Aspigoladol

Package leaflet: Information for the patient

Aspigoladol 8.75 mg orange-flavoured tablets

flurbiprofene
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after 3 days.

Contents of this leaflet

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

1. What Aspigoladol is and what it is used for

Aspigoladol contains the active substance flurbiprofen. Flurbiprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which have analgesic and anti-inflammatory properties in the treatment of sore throat. These medicines work by altering the way the body responds to pain, swelling, and elevated temperatures.
Aspigoladol is used for the short-term treatment of symptoms of throat pain and inflammation, such as sore throat, pain and swelling, and difficulty swallowing, in adults and adolescents over 12 years of age.
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 Aspigoladol

Do not use Aspigoladol

• if you are allergic to flurbiprofen or to any of the other ingredients of this medicine (listed in section 6);
• if you have experienced asthma, breathlessness or difficulty breathing, runny nose, facial swelling or itchy skin rash (urticaria) after taking acetylsalicylic acid or similar substances used to treat pain, inflammation or rheumatic conditions, known as non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have or have had two or more episodes of gastric or intestinal ulcer;
• if you have or have had gastric or intestinal bleeding or perforation, severe colitis (inflammation of the intestine), or blood disorders after using another NSAID;
• if you suffer from heart, liver or kidney failure;
• if you are in the last three months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Aspigoladol if:
Aspigoladol F.ill 2a (Label Event-001119)

• you are taking other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac or prednisolone) to treat pain, inflammation or rheumatic conditions, as this may increase the risk of adverse events, particularly stomach and intestinal problems such as ulcers and bleeding;
• you have an infection. 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 symptoms persist or worsen, contact your doctor or pharmacist immediately.
• you have or have had asthma or suffer from allergies;
• you have heart, liver or kidney problems;
• you have had a stroke;
• you have a history of stomach or intestinal diseases (ulcerative colitis, Crohn's disease);
• you suffer from hypertension;
• you have a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease).

Elderly
Elderly patients are more likely to experience the adverse effects listed in this leaflet.
Children
Do not give this medicine to children under 12 years of age.
Other medicines and Aspigoladol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially if you are using medicines containing:

• other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, sodium diclofenac or prednisolone) to treat pain, inflammation or rheumatic conditions;
• low-dose acetylsalicylic acid (up to 100 mg per day);
• substances that inhibit blood clotting or dissolve blood clots;
• medicines for high blood pressure or heart failure (antihypertensives, cardiac glycosides);
• methotrexate (a medicine used to treat autoimmune diseases or cancer);
• mifepristone (a medicine used for medical termination of pregnancy);
• oral antidiabetics (for treating diabetes);
• phenytoin (a medicine used to treat epilepsy);
• agents that increase water elimination through the kidneys (diuretics, including potassium-sparing agents);
• gout-treating agents (probenecid, sulfinpyrazone);
• quinolone antibiotics (such as ciprofloxacin);
• lithium or selective serotonin reuptake inhibitors (medicines used to treat depression);
• cyclosporine or tacrolimus (medicines used to suppress the immune system after organ transplantation);
• zidovudine (used to treat HIV infection).

Aspigoladol with food, drinks and alcohol
Avoid consuming alcohol during treatment with Aspigoladol, as it may increase the risk of gastric or intestinal bleeding.
Pregnancy, breastfeeding and fertility
Oral formulations of medicines containing flurbiprofen (e.g. tablets) may cause adverse effects in the newborn. It is not known whether the same risk applies to Aspigoladol.
If you are pregnant, breastfeeding, suspect you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Do not use Aspigoladol if you are in the last three months of pregnancy.
Do not use Aspigoladol during the first six months of pregnancy unless strictly necessary and on medical advice. If treatment is required during this period, the lowest effective dose for the shortest possible duration should be used.
If you are breastfeeding, talk to your doctor before taking this medicine.
Flurbiprofen belongs to a group of medicines that may affect fertility in women. This effect is reversible upon discontinuation of the medicine. Occasional use of this medicine is unlikely to affect your chances of becoming pregnant; however, speak with your doctor before taking this medicine if you have difficulty conceiving.
Driving and using machines
Aspigoladol is not known to affect the ability to drive or operate machinery. However, dizziness and visual disturbances are possible side effects after taking NSAIDs. If these occur, do not drive or operate machinery.
Aspigoladol contains isomalt and maltitol.
If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Aspigoladol contains Ponceau 4R and Orange Yellow S.
These may cause allergic reactions.

3. How to use Aspigoladol

Take 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.
The recommended dose is:
Adults and adolescents over 12 years of age:
1 tablet every 3–6 hours, if needed.
Do not exceed the maximum daily dose of 5 tablets.
Method of administration:
For oral mucosa use.

• Allow the tablet to dissolve slowly in the mouth; do not swallow or chew the tablet.
• Move the tablet continuously around the mouth while it dissolves.

Duration of treatment
Do not take Aspigoladol for more than 3 days without consulting your doctor.
The lowest effective dose for the shortest time necessary to relieve symptoms should be used. If you have an infection, contact your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2 Warnings and precautions).
If mouth irritation occurs, treatment with Aspigoladol should be discontinued.
If you take more Aspigoladol than you should
Speak to your doctor or pharmacist or go immediately to the nearest hospital if you suspect an overdose.
Symptoms of overdose may include: nausea or vomiting, stomach ache or, more rarely, diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Aspigoladol F.ill 2a (Label Event-001119)
Like all medicines, this medicine can cause side effects, although not everyone gets them.

STOP TAKING this medicine, contact a doctor immediately or go to the nearest hospital if you experience:

• signs of allergic reactions such as asthma, sudden breathlessness or difficulty breathing, itching, runny nose, skin rashes;
• swelling of the face, tongue or throat causing difficulty breathing, tachycardia and drop in blood pressure leading to shock (these events may also occur with the first use of the medicine);
• severe skin reactions such as redness, swelling, peeling, blistering, skin shedding or skin and mucosal ulceration.

Talk to your doctor or pharmacist if you experience any of the following side effects or any other side effect not described:
Common (may affect up to 1 in 10 people)

• dizziness, headache
• throat irritation
• mouth ulcers or mouth pain
• sore throat
• sensation of discomfort or unusual sensation in the mouth (such as warmth, burning, tingling, prickling)
• nausea and diarrhoea
• skin tingling and itching

Uncommon (may affect up to 1 in 100 people)

• drowsiness
• feeling drowsy or difficulty sleeping
• worsening of asthma, wheezing, difficulty breathing
• blistering in the mouth or throat, numbness in the throat
• dry mouth
• burning sensation in the mouth, altered taste sensation
• abdominal pain, bloated stomach, flatulence, constipation, indigestion, vomiting
• reduced throat sensitivity
• fever, pain
• skin rashes, itching

Rare (may affect up to 1 in 1,000 people)

• anaphylactic reaction

Frequency not known (cannot be estimated from the available data)

• anaemia, thrombocytopenia (low platelet count in the blood which may cause bruising and bleeding)
• swelling (oedema), hypertension, heart failure or heart attack
• severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis
• 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 . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aspigoladol

Aspigoladol F.ill 2a (Label Event-001119)
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 on the aluminium foil of the
blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any 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 Aspigoladol contains
The active substance is flurbiprofen. One tablet contains 8.75 mg of flurbiprofen.
The other components are:
Isomalt
Maltitol, liquid
Acesulfame potassium
Macrogol 300
Potassium hydroxide
Ponceau 4R (E-124)
Orange yellow S (E-110)
Natural orange flavour
Levomenthol

Description of the appearance of Aspigoladol and contents of the pack
Aspigoladol tablets are orange-coloured, round tablets with a diameter of 19±1 mm, with an orange flavour.
The tablets are available in PVC-PVDC/aluminium blisters within a printed cardboard box.
Pack sizes: 8, 12, 16 or 24 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Bayer S.p.A. Viale Certosa 130, 20156 Milan, Italy
Manufacturer
Lozy's Pharmaceuticals S.L.
Campus Empresarial Lekaroz
Navarra 31795, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Aspigoladol F.ill 2a (Label Event-001119)