Gardifen direct

Package leaflet: Information for the user

GARDIFEN Direct, 8.75 mg/dose, oral spray, solution
Flurbiprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as
instructed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if your condition worsens, contact your doctor.

Contents of the leaflet

1. What GARDIFEN Direct is and what it is used for
2. Important information before using GARDIFEN Direct
3. How to use GARDIFEN Direct
4. Possible side effects
5. How to store GARDIFEN Direct
6. Contents of the pack and other information

1. What GARDIFEN Direct is and what it is used for

The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which work by altering the body's response to pain, swelling, and high temperature.
GARDIFEN Direct is intended for short-term relief of symptoms of inflammatory conditions of the throat, such as sore throat, swelling, and difficulty swallowing, in adults aged 18 years and older.
If there is no improvement after 3 days or if you feel worse, consult your doctor.

2. Important information before using the medicine Direct

When not to use the medicine Direct:

• if the patient is allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced an allergic reaction after taking non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid), e.g. asthma, wheezing, itching, rhinitis, skin rash, swelling;
• if the patient has or has had two or more episodes of gastric ulcers or bleeding, or intestinal ulcers;
• if the patient has ever had severe colitis (inflammation of the large intestine);
• if the patient has ever had blood clotting disorders or bleeding after taking NSAIDs;
• if the patient is in the last three months of pregnancy;
• if the patient has severe heart, kidney or liver failure.

Warnings and precautions
Before starting to use the medicine Direct, discuss with a doctor or pharmacist if:

• the patient is already taking any other non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid;
• the patient has tonsillitis or suspects a bacterial throat infection (antibiotic treatment may be required);
• the patient is elderly (may be more susceptible to adverse effects);
• the patient has or has ever had asthma or suffers from allergies;
• the patient has a skin condition called systemic lupus erythematosus or mixed connective tissue disease;
• the patient has been diagnosed with high blood pressure (hypertension);
• the patient has previously had intestinal disease (ulcerative colitis, Crohn's disease);
• the patient has or has ever had heart, kidney or liver disease;
• the patient has had a stroke;
• the patient is in the first six months of pregnancy or is breastfeeding;
• the patient suffers from medication-overuse headaches;
• the patient has diabetes;
• the patient develops an infection – see subsection "Infections" below.

While using the medicine Direct

• At the first signs of any hypersensitivity reaction (rash, peeling, blisters) or other symptoms of an allergic reaction, stop using the aerosol immediately and consult a doctor.
• Report any unusual gastrointestinal symptoms (especially bleeding) to a doctor.
• If the patient's condition does not improve, worsens, or new symptoms appear, consult a doctor.
• Medicines such as flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. The risk is greater with higher doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment (see section 3).

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, seek immediate advice from a doctor or pharmacist.

Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.

Direct and 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:

• other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors used for pain or inflammation, as they may increase the risk of gastrointestinal bleeding;
• warfarin, acetylsalicylic acid, and other anticoagulant and antiplatelet medicines;
• angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (medicines used to lower blood pressure);
• diuretics (water tablets), including potassium-sparing diuretics;
• SSRIs (selective serotonin reuptake inhibitors) used to treat depression;
• cardiac glycosides (used in heart conditions) such as digoxin;
• cyclosporine (used to prevent organ rejection after transplantation);
• corticosteroids (reduce inflammation);
• lithium (used to treat mood disorders);
• methotrexate (used to treat psoriasis, arthritis, and cancer);
• mifepristone (used to terminate pregnancy); NSAIDs should not be used within 8–12 days after mifepristone administration, as they may reduce the effectiveness of mifepristone;
• oral antidiabetic medicines;
• phenytoin (used to treat epilepsy);
• probenecid, sulfinpyrazone (used to treat gout and arthritis);
• quinolone antibiotics (used to treat bacterial infections), such as ciprofloxacin, levofloxacin;
• tacrolimus (an immunosuppressant used after organ transplantation);
• zidovudine (used in HIV infection);
• fluconazole (an antifungal medicine used to treat various fungal infections);
• acid-neutralizing medicines (used to treat stomach acidity);
• acetazolamide (used to treat glaucoma or fluid retention).

Direct with food, drink and alcohol
While using this medicine, avoid consuming alcohol, as it may increase the risk of gastrointestinal bleeding.
Taking the medicine with food may delay the onset of its effect.

Pregnancy, breastfeeding and fertility

Pregnancy
Oral forms (e.g. tablets) of flurbiprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies to Direct, an oral cavity aerosol solution.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine. Do not use Direct during the last 3 months of pregnancy. Do not use Direct during the first 6 months of pregnancy unless clearly necessary and prescribed by a doctor. If treatment is required during this period, the lowest effective dose should be used for the shortest possible time.

Breastfeeding
This medicine is not recommended during breastfeeding.

Effect on fertility
This medicine belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible after stopping the medicine.

Driving and using machines
This medicine is unlikely to affect the ability to drive or operate machinery. However, dizziness and visual disturbances may occur after taking NSAIDs. In such cases, do not drive or operate machinery.

Direct contains sodium, ethanol and flavouring agents containing d-limonene, citral and eugenol
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".
This medicine contains 0.14 mg of alcohol (ethanol) per dose. The amount of alcohol in each dose is equivalent to less than 0.0035 mL of beer or 0.0014 mL of wine. The small amount of alcohol in this medicine will not cause noticeable effects.
This medicine contains flavouring agents containing d-limonene, citral and eugenol, which may cause allergic reactions.

3. How to use the medicine Direct

This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose is:
Adults aged 18 years and above
One dose (3 sprays of the aerosol) to the back of the throat every 3–6 hours, as needed. Do not
administer more than 5 doses (15 sprays of the aerosol) within a 24-hour period.
One dose (3 sprays of the aerosol) contains 8.75 mg of flurbiprofen.
Use in children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
For oral use only.

• Spray the aerosol only onto the back of the throat.
• Do not inhale during aerosol spraying.
• Do not administer more than 5 doses (15 sprays of the aerosol) within 24 hours.

GARDIFEN Direct is intended for short-term use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. 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).
If irritation of the mouth occurs, discontinue use of flurbiprofen.
Do not use the medicine for longer than 3 days unless advised by a doctor.
If there is no improvement, if symptoms worsen, or if new symptoms appear, consult a doctor or
pharmacist.
Priming the pump
At first use of the pump (or after prolonged storage), shake the applicator and prime the pump.
Point the nozzle away from you and spray the aerosol at least four times until a fine, uniform mist is
obtained. The pump is now ready for use. If the product has not been used for some time, point the
nozzle away from you and spray the aerosol at least once to achieve a fine, uniform mist.
Before each administration, always ensure that a fine, uniform mist is produced.
Using the aerosol
Direct the nozzle towards the back of the throat.

With a quick, smooth motion, press the pump three times, ensuring that the pump is fully depressed
with each spray, and remove your finger from the top of the pump between each spray.

Do not inhale during aerosol spraying.
Taking more medicine Direct than recommended
Seek advice from a doctor or pharmacist or go to the nearest hospital immediately. Symptoms of
overdose may include: nausea or vomiting, stomach pain or, less commonly, diarrhoea. Tinnitus,
headache, and gastrointestinal bleeding may also occur.
If you forget to use medicine Direct
Do not use a double dose to make up for a forgotten dose.
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 everyone will experience them.
STOP TAKING THE MEDICINE AND CONTACT YOUR DOCTOR IMMEDIATELY
if any of the following symptoms occur:

• severe skin reactions, such as blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare conditions caused by serious adverse drug reactions or infections, in which there is a severe reaction affecting the skin and mucous membranes). Frequency: unknown (frequency cannot be estimated from available data).
• symptoms of anaphylactic shock characterized by swelling of the face, tongue or throat, causing difficulty in breathing, rapid heartbeat, and drop in blood pressure leading to shock (may occur even after first use of the medicine). Frequency: rare (may occur in up to 1 in 1,000 people).
• symptoms of hypersensitivity and skin reactions, such as redness, swelling, peeling, blistering or ulceration of the skin and mucous membranes. Frequency: uncommon (may occur in up to 1 in 100 people).
• symptoms of allergic reaction, e.g. asthma, unexplained wheezing or shortness of breath, itching, runny nose or skin rash. Frequency: uncommon (may occur in up to 1 in 100 people).
• swelling of various body parts (angioedema). Frequency: very rare (may occur in up to 1 in 10,000 people).

If any of the following symptoms or unlisted adverse reactions occur,
consult your doctor or pharmacist:
Very common ( may affect more than 1 in 10 people )

• inflammation of the oral mucosa (inflammation of the mouth)

Common ( may affect up to 1 in 10 people )

• dizziness, headache
• throat irritation
• mouth ulceration, pain and numbness in the mouth
• sore throat
• discomfort (sensation of warmth, burning or tingling) in the mouth
• nausea and diarrhoea
• skin tingling and itching

Uncommon ( may affect up to 1 in 100 people )

• blisters in the mouth or throat, sensation of throat numbness
• abdominal distension, abdominal pain, flatulence, constipation, indigestion, vomiting
• dryness of the mouth
• burning sensation in the mouth, taste disturbances
• fever, pain
• drowsiness or difficulty sleeping
• reduced sensation in the throat

Rare ( 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 (black, hard stools accompanied by abdominal pain, possible appearance of blood in stool or vomiting blood)

Frequency unknown ( frequency cannot be estimated from available data )

• anaemia, thrombocytopenia (low platelet count, which may cause bruising and bleeding)
• oedema, high blood pressure, heart failure or heart attack
• 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 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 provide more information on the safety of the medicine.

5. How to store the medicine Direct

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 bottle after:
"EXP". The expiry date refers to the last day of the stated month.
Do not use this medicine for longer than 1 month after first opening.
There are no special storage instructions 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. These measures will help protect the environment.

6. Contents of the packaging and other information

What the medicine contains

• The active substance is flurbiprofen. One dose (3 sprays) contains 8.75 mg of flurbiprofen. One spray contains 2.92 mg of flurbiprofen. 1 mL of oral spray contains 16.2 mg of flurbiprofen.
• The other ingredients are: betadex (E 459), hydroxypropylbetadex, disodium phosphate dodecahydrate, citric acid (E 330), sodium hydroxide, sodium saccharin (E 954), purified water, cherry flavour (containing natural flavouring substances: d-limonene, citral, eugenol; ethanol, glyceryl triacetate (E 1518), water, propylene glycol (E 1520), ascorbic acid (E 300), alpha-tocopherol (E 307), citric acid (E 330)), mint flavour (containing natural flavouring substances: d-limonene; propylene glycol (E 1520), glyceryl triacetate (E 1518), alpha-tocopherol (E 307), ethanol, pulegone, menthofuran).

What the medicine looks like and contents of the pack
GARDIFEN Direct, 8.75 mg/dose, oral spray, solution, in an HDPE bottle with a dosing pump made of PE/PP/POM, in a cardboard box.
Each bottle contains 15 mL of solution, providing 83 sprays.

Marketing Authorisation Holder
Pharmalab Poland Sp. z o.o.
ul. Siemianowicka 84, 41-902 Bytom
[email protected]

Manufacturer
INFARMADE S.L.
C/Torre de los Herberos, 35
P.I. „Carretera de la Isla”,
41703 Dos Hermanas (Sevilla), Spain

This medicine is authorised in the following European Economic Area countries under the following names:
Poland: GARDIFEN Direct
Slovakia: Flurbiprofen Naiax