Gardum vox

Package leaflet: Information for the patient

Gardum Vox, 8.75 mg, hard lozenges, lemon flavoured
Flurbiprofen
Please read carefully the entire leaflet before using this 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 the doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If advice or further information is needed, please contact your pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the 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 Gardum Vox is and what it is used for
2. Important information before taking Gardum Vox
3. How to take Gardum Vox
4. Possible side effects
5. How to store Gardum Vox
6. Contents of the pack and other information

1. What Gardum Vox is and what it is used for

Gardum Vox 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 modifying the body's response to pain, swelling, and high temperature.
Gardum Vox is intended for the short-term 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 the patient feels worse, consult a doctor.

2. Important information before using Gardum Vox

When not to use Gardum Vox

• 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 Gardum Vox, 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 (an antibiotic may be needed);
• if the patient has cardiovascular disorders, or impaired liver or kidney function;
• if the patient has had a stroke;
• if the patient has previously had intestinal disease (ulcerative colitis, Crohn's disease);
• if the patient has 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, as they 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 has medication-overuse headache;
• if the patient has an infection – see section “Infections” below.

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

• At the first signs of a skin reaction (rash, peeling) or other symptoms of an allergic reaction, stop using the medicine and consult a doctor immediately.
• 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. The risk is greater with higher doses or long-term treatment. Do not exceed the recommended dose or duration of treatment (3 days).

Children and adolescents
Do not use in children and adolescents under 12 years of age.
Gardum Vox with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription. In particular, inform the doctor if the patient is taking any of the following medicines:

• acetylsalicylic acid in low doses (up to 75 mg per day)
• medicines that lower blood pressure or are used in heart failure (antihypertensives, cardiac glycosides)
• diuretics (diuretics, including potassium-sparing diuretics)
• blood-thinning medicines (anticoagulants, antiplatelet agents)
• medicines used to treat gout (probenecid, sulfinpyrazone)
• other NSAIDs or corticosteroids (e.g. celecoxib, ibuprofen, sodium diclofenac or 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 to treat diabetes)
• zidovudine (a medicine used to treat HIV infection).

Gardum Vox with food, drink and alcohol
While using Gardum Vox, avoid consuming alcohol, as this may increase the risk of bleeding in the stomach or intestines.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 Gardum Vox.
Do not use this medicine during the last trimester of pregnancy.
If the patient is in the first 6 months of pregnancy or is breastfeeding, she should consult a doctor before using this medicine.
Flurbiprofen belongs to a group of medicines that may impair fertility in women. This effect is reversible after stopping the medicine. It is unlikely that occasional use of these pastilles will affect the chances of becoming pregnant; however, the patient should inform the doctor before using this medicine if she has difficulty becoming pregnant.
Driving and operating machinery
The effect of Gardum Vox on the ability to drive and operate machinery is unknown; however, after using non-steroidal anti-inflammatory drugs, adverse effects such as dizziness and visual disturbances may occur. If such effects occur, do not drive or operate machinery.
Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask symptoms 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.
Gardum Vox 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 take Gardum Vox

Gardum Vox must always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your 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, the pastille should always be moved around in 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 the patient has an infection, consult a doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Do not use Gardum Vox 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.

Taking more than the recommended dose of Gardum Vox
If more than the recommended dose has been taken, consult a doctor or pharmacist immediately or go to the nearest hospital. Symptoms of overdose may include nausea or vomiting, stomach 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 any medicine, this medicine can 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, unexplained 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 after the first dose of the medicine);
• severe skin reactions such as peeling, blistering or skin detachment.

If any of the symptoms listed below occur, or any symptoms not listed in this leaflet, you should
inform your doctor or pharmacist.
Other possible adverse reactions include:
Common (may occur in less than 1 in 10 patients)

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

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

• drowsiness
• feeling of drowsiness or difficulty sleeping
• worsening of asthma, wheezing, breathing difficulties
• 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 sensation in the throat
• fever, pain
• skin rash, skin itching.

Rare (may occur in less than 1 in 1000 patients)

• anaphylactic reaction.

Frequency unknown (frequency cannot be estimated from 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, you should inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring 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 this medicine.

5. How to store Gardum Vox

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 after 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 you no longer use. Such measures help protect the environment.

6. Contents of the package and other information

What Gardum Vox contains
The active substance is flurbiprofen. Each hard pastille contains 8.75 mg of flurbiprofen.
The other ingredients are: isomalt (E 953), maltitol liquid (E 965), acesulfame potassium (E 950),
macrogol 300 (E 1521), potassium hydroxide (E 525), lemon flavour, levomenthol.

What Gardum Vox looks like and contents of the pack
Gardum Vox 8.75 mg, hard pastilles, are round, transparent to yellowish pastilles, 19±1 mm in diameter, with a lemon flavour.
The pastilles are available in PVC/PVDC/aluminium 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
Silesian Pharma Sp. z o.o.
Szopienicka Street 77,
40-431 Katowice,
Poland
Tel: (32) 20 80 600
{logo of the marketing authorisation holder}

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

This medicinal product is authorised in the European Economic Area under the following names:
Spain: Tantufen 8,75 mg pastillas para chupar sabor limón
Portugal: Tantumflam Limão