Angifen 8.75 mg orange-flavored lozenges

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Angifen 8.75 mg orange-flavoured lozenges

Flurbiprofen

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

Follow exactly the instructions for use provided 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 adverse effects, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days of treatment.

Contents of the leaflet

1. What Angifen is and what it is used for
2. What you need to know before taking Angifen
3. How to take Angifen
4. Possible adverse effects
5. How to store Angifen
6. Contents of the pack and other information

1. What Angifen is and what it is used for

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

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

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

2. What you need to know before taking Angifen

Do not take Angifen

• if you are allergic to flurbiprofen or to any of the other ingredients of this medicine (listed in section 6)
• if after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory drug (NSAID) you have ever experienced asthma, sudden wheezing or difficulty breathing, nasal discharge, swelling of the face or itchy rash (urticaria)
• if you currently have or have previously had a stomach or intestinal ulcer (two or more episodes of gastric or duodenal ulcer)
• 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 currently have or have previously had severe heart, kidney, or liver failure

Warnings and precautions

Talk to your doctor or pharmacist before taking Angifen:

• if you have ever had asthma or suffer from allergies
• if you have tonsillitis (inflammation of the tonsils) or suspect 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 bowel 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 elderly, 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 suffer from medication-overuse headache

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

Infections

Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain. This could delay the start of appropriate treatment for the infection, increasing the risk of complications. If you take this medicine while having an infection and your symptoms persist or worsen, consult your doctor or pharmacist immediately.

While taking Angifen

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

Children and adolescents

This medicine must not be used in children or adolescents under 12 years of age.

Other medicines and Angifen

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine, including over-the-counter medicines. Specifically, if you are taking:

• acetylsalicylic acid at low doses (up to 75 mg per day)
• medicines for high blood pressure or heart failure (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, sodium diclofenac, or prednisolone) (see section “Warnings and precautions”)
• mifepristone (a medicine used for abortion)
• quinolone antibiotics (such as ciprofloxacin)
• cyclosporine or tacrolimus (medicines used to suppress the immune system)
• phenytoin (a medicine for epilepsy)
• methotrexate (a medicine for autoimmune diseases or cancer)
• lithium or selective serotonin reuptake inhibitors (medicines for depression)
• oral antidiabetics (for treating diabetes)
• zidovudine (for treating HIV)

Taking Angifen with food, drinks, and alcohol

Alcohol consumption 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 unknown whether the same risk exists 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 clearly necessary and advised by your doctor. If treatment is needed during this period, the lowest possible dose for the shortest possible time should be used.

Flurbiprofen belongs to a group of medicines that may affect fertility in women. This effect is reversible upon stopping the medicine. Occasional use of this medicine is unlikely to affect your chances of becoming pregnant, but inform your doctor before taking this medicine if you have difficulty conceiving.

Driving and using machines

This medicine should not affect your ability to drive or use machines. However, if adverse reactions such as dizziness and/or visual disturbances occur, do not drive or operate machinery.

Angifen contains isomalt and maltitol

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

3. How to take Angifen

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in 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).

Recommended dose:

Adults and children over 12 years of age:

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

Method of administration:

Oral use

Allow the lozenge to dissolve slowly in the mouth; do not swallow or chew it.

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

Use in children:

This medicine must not be given to children under 12 years of age.

These lozenges are intended for short-term treatment only .

Take the minimum number of lozenges necessary for the shortest time needed to relieve your symptoms. If mouth irritation occurs, discontinue treatment with this medicine.

Do not take Angifen for longer than 3 days . If your symptoms do not improve, worsen, 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 more rarely, diarrhea. Tinnitus, headache, and gastrointestinal bleeding may also occur.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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, runny nose, skin rashes, etc.
• Swelling of the face, tongue, or throat causing difficulty breathing, palpitations, or drop in blood pressure leading to shock (these effects may occur even when the medicine is used for the first time).
• Severe skin reactions such as skin peeling, blistering, or flaking of the skin.

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

The following adverse effects may occur:

Frequent (may affect up to 1 in 10 people)

• Dizziness, headache
• Sore throat
• Mouth ulcers or mouth pain
• Sore throat
• Mouth discomfort or unusual sensations in the mouth (burning sensation, tingling, itching, prickling, etc.)
• Nausea and diarrhea
• Itching and pruritus of the skin

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, throat numbness
• Dry mouth
• Burning sensation in the mouth, altered taste sensation, abdominal distension
• Abdominal pain, flatulence, constipation, indigestion, vomiting
• Reduced throat sensitivity
• Fever, pain
• Skin rashes, skin 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 which may lead to bruising and bleeding)
• Swelling (edema), high blood pressure, heart failure, or heart attack
• Severe forms of skin reactions such as blistering reactions, including Stevens-Johnson syndrome, Lyell's syndrome, and toxic epidermal necrolysis
• Hepatitis (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 via the Spanish Pharmacovigilance System for Human Medicines (www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Angifen

Keep out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Angifen

The active substance is flurbiprofen. Each pastille for sucking contains 8.75 mg of flurbiprofen.

The other components are:

Isomalt (E 953)

Maltitol (E 965)

Potassium acesulfame (E 950)

Macrogol 300 (E 1521)

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

Potassium hydroxide (E 525)

Levomenthol

Appearance of the product and contents of the pack

Angifen 8.75 mg pastilles for sucking, orange flavour, are presented as round, light to yellowish tablets, 19±1 mm in diameter, with an orange flavour.

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

Pack sizes: 8, 12, 16, 20 or 24 pastilles for sucking.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Alfasigma España, S.L.

C/Aribau 195, 4º

08021 Barcelona. SPAIN

Manufacturer responsible

Lozy’s Pharmaceuticals, S.L.

Campus Empresarial s/n

31795 Lekaroz, Navarra

Spain

Date of the most recent revision of this leaflet: October 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es