Package leaflet: Information for the user

Flurbiprofene EG STADA 8.75 mg tablets

Read this entire leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse 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, pharmacist or nurse. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet

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

1. What Flurbiprofene EG STADA is and what it is used for

Flurbiprofene EG STADA contains flurbiprofene. Flurbiprofene belongs to a class of medicines known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which have analgesic, antipyretic and anti-inflammatory properties.
Flurbiprofene EG STADA is used for the short-term local relief of sore throat symptoms, such as irritation, pain and swelling of the throat, and difficulty swallowing, in adults and adolescents over 12 years of age.
Consult a doctor if you do not feel better or feel worse after 3 days.

2. What you need to know before taking Flurbiprofene EG STADA

Do NOT take Flurbiprofene EG STADA if:

you are allergic to flurbiprofen or to any of the other ingredients of this medicine (listed in section 6);
you have ever experienced unexpected asthma, wheezing or breathlessness, runny nose, facial swelling or hives after taking acetylsalicylic acid or other NSAIDs;
you have or have had two or more episodes of gastric or intestinal ulcer or gastrointestinal bleeding;
you have a history of gastrointestinal bleeding or perforation, severe colitis (inflammation of the intestine), or coagulation disorders following the use of NSAIDs;
you are in the last trimester of pregnancy;
you suffer from severe heart, kidney or liver failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking Flurbiprofene EG STADA if:

you have or have had asthma or suffer from allergies;
you have tonsillitis (inflamed tonsils) or suspect you have a bacterial throat infection (an antibiotic may be needed);
you have an infection – see the section “Infections” below;
you have a heart, kidney or liver problem;
you have had a stroke;
you have a history of intestinal diseases (e.g. ulcerative colitis, Crohn’s disease);
you suffer from a chronic autoimmune disease (e.g. systemic lupus erythematosus or mixed connective tissue disease);
you are elderly, as you are more likely to experience the side effects listed in this leaflet;
you are in the first 6 months of pregnancy or are breastfeeding;
you have high blood pressure;
you suffer from analgesic rebound headache;
you are already taking other non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids or acetylsalicylic acid – see “Other medicines and Flurbiprofene EG STADA” below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask symptoms of infection, such as fever and pain, thereby delaying appropriate treatment and increasing the risk of complications. If you are taking this medicine while having an ongoing infection and symptoms of infection persist or worsen, contact a doctor or pharmacist immediately.
While using Flurbiprofene EG STADA

If you develop any skin reaction (rash, peeling, blisters) or signs of an allergic reaction, stop using this medicine and contact your doctor immediately.
Inform your doctor of any unusual abdominal symptoms (especially bleeding).
If symptoms do not improve, worsen or new symptoms appear, consult your doctor.
The use of medicines containing flurbiprofen may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. The risk is higher with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (3 days).

Children
This medicine must not be used in children under 12 years of age.
Other medicines and Flurbiprofene EG STADA
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. In particular, inform them if you are taking:

low-dose acetylsalicylic acid (up to 75 mg/day);
medicines for the treatment of high blood pressure or heart failure (antihypertensives, cardiac glycosides);
tablets that promote diuresis (diuretics, including potassium-sparing agents);
medicines to thin the blood (anticoagulants, antiplatelets);
medicines for the treatment of gout (probenecid, sulfinpyrazone);
other NSAIDs, including selective cyclooxygenase-2 inhibitors or corticosteroids (e.g. celecoxib, ibuprofen, sodium diclofenac, or prednisolone);
mifepristone (a medicine used to terminate pregnancy);
quinolone antibiotics (such as ciprofloxacin);
cyclosporine or tacrolimus (medicines used to suppress the immune system);
phenytoin (a medicine for the treatment of epilepsy);
methotrexate (a medicine for the treatment of autoimmune diseases or cancer);
lithium or selective serotonin reuptake inhibitors (medicines for the treatment of depression);
oral antidiabetics (for the treatment of diabetes);
zidovudine (for the treatment of HIV).

Flurbiprofene EG STADA with food, drinks and alcohol
It is recommended to avoid alcohol during treatment with this medicine due to an increased risk of stomach and intestinal bleeding.
Pregnancy, breastfeeding and fertility
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies to Flurbiprofene EG STADA. If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Flurbiprofene EG STADA if you are in the last trimester of pregnancy.
You must not use Flurbiprofene EG STADA during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment during this period is required, the lowest possible dose for the shortest possible time should be used.
The use of this medicine during breastfeeding is not recommended.
Flurbiprofen belongs to a group of medicines that may impair fertility in women. This effect is reversible upon discontinuation of the medicine. Occasional use of the tablets is unlikely to affect the chances of becoming pregnant; however, inform your doctor if you have difficulty conceiving before taking this medicine.
Driving and using machines
No studies have been conducted on the effects of this medicine on the ability to drive or operate machinery. However, dizziness or visual disturbances may occur after using NSAIDs. Do not drive or operate machinery if you are affected by these symptoms.
Flurbiprofene EG STADA contains isomalt (E 953), liquid maltitol (E 965) and lemon flavour
containing limonene and geraniol.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Calorific value: 2.3 kcal/g for liquid maltitol (E 965) and isomalt.
A mild laxative effect may occur.
This medicine contains lemon flavour with limonene and geraniol which may cause allergic reactions.

3. How to take Flurbiprofene EG STADA

Take this medicine exactly as stated in this leaflet and according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents over 12 years of age

Take one tablet orally and suck it slowly.
Keep moving the tablet around in your mouth while sucking.
The tablet should start working within 30 minutes.
Afterwards, take one tablet every 3–6 hours, if needed.
Do not take more than 5 tablets in 24 hours.

Use in children
This medicine must not be used in children under 12 years of age.
These tablets are intended exclusively for short-term use. The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection and symptoms (e.g. fever and pain) persist or worsen, consult your doctor or pharmacist immediately (see section 2). If mouth irritation occurs, stop treatment with flurbiprofen.
Do not take Flurbiprofene EG STADA for more than 3 days, unless your doctor tells you otherwise. If symptoms do not improve, worsen, or new symptoms appear, consult your doctor or pharmacist.
If you take more Flurbiprofene EG STADA than you should
Contact your doctor or pharmacist or go immediately to the nearest emergency department. Symptoms of overdose may include nausea, vomiting, stomach ache, or, less commonly, diarrhoea. Other possible symptoms include ringing in the ears (tinnitus), headache, and gastrointestinal bleeding.
If you forget to take Flurbiprofene EG STADA
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use 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.
STOP TAKING this medicine and contact your doctor immediately if you develop:

signs of an allergic reaction such as asthma, unexplained wheezing or shortness of breath, itching, runny nose, skin rash, etc.;
swelling of the face, tongue or throat, causing breathing difficulties, rapid heartbeat and drop in blood pressure leading to shock (these may also occur with the first use of the medicine);
severe skin reactions such as peeling, blistering or skin detachment.

Tell your doctor or pharmacist if you notice any of the following side effects or any side effect not listed below:
Common (may affect up to 1 in 10 people)

dizziness, headache;
throat irritation;
mouth ulcers or mouth pain;
sore throat;
discomfort or unusual sensation in the mouth (e.g. warmth, burning, tingling, prickling, etc.);
nausea and diarrhoea;
skin tingling or itching.

Uncommon (may affect up to 1 in 100 people)

drowsiness;
blisters in the mouth or throat, throat numbness;
abdominal swelling, abdominal pain, flatulence, constipation, indigestion, vomiting;
dry mouth;
burning sensation in the mouth, altered taste;
skin rash, skin itching;
fever, pain;
drowsiness or difficulty sleeping;
worsening of asthma, wheezing, shortness of breath;
reduced throat sensitivity.

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

anaphylactic reaction.

Frequency not known (frequency cannot be estimated from the available data)

anaemia, thrombocytopenia (low platelet count in the blood which may lead to bruising and bleeding);
swelling (oedema), high blood pressure, heart failure or heart attack;
severe skin reactions such as blistering reactions, including Stevens-Johnson syndrome, Lyell’s syndrome and toxic epidermal necrolysis;
hepatitis (inflammation of the liver).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can 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 Flurbiprofene EG STADA

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 pack or blister after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Flurbiprofene EG STADA contains
The active substance is flurbiprofen. Each tablet contains 8.75 mg of flurbiprofen.
The other components are:
Isomalt (E 953)
Liquid maltitol (E 965)
Acesulfame potassium (E 950)
Macrogol 300 (E 1521)
Lemon flavour (contains beta-pinene, sabinene, limonene, gamma-terpinene, beta-caryophyllene, nerol, alpha-
terpineol, nerol acetate, geraniol, geranyl acetate)
Potassium hydroxide (E 525)
Levomenthol

Description of the appearance of Flurbiprofene EG STADA and package contents
Flurbiprofene EG STADA 8.75 mg sugar-free lemon-flavoured tablets: round, transparent to yellowish tablet, 19 mm in diameter and 7.5 mm thick.
The tablets are packaged in PVC/PVdC/Aluminium blisters.
Pack sizes: 8, 10, 12, 16, 20, 24, 30, 36 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

Manufacturers
Lozy’s Pharmaceuticals S.L., Campus Empresarial Lekaroz No 1, 31795 Lekaroz, Navarra - Spain
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel - Germany
Clonmel Healthcare Limited, Waterford Road, E91 D768 Clonmel, Co. Tipperary - Ireland
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna - Austria

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Lemocin Flurbiprofen Zitronengeschmack 8.75 mg Lutschtabletten
Belgium Flurbiprofen EG Suikervrij 8.75 mg zuigtabletten
Bulgaria Orofar Intense sugar-free Lemon 8.75 mg lozenges
Cyprus Flurbiprofen Stada 8.75 mg τροχίσκοι
Croatia Orofar bez šećera 8.75 mg pastile
Denmark Flurbiprofen STADA
Estonia Flurbiprofen STADA
Finland Flurbiprofen STADA 8.75 mg imeskelytabletti
Germany Flurbiprofen AL 8.75 mg Lutschtabletten
Greece OROFEN® Lemon Sugar-free 8.75 mg τροχίσκοι
Ireland Medisils Intensive 8.75 mg lozenges
Italy FLURBIPROFENE EG STADA
Latvia Flurbiprofen STADA 8.75 mg sūkājamās tabletes
Luxembourg Flurbiprofen EG Sans Sucre 8.75 mg pastilles
Norway Flurbiprofen STADA
Netherlands Kruidvat flurbiprofen citroen 8.75 mg suikervrij, zuigtabletten
Poland Cholinex Direct smak cytrynowy
Portugal Mebocaína Intens
Czech Republic Flurbiprofen STADA
Romania Orofar Intensiv Lămâie fără zahăr 8.75 mg pastile
Slovakia Oroflurb Neo pastilky s citrónovou príchuťou
Slovenia Flurbiprofen STADA 8.75 mg pastile
Sweden Flurbiprofen STADA
Hungary Meboflur cukormentes citromízű 8.75 mg szopogató tabletta