ZERINOACTIV 8.75 MG Lozenge

Зміст інструкції

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

ZERINOACTIV GOLA 8.75 mg lemon and honey flavored lozenges

Flurbiprofen

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those 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 ZERINOACTIV GOLA is and what it is used for
• 2. What you need to know before you take ZERINOACTIV GOLA
• 3. How to take ZERINOACTIV GOLA
• 4. Possible side effects
• 5. How to store ZERINOACTIV GOLA
• 6. Contents of the pack and other information

1. What is ZERINOACTIV GOLA and what is it used for

ZERINOACTIV GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and
analgesic (pain reliever) medicine, which acts against inflammation and pain
of the throat, mouth and gums.
ZERINOACTIV GOLA is used in adultsand adolescents over the age of 12
yearsin the treatment of symptoms of pain and irritation of the gums, mouth and
throat (for example, gingivitis, stomatitis, pharyngitis).
See a doctor if you do not feel better or if you feel worse after 3 days of
treatment (see section 3).

2. What you need to know before taking ZERINOACTIV GOLA

Do not take ZERINOACTIV GOLA

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if you 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 ZERINOACTIV GOLA”);
• if you 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 suffer from chronic inflammatory diseases of the intestine (ulcerative colitis and Crohn's disease);
• if you frequently suffer from peptic ulcer (lesion of the stomach) or bleeding of the stomach or intestine (two or more distinct episodes of ulcer or bleeding);
• if you suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function) and severe kidney failure (reduced kidney function);
• if you are in the last 3 months of pregnancy (see section “Pregnancy and breastfeeding”).

Do not give ZERINOACTIV GOLA to children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking ZERINOACTIV GOLA.
In particular, tell your doctor if:

• you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you may experience bronchospasm (narrowing of the bronchi which causes severe difficulty breathing due to reduced air passage);
• you have previously suffered from allergies;
• you are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
• you suffer from systemic lupus erythematosus or mixed connective tissue disease;
• you suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic insufficiency);
• you suffer from hypertension (high blood pressure);
• you have been taking other painkillers for a long time or without respecting the dosage, as headache (headache) may occur;
• you have previously suffered from peptic ulcer (lesion of the stomach) 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”);
• you are elderly (as you are more likely to experience side effects);
• you have problems with the heart or blood vessels, as medicines like ZERINOACTIV GOLA 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 ZERINOACTIV GOLA 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);
• you have an infection - refer to the “Infections” section below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections
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, see
your doctor or pharmacist immediately.
Tell your doctor about any unusual abdominal symptoms.
The use of this medicine, especially if prolonged, can give rise to allergic or
local irritation phenomena (see section 4 “Possible side effects”); in such cases
stop treatment and consult your doctor who, if necessary, will carry out suitable
therapy.
If you experience irritation of the mouth, stop treatment.

Children and adolescents
Do not give this medicine to children under 12 years of age (see “Do not take
ZERINOACTIV GOLA”).

Other medicines and ZERINOACTIV GOLA
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicines.
Tell your doctor if you are taking any of the following medicines:

• medicines 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 acetylsalicylic acid), as this increases the risk of bleeding from the stomach and intestine;
• anticoagulants(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.

Pregnancy, breastfeeding and fertility
Oral formulations (e.g. tablets) of flurbiprofen can cause adverse effects in the
newborn. It is not known whether the same risk applies to ZERINOACTIV GOLA. If you are
pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist before taking this
medicine.

Pregnancy
Do not use ZERINOACTIV GOLA in the last three months of pregnancy. Do not use
ZERINOACTIV GOLA if you are in the first 6 months of pregnancy unless absolutely
necessary and as directed by your doctor. If treatment is necessary during this
period, you should take the minimum dose for the shortest possible time.
The use of flurbiprofen in the last 3 months of pregnancy is contraindicated.

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 may affect female fertility.
This effect is reversible when taking the medicine is stopped. It is
unlikely that occasional use of this medicine will have an effect on the chances
of getting pregnant. However, ask your doctor if you have fertility problems before
taking the medicine.

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

ZERINOACTIV GOLA contains glucose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.

3. How to take ZERINOACTIV GOLA

Take 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.

HOW MUCH AND HOW
Undesirable effects can be minimized by using low doses for the shortest
possible duration of treatment necessary to control the symptoms.
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).
Warning: do not exceed the indicated doses without your doctor's advice.

Adults and adolescents over 12 years of age
The recommended dose is 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 have had an ulcer (stomach lesion) in the past
If you are elderly or have had a history of peptic ulcer (stomach lesion), it is
recommended to use the lowest recommended dose, as there is a greater 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
Do not give ZERINOACTIV GOLA to children under 12 years of age.

Duration of treatment
Use ZERINOACTIV GOLA only for short periods of treatment, not exceeding 7 days.
If no appreciable improvement is noticed after 3 days of treatment, the cause may be a
different medical 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 more ZERINOACTIV GOLA than you should
If you accidentally ingest/take an excessive dose of ZERINOACTIV GOLA
immediately notify your doctor or go to the nearest hospital.
In the event of accidental ingestion of significant amounts of flurbiprofen
you may experience symptoms such as: nausea, vomiting, irritation of the stomach or
intestines, stomach pain or rarely diarrhea. Ringing in the ears,
headache and bleeding of the stomach or intestines can also occur. In such cases, the doctor will adopt the
appropriate treatments.

If you forget to take ZERINOACTIV GOLA
Do not take a double dose to make up for a missed dose.

If you stop taking ZERINOACTIV GOLA
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 ZERINOACTIV GOLA,

STOPtreatment and immediatelycontact your doctor:

• allergic reactions (hypersensitivity 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
• 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 ZERINOACTIV GOLA,
immediatelycontact your doctor:

• abdominal pain
• peptic ulcer (lesion of the stomach)
• perforation and bleeding of the stomach or intestine.

These side effects can be fatal and you may experience them with or without
warning symptoms. These side effects occur especially if you are
elderly or if you have previously suffered from stomach and intestinal diseases.
You may also 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 that causes 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 in the mouth
• abdominal distension
• abdominal pain
• constipation
• dry mouth
• difficulty digesting
• flatulence (emission of gas from the intestines)
• 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)
• gastritis (inflammation of the stomach)
• peptic ulcer
• gastric perforation.

Effects affecting the skin and subcutaneous tissue

• rash
• itching
• urticaria (redness of the skin accompanied by itching)
• purpura (appearance of skin patches of various sizes, purple in 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 which involves a loss of proteins with the urine)
• renal insufficiency (reduction of kidney function).

General effects and at the site of administration

• fever
• pain
• discomfort
• fatigue.

Effects affecting the liver

• hepatitis.

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, please inform 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 ZERINOACTIV GOLA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which 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 ZERINOACTIV GOLA contains

• The active ingredient is flurbiprofen. One lozenge contains 8.75 mg of flurbiprofen.
• The other ingredients are: sucrose, glucose, macrogol, potassium hydroxide, lemon flavour, levomenthol, honey.

Description of the appearance of ZERINOACTIV GOLA and contents of the pack
ZERINOACTIV GOLAis available in the form of lozenges contained in blisters.
The pack contains 16 or 24 lozenges.

Marketing Authorisation Holder
Zentiva Italia S.r.l. – Via P. Paleocapa, 7, 20121 Milano

Manufacturer

• Lozy's Pharmaceuticals, S.L. - Campus Empresarial, 1 - 31795 Lekaroz (Navarra)
• SPAIN
• Industria Farmaceutica Nova Argentia S.r.l. - Via G. Pascoli, 1 - 20064 Gorgonzola (MI) -Italy.