Coryfin sore throat pain: detailed information

Package leaflet: Information for the patient

CORYFIN GOLA DOLORE 2.5 mg/ml mouthwash

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

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

Contents of this leaflet:

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

1. What CORYFIN GOLA DOLORE is and what it is used for

CORYFIN GOLA DOLORE contains flurbiprofen, which belongs to a group of medicines called
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
NSAIDs work against inflammation and pain.
This medicine is used to treat symptoms of inflammation and irritation of the mouth and
throat (e.g. gingivitis, stomatitis, pharyngitis) and to relieve pain, including pain following dental procedures.
Consult your doctor if you do not feel better or if you feel worse after a few days (3) of treatment.

2. What you should know before using CORYFIN GOLA DOLORE

Do not use CORYFIN GOLA DOLORE

if you are allergic to the active substance 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 CORYFIN GOLA DOLORE”);
if you have experienced asthma (difficulty breathing) or skin reactions (e.g. urticaria) after taking acetylsalicylic acid or similar medicines (other NSAIDs). You may be hypersensitive or allergic to these medicines;
if you have or have had episodes of stomach ulcer (lesion of the stomach), perforation or bleeding of the stomach or intestines (two or more distinct episodes of ulcer or bleeding);
if you have previously experienced stomach or intestinal bleeding or perforation related to prior treatment with non-steroidal anti-inflammatory drugs (NSAIDs);
if you have inflammatory bowel diseases (ulcerative colitis, Crohn’s disease);
if you have severe heart failure (reduced heart function), severe liver failure (reduced liver function), or severe renal failure (reduced kidney function);
if you are in the last three months of pregnancy (see section “Pregnancy and breastfeeding”).

Do not give CORYFIN GOLA DOLORE to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using CORYFIN GOLA DOLORE if:

you are in the first six months of pregnancy;
you are breastfeeding.

In particular, inform your doctor if:

you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk of experiencing bronchospasm (narrowing of the airways causing severe breathing difficulty 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 of recurrence. This risk increases especially with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer was complicated by bleeding or perforation of the stomach or intestines (see section 4);
if you are elderly (as you are more likely to experience adverse effects);
if you have heart or blood vessel problems, as medicines such as CORYFIN GOLA DOLORE may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk of adverse effects increases with higher doses and prolonged treatment; do not exceed the recommended dose of CORYFIN GOLA DOLORE or 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).

Tell your doctor about any unusual abdominal symptoms.
Prolonged or frequent use of this medicine may cause allergic reactions or local irritation (see section 4 “Possible side effects”). In such cases, stop treatment and consult your doctor, who will start appropriate therapy if necessary.
Children and adolescents
The use of CORYFIN GOLA DOLORE in children under 12 years of age is contraindicated.
Other medicines and CORYFIN GOLA DOLORE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 adverse effects;
antiplatelet agents (medicines that make the blood thinner, such as low-dose daily aspirin), 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 drugs may increase renal toxicity;
alcohol, as it may increase the risk of adverse effects, especially gastrointestinal 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 renal 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 cancer), 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 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 for inflammation and pain), as their combined use may enhance effects and increase the risk of adverse effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Do not use this medicine during the first six months of pregnancy unless strictly necessary and under medical supervision.
The use of flurbiprofen during the last three months of pregnancy is contraindicated.
Breastfeeding
This medicine is not recommended during breastfeeding, as breast milk may contain traces of the medicine.
Fertility
Flurbiprofen belongs to a group of medicines that may affect female fertility. This effect is reversible when treatment is stopped. Occasional use of this medicine is unlikely to affect the ability to become pregnant. However, consult your doctor if you have fertility problems before taking this medicine.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
CORYFIN GOLA DOLORE contains:

macrogol glycerol hydroxystearate (polyoxylated hydrogenated castor oil): may cause local skin reactions and gastrointestinal disturbances;
methyl para-hydroxybenzoate and propyl para-hydroxybenzoate: may cause allergic reactions (including delayed reactions).

3. How to use CORYFIN GOLA DOLORE

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
DOSE AND METHOD OF ADMINISTRATION
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Caution: 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 using 10 ml of mouthwash.
The mouthwash may be diluted with water. Do not swallow.
If you are elderly or have previously suffered from stomach ulcer (stomach lesion):
If you are elderly or have previously had 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 the risk of developing stomach or intestinal ulcers, bleeding, or perforation is higher (see section 4 “Possible side effects”).
Use in children and adolescents
Do not give CORYFIN GOLA DOLORE to children under 12 years of age.
Duration of treatment
Use CORYFIN GOLA DOLORE only for short-term treatment, not exceeding 7 days. If no noticeable improvement occurs after a few days (3) of treatment, the cause may be a different medical condition; in this case, consult your doctor.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.
If you use more CORYFIN GOLA DOLORE than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
Some symptoms of overdose may include nausea, vomiting, and gastrointestinal disturbances (gastrointestinal irritation), stomach ache or diarrhoea. Tinnitus, headache, and stomach or intestinal bleeding may also occur. In such cases, the doctor will initiate appropriate treatment.
If you forget to use CORYFIN GOLA DOLORE
Do not take a double dose to make up for a forgotten dose.
If you stop using CORYFIN GOLA DOLORE
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects during treatment with CORYFIN GOLA DOLORE,
STOP the treatment and contact your doctor immediately:

Allergic reactions (hypersensitivity reactions):
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 CORYFIN GOLA DOLORE, 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 you may experience them 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 (reduction in the amount 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 or tingling in limbs or other parts of the body)
drowsiness
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 (a 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)
dyspnea (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 ulcers
nausea
mouth and throat pain
sensation of warmth or burning, tingling in the mouth
abdominal bloating
stomach pain
constipation
dry mouth
indigestion
flatulence (passing gas from the intestine)
inflammation of the tongue
altered taste
vomiting
blood in the stool
blood in vomit
gastrointestinal bleeding
colitis
worsening of inflammatory bowel diseases (Crohn’s disease)
inflammation of the stomach (gastritis)
inflammation of the pancreas (pancreatitis)
peptic ulcer
gastric perforation.

Effects related to the skin and underlying tissue

skin rash
itching
urticaria (red, itchy skin rashes)
purpura (appearance of purple-coloured skin patches of varying 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 (damage to the kidney glomeruli leading to protein loss in urine)
renal failure (reduced kidney function).

General effects and at the site of administration

fever
pain
discomfort, local irritation
fatigue.

Effects related to the liver

hepatitis.

General effects and at the site of administration

fever.

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 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 CORYFIN GOLA DOLORE

This medicine does not require any special storage conditions.
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 "Expiry".
The expiry date refers to the last day of that month.
Do not use this medicine more than 9 weeks after first opening the bottle.
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 CORYFIN GOLA DOLORE contains

The active substance is flurbiprofen. 1 ml contains 2.5 mg of flurbiprofen.
The other components are: glycerol (98 percent), ethanol 96 percent, liquid non-crystallizable sorbitol, macrogol glycerol hydroxystearate, sodium saccharin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, mint flavour, patent blue V dye (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of CORYFIN GOLA DOLORE and the contents of the pack
Carton containing an amber glass bottle holding 160 ml of mouthwash and a measuring cup.
Marketing Authorization Holder
Laboratorio Farmaceutico SIT S.r.l. – Via Cavour, 70 – 27035 Mede (PV)
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)
Patient Information Leaflet

CORYFIN GOLA DOLORE 2.5 mg/ml oral mucosa spray

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If 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 your symptoms worsen after a few days (3) of treatment.

Contents of this leaflet:

What CORYFIN GOLA DOLORE is and what it is used for
What you need to know before using CORYFIN GOLA DOLORE
How to use CORYFIN GOLA DOLORE
Possible side effects
How to store CORYFIN GOLA DOLORE
Package contents and other information

1. What CORYFIN GOLA DOLORE is and what it is used for

2. What you need to know before using CORYFIN GOLA DOLORE

Do not use CORYFIN GOLA DOLORE

if you are allergic to the active substance 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 disorders) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and CORYFIN GOLA DOLORE”);
if you have previously experienced asthma (difficulty breathing) or skin reactions (e.g. urticaria) after taking acetylsalicylic acid or similar medicines (other NSAIDs). You may be hypersensitive or allergic to these medicines;
if you have or have had episodes of gastric ulcer (stomach lesion), perforation or bleeding of the stomach or intestine (two or more distinct episodes of ulcer or bleeding);
if you have previously experienced bleeding or perforation of the stomach or intestine related to prior treatment with non-steroidal anti-inflammatory drugs (NSAIDs);
if you have inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
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 CORYFIN GOLA DOLORE to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using CORYFIN GOLA DOLORE if:

you are in the first six months of pregnancy;
you are breastfeeding.

In particular, inform your doctor if:

you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk of experiencing bronchospasm (narrowing of the bronchi causing severe breathing difficulty 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 have reduced kidney, heart or liver function (kidney, heart or liver failure);
you have hypertension (high blood pressure);
you have been taking other analgesics 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 and intestinal diseases, as this increases the risk of recurrence. This risk is especially increased with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer was complicated by bleeding or perforation of the stomach and intestine (see section 4);
if you are elderly (as you are more likely to experience adverse effects);
if you have heart or blood vessel problems, as medicines such as CORYFIN GOLA DOLORE may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. The risk of adverse effects increases with higher doses and prolonged treatment; do not exceed the recommended dose of CORYFIN GOLA DOLORE or 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).
Report any unusual abdominal symptoms to your doctor.
Prolonged use, especially, of this medicine may cause allergic reactions or local irritation
(see section 4 “Possible side effects”). In such cases, discontinue treatment and
consult your doctor, who will start appropriate therapy if necessary.
Children and adolescents
The use of CORYFIN GOLA DOLORE is contraindicated in children under 12 years of age.
Other medicines and CORYFIN GOLA DOLORE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Inform your doctor if you are taking any of the following medicines:

medicines containing acetylsalicylic acid (medicines for inflammation, pain, fever and heart disorders), as they may increase adverse effects;
antiplatelet agents (medicines that make the blood thinner, such as low-dose daily aspirin), as they increase the risk of stomach and intestinal bleeding;
anticoagulants (medicines that slow down or inhibit blood clotting, such as warfarin), because their effect may be enhanced by NSAIDs;
selective serotonin reuptake inhibitors (medicines used for depression), as they increase the risk of stomach and intestinal bleeding;
antihypertensive medicines (ACE inhibitors, angiotensin II antagonists and diuretics), as NSAIDs may reduce the effect of diuretics or some antihypertensive drugs may increase renal toxicity;
alcohol, as it may increase the risk of adverse effects, especially the risk of stomach and intestinal bleeding;
cardiac glycosides (medicines affecting 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 renal toxicity;
corticosteroids (medicines used for inflammation/allergies), as they increase 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 seizures;
tacrolimus (an immunosuppressant 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 for inflammation and pain), as their effects may be enhanced and the risk of adverse effects increased.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor before taking this medicine.
Pregnancy
Do not use this medicine during the first six months of pregnancy unless strictly necessary and
under medical supervision.
The use of flurbiprofen during the last three months of pregnancy is contraindicated.
Breastfeeding
This medicine is not recommended during breastfeeding because breast milk may contain traces of the medicine.
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 chances of becoming pregnant. However, consult your doctor if you have fertility problems before taking this medicine.
Driving and use of machines
This medicine does not impair the ability to drive or operate machinery.
CORYFIN GOLA DOLORE contains:

macrogol glycerol hydroxystearate (polyoxyl 40 hydrogenated castor oil): may cause local skin reactions and gastrointestinal disturbances;
methyl parahydroxybenzoate and propyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions).

3. How to use CORYFIN GOLA DOLORE

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.
DOSE AND METHOD OF ADMINISTRATION
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
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 daily.
Apply directly to the affected area.
Instructions for use
Rotate the nozzle to the right or left without unscrewing the dispenser.
At first use, press the dispenser several times to achieve a regular spray, since the CORYFIN GOLA DOLORE 2.5 mg/ml oral mucosa spray bottle does not contain propellant gas.
If you are elderly or have previously suffered from stomach ulcer:
If you are elderly or have previously had a peptic ulcer (stomach lesion), it is recommended to use the lowest recommended dose, as the risk of serious consequences from adverse effects is higher. The risk of developing stomach or intestinal ulcers, bleeding, or perforation is also increased (see section 4 “Possible side effects”).
Use in children and adolescents
Do not give CORYFIN GOLA DOLORE to children under 12 years of age.
Duration of treatment
Use CORYFIN GOLA DOLORE only for short-term treatment, not exceeding 7 days. If no significant improvement is observed after a few days (3) of treatment, the cause may be a different medical condition; in this case, consult your doctor.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.
If you use more CORYFIN GOLA DOLORE than you should
In case of accidental ingestion or overdose of CORYFIN GOLA DOLORE, contact your doctor immediately or go to the nearest hospital.
Some symptoms of overdose may include: nausea, vomiting, and gastrointestinal disturbances (gastrointestinal irritation), stomach pain or diarrhea. Tinnitus, headache, and gastrointestinal bleeding may also occur. In such cases, the doctor will initiate appropriate treatment.
If you forget to use CORYFIN GOLA DOLORE
Do not use a double dose to make up for the missed dose.
If you stop using CORYFIN GOLA DOLORE
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects during treatment with CORYFIN GOLA DOLORE,
STOP treatment immediately and contact your doctor immediately:

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, 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 CORYFIN GOLA DOLORE, 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 you may experience them with or without warning symptoms. These side effects are especially 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 (reduction in the amount 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 parts of the body)
somnolence (drowsiness)
cerebrovascular events (diseases caused by impaired 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 (a 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 airways 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
lesions inside the mouth
nausea
pain in the mouth and throat
sensation of heat or burning, tingling in the mouth
bloating
stomach pain
constipation
dry mouth
difficulty digesting
flatulence (passing gas from the intestine)
inflammation of the tongue
altered taste
vomiting
blood in the stool
blood in vomit
bleeding from the stomach and intestine
colitis
worsening of inflammatory bowel diseases (Crohn’s disease)
inflammation of the stomach (gastritis)
inflammation of the pancreas (pancreatitis)
peptic ulcer
gastric perforation.

Effects related to the skin and underlying tissue

skin rashes
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 areas of 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 the urine)
renal failure (reduced kidney function).

General effects and effects at the site of administration

fever
pain
discomfort, local irritation
fatigue.

Effects related to the liver

hepatitis.

General effects and effects at the site of administration

fever.

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, please inform your doctor or pharmacist. You may also report side effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CORYFIN GOLA DOLORE

This medicine does not require any special storage conditions.
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 "Expiry".
The expiry date refers to the last day of that month.
Do not use this medicine more than 21 weeks after first opening the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CORYFIN GOLA DOLORE contains

The active substance is flurbiprofen. 1 ml contains 2.5 mg of flurbiprofen.
The other components are: glycerol (98 percent), ethanol 96 percent, liquid non-crystallizable sorbitol, macrogol glycerol hydroxystearate, sodium saccharin, methyl para-hydroxybenzoate, propyl para-hydroxybenzoate, mint flavor, patent blue V dye (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of CORYFIN GOLA DOLORE and contents of the pack
Carton pack containing an amber-colored glass bottle, externally plastic-coated, containing 15 ml of solution, with micro-dosing pump and dispenser.
Marketing Authorization Holder
Laboratorio Farmaceutico SIT S.r.l., via Cavour 70, 27035 Mede (PV)
Manufacturer
Doppel Farmaceutici S.r.l., via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)