GARDUM 8.75 mg Lozenge

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
2. What is Gardum Vox and what is it used for
3. Important information before taking Gardum Vox
   1. When not to take Gardum Vox
   2. Warnings and precautions
   3. During treatment with Gardum Vox
   4. Children and adolescents
   5. Gardum Vox and other medicines
   6. Gardum Vox with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Infections
   10. Gardum Vox contains isomalt and maltitol
4. How to take Gardum Vox
   1. Use in children
   2. Overdose of Gardum Vox
5. Possible side effects
   1. Reporting side effects
6. How to store Gardum Vox
7. Contents of the pack and other information
   1. What Gardum Vox contains
   2. What Gardum Vox looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Gardum Vox, 8.75 mg, hard lozenges, lemon flavor
Flurbiprofen

Read the package 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 package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

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

Table of Contents of the Leaflet

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

Gardum Vox contains flurbiprofen. Flurbiprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which have analgesic and anti-inflammatory properties in the treatment of sore throat. These medicines work by changing the body's response to pain, swelling, and high temperature.
Gardum Vox is intended for short-term relief of inflammatory throat symptoms, such as irritation, pain, and swelling of the throat and difficulty swallowing in adults and adolescents over 12 years of age.
If after 3 days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Gardum Vox

When not to take Gardum Vox

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6),
• if you have ever had asthma, unexplained wheezing, or shortness of breath, nasal discharge, facial swelling, or skin rash (hives) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs,
• if you have or have had stomach or intestinal ulcers (two or more episodes of stomach or duodenal ulcers),
• if you have had bleeding or perforation of the gastrointestinal tract, severe ulcerative colitis, or blood disorders associated with previous treatment with nonsteroidal anti-inflammatory drugs,
• if you are in the last 3 months of pregnancy,
• if you have or have had severe heart, liver, or kidney failure.

Warnings and precautions

Before starting treatment with Gardum Vox, discuss it with your doctor or pharmacist:

• if you have or have had asthma or allergies;
• if you have tonsillitis (swollen tonsils) or suspect you may have a bacterial throat infection (you may need an antibiotic);
• if you have cardiovascular, liver, or kidney disorders;
• if you have had a stroke;
• if you have had intestinal disease (ulcerative colitis, Crohn's disease);
• if you have high blood pressure;
• if you have a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease);
• if you are elderly (you may be more prone to side effects listed in the leaflet);
• if you are pregnant or breastfeeding;
• if you have headaches caused by painkillers;
• if you have an infection - see "Infections" below.

Avoid taking two or more nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone) at the same time, as this may increase the risk of side effects, particularly gastrointestinal ones, such as ulcers and bleeding (see "Gardum Vox and other medicines" below).

During treatment with Gardum Vox

• At the first signs of any skin reactions (rash, peeling) or other symptoms of an allergic reaction, stop taking the medicine and consult a doctor immediately.
• Report any unusual abdominal symptoms (especially bleeding) to your doctor. If there is no improvement, or you feel worse, or 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 longer treatment. Do not exceed the recommended dose or duration of treatment (3 days).

Children and adolescents

Do not give this medicine to children and adolescents under 12 years of age.

Gardum Vox and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription. In particular, inform your doctor about taking the following medicines:

• acetylsalicylic acid [except for low doses (up to 75 mg per day) prescribed by a doctor]
• blood pressure-lowering medicines or those used in heart failure (antihypertensives, cardiac glycosides)
• 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, diclofenac sodium, prednisolone) (see "Warnings and precautions" above)
• 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).

Gardum Vox with food, drink, and alcohol

Avoid consuming alcohol while taking Gardum Vox, as it may increase the risk of stomach or intestinal bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medicine.
Oral forms (e.g., tablets) of flurbiprofen may cause side effects in the unborn child. It is not known if the same risk applies to Gardum Vox.
Do not take this medicine in the last trimester of pregnancy.
If you are in the first 6 months of pregnancy or breastfeeding, consult a doctor before taking this medicine.
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 occasional use of these lozenges will affect the chances of getting pregnant; however, tell your doctor before taking this medicine if you have problems getting pregnant.

Driving and using machines

The effect of Gardum Vox on the ability to drive and use machines is not known; however, after taking nonsteroidal anti-inflammatory drugs, side effects such as dizziness and vision disturbances may occur. If these occur, do not drive or operate machinery.

Infections

Nonsteroidal anti-inflammatory drugs (NSAIDs) may mask the symptoms of infection, such as fever and pain. This may delay appropriate treatment of infections, leading to increased risk of complications. If you are taking this medicine during an ongoing infection and your symptoms persist or worsen, consult a doctor or pharmacist immediately.

Gardum Vox contains isomalt and maltitol

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Gardum Vox

Gardum Vox should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years of age:
1 hard lozenge every 3 to 6 hours, as needed.
Do not take more than 5 lozenges in 24 hours.
Method of administration
For oral use.
The lozenge should be slowly dissolved in the mouth, do not swallow or chew the lozenge.
While dissolving, always move the lozenge around the mouth.

Use in children

Do not give this medicine to children under 12 years of age.
These lozenges are intended for short-term use only.Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If oral irritation occurs, discontinue use of flurbiprofen.
If you have an infection, consult a doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Do not take Gardum Vox for more than 3 days. If there is no improvement, or you feel worse, or new symptoms appear, consult a doctor or pharmacist.

Overdose of Gardum Vox

If you take more than the recommended dose of Gardum Vox, consult a doctor or pharmacist or go to the nearest hospital. Symptoms of overdose may include: nausea or vomiting, stomach pain, or diarrhea. There may also be ringing in the ears, headache, and gastrointestinal bleeding.
If you have any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP TAKING THIS MEDICINE AND CONTACT A DOCTOR IMMEDIATELY IF YOU EXPERIENCE:

• symptoms of allergic reactions, such as asthma, unexplained wheezing, or shortness of breath, itching, nasal congestion, skin rash, etc.;
• swelling of the face, tongue, or throat causing difficulty breathing, rapid heartbeat, and low blood pressure leading to shock (may occur even after the first dose);
• severe skin reactions such as peeling, blistering, or shedding of the skin.

If you experience any of the following symptoms or symptoms not listed in this leaflet, tell your doctor or pharmacist.
Other side effects that may occur:

Common(may affect up to 1 in 10 people)

• dizziness, headache
• throat irritation
• mouth ulcers or mouth pain
• throat pain
• discomfort or unusual sensations in the mouth (feeling of heat, burning, tingling, pricking, etc.)
• nausea and diarrhea
• tingling and itching of the skin.

Uncommon(may affect up to 1 in 100 people)

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

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

• anaphylactic reaction.

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

• anemia, thrombocytopenia (low platelet count, which may cause bruising and bleeding)
• edema, high blood pressure, heart failure, or heart attack
• severe skin reactions, such as blistering, including Stevens-Johnson syndrome, Lyell's syndrome, and toxic epidermal necrolysis
• hepatitis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gardum Vox

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 after EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storage.
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 Gardum Vox contains

The active substance is flurbiprofen. One hard lozenge contains 8.75 mg of flurbiprofen.
The other ingredients are:
Isomalt
Liquid maltitol
Potassium acesulfame (E 950)
Macrogol 300
Potassium hydroxide
Lemon flavor
Levomenthol

What Gardum Vox looks like and contents of the pack

Gardum Vox, 8.75 mg, hard lozenges, are round, orange lozenges, 19±1 mm in diameter, with a lemon flavor.
The lozenges are available in PVC/PVDC/Aluminum blister packs in a cardboard box.
Package sizes: 8, 12, 16, 20, or 24 hard lozenges.
Not all pack sizes may be marketed.

Marketing authorization holder

Silesian Pharma Sp. z o.o.
Szopienicka 77
40-431 Katowice
Tel: (32) 20 80 600

Manufacturer

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

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

Spain: Tantufen 8,75mg pastillas para chupar sabor limón
Portugal: Tantumflam Limão

Date of last revision of the leaflet: