Leaflet: information for the user

Lizifen 8.75 mg chewable tablets, honey and lemon 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.
• 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 Lizifen and what it is used for

2. What you need to know before starting to take Lizifen

3. How to take Lizifen

4. Possible side effects

5. Storage of Lizifen

6. Contents of the pack and additional information

Lizifen contains flurbiprofen. Flurbiprofen belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). These medications act by modifying the body's response to pain, swelling, and fever.

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

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

Do not takeLizifen if you:

• are allergic to flurbiprofen or any of the other components of this medication (listed in section 6)
• have experienced asthma, sudden wheezing or difficulty breathing, nasal secretion, facial swelling, or an itchy rash (urticaria) after taking acetylsalicylic acid (Aspirin) or any other nonsteroidal anti-inflammatory drug (NSAID)
• have or have had stomach or intestinal ulcers (two or more episodes of gastric or intestinal ulcers)
• have had gastrointestinal bleeding or perforation, severe colitis, or blood disorders after taking any other NSAID
• are in the last three months of pregnancy
• have or have had severe heart, kidney, or liver disease

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lizifen if you:

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

Avoid concomitant use of two or more NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone), as this may increase the risk of adverse effects, particularly gastrointestinal events such as ulcers and bleeding (see section "Other medications and Lizifen”)

While takingLizifen

• Stop taking this medication and consult a doctor immediately if you experience the first sign of a skin reaction (rash, exfoliation) or other allergic reaction
• 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 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

This medication cannot be used by children under 12 years old

Other medications and Lizifen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take another 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, including selective cyclooxygenase-2 inhibitors 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)

Lizifen with food, drinks, and alcohol

Avoid consuming alcohol during treatment with Lizifen, as it may increase the risk of gastrointestinal bleeding

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 Lizifen

Do not take this medication if you are in the last 3 months of pregnancy. If you are in the first 6 months of pregnancy or breastfeeding, consult your doctor before taking this medication. If you need treatment during this period, the lowest possible dose should be used for the shortest possible time

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication

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

Lizifen contains isomalta, maltitol, and fragrances that contain allergens

This medication contains isomalta and maltitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause a mild laxative effect. Caloric value: 2.3 kcal/g of maltitol/isomalta

This medication contains fragrances with d-limonene and geraniol

D-limonene and geraniol may cause allergic reactions

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

Take 1 tablet every 3-6 hours as needed.

Do not take more than 5 tablets in 24 hours.

• Take a tablet in the mouth and suck it slowly.Do not swallow or chew the tablet.
• Movethe tablet around in the 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.You should use the most effective dose for the shortest time 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).

Do not take Lizifen 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 Lizifen than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist or go to the nearest hospital. You can also call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount taken. Overdose symptoms may include the following: nausea or vomiting, stomach pain or, less frequently, diarrhea. You may also experience ringing in the ears, headache, and gastrointestinal bleeding.

If you have any other questions about the use of this medication, 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:

Common(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

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

• numbness
• drowsiness or difficulty falling asleep
• worsening of asthma, sneezing, breathing difficulty
• 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).
• hypersensitivity

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction that does not appear 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 reactions, 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 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 unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

Do not store above 86°F (30°C).

Composition of Lizifen

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

The other components are:

Isomalta (E-953)

Maltitol (E-965)

Macrogol 300

Mint oil (contains d-limonene).

Lemon essence (contains d-limonene and geraniol).

Honey aroma

Appearance of the product and contents of the packaging

Round tablets, light to yellowish in color, with a diameter of 19±1 mm.

The tablets are available in PVC-PVDC/Aluminum blisters

Packaging size: 8, 12, 16, 20, 24 sucking tablets

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Sanofi Group

Responsible for manufacturing

Lozy’s Pharmaceuticals, S.L.

Campus Empresarial s/n

31795 Lekaroz, Navarra

Spain

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

Austria:ratioDolor Flurbiprofen 8.75 mg Lozenges with Lemon Flavor

Spain:Lizifen 8.75 Sucking Tablets with Honey and Lemon Flavor

Portugal:Macifen Mel e Limão

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your smartphone.

You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/81912/P_81912.html

Last review date of this prospectus:July 2022