Vocaflam

Leaflet accompanying the packaging: information for the user

Vocaflam, 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 or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Vocaflam and what is it used for

Vocaflam contains flurbiprofen. Flurbiprofen belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs) with analgesic, antipyretic, and anti-inflammatory properties.

Vocaflam is used for the short-term treatment of sore throat, such as irritation, pain, and swelling, as well as difficulty swallowing, in adults and adolescents over 12 years of age.

If after 5 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Vocaflam

When not to take Vocaflam

• if the patient is allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6).
• if the patient has asthma, unexpected wheezing, or breathing difficulties, runny nose, facial swelling, or skin rash, as with acetylsalicylic acid or other NSAIDs.
• 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 ulcerative colitis, or blood disorders associated with previous NSAID treatment.
• if the patient is in the last three months of pregnancy.
• if the patient has or has had severe heart, liver, or kidney failure.

Warnings and precautions

Before taking Vocaflam, the patient should discuss it with their doctor or pharmacist.

• if the patient has ever had asthma or allergies.
• if the patient has tonsillitis (tonsil swelling) or thinks 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 a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease).
• if the patient is elderly, as there is a greater likelihood of side effects listed in this leaflet.
• if the patient is pregnant or breastfeeding.
• if the patient is taking painkillers for headaches for a long time, it may worsen them.

During treatment with Vocaflam

• In case of the first signs of skin reaction (rash, peeling) or other signs of allergic reaction, 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 increases with high doses and prolonged treatment. The patient should not take higher doses than recommended and not prolong the treatment period (5 days).

Children

This medicine should not be given to children under 12 years of age.

Vocaflam and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take, including those obtained without a prescription.

In particular, the patient should inform their doctor about taking the following medicines:

• acetylsalicylic acid in small doses (up to 75 mg per day)
• blood pressure-lowering medicines or those used in heart failure (antihypertensives, cardiac glycosides)
• diuretics (including potassium-sparing diuretics)
• blood thinners (anticoagulants, antiplatelets)
• medicines used to treat gout (probenecid, sulfinpyrazone)
• other NSAIDs or corticosteroids (e.g., celecoxib, ibuprofen, diclofenac sodium, prednisolone)
• 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)
• fluconazole (an antifungal medicine used to treat many fungal infections)

Taking Vocaflam with food, drink, and alcohol

The patient should avoid drinking alcohol while taking Vocaflam, as it 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 child, they should consult their doctor or pharmacist before taking this medicine.

The patient should not take Vocaflam if they are in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Vocaflam may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the patient and child and cause delayed or prolonged labor. During the first six months of pregnancy, Vocaflam should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible time.

From the 20th week of pregnancy, Vocaflam may cause kidney problems in the unborn child if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, the doctor may recommend additional monitoring.

Vocaflam is not recommended for use in breastfeeding mothers.

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 these lozenges will affect the chances of getting pregnant when taken occasionally; however, the patient should tell their doctor before taking this medicine if they have difficulty getting pregnant.

Driving and using machines

Vocaflam is unlikely to affect the ability to drive or use machines.

However, dizziness and vision disturbances are possible side effects of NSAIDs. Patients should not drive or operate machinery if they experience these symptoms.

Drowsiness is also a possible side effect and may affect the ability to drive or use machines.

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

Vocaflam contains citrus flavor with citral, citronellol, geraniol, limonene, and linalool, which may cause allergic reactions.

3. How to take Vocaflam

Vocaflam should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

In case of doubt, the patient should consult their doctor or pharmacist.

The recommended dose is: adults and adolescents over 12 years of age: 1 lozenge every 3-6 hours, as needed.

The patient should not take more than 5 lozenges per day.

The patient should take 1 lozenge and slowly dissolve it in their mouth. While dissolving, the patient should always move the lozenge around their mouth.

Use in children

These lozenges should not be given to children under 12 years of age.

The lozenges are for short-term use only.The patient should take the lowest number of lozenges necessary for the shortest time to relieve symptoms. If the patient experiences irritation in their mouth, they should stop taking flurbiprofen.

Vocaflam should not be taken for more than 5 days, unless the doctor recommends otherwise. If there is no improvement or the patient feels worse, or if new symptoms occur, the patient should consult their doctor or pharmacist.

Taking a higher dose of Vocaflam than recommended

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

Symptoms of overdose may include: nausea, vomiting, stomach pain, and diarrhea.

It is also possible to experience ringing in the ears, headache, and gastrointestinal bleeding.

In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking Vocaflam and contact their doctor immediately if they experience the following symptoms:

• symptoms of allergic reactions, such as asthma, unexpected wheezing, or shortness of breath, itching, runny nose, skin rash, etc.
• swelling of the face, tongue, or throat causing difficulty breathing, rapid heartbeat, and low blood pressure leading to shock (these can occur even with the first use of the medicine).
• severe skin reactions such as peeling, blistering, or shedding of the skin.

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

Further side effects that may occur:

Very common(may affect more than 1 in 10 people)

• mouth inflammation

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• drowsiness
• sleepiness or difficulty sleeping
• worsening of asthma and bronchospasm, shortness of breath, wheezing
• blistering in the mouth and throat, numbness of the throat
• dry mouth
• pain or sensation of heat, burning sensation in the mouth (glossodynia), change in taste, bloating, stomach pain, gas, constipation, indigestion, vomiting
• decreased sensation in the throat
• fever, pain
• skin rash, itching

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

• anaphylactic reaction
• jaundice

Very rare(may affect up to 1 in 10,000 people)

• gastrointestinal bleeding
• angioedema

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

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell 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: +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 this medicine.

5. How to store Vocaflam

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

Do not use this medicine after the expiry date stated on the carton and blister pack after: EXP. The expiry 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 they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Vocaflam contains

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

The other ingredients are:

Sucrose

Glucose liquid

Macrogol 400

Levomenthol

Honey flavor (contains citronellol)

Lemon flavor (contains citral, citronellol, geraniol, limonene, and linalool)

What Vocaflam looks like and contents of the pack

Vocaflam, 8.75 mg, hard lozenges, is presented as a white to pale yellow, round, flat lozenge with a honey and lemon flavor, 7.0 to 8.0 mm thick and 18.0 to 19.0 mm in diameter.

Pack size: 16 or 24 hard lozenges.

Marketing authorization holder and importer

Marketing authorization holder

Mapaex Consumer Healthcare (Ireland) Private Limited

IDA Business Park, Green Road, Newbridge

KILDARE

W12 X902

Ireland

+353 45 437 200

Importer

Infarmade S.L.

Calle De La Torre De Los Herberos 35

Polígono Industrial Carretera De La Isla

Dos Hermanas

41703 Sevilla

Spain

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

Slovakia: Vocasept 8.75 mg tvrdé pastilky

Poland: Vocaflam

Date of last revision of the leaflet: