Voxifen intensive

Package leaflet: Information for the patient

Voxifen Intensive, 8.75 mg, hard pastilles with honey-menthol flavour
Flurbiprofen
Please read the entire leaflet carefully before using 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 a
doctor, pharmacist, or nurse.

• Keep this leaflet for possible future reference.
• If advice or further information is needed, please consult a pharmacist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Table of contents

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

1. What Voxifen Intensive is and what it is used for

Voxifen Intensive contains flurbiprofen. Flurbiprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic and anti-inflammatory properties in the treatment of sore throat. These medicines work by altering the body's response to pain, swelling, and high temperature.
Voxifen Intensive is intended for short-term relief of inflammatory symptoms of the 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 the patient feels worse, consult a doctor.

2. Information before using Voxifen Intensive

When not to use Voxifen Intensive

• 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, 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 treatment with non-steroidal anti-inflammatory drugs,
• if the patient is in the last 3 months of pregnancy,
• if the patient currently has or has had severe heart, liver or kidney failure.

Warnings and precautions
Before starting to use Voxifen Intensive, discuss this with your doctor or pharmacist:

• if the patient has or has ever had asthma or suffers from allergies;
• if the patient has tonsillitis (swollen tonsils) or suspects a bacterial throat infection (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 had intestinal disorders in the past (e.g. 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 (may be more susceptible to the adverse effects listed in this leaflet);
• if the patient is in the first 6 months of pregnancy or is breastfeeding;
• if the patient suffers from medication-overuse headache;
• if the patient develops an infection – see subsection “Infections” below.

Avoid concomitant use of two or more NSAIDs or corticosteroids (such as celecoxib, ibuprofen, sodium diclofenac or prednisolone), as this may increase the risk of adverse effects, particularly gastrointestinal effects such as ulcers and bleeding (see section “Voxifen Intensive and other medicines” below).
While using Voxifen Intensive

• At the first signs of any skin reactions (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 (especially bleeding) to your doctor. If there is no improvement, if the patient feels worse or if new symptoms appear, consult a doctor.
• Medicines containing flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with higher doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment (3 days).

Children and adolescents
This medicine must not be used in children and adolescents under 12 years of age.
Voxifen Intensive and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without prescription. In particular, inform your doctor if you are taking any of the following medicines:

• acetylsalicylic acid [except low doses (up to 75 mg daily) prescribed by a doctor]
• medicines used to lower blood pressure or in heart failure (antihypertensives, cardiac glycosides)
• diuretics (including potassium-sparing diuretics)
• anticoagulant or antiplatelet medicines (blood-thinning medicines)
• medicines used in the treatment of gout (probenecid, sulfinpyrazone)
• other NSAIDs or corticosteroids (e.g. celecoxib, ibuprofen, sodium diclofenac, prednisolone) (see above “Warnings and precautions”)
• 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 cancers)
• lithium or medicines from the group of selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat depression)
• oral antidiabetic medicines (used in the treatment of diabetes)
• zidovudine (a medicine used to treat HIV infection).

Voxifen Intensive with food, drink and alcohol
During treatment with Voxifen Intensive, avoid consuming alcohol, as this may increase the risk of gastrointestinal bleeding in the stomach or intestines.
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 her 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 Voxifen Intensive.
This medicine must not be used during the last trimester of pregnancy.
If the patient is in the first 6 months of pregnancy or is breastfeeding, she should consult her doctor before using this medicine.
Flurbiprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible after stopping the medicine. It is unlikely that occasional use of these pastilles would affect the chances of becoming pregnant; however, patients with difficulty conceiving should inform their doctor before using this medicine.
Driving and operating machinery
The effect of Voxifen Intensive on the ability to drive or operate machinery is unknown. However, after using non-steroidal anti-inflammatory drugs, adverse effects such as dizziness and visual disturbances may occur. If these occur, do not drive or operate machinery.
Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain. This may delay appropriate treatment of infections, potentially increasing the risk of complications. If the patient takes this medicine during an ongoing infection and symptoms persist or worsen, consult a doctor or pharmacist immediately.
Voxifen Intensive contains isomalt and maltitol
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Voxifen Intensive

Voxifen Intensive must always be used exactly as described in this patient information leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose
Adults and adolescents over 12 years of age:
1 hard pastille every 3 to 6 hours, as needed.
Do not take more than 5 pastilles within 24 hours.

Method of administration
For oral use.
Allow the pastille to dissolve slowly in the mouth. Do not swallow or chew the pastille.
While dissolving, always move the pastille around within the mouth.

Use in children
This medicine must not be used in children under 12 years of age.

These pastilles are intended for short-term use only. Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If irritation occurs in the mouth, discontinue use of flurbiprofen.

If an infection is present, consult a doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Do not use Voxifen Intensive for longer than 3 days. If there is no improvement, if the patient feels worse, or if new symptoms appear, consult a doctor or pharmacist.

Overdose of Voxifen Intensive
If more than the recommended dose is taken, consult a doctor or pharmacist or go to the nearest hospital immediately. Symptoms of overdose may include nausea or vomiting, abdominal pain, or less commonly diarrhoea. Tinnitus, headache, and gastrointestinal bleeding may also occur.

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 everybody will experience them.
YOU SHOULD DISCONTINUE USE of this medicine and contact your doctor immediately if any of the following symptoms occur:

• signs of allergic reactions such as asthma, unexplained wheezing or shortness of breath, itching, nasal mucosal inflammation, skin rashes, 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 after the first dose of the medicine);
• severe skin reactions such as peeling, blistering or skin shedding.

If any of the symptoms listed below occur, or any symptoms not listed in this leaflet, you should inform your doctor or pharmacist.
Other adverse reactions that may occur:
Common (may affect up to 1 in 10 people)

• dizziness, headache
• throat irritation
• mouth ulcers or mouth pain
• sore throat
• discomfort or unusual sensations in the mouth (such as warmth, burning, tingling, stinging, etc.)
• nausea and diarrhoea
• skin tingling and itching.

Uncommon (may affect up to 1 in 100 people)

• drowsiness
• feeling sleepy or difficulty sleeping
• worsening of asthma, wheezing, difficulty breathing
• blistering in the mouth and throat, throat numbness
• dry mouth
• burning sensation in the mouth, taste disturbances, bloating
• abdominal pain, flatulence, constipation, indigestion, vomiting
• reduced throat sensation
• fever, pain
• skin rashes, skin itching.

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

• anaphylactic reaction.

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

• anaemia, thrombocytopenia (low platelet count, which may lead to bruising and bleeding)
• oedema, 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.

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, 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Voxifen Intensive

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater 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 pack and other information

What Voxifen Intensive contains
The active substance is flurbiprofen. One hard pastille contains 8.75 mg of flurbiprofen.
Other ingredients are:
Isomalt
Maltitol liquid
Acesulfame potassium (E 950)
Macrogol 300
Potassium hydroxide
Honey flavour
Peppermint essential oil
l-Menthol

What Voxifen Intensive looks like and contents of the pack
Voxifen Intensive 8.75 mg, hard pastilles, are round, orange-coloured pastilles, 19±1 mm in diameter, with a honey-menthol taste.
The pastilles are available in PVC/PVDC/Aluminium foil blisters, packed in a cardboard box.
Pack sizes: 8, 12, 16, 20 or 24 hard pastilles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fortis Pharmaceuticals Sp. z o.o.
ul. Mickiewicza 29
40-085 Katowice
tel.: +48 32 726 66 67

Manufacturer
Lozy´s Pharmaceuticals S.L.
Campus Empresarial Lekaroz No 1
31795 Lecaroz
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:
Spain: Tantufen 8.75 mg pastillas para chupar sabor miel y menta
Portugal: Tantumflam mel e hortelã-pimenta