Frobenpret: detailed information

Patient Information Leaflet

FROBENPRET 8.75 mg lemon and honey flavoured tablets

flurbiprofen
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take 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 advice or information, consult your pharmacist.
If you experience any 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 any improvement, or if your symptoms worsen after 3 days.

Contents of this leaflet:

What FROBENPRET is and what it is used for
What you need to know before taking FROBENPRET
How to take FROBENPRET
Possible side effects
How to store FROBENPRET
Contents of the pack and other information

1. What FROBENPRET is and what it is used for

FROBENPRET contains the active substance flurbiprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It acts against inflammation and pain in the throat, mouth and gums.
FROBENPRET is used in adults and adolescents over 12 years of age to relieve symptoms of pain and irritation of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis).
Consult your doctor if you do not feel better or if you feel worse after 3 days (see section 3).

2. What you should know before taking FROBENPRET

Do not take FROBENPRET

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 aspirin (acetylsalicylic acid) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and FROBENPRET”);
if you have previously experienced allergic reactions such as asthma and/or skin rash, wheezing after taking this medicine or other medicines belonging to the category of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid);
if you have previously had bleeding due to stomach or intestinal injuries or perforations related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
if you currently have or have previously had intestinal inflammation characterized by lesions (ulcerative colitis), including chronic forms (Crohn's disease);
if you currently have or have previously had two or more episodes of stomach or intestinal injuries or bleeding (recurrent peptic ulcer or gastrointestinal haemorrhage);
if you suffer from severe heart, kidney or liver problems (reduced cardiac, renal or hepatic function);

Do not take FROBENPRET if you are in the last 3 months of pregnancy (see "Pregnancy and
breastfeeding").
Do not give this medicine to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking FROBENPRET.
In particular, inform your doctor if you:

suffer from heart, kidney or liver problems (heart, kidney or liver failure);
suffer from high blood pressure;
have had asthma problems (bronchial asthma), as this increases the risk of developing bronchospasm (narrowing of the airways causing severe breathing difficulties due to reduced airflow);
have previously suffered from allergies;
suffer from systemic lupus erythematosus (SLE, commonly known as lupus) or mixed connective tissue disease, conditions affecting connective tissue causing joint or muscle pain, skin changes and problems in other organs;
have previously suffered from stomach or intestinal injuries (peptic ulcer) or other stomach and intestinal diseases, as this increases the risk of recurrence of these conditions. This risk is particularly increased with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer was complicated by bleeding or perforation of the stomach or intestine (see section 4 “Possible side effects”);
are already taking other non-steroidal anti-inflammatory drugs (NSAIDs) (see “Other medicines and FROBENPRET”) and other medicines that increase the risk of gastrointestinal bleeding;
have been taking other painkillers for a long time or without following the prescribed dosage, as this may cause headache (cephalalgia);
are planning a pregnancy or undergoing fertility investigations;
you are elderly (as you are more likely to experience side effects, particularly gastrointestinal bleeding and perforation, which can be life-threatening);
have heart or blood vessel problems, as medicines such as FROBENPRET may be associated with a modestly 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 FROBENPRET or 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, high cholesterol or smoke);
have an infection – refer to the section “Infections” below.

Your doctor will assess whether it is necessary to prescribe protective agents such as misoprostol or proton pump inhibitors to reduce the risk of gastrointestinal side effects.
During treatment with FROBENPRET, inform your doctor of any unusual abdominal symptoms.
Additionally, inform your doctor if signs of a bacterial infection appear or worsen.
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 may recommend appropriate therapy.
If you experience mouth irritation, stop treatment.
Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain. This may delay appropriate treatment of the infection, thereby increasing the risk of complications. If you take this medicine during an infection and infection symptoms persist or worsen, contact your doctor or pharmacist immediately.
Children and adolescents
This medicine must not be given to children under 12 years of age (see “Do not take FROBENPRET”).
Other medicines and FROBENPRET
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, if you are taking:

aspirin and medicines containing acetylsalicylic acid;
antiplatelet agents (used to make the blood less sticky), as FROBENPRET could increase the risk of gastrointestinal bleeding;
anticoagulants (such as warfarin), as FROBENPRET could increase the risk of bleeding;
selective serotonin reuptake inhibitors (medicines used to treat depression);
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;
cardiac glycosides (used to help heart function);
cyclosporine and tacrolimus (used after organ transplants);
corticosteroids (medicines used for inflammation/allergies);
lithium (a medicine used for behavioural disorders);
methotrexate (used for psoriasis, arthritis and cancer);
mifepristone (used for termination of pregnancy): anti-inflammatory medicines such as flurbiprofen must not be used within 8–12 days after taking mifepristone;
quinolone antibiotics (used for bacterial infections);
zidovudine (used for HIV);
Cox-2 inhibitors and other NSAIDs (medicines used for inflammation and pain).

The side effects of FROBENPRET, especially those affecting the gastrointestinal tract, may be increased when taken together with certain medicines.
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.
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the newborn. It is not known whether the same risk applies to FROBENPRET.
Pregnancy
Do not take FROBENPRET during the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause serious problems to the heart, lungs and kidneys of the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour more than expected.
Do not take FROBENPRET during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible time should be used. From week 20 of pregnancy, if FROBENPRET is taken for more than a few days, it may cause kidney problems in the fetus, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.
Breastfeeding
Avoid using FROBENPRET during breastfeeding.
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary and advised by your doctor.
Fertility
If you are planning to become pregnant or have fertility problems, consult your doctor, as this medicine may affect female fertility.
Driving and using machines
This medicine may cause drowsiness, visual disturbances, dizziness and fatigue. Make sure you do not experience these side effects before driving or operating machinery.
FROBENPRET contains glucose, sucrose and flavourings containing allergens
This medicine contains glucose and sucrose, two types of sugars.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains a flavouring which itself contains d-limonene and citral.
D-limonene and citral may cause allergic reactions.

3. How to take FROBENPRET

Take 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.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The recommended dose is: 1 tablet every 3–6 hours, as needed. Do not exceed a dose of 8 tablets in 24 hours. Use this medicine for a maximum of 3 days.
The lowest effective dose for the shortest time needed to relieve symptoms should be used. If you have an infection, consult your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2).
Allow the tablet to dissolve slowly in the mouth. As with all lozenges, in order to avoid local irritation, flurbiprofen-containing lozenges should be moved around within the mouth during administration. If mouth irritation occurs, treatment should be discontinued.
Use in children and adolescents
Do not administer to children under 12 years of age.
Use in the elderly: the lowest recommended dose is advised, as there is an increased risk of serious consequences in case of adverse effects.
Caution: Do not exceed the recommended doses without medical advice. Use this medicine for a maximum of three days. If no significant improvement is observed after 3 days of treatment, the cause may be a different pathological condition; therefore, consult your doctor.
You should use the lowest dose necessary for the shortest possible time to relieve symptoms, in order to reduce the risk of adverse effects.
Consult your doctor or pharmacist if you do not notice any improvement, if your condition worsens, or if you develop new symptoms.
If you take more FROBENPRET than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
If a large amount of flurbiprofen is accidentally ingested, symptoms such as nausea, vomiting, stomach and intestinal disturbances (gastrointestinal irritation), stomach pain, or rarely diarrhea may occur. Tinnitus, headache, and gastrointestinal bleeding may also occur. In such cases, the doctor will initiate appropriate treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you forget to take FROBENPRET
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects during treatment with FROBENPRET,
STOP treatment immediately and contact your doctor without delay:

allergic reactions (hypersensitivity reactions): allergic reaction, anaphylactic reactions (severe allergic reactions), sudden swelling of the mouth/throat and mucous membranes (angioedema)
local irritation
sensations of warmth or tingling in the mouth and throat
asthma, bronchospasm, breathlessness or shortness of breath
various skin disorders: skin rashes, itching, redness, swelling, skin loss, blisters, peeling or tearing of the skin and mucous membranes.

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

abdominal pain
stomach damage (peptic ulcer)
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.

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

anaemia, haemolytic anaemia (reduction in the number of red blood cells in the blood)
neutropenia (reduction in certain white blood cells in the blood)
thrombocytopenia (reduction in the number of platelets in the blood)
leucopenia (reduction in the number of white blood cells 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 immune system
anaphylactic reactions (severe allergic reaction), hypersensitivity. Effects related to metabolism
fluid retention. Effects related to psychiatric disorders
insomnia, depression, hallucination, confusion. Effects related to the nervous system
dizziness, headache, migraine (chronic condition characterized by recurrent headaches)
paraesthesia (numbness or tingling in limbs or other body parts)
somnolence
cerebrovascular events (diseases caused by inadequate blood flow to an area of the brain)
optic neuritis (severe inflammation of the optic nerve, which may lead to vision loss up to blindness)
confusion, dizziness
aseptic meningitis (especially in patients with pre-existing autoimmune disorders such as Systemic Lupus Erythematosus and connective tissue disorders), with symptoms such as stiff neck, headache, nausea, vomiting, fever, or disorientation. Effects related to the eye: visual disturbances. Effects related to the ear and labyrinth: tinnitus (ringing in the ears), vertigo. Effects related to the cardiovascular system
heart failure
swelling
hypertension (high blood pressure). Effects related to the bronchi and lungs
throat irritation
asthma, dyspnoea (shortness of breath)
bronchospasm (narrowing of the bronchi causing severe breathing difficulty due to reduced airflow). Effects related to the mouth, stomach, and intestine
diarrhoea, constipation, nausea, vomiting
lesions inside the mouth, blisters in the mouth or throat, pain in the mouth and throat, numbness of the mouth or throat
sensation of heat or burning, tingling in the mouth, dry mouth
abdominal distension, abdominal pain
difficulty digesting
flatulence (passing gas from the intestine)
inflammation of the tongue, altered taste
blood in the stools, blood in vomit
colitis
worsening of inflammatory bowel diseases (Crohn's disease)
gastritis (inflammation of the stomach)
gastric ulcer, duodenal ulcer (bleeding from the stomach and intestine), gastrointestinal perforation
pancreatitis (inflammation of the pancreas). Effects related to the liver: altered liver function, hepatitis (inflammation of the liver), jaundice, cholestatic jaundice. Effects related to the skin and underlying tissue
skin rashes, itching, urticaria (red, itchy skin patches)
purpura (appearance of purple-coloured skin spots of varying sizes)
angioedema (inflammatory skin reaction)
severe skin lesions (bullous dermatoses characterized by erythema, blistering lesions with areas of skin detachment, including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and erythema multiforme)
increased sensitivity to light (photosensitisation). Effects related to the kidneys and urinary tract
kidney toxicity
tubulo-interstitial nephritis (inflammation of the kidneys)
nephrotic syndrome (alteration of the kidney glomeruli leading to protein loss in urine)
renal failure, including acute (reduced kidney function)
glomerulonephritis (inflammation of the kidney). General effects and effects at the site of administration
fever, pain, discomfort, fatigue, malaise, oedema. Effects on laboratory tests
changes in liver function test results
prolonged bleeding time.

The use of this medicine, especially if prolonged, may lead to hypersensitivity reactions or local irritation, including sensations of warmth or tingling in the oropharynx.
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 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 FROBENPRET

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
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 FROBENPRET contains

The active substance is: flurbiprofen. One tablet contains 8.75 mg of flurbiprofen.
The other components are: sucrose, glucose, macrogol, potassium hydroxide, lemon flavour, levomenthol, honey.

Description of the appearance of FROBENPRET and package contents
FROBENPRET is presented as tablets contained in blisters.
Pack sizes: 16 or 24 tablets.
Marketing Authorisation Holder and Manufacturer
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)
Manufacturer
LOZY'S PHARMACEUTICALS S.L., Campus empresarial, 1 - 31795 Lekaroz – Spain
Industria Farmaceutica NOVA ARGENTIA S.r.l.
Via G. Pascoli, 1
20064 Gorgonzola (MI)