TANTUFEN 8.75 mg lozenges honey and mint flavored

Introduction

Package Leaflet: Information for the User

Tantufen 8.75 mg lozenges with honey and mint flavor

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication 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.

Contents of the Package Leaflet

1. What Tantufen is and what it is 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 Tantufen is and what it is used for

Tantufen contains flurbiprofen. Flurbiprofen belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs) that have analgesic and anti-inflammatory properties in the treatment of sore throat. These medications 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 old.

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, swelling of the face, or itching (hives).
• 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 medication.

• 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 a 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 side 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 side effects, particularly gastrointestinal ones such as ulcers and bleeding (see the section "Using Tantufen with other medications").

While using this medication

• At the first sign of a skin reaction (rash, exfoliation, etc.) or any other sign of an allergic reaction, stop using this medication 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.
• Taking medications 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 treatment. Do not exceed the recommended dose or treatment duration indicated in this package leaflet (3 days).

Children and Adolescents

This medication should not be used in children and adolescents under 12 years old.

Using Tantufen with other medications.

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

• Low-dose acetylsalicylic acid (up to 75 mg per day).
• Medications for hypertension or heart failure (antihypertensives, cardiac glycosides).
• Diuretics (including potassium-sparing diuretics).
• Medications to thin the blood (anticoagulants, antiplatelet agents).
• Medications for gout (probenecid, sulfinpyrazone).
• Other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone) (see the section "Warnings and Precautions").
• Mifepristone (a medication used for abortion).
• Quinolone antibiotics (such as ciprofloxacin).
• Cyclosporin 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 medication, 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 medication.

Do not take this medication 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 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 can affect your chances of becoming pregnant; however, inform your doctor before taking this medication if you have difficulty becoming pregnant.

Driving and Using Machines

This medication should not affect your ability to drive or use machines. However, if you experience side effects such as dizziness and/or visual disturbances, do not drive or use machines.

Tantufen containsmaltitol and isomalt

This medication contains maltitol and isomalt. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. 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 for the medication 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 old:

• 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 medication in children under 12 years old.

These lozenges are for short-term treatment 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 medication 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 medication and the amount taken.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

STOP TAKING this medication 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 medication for the first time).
• Severe skin reactions such as exfoliation, blisters, or skin peeling.

Tell 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:

Frequent(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 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 Medications (www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tantufen

Keep this medication out of sight and reach of children.

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

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. 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)

Potassium acesulfame (E950)

Macrogol 300 (E-1521)

Potassium hydroxide (E 525)

Levomenthol

Honey flavor

Mint essence

Appearance of the product and package contents

Tantufen 8.75 mg lozenges with honey and mint flavor are light-colored to yellowish, round lozenges with a diameter of approximately 19±1 mm and a honey and mint 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 medication is authorized in the Member States of the European Economic Area under the following names:

PT: Tantumflam 8.75 mg pastilhas Mel e Hortelã

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

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