Faringo Intensiv

Leaflet accompanying the packaging: information for the user

Faringo INTENSIV, 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 directed 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 those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Faringo INTENSIV and what is it 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 packaging and other information

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

Faringo INTENSIV contains flurbiprofen. This substance belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by changing the body's response to pain, swelling, and high temperature.

Faringo INTENSIV is used for short-term relief of throat pain symptoms such as irritation, pain, and swelling of the throat, as well as difficulty swallowing, in adults and adolescents over 12 years of age.

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

2. Important information before taking Faringo INTENSIV

When not to take 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 had asthma or an allergic reaction after taking acetylsalicylic acid or other NSAIDs (e.g., wheezing, shortness of breath, runny nose, facial swelling, or hives).
• 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 digestive tract, severe colitis, or blood disorders related to previous NSAID treatment.
• If the patient is in the last trimester of pregnancy.
• If the patient has or has had severe heart, liver, or kidney failure.

Warnings and precautions

Before starting Faringo INTENSIV, the patient should discuss it with their doctor or pharmacist.

• If the patient has ever had asthma or allergies.
• If the patient has tonsillitis (swollen tonsils) or suspects they may have a bacterial throat infection (as antibiotic treatment may be necessary).
• If the patient has cardiovascular, liver, or kidney disorders.
• 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 high blood pressure.
• If the patient has an autoimmune disease (e.g., systemic lupus erythematosus or mixed connective tissue disease).
• If the patient is elderly, as there is a higher risk of side effects listed in this leaflet.
• If the patient is pregnant or breastfeeding.
• If the patient has an infection - see "Infections" below.

During Faringo INTENSIV treatment

• At the first sign of skin reaction (rash, peeling) or other allergic reaction symptoms, the patient should stop taking the medicine and consult their doctor immediately.
• The patient should report any unusual abdominal symptoms to their doctor (especially bleeding). If the patient's condition does not improve, worsens, or other symptoms occur, they should talk to their doctor.
• Taking flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and long-term treatment. The patient should not take higher doses than recommended or exceed the treatment duration (3 days).

Infections

NSAIDs may mask the symptoms of infection, such as fever and pain. This may delay appropriate treatment of infections, leading 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

This medicine should not be used in children and adolescents under 12 years of age.

Faringo INTENSIV 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 if they are taking:

• acetylsalicylic acid (except for low doses, up to 75 mg per day, as directed by a doctor)
• blood pressure-lowering medicines or those used for heart failure (antihypertensives, cardiac glycosides)
• diuretics (including potassium-sparing diuretics)
• blood-thinning medicines (anticoagulants, antiplatelets)
• medicines used to treat gout (probenecid, sulfinpyrazone)
• other NSAIDs or corticosteroids (e.g., celecoxib, ibuprofen, diclofenac sodium, or prednisolone)

mifepristone (a medicine used to terminate pregnancy medically)

• quinolone antibiotics (such as 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)
• zydovudine (a medicine used to treat HIV infection)

Faringo INTENSIV with food, drink, and alcohol

The patient should avoid drinking alcohol while taking Faringo INTENSIV, as it may increase the risk of stomach or intestinal bleeding.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, 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 Faringo INTENSIV.

Flurbiprofen belongs to a group of medicines that may affect fertility in women. This effect is reversible after stopping the medicine. It does not seem that occasional use of hard lozenges affects the chances of getting pregnant; however, if the patient has problems getting pregnant, they should consult their doctor before starting the medicine.

Faringo INTENSIV should not be used in the last trimester of pregnancy. Faringo INTENSIV should not be used during the first 6 months of pregnancy unless absolutely necessary and directed by a doctor. If treatment is necessary during this period, the smallest effective dose should be used for the shortest possible time.

Driving and using machines

No studies have been conducted on the effects of the medicine on the ability to drive or operate machinery. However, dizziness and vision disturbances are possible side effects of 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 diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

This medicine contains 1.127 g of glucose and 1.350 g of sucrose per dose. This should be taken into account for patients with diabetes.

3. How to take Faringo INTENSIV

Faringo INTENSIV should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

The recommended dose is: adults and adolescents over 12 years of age:

• 1 hard lozenge every 3-6 hours, as needed.
• Do not take more than 5 lozenges per day.
• After taking 1 lozenge, the patient should suck it slowly, allowing it to dissolve in the mouth.
• While dissolving, the patient should change the position of the lozenge in their mouth.

Use in children:

Faringo INTENSIV should not be given to children under 12 years of age in the form of hard lozenges.

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

If the patient has an infection, they should consult their doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (see section 2). If the patient experiences mouth irritation, they should stop taking flurbiprofen.

Faringo INTENSIV should not be used for more than 3 days, unless directed by a doctor. If there is no improvement or the patient feels worse, or if new symptoms occur, they should consult their doctor or pharmacist.

Overdose of Faringo INTENSIV

The patient should immediately consult their doctor or pharmacist or go to the nearest hospital.

Overdose symptoms may include: nausea or vomiting, abdominal pain, and diarrhea. It is also possible to experience ringing in the ears, headache, and gastrointestinal bleeding.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Faringo INTENSIV can cause side effects, although not everybody gets them.

The patient should stop taking this medicine and contact their doctor immediately if they experience:

• allergic reaction symptoms, such as asthma, unexpected wheezing or shortness of breath, itching, runny nose (rhinitis), skin rash, etc.
• facial swelling, tongue, or throat swelling causing difficulty breathing, rapid heartbeat, and low blood pressure leading to shock (which may occur even after the first use of the medicine).
• severe skin reactions, such as peeling, blistering, or skin exfoliation.

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

Other side effects that may occur:

Common(may affect up to 1 in 10 people):

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

Uncommon(may affect up to 1 in 100 people):

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

Rare(may affect up to 1 in 1000 people):

• anaphylactic reaction

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

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

Reporting side effects

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

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

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

5. How to store Faringo INTENSIV

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

Faringo INTENSIV should not be used after the expiration date stated on the packaging and blister after: "EXP". The expiration date refers to the last day of the month stated.

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

Do not store above 30°C.

6. Contents of the packaging and other information

What Faringo INTENSIV contains

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

The other ingredients of the medicine are:

Sucrose

Glucose liquid

Macrogol 300

Peppermint oil

Levomenthol

Potassium hydroxide

What Faringo INTENSIV looks like and contents of the pack

Faringo INTENSIV is a pale yellow to brown, round hard lozenge with a diameter of 19±1 mm.

The hard lozenges are available in PVC-PVDC/Aluminum blisters in a cardboard box.

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

Marketing authorization 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 authorized in the Member States of 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

Date of last revision of the leaflet: