TANTUM VERDEDOL*16PASTILLES LIM MI

TANTUM VERDEDOL 8.75 mg lemon and honey flavored lozenges
Flurbiprofen

What it is and what it is used for
TANTUM VERDEDOL contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine, which acts against inflammation and pain in the throat, mouth, and gums.

TANTUM VERDEDOL is used in adults and adolescents over 12 years of age for the treatment of pain symptoms and irritations of the gums, mouth, and throat (e.g. gingivitis, stomatitis, pharyngitis).

Consult your doctor if you/your child do not feel better or feel worse after 3 days of treatment.

What you need to know before taking the medicine
Do not take/give TANTUM VERDEDOL to your child
- If you and/or your child are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in paragraph 6);
- If you and/or your child are allergic to acetylsalicylic acid (medicine for inflammation, pain, fever, and heart conditions) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see paragraph Other medicines and TANTUM VERDEDOL);
- if you and/or your child have a history of bleeding or perforation of the stomach or intestine related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
- if you and/or your child suffer from chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
- if you and/or your child frequently suffer from peptic ulcers (stomach lesions) or bleeding from the stomach or intestine (two or more distinct episodes of ulcer or bleeding);
- if you and/or your child suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function), and severe kidney failure (reduced kidney function).

Do not take/give TANTUM VERDEDOL during the last 3 months of pregnancy (see Pregnancy and breastfeeding).

Do not give TANTUM VERDEDOL to children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking/giving TANTUM VERDEDOL to your child.

Consult your doctor or pharmacist if you have an infection - refer to the Infections paragraph below.

In particular, inform your doctor if you and/or your child:
- have a history of bronchial asthma (a respiratory disease), as the risk of you/your child developing bronchospasm (narrowing of the bronchi causing severe respiratory difficulty due to reduced air passage) increases;
- have a history of allergies;
- are taking other non-steroidal anti-inflammatory drugs (NSAIDs) (see Other medicines and TANTUM VERDEDOL);
- suffer from systemic lupus erythematosus or mixed connective tissue disease;
- suffer from reduced kidney, heart, or liver function (kidney, heart, or liver failure);
- suffer from hypertension (high blood pressure);
- have been taking other analgesics for a long time or without respecting the dosage, as headaches may occur;
- have a history of peptic ulcer (stomach lesion) and other stomach and intestinal diseases, as the risk of these diseases recurring increases.
This risk increases especially with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer has been complicated by bleeding or perforation of the stomach and intestine (see paragraph 4 Possible side effects);
- if you are elderly (as you are more likely to experience side effects);
- if you have heart or blood vessel problems, as medicines like TANTUM VERDEDOL may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke. The risk of having side effects increases with high doses and prolonged treatments; do not exceed the dose of TANTUM VERDEDOL and do not take it for long periods. Inform your doctor if you have heart problems, a history of stroke, or think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or smoke).

Report any unusual abdominal symptoms to your doctor.

The use of this medicine, especially if prolonged, can lead to allergic phenomena or local irritation (see paragraph 4 Possible side effects); in such cases, stop treatment and consult your doctor who, if necessary, will carry out appropriate therapy.

If you or your child experience mouth irritation, stop treatment.

Children and adolescents
Do not give TANTUM VERDEDOL to children under 12 years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following side effects during treatment with TANTUM VERDEDOL, STOP treatment and contact your doctor immediately:
• allergic phenomena (sensitization phenomena):
- allergic reaction
- anaphylactic reactions (severe allergic reactions)
- angioedema (sudden swelling of the mouth/throat and mucous membranes)
• local irritation
• sensations of warmth or tingling in the mouth and throat (this effect may occur with lozenges)
• respiratory phenomena: asthma, bronchospasm, shortness of breath or difficulty breathing
• various skin disorders: skin rashes of various types, itching, redness, swelling, skin loss, blisters, desquamation or ulceration of the skin and mucous membranes.

If you experience the following side effects at the beginning of treatment with TANTUM VERDEDOL, contact your doctor immediately:
- abdominal pain
- peptic ulcer (stomach lesion)
- perforation and bleeding of the stomach or intestine.
These side effects can be fatal and you and/or your child may experience them with or without warning symptoms. These side effects occur especially if you are elderly or if you and/or your child have a history of stomach and intestinal diseases.

In addition, you may experience the following side effects:

Effects on the blood
- anemia (reduction in the number of red blood cells in the blood)
- thrombocytopenia (reduction in the number of platelets in the blood)
- aplastic anemia (reduction in the quantity of all types of blood cells, red blood cells, white blood cells, platelets)
- agranulocytosis (reduction in the number of granulocytes, a type of white blood cell, in the blood).

Effects on the nervous system
- dizziness
- headache
- paresthesia (numbness of the limbs or other parts of the body)
- drowsiness
- cerebrovascular accidents (diseases caused by lack of blood flow to an area of the brain)
- visual disturbances
- optic neuritis (severe inflammation of the optic nerve, which can lead to reduced vision up to blindness)
- migraine (chronic disease characterized by recurrent headaches)
- confusion
- vertigo.

Effects on the immune system
- anaphylactic reactions (severe allergic reaction)
- angioedema (inflammatory skin reaction)
- hypersensitivity.

Effects on the eye
- visual disturbances.

Effects on the ear and labyrinth
- tinnitus (ringing in the ears).

Effects on the cardiovascular system
- heart failure
- swelling
- hypertension (high blood pressure)

Effects on the bronchi and lungs
- throat irritation
- asthma
- bronchospasm (narrowing of the bronchi causing severe respiratory difficulty due to reduced air passage)
- dyspnea (shortness of breath)
- blisters in the mouth or throat
- numbness of the mouth or throat.

Effects on the mouth, stomach, and intestine
- diarrhea
- lesions inside the mouth
- nausea
- pain in the mouth and throat
- sensation of warmth or burning, tingling of the mouth
- abdominal distension
- abdominal pain
- constipation
- dry mouth
- indigestion
- flatulence (emission of gas from the intestine)
- inflammation of the tongue
- altered taste
- vomiting
- blood in the stools
- blood in the vomit
- bleeding from the stomach and intestine
- colitis
- worsening of inflammatory diseases of the colon and intestine (Crohn's disease)
- inflammation of the stomach (gastritis)
- gastritis
- peptic ulcer
- gastric perforation.

Effects on the skin and subcutaneous tissue
- skin rashes
- itching
- urticaria (redness of the skin accompanied by itching)
- purpura (appearance of purplish skin patches of different sizes)
- bullous dermatoses (severe skin lesions characterized by erythema, bullous lesions with areas of skin detachment), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Erythema Multiforme.

Effects on the kidneys and urinary tract
- renal toxicity
- tubulointerstitial nephritis (inflammation of the kidneys)
- nephrotic syndrome (alteration of the renal glomeruli leading to protein loss in the urine)
- renal failure (reduced kidney function).

General effects and effects at the administration site
- fever
- pain
- discomfort
- fatigue

Effects on the liver
- hepatitis

General effects and effects at the administration site
- fever

Psychiatric effects
- insomnia
- depression
- hallucination.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.