Patient Information Leaflet

Straben, 8.75 mg, hard pastilles
Flurbiprofenum
Please read all of this leaflet carefully before taking this medicine, because
it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet
or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

What Straben is and what it is used for
Important information before taking Straben
How to take Straben
Possible side effects
How to store Straben
Contents of the pack and other information

1. What Straben is and what it is used for

Straben contains flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieve pain, inflammation and fever by altering the body's response to these symptoms. Straben is used for the short-term relief of sore throat symptoms in adults and children over 12 years of age.

2. Important information before taking Straben

When not to take Straben

If the patient is allergic to flurbiprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6).
If the patient currently has, or has had (two or more episodes) gastric or duodenal ulcer, or gastrointestinal bleeding.
If the patient has ever experienced allergic symptoms such as difficulty breathing (asthma), sudden wheezing or shortness of breath, nasal congestion, facial swelling (angioedema), or itchy rash (urticaria) after taking acetylsalicylic acid or another NSAID.
If the patient has previously experienced gastrointestinal bleeding or perforation, severe colitis (inflammation of the colon), or bleeding disorders while taking NSAIDs.
If the patient is currently taking high-dose acetylsalicylic acid (more than 75 mg acetylsalicylic acid per day) or another NSAID (e.g. celecoxib, ibuprofen, sodium diclofenac, etc.).
If the patient has severe heart, kidney, or liver failure.
During the last 3 months of pregnancy.

Warnings and precautions
Before starting treatment with Straben, consult your doctor or
pharmacist if:

The patient currently has or has ever had asthma or allergies;
The patient is taking other non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid;
The patient develops an infection – see section “Infections” below;
The patient develops heart, kidney, or liver function disorders;
The patient develops circulatory failure after stroke;
The patient has previously had gastrointestinal diseases (such as ulcerative colitis or Crohn's disease);
The patient has a chronic autoimmune disease such as systemic lupus erythematosus or mixed connective tissue disease;
The patient has persistent headaches;
The patient is at increased risk of conditions such as high blood pressure (hypertension), diabetes, high blood cholesterol (hypercholesterolemia), or is a tobacco smoker;
The patient is elderly, as adverse effects described in this leaflet are more likely;
The patient is in the first or second trimester of pregnancy or is breastfeeding.

While taking Straben:

At the first sign of any hypersensitivity reaction (rash, skin peeling, blisters) or other allergic symptoms, discontinue Straben immediately and consult a doctor.
Report any unusual gastrointestinal symptoms (especially bleeding) to a doctor.
If there is no improvement or new symptoms appear, contact a doctor.
Medicines such as flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. The risk is greater with higher doses and prolonged use.

Do not exceed the recommended dose or duration of treatment (see section 3).
Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask symptoms of infection such as
fever and pain. This may delay appropriate treatment of infections, potentially increasing the
risk of complications. If the patient is taking this medicine during an ongoing infection and
symptoms persist or worsen, consult a doctor or pharmacist immediately.
Children
Straben must not be used in children under 12 years of age.
Straben and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, if the patient is taking:

high-dose acetylsalicylic acid (more than 75 mg per day);
medicines for high blood pressure or heart failure (antihypertensives, cardiac glycosides);
diuretics, including potassium-sparing diuretics (e.g. spironolactone);
medicines used to reduce blood clotting (anticoagulants, antiplatelet agents);
medicines used to treat gout (e.g. probenecid, sulfinpyrazone);
another NSAID (such as celecoxib, ibuprofen, sodium diclofenac) or a corticosteroid (e.g. prednisolone);
mifepristone (a medicine used to terminate pregnancy);
quinolone antibiotics (such as ciprofloxacin);
cyclosporine or tacrolimus (immunosuppressive medicines);
phenytoin (a medicine used to treat epilepsy);
methotrexate (a medicine used to treat autoimmune diseases or cancer);
lithium or selective serotonin reuptake inhibitors (SSRIs) used to treat depression;
oral antidiabetic medicines (medicines used to treat diabetes);
zidovudine (a medicine used to treat HIV infection).

Straben and alcohol
Avoid drinking alcohol while taking Straben, as it increases the risk of stomach or intestinal bleeding.
Pregnancy, breastfeeding, and fertility
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the unborn child. It is unknown whether the same risk applies to Straben.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine. Do not take Straben if the patient is in the last trimester of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both the mother and the child and may result in delayed or prolonged labour. Straben must not be used during the last 3 months of pregnancy. Straben should not be used during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period, the lowest effective dose should be used for the shortest possible duration.
Use of Straben for more than a few days, starting from week 20 of pregnancy, may cause kidney problems in the unborn child, leading to reduced amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If longer-term treatment is required, the doctor may recommend additional monitoring.
Flurbiprofen may appear in human breast milk in very low concentrations; therefore, use of Straben should be avoided during breastfeeding.
Straben belongs to a group of medicines that may adversely affect fertility in women. This effect is reversible after discontinuation of the medicine. It is unlikely that occasional use of lozenges will affect fertility; however, the patient should inform the doctor before taking this medicine if she has difficulty becoming pregnant. If Straben is used by a woman trying to conceive, the lowest possible dose for the shortest possible duration should be used.
Driving and operating machinery
Straben has no influence on the ability to drive or operate machinery.
Straben contains sorbitol
This medicine contains 577.34 mg of sorbitol per lozenge. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, the patient should consult a doctor before taking this medicine or giving it to a child.
Straben contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Straben

This medicine should always be taken exactly as described in this patient information leaflet
or as directed by a doctor or pharmacist. If in doubt, consult a
doctor or pharmacist.
The recommended dose for adults and children aged 12 years and older is one hard pastille every
3 to 6 hours, as needed.
Do not take more than 5 hard pastilles in 24 hours.
Method of administration

Take one hard pastille orally and suck slowly.
While sucking, always move the pastille around in the mouth.

Use in children
Do not give to children under 12 years of age.
Elderly patients
Some elderly patients may be more susceptible to adverse effects.
These hard pastilles are intended for short-term use only. Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If the patient has an infection, consult a doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (see section 2). If irritation of the oral cavity occurs, discontinue treatment with Straben.
Do not take Straben for longer than 3 days unless otherwise advised by a doctor. If pain persists or worsens, or if new symptoms occur, consult a doctor or pharmacist.
Overdose of Straben
The patient may experience drowsiness or nausea. In case of overdose, the patient should contact a doctor immediately, even if feeling well.
Missed dose of Straben
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
The risk of adverse reactions can be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
The patient should stop taking this medicine and contact a doctor immediately if any of the following occur:

symptoms of allergic reactions such as asthma, wheezing or unexplained shortness of breath, itchy skin, runny nose, skin rash, etc.
swelling of the face, tongue or throat causing difficulty in breathing, and drop in blood pressure leading to shock (these symptoms may occur even after the first dose of the medicine)
severe skin reactions such as peeling, blistering or skin detachment.

The patient should inform their doctor or pharmacist if they notice any of the following adverse reactions or any adverse reactions not listed in this leaflet:
Common adverse reactions (may occur in less than 1 in 10 people)

dizziness, headache
sore throat, throat irritation
mouth ulcers or pain, discomfort or unusual sensations in the mouth (such as warmth, tingling, pricking, etc.)
nausea, diarrhoea
skin pricking sensation, skin burning sensation

Uncommon adverse reactions (may occur in less than 1 in 100 people)

drowsiness
mouth or throat blisters, throat numbness
abdominal bloating, abdominal pain, bloating with flatulence, constipation, indigestion, vomiting
dry mouth, altered taste sensation, mouth burning
skin rash, itchy skin
fever, pain
feeling of drowsiness or difficulty sleeping
worsening of asthma, wheezing, shortness of breath
worsening of throat sensation

Rare adverse reactions (may occur in less than 1 in 1,000 people)

allergic and anaphylactic reaction
kidney failure
liver failure

Very rare adverse reactions (may occur in less than 1 in 10,000 people)

blood disorders

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

anaemia (reduction in red blood cells which may cause pale skin, weakness or breathlessness), thrombocytopenia (low platelet count which may cause bruising and bleeding), neutropenia (low white blood cell count), agranulocytosis (marked decrease in white blood cells which increases the likelihood of infection)
high blood pressure (hypertension), heart failure or heart attack (heart disorders which may cause breathlessness or ankle swelling)
severe forms of skin reactions, including Stevens-Johnson syndrome (a serious illness with skin, mouth, eye and genital blisters), toxic epidermal necrolysis (a serious illness with skin blisters), erythema multiforme (a skin reaction which may be triggered by infection or certain medicines)
hepatitis, yellowing of the skin or whites of the eyes due to liver disorders (jaundice), liver function abnormalities
depression, confusion, hallucinations
visual disturbances
ringing in the ears
fatigue, swelling or puffiness of the face, abdomen, thighs or ankles, passing less urine or problems passing urine, and back pain (symptoms of kidney problems)
increased sensitivity of the skin to sunlight
stroke
inflammation of the protective membrane surrounding the brain (aseptic meningitis) with symptoms such as neck stiffness, headache, nausea, vomiting, fever or disorientation
gastrointestinal bleeding, gastric ulcer, intestinal perforation

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Straben

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special precautions regarding storage temperature are required.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Contents of the pack and other information

What Straben contains

The active substance is flurbiprofen. Each hard lozenge contains 8.75 mg of flurbiprofen.
Other ingredients are: monohydrate lactose, magnesium stearate (E572), orange flavour (containing: natural flavouring substances, flavouring preparations, corn maltodextrin, modified starch, corn starch), colloidal anhydrous silica, sorbitol (E420), corn starch, talc (E553b).

What Straben looks like and contents of the pack
Straben is a flat, white hard lozenge.
One cardboard box contains 20 hard lozenges, packed in 2 blisters made of OPA/Aluminium/PVC/Aluminium foil, each containing 10 hard lozenges, with an enclosed Patient Leaflet.
Marketing Authorisation Holder and Manufacturer
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
14 km National Road 1
GR-145 64 Kifisia
Greece
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Malta: Straben 8.75 mg lozenges
Poland: Straben 8.75 mg hard lozenges