Aspigoladolact

Package leaflet: Information for the user

Aspigoladolact 8.75 mg/dose Oral Mucosa Spray, solution

Flurbiprofen
Equivalent medicinal product
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Always use this medicine exactly as described in this leaflet or as advised by your doctor or pharmacist.
• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
• Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3 days.

Contents of this leaflet

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

1. What Aspigoladolact is and what it is used for

Aspigoladolact contains the active substance flurbiprofen. Flurbiprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by modifying the body's response to pain, swelling, and fever.
Aspigoladolact is indicated for the short-term relief of sore throat symptoms such as throat inflammation, pain, difficulty swallowing, and swelling in adults aged 18 years and older.

2. What you need to know before using Aspigoladolact

Do not use Aspigoladolact if:

• You are allergic to flurbiprofen, or to other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as aspirin (acetylsalicylic acid), or to any of the excipients 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, runny nose, skin rashes, or swelling.
• You have or have had 2 or more episodes of gastric ulcers or gastrointestinal bleeding, or intestinal ulcers.
• You have ever had severe colitis (inflammation of the intestine).
• You have ever had blood clotting disorders or bleeding problems after taking NSAIDs.
• You are in the last three months of pregnancy (see section "Pregnancy, breastfeeding and fertility").
• You have severe heart, kidney, or liver failure.

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

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

During use of Aspigoladolact

• At the first sign of any skin reaction (rash, peeling, blisters) or other signs of an allergic reaction, stop using the spray immediately and consult a doctor without delay.
• Inform your doctor of any unusual abdominal symptoms (especially bleeding).
• Consult your doctor if you notice no improvement, if symptoms worsen, or if new symptoms develop.
• 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, thereby increasing the risk of
complications. If you take this medicine during an infection and infection symptoms persist or
worsen, consult your 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 Aspigoladolact
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those not requiring 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, aspirin (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 behavioral disorders)
• methotrexate (for psoriasis, arthritis, and cancer)
• mifepristone (used to terminate 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 (an immunosuppressant used after organ transplantation)
• zidovudine (for HIV)

Aspigoladolact 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.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, or if you suspect or are planning a pregnancy,
consult your doctor or pharmacist before taking this medicine.
Oral formulations (e.g., tablets) of flurbiprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies to Aspigoladolact.
Pregnancy
Do not take Aspigoladolact during the last three months of pregnancy.
Do not take Aspigoladolact during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period, take the lowest effective dose for the shortest possible time.
Breastfeeding
Do not use this medicine if you are breastfeeding.
Fertility
Flurbiprofen belongs to a group of medicines that may affect female fertility. This effect is
reversible when treatment is stopped. Occasional use of this medicine is unlikely to affect the ability to become pregnant. However, if you have fertility problems, consult your doctor before taking this medicine.
Driving and using machines
This medicine has no effect on the ability to drive or operate machinery. However, dizziness and visual disturbances are possible side effects following the use of NSAIDs. If these occur, do not drive or operate machinery.
Aspigoladolact contains ethanol
This medicine contains small amounts of alcohol (ethanol), less than 100 mg per dose (3 sprays).
This medicine contains 0.22 mg ethanol per dose (3 sprays), equivalent to 0.044% (w/v). The amount
in a single dose of this medicine is equivalent to less than 0.9 ml of beer or 0.4 ml of wine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose (3 sprays), i.e., essentially ‘sodium-free’.

3. How to use Aspigoladolact

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose:
Adults aged 18 years and over:
Administer 3 sprays (one dose) directed at the affected area of the throat every 3–6 hours as needed. Do not exceed 5 doses within a 24-hour period.
One dose (3 sprays) contains 8.75 mg of flurbiprofen.
Do not reduce the number of sprays per dose.

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.
• Do not administer more than 5 doses (15 sprays) in 24 hours.

Aspigoladolact is intended only for short-term treatment.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2).
If irritation of the mouth 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 pump
When using the spray dispenser for the first time (or after a long period without using the product), the pump must be primed beforehand.
Point the spray away from your body and spray at least 4 times until a uniform and consistent mist is obtained. The spray is then primed and ready for use. If the product has not been used for a long time, point the spray away from your body and spray at least once until a uniform and consistent mist is obtained.
Before each use, always ensure that the spray produces a uniform and consistent mist.

Using the spray pump
Direct the spray toward the back of the throat.

Press the spray 3 times with a quick motion, making sure each spray is fully completed. Release your finger from the spray between each spray.

Do not inhale the product during administration.

If you use more Aspigoladolact than you should
Consult a doctor, pharmacist, or go to the nearest hospital immediately. Symptoms of overdose may include: feeling unwell, malaise, stomach discomfort, or rarely diarrhea. Other possible symptoms include tinnitus, headache, and gastrointestinal bleeding.

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.
If you experience any of the following side effects, STOP TAKING Aspigoladolact and inform your doctor
immediately:

• 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 affecting 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 difficulty in breathing, rapid heartbeat, drop in blood pressure which may lead to shock (these side effects 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 (rashes) such as redness, swelling, skin cracking, blisters, peeling 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 breathlessness or shortness of breath, itching, runny nose or skin rashes. Frequency: Uncommon (may affect up to 1 in 100 people)

If you experience any of the following side effects or any other side effect not listed here, inform your doctor or
pharmacist:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• drowsiness
• blisters in the mouth or throat, mouth numbness
• abdominal swelling, abdominal pain, flatulence, constipation, indigestion, malaise
• dry mouth
• burning sensation in the mouth, altered taste sensation
• fever, pain
• drowsiness or difficulty sleeping
• worsening of asthma, wheezing, shortness of breath
• reduced sensitivity of the throat

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

• anaemia, thrombocytopenia (reduced 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 may also report side effects directly via 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 Aspigoladolact

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 container after "Exp.". The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
The shelf life of the medicinal product after first opening is 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Aspigoladolact contains:
The active substance is flurbiprofen. One dose (3 sprays) contains 8.75 mg of flurbiprofen, corresponding to 17.16 mg/ml of flurbiprofen.
The other components are betadex (E459), hydroxypropylbetadex, disodium phosphate dodecahydrate, citric acid monohydrate, sodium hydroxide, cherry flavour, sodium saccharin (E954), purified water.

Description of the appearance of Aspigoladolact and pack contents
Aspigoladolact is an oral mucosal spray and is presented as a clear, colourless solution with a cherry flavour.
Pack: 15 ml bottle (equivalent to approximately 30 doses) of solution.

Marketing Authorization Holder
Bayer S.p.A., Viale Certosa 130, 20156 Milan, Italy

Manufacturer responsible for batch release
LABORATORIUM SANITATIS SL, P.T. Alava - C/ Leonardo Da Vinci, 11, Parque tecnologico de Alava, 01510, Miñano, Álava, Spain.
and
INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR S.A., C/ De La Laguna 66 68 70, Polígono Industrial Urtinsa II, 28923 Alcorcón, Madrid – Spain.