TANTUM 8.75 MG Lozenge

Зміст інструкції

1. TANTUM VERDEDOL 8.75 mg lemon and honey flavored lozenges
   1. What is TANTUM VERDEDOL and what is it used for
   2. What you need to know before taking/giving TANTUM VERDEDOL to the child
   3. How to take this medicine
   4. Possible side effects
   5. How to store TANTUM VERDEDOL
   6. Contents of the pack and other information

TANTUM VERDEDOL 8.75 mg lemon and honey flavored lozenges

Flurbiprofen

Read this leaflet carefully before taking/givingto the childthis medicine as it contains
important information for you.
Always take/give this medicine to the child exactly as described in this leaflet or as the
doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your 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 TANTUM VERDEDOL to the child
• 3. How to take/give TANTUM VERDEDOL to the child
• 4. Possible side effects
• 5. How to store TANTUM VERDEDOL
• 6. Contents of the pack and other information

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

TANTUM VERDEDOL contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain relieving) medicine that acts against inflammation and pain of the throat, mouth and gums.
TANTUM VERDEDOL is used in adultsand adolescents over 12 years of agein the treatment of
symptoms of pain and irritation of the gums, mouth and throat (e.g. gingivitis, stomatitis,
pharyngitis).
See a doctor if you/the child do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking/giving TANTUM VERDEDOL to the child

Do not take/give TANTUM VERDEDOL to the child

• If you and/or the child are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• If you and/or the child are allergic to acetylsalicylic acid (a medicine against inflammation, pain, fever and heart problems) or 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 diseases of the intestine (ulcerative colitis and Crohn's disease);
• If you and/or the child frequently suffer from peptic ulcer (stomach lesion) or bleeding from the stomach or intestine (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) and severe kidney failure (reduced kidney function).

Do nottake/give TANTUM VERDEDOL in the last 3 months of pregnancy (see “Pregnancy and breastfeeding”).

Do notgive TANTUM VERDEDOL to children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking/giving TANTUM VERDEDOL to the child.
Consult your doctor or pharmacist if you have an infection - see section “Infections” below.
In particular, tell 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 bronchi 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 (renal, cardiac or hepatic insufficiency);
• suffer from hypertension (high blood pressure);
• are taking other painkillers for a long time or without respecting the dosage, as headache (headache) may occur;
• have previously suffered from a peptic ulcer (stomach lesion) and other diseases of the stomach and intestine as this increases the risk that these diseases may recur. 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 section 4 “Possible side effects”);
• if you are elderly (as you are more likely to experience side effects);
• if you have problems with the heart or blood vessels, as medicines like TANTUM VERDEDOL may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. The risk of adverse effects increases with high doses and prolonged treatments; do not exceed the dose of TANTUM VERDEDOL and do not take it for long periods. Tell 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 or high cholesterol or smoke).

Report any unusual abdominal symptoms to your doctor.
The use of this medicine, especially if prolonged, can give rise to allergic or irritation phenomena
locally (see section 4 “Possible side effects”); in such cases, discontinue treatment and consult your doctor who,
if necessary, will carry out appropriate therapy.
If you or the child experience irritation of the mouth, discontinue treatment.

Children and adolescents
Do notgive TANTUM VERDEDOL to children under 12 years of age.

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

• Aspirin andmedicines containing acetylsalicylic acid(a medicine against inflammation, pain, fever and heart problems), as they may increase the side effects;
• antiplatelet agents(medicines that make the blood more fluid, such as low-dose daily aspirin), as this increases the risk of bleeding from the stomach and intestine;
• anticoagulant agents(medicines that slow down or inhibit the blood clotting process, such as warfarin), as their effect may be potentiated by NSAIDs;
• selective serotonin reuptake inhibitors(medicines used against depression), as this increases the risk of bleeding from the stomach and intestine;
• 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 bleeding in the stomach and intestine;
• cardiac glycosides(medicines that affect heart function), as NSAIDs may worsen heart failure and increase the level of glycosides in the blood;
• cyclosporine(a medicine that prevents rejection after organ transplantation), as it increases the risk of renal toxicity;
• corticosteroids(medicines used against inflammation/allergies), as it increases the risk of having lesions or bleeding in the stomach and intestine;
• lithium(a medicine used for behavioral disorders), as the level of lithium in the blood may increase;
• methotrexate(a medicine used for psoriasis, arthritis and tumors), as the level of methotrexate in the blood may increase;
• mifepristone(a medicine used to terminate a pregnancy): NSAIDs should not be used for 8-12 days after taking mifepristone, as they reduce its effect;
• quinolone antibiotics(medicines used for bacterial infections), as NSAIDs may increase the risk of developing seizures;
• tacrolimus(an immunosuppressant medicine used after organ transplantation), as NSAIDs may increase the risk of renal toxicity;
• zidovudine(a medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
• Cox-2 inhibitors and other NSAIDs(medicines used against inflammation and pain), as it may increase the effect of these medicines and the risk of side effects.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infection such as fever and pain. This
can delay appropriate treatment of the infection, which in turn can lead to an increased risk of
complications. If you take this medicine during an infection and the symptoms of the infection persist or
worsen, consult your doctor or pharmacist immediately.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor for advice before taking this medicine.

Pregnancy
Oral formulations of flurbiprofen can 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 or are planning a pregnancy,
ask your doctor or pharmacist for advice before taking this medicine.

Do nottake Tantum Verdedol in the last three months of pregnancy.

Do nottake Tantum Verdedol in the first 6 months of pregnancyunless in case of absolute necessity and
under the guidance of a doctor. If treatment is necessary during this period, you should take the minimum
dose for the shortest possible time.

Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary and advised
by your doctor.

Fertility
Flurbiprofen belongs to a group of medicines that can affect female fertility. This effect
is reversible when taking the medicine is stopped. Occasional use of this
medicine is unlikely to affect the chances of getting pregnant. However, ask your doctor if you have
fertility problems before taking the medicine.

Driving and operating machinery
This medicine does not interfere with the ability to drive vehicles and operate machinery.

TANTUM VERDEDOL containsglucose,sucroseand lemon flavour.
Glucose and sucrose: if you have been diagnosed with an intolerance to certain sugars, contact your
doctor before taking this medicine.
This medicine contains lemon flavour 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 following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The minimum effective dose should be used for the shortest time necessary to relieve symptoms. If you have
an infection, consult your doctor or pharmacist immediately if symptoms (such as fever and pain) persist
or worsen (refer to paragraph 2).

How much and how
Undesirable effects can be minimized by using low doses for the shortest possible duration of
treatment needed to control the symptoms.
Caution: do not exceed the indicated doses without medical advice.

Adults and adolescents over 12 years of age

The recommended doseis: 1 lozenge every 3-6 hours, as needed. Do not exceed the dose of 8 lozenges
in 24 hours.
Dissolve the lozenge slowly in your mouth.

If you are elderly or you and/or the child have suffered in the past from an ulcer (stomach lesion)
If you are elderly or you and/or the child have suffered in the past from a peptic ulcer (stomach lesion), it is recommended
to use the lowest recommended dose, as there is an increased risk of serious consequences in case of
undesirable effects and the risk of developing an ulcer, bleeding or perforation of the stomach and intestines
is greater (see paragraph 4 “Possible side effects”).

Use in children and adolescents
Donot give TANTUM VERDEDOL to children under 12 years of age.

Duration of treatment
Use TANTUM VERDEDOL only for short periods of treatment, not exceeding 7 days. If no appreciable results are noticed after 3 days of treatment, the cause may be a different pathological condition,
therefore consult your doctor.
Consult your doctor if the disorder recurs or if you have noticed any recent change in its characteristics.

If you take/give the child more TANTUM VERDEDOL than you should
If you/the child accidentally ingest/take an excessive dose of TANTUM VERDEDOL, immediately notify
your doctor or go to the nearest hospital.
In the event of accidental ingestion of significant amounts of flurbiprofen, symptoms such as: nausea, vomiting, irritation of the stomach or intestines, stomach pain or rarely diarrhea may occur.
Ringing in the ears, headache and bleeding of the stomach or intestines can also occur. In such cases, the doctor
will adopt appropriate treatments.

If you forget to take/give the child TANTUM VERDEDOL
Do not take/give the child a double dose to compensate for a missed dose.

If you stop taking TANTUM VERDEDOL
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience the following side effects during treatment with TANTUM VERDEDOL, STOPthe
treatment and contact your doctor immediately:

• allergic reactions (sensitization reactions):
• allergic reaction
• anaphylactic reactions (severe allergic reactions)
• angioedema (sudden swelling of the mouth/throat and mucous membranes)
• local irritation
• sensations of heat or tingling in the mouth and throat(this effect can occur with the 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, scaling 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 the child may experience them with or without warning symptoms. These effects occur especially if you are elderly or if you and/or the child have suffered from stomach and intestinal diseases in the past.

In addition, you may experience the following side effects:

Effects affecting 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 number 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 cells, in the blood).

Effects affecting the nervous system

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

Effects affecting the immune system

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

Effects affecting the eye

• visual disturbances.

Effects affecting the ear and labyrinth

• tinnitus (ringing in the ears).

Effects affecting the cardiovascular system

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

Effects affecting the bronchi and lungs

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

Effects affecting the mouth, stomach and intestines

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

Effects affecting the skin and underlying tissue

• skin rash
• itching
• urticaria (reddening of the skin accompanied by itching)
• purpura (appearance of patches of skin of various sizes with a purplish color)
• bullous dermatoses (severe skin lesions characterized by erythema, blistering lesions with areas of skin detachment), including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis and Erythema multiforme.

Effects affecting the kidneys and urinary tract

• renal toxicity
• tubulo-interstitial nephritis (inflammation of the kidneys)
• nephrotic syndrome (alteration of the renal glomeruli resulting in protein loss with urine) renal failure (reduction of kidney function). General effects and at the site of administration
• fever
• pain
• discomfort
• fatigue

Effects affecting the liver

• hepatitis

General effects and at the site of administration

• fever

Effects affecting the psychiatric sphere

• insomnia
• depression
• hallucination.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can contribute to providing 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 particular storage conditions.
Do not use this medicine after the expiry date that is stated on the packaging after “Exp”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TANTUM VERDEDOL contains

• The active ingredient is: flurbiprofen. One lozenge contains 8.75 mg of flurbiprofen.
• The other ingredients are: sucrose, glucoseliquid, lemon flavour(see paragraph “Tantum Verdedol contains glucose, sucrose, lemon flavour”), macrogol, potassium hydroxide, levomenthol, honey flavour.

Description of the appearance of TANTUM VERDEDOL and contents of the pack
TANTUM VERDEDOL is available in the form of lozenges contained in blisters.
The pack contains 16 or 24 lozenges.

Marketing Authorisation Holder
Angelini Pharma S.p.A. Viale Amelia 70, 00181 Rome

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)