TANTUFEN 8.75 mg LOZENGES LEMON FLAVORED

Introduction

Package Leaflet: Information for the User

Tantufen 8.75 mg Lemon Flavor Lozenges

Flurbiprofen

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 or pharmacist, even if they are possible side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Package Leaflet Contents

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

1. What is Tantufen and what is it used for

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

Flurbiprofen 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 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 using Tantufen

Do not use Tantufen:

• If you are allergic to flurbiprofen or any of the other components (listed in section 6).
• If after taking non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid, you have suffered from asthma, sudden wheezing or difficulty breathing, nasal discharge, facial swelling, or itching (urticaria).
• If you have or have had a stomach or intestinal ulcer (two or more episodes of gastric or duodenal ulcer).
• If you have ever had gastrointestinal bleeding or perforation, severe colitis, or blood disorders after taking NSAIDs.
• 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 use this medicine.

• If you have ever had asthma or allergies.
• If you have tonsillitis (inflammation of the tonsils) or think you may have a bacterial throat infection (as you may need antibiotics).
• 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 (hypertension).
• If you have any chronic autoimmune disease (including 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 package leaflet.
• If you are in the first 6 months of pregnancy or are breastfeeding.
• If you have headache induced by analgesics.

Avoid using two or more NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone) at the same time, as this may increase the risk of adverse effects, particularly gastrointestinal ones such as ulcers and bleeding (see the section "Use of Tantufen with other medicines").

While using this medicine

• At the first sign of a skin reaction (rash, exfoliation, etc.) or any other sign of an allergic reaction, stop using this medicine and consult a doctor immediately.
• Inform your doctor of any unusual abdominal symptoms that may occur (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 suffering a heart attack (myocardial infarction) or stroke. Any risk is more likely at high doses and with prolonged treatments. Do not exceed the recommended dose or the duration of treatment indicated in this package leaflet (3 days).

Children and Adolescents

This medicine should not be used in children and adolescents under 12 years of age.

Use of Tantufen with other medicines.

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take other medicines, including those obtained without a prescription. In particular, if you are taking:

• Low-dose acetylsalicylic acid (up to 75 mg per day).
• Medicines for hypertension 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, diclofenac sodium, or prednisolone) (see the section "Warnings and Precautions").
• Mifepristone (a medicine used for abortion).
• Quinolone antibiotics (such as ciprofloxacin).
• Cyclosporine or tacrolimus (to suppress the immune system).
• Phenytoin (to treat epilepsy).
• Methotrexate (to treat autoimmune diseases or cancer).
• Lithium or selective serotonin reuptake inhibitors (for depression).
• Oral antidiabetics (to treat diabetes).
• Zidovudine (to treat HIV).

Taking Tantufen with food, drinks, and alcohol.

Alcohol consumption should be avoided during treatment with this medicine, as it may increase the risk of stomach or intestinal bleeding.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine if you are in the last trimester of pregnancy. If you are in the first semester of pregnancy or breastfeeding, consult your doctor 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 can affect your chances of becoming pregnant; however, inform your doctor before taking this medicine if you have problems becoming pregnant.

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 use machines.

Tantufen containsmaltitol and isomalt

This medicine contains maltitol and isomalt. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It may have a mild laxative effect because it contains 2.03 g of isomalt and 0.43 g of maltitol per lozenge.

Caloric value: 2.3 kcal/g maltitol/isomaltose

3. How to use Tantufen

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 12 years of age:

• Take one lozenge every 3 to 6 hours as needed.
• Do not take more than 5 lozenges in 24 hours.

Method of administration:

Oral

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

Move the lozenge around in the mouth while it dissolves.

Use in children

Do not use this medicine in children under 12 years of age.

These lozenges are for short-term use only. Take the minimum number of lozenges you need for the shortest time necessary to relieve your symptoms. If irritation occurs in the mouth, you should stop treatment with flurbiprofen.

Do not take this medicine for more than 3 days. If it does not improve, worsens, or if new symptoms appear, consult your doctor or pharmacist.

If you take more Tantufen than you should

Consult your doctor or pharmacist or go to the nearest hospital as soon as possible. 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.

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

If you have any other questions about 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 TAKING this medicine and consult a doctor immediately if you notice:

• Signs of an allergic reaction such as asthma, shortness of breath or wheezing without explanation, itching, nasal discharge, skin rash, etc.
• Swelling of the face, tongue, or throat that causes difficulty breathing, palpitations, decreased 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 skin peeling.

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

Other side effects may also occur:

Common(may affect up to 1 in 10 people)

• Dizziness, headache.
• Irritation of the throat.
• Ulcers in the mouth, pain in the mouth.
• Sore throat.
• Discomfort or unusual sensation in the mouth (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.
• Somnolence or difficulty falling asleep.
• Worsening of asthma, wheezing, shortness of breath.
• 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.
• Decreased 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).
• Edema (swelling), high blood pressure, heart failure, or heart attack.
• Severe skin reactions such as blistering reactions, including Stevens-Johnson syndrome, Lyell syndrome, and toxic epidermal necrolysis.
• Hepatitis (inflammation of the liver).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet.

You can also report them 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 Tantufen

Keep this medicine out of the sight and reach of children.

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tantufen

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

The other components (excipients) are:

Isomalt (E953)

Maltitol (E965)

Acesulfame potassium (E-950), Macrogol 300 (E-1521)

Potassium hydroxide (E 525)

Levomenthol

Lemon flavor

Appearance of the product and package contents

Tantufen 8.75 mg Lemon Flavor Lozenges are light yellow to yellowish-colored, round lozenges with a diameter of approximately 19±1 mm and a lemon flavor.

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

Package sizes: 8, 12, 16, 20, or 24 lozenges.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Angelini Pharma España SL

C/Antonio Machado, 78. Módulo A, 3ª planta, Edificio Australia

08840 Viladecans, Barcelona

Spain

Manufacturer

Lozy's Pharmaceuticals S.L.

Campus Empresarial Lekaroz nº1

31795 Lekaroz (Navarra), Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

PT: Tantumflam 8,75 mg pastilhas Limão

Date of the last revision of this package leaflet: November 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es