Lisomucil Golmed

Italy
Brand name Lisomucil Golmed
Form spray, oral solution
Active substance / Dosage
FLURBIPROFENE
Prescription type Over-the-counter
ATC code
R02AX01
Registration number 051742
Manufacturer EG S.P.A.

Table of Contents

Package leaflet: Information for the user

LisomucilGOL med 8.75 mg/dose oral mucosa spray, solution
Flurbiprofen
Please read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

  • Keep this leaflet. You may need to read it again.
  • If you need more information or advice, consult your pharmacist.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
  • Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

  1. What LisomucilGOL med is and what it is used for
  2. What you need to know before using LisomucilGOL med
  3. How to use LisomucilGOL med
  4. Possible side effects
  5. How to store LisomucilGOL med
  6. Contents of the pack and other information

1. What LisomucilGOL med is and what it is used for

The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by altering the body's response to pain, swelling, and fever.
LisomucilGOL med is indicated for the short-term relief of sore throat symptoms such as throat inflammation, pain, swelling, and difficulty swallowing in adults aged 18 years and over.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before using LisomucilGOL med

Do not use LisomucilGOL med if:

  • you are allergic to flurbiprofen or to any of the other ingredients of this medicine (listed in section 6);
  • you have previously experienced allergic reactions after taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or aspirin (acetylsalicylic acid); for example, asthma, wheezing, itching sensation, runny nose, skin rashes, swelling;
  • you have or have had two or more episodes of gastric ulcers or bleeding, or intestinal ulcers;
  • you have ever had severe colitis (inflammation of the intestine);
  • you have ever had blood clotting problems or bleeding problems after taking NSAIDs;
  • you are in the last 3 months of pregnancy;
  • you have severe heart, kidney, or liver failure.

Warnings and precautions
Talk to your doctor or pharmacist before using LisomucilGOL med if:

  • you are already taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or acetylsalicylic acid;
  • you suffer from tonsillitis (inflammation of the tonsils) or suspect you have a bacterial throat infection (since antibiotics may be needed);
  • you are elderly (as you are more likely to experience side effects);
  • you have or have had asthma attacks or suffer from allergies;
  • you suffer from a skin condition known as systemic lupus erythematosus or mixed connective tissue disease;
  • you have high blood pressure (hypertension);
  • you have a history of intestinal diseases (ulcerative colitis, Crohn’s disease);
  • you have or have previously had heart, kidney, or liver problems;
  • you have had a stroke;
  • you are in the first 6 months of pregnancy or are breastfeeding;
  • you suffer from analgesic-induced headache;
  • you have diabetes;
  • you have an infection; please consult the section “Infections” below.

During use of LisomucilGOL med

  • At the first sign of any skin reaction (rash, peeling, blistering rash) or other signs of an allergic reaction, stop using the spray immediately and consult a doctor right away.
  • Inform your doctor of any unusual abdominal symptoms (especially bleeding).
  • Consult your doctor if you do not notice improvement, if symptoms worsen, or if you develop new symptoms.
  • Medicines such as flurbiprofen may be associated with a small increased risk of heart attack or stroke. Any risk is more likely 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 signs of infection such as fever and pain. This
could delay appropriate treatment of the infection, possibly increasing the risk of complications. If you take this medicine while having an infection and symptoms of infection persist or worsen, consult a doctor or pharmacist immediately.
Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Other medicines and LisomucilGOL med
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. In particular:

  • other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors for pain or inflammation, as they may increase the risk of stomach or intestinal bleeding;
  • warfarin, acetylsalicylic acid, and other anticoagulant or blood-thinning medicines;
  • ACE inhibitors, angiotensin II antagonists (antihypertensive medicines);
  • diuretics (medicines that increase urine production), including potassium-sparing diuretics;
  • SSRIs (selective serotonin reuptake inhibitors) for depression;
  • cardiac glycosides such as digoxin (for heart problems);
  • cyclosporine (to prevent organ transplant rejection);
  • corticosteroids (to reduce inflammation);
  • lithium (for mood disorders);
  • methotrexate (for psoriasis, arthritis, and cancer);
  • mifepristone (used to terminate a pregnancy). NSAIDs must not be used for 8–12 days after taking mifepristone, as they reduce its effectiveness;
  • oral antidiabetic medicines;
  • phenytoin (for epilepsy);
  • probenecid, sulfinpyrazone (for gout and arthritis);
  • quinolone antibiotics (for bacterial infections) such as ciprofloxacin, levofloxacin;
  • tacrolimus (an immunosuppressant used after organ transplant);
  • zidovudine (for HIV);
  • fluconazole (an antifungal medicine used to treat various fungal infections);
  • acetazolamide (to treat glaucoma or fluid retention).

LisomucilGOL med with food, drinks, and alcohol
Alcohol intake should be avoided during treatment with this medicine, as it may increase the risk of stomach and intestinal bleeding.
Concurrent administration with food may delay the onset of effectiveness.
Pregnancy, breastfeeding, and fertility
Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects on the fetus. It is not known whether the same risk applies to LisomucilGOL med.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine if you are in the last 3 months of pregnancy.
Avoid using LisomucilGOL med during the first 6 months of pregnancy unless absolutely necessary and under medical supervision.
If treatment is required during this period, the lowest possible dose for the shortest possible time should be used.
Breastfeeding
This medicine is not recommended during breastfeeding.
Fertility
This medicine belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible upon discontinuation of the medicine.
Driving and using machines
This medicine is not considered to affect the ability to drive or use machinery.
However, dizziness and visual disturbances are possible side effects following the use of NSAIDs. If these occur, do not drive or operate machinery.
LisomucilGOL med contains sodium, ethanol, and fragrances based on d-limonene, citral, and eugenol
LisomucilGOL med This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.
This medicine contains 0.14 mg of alcohol (ethanol) in each dose. The amount contained in one dose of this medicine corresponds to less than 0.0035 ml of beer or 0.0014 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
LisomucilGOL med This medicine contains fragrances based on d-limonene, citral, and eugenol which may cause allergic reactions.

3. How to use LisomucilGOL med

Use this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults aged 18 years and over:
One dose of 3 sprays directed to the back of the throat every 3–6 hours as needed, up to
a maximum of 5 doses (15 sprays) within 24 hours.
One dose (3 sprays) contains 8.75 mg of flurbiprofen.
Use in children and adolescents
Do not use this medicine in children and adolescents under 18 years of age.
For oral mucosa use only.

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

LisomucilGOL med is intended only for short-term treatment.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. In
case of infection, consult a doctor or pharmacist immediately if symptoms (such as fever and pain)
persist or worsen (see section 2).
If mouth irritation occurs, treatment with flurbiprofen should be discontinued.
Do not use this medicine for more than 3 days without medical advice.
Consult your doctor or pharmacist if you do not notice improvement, if symptoms worsen, or if
new symptoms develop.
Priming the spray pump
When using the spray pump for the first time (or after a long period of non-use), it is first necessary to shake the device and prime the pump.
Point the nozzle away from your body and spray at least 4 times until a fine, consistent mist is produced. The spray pump is now primed and ready for use. If the product has not been used for a long time, point the nozzle away from your body and spray at least once until a fine, consistent mist is produced.
Before each use, always ensure that the spray produces a fine and consistent mist.
How to use the spray
Direct the spray towards the back of the throat

Two diagrams show the

Press the spray pump 3 times with a quick, even motion, making sure that each press is fully completed. Release your finger from the top of the pump between each spray.

Technical drawing showing two hands pressing down three times on the

Do not inhale the product during administration.
If you use more LisomucilGOL med than you should
Consult your doctor or pharmacist or go immediately to the nearest hospital. Symptoms of overdose may include: feeling unwell, nausea, stomach pain, or more rarely, diarrhoea. Other possible symptoms include tinnitus, headache, and gastrointestinal bleeding.
If you forget to use LisomucilGOL med
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP taking this medicine and contact your doctor immediately if you experience:

  • severe forms of skin reactions such as blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (these are rare conditions caused by serious adverse reactions to treatment or infection, in which there is a severe reaction of the skin or mucous membranes. Frequency: not known (frequency cannot be estimated from the available data);
  • signs of anaphylactic shock characterized by swelling of the face, tongue or throat causing breathing difficulties, rapid heartbeat, drop in blood pressure leading to shock (side effects that may even occur with the first use of the medicine). Frequency: rare (may affect up to 1 in 1,000 people);
  • signs of hypersensitivity and skin reactions such as redness, swelling, peeling of the skin, skin rash with blisters, desquamation or ulceration of the skin and mucous membranes. Frequency: uncommon (may affect up to 1 in 100 people);
  • signs of allergic reaction such as asthma, unexplained wheezing or shortness of breath, itching, runny nose or skin rash. Frequency: uncommon (may affect up to 1 in 100 people);
  • swelling of different parts of the body (angioedema). Frequency: very rare (may affect up to 1 in 10,000 people).

If you experience any of the following side effects or notice any unlisted effects, inform your doctor or pharmacist:
Very common (may affect more than 1 in 10 people)

  • inflammation of the oral mucosa (stomatitis).

Common (may affect up to 1 in 10 people)

  • dizziness, headache;
  • throat irritation;
  • mouth ulcers, mouth pain or numbness;
  • sore throat;
  • oral discomfort (sensation of heat or burning, tingling);
  • nausea and diarrhoea;
  • tingling and itching of the skin.

Uncommon (may affect up to 1 in 100 people)

  • blistering rash in the mouth or throat, throat numbness;
  • bloated stomach, abdominal pain, abdominal gas, constipation, indigestion, malaise;
  • dry mouth;
  • burning sensation in the mouth, altered taste sensation;
  • fever, pain;
  • drowsiness or difficulty falling asleep;
  • reduced sensitivity of 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)

  • bleeding in the gastrointestinal tract (black, hard stools with abdominal pain, possible presence of blood in stools or vomiting blood);

Not known (frequency cannot be estimated from the available data)

  • anaemia, thrombocytopenia (low platelet count in the blood which may cause bruising and bleeding);
  • swelling (oedema), high blood pressure, heart failure or heart attack;
  • hepatitis (inflammation of the liver).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store LisomucilGOL med

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the outer carton. The expiry date refers to the last day of that month.
Do not use this medicine for more than 1 month after first use.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LisomucilGOL med contains
The active substance is flurbiprofen. One dose (3 sprays) contains 8.75 mg of flurbiprofen. One spray contains 2.92 mg of flurbiprofen. One millilitre of oral mucosal spray contains 16.2 mg of flurbiprofen.
The other components are: Betadex (E459), hydroxypropylbetadex, dibasic sodium phosphate dodecahydrate, citric acid (E330), sodium hydroxide, sodium saccharin (E954), purified water, cherry flavour (containing natural flavouring substance(s): d-limonene, citral, eugenol; ethyl alcohol, glyceryl triacetate (E1518), water, propylene glycol (E1520), ascorbic acid (E300), alpha-tocopherol (E307), citric acid (E330)), mint flavour (containing natural flavouring substance(s): d-limonene, propylene glycol (E1520); glyceryl triacetate (E1518), alpha-tocopherol (E307), ethyl alcohol, pulegone, menthofuran).

Description of the appearance of LisomucilGOL med and contents of the pack
LisomucilGOL med 8.75 mg/dose oral mucosal spray, solution is a clear solution with a cherry and mint flavour, packed in HPDE bottles with a metering pump.
Each bottle contains 15 ml of solution, providing 84 administrations.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milan, Italy

Manufacturers
INFARMADE S.L., C/ Torre de los Herberos, 35, P.I. Carretera de la Isla, Dos Hermanas, Sevilla 41703 - Spain
STADA Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel - Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
BE Flurbiprofen EG Spray Kers en Munt 8.75mg/dose spray voor oromucosaal gebruik, oplossing
CY OROPFEN
DE Flurbiprofen STADA 8.75 mg/Dosis Spray zur Anwendung in der Mundhöhle, Lösung
DK Flurbiprofen Stada
FI Flurbiprofen STADA 16.2 mg/ml sumute suuonteloon, liuos
GR OROPFEN
IT LisomucilGOL med
LU Flurbiprofen EG Spray Cerise et Menthe 8.75mg/dose solution pour pulvérisation buccale
NO Flurbiprofen Stada
PL Orofar Ultra Spray
SE Flurbiprofen STADA 16.2 mg/ml munhålespray, lösning
SK Flurbiprofen STADA