Flurbiprofen Doc Generici: detailed information

Patient Information Leaflet

FLURBIPROFENE DOC 0.25% mouthwash, oral mucosa spray

Generic medicine
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.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after short periods of treatment.

Contents of this leaflet:

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

1. What FLURBIPROFENE DOC is and what it is used for

FLURBIPROFENE DOC contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine that acts against inflammation and pain in the throat, mouth and gums.
FLURBIPROFENE DOC 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 should know before using FLURBIPROFENE DOC

Do not use FLURBIPROFENE DOC

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 disorders) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and FLURBIPROFENE DOC”);
if you have previously experienced gastrointestinal bleeding or perforation related to prior treatment 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 ulcer) 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).
Do not use FLURBIPROFENE DOC during the last 3 months of pregnancy (see section “Pregnancy and breastfeeding”).

Do not give FLURBIPROFENE DOC to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using FLURBIPROFENE DOC.
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 had allergic reactions;
you are taking other non-steroidal anti-inflammatory drugs (NSAIDs);
you suffer from systemic lupus erythematosus or mixed connective tissue disease;
you suffer from impaired 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 ulcer) or other stomach or intestinal diseases, as this increases the risk of recurrence. This risk is particularly increased 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 such as FLURBIPROFENE DOC 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 FLURBIPROFENE DOC 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). Report any unusual abdominal symptoms to your doctor. 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, discontinue treatment.

Children and adolescents
Do not give FLURBIPROFENE DOC to children under 12 years of age.
Other medicines and FLURBIPROFENE DOC
Inform your doctor or pharmacist if you are currently 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 used for inflammation, pain, fever and heart disorders), 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 drugs 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 renal toxicity;
corticosteroids (medicines used for inflammation/allergies), as they increase the risk of stomach and intestinal ulcers 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 effects may be enhanced and the risk of side effects increased.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use FLURBIPROFENE DOC during the first six months of pregnancy, unless strictly necessary.
The use of flurbiprofen during the last 3 months of pregnancy is contraindicated.
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 treatment is stopped. 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 using machines
This medicine does not impair the ability to drive or operate machinery.
FLURBIPROFENE DOC mouthwash and oral spray contain parahydroxybenzoates, polyoxyl 40 hydrogenated castor oil, ethanol (alcohol), and patent blue dye
These medicines contain parahydroxybenzoates which may cause allergic reactions (including delayed reactions).
These medicines contain polyoxyl 40 hydrogenated castor oil which may cause local skin reactions.
These medicines contain small amounts of ethanol (alcohol), less than 100 mg per dose.
These medicines contain patent blue V (E131), which may cause allergic reactions.

3. How to use FLURBIPROFENE DOC

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
HOW MUCH AND HOW TO USE
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Warning: Do not exceed the recommended doses without consulting your doctor.
Adults and adolescents over 12 years of age

Mouthwash: The recommended dose is two or three rinses or gargles per day (hold in the mouth for up to 1 minute). You may use the undiluted mouthwash (without diluting with water), using 10 ml (1 measuring cup) of solution, or diluted by adding 10 ml (1 measuring cup) of mouthwash to half a glass of water.
Oral mucosa spray: The recommended dose is 2 sprays, 3 times daily. Direct the spray solution onto the affected area (mouth and throat). Accidental ingestion at the recommended doses is not harmful, although ingestion of the product should be avoided.

If you are elderly or have previously suffered from ulcers (stomach lesions)
If you are elderly or have previously had a peptic ulcer (stomach lesion), it is advisable to use the lowest recommended dose, as there is an increased risk of serious consequences from 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 FLURBIPROFENE DOC to children under 12 years of age.
Duration of treatment
Use FLURBIPROFENE DOC only for short-term treatment, not exceeding 7 days.
If no significant improvement is observed after 3 days of treatment, the underlying cause may be a different pathological condition; consult your doctor.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.
Instructions for use of FLURBIPROFENE DOC 0.25% Oral Mucosa Spray: 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 FLURBIPROFENE DOC than you should
If you accidentally ingest/overdose on FLURBIPROFENE DOC 0.25% mouthwash or FLURBIPROFENE DOC 0.25% oral mucosa spray, contact your doctor immediately or go to the nearest hospital.
In case of accidental ingestion of large amounts of flurbiprofen, you may experience symptoms such as: nausea, vomiting,
irritation of the stomach or intestine, stomach pain, or rarely diarrhea.
Tinnitus, headache, and gastrointestinal bleeding may also occur. In such cases, the doctor will initiate appropriate treatment.
If you forget to use FLURBIPROFENE DOC
Do not take a double dose to make up for a missed dose.
If you stop using FLURBIPROFENE DOC
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following side effects during treatment with FLURBIPROFENE DOC, STOP treatment immediately 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, 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 the following side effects at the beginning of treatment with FLURBIPROFENE, 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 (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
paraesthesia (numbness of limbs or other parts of the body)
somnolence (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 reactions)
angioedema (inflammatory skin reaction)
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 lesions
nausea
pain in the mouth and throat
abdominal bloating
abdominal pain
constipation
dry mouth
indigestion
flatulence (passing gas from the intestine)
inflammation of the tongue
altered taste
vomiting
blood in the faeces
blood in vomit
bleeding from the stomach and intestine
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

skin rash
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 (damage to the kidney glomeruli causing protein loss in the 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
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 FLURBIPROFENE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package.
The expiry date refers to the last day of that month and applies to the medicine stored correctly.
FLURBIPROFENE DOC 0.25% mouthwash
After opening the bottle, use within 9 weeks.
FLURBIPROFENE DOC 0.25% oral mucosa spray
After opening, 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 FLURBIPROFENE DOC contains
FLURBIPROFENE DOC 0.25% mouthwash

The active substance is flurbiprofen. 100 ml of solution contain 0.25 g of flurbiprofen.
The other components are: glycerol (98%), ethanol, liquid non-crystallizable sorbitol, polyoxyl 40 hydrogenated castor oil, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, peppermint flavour, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

FLURBIPROFENE DOC 0.25% oral mucosal spray

The active substance is flurbiprofen. 100 ml of solution contain 0.25 g of flurbiprofen.
The other components are: glycerol (98%), ethanol, liquid non-crystallizable sorbitol, polyoxyl 40 hydrogenated castor oil, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, peppermint flavour, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of FLURBIPROFENE DOC and contents of the pack
FLURBIPROFENE DOC 0.25% mouthwash
Pack containing a bottle with measuring cup and safety cap, 160 ml.
FLURBIPROFENE DOC 0.25% oral mucosal spray
Pack containing a bottle with dosing pump and spray applicator, 15 ml.

Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC) – Italy