Vocaflam orange flavor sugar-free

Patient Information Leaflet

Vocaflam orange flavour sugar-free, 8.75 mg, hard pastilles
Flurbiprofenum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents

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

1. What Vocaflam orange flavour sugar-free is and what it is used for

Vocaflam orange flavour sugar-free 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 orange flavour sugar-free is used for the short-term local relief of symptoms of
inflammatory sore throat, such as irritation, pain and swelling of the throat, and difficulty in
swallowing, in adults and adolescents over 12 years of age.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before taking Vocaflam orange flavour sugar-free
When not to use Vocaflam orange flavour sugar-free

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6).
• if you have asthma, unexpected breathing sounds, difficulty breathing, nasal congestion, facial swelling or skin rash such as hives (urticaria) after taking acetylsalicylic acid or other NSAIDs.
• if you have or have had a peptic ulcer (two or more episodes of gastric or duodenal ulcers) in the stomach or intestines.
• if you have experienced gastrointestinal bleeding or perforation, severe colitis or blood disorders associated with 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 orange flavour sugar-free, discuss with your doctor or pharmacist:

• if you have ever had asthma or allergies.
• if you have tonsillitis (swollen tonsils) or suspect you may have a bacterial throat infection (as antibiotic treatment may be required).
• if you have cardiovascular, liver or kidney disorders.
• if you have had a stroke.
• if you have a history of intestinal diseases (ulcerative colitis, Crohn's disease).
• if you have high blood pressure or heart failure.
• if you have a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease).
• if you are elderly, as there is a higher likelihood of experiencing the side effects listed in this leaflet.
• if you are in the first six months of pregnancy or are breastfeeding.
• if you suffer from medication-induced headache.
• if you have diabetes.
• if you have an infection – see section "Infections" below.

While using Vocaflam orange flavour sugar-free

• If you experience the first signs of a skin reaction (rash, peeling) or other symptoms of an allergic reaction, stop taking the medicine immediately and consult your doctor without delay.
• Report any unusual gastrointestinal symptoms to your doctor (especially bleeding). If your condition does not improve, worsens, or new symptoms appear, consult your doctor.
• 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 (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 the infection, potentially increasing the risk of complications.
If you take this medicine during an infection and symptoms persist or worsen, consult your doctor or pharmacist immediately.

Children and adolescents
This medicine is not recommended for children under 12 years of age.

Vocaflam orange flavour sugar-free with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription.
In particular, inform your doctor if you are taking:

• 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)
• anticoagulant or antiplatelet medicines (blood thinners)
• medicines used in the treatment of 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)
• medicines that neutralize stomach acid (used to treat gastric acidity)
• acetazolamide (used to treat glaucoma or fluid retention)

Vocaflam orange flavour sugar-free with food, drink and alcohol
Avoid drinking alcohol while taking Vocaflam orange flavour sugar-free, as it may increase the risk of gastrointestinal bleeding. Taking the medicine with food may delay the onset of action.

Pregnancy, breastfeeding and fertility
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 Vocaflam orange flavour sugar-free.
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 use Vocaflam orange flavour sugar-free during the last three months of pregnancy.
Do not use Vocaflam orange flavour sugar-free during the first six months of pregnancy unless clearly necessary and recommended by your doctor. If treatment is necessary during this period, use the lowest effective dose for the shortest possible time.

Flurbiprofen belongs to a group of medicines that may affect female fertility. This effect is reversible after stopping the medicine. It is unlikely that these pastilles will affect the chances of becoming pregnant when used occasionally, but you should inform your doctor before using this medicine if you have difficulty becoming pregnant.

Driving and using machines
Vocaflam orange flavour sugar-free 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, do not drive or operate machinery. Drowsiness is also a possible side effect and may affect your ability to drive.

Vocaflam orange flavour sugar-free contains isomalt (E953) and maltitol (E965)
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Vocaflam orange flavour sugar-free may have a mild laxative effect. The caloric value of maltitol and isomalt is 2.3 kcal/g.
Vocaflam orange flavour sugar-free contains a flavouring substance composed of citral, citronellol, geraniol and linalool, which may cause allergic reactions.

3. How to use Vocaflam orange flavour sugar-free

Vocaflam orange flavour sugar-free must always be used exactly as described
in this patient information leaflet or as recommended by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 12 years and over:
1 tablet every 3 to 6 hours, as needed.
Do not use more than 5 tablets in 24 hours.
Take 1 tablet and allow it to dissolve slowly in the mouth. While dissolving, the tablet should
always be moved around in the mouth.
Use in children
These tablets are not recommended for children under 12 years of age.
These hard tablets are intended for short-term use only. Use the lowest effective dose for the
shortest duration necessary to relieve symptoms.
In case of infection, consult a doctor or pharmacist immediately if symptoms (such as fever and
pain) persist or worsen (see section 2). If irritation of the mouth occurs, discontinue treatment with
flurbiprofen.
Do not use Vocaflam orange flavour sugar-free for longer than 3 days. If there is no improvement
or symptoms worsen, or if new symptoms appear, consult a doctor.
Taking more than the recommended dose of Vocaflam orange flavour sugar-free
Seek immediate medical advice from a doctor or pharmacist, or go to the nearest hospital.
Symptoms of overdose may include: nausea or vomiting, abdominal pain, less commonly diarrhoea.
Tinnitus, headache and gastrointestinal bleeding may also occur.
Missed dose of Vocaflam orange flavour sugar-free
Do not take a double dose to make up for a missed dose.
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 may cause adverse reactions, although not everyone experiences 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 administration 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:
Very common ( may occur in more than 1 in 10 people )

• Stomatitis (inflammation of the mouth)

Common ( may occur in less than 1 in 10 people )

• Dizziness, headache, tingling and itching of the skin (paresthesia)
• Sore throat
• Ulcers in the mouth or mouth pain
• Sore throat
• Discomfort or unusual sensation in the mouth (e.g. burning or warmth in the mouth, tingling, pricking, etc.)
• Nausea and diarrhea
• Abdominal pain

Uncommon ( may occur in less than 1 in 100 people )

• Drowsiness 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, taste disturbance, bloating, flatulence, constipation, indigestion, vomiting
• Reduced throat sensation
• Fever, pain
• Skin rash, skin itching

Rare ( may occur in less than 1 in 1,000 people )

• Anaphylactic reaction
• Jaundice and reduced platelet count (thrombocytopenia), which usually resolve after discontinuation of the medicine

Very rare ( may occur in less than 1 in 10,000 people )

• Gastrointestinal bleeding (black, tarry stools with abdominal pain, possibly blood in stool or vomiting blood)
• Swelling of various body parts (angioedema)

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

• Anemia
• Edema (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 (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 of 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 can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vocaflam orange flavour sugar-free

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

6. Contents of the pack and other information

What Vocaflam Orange Flavour Sugar Free contains
The active substance is flurbiprofen. One hard pastille contains 8.75 mg of flurbiprofen.
The other ingredients are: isomalt (E953), liquid maltitol (E965), potassium acesulfame (E950), macrogol 400, levomenthol, orange juice flavour (containing triacetin (E1518), flavouring agents and natural flavouring substances, including citral, citronellol, geraniol and linalool).

What Vocaflam Orange Flavour Sugar Free looks like and contents of the pack
Vocaflam Orange Flavour Sugar Free 8.75 mg, hard pastilles, are white to light yellow, round, flat-faced orange-flavoured pastilles, 7 to 8 mm thick and 18 to 19 mm in diameter.
The pastilles are supplied in white, opaque PVC/PVDC/Aluminium blisters, packed in printed cardboard cartons.
Pack sizes: 8, 16 or 24 hard pastilles.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Mapaex Consumer Healthcare (Ireland) Private Limited
IDA Business Park, Green Road, Newbridge
KILDARE
W12 X902
Ireland
Tel. +353 45 437 200

Importer
Infarmade S.L.
C/ Torre de los Herberos, 35
P.I. Carretera de la Isla
41703 Dos Hermanas, Seville
Spain

This medicinal product is authorised in the European Economic Area under the following names:
Slovakia: Vocasept s pomarančovou príchuťou bez cukru 8,75 mg tvrdé pastilky
Poland: Vocaflam smak pomarańczowy bez cukru
Czech Republic: Vocafen pomeranč bez cukru
Romania: Vocaflam Portocale fără zahăr 8,75 mg pastile
Hungary: Vocafen cukormentes narancsízű 8,75 mg szopogató tabletta
Bulgaria: Vocasept Orange Sugar free 8,75 mg Lozenges
Estonia: Vocasept apelsin suhkruvaba
Latvia: Vocafen ar apelsīna garšu 8,75 mg sūkājamās tabletes
Lithuania: Effafen apelsinų skonio 8,75 mg kietosios pastilės