Zerinoactiv throat

Italy
Brand name Zerinoactiv throat
Form tablets, film-coated
Active substance / Dosage
FLURBIPROFENE
Prescription type Over-the-counter
ATC code
A01AD11
Registration number 042814
Manufacturer ZENTIVA ITALIA S.R.L.

Table of Contents

Package leaflet: Information for the user

ZERINOACTIV GOLA 8.75 mg lemon and honey flavoured tablets

Flurbiprofen
Read all of this leaflet carefully before taking this medicine because 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 to.

  • Keep this leaflet. You may need to read it again.
  • If you need more information or advice, consult your pharmacist.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
  • Contact your doctor if you do not notice any improvement 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 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

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

ZERINOACTIV GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and
analgesic (pain-relieving) medicine that acts against inflammation and pain in the
throat, mouth and gums.
ZERINOACTIV GOLA is used in adults and adolescents over 12 years of age for the
treatment of symptoms of pain and irritation affecting the gums, mouth and throat (e.g.
gingivitis, stomatitis, pharyngitis).
Consult your 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 to any of the other ingredients of this medicine (listed in section 6);
  • if you are allergic to acetylsalicylic acid (a medicine used for inflammation, pain, fever and heart conditions) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and ZERINOACTIV GOLA”);
  • if you have previously experienced gastrointestinal bleeding or perforation related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
  • if you suffer from chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
  • if you frequently suffer from peptic ulcer (stomach lesion) or gastrointestinal bleeding (two or more distinct episodes of ulcer or bleeding);
  • if you have severe heart failure (reduced heart function), severe liver failure (reduced liver function), or 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, inform 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 airways causing severe breathing difficulties due to reduced airflow);
  • 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 analgesics for a long time or without following the recommended dosage, as this may lead to headache;
  • you have previously suffered from peptic ulcer (stomach lesion) or other stomach and intestinal diseases, as this increases the risk that these conditions may recur. This risk is especially increased with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer was complicated by gastrointestinal bleeding or perforation (see section 4 “Possible side effects”);
  • you are elderly (as you are more likely to experience side effects);
  • you have heart or blood vessel problems, as medicines like ZERINOACTIV GOLA 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 ZERINOACTIV GOLA 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);
  • you have an infection – refer to the section “Infections” below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain.
This could delay appropriate treatment of the infection, which in turn may increase the risk of complications. If you take this medicine during an infection and infection symptoms persist or worsen, contact your doctor or pharmacist immediately.
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 will prescribe appropriate therapy if necessary.
If you experience mouth irritation, discontinue 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

  • medicines containing acetylsalicylic acid (a medicine used for inflammation, pain, fever and heart conditions), as they may increase side effects;
  • antiplatelet agents (medicines that make the blood less sticky, such as low-dose daily acetylsalicylic acid), as this increases 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 this increases 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 drugs may increase the risk of kidney toxicity;
  • alcohol, as it may increase the risk of side effects, especially the risk of stomach and intestinal bleeding;
  • cardiac glycosides (medicines that affect 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 this increases the risk of kidney toxicity;
  • corticosteroids (medicines used for inflammation/allergies), as this increases 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 for 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 medicine 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 this may enhance the effect of these medicines and increase the risk of side effects.

Pregnancy, breastfeeding, and fertility
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the newborn. It is not known whether the same risk applies to ZERINOACTIV GOLA. If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use ZERINOACTIV GOLA during the last three months of pregnancy. Do not use ZERINOACTIV GOLA during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is required during this period, take the lowest effective dose for the shortest possible time.
The use of flurbiprofen during the last three months of pregnancy is contraindicated.
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 your 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 your ability to drive or operate machinery.
ZERINOACTIV GOLA contains glucose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take ZERINOACTIV GOLA

Take 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.
HOW MUCH AND HOW TO TAKE
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The lowest effective dose for the shortest necessary time 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).
Warning: 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 have previously suffered from stomach ulcer (stomach lesion)
If you are elderly or have previously suffered from peptic ulcer (stomach lesion), it is advisable to use the lowest recommended dose, as the risk of serious consequences from adverse effects is higher, and the risk of developing stomach or intestinal ulcers, bleeding, or perforation is increased (see section 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-term treatment, not exceeding 7 days.
If no noticeable improvement occurs after 3 days of treatment, the cause may be a different pathological 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 more ZERINOACTIV GOLA than you should
If you accidentally ingest/overdose on ZERINOACTIV GOLA, contact your doctor immediately or go to the nearest hospital.
In case of accidental ingestion of large amounts of flurbiprofen, you may experience symptoms such as nausea, vomiting, irritation of the stomach or intestine, stomach ache, or rarely diarrhea. Other possible symptoms include tinnitus, headache, and gastrointestinal bleeding. In such cases, the doctor will initiate appropriate treatment.
If you forget to take ZERINOACTIV GOLA
Do not take a double dose to make up for the missed dose.
If you stop taking ZERINOACTIV GOLA
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 everyone experiences them.
STOP treatment and contact your doctor immediately if you experience any of the following adverse effects during treatment with ZERINOACTIV GOLA:

  • 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 warmth or tingling in the mouth and throat
  • Respiratory events: asthma, bronchospasm, breathlessness or shortness of breath
  • Various skin disorders: skin rashes of different types, itching, redness, swelling, skin peeling, blisters, desquamation or ulceration of the skin and mucous membranes.

Contact your doctor immediately if you experience any of the following adverse effects at the beginning of treatment with ZERINOACTIV GOLA:

  • abdominal pain
  • peptic ulcer (stomach ulcer)
  • 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 especially likely if you are elderly or have previously suffered from stomach or intestinal diseases.

Additionally, you may experience the following adverse effects:

Effects related to the blood

  • Anaemia (reduced number of red blood cells in the blood)
  • Thrombocytopenia (reduced number of platelets in the blood)
  • Aplastic anaemia (reduced number of all types of blood cells: red blood cells, white blood cells, platelets)
  • Agranulocytosis (reduced number of granulocytes, a type of white blood cells, in the blood)

Effects related to the nervous system

  • Dizziness
  • Headache
  • Paresthesia (numbness of limbs or other body parts)
  • Somnolence (drowsiness)
  • Cerebrovascular events (diseases caused by impaired blood flow to an area 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 reactions)
  • Angioedema (inflammatory skin reaction)
  • 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 airways causing severe breathing difficulty due to reduced airflow)
  • Dyspnea (shortness of breath)
  • Blisters in the mouth or throat
  • Numbness of the mouth or throat

Effects related to the mouth, stomach and intestine

  • Diarrhea
  • Mouth sores
  • 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 gas from the intestine)
  • Inflammation of the tongue
  • Taste disturbances
  • Vomiting
  • Blood in stool
  • Blood in vomit
  • Bleeding from the stomach and intestine
  • Colitis
  • Worsening of inflammatory bowel diseases (e.g. Crohn's disease)
  • Gastritis (inflammation of the stomach)
  • Peptic ulcer
  • Gastric perforation

Effects related to the skin and underlying tissues

  • Rash (skin eruption)
  • Itching
  • Urticaria (red, itchy skin patches)
  • Purpura (appearance of purple-colored skin spots 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 and administration site-related effects

  • Fever
  • Pain
  • Discomfort
  • Fatigue

Effects related to the liver

  • Hepatitis

Effects related to psychiatric disorders

  • Insomnia
  • Depression
  • Hallucinations

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the 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 ZERINOACTIV GOLA

Keep this medicine out of the sight and reach of children.
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 ZERINOACTIV GOLA contains

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

Description of the appearance of ZERINOACTIV GOLA and contents of the pack
ZERINOACTIV GOLA is presented as tablets contained in blisters.
Pack contents: 16 or 24 tablets.
Marketing Authorization Holder
Zentiva Italia S.r.l. – Via P. Paleocapa, 7, 20121 Milan, Italy
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