POLOPIRYNA 8.75 mg Lozenge

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. POLOPIRYNA GARDŁO, 8.75 mg, hard lozenges
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Polopiryna Gardło and what is it used for
4. Important information before taking Polopiryna Gardło
   1. When not to take Polopiryna Gardło
   2. Warnings and precautions
   3. During treatment with Polopiryna Gardło
   4. Infections
   5. Children and adolescents
   6. Polopiryna Gardło and other medicines
   7. Polopiryna Gardło with food, drink, and alcohol
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. Polopiryna Gardło contains isomalt and maltitol
   11. Polopiryna Gardło contains cochineal red (E 124) and orange yellow (E 110)
5. How to take Polopiryna Gardło
   1. Use in children
   2. Taking a higher dose of Polopiryna Gardło than recommended
6. Possible side effects
   1. Reporting side effects
7. How to store Polopiryna Gardło
8. Contents of the pack and other information
   1. What Polopiryna Gardło contains
   2. What Polopiryna Gardło looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

POLOPIRYNA GARDŁO, 8.75 mg, hard lozenges

Flurbiprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Polopiryna Gardło and what is it used for
• 2. Important information before taking Polopiryna Gardło
• 3. How to take Polopiryna Gardło
• 4. Possible side effects
• 5. How to store Polopiryna Gardło
• 6. Contents of the pack and other information

1. What is Polopiryna Gardło and what is it used for

Polopiryna Gardło contains flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic and anti-inflammatory properties in the treatment of sore throat. These medicines work by changing the body's response to pain, swelling, and high temperature.

Polopiryna Gardło is intended for short-term relief of symptoms of throat inflammation, such as irritation, pain, and swelling of the throat and difficulty swallowing in adults and adolescents over 12 years of age.

If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Polopiryna Gardło

When not to take Polopiryna Gardło

• if the patient is allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever had asthma, unexpected breathing sounds, or difficulty breathing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• if the patient has or has had stomach or intestinal ulcers (two or more episodes of stomach or duodenal ulcers),
• if the patient has had bleeding or perforation of the gastrointestinal tract, severe colitis, or blood disorders related to previous treatment with non-steroidal anti-inflammatory drugs,

if the patient has or has had severe heart, liver, or kidney failure,

• if the patient is in the last 3 months of pregnancy.

Warnings and precautions

Before starting to take Polopiryna Gardło, the patient should discuss it with their doctor or pharmacist:

• if the patient has or has ever had asthma or allergies;
• if the patient has tonsillitis (swollen tonsils) or suspects they may have a bacterial throat infection (an antibiotic may be necessary);
• if the patient has cardiovascular, liver, or kidney disorders;
• if the patient has had a stroke;
• if the patient has had intestinal disease (ulcerative colitis, Crohn's disease);
• if the patient has high blood pressure;
• if the patient has a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease);
• if the patient is elderly (may be more susceptible to side effects listed in the leaflet);
• if the patient is pregnant or breastfeeding;
• if the patient experiences headaches caused by painkillers;
• if the patient has an infection - see "Infections" below.

The patient should avoid taking two or more non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone) at the same time, as this may increase the risk of side effects, particularly gastrointestinal ones such as ulcers and bleeding (see "Polopiryna Gardło and other medicines" below).

During treatment with Polopiryna Gardło

• At the first signs of any skin reactions (rash, peeling) or other symptoms of an allergic reaction, the patient should stop taking the medicine and consult their doctor immediately.
• The patient should report any unusual abdominal symptoms (especially bleeding) to their doctor. If there is no improvement, the patient feels worse, or new symptoms appear, they should consult their doctor.
• Medicines containing flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. The risk is more likely with higher doses or longer treatment. The patient should not exceed the recommended dose or duration of treatment (3 days).

Infections

Non-steroidal anti-inflammatory drugs (NSAIDs) may mask the symptoms of infection, such as fever and pain. This may delay appropriate treatment of infections, which can lead to increased risk of complications. If the patient is taking this medicine during an ongoing infection and their symptoms persist or worsen, they should consult their doctor or pharmacist immediately.

Children and adolescents

The medicine should not be taken by children and adolescents under 12 years of age.

Polopiryna Gardło and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those obtained without a prescription. In particular, the patient should inform their doctor about taking the following medicines:

• acetylsalicylic acid (except for low doses (up to 75 mg per day) prescribed by a doctor)
• medicines that lower blood pressure or are used in heart failure (antihypertensive medicines, cardiac glycosides)
• diuretics (including potassium-sparing diuretics)
• blood-thinning medicines (anticoagulant, antiplatelet medicines)
• medicines used to treat gout (probenecid, sulfinpyrazone)
• other NSAIDs or corticosteroids (e.g., celecoxib, ibuprofen, diclofenac sodium, prednisolone) (see "Warnings and precautions" above)
• mifepristone (a medicine used to terminate pregnancy)
• quinolone antibiotics (e.g., ciprofloxacin)
• cyclosporine or tacrolimus (medicines that suppress the immune system)
• phenytoin (a medicine used to treat epilepsy)
• methotrexate (a medicine used to treat autoimmune diseases or cancer)
• lithium or selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat depression)
• oral antidiabetic medicines (used to treat diabetes)
• zidovudine (a medicine used to treat HIV infection).

Polopiryna Gardło with food, drink, and alcohol

While taking Polopiryna Gardło, the patient should avoid consuming alcohol, as this may increase the risk of stomach or intestinal bleeding.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Oral forms (e.g., tablets) of flurbiprofen may cause side effects in the unborn child. It is not known if the same risk applies to Polopiryna Gardło.

The patient should not take this medicine in the last trimester of pregnancy.

If the patient is in the first 6 months of pregnancy or breastfeeding, they should consult their doctor before taking this medicine. The patient should not take Polopiryna Gardło during the first 6 months of pregnancy unless absolutely necessary and advised by a doctor. If treatment is necessary during this period, the patient should use the smallest dose for the shortest time.

Flurbiprofen belongs to a group of medicines that may affect fertility in women. This effect is reversible after stopping the medicine. It is unlikely that occasional use of lozenges will affect the chances of getting pregnant; however, the patient should tell their doctor before taking the medicine if they have problems getting pregnant.

Driving and using machines

The effect of Polopiryna Gardło on the ability to drive and use machines is not known; however, after taking non-steroidal anti-inflammatory drugs, side effects such as dizziness and vision disturbances may occur. If these occur, the patient should not drive or operate machinery.

Polopiryna Gardło contains isomalt and maltitol

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

The medicine may have a mild laxative effect. The energy value is 2.3 kcal/g for maltitol and isomalt.

Polopiryna Gardło contains cochineal red (E 124) and orange yellow (E 110)

The medicine may cause allergic reactions.

3. How to take Polopiryna Gardło

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

The patient should take the smallest effective dose for the shortest time necessary to relieve symptoms. If the patient has an infection, they should consult their doctor or pharmacist immediately if their symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose is:

Adults and adolescents over 12 years of age: 1 hard lozenge every 3 to 6 hours, as needed.

The patient should not take more than 5 lozenges in 24 hours.

Method of administration

For oral use.

The lozenge should be slowly dissolved in the mouth, not swallowed, and not chewed.

While dissolving, the lozenge should always be moved around the mouth.

Use in children

The medicine should not be taken by children under 12 years of age.

The patient should not take Polopiryna Gardło for more than 3 days. If there is no improvement, the patient feels worse, or new symptoms appear, they should consult their doctor or pharmacist.

Taking a higher dose of Polopiryna Gardło than recommended

If the patient takes a higher dose of the medicine than recommended, they should consult their doctor or pharmacist or go to the nearest hospital. Symptoms of overdose may include: nausea or vomiting, stomach pain, or diarrhea. The patient may also experience ringing in the ears, headache, and gastrointestinal bleeding.

If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Polopiryna Gardło can cause side effects, although not everybody gets them.

The patient should STOP TAKINGthis medicine and contact their doctor immediately if they experience:

• symptoms of an allergic reaction, such as asthma, unexplained wheezing, shortness of breath, itching, nasal congestion, skin rash, etc.
• swelling of the face, tongue, or throat, causing difficulty breathing, rapid heartbeat, and low blood pressure leading to shock (may occur even after the first dose);
• severe skin reactions, such as peeling, blistering, or shedding of the skin.

If the patient experiences any of the following symptoms or side effects not listed in the leaflet, they should tell their doctor or pharmacist.

Other side effects that may occur:

Common(may affect up to 1 in 10 people)

• dizziness, headache
• irritation of the throat
• mouth ulcers or pain in the mouth
• throat pain
• discomfort or unusual sensations in the mouth (feeling of heat, burning, tingling, pricking, etc.)
• nausea and diarrhea
• tingling and itching of the skin.

Uncommon(may affect up to 1 in 100 people)

• drowsiness or difficulty sleeping
• worsening of asthma, wheezing, difficulty breathing
• blistering in the mouth and throat, numbness of the throat
• dry mouth
• burning sensation in the mouth, taste disturbances, bloating
• stomach pain, gas, constipation, indigestion, vomiting
• reduced sensation in the throat
• fever, pain
• skin rash, itching.

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

• anaphylactic reaction.

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

• anemia, thrombocytopenia (low platelet count, which can cause bruising and bleeding)
• edema, high blood pressure, heart failure, or heart attack
• severe skin reactions, such as blistering, including Stevens-Johnson syndrome, Lyell's syndrome, and toxic epidermal necrolysis
• hepatitis.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Polopiryna Gardło

The medicine should be stored out of sight and reach of children.

The patient should not take this medicine after the expiry date stated on the carton and blister after EXP.

The expiry date refers to the last day of the month stated.

There are no special precautions for storage.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Polopiryna Gardło contains

The active substance is flurbiprofen. One hard lozenge contains 8.75 mg of flurbiprofen.

The other ingredients are: isomalt (E 953), liquid maltitol (E 965), cochineal red (E 124), orange yellow (E 110), acesulfame potassium, potassium hydroxide, orange flavor (limonene (50.0%-100%), decanal (0.0%-10%), citral, citronellol (0.1%-1.0%)), levomenthol.

What Polopiryna Gardło looks like and contents of the pack

Polopiryna Gardło, 8.75 mg, hard lozenges, are orange, round lozenges, 19±1 mm in diameter, with an orange flavor.

The lozenges are available in PVC-PVDC/Aluminum blisters in a cardboard box or in PVC-PVDC/Aluminum blisters with a child-resistant closure, in a cardboard box.

Pack sizes: 8, 12, 16, 20, or 24 hard lozenges.

Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański, Poland

tel. +48 22 364 61 01

Manufacturer

LOZY'S PHARMACEUTICALS S.L.

Campus Empresarial Lekaroz nº1

31795 Lecároz, Navarra

Spain

Dexcel Pharma GmbH

Carl-Zeiss-Str. 2

63755 Alzenau

Germany

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra)

Spain

Przedsiębiorstwo Produkcyjno - Handlowe “EWA” S.A.

ul. Zamkowy Folwark 9

63-700 Krotoszyn

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Bucopro 8.75 mg pastillas para chupar sabor Naranja

Czech Republic: Flurbiprofen Galenika

Slovakia: Flurbiprofen Galenika

Portugal: Geilozen 8.75 mg pastilhas

Romania: Septazulen Portocale 8.75 mg pastile

Germany: Flurbiprofen Dexcel 8.75 mg Lutschtabletten

Bulgaria: СЕПТАЗУЛЕН ПОРТОКАЛ 8.75 mg ТАБЛЕТКИ (Septazulen Orange 8.75 mg lozenges)

Latvia: Tonzirin 8.75 mg sūkājamās tabletes

Date of last revision of the leaflet:March 2025