LISOMUCILGOLMED 8.75 мг Оральный мукозный спрей, раствор

Содержание инструкции

1. What is LisomucilGOL med and what is it 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. Package Contents and Other Information

LisomucilGOLmed8.75 mg/dose oral mucosal spray, solution
Flurbiprofen

Read this leaflet carefully before using this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

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

The active ingredient is flurbiprofen. Flurbiprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing the body's response to pain, swelling and fever.
LisomucilGOL medis indicated to relieve the short-term symptoms of sore throat such as throat inflammation, pain, swelling, and difficulty swallowing in adults aged 18 years or older.
See a 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 LisomucilGOLmedif:

• you are allergic to flurbiprofen, or to any of the other ingredients of this medicine (listed in section 6);
• you have previously had allergic reactions after taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or aspirin (acetylsalicylic acid); for example asthma, wheezing, a feeling of itching, runny nose, skin rashes, swelling;
• you have or have had two or more episodes of stomach or intestinal ulcers or bleeding;
• you have ever had severe colitis (inflammation of the intestine);
• you have ever had problems with blood clotting or bleeding 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 think you have a bacterial infection of the throat (as antibiotics may be needed);
• you are elderly (as you are more likely to experience unwanted effects);
• you have or have had episodes of asthma or suffer from allergies;
• you suffer from a condition affecting the skin known as systemic lupus erythematosus or mixed connective tissue disease;
• you suffer from high blood pressure (hypertension);
• you have a history of intestinal diseases (ulcerative colitis, Crohn's disease);
• you have or have had problems with your heart, kidneys or liver;
• you have had a stroke;
• you are in the first 6 months of pregnancy or are breastfeeding;
• you suffer from headache induced by painkillers;
• you have diabetes;
• you have an infection, see section “Infections” below.

During the use of LisomucilGOLmed

• At the first sign of any skin reaction (rash, peeling, blistering rash) or other evidence of an allergic reaction, stop using the spray immediately and consult a doctor right away.
• Tell your doctor about any unusual symptoms in your abdomen (bleeding in particular).
• See a doctor if you do not notice any improvement or if you notice worsening or if you develop new symptoms.
• Medicines such as flurbiprofen may be associated with a modest increase in the 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) can mask the signs of infections such as fever and pain. This
can lead to delayed appropriate treatment of the infection, resulting in a possible increased
risk of complications. If you are taking this medicine with an ongoing infection and the symptoms
persist or worsen, consult your doctor or pharmacist immediately.

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

Other medicines and LisomucilGOLmed
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained 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 medicines that thin or prevent blood clotting;
• ACE inhibitors, angiotensin II receptor antagonists (medicines for high blood pressure);
• diuretics (medicines that increase urine production) including potassium-sparing diuretics;
• SSRIs (selective serotonin re-uptake inhibitors) for depression;
• cardiac glycosides such as digoxin (for heart problems);
• cyclosporine (to prevent organ rejection after transplantation);
• corticosteroids (to reduce inflammation);
• lithium (for mood disorders);
• methotrexate (for psoriasis, arthritis and cancer);
• mifepristone (used to terminate a pregnancy). NSAIDs should not be used for 8 - 12 days after taking mifepristone, as they reduce its effect;
• oral antidiabetic medicines;
• phenytoin (for epilepsy);
• probenecid, sulfinpyrazone (for gout and arthritis);
• quinolone antibiotics (for bacterial infections) such as ciprofloxacin, levofloxacin;
• tacrolimus (immunosuppressant used after organ transplantation);
• zidovudine (for HIV);
• fluconazole (antifungal medicine used for the treatment of various fungal infections);
• acetazolamide (to treat glaucoma or fluid retention).

LisomucilGOLmedwith food, drinks and alcohol
Drinking alcohol should be avoided during treatment with this medicine, as it may increase
the risk of stomach and intestinal bleeding.
Concomitant administration with food may delay the onset of efficacy.

Pregnancy, breastfeeding and fertility
Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen can 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 or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use this medicine if you are in the last 3 months of pregnancy.
Avoid using LisomucilGOL medin the first 6 months of pregnancy unless absolutely necessary and under
medical prescription.
If treatment is necessary during this period, the lowest dose should be used for the shortest possible time.
Breastfeeding
This medicine is not recommended during breastfeeding.
Fertility
The medicine belongs to a group of medicines (NSAIDs) that can impair
female fertility. This effect is reversible by stopping the medicine.

Driving and using machines
This medicine is not thought to affect the ability to drive or operate machines.
However, dizziness and visual disturbances are possible side effects following the use of NSAIDs. If these
occur, do not drive or operate machinery.

LisomucilGOLmedcontains sodium, ethanol and fragrances based on d-limonene, citral and eugenol
LisomucilGOL medThis medicine contains less than 1 mmol (23 mg) of sodium per dose, which is
essentially ‘sodium-free’.
This medicine contains 0.14 mg of alcohol (ethanol) in each dose. The amount contained in a dose of
this medicine 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 have any noticeable effects.
LisomucilGOL medThis medicine contains fragrances based on d-limonene, citral and eugenol which
may cause allergic reactions.

3. How to use LisomucilGOL med

Use this medicine following exactly as described 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:
A 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 a 24-hour period.
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 the age of 18 years.
For oral mucosal use only.

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

LisomucilGOL medis indicated only for short-term treatments.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. In case of infection, consult your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (see paragraph 2).
If oral irritation occurs, discontinue treatment with flurbiprofen.
Do not use this medicine for more than 3 days without your doctor's advice.
Contact your doctor or pharmacist if you do not notice any improvement or if your condition worsens or if you develop new symptoms.

Activating the dispenser
When using the dispenser for the first time (or after a long period of non-use of the product), 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 and consistent mist is released. The dispenser is then activated and ready for use. If the product has not been used for a long time, point the dispenser away from your body, and spray at least 1 time until a fine and consistent mist is released.
Always ensure that the mist is fine and consistent before using the product.

Using the Spray
Direct the dispenser towards the back of the throat

Press the dispenser 3 timeswith a quick and steady motion, making sure that each press on the dispenser is complete with each spray. Between each spray, release your finger from the top of the pump

Do not inhale the product during delivery.

If you use more LisomucilGOLmedthan you should
Consult your doctor or pharmacist or go to the nearest hospital immediately. Symptoms of overdose may include: feeling unwell or sick, stomach pain or, more rarely, diarrhea. The following may also occur: ringing in the ears, headache and gastrointestinal bleeding.

If you forget to use LisomucilGOLmed
Do not use a double dose to make up for a missed dose.
If you have any questions about using this medicine, ask your 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 tell 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 due to severe adverse reactions to treatment or an infection in which there is a severe reaction of the skin or mucous membranes. Frequency: not known (frequency cannot be defined based on available data));
• signs of anaphylactic shock characterized by swelling of the face, tongue or throat causing difficulty breathing, rapid heartbeat, decreased blood pressure up to shock (side effects that can occur even with the first use of the medicine). Frequency: rare (may affect up to 1 in 1000 people);
• signs of hypersensitivity and skin reactions such as redness, swelling, skin exfoliation, rash with blisters, desquamation or ulcerations of the skin and mucous membranes. Frequency: uncommon (may affect up to 1 in 100 people);
• signs of an allergic reaction such as asthma, unexplained wheezing or shortness of breath, itching, runny nose or skin rashes. Frequency: uncommon (may affect up to 1 in 100 people);
• swelling of various parts of the body (angioedema). Frequency: very rare (may affect up to 1 in 10,000).

If you experience any of the following side effects or notice the appearance of effects not listed, tell 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;
• sore throat;
• mouth ulcers, pain or numbness of the mouth;
• sore throat;
• discomfort in the mouth (feeling of heat or burning, tingling);
• nausea and diarrhea;
• tingling and itching of the skin.

Uncommon(may affect up to 1 in 100 people)

• rash with blisters in the mouth or throat, numbness of the throat;
• bloated stomach, abdominal pain, abdominal gas, constipation, indigestion, malaise;
• dry mouth;
• burning sensation in the mouth, altered sense of taste;
• fever, pain;
• feeling sleepy 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 digestive tract (hard black stools with abdominal pain, possible presence of blood in the stool or vomiting of blood);

Not known(frequency cannot be defined on the basis of available data)

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you 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 which is stated on the bottle and the packaging. The expiry date refers to the last day of that month.
Do not use this medicine for more than 1 month from first use.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 LisomucilGOLmedcontains
The active ingredient 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 ingredients are: Betadex (E459), hydroxypropyl betadex, disodium 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, triacetin (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); triacetin
(E1518), alpha-tocopherol (E307), ethyl alcohol, pulegone, menthofuran).

Description of the appearance of LisomucilGOLmedand package contents
LisomucilGOL med8.75 mg/dose oral mucosal spray, solution is a clear solution with a taste of
cherry and mint, packaged in HDPE bottles with a dosing pump.
Each bottle contains 15 ml of solution providing 84 sprays.

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

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 Bad Vilbel 61118 - Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
BE Flurbiprofen EG Spray Kers en Munt 8,75mg/dose spray for oromucosal use, solution
CY OROPFEN
DE Flurbiprofen STADA 8,75 mg/Dose Spray zur Anwendung in der Mundhöhle, Lösung
DK Flurbiprofen Stada
FI Flurbiprofen STADA 16,2 mg/ml oral spray, solution
GR OROPFEN
IT LisomucilGOL med
LU Flurbiprofen EG Spray Cerise et Menthe 8,75mg/dose solution for buccal spray
NO Flurbiprofen Stada
PL Orofar Ultra Spray
SE Flurbiprofen STADA 16,2 mg/ml oral spray, solution
SK Flurbiprofen STADA