ANGIFEN 8.75 mg LOZENGES MINT FLAVOR

Introduction

Package Leaflet: Information for the User

Angifen 8.75 mg lozenges, mint flavor

Flurbiprofen

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

Contents of the Package Leaflet

1. What is Angifen and what is it used for
2. What you need to know before taking Angifen
3. How to take Angifen
4. Possible side effects
5. Storage of Angifen
6. Package Contents and Additional Information

1. What is Angifen and what is it used for

Angifen contains 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.

Angifen is used for the short-term relief of symptoms of sore throat, such as pain, difficulty swallowing, and throat inflammation in adults and children over 12 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

2. What you need to know before taking Angifen

Do not takeAngifen

• if you are allergic to flurbiprofen or any of the other components of this medicine (listed in section 6)
• if after taking acetylsalicylic acid (Aspirin) or any other NSAID, you have ever experienced asthma, sudden wheezing, or difficulty breathing, nasal discharge, facial swelling, or itchy rash (urticaria).
• if you have or have had an ulcer (two or more episodes of gastric or intestinal ulcer) in your stomach or intestines.
• if after taking any other NSAID, you have had gastrointestinal bleeding or perforation, severe colitis, or blood disorders.
• if you are in the last trimester of pregnancy.
• if you have or have had severe heart, kidney, or liver failure.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Angifen:

• if you have ever had asthma or allergies
• if you have tonsillitis (inflammation of the tonsils) or think you may have a bacterial throat infection (as you may need antibiotics)
• if you have an infection - see the section "Infections" below.
• if you have heart, kidney, or liver problems
• if you have had a stroke
• if you have a history of intestinal disease (ulcerative colitis, Crohn's disease)
• if you have high blood pressure.
• if you have a chronic autoimmune disease (such as systemic lupus erythematosus or connective tissue disease).
• if you are an elderly patient, as you are more likely to experience the adverse reactions described in this leaflet.
• if you are in the first 6 months of pregnancy or are breastfeeding.

Infections

Non-steroidal anti-inflammatory drugs (NSAIDs) may hide signs of infections such as fever and pain. This may delay the start of appropriate treatment for the infection, which can lead to a higher risk of complications. If you take this medicine while having an infection and your symptoms persist or worsen, consult your doctor or pharmacist without delay.

While takingAngifen

• At the first sign of a skin reaction (rash, exfoliation) or other sign of allergic reaction, stop taking this medicine and consult a doctor immediately.
• Tell your doctor about any unusual abdominal symptoms that you may experience (especially bleeding). Consult your doctor if it does not improve, worsens, or if new symptoms appear.
• Taking medicines containing flurbiprofen may be associated with a small increased risk of having a heart attack (myocardial infarction) or stroke. Any risk is more likely at high doses and with prolonged treatments. Do not exceed the recommended dose or treatment duration (3 days).

Children and Adolescents

This medicine must not be used by children and adolescents under 12 years of age.

Other Medicines and Angifen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, if you are taking:

• acetylsalicylic acid (Aspirin) at low doses (up to 75 mg per day).
• medicines for high blood pressure or heart problems (antihypertensives, cardiac glycosides).
• diuretics (including potassium-sparing diuretics)
• medicines to thin the blood (anticoagulants, antiplatelet agents).
• medicines for gout (probenecid, sulfinpyrazone)
• other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone).
• mifepristone (a medicine used for abortion).
• quinolone antibiotics (such as ciprofloxacin).
• cyclosporin or tacrolimus (medicines used to 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 (medicines for depression).
• oral antidiabetics (medicines for diabetes).
• zidovudine (a medicine used to treat HIV).

Taking Angifen with Food, Drinks, and Alcohol

Consumption of alcohol should be avoided during treatment with Angifen, as it may increase the risk of stomach or intestinal bleeding.

Pregnancy, Breastfeeding, and Fertility

Oral forms (e.g., tablets) of flurbiprofen may cause adverse effects in unborn babies. It is not known if there is the same risk with Angifen.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine. Do not use Angifen if you are in the last trimester of pregnancy. You should not take Angifen during the first six months of pregnancy unless it is clearly necessary and your doctor advises you to do so. If you need treatment during this period, you should use the lowest possible dose and for the shortest possible time.

Flurbiprofen belongs to a group of medicines that may affect fertility in women. This effect is reversible when the medicine is stopped. It is unlikely that occasional use of this medicine can affect your chances of getting pregnant; however, inform your doctor before taking this medicine if you have problems conceiving.

Driving and Using Machines

No studies have been conducted on the effects on the ability to drive and use machines. However, if adverse reactions such as dizziness and/or visual disturbances occur, do not drive or use machines.

Angifen contains Saccharose and Glucose

This medicine contains saccharose and glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains 1.350 g of saccharose and 1.127 g of glucose per dose, which should be taken into account in patients with diabetes mellitus.

3. How to take Angifen

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use the lowest effective dose for the shortest necessary duration to relieve symptoms. If you have an infection, consult a doctor or pharmacist without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose is: Adults and adolescents over 12 years of age:

1. 1 lozenge every 3-6 hours as needed.

Do not take more than 5 lozenges in 24 hours.

• Suck one lozenge slowly in the mouth.
• Move the lozenge around in the mouth while sucking it.

Use in Children

Children under 12 years of age must not take this medicine.

These lozenges are for short-term treatment only.

Take the minimum number of lozenges you need for the shortest duration necessary to relieve your symptoms. If irritation occurs in the mouth, you should stop treatment with the medicine.

Do not take Angifen for more than 3 days,unless your doctor recommends it. If you do not improve, if your symptoms worsen, or if new symptoms appear, consult your doctor or pharmacist.

If you take more Angifen than you should

Call a doctor or pharmacist or go to the nearest hospital. Symptoms of overdose may include stomach pain or, more rarely, diarrhea. You may also experience ringing in the ears, headache, and gastrointestinal bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP TAKINGthis medicine and consult your doctor immediately if you develop:

• allergic reactions such as asthma, wheezing, or shortness of breath, itching, nasal discharge, skin rash, etc.
• swelling of the face, tongue, or throat that causes difficulty breathing, palpitations, low blood pressure that causes shock (all these effects can occur even when using the medicine for the first time).
• severe skin reactions such as exfoliation, blisters, or skin peeling.

Tell your doctor or pharmacist if you notice any of the following effects or any effect not described in this leaflet:

The following side effects may occur:

Common(may affect up to 1 in 10 people)

• dizziness, headache
• throat irritation
• mouth ulcers or mouth pain
• throat pain
• mouth discomfort (feeling of heat, burning, itching, tingling, etc.)
• nausea and diarrhea
• itching and skin rash

Uncommon(may affect up to 1 in 100 people)

• numbness
• drowsiness or difficulty sleeping
• worsening of asthma, wheezing, shortness of breath
• blisters in the mouth or throat, numbness in the throat
• dry mouth
• burning sensation in the mouth, altered taste
• abdominal distension, abdominal pain, gas, constipation, indigestion, vomiting
• reduced sensitivity in the throat
• fever, pain
• skin rash, itching

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

• anaphylactic reaction

Frequency Not Known(cannot be estimated from the available data)

• anemia, thrombocytopenia (low platelet count in the blood that can lead to bruising and bleeding)
• edema (swelling), high blood pressure, heart failure, or heart attack
• severe forms of skin reactions such as blistering reactions, including Stevens-Johnson syndrome, Lyell syndrome, and toxic epidermal necrolysis
• hepatitis (inflammation of the liver).

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Angifen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Do not store above 30°C.

6. Package Contents and Additional Information

Composition of Angifen

The active ingredient is flurbiprofen. One lozenge contains 8.75 mg of flurbiprofen.

The other ingredients (excipients) are:

Saccharose

Glucose liquid

Macrogol 300 (E-1521)

Peppermint oil

Levomenthol

Potassium hydroxide (E-525)

Appearance of the Product and Package Contents

Angifen 8.75 mg lozenges, mint flavor, are presented as round lozenges, light yellow to brown in color, with a diameter of 19±1 mm.

The lozenges are available in PVC-PVDC/Aluminum blisters

Package size: 8, 12, 16, 20, 24 lozenges, mint flavor

Marketing Authorization Holder

Alfasigma España, S.L.

Avda. Diagonal, 490

08006 Barcelona, SPAIN

Manufacturer

Lozy’s Pharmaceuticals, S.L.

Campus Empresarial s/n

31795 Lekaroz, Navarra

Spain

Terapia S.A.

Strada Fabricii nr. 124, Cluj-Napoca

Romania

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

Italy: Flurbiprofen Geiser 8,75 pastiglie

Portugal: Mentocaína F

Romania: Faringo Internsiv 8,75 pastile

Date of the Last Revision of this Leaflet:December 2023

Other Sources of Information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.