water.
When used at the recommended doses, accidental ingestion is unlikely to cause harm, although ingestion of the product should be avoided.
If you are elderly or have previously suffered from stomach ulcer
If you are elderly or have previously had peptic ulcer (stomach lesion), use of the lowest recommended dose is advised, as there is an increased risk of serious consequences in case of adverse effects, and a higher risk of developing stomach or intestinal ulcers, bleeding, or perforation (see section 4 “Possible side effects”).
Use in children and adolescents
Do not give ZERINOMED GOLA to children under 12 years of age.
Duration of treatment
Use ZERINOMED GOLA only for short-term treatment, not exceeding 7 days. If no noticeable improvement occurs after 3 days of treatment, the cause may be a different medical condition; therefore, consult your doctor.
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.
If you use more ZERINOMED GOLA than you should
If you accidentally ingest/overdose on ZERINOMED GOLA, inform your doctor immediately or go to the nearest hospital.
In case of accidental ingestion of a large amount of flurbiprofen, symptoms such as nausea, vomiting, stomach or intestinal irritation, stomach pain, or rarely diarrhea may occur. Ringing in the ears (tinnitus), headache, and gastrointestinal bleeding may also occur. In such cases, the doctor will initiate appropriate treatment.
If you forget to use ZERINOMED GOLA
Do not use a double dose to make up for the forgotten dose.
If you stop using ZERINOMED GOLA
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.
STOP treatment and contact your doctor immediately if you experience any of the following side effects while taking ZERINOMED GOLA:

Allergic reactions (sensitization phenomena):
allergic reaction
anaphylactic reactions (severe allergic reactions)
angioedema (sudden swelling of the mouth/throat and mucous membranes)
Local irritation
Respiratory events: asthma, bronchospasm, shortness of breath or difficulty breathing
Various skin disorders: skin rashes of different types, itching, redness, swelling, peeling of the skin, blisters, desquamation or ulceration of the skin and mucous membranes.

If you experience any of the following side effects at the beginning of treatment with ZERINOMED GOLA, contact your doctor immediately:

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

In addition, you may experience the following side effects:
Effects related to the blood

anaemia (reduced number of red blood cells)
thrombocytopenia (reduced number of platelets in the blood)
aplastic anaemia (reduced number of all types of blood cells: red blood cells, white blood cells, platelets)
agranulocytosis (reduced number of granulocytes, a type of white blood cell, in the blood).

Effects related to the nervous system

dizziness
headache
paraesthesia (numbness of limbs or other body parts)
somnolence
cerebrovascular accidents (diseases caused by lack of blood flow to an area of the brain)
visual disturbances
optic neuritis (severe inflammation of the optic nerve, which may lead to reduced vision or blindness)
migraine (chronic condition characterized by recurrent headaches)
confusion
vertigo.

Effects related to the immune system

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

Effects related to the eye

visual disturbances.

Effects related to the ear and labyrinth

tinnitus (ringing in the ears).

Effects related to the cardiovascular system

heart failure
swelling
hypertension (high blood pressure).

Effects related to the bronchi and lungs

throat irritation
asthma
bronchospasm (narrowing of the bronchi causing severe breathing difficulty due to reduced airflow)
dyspnoea (shortness of breath)
blisters in the mouth or throat
numbness of the mouth or throat.

Effects related to the mouth, stomach and intestine

diarrhoea
mouth sores
nausea
mouth and throat pain
abdominal bloating
abdominal pain
constipation
dry mouth
indigestion
flatulence (passing gas from the intestine)
inflammation of the tongue
altered taste
vomiting
blood in stools
blood in vomit
gastrointestinal bleeding
colitis
worsening of inflammatory bowel diseases (Crohn's disease)
gastritis (inflammation of the stomach)
peptic ulcer
gastric perforation.

Effects related to the skin and underlying tissue

rash (skin eruption)
pruritus
urticaria (red, itchy skin patches)
purpura (appearance of purple-coloured skin patches of various sizes)
bullous dermatoses (severe skin lesions characterised by erythema, blistering and skin detachment), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema Multiforme.

Effects related to the kidneys and urinary tract

renal toxicity
tubulo-interstitial nephritis (inflammation of the kidneys)
nephrotic syndrome (alteration of the kidney glomeruli leading to protein loss in urine)
renal failure (reduced kidney function).

General effects and effects at the site of administration

fever
pain
discomfort
fatigue.

Effects related to the liver

hepatitis.

Effects related to psychiatric disorders

insomnia
depression
hallucination.

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

5. How to store ZERINOMED 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 after "Exp".
The expiry date refers to the last day of that month.
After opening the bottle, use within 9 weeks.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ZERINOMED GOLA contains

The active substance is flurbiprofen. 100 ml of solution contain 250 mg of flurbiprofen.
The other components are: glycerol (98%), ethanol, liquid non-crystallizable sorbitol, polyoxethylated hydrogenated castor oil-40, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavour, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of ZERINOMED GOLA and package contents
Pack containing one bottle with dosing cup and safety cap, 160 ml.
Marketing Authorization Holder
Zentiva Italia S.r.l. - Via P. Paleocapa, 7 - 20121 Milan, Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC), Italy

Package leaflet: information for the user

ZERINOMED GOLA 2.5 mg/ml oral mucosa spray

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

Keep this leaflet. You may need to read it again.
If you need further information or advice, consult your pharmacist.
If any of the side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

What ZERINOMED GOLA is and what it is used for
What you need to know before using ZERINOMED GOLA
How to use ZERINOMED GOLA
Possible side effects
How to store ZERINOMED GOLA
Contents of the pack and other information

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

ZERINOMED GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine that acts against inflammation and pain in the throat, mouth and gums.
ZERINOMED GOLA is used in adults and adolescents over 12 years of age for the treatment of symptoms of pain and irritation of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), including pain following conservative or extraction dental procedures (e.g. dental caries treatment or tooth extraction).
Consult your 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 ZERINOMED GOLA

Do not use ZERINOMED GOLA

if you are allergic to flurbiprofen or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to acetylsalicylic acid (a medicine for inflammation, pain, fever, and heart conditions) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and ZERINOMED GOLA”);
if you have previously experienced stomach or intestinal bleeding or perforation related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
if you suffer from chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
if you frequently suffer from peptic ulcer (stomach lesion) or gastrointestinal bleeding (two or more separate episodes of ulcer or bleeding);
if you suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function), or severe kidney failure (reduced kidney function);
if you are in the last 3 months of pregnancy (see section “Pregnancy and breastfeeding”).

Do not give ZERINOMED GOLA to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using ZERINOMED GOLA.
In particular, inform 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 airways 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 analgesics for a long time or without following the recommended dosage, as this may lead to headache;
you have previously suffered from peptic ulcer (stomach lesion) or other stomach and intestinal diseases, as this increases the risk that these conditions may recur. This risk increases especially with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer was complicated by gastrointestinal bleeding or perforation (see section 4 “Possible side effects”);
you are elderly (as you are more likely to experience side effects);
you have heart or blood vessel problems, as medicines like ZERINOMED GOLA may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with higher doses and prolonged treatment; do not exceed the recommended dose of ZERINOMED GOLA and do not use it for long periods. Inform 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, high cholesterol, or smoke);
you have an infection – refer to the section “Infections” below. Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain. This may delay appropriate treatment of the infection, which in turn may increase the risk of complications. If you use this medicine during an infection and infection symptoms persist or worsen, contact your doctor or pharmacist immediately.

Inform your doctor of any unusual abdominal symptoms.
The use of this medicine, especially if prolonged, may cause allergic reactions or local irritation (see section 4 “Possible side effects”); in such cases, stop treatment and consult your doctor, who will prescribe appropriate therapy if necessary.
If you experience mouth irritation, stop treatment.
Children and adolescents
Do not give ZERINOMED GOLA to children under 12 years of age.
Other medicines and ZERINOMED GOLA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking any of the following medicines:

medicines containing acetylsalicylic acid (a medicine for inflammation, pain, fever, and heart conditions), as they may increase side effects;
antiplatelet agents (medicines that make the blood thinner, such as low-dose daily acetylsalicylic acid), as this increases the risk of gastrointestinal bleeding;
anticoagulants (medicines that slow down or inhibit blood clotting, such as warfarin), as their effect may be enhanced by NSAIDs;
selective serotonin reuptake inhibitors (medicines used for depression), as this increases the risk of gastrointestinal bleeding;
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 stomach and intestinal bleeding;
cardiac glycosides (medicines that affect heart function), as NSAIDs may worsen heart failure and increase blood levels of glycosides;
cyclosporine (a medicine used to prevent organ transplant rejection), as this increases the risk of kidney toxicity;
corticosteroids (medicines used for inflammation/allergies), as this increases the risk of stomach and intestinal lesions or bleeding;
lithium (a medicine used for behavioral disorders), as blood levels of lithium may increase;
methotrexate (a medicine used for psoriasis, arthritis, and tumors), as blood levels of methotrexate may increase;
mifepristone (a medicine used to terminate pregnancy): NSAIDs should not be used for 8–12 days after taking mifepristone, as they reduce its effectiveness;
quinolone antibiotics (medicines used for bacterial infections), as NSAIDs may increase the risk of developing seizures;
tacrolimus (an immunosuppressive medicine used after organ transplantation), as NSAIDs may increase the risk of kidney toxicity;
zidovudine (a medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
Cox-2 inhibitors and other NSAIDs (medicines used for inflammation and pain), as this may enhance the effect of these medicines and increase the risk of side effects.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Oral formulations (e.g., tablets) of flurbiprofen may cause adverse effects in the newborn.
It is not known whether the same risk applies to ZERINOMED GOLA.
Do not use ZERINOMED GOLA during the last three months of pregnancy. Do not use ZERINOMED GOLA during the first 6 months of pregnancy unless strictly necessary and under medical advice.
If treatment is needed during this period, use the lowest effective dose for the shortest possible time.
Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary and advised by a doctor.
Fertility
Flurbiprofen belongs to a group of medicines that may affect female fertility.
This effect is reversible when the medicine is discontinued. Occasional use of this medicine is unlikely to affect your chances of becoming pregnant.
However, consult your doctor if you have fertility problems before using this medicine.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
ZERINOMED GOLA contains parahydroxybenzoates, hydrogenated castor oil-40 polyoxylated, and ethanol
Parahydroxybenzoates: may cause allergic reactions (including delayed reactions).
Hydrogenated castor oil-40 polyoxylated: may cause localized skin reactions.
This medicine contains 86.4 mg of alcohol (ethanol) per ml. It may cause a burning sensation on damaged skin.

3. How to use ZERINOMED GOLA

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
DOSE AND METHOD OF ADMINISTRATION
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2).
Caution: do not exceed the recommended doses without medical advice.
Adults and adolescents over 12 years of age
The recommended dose is 2 sprays, 3 times a day.
Spray the solution directly onto the affected area (mouth, throat).
When used at the recommended doses, accidental ingestion is unlikely to cause harm, although ingestion of the product should be avoided.
If you are elderly or have previously suffered from ulcer (stomach lesion)
If you are elderly or have previously suffered from peptic ulcer (stomach lesion), it is advisable to use the lowest recommended dose, as there is an increased risk of serious consequences in case of adverse effects, and a higher risk of developing ulcers, bleeding or perforation of the stomach and intestines (see section 4 “Possible side effects”).
Use in children and adolescents
Do not give ZERINOMED GOLA to children under 12 years of age.
Duration of treatment
Use ZERINOMED GOLA only for short-term treatment, not exceeding 7 days. If no noticeable improvement occurs after 3 days of treatment, the cause may be a different pathological condition; in this case, consult your doctor.
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.
Method of administration
Rotate the nozzle to the right or left without tampering with the dispenser.
At first use, press the dispenser several times until a regular spray is obtained.
If you use more ZERINOMED GOLA than you should
If you accidentally ingest/absorb an excessive dose of ZERINOMED GOLA, inform your doctor immediately or go to the nearest hospital.
In case of accidental ingestion/absorption of large amounts of flurbiprofen, symptoms such as nausea, vomiting, irritation of the stomach or intestines, stomach ache or rarely diarrhoea may occur. Tinnitus, headache, and gastrointestinal bleeding may also occur. In such cases, the doctor will adopt appropriate treatments.
If you forget to use ZERINOMED GOLA
Do not use a double dose to make up for the forgotten dose.
If you stop using ZERINOMED GOLA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

allergic reactions (sensitization phenomena):
allergic reaction
anaphylactic reactions (severe allergic reactions)
angioedema (sudden swelling of the mouth/throat and mucous membranes)
local irritation
respiratory events: asthma, bronchospasm, breathlessness or shortness of breath
various skin disorders: skin rashes of different types, itching, redness, swelling, skin peeling, blisters, desquamation or ulceration of the skin and mucous membranes.

If you experience any of the following side effects at the beginning of treatment with ZERINOMED GOLA, contact your doctor immediately:

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

In addition, you may experience the following side effects:
Effects related to blood

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

Effects related to the nervous system

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

Effects related to the immune system

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

Effects related to the eye

visual disturbances.

Effects related to the ear and labyrinth

tinnitus (ringing in the ears).

Effects related to the cardiovascular system

heart failure
swelling
hypertension (high blood pressure).

Effects related to the bronchi and lungs

throat irritation
asthma
bronchospasm (narrowing of the bronchi causing severe breathing difficulty due to reduced airflow)
dyspnea (shortness of breath)
blisters in mouth or throat
numbness of mouth or throat.

Effects related to the mouth, stomach and intestine

diarrhoea
mouth lesions
nausea
mouth and throat pain
abdominal bloating
abdominal pain
constipation
dry mouth
indigestion
flatulence (passing intestinal gas)
inflammation of the tongue
taste disturbances
vomiting
blood in the stool
blood in vomit
gastrointestinal bleeding
colitis
worsening of inflammatory bowel diseases (Crohn's disease)
gastritis (inflammation of the stomach)
peptic ulcer
gastric perforation.

Effects related to the skin and underlying tissue

rash (skin eruption)
itching
urticaria (red, itchy skin patches)
purpura (appearance of purple-coloured skin patches of varying sizes)
bullous dermatoses (severe skin lesions characterized by erythema, blistering and skin detachment), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema Multiforme.

Effects related to the kidneys and urinary tract

renal toxicity
tubulo-interstitial nephritis (inflammation of the kidneys)
nephrotic syndrome (alteration of the kidney glomeruli leading to protein loss in urine)
renal failure (reduced kidney function).

General and administration site-related effects

fever
pain
discomfort
fatigue.

Effects related to the liver

hepatitis.

Effects related to psychiatric disorders

insomnia
depression
hallucinations.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: Zerinomed Gola Coll_FI.docx
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 ZERINOMED GOLA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Once the bottle has been opened, use within 21 weeks.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ZERINOMED GOLA contains

The active substance is flurbiprofen. 250 mg of flurbiprofen are contained in 100 ml of solution.
The other components are: glycerol (98%), ethanol, liquid non-crystallizable sorbitol, polyoxethylated hydrogenated castor oil-40, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, peppermint flavour, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of ZERINOMED GOLA and contents of the pack
Pack containing one bottle with a dosing pump and dispenser of 15 ml.
Marketing Authorization Holder
Zentiva Italia S.r.l. - Via P. Paleocapa, 7 - 20121 Milan, Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy