Flurbiprofen Geiser Pharma

Leaflet accompanying the packaging: patient information

Flurbiprofen Geiser Pharma, 8.75 mg, hard lozenges, honey-mint flavor
Flurbiprofen

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

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Flurbiprofen Geiser Pharma and what is it used for

Flurbiprofen Geiser Pharma 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.
Flurbiprofen Geiser Pharma is intended for short-term relief of symptoms of throat inflammation, such as irritation, pain, and swelling of the throat and difficulty swallowing in adults and adolescents over 12 years of age.
If there is no improvement after 3 days or the patient feels worse, they should consult a doctor.

2. Important information before taking Flurbiprofen Geiser Pharma

When not to take Flurbiprofen Geiser Pharma

• 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 had asthma or an allergic reaction after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (e.g., wheezing, shortness of breath, runny nose, facial swelling, or skin rash with itching),
• if the patient has or has had stomach or intestinal ulcers (two or more episodes of stomach or duodenal ulcers),
• if the patient has had bleeding or perforation of the digestive tract, severe colitis, or blood disorders associated with previous treatment with nonsteroidal anti-inflammatory drugs,

if the patient is in the last 3 months of pregnancy,

• if the patient has or has had severe heart, liver, or kidney failure.

Warnings and precautions

Before taking Flurbiprofen Geiser Pharma, the patient should discuss it with their doctor or pharmacist:

• if the patient has or has had asthma or allergies;
• if the patient has tonsillitis (swollen tonsils) or suspects they may have a bacterial throat infection (an antibiotic may be necessary);
• if the patient has cardiovascular, liver, or kidney disorders;
• if the patient has had a stroke;
• if the patient has had intestinal disease (ulcerative colitis, Crohn's disease);
• if the patient has high blood pressure;
• if the patient has a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease);
• if the patient is elderly (may be more susceptible to side effects listed in the leaflet);
• if the patient is pregnant or breastfeeding;
• if the patient experiences medication-induced headaches;
• if the patient has an infection - see "Infections" below.

The patient should 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 side effects such as ulcers and bleeding (see below "Flurbiprofen Geiser Pharma and other medicines").

During treatment with Flurbiprofen Geiser Pharma

• At the first signs of any skin reactions (rash, peeling) or other symptoms of an allergic reaction, the patient should stop taking the medicine and consult their doctor immediately.
• The patient should report any unusual abdominal symptoms (especially bleeding) to their doctor. If there is no improvement, or the patient feels worse or new symptoms appear, they should consult their 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. The patient should not exceed the recommended dose or duration of treatment (3 days).

Children and adolescents

This medicine should not be taken by children and adolescents under 12 years of age.

Flurbiprofen Geiser Pharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. In particular, the patient should inform their doctor about taking the following medicines:

• acetylsalicylic acid (except for low doses (up to 75 mg per day) prescribed by a doctor)
• medicines that lower blood pressure or are used in heart failure (antihypertensive medicines, cardiac glycosides)
• diuretics (including potassium-sparing diuretics)
• blood thinners (anticoagulant or antiplatelet medicines)
• medicines used to treat gout (probenecid, sulfinpyrazone)
• other NSAIDs or corticosteroids (e.g., celecoxib, ibuprofen, diclofenac sodium, prednisolone) (see above "Warnings and precautions")
• 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)
• zydovudine (a medicine used to treat HIV infection).

Flurbiprofen Geiser Pharma with food, drink, and alcohol

While taking Flurbiprofen Geiser Pharma, the patient should avoid consuming alcohol, as this may increase the risk of stomach or intestinal bleeding.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their 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 Flurbiprofen Geiser Pharma.
This medicine should not be taken during the last trimester of pregnancy.
If the patient is in the first 6 months of pregnancy or is breastfeeding, they should consult their 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 becoming pregnant; however, the patient should inform their doctor about this before taking the medicine if they have problems becoming pregnant.

Driving and using machines

The effect of Flurbiprofen Geiser Pharma 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, the patient should 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, which may lead to increased risk of complications. If the patient is taking this medicine during an ongoing infection and their symptoms persist or worsen, they should consult their doctor or pharmacist immediately.

Flurbiprofen Geiser Pharma contains isomalt and maltitol

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Flurbiprofen Geiser Pharma

Flurbiprofen Geiser Pharma should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their 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.
No more than 5 lozenges should be taken in 24 hours.
Method of administration
For oral use.
The lozenge should be slowly dissolved in the mouth, not swallowed, and not chewed.
While dissolving, the lozenge should always be moved around the mouth.

Use in children

This medicine should not be taken by children under 12 years of age.
These lozenges are intended for short-term use only.The patient should use the smallest effective dose for the shortest duration necessary to relieve symptoms. If irritation of the mouth occurs, the patient should stop taking flurbiprofen.
If the patient has an infection, they should consult their doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Flurbiprofen Geiser Pharma should not be taken for more than 3 days. If there is no improvement, or the patient feels worse or new symptoms appear, they should consult their doctor or pharmacist.

Overdose of Flurbiprofen Geiser Pharma

In case of overdose, the patient should consult their doctor or pharmacist or go to the nearest hospital. Symptoms of overdose may include: nausea or vomiting, stomach pain, or diarrhea. The patient may also experience ringing in the ears, headache, and gastrointestinal bleeding.
If the patient has any further questions about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Flurbiprofen Geiser Pharma can cause side effects, although not everybody gets them.
The patient should stop taking this medicine and contact their doctor immediately if they experience:

• symptoms of an allergic reaction, such as asthma, unexplained wheezing, shortness of breath, itching, rhinitis, 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 the patient experiences any of the following symptoms or symptoms not listed in the leaflet, they should inform their 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, shortness of breath
• 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 can 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, the patient can help provide more information on the safety of the medicine.

5. How to store Flurbiprofen Geiser Pharma

The medicine should be stored out of sight and reach of children.
This medicine should not be taken 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Flurbiprofen Geiser Pharma 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
Honey flavor
Peanut oil
Levomenthol

What Flurbiprofen Geiser Pharma looks like and contents of the pack

Flurbiprofen Geiser Pharma, 8.75 mg, hard lozenges, are orange, round lozenges, 19±1 mm in diameter, with a honey-mint flavor.
The lozenges are available in PVC/PVDC/Aluminum blister packs in a cardboard box.
Pack sizes: 8, 12, 16, 20, or 24 hard lozenges.
Not all pack sizes may be marketed.

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

Spain: Tantufen 8,75mg pastillas para chupar sabor miel y menta
Portugal: Tantumflam mel e hortelã-pimenta

Date of last revision of the leaflet: