Angifen 8,75 mg pastillas para chupar sabor menta

Leaflet: information for the user

Angifen 8.75 mg chewing tablets, peppermint flavor

Flurbiprofen

Read this leaflet carefully before you start taking this medicine, as 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.
• For advice on any matter relating to this medicine or for information about any aspect of its use, 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 must see 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 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 aged 12 years and above.

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

Do not takeAngifen

• if you are allergic to flurbiprofen or any of the other components of this medication (listed in section 6)
• if after taking acetylsalicylic acid (Aspirin) or any other nonsteroidal anti-inflammatory drug (NSAID) you have ever experienced asthma, sudden onset of wheezing or difficulty breathing, nasal secretion, facial swelling, or an itchy skin rash (urticaria).
• if you have or have had stomach or intestinal ulcers (two or more episodes of gastric or intestinal ulcers).
• 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 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

Nonsteroidal anti-inflammatory drugs (NSAIDs) can 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 you have 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 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 having a heart attack (myocardial infarction) or stroke. Any risk is more likely at high doses and with prolonged treatment. 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 any other medication. In particular, if you are taking:

• acetylsalicylic acid (Aspirin) at low doses (up to 75 mg per day).
• medications for high blood pressure or heart problems (anti-hypertensives, cardiac glycosides).
• diuretics (including potassium-sparing diuretics)
• blood thinners (anticoagulants, antiplatelet agents).
• medications for gout (probencid, sulfinpyrazone)
• other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone).
• 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 epilepsy).
• methotrexate (a medication for autoimmune diseases or cancer).
• lithium or selective serotonin reuptake inhibitors (medications for depression).
• oral antidiabetic medications (medications for diabetes).
• zidovudine (a medication for HIV).

Taking Angifen with food, drinks, and alcohol

Avoid consuming alcohol during treatment with Angifen, as it may increase the risk of stomach or intestinal bleeding.

Pregnancy, breastfeeding, and fertility

The oral forms (e.g., tablets) of flurbiprofen may cause adverse effects in unborn babies. It is unknown whether the same risk applies to 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

No studies have been conducted on the effects on the 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 saccharose and glucose

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

This medication 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.

Follow exactly the administration instructions for this medication as 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 adolescents over 12 years:

1. Take one tablet every 3-6 hours as needed.

Do not take more than 5 tablets in 24 hours.

• Place one tablet in your mouth and suck it slowly.
• Movements the tablet in your mouth while sucking it.

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,unless your doctor recommends it. If you do not improve, if you 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 the following: stomach pain or, less frequently, diarrhea. You may also experience ear problems, headache, and gastrointestinal bleeding.

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:

• allergic reactions such as asthma, sneezing, or 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 (all 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 observe any of the following effects or any effect not described in this leaflet:

The following side effects may occur:

Frequent(may affect up to 1 in 10 people)

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

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

• numbness
• drowsiness or difficulty falling asleep
• worsening of asthma, sneezing, or shortness of breath
• mouth or throat blisters, 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

Unknown frequency(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
• 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 a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish System for 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 this medication out of the sight and reach of children.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Do not store at a temperature above 30 °C.

Composition of Angifen

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

The other components (excipients) are:

Sucrose

Liquid glucose

Macrogol 300 (E-1521)

Menthol oil

Levomenthol

Potassium hydroxide (E-525)

Appearance of the product and content of the packaging

Angifen 8.75 mg chewable tablets, mint flavor, are presented as round, yellowish-brown tablets with a diameter of 19 ± 1 mm.

The tablets are available in PVC-PVDC/Aluminum blisters.

Packaging size: 8, 12, 16, 20, 24 chewable tablets, mint flavor

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

Terapia S.A.

Strada Fabricii nr. 124, Cluj-Napoca

Romania

This medicine is authorized in the member states of the European Economic Area with the following names:

Italy: Flurbiprofen Geiser 8.75 tablets

Portugal: Mentocaína F

Romania: Faringo Internsiv 8.75 tablets

Last review date of this leaflet:December 2023

Other sources of information

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