LIZIFEN 8.75 mg LOZENGES HONEY & LEMON FLAVORED

Introduction

Package Leaflet: Information for the User

Lizifen 8.75 mg lozenges with honey and lemon 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 it is possible side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days of treatment.

Contents of the Package Leaflet

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

1. What is Lizifen and what is it used for

Lizifen contains flurbiprofen. Flurbiprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). These medicines work 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 from 12 years of age.

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

2. What you need to know before taking Lizifen

Do not takeLizifen if you:

• are allergic to flurbiprofen or any of the other components of this medicine (listed in section 6)
• have experienced asthma, wheezing, or shortness of breath, nasal congestion, facial swelling, or itchy rash (urticaria) after taking acetylsalicylic acid (Aspirin) or any other NSAID.
• have or have had a stomach ulcer (two or more episodes of stomach or intestinal ulcer) or bleeding in your stomach or intestines.
• 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 failure.

Warnings and Precautions

Consult your doctor or pharmacist before taking Lizifen if you:

• have ever had asthma or allergies
• have tonsillitis (inflammation of the tonsils) 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 elderly, as you are more likely to experience the adverse reactions described in this leaflet.
• are in the first 6 months of pregnancy or are 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 also section "Other Medicines and Lizifen").

While taking Lizifen

• 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 you may experience (especially bleeding). Consult your doctor if it 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 risk is more likely at high doses and with prolonged treatment. Do not exceed the recommended dose or treatment duration (3 days).

Children

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

Other Medicines and Lizifen

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, including selective cyclooxygenase-2 inhibitors 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 to treat diabetes).
• zidovudine (a medicine used to treat HIV).

Taking Lizifen with Food, Drinks, and Alcohol

Consumption of alcohol should be avoided during treatment with Lizifen, 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 Lizifen.

Do not take this medicine if you are in the last 3 months of pregnancy. If you are in the first 6 months of pregnancy or are breastfeeding, consult your doctor before taking this medicine. 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 will affect your ability to get pregnant; however, inform your doctor before taking this medicine if you have problems conceiving.

Driving and Using Machines

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

Lizifen contains isomalt, maltitol, and fragrances that contain allergens.

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

This medicine contains fragrances with d-limonene and geraniol.

D-limonene and geraniol may cause allergic reactions.

Infections

Nonsteroidal 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 may lead to a greater 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.

3. How to take Lizifen

Follow the instructions for administration of the medicine contained in this leaflet or as 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 lozenge every 3-6 hours as needed.

Do not take more than 5 lozenges in 24 hours.

• Take a lozenge in your mouth and suck it slowly. Do not swallow or chew the lozenge.
• Move the lozenge around in your mouth while sucking it.

Use in Children:

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

These lozenges are for short-term use only.

Take the minimum number of lozenges you need for the shortest possible time to relieve your symptoms. The effective lowest 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).

Do not take Lizifen for more than 3 days,unless your doctor recommends it. If it does not improve, worsens, 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. Symptoms of overdose may include nausea or vomiting, stomach pain, or, more rarely, diarrhea. You may also experience ringing in the ears, headache, and gastrointestinal bleeding.

If you have any further questions on the use of this medicine, 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 congestion, 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 peeling of the skin.

Tell your doctor or pharmacist if you notice any of the following effects or any effect not listed 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
• mouth discomfort (feeling of heat, burning, itching, tingling, 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, difficulty breathing
• 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 of the skin

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)
• swelling (edema), 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).
• hypersensitivity

Reporting of Side Effects

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

5. Storage of Lizifen

Keep 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. Return the packaging and any unused medicine to a pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Do not store above 30°C.

6. Package Contents and Additional Information

Composition of Lizifen

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

The other ingredients are:

Isomalt (E-953)

Maltitol (E-965)

Macrogol 300

Peppermint oil (contains d-limonene).

Lemon flavor (contains d-limonene and geraniol).

Honey flavor

Appearance and Package Contents

Round lozenges, light yellow to yellowish 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

Not all pack sizes may be marketed.

Marketing Authorization Holder

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Sanofi Group

Manufacturer

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 under the following names:

Austria: ratioDolor Flurbiprofen 8,75 mg Lutschtabletten mit Zitronengeschmack

Spain: Lizifen 8,75 pastillas para chupar sabor miel y limón

Portugal: Macifen Mel e Limão

Hungary: Dolioflen 8,75 mg szopogató tabletta

Germany: Flurbiprofen-ratiopharm mit Honig- und Zitronengeschmack

Finland: Flusils hunaja-sitruuna 8,75 mg, imeskelytabletti

Luxembourg: Flurbiprofen-ratiopharm mit Honig-Zitrone-Geschmack

Bulgaria: Efisol Intense 8.75 mg lozenges

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet 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

Date of the last revision of this leaflet:July 2022