Tantum VerdeDol

Italy
Brand name Tantum VerdeDol
Form tablets, film-coated
Active substance / Dosage
FLURBIPROFENE
Prescription type Over-the-counter
ATC code
A01AD11
Registration number 042810
Manufacturer AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.
Tantum VerdeDol tablets, film-coated

Table of Contents

Package leaflet: Information for the patient

TANTUM VERDEDOL 8.75 mg lozenges, lemon and honey flavour

Flurbiprofen
Please read this leaflet carefully before taking/giving the child this medicine as it contains important information for you.
Always take/give the child this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

  • Keep this leaflet. You may need to read it again.
  • If you need more information or advice, consult your pharmacist.
  • If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
  • Consult your doctor if you do not notice improvement or if symptoms worsen after 3 days of treatment.

Contents of this leaflet:

  1. What TANTUM VERDEDOL is and what it is used for
  2. What you need to know before taking/giving the child TANTUM VERDEDOL
  3. How to take/give the child TANTUM VERDEDOL
  4. Possible side effects
  5. How to store TANTUM VERDEDOL
  6. Contents of the pack and other information

1. What TANTUM VERDEDOL is and what it is used for

TANTUM VERDEDOL contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine that 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 and irritation symptoms affecting the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis).
Consult a doctor if you/your child do not feel better or feel worse after 3 days of treatment.

2. What you should know before taking/giving TANTUM VERDEDOL to a child

Do not take/do not give the child TANTUM VERDEDOL

  • If you and/or the child are allergic to flurbiprofen or to any of the other components of this medicine (listed in section 6);
  • If you and/or the child are allergic to acetylsalicylic acid (a medicine used for inflammation, pain, fever and heart disorders) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and TANTUM VERDEDOL”);
  • If you and/or the child have previously suffered from bleeding or perforation of the stomach or intestine related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
  • If you and/or the child suffer from chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
  • If you and/or the child frequently suffer from peptic ulcer (lesion of the stomach) or gastrointestinal bleeding (two or more distinct episodes of ulcer or bleeding); if you and/or the child suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function), or 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
Talk to your doctor or pharmacist before taking/giving TANTUM VERDEDOL to the child.
Talk to your doctor or pharmacist if you have an infection – refer to the section “Infections” below.
In particular, inform your doctor if you and/or the child:

  • Have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you/the child may experience bronchospasm (narrowing of the airways causing severe breathing difficulties due to reduced airflow);
  • Have previously suffered from 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 painkillers for a long time or without following the prescribed dosage, as this may cause headache;
  • Have previously suffered from peptic ulcer (stomach lesion) and other stomach and intestinal diseases, as this increases the risk that these conditions may recur. This risk increases especially with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer was complicated by bleeding or perforation of the stomach and intestine (see section 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 such as TANTUM VERDEDOL may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with higher doses and prolonged treatment; do not exceed the recommended 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).

Inform your doctor of any unusual abdominal symptoms.
The use of this medicine, especially if prolonged, may cause allergic reactions or local irritation
(see section 4 “Possible side effects”); in such cases, stop treatment and consult your doctor, who,
if necessary, will initiate appropriate therapy.
If you or the child experience mouth irritation, stop treatment.

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

Other medicines and TANTUM VERDEDOL
Inform your doctor or pharmacist if you/the child are taking, have recently taken, or might take any other medicines.
Inform your doctor if you/the child are taking any of the following medicines:

  • Aspirin and medicines containing acetylsalicylic acid (medicines used for inflammation, pain, fever and heart disorders), as they may increase side effects;
  • Antiplatelet agents (medicines that make the blood thinner, such as low-dose daily aspirin), as they increase the risk of gastrointestinal bleeding;
  • Anticoagulants (medicines that slow down or inhibit blood clotting, such as warfarin), as their effect may be enhanced by NSAIDs;
  • Selective serotonin reuptake inhibitors (medicines used for depression), as they increase the risk of gastrointestinal bleeding;
  • Antihypertensive medicines (ACE inhibitors, angiotensin II antagonists, and diuretics), as NSAIDs may reduce the effect of diuretics or some antihypertensive medicines may increase renal toxicity;
  • Alcohol, as it may increase the risk of side effects, especially the risk of stomach and intestinal bleeding;
  • Cardiac glycosides (medicines affecting heart function), as NSAIDs may worsen heart failure and increase glycoside levels in the blood;
  • Cyclosporine (a medicine used to prevent organ transplant rejection), as it increases the risk of kidney toxicity;
  • Corticosteroids (medicines used for inflammation/allergies), as they increase the risk of stomach and intestinal lesions or bleeding;
  • Lithium (a medicine used for behavioral disorders), as lithium blood levels may increase;
  • Methotrexate (a medicine used for psoriasis, arthritis, and cancer), as methotrexate blood levels may increase;
  • Mifepristone (a medicine used to terminate pregnancy): NSAIDs should not be used within 8–12 days after taking mifepristone, as they reduce its effectiveness;
  • Quinolone antibiotics (medicines used for bacterial infections), as NSAIDs may increase the risk of seizures;
  • Tacrolimus (an immunosuppressant used after organ transplantation), as NSAIDs may increase the risk of kidney toxicity;
  • Zidovudine (a medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
  • Cox-2 inhibitors and other NSAIDs (medicines used for inflammation and pain), as they may enhance the effect of these medicines and increase the risk of side effects.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain.
This may delay appropriate treatment of the infection, thereby increasing the risk of complications.
If you take this medicine during an infection and infection symptoms persist or worsen, contact your doctor or pharmacist immediately.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Oral formulations of flurbiprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies to Tantum Verdedol.
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Do not take Tantum Verdedol during the last three months of pregnancy.
Do not take Tantum Verdedol during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is necessary during this period, take the lowest possible dose for the shortest possible time.
Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary and advised by a doctor.
Fertility
Flurbiprofen belongs to a group of medicines that may affect female fertility. This effect is reversible when the medicine is discontinued. Occasional use of this medicine is unlikely to affect the chances of becoming pregnant. However, consult your doctor if you have fertility problems before taking this medicine.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

TANTUM VERDEDOL contains glucose, sucrose, and lemon flavor.
Glucose and sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains lemon flavor, which in turn contains D-Limonene and citral.
D-Limonene and citral may cause allergic reactions.

3. How to take this medicine

Take/give this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest necessary duration should be used in order to relieve symptoms. If you have an infection, contact your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2).
Dosage and method of administration
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration needed to control symptoms.
Caution: Do not exceed the recommended doses without medical advice.
Adults and adolescents over 12 years of age
The recommended dose is: 1 tablet every 3–6 hours as needed. Do not exceed 8 tablets in 24 hours.
Allow the tablet to dissolve slowly in the mouth.
If you are elderly or if you and/or the child have previously suffered from peptic ulcer (stomach lesion)
If you are elderly or if you and/or the child have previously suffered from peptic ulcer (stomach lesion), it is advisable to use the lowest recommended dose, as there is a higher risk of serious consequences in case of adverse effects, and an increased risk of developing stomach or intestinal ulcers, bleeding, or perforation (see section 4 “Possible side effects”).
Use in children and adolescents
Do not give TANTUM VERDEDOL to children under 12 years of age.
Duration of treatment
Use TANTUM VERDEDOL only for short-term treatment, not exceeding 7 days. If no noticeable improvement occurs after 3 days of treatment, the cause may be a different medical condition; therefore, consult your doctor.
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.
If you take/give the child more TANTUM VERDEDOL than you should
If you/the child accidentally ingest/overdose on TANTUM VERDEDOL, contact your doctor immediately or go to the nearest hospital.
In case of accidental ingestion of large amounts of flurbiprofen, symptoms such as nausea, vomiting, irritation of the stomach or intestines, stomach ache, or rarely diarrhea may occur. Tinnitus, headache, and stomach or intestinal bleeding may also occur. In such cases, the doctor will initiate appropriate treatment.
If you forget to take/give the child TANTUM VERDEDOL
Do not take/give a double dose to make up for the missed dose.
If you stop treatment with TANTUM VERDEDOL
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
If you experience any of the following adverse effects during treatment with TANTUM VERDEDOL, STOP
treatment immediately and contact your doctor without delay:

  • Allergic reactions (sensitization phenomena):
    • allergic reaction
    • anaphylactic reactions (severe allergic reactions)
    • angioedema (sudden swelling of the mouth/throat and mucous membranes)
  • Local irritation
  • Sensation of warmth or tingling in the mouth and throat (this effect may occur with the tablets)
  • Respiratory events: asthma, bronchospasm, shortness of breath or difficulty breathing
  • Various skin disorders: skin rashes of different types, itching, redness, swelling, skin peeling, blisters, desquamation or ulceration of the skin and mucous membranes.

If you experience any of the following adverse 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 adverse effects can be fatal and may occur with or without warning symptoms. These adverse effects are more likely if you are elderly or if you and/or the child have previously suffered from stomach or intestinal diseases.

In addition, you may experience the following adverse effects:
Effects related to the blood

  • anaemia (reduction in the number of red blood cells)
  • thrombocytopenia (reduction in the number of platelets in the blood)
  • aplastic anaemia (reduction in all types of blood cells: red blood cells, white blood cells, platelets)
  • agranulocytosis (reduction in the number of granulocytes, a type of white blood cells, in the blood).

Effects related to the nervous system

  • dizziness
  • headache
  • paraesthesia (numbness of limbs or other body parts)
  • somnolence (drowsiness)
  • cerebrovascular accidents (diseases caused by interruption of blood flow to part of the brain)
  • visual disturbances
  • optic neuritis (severe inflammation of the optic nerve, which may lead to reduced vision or blindness)
  • migraine (a chronic condition characterized by recurrent headaches)
  • confusion
  • vertigo.

Effects related to the immune system

  • anaphylactic reactions (severe allergic reaction)
  • angioedema (inflammatory reaction of the skin)
  • hypersensitivity.

Effects related to the eye

  • visual disturbances.

Effects related to the ear and labyrinth

  • tinnitus (ringing in the ears).

Effects related to the cardiovascular system

  • heart failure
  • swelling
  • hypertension (high blood pressure).

Effects related to the bronchi and lungs

  • throat irritation
  • asthma
  • bronchospasm (narrowing of the bronchi causing severe breathing difficulty due to reduced airflow)
  • dyspnoea (shortness of breath)
  • blisters in the mouth or throat
  • numbness of the mouth or throat.

Effects related to the mouth, stomach and intestine

  • diarrhoea
  • mouth lesions
  • nausea
  • pain in the mouth and throat
  • sensation of heat or burning, tingling in the mouth
  • abdominal bloating
  • abdominal pain
  • constipation
  • dry mouth
  • indigestion
  • flatulence (passing intestinal gas)
  • inflammation of the tongue
  • altered taste
  • vomiting
  • blood in the stools
  • blood in vomit
  • bleeding from the stomach and intestine
  • colitis
  • worsening of inflammatory bowel diseases (Crohn's disease)
  • inflammation of the stomach (gastritis)
  • gastritis
  • peptic ulcer
  • gastric perforation.

Effects related to the skin and underlying tissue

  • skin rashes
  • itching
  • urticaria (red, itchy skin patches)
  • purpura (appearance of purple-coloured skin patches of varying sizes)
  • bullous dermatoses (severe skin lesions characterized by erythema, blistering and skin detachment), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema Multiforme.

Effects related to the kidneys and urinary tract

  • renal toxicity
  • tubulo-interstitial nephritis (inflammation of the kidneys)
  • nephrotic syndrome (alteration of the kidney glomeruli leading to protein loss in urine)
  • renal failure (reduced kidney function).

General effects and effects at the site of administration

  • fever
  • pain
  • discomfort
  • fatigue

Effects related to the liver

  • hepatitis

General effects and effects at the site of administration

  • fever

Effects related to psychiatric disorders

  • insomnia
  • depression
  • hallucination.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report adverse effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help
provide more information on the safety of this medicine.

5. How to store TANTUM VERDEDOL

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TANTUM VERDEDOL contains

  • The active substance is: flurbiprofen. Each tablet contains 8.75 mg of flurbiprofen.
  • The other ingredients are: sucrose, liquid glucose, lemon flavoring (see section “Tantum Verdedol contains glucose, sucrose, lemon flavoring”), macrogol, potassium hydroxide, levomenthol, honey flavoring.

Description of the appearance of TANTUM VERDEDOL and contents of the pack
TANTUM VERDEDOL is presented as tablets contained in blisters.
Pack contents: 16 or 24 tablets.
Marketing Authorization Holder
Angelini Pharma S.p.A. Viale Amelia 70, 00181 Rome, Italy
Manufacturer
LOZY'S PHARMACEUTICALS S.L. Campus empresarial, 1-31795 Lekaroz (Navarra) - Spain
INDUSTRIA FARMACEUTICA NOVA ARGENTIA S.r.L. Via G. Pascoli n.1 – Gorgonzola (Milan)