Patient Information Leaflet

Vocaflam, 8.75 mg, hard pastilles
Flurbiprofen
Please read this leaflet carefully before using 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, as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 5 days, or if you feel worse, consult your doctor.

Table of contents

What Vocaflam is and what it is used for
Important information before taking Vocaflam
How to take Vocaflam
Possible side effects
How to store Vocaflam
Contents of the pack and other information

1. What Vocaflam is and what it is used for

Vocaflam contains flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic and anti-inflammatory properties.
Vocaflam is used for the short-term treatment of sore throat symptoms such as irritation, pain, swelling, and difficulty swallowing in adults and adolescents over 12 years of age.
If there is no improvement after 5 days, or if you feel worse, consult your doctor.

2. Important information before taking Vocaflam
When not to use Vocaflam

if you are allergic to flurbiprofen or to any of the other ingredients of this medicine (listed in section 6).
if you have asthma, unexpected breathing sounds or difficulty breathing, runny nose, facial swelling or skin rash such as itching (urticaria) after taking acetylsalicylic acid or other NSAIDs.
if you have or have had a peptic ulcer (two or more episodes of stomach or duodenal ulcers) in the stomach or intestines.
if you have experienced gastrointestinal bleeding or perforation, severe colitis, or blood disorders related to previous treatment with NSAIDs.
if you are in the last three months of pregnancy.
if you have or have had severe heart, liver or kidney failure.

Warnings and precautions
Before starting to take Vocaflam, discuss this with your doctor or pharmacist if:

you have ever had asthma or allergies.
you have tonsillitis (swollen tonsils) or suspect you may have a bacterial throat infection (as antibiotic treatment may be necessary).
you have cardiovascular, liver or kidney disorders.
you have had a stroke.
you have a history of intestinal diseases (ulcerative colitis, Crohn's disease).
you have high blood pressure.
you suffer from a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease).
you are elderly, as there is an increased likelihood of experiencing the adverse effects listed in this leaflet.
you are in the first six months of pregnancy or are breastfeeding.
you have been taking painkillers for headaches over a long period, as this may worsen the headaches.

While taking Flurbifex

If you experience the first signs of a skin reaction (rash, peeling) or other signs of an allergic reaction, stop taking the medicine and consult your doctor immediately.
Inform your doctor about any unusual abdominal symptoms (especially bleeding). If your condition does not improve, worsens, or new symptoms appear, talk to your doctor.
The use of medicines containing flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with higher doses and prolonged treatment. Do not exceed the recommended dose or extend the treatment period (5 days).

Children
Do not use this medicine in children under 12 years of age.
Vocaflam and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.
In particular, inform your doctor if you are taking the following medicines:

acetylsalicylic acid in low doses (up to 75 mg per day)
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 to treat gout (probenecid, sulfinpyrazone)
other NSAIDs or corticosteroids (e.g. celecoxib, ibuprofen, sodium diclofenac, prednisolone)
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 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 for various fungal infections)

Taking Vocaflam with food, drink and alcohol
Avoid drinking alcohol while taking Vocaflam, as it may increase the risk of stomach or intestinal bleeding.
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Do not take Vocaflam if you 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 increase the tendency to bleeding in both mother and child and may delay or prolong labour.
Do not use Vocaflam during the first six months of pregnancy unless your doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time.
From week 20 of pregnancy, Vocaflam may cause kidney problems in the unborn child if taken for longer than a few days – this 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 for longer than a few days is required, your doctor may recommend additional monitoring.
Vocaflam is not recommended for use during breastfeeding.
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 pastilles will affect the chances of becoming pregnant when taken occasionally, but you should tell your doctor before using this medicine if you have difficulty becoming pregnant.

Driving and using machines
Vocaflam is unlikely to affect your ability to drive or operate machinery. However, dizziness and visual disturbances are possible side effects of NSAIDs. If these occur, patients should not drive or operate machinery. Drowsiness is also a possible side effect and may affect the ability to drive.

Vocaflam contains sucrose and glucose. If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
Vocaflam contains citral, citronellol, geraniol, limonene and linalool flavourings, 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 your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose: Adults and adolescents over 12 years of age:
1 pastille every 3 to 6 hours, as needed.
Do not take more than 5 pastilles per day.
Take 1 pastille and slowly dissolve it in the mouth. While dissolving, always move the pastille around in the mouth.
Use in children
Do not give these pastilles to children under 12 years of age.
Hard pastilles are intended for short-term use only. Take the lowest possible number of pastilles for the shortest time necessary to relieve symptoms. If irritation occurs in the mouth, discontinue use of flurbiprofen.
Do not use Vocaflam for longer than 5 days, unless otherwise advised by a doctor. If there is no improvement, if your condition worsens, or if new symptoms appear, contact your doctor or pharmacist.
Taking more Vocaflam than recommended
Contact your doctor or pharmacist immediately or go to the nearest hospital.
Symptoms of overdose may include: nausea, vomiting, stomach pain, and 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 any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
YOU SHOULD DISCONTINUE USE of this medicine and contact your doctor immediately if
any of the following symptoms occur:

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 in breathing, rapid heartbeat and drop in blood pressure leading to shock (these may occur even during the first use 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 occur, inform your doctor or pharmacist.
Other possible adverse reactions include:
Very common ( may affect more than 1 in 10 people )

Stomatitis

Common ( may affect up to 1 in 10 people )

Dizziness, headache, tingling and itching of the skin (paresthesia)
Throat irritation
Ulcers in the mouth or mouth pain
Sore throat
Discomfort in the mouth or unusual sensations in the mouth (e.g. burning or warmth in the mouth, tingling, pricking, etc.)
Nausea and diarrhoea

Uncommon ( may affect up to 1 in 100 people )

Drowsiness
Lethargy or difficulty sleeping
Worsening of asthma and bronchospasm, shortness of breath, wheezing
Blistering in the mouth and throat, throat numbness
Dryness in the mouth
Pain or sensation of heat, burning sensation in the mouth (glossodynia), altered taste, bloating, abdominal pain, flatulence, constipation, indigestion, vomiting
Reduced sensation in the throat
Fever, pain
Skin rash, itchy skin

Rare adverse reactions ( 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)

Anaemia, thrombocytopenia (low platelet count which may cause excessive bruising and bleeding), oedema (swelling), 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
Sinus pain

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 Reactions of Medicinal Products, 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store the medicine Vocaflam

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the blister foil after:
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the packaging and other information

What Vocaflam contains
The active substance is flurbiprofen. One hard tablet contains 8.75 mg of flurbiprofen.
Other ingredients are:
Sucrose
Liquid glucose
Macrogol 400
Levomenthol
Honey flavour (contains citronellol)
Lemon flavour (contains citral, citronellol, geraniol, limonene and linalool)

What Vocaflam looks like and contents of the pack
Vocaflam 8.75 mg, hard tablets, are presented as white to pale yellow, round, flat-faced tablets with a honey and lemon taste, with a thickness of 7.0 to 8.0 mm and a diameter of 18.0 to 19.00 mm.
Pack sizes: 16 or 24 hard tablets.

Marketing Authorisation Holder and Importer
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Slovakia: Vocasept 8.75 mg tvrdé pastilky
Poland: Vocaflam