Polopiryna for throat

Package leaflet: Information for the patient

POLOPIRYNA GARDŁO, 8.75 mg, hard pastilles
Flurbiprofenum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor, pharmacist, or nurse.

• 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, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult a doctor.

Table of contents

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

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

Polopiryna Gardło contains flurbiprofen. Flurbiprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic and anti-inflammatory properties in the treatment of sore throat. These medicines work by modifying 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, sore throat, swelling of the throat, and difficulty swallowing in adults and adolescents over 12 years of age.
If there is no improvement after 3 days, or if you feel worse, consult a doctor.

2. Important information before using Polopiryna Gardło

When not to use 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 previously experienced asthma, unexpected breathing sounds, or difficulty breathing, nasal discharge, facial swelling, or skin rash with itching (urticaria) after taking acetylsalicylic acid or other medicines from the group of nonsteroidal anti-inflammatory drugs (NSAIDs),
• if the patient currently has or has previously had a stomach or intestinal ulcer (two or more episodes of gastric or duodenal ulcers),
• if the patient has experienced gastrointestinal bleeding or perforation, severe colitis, or blood disorders related to previous treatment with nonsteroidal anti-inflammatory drugs,
• if the patient currently has or has previously had severe heart, liver, or kidney failure,
• if the patient is in the last 3 months of pregnancy.

Warnings and precautions
Before starting treatment with Polopiryna Gardło, discuss this with a doctor or pharmacist:

• if the patient has or has ever had asthma or suffers from allergies;
• if the patient has tonsillitis (swollen tonsils) or suspects a bacterial throat infection (an antibiotic may be required);
• if the patient has cardiovascular disorders, liver or kidney dysfunction;
• if the patient has previously suffered a stroke;
• if the patient has previously had intestinal diseases (ulcerative colitis, Crohn's disease);
• if the patient has hypertension (high blood pressure);
• if the patient suffers from a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease);
• if the patient is elderly (may be more susceptible to adverse effects listed in the leaflet);
• if the patient is in the first 6 months of pregnancy or is breastfeeding;
• if the patient experiences medication-overuse headaches;
• if the patient develops an infection – see subsection “Infections” below.

Avoid concomitant use of two or more NSAIDs or corticosteroids (such as celecoxib, ibuprofen, sodium diclofenac, or prednisolone), as this may increase the risk of adverse effects, particularly gastrointestinal effects such as ulcers and bleeding (see section “Polopiryna Gardło and other medicines” below).
While using Polopiryna Gardło

• At the first signs of any skin reactions (rash, peeling) or occurrence of other symptoms of an allergic reaction, discontinue use of the medicine and consult a doctor immediately.
• Report any unusual abdominal symptoms (especially bleeding) to a doctor. If there is no improvement, if the patient feels worse, or if new symptoms appear, consult a doctor.
• Medicines containing flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with higher doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment (3 days).

Infections
Nonsteroidal 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 takes this medicine during an ongoing infection and symptoms persist or worsen, consult a doctor or pharmacist immediately.
Children and adolescents
Do not use in children and adolescents under 12 years of age.
Polopiryna Gardło and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use, including over-the-counter medicines. In particular, inform the doctor if the patient is taking any of the following medicines:

• acetylsalicylic acid (except low doses (up to 75 mg per day) prescribed by a doctor)
• medicines that lower blood pressure or are used in heart failure (antihypertensives, cardiac glycosides)
• diuretics (including potassium-sparing diuretics)
• anticoagulants or antiplatelet medicines (blood thinners)
• medicines used in the treatment of gout (probenecid, sulfinpyrazone)
• other NSAIDs or corticosteroids (e.g. celecoxib, ibuprofen, sodium diclofenac, prednisolone) (see above “Warnings and precautions”)
• mifepristone (a medicine used to terminate pregnancy)
• quinolone antibiotics (e.g. ciprofloxacin)
• cyclosporine or tacrolimus (immunosuppressive medicines)
• phenytoin (a medicine used to treat epilepsy)
• methotrexate (a medicine used to treat autoimmune diseases or cancers)
• lithium or medicines from the group of 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
Avoid consuming alcohol while using Polopiryna Gardło, as this may increase the risk of gastrointestinal bleeding (in the stomach or intestines).
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
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 Polopiryna Gardło.
Do not use this medicine during the last trimester of pregnancy.
If the patient is in the first 6 months of pregnancy or is breastfeeding, she should consult a doctor before using this medicine. Do not use Polopiryna Gardło during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period, use the lowest dose for the shortest possible time.
Flurbiprofen belongs to a group of medicines that may impair fertility in women. This effect is reversible upon discontinuation of the medicine. It is unlikely that occasional use of lozenges would affect the chances of becoming pregnant; however, inform the doctor before using the medicine if the patient has difficulty conceiving.
Driving and operating machinery
The effect of Polopiryna Gardło on the ability to drive and operate machinery is unknown. However, after using nonsteroidal anti-inflammatory drugs, adverse effects such as dizziness and visual disturbances may occur. If such effects occur, do not drive or operate machinery.
Polopiryna Gardło contains isomalt and maltitol
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine may have a mild laxative effect. Calorific value: 2.3 kcal/g for maltitol and isomalt.
Polopiryna Gardło contains carmine red (E 124) and orange yellow (E 110)
This medicine may cause allergic reactions.

3. How to take Polopiryna Gardło

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 lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If the patient has an infection, medical advice should be sought immediately from a doctor or pharmacist if symptoms (such as fever and pain) persist or worsen (see section 2).

Recommended dose:
Adults and adolescents over 12 years of age: 1 hard pastille every 3 to 6 hours, as needed.
Do not take more than 5 pastilles in 24 hours.

Method of administration
For oral use.
The pastille should be slowly dissolved in the mouth. Do not swallow or chew the pastille.
While dissolving, the pastille should always be moved around in the mouth.

Use in children
Polopiryna Gardło must not be used in children under 12 years of age.

Do not use Polopiryna Gardło for longer than 3 days. If there is no improvement, if symptoms worsen, or if new symptoms appear, consult a doctor or pharmacist.

Overdose of Polopiryna Gardło
If more than the recommended dose has been taken, consult a doctor or pharmacist or go to the nearest hospital immediately. Symptoms of overdose may include: nausea or vomiting, abdominal pain, or less commonly, diarrhoea. Tinnitus, headache, and gastrointestinal bleeding may also occur.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
YOU SHOULD DISCONTINUE USE of this medicine and contact your doctor immediately if
any of the following symptoms occur:

• signs of allergic reactions, such as asthma, unexplained wheezing or shortness of breath, itching, nasal mucosal inflammation, skin rashes, etc.;
• swelling of the face, tongue or throat causing breathing difficulties, rapid heartbeat and drop in blood pressure leading to shock (these may occur even after the first dose of the medicine);
• severe skin reactions such as peeling, blistering or skin detachment.

If any of the symptoms listed below or other symptoms not mentioned in this leaflet occur,
you should inform your doctor or pharmacist.
Other possible adverse reactions include:
Common (may occur in less than 1 in 10 patients)

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

Uncommon (may occur in less than 1 in 100 patients)

• drowsiness or difficulty sleeping
• worsening of asthma, wheezing, breathing difficulties
• blister formation in the mouth and throat, throat numbness
• dryness in the oral cavity
• burning sensation in the mouth, taste disturbances, bloating
• abdominal pain, flatulence, constipation, indigestion, vomiting
• reduced throat sensation
• fever, pain
• skin rashes, skin itching.

Rare (may occur in less than 1 in 1,000 patients)

• anaphylactic reaction.

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Polopiryna Gardło

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices will help protect the environment.

6. Contents of the pack and other information

What Polopiryna Gardło contains
The active substance is flurbiprofen. Each hard pastille contains 8.75 mg of flurbiprofen.
The other ingredients are: isomalt (E 953), maltitol liquid (E 965), carmine red (E 124), orange yellow (E 110), acesulfame potassium, potassium hydroxide, orange flavour (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 pastilles, are round, orange-coloured pastilles with an orange flavour, 19±1 mm in diameter.
The pastilles are available in PVC-PVDC/Aluminium blisters in cardboard boxes or in PVC-PVDC/Aluminium blisters with child-resistant packaging, in cardboard boxes.
Pack sizes: 8, 12, 16, 20 or 24 hard pastilles.
Not all pack sizes may be marketed.

Marketing Authorisation 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
Poland

This medicinal product is authorised in the European Economic Area countries 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