Faringo intensiv

Package leaflet: Information for the user

Faringo INTENSIV, 8.75 mg, hard tablets
Flurbiprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if your condition worsens, consult your doctor.

Contents of the leaflet

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

1. What Faringo INTENSIV is and what it is used for

Faringo INTENSIV contains flurbiprofen. This substance belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). These medicines work by altering the body's response to pain, swelling, and high temperature.
Faringo INTENSIV is used for the short-term relief of sore throat symptoms such as irritation, pain, swelling of the throat, and difficulty swallowing, in adults and adolescents aged 12 years and older.
If there is no improvement after 3 days or if you feel worse, you should consult your doctor.

2. Important information before using Faringo INTENSIV

When not to use Faringo INTENSIV

• 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 (rhinitis), facial swelling or itchy skin rash (urticaria) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If the patient currently has or has 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 associated with previous NSAID treatment.
• If the patient is in the last trimester of pregnancy.
• If the patient currently has or has had severe heart, liver or kidney failure.

Warnings and precautions
Before starting to use Faringo INTENSIV, discuss this with your doctor or
pharmacist.

• If the patient has ever had asthma or allergies.
• If the patient has tonsillitis (swollen tonsils) or suspects a bacterial throat infection (as antibiotic treatment may be necessary).
• If the patient has cardiovascular disorders, liver or kidney dysfunction.
• If the patient has had a stroke.
• If the patient has a history of 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, as there is an increased likelihood of experiencing the adverse effects listed in this leaflet.
• 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 Faringo INTENSIV

• In case of first signs of skin reaction (rash, peeling) or other symptoms of allergic reaction, discontinue use of the medicine immediately and consult a doctor without delay.
• Report any unusual abdominal symptoms to your doctor (especially bleeding). If the patient's condition does not improve, worsens, or new symptoms appear, consult a doctor.
• Use of medicines containing flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is greater with higher doses and prolonged treatment. Do not use doses higher than recommended or exceed the recommended duration of treatment (3 days).

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 leading to an increased risk of
complications. If the patient takes this medicine during an ongoing infection and symptoms persist
or worsen, seek immediate advice from a doctor or pharmacist.
Children and adolescents
Do not use this medicine in children and adolescents under 12 years of age.
Faringo INTENSIV and other medicines
Tell your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines. In particular, inform the doctor if the patient is taking:

• acetylsalicylic acid (except low doses up to 75 mg per day, as prescribed by a doctor)
• medicines to lower blood pressure or 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 or

prednisolone)

• mifepristone (a medicine used to terminate pregnancy pharmacologically)
• 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) (medicines used to treat depression)
• oral antidiabetic medicines (used to treat diabetes)
• zidovudine (a medicine used to treat HIV infection).

Faringo INTENSIV with food, drink and alcohol
Avoid drinking alcohol while using Faringo INTENSIV, as this may
increase the risk of gastrointestinal bleeding.
Pregnancy, breastfeeding and 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 Faringo INTENSIV.
Flurbiprofen belongs to a group of medicines that may affect female fertility. This effect is
reversible after stopping the medicine. Occasional use of hard pastilles is unlikely to affect chances of conception; however, if the patient has difficulty becoming pregnant, she should consult a doctor before starting treatment.
Do not use Faringo INTENSIV during the last trimester of pregnancy. Do not use Faringo INTENSIV during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period, use the lowest dose for the shortest possible duration.
Driving and operating machinery
Studies on the effect of the medicine on the ability to drive and operate machinery have not been conducted. However, dizziness and visual disturbances are possible
adverse effects after using NSAIDs. If these occur, patients should not drive or operate machinery.
Faringo INTENSIV contains sucrose and glucose
This medicine contains sucrose and glucose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
This medicine contains 1.127 g of glucose and 1.350 g of sucrose per dose. This should be taken into account in patients with diabetes.

3. How to use Faringo INTENSIV

Faringo INTENSIV should always be taken exactly as described in this patient leaflet or as recommended by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose: Adults and adolescents over 12 years of age:

• 1 hard pastille every 3–6 hours, as needed.
• Do not exceed 5 pastilles per day.
• After taking 1 pastille, suck it slowly, allowing it to dissolve in the mouth.
• During dissolution, change the position of the pastille in the mouth.

Use in children:
Faringo INTENSIV hard pastilles must not be given to children under 12 years of age.

Faringo INTENSIV is intended for short-term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

In case of infection, consult your doctor or pharmacist promptly if symptoms (such as fever and pain) persist or worsen (see section 2). If irritation in the mouth occurs, discontinue use of flurbiprofen.

Do not use Faringo INTENSIV for longer than 3 days, unless otherwise advised by a doctor. If there is no improvement, symptoms worsen, or new symptoms appear, consult your doctor or pharmacist.

Taking more than the recommended dose of Faringo INTENSIV
Seek immediate medical advice from a doctor or pharmacist, or go to the nearest hospital.
Symptoms of overdose may include: nausea or vomiting, stomach pain, and less commonly, diarrhoea. Tinnitus, headache, and gastrointestinal bleeding are also possible.

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 MUST STOP USING this medicine and contact your doctor immediately if
any of the following symptoms occur:

• symptoms of allergic reactions, such as asthma, unexpected wheezing or difficulty breathing, itching, inflammation of the nasal mucosa (rhinitis), skin rash, etc.
• swelling of the face, tongue or throat causing difficulty breathing, 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 shedding of the skin.

If any of the following symptoms occur, or if any symptoms not listed in this leaflet appear, inform your doctor or pharmacist.
Other possible adverse reactions:
Common (may occur in less than 1 in 10 patients):

• dizziness, headache
• throat irritation
• oral ulcers or mouth pain
• sore throat
• discomfort or unusual sensations in the mouth (e.g. burning or warm sensation in the mouth, tingling, pricking, etc.)
• nausea and diarrhoea
• skin tingling and itching

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

• drowsiness
• somnolence or difficulty sleeping
• worsening of asthma, wheezing, breathing difficulties
• blistering in the mouth and throat, throat numbness
• dryness in the mouth
• burning sensation in the mouth, taste disturbances, bloating, abdominal pain, flatulence, constipation, indigestion, vomiting
• reduced sensation in the throat
• fever, pain
• skin rash, 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 (swelling)
• high blood pressure
• heart failure or heart attack
• severe forms of skin reactions such as blistering eruptions, including Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis)
• hepatitis.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, 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.: 22 49 21 301,
fax: 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 this medicine.

5. How to store Faringo INTENSIV

Keep this medicine out of sight and reach of children.
Do not use Faringo INTENSIV after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the stated 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.
Do not store above 30°C.

6. Contents of the pack and other information

What Faringo INTENSIV contains
The active substance is flurbiprofen. One hard pastille contains 8.75 mg of flurbiprofen.
Other components of the medicine are:
Sucrose
Liquid glucose
Macrogol 300
Peppermint essential oil
Levomenthol
Potassium hydroxide

What Faringo INTENSIV looks like and contents of the pack
Faringo INTENSIV is pale yellow to brown, round hard pastilles with a diameter of 19±1 mm.
The hard pastilles are available in blisters made of PVC-PVDC/Aluminium, packed in a cardboard box.
Pack sizes: 8, 12, 16, 20 or 24 hard pastilles.

Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
ul. Ludwika Idzikowskiego 16
00-710 Warsaw
tel. 22 642 07 75

Manufacturer/Importer:
LOZY’S PHARMACEUTICALS, S.L
Campus Empresarial Lekaroz 1
31795 Lekaroz, Spain
Terapia S.A.
Strada Fabricii Nr 124
400632 Cluj-Napoca
Romania

This medicine is authorised for sale in the European Economic Area under the following names:
Spain: Angifen 8.75 mg pastillas para chupar sabor menta
Portugal: Mentocaína Anti-Inflam 8.75 mg pastilhas
Romania: Faringo Intensiv 8.75 mg pastile