DOLAUT 0.25 % Mouthwash

Зміст інструкції

1. DOLAUT GOLA 0,25% spray per mucosa orale
   1. What is Dolaut gola and what is it used for
   2. What you need to know before using Dolaut gola
   3. How to use Dolaut gola
   4. Possible side effects
   5. How to store Dolaut gola
   6. Contents of the pack and other information
2. DOLAUT GOLA 0,25% mouthwash
   1. What is Dolaut gola and what is it for
   2. What you need to know before using Dolaut gola
   3. How to use Dolaut gola
   4. Possible side effects
   5. How to store Dolaut gola
   6. Contents of the pack and other information

DOLAUT 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.

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

Contents of this leaflet:

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

1. What is Dolaut gola and what is it used for

Dolaut gola contains flurbiprofen which is a medicine against inflammation, used for
conditions of the oral cavity.
Dolaut gola is used for the treatment of symptoms of irritation and inflammation, also associated with pain
of the mouth and throat (for example gingivitis, stomatitis, pharyngitis), even as a result of dental therapies
(conservative or extractions).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Dolaut gola

Do not use Dolaut gola

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• if you have had asthma, urticaria or any other allergic reaction after taking acetylsalicylic acid, known as aspirin, or other NSAIDs;
• if you have a peptic ulcer (ulcer in the stomach or duodenum) or Crohn's disease, suffer from or have suffered from ulcerative colitis, have had two or more episodes of stomach or intestinal ulcer or bleeding, have had even one episode of bleeding or perforation of the stomach and/or intestine due to NSAIDs;
• if you have serious problems with your heart, kidneys or liver;
• in the last three months of pregnancy.

Warnings and precautions
Consult your doctor before taking DOLAUT GOLA if:

• you are elderly, as you are more likely to develop adverse reactions to this medicine;

medicine;

• you are pregnant or intend to become pregnant, or are breastfeeding;
• you have liver or kidney problems;
• you have heart or blood vessel problems, as medicines like DOLAUT GOLA may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. The risk of experiencing undesirable effects increases with high doses and prolonged treatments; do not exceed the dose of DOLAUT GOLA and do not take 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 or high cholesterol or smoke);
• you have had a peptic ulcer (ulcer in the stomach or duodenum) or other diseases of the stomach or intestine;
• you have asthma;
• you suffer from systemic lupus erythematosus (SLE, known as lupus) or mixed connective tissue disease, diseases that affect connective tissue causing joint or muscle pain, skin changes and problems with other organs.
• you are in a state of dehydration as you are more likely to have kidney problems.

PAY ATTENTION, as during treatment with all pain and inflammation medications (NSAIDs):

• at any time, with or without warning symptoms, even in patients without a history of serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be fatal.
• even if very rarely, serious skin reactions have been reported, some of which have been fatal, which manifest with redness, blistering and exfoliation (for example, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). In the early stages of therapy, patients appear to be at higher risk: such reactions occur in most cases within the first month of treatment.

STOP treatment and contact your doctor if:

• you notice any symptoms affecting the stomach and intestines (gastrointestinal), especially if it is bleeding;
• a skin rash, mucosal lesions or any other sign of an allergic reaction appears (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure).

The effects reported above have been reported particularly after the administration of
formulations based on Flurbiprofen for systemic use.
DOLAUT GOLA contains the blue patent V(E131) dye which may cause allergic reactions.

Other medicines and Dolaut gola
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine, as some medicines may interact with DOLAUT GOLA or
increase the risk of adverse events, even serious.
In particular, contact your doctor if you are taking:

• diuretics (medicines that increase urine production, e.g. furosemide and spironolactone);
• cardiac glycosides (medicines used for heart disease, such as digoxin);
• ACE inhibitors (e.g. captopril) or angiotensin II antagonists (e.g. losartan), medicines used for high blood pressure (hypertension);
• anticoagulant drugs (e.g. warfarin), used to prevent blood from clotting;
• antiplatelet drugs, used to thin the blood;
• lithium, used in depression;
• zidovudine, a drug against viruses;
• methotrexate, used to treat some cancers and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cyclosporine and tacrolimus, immunosuppressant drugs used to reduce your immune response;
• medicines known as corticosteroids, used in the treatment of inflammatory diseases (e.g. prednisone, dexamethasone, hydrocortisone);
• antidepressant drugs called ‘selective serotonin reuptake inhibitors (SSRIs)’ (e.g. paroxetine, fluoxetine);
• antibiotics called quinolones (e.g. ciprofloxacin);
• mifepristone, a drug used for abortion (taken now or in the last 12 days);
• any other medicine used against inflammation (NSAIDs), including acetylsalicylic acid, known as aspirin, and drugs belonging to the class of COX-2 inhibitors (e.g. celecoxib).

The interactions reported above have been reported particularly after the administration of
formulations based on Flurbiprofen for systemic use.
At the recommended doses, interactions with other medicines or of another kind have not been reported.

Pregnancy, breastfeeding and fertility
If you want to become pregnant or have problems conceiving, consult your doctor, as
this medicine may impair fertility.
Avoid using DOLAUT GOLA during the first or second trimester of pregnancy, unless specifically
indicated by your doctor;
Do not use DOLAUT GOLA in the last three months of pregnancy.
Avoid using DOLAUT GOLA during breastfeeding

Driving and operating machinery
DOLAUT GOLA may cause drowsiness, visual disturbances, dizziness, fatigue and vertigo. Make sure
you do not suffer from these undesirable effects before driving vehicles or using
machinery.

Dolaut contains

• blue patent V(E131) dye which may cause allergic reactions;
• ethanol. This medicine contains small amounts of ethanol (alcohol) less than 100 mg per dose.

For those who play sports: the use of medicines containing ethyl alcohol may result in
positive doping tests in relation to the concentration limits of alcohol indicated by some
sports federations.

3. How to use Dolaut gola

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2 sprays 3 times a day. Direct the spray onto the affected area.
For the first use of Dolaut gola oral mucosa spray, gently rotate the nozzle to the right or left and then press the dispenser several times until a regular spray is obtained.
Do not exceed the indicated doses.
Use the medicine as needed, at any time of the day.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics.
Use only for short periods of treatment.

If you use more Dolaut gola than you should
In case of accidental ingestion of an excessive dose of DOLAUT GOLA, immediately inform your doctor or go to the nearest hospital. Remember to bring your package of DOLAUT GOLA with you. If you forget to use Dolaut gola
Do not use a double dose to compensate for a missed dose.

If you stop treatment with Dolaut gola
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

Use in children and adolescents:
No data are available in this regard and therefore the use of DOLAUT GOLA in the pediatric population is not recommended

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. In particular, some side effects that occur with other medicines containing flurbiprofene, taken orally or topically (for example tablets or patches), or with other anti-inflammatory drugs (NSAIDs), may also occur during treatment with
DOLAUT GOLA.

Stop taking DOLAUT GOLA immediately and contact your doctor if any of the following conditions occur:

• severe burning or abdominal pain, due to stomach or duodenal ulcer (peptic). These side effects are uncommon;
• sudden and severe pain in the epigastrium (ulcer perforation). This side effect is uncommon;
• vomiting containing blood (hematemesis) or black stools (melena), associated with bleeding from the stomach or intestines, abnormal fatigue with reduced urine output (due to non-visible bleeding). These side effects are common;
• severe allergic reactions such as swelling (angioedema) of the face, eyes, lips, throat with breathing problems (these side effects are uncommon), with a sudden drop in blood pressure (anaphylactic reaction) (these side effects are rare);
• severe skin rashes with redness, exfoliation and/or blistering (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). These side effects are very rare;
• breathing problems, even severe such as asthma, and dyspnea (these side effects are uncommon) or bronchospasm (this side effect is uncommon);
• inflammation of the pancreas (pancreatitis). This side effect is very rare;
• swelling of the face, hands, legs (edema), decrease in urine output or difficulty urinating (fluid retention). These side effects are common;
• fatigue, shortness of breath and leg swelling, symptoms of heart failure; high blood pressure. These side effects are uncommon;
• blood clots in the arteries (causing e.g. heart attack or stroke), diseases of the brain vessels (cerebrovascular accidents). The frequency of these side effects is not known.

Common side effects(may affect up to 1 in 10 people)

• nausea, vomiting, diarrhea, flatulence, difficulty defecating (constipation), indigestion, abdominal pain;
• changes in tests that assess liver function, increased bleeding time;
• dizziness, headache, fatigue, malaise.

Uncommon side effects(may affect up to 1 in 100 people)

• decrease in red blood cells (anemia);
• gastritis, mouth ulcers
• more or less sudden appearance of skin lesions, for example color changes in patches or widespread (rash, purpura) even following exposure to the sun (photosensitivity reactions), urticaria, itching;
• ringing, whistling, ringing, hissing or other persistent sounds in the ears;
• visual disturbances, altered sensitivity, vertigo.

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

• depression, confusion, drowsiness, difficulty falling asleep (insomnia);
• kidney problems (nephrotoxicity) such as nephrotic syndrome, kidney inflammation (tubulointerstitial nephritis), altered function (renal insufficiency).

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

• alteration of blood parameters: decrease in platelets (thrombocytopenia), reduction of white blood cells (leukopenia) or neutrophils (neutropenia), severe reduction of granulocytes (agranulocytosis), decrease in red blood cells due to bone marrow problems (aplastic anemia), destruction of red blood cells with a consequent reduction in their number (hemolytic anemia);
• yellowing of the eyes or skin (jaundice, cholestatic jaundice), dark urine, pale stools, itching or abdominal pain, possible signs of liver problems;
• hallucinations.

Side effects with unknown frequency(frequency cannot be estimated based on available data)

• inflammation of the colon and Crohn's disease;
• problems with vision due to inflammation of the optic nerve (optic neuritis);
• kidney inflammation (glomerulonephritis).

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 “www.agenziafarmaco.gov.it/it/responsabili”.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dolaut gola

This medicine does not require any particular storage conditions.
After first opening, store at a temperature not exceeding 25°C and for no more than 30 days.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after “expiry”. 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 Dolaut gola contains

• The active ingredient is flurbiprofen. 100 ml of oral mucosa spray contains 250 mg of flurbiprofen.
• The other ingredients are: propylene glycol, ethanol (96%), chlorhexidine digluconate solution, hydrogenated castor oil-40-polyoxyethylene, sodium hydroxide, sodium saccharin, mint aroma, Patent Blue V (E 131), Quinoline Yellow (E 104), purified water.

Description of the appearance of Dolaut gola and contents of the pack
Dolaut gola is presented in the form of an oral mucosa spray.
The pack contains a 15 ml dark glass bottle.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.P.A. Via San Giuseppe Cottolengo, 15, 20143 - MILANO (MI)

Manufacturer
Francia Farmaceutici – Industria Farmaco Biologica Srl
Via dei Pestagalli, 7 - 20138 Milano

DOLAUT 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 a short period of treatment.

Contents of this leaflet:

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

1. What is Dolaut gola and what is it for

Dolaut gola contains flurbiprofen which is a medicine against inflammation, used for
conditions of the oral cavity.
Dolaut gola is used for the treatment of symptoms of irritation and inflammation, also associated with pain
of the mouth and throat (for example gingivitis, stomatitis, pharyngitis), even as a result of dental therapies
(conservative or extraction).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Dolaut gola

Do not use Dolaut gola

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), especially when the allergy is associated with asthma or urticaria,
• if you are in the third trimester of pregnancy (See "Pregnancy and breastfeeding"),
• if you have or have had in the past a lesion of the stomach or intestine (peptic ulcer).
• if you are breastfeeding

Warnings and precautions
Consult your doctor or pharmacist before using Dolaut gola.

• At the recommended doses, accidental swallowing of Dolaut gola does not cause any harm as the amount ingested is well below that of a single dose of the medicine taken systemically (e.g. by mouth).
• If you use Dolaut gola mouthwash, especially for a prolonged period, you may experience sensitization or local irritation; in such cases, discontinue treatment and consult your doctor for, if necessary, appropriate therapy.
• If you do not obtain appreciable results after a short period of treatment, consult your doctor.
• If you suffer from kidney, heart or liver failure, use the medicine with caution.
• Do not combine Dolaut gola with other non-steroidal anti-inflammatory drugs (NSAIDs).

Other medicines and Dolaut gola
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
No interactions of Dolaut gola with other medicines are known at the recommended doses. Flurbiprofen may
occasionally affect the activity of the following medicines:

• furosemide (a medicine that increases urine production), as flurbiprofen may reduce its activity;
• anticoagulant medicines (that thin the blood), as flurbiprofen may interfere with their activity.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
During pregnancy, Dolaut gola should only be used after consulting your doctor and evaluating with
him the risk/benefit ratio in your case.
The medicine administered during pregnancy may delay the onset of labour and increase its
duration.
Dolaut gola should not be used in the third trimester of pregnancy.

Breastfeeding
The use of Dolaut gola during breastfeeding is not recommended.

Driving and operating machinery
Dolaut gola does not interfere with the ability to drive vehicles and operate machinery.

Dolaut contains ethyl alcohol
This medicine contains 816.8 mg of alcohol (ethanol 96%) in 10 ml (1 measuring spoon). It may cause
a burning sensation on damaged skin.

Dolaut gola contains propylene glycol
This medicine contains 2000 mg of propylene glycol in 10 ml (1 measuring spoon). It may cause irritation
of the skin.

Dolaut gola containshydrogenated castor oil-40-polyoxyethylene
It may cause localized skin reactions.

3. How to use Dolaut gola

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2-3 rinses or gargles per day with 10 ml (1 measuring cup) of mouthwash. You may
dilute the mouthwash in water.
Pour 10 ml of solution into the dosing cup and use it undiluted, as a gargle, or diluted, in half a glass of water, as a mouth rinse.
Do not exceed the indicated doses.
Use the medicine as needed, at any time of the day.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change
in its characteristics.
Use only for short periods of treatment.

If you use more Dolaut gola than you should
Use Dolaut gola mouthwash only for rinses or gargles; small accidental ingestions of the medicine
do not cause problems.
In case of ingestion / accidental intake of an excessive dose of Dolaut gola, immediately notify
your doctor or go to the nearest hospital. Overdose symptoms may
include nausea, vomiting, and irritation of the stomach and intestines (gastrointestinal).

If you forget to use Dolaut gola
Do not use a double dose to make up for a missed dose.

If you stop using Dolaut 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.
Use of the medicine, especially if prolonged, may give rise to sensitization or local irritation; in such cases discontinue treatment and your doctor, if necessary, will prescribe you suitable therapy.
Following the instructions contained in the package leaflet reduces the risk of side effects.
The following side effects have been reported, particularly after administration of systemic formulations e.g.
oral (by mouth):

• alteration of blood cells (thrombocytopenia, aplastic anemia and agranulocytosis)
• allergic reactions, including severe ones (anaphylaxis, angioedema, allergic reaction)
• dizziness
• damage to blood vessels in the brain (cerebrovascular accidents)
• visual disturbances, inflammation of the optic nerves (optic neuritis)
• migraine
• alteration of the sensitivity of the limbs and other parts of the body (paresthesia)
• depression, confusion, hallucination
• vertigo
• malaise
• fatigue and drowsiness
• ringing in the ears (tinnitus)
• difficulty breathing due to inflammation (asthma, bronchospasm and dyspnea)
• nausea, vomiting, diarrhea, passage of gas from the anus (flatulence), constipation, difficulty digesting (dyspepsia), abdominal pain, blood in the stool (melena), vomiting blood (hematemesis), inflammation of the mouth with lesions that are difficult to heal (stomatitis

ulcerative), bleeding from the stomach and intestines and worsening of inflammation
of a part of the intestine called the colon (exacerbation of colitis) and a disease called
Crohn's disease

• inflammation of the stomach (gastritis), lesions, perforations and bleeding from the stomach and intestines (peptic ulcer, perforation and ulcer bleeding)
• skin disorders (rash, itching, urticaria, purpura and very rarely blistering dermatoses, including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme)
• kidney damage (including interstitial nephritis and nephrotic syndrome and rare cases of renal failure as observed with other non-steroidal anti-inflammatory drugs - NSAIDs).

Reporting of side effects
If you get any side effects, even if 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 Dolaut gola

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the label after “expiry”. 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 Dolaut gola contains

• The active ingredient is flurbiprofen. 100 ml of mouthwash contains 250 mg of flurbiprofen.
• The other ingredients are: propylene glycol, ethanol (96%), chlorhexidine digluconate solution, hydrogenated castor oil-40-polyoxyethylene, sodium hydroxide, sodium saccharin, mint aroma, Patent Blue V (E 131), Quinoline Yellow (E 104), purified water.

Description of the appearance of Dolaut gola and contents of the pack
Dolaut gola is presented in the form of a mouthwash.
The pack contains a dark glass bottle equipped with a measuring cup containing 150 ml of
solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A. Via San Giuseppe Cottolengo, 15 – 20143 Milano

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