Polopiryna throat spray

Package leaflet: Information for the user

POLOPIRYNA GARDŁO SPRAY, 8.75 mg/dose, oropharyngeal spray, solution
Flurbiprofenum
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any 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

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

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

The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which work by altering the body's response to pain, swelling, and fever.
Polopiryna Gardło Spray is intended for short-term relief of symptoms of throat inflammation, such as irritation, sore throat, difficulty swallowing, and swelling in adults aged 18 years and older.

2. Important Information Before Using Polopiryna Gardło Spray

When not to use Polopiryna Gardło Spray

• If the patient is allergic to flurbiprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has previously experienced an allergic reaction after taking non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid, e.g. asthma, wheezing, itching, rhinitis, skin rash, swelling;
• if the patient has or has had two or more episodes of stomach ulcers, gastrointestinal bleeding or intestinal ulcers;
• if the patient has ever had severe colitis (inflammation of the large intestine);
• if the patient has ever had coagulation disorders or bleeding problems after taking NSAIDs;
• if the patient is in the last 3 months of pregnancy;
• if the patient has severe heart, kidney or liver failure.

Warnings and Precautions
Before starting treatment with Polopiryna Gardło Spray, discuss with your doctor or
pharmacist:

• if the patient is already taking any other non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid;
• if the patient has tonsillitis or suspects a bacterial throat infection (antibiotic treatment may be necessary);
• if the patient is elderly (may be more susceptible to adverse effects);
• if the patient has asthma or suffers from allergies;
• if the patient suffers from a skin disease called systemic lupus erythematosus or mixed connective tissue disease;
• if the patient has hypertension (high blood pressure);
• if the patient has previously had intestinal disease (ulcerative colitis, Crohn's disease);
• if the patient suffers from heart, kidney or liver disease;
• if the patient has had a stroke;
• if the patient is in the first 6 months of pregnancy or is breastfeeding;
• if the patient develops an infection - see section "Infections" below.

While using Polopiryna Gardło Spray

• At the first signs of any skin reactions (rash, peeling, blisters) or other symptoms of an allergic reaction, stop using the spray immediately and consult a doctor.
• Report any unusual abdominal symptoms (especially bleeding) to your doctor.
• If there is no improvement, the patient feels worse, or new symptoms appear, consult 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 or prolonged treatment. 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, seek immediate advice from a doctor or pharmacist.
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.
Polopiryna Gardło Spray 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 about:

• other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors used to treat pain or inflammation, as they may increase the risk of gastrointestinal bleeding;
• warfarin, acetylsalicylic acid, and other anticoagulant and antiplatelet medicines;
• angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (medicines that lower blood pressure);
• diuretics, including potassium-sparing diuretics;
• selective serotonin reuptake inhibitors (SSRIs) used to treat depression;
• cardiac glycosides (medicines used in heart conditions), such as digoxin;
• cyclosporine (prevents organ rejection after transplantation);
• corticosteroids (reduce inflammation);
• lithium (treatment of mood disorders);
• methotrexate (treatment of psoriasis, arthritis, and cancers);
• mifepristone (used for medical abortion): NSAIDs should not be used within 8–12 days after mifepristone administration, as they may reduce the effectiveness of mifepristone;
• oral antidiabetic medicines;
• phenytoin (treatment of epilepsy);
• probenecid, sulfinpyrazone (treatment of gout and arthritis);
• quinolone antibiotics (used to treat bacterial infections), such as ciprofloxacin, levofloxacin;
• tacrolimus (an immunosuppressant used after organ transplantation);
• zidovudine (used in HIV infection).

Polopiryna Gardło Spray with food, drink and alcohol
During treatment with this medicine, avoid consuming alcohol, as it may increase the
risk of gastrointestinal bleeding.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning 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 Spray.
Pregnancy
Do not use this medicine during the last trimester of pregnancy.
Do not use Polopiryna Gardło Spray 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.
Breastfeeding
Do not use this medicine during breastfeeding.
Fertility
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 this medicine will affect the chances of becoming pregnant; however, inform your doctor before using the medicine if you have difficulty becoming pregnant.
Driving and operating machinery
This medicine is unlikely to affect the ability to drive or operate machinery.
However, dizziness and visual disturbances may occur after taking NSAIDs. In such
cases, do not drive or operate machinery.
Polopiryna Gardło Spray contains cyclodextrin (betadex and hydroxypropylbetadex)
The medicine contains 9.91 mg of cyclodextrins (9.58 mg of betadex and 0.33 mg of hydroxypropylbetadex)
per dose (3 sprays), equivalent to 19.15 mg/ml of cyclodextrins (18.50 mg/ml of betadex
and 0.65 mg/ml of hydroxypropylbetadex).

3. How to use Polopiryna Throat Spray

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose
Adults aged 18 years and over: One dose (3 sprays of aerosol) to the back of the throat every 3–6 hours, as needed. Do not take more than 5 doses within a 24-hour period.
One dose (3 sprays of aerosol) contains 8.75 mg of flurbiprofen.

Use in children and adolescents
Do not use this medicine in children and adolescents under 18 years of age.
For oral use only.

• Spray the aerosol only onto the back of the throat.
• Do not inhale during spraying.
• Do not take more than 5 doses (15 sprays of aerosol) within 24 hours.

Polopiryna Throat Spray is 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).
Do not use this medicine for longer than 3 days unless advised by a doctor.
If there is no improvement, if the patient feels worse, or if new symptoms appear, consult a doctor or pharmacist.

Priming the pump
Before the first use of the aerosol (or after prolonged storage), shake the bottle first, then prime the pump.
Point the nozzle away from you and spray the aerosol at least four times until a uniform, fine mist is produced. The pump is now primed and ready for use. If the medicine has not been used for some time, point the nozzle away from you and spray the aerosol at least once to produce a uniform, fine mist. Before each use, always ensure that a uniform, fine mist is being produced.

Using the aerosol
Direct the nozzle toward the back of the throat.

With a quick, smooth motion, press the pump three times, making sure to fully depress the pump with each spray, removing your finger from the top of the pump between each spray.

Do not inhale during spraying.

Taking more Polopiryna Throat Spray than recommended
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 questions 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 everybody will experience them.
YOU MUST STOP TAKING THE MEDICINE AND CONTACT A DOCTOR IMMEDIATELY IF
THE FOLLOWING SYMPTOMS OCCUR:

• symptoms of an allergic reaction, e.g. asthma, unexplained wheezing or shortness of breath, itching, runny nose or skin rash;
• swelling of the face, tongue or throat, causing difficulty in breathing, palpitations, drop in blood pressure leading to shock (these may occur even after the first use of the medicine);
• symptoms of hypersensitivity and skin reactions such as redness, swelling, peeling, formation of blisters or ulceration of the skin and mucous membranes.

Other adverse reactions may occur:
IF ANY OF THE FOLLOWING SYMPTOMS OR UNLISTED ADVERSE REACTIONS OCCUR,
CONSULT A DOCTOR OR PHARMACIST:
Common (may affect up to 1 in 10 patients)

• dizziness, headache
• throat irritation
• oral ulceration, pain and numbness in the mouth
• sore throat
• discomfort (sensation of warmth, burning or tingling) in the mouth
• nausea and diarrhoea
• skin tingling and itching

Uncommon (may affect up to 1 in 100 patients)

• drowsiness
• blisters in the mouth or throat, sensation of throat numbness
• abdominal distension, abdominal pain, flatulence, constipation, indigestion, vomiting
• dryness of the mouth
• burning sensation in the mouth, taste disturbances
• skin rashes, skin itching
• fever, pain
• drowsiness or difficulty in falling asleep
• worsening of asthma, wheezing, shortness of breath
• reduced sensation in the throat

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

• anaphylactic reaction

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

• anaemia, thrombocytopenia (low number of blood platelets, 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 lesions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare diseases caused by severe adverse drug reactions or infection, in which there is a severe reaction of the mucous membranes and skin)
• hepatitis

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a 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 may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Polopiryna Gardło Spray

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle.
The expiry date refers to the last day of the month indicated.
Usable period after first use: 1 month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Polopiryna Gardło Spray contains
The active substance is flurbiprofen. One dose (3 sprays) contains 8.75 mg of flurbiprofen.
One spray contains 2.92 mg of flurbiprofen. 1 ml of solution contains 17.16 mg of flurbiprofen.
The other ingredients are: sodium saccharin (E 954), citric acid, sodium hydroxide, disodium
phosphate dodecahydrate, betadex (E 459), hydroxypropylbetadex, cherry flavour, purified water.
Composition of cherry flavour: flavouring and aroma components, ethanol, glyceryl triacetate, propylene
glycol (E 1520), ascorbic acid, DL-alpha-tocopherol, water.

What Polopiryna Gardło Spray looks like and contents of the pack
An oral spray solution, liquid – a clear, colourless solution with a cherry odour and taste.
Polopiryna Gardło Spray consists of a plastic bottle containing the solution and a dosing device in the form of a mechanical spray pump.
Each bottle contains 15 ml of solution, sufficient for 88 sprays.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
tel. + 48 22 364 61 01

Manufacturer
Bohm, S.A.
C/ Molinaseca 23
Poligono Industrial Cobo Calleja
28947 Fuenlabrada, Madrid
Spain
Laboratorio Sanitatis S.L.
C/ Leonardo Da Vinci, 11
(Parque Tecnológico de Álava)
01510 Miñano (Álava)
Spain
S.C. Terapia SA
Strada Fabricii nr. 124,
Cluj-Napoca 400632 Judet Cluj
Romania
Industria Quimica Y Farmaceutica Vir S.A.
C/ De La Laguna 66 68 70
Poligono Industrial Urtinsa II
28923 Alcorcon, Madrid
Spain