Package Leaflet: Information for the user

Angifen 8.75 mg Lozenges, Orange Flavour

Flurbiprofen

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

Follow exactly the administration instructions contained in this leaflet or those given 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 any side effects, consult your doctor, pharmacist or nurse, even if they are 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.

1. What is Angifen and what it is 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. Contents of the pack and additional information

Angifen contains flurbiprofen. Flurbiprofen belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs) that have analgesic and anti-inflammatory properties for the treatment of sore throat. These medications act by modifying the body's response to pain, inflammation, and fever.

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

You should consult a doctor if it worsens or does not improve after 3 days of treatment.

Do not take Angifen

• if you are allergic to flurbiprofen or any of the other components of this medication (listed in section 6)
• if after taking acetylsalicylic acid or any other nonsteroidal anti-inflammatory drug (NSAID) you have ever experienced asthma, sudden wheezing, or difficulty breathing, nasal secretion, facial swelling, or an itchy rash (urticaria).
• if you have or have ever had an ulcer (two or more episodes of gastric or duodenal ulcers) in your stomach or intestine.
• if after taking any other NSAID you have experienced gastrointestinal bleeding or perforation, severe colitis, or blood disorders.
• if you are in the last trimester of pregnancy.
• if you have or have ever 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 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 mixed connective tissue disease).
• if you are an elderly patient, as you are more likely to experience the adverse effects described in this leaflet.
• if you are in the first 6 months of pregnancy or are breastfeeding.
• if you have headache-induced analgesic pain

Avoid concomitant use of two or more NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone), as they may increase the risk of adverse effects, particularly gastrointestinal ones such as ulcers and bleeding (see the section “Taking Angifen with other medications” below).

Infections

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

While taking Angifen

• At the first sign of a skin reaction (rash, exfoliation) or other allergic reaction, stop taking this medication and consult a doctor immediately.
• Inform your doctor of any unusual abdominal symptoms that may occur (especially bleeding). Consult your doctor if they do not improve, worsen, or if new symptoms appear.
• The use of medications containing flurbiprofen may be associated with a small increase in the risk of suffering a heart attack (myocardial infarction) or stroke. Any risk is more likely at high doses and in prolonged treatments. Do not exceed the recommended dose or treatment duration (3 days).

Children and adolescents

This medication cannot be used by children or adolescents under 12 years old.

Other medications and Angifen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take another medication, including over-the-counter medications. In particular, if you are taking:

• acetylsalicylic acid at low doses (up to 75 mg per day).
• medications for high blood pressure or heart failure (anti-hypertensives, cardiac glycosides).
• diuretics (including potassium-sparing diuretics)
• blood-thinning medications (anticoagulants, antiplatelet agents).
• medications for gout (probencid, sulfinpyrazone)
• other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone) (see the section “Warnings and precautions”).
• mifepristone (a medication used for abortion).
• quinolone antibiotics (such as ciprofloxacin).
• ciclosporin or tacrolimus (medications used to inhibit the immune system).
• phenytoin (a medication for treating epilepsy).
• methotrexate (a medication for treating autoimmune diseases or cancer).
• lithium or selective serotonin reuptake inhibitors (medications for depression).
• oral antidiabetic medications (for treating diabetes).
• zidovudine (for treating HIV).

Taking Angifen with food, drinks, and alcohol

It is recommended to avoid consuming alcohol during treatment with Angifen, as it may increase the risk of gastrointestinal bleeding or perforation.

Pregnancy, breastfeeding, and fertility

The oral forms (such as tablets) of flurbiprofen may cause adverse effects in unborn babies. It is unknown if the same risk exists with Angifen.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medication. Do not use Angifen if you are in the last trimester of pregnancy. Do 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, use the lowest possible dose and for the shortest possible time.

Flurbiprofen belongs to a group of medications that may affect fertility in women. This effect is reversible when the medication is stopped. It is unlikely that occasional use of this medication will affect your chances of becoming pregnant, but inform your doctor before taking this medication if you have difficulty conceiving.

Driving and operating machinery

This medication should not affect your ability to drive and operate machinery. However, if you experience adverse reactions such as dizziness and/or visual disturbances, do not drive or operate machinery.

Angifen contains isomalta and maltitol

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The lowest effective dose should be used for the shortest duration necessary 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 children over 12 years:

• 1 tablet every 3-6 hours as needed.
• Do not take more than 5 tablets in 24 hours.

Administration form:

Oral route

Dissolve the tablet slowly in the mouth, do not swallow and do not chew.

Always move the tablet around in the mouth while it dissolves.

Use in children:

Children under 12 years cannot take this medication.

These tablets are only for short treatments.

Take the minimum amount of tablets you need for the shortest period of time necessary to relieve your symptoms. If mouth irritation appears, discontinue treatment with the medication.

Do not take Angifen for more than 3 days. If it does not improve, worsens, or 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 immediately. Symptoms of overdose may include: nausea or vomiting, stomach pain or, less frequently, diarrhea. Also, tinnitus, headache, and gastrointestinal bleeding may appear.

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

STOP TAKING this medicine and consult your doctor immediately if you develop:

• Signs of an allergic reaction such as asthma, wheezing, or unexplained shortness of breath, itching, nasal discharge, skin rashes, etc.
• Swelling of the face, tongue, or throat that causes difficulty breathing, palpitations, a drop in blood pressure that causes shock (these effects can occur even when the medicine is used for the first time).
• Severe skin reactions such as peeling, blisters, or skin flaking.

Inform 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
• Sore throat
• Unusual mouth sensations (sensation of heat, burning, itching, tingling, etc.)
• Nausea and diarrhea
• Sensation of itching and pruritus on the skin

Uncommon(may affect up to 1 in 100 people):

• Numbness
• Drowsiness or difficulty falling asleep
• Worsening of asthma, wheezing, or shortness of breath
• Blisters in the mouth or throat, throat numbness
• Dry mouth
• Sensation of burning in the mouth, altered sense of taste, abdominal distension
• Abdominal pain, gas, constipation, indigestion, vomiting
• Reduced sensitivity in the throat
• Fever, pain
• Skin rashes, itching on the skin

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

• Anaphylactic reaction

Frequency not known(cannot be estimated from available data)

• Anemia, thrombocytopenia (low platelet count in the blood that may cause bruising and bleeding)
• Swelling (edema), high blood pressure, heart failure, or heart attack
• Severe skin reactions such as blistering, including Stevens-Johnson syndrome, Lyell syndrome, and toxic epidermal necrolysis
• Heatitis (inflammation of the liver).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use (www.notificaram.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and in the blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Angifen

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

The other components are:

Isomalta (E 953)

Maltitol (E 965)

Potassium acesulfame (E 950)

Macrogol 300 (E 1521)

Orange flavor (Limonene (50.0%-100%), decanal (0.0%-10%), citral, citronellol (0.1%-1.0%))

Potassium hydroxide (E 525)

Levomenthol

Appearance of the product and content of the container

Angifen 8.75 mg orange-flavored lozenges are presented as round, light yellow to yellow-colored lozenges, with a diameter of 19±1 mm, with orange flavor.

The lozenges are available in PVC-PVDC/Aluminum blisters in printed cardboard boxes or PVC-PVDC/Aluminum child-resistant blisters in printed cardboard boxes.

Container size: 8, 12, 16, 20, or 24 lozenges.

Only some container sizes may be commercially available.

Marketing authorization holder

Alfasigma España, S.L.

Avda. Diagonal, 490

08006 Barcelona. SPAIN

Responsible for manufacturing

Lozy’s Pharmaceuticals, S.L.

Campus Empresarial s/n

31795 Lekaroz, Navarra

Spain

Last review date of this leaflet:October 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es