Lizifen 8.75 Mg 16 Lozenges To Suck (Honey And Lemon Flavor)

Lizifen (8.75 Mg 16 Lozenges To Suck (Honey And Lemon Flavor))

ACTION AND MECHANISM

Non-steroidal anti-inflammatory (NSAID) belonging to the group of arylpropionics, which acts by preventing the synthesis of prostaglandins, through competitive and reversible inhibition of cyclooxygenase activity, an enzyme that converts arachidonic acid into prostaglandins.

INDICATIONS

- Short-term symptomatic relief of [SORE THROAT].

POSOLOGY

"DOSAGE OF TABLETS TO SUCK"

- Adults and adolescents from 12 years: 1 tablet/3-6 h, up to a maximum of 5 tablets/24 h.

- Children < 12 years: not recommended or contraindicated.

- Elderly: clinical experience is very limited and does not allow specific dosage recommendations to be established.

Duration of treatment : maximum 3 days.

DOSAGE IN RENAL FAILURE

- Mild to moderate renal insufficiency (CrCl 30-90 ml/min): no dose adjustment is required.

- Severe renal failure (CrCl < 30 ml/min): contraindicated.

DOSAGE IN LIVER FAILURE

- Mild to moderate hepatic impairment (Child-Pugh classes A and B): no dose adjustment required.

- Severe hepatic impairment (Child-Pugh class C): contraindicated.

RULES FOR CORRECT ADMINISTRATION

- Lozenges to suck: suck slowly into the mouth. To avoid local irritation, it should be kept in motion while it dissolves.

CONTRAINDICATIONS

- Known hypersensitivity to flurbiprofen or [NSAID ALLERGY].

- Patients with a history of hypersensitivity to acetylsalicylic acid or other NSAIDs, which include patients who have experienced asthma attacks, acute rhinitis, urticaria or angioneurotic edema after using acetylsalicylic acid or other NSAIDs.

- [DIGESTIVE BLEEDING], [PEPTIC ULCERA] active.

- Severe renal failure (CrCl < 30 ml/min).

- Severe hepatic impairment (Child-Pugh class C).

- [HEART FAILURE] severe.

- Third trimester of pregnancy.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. Contraindicated use in severe renal failure. NSAIDs could lead to decreased renal blood flow with reversible acute renal failure due to inhibition of vasodilator prostaglandin synthesis, and cases of nephrotic syndrome and acute interstitial nephritis have even been described with prolonged treatments. Patients with the highest risk of renal failure are those with previous renal failure, the elderly or situations that could reduce renal flow, such as [HYPOVOLEMIA], [DEHYDRATION], low-sodium diets, [HEART FAILURE], liver failure, [LIVER CIRRHOSIS] or treatment with diuretics, ACE inhibitors or ARAII. In high-risk patients, during prolonged treatments, it is recommended to determine renal functionality (serum creatinine, CLcr) before starting treatment, and periodically. In case of worsening renal function, a dose reduction may be necessary.

- [LIVER FAILURE]. The use in severe insufficiency is contraindicated.

- Gastrointestinal toxicity. Treatment with NSAIDs has resulted in gastroduodenal ulcers, as well as life-threatening bleeding and perforation. There is a greater risk of ulcer with treatments with high doses or for long periods of time, with a history of peptic ulcer, especially if they have already had bleeding or gastrointestinal perforation due to NSAIDs, as well as in [SMOKING], [CHRONIC ALCOHOLISM] or elderly or debilitated patients. However, short-term treatment is not without risk either.

As a general rule to reduce gastric damage, it is advisable to administer any NSAID with food. In addition, in risk groups it is advisable to start treatment with the lowest possible dose, and always associate an anti-ulcer drug (anti H2 or PPI) whenever possible.

High-risk patients should be closely monitored, as well as those who are being treated with drugs that may favor or aggravate gastrointestinal bleeding, such as oral anticoagulants, antiplatelet agents, corticosteroids or SSRIs. If a peptic ulcer or gastrointestinal bleeding appears, treatment will be discontinued. On the other hand, it should be used with caution in people with [INFLAMATORY BOWEL DISEASE], where NSAIDs could precipitate a crisis.

- Cardiovascular diseases. NSAIDs could lead to fluid retention and edema, which could increase blood pressure and worsen the symptoms of patients with cardiovascular diseases. It is recommended to individually evaluate the benefit/risk ratio in patients with [ARTERIAL HYPERTENSION], [HEART FAILURE], [ISCHEMIC HEART DISEASE], [CEREBRAL ISCHEMIA], [Stroke] or [PERIPHERAL ARTERY DISEASE], as well as in patients with cardiovascular risk factors, such as [DYSLIPEMIA], [DIABETES] or [SMOKING]. NSAIDs should always be used at the lowest effective dose and for the shortest period of time.

- Hepatic effects. Patients with [HEPATIC FAILURE] could see increased plasma levels. In addition, due to its high binding to plasma proteins, its free plasma levels could be increased, as has been verified in the case of [HEPATIC CIRRHOSIS].

On the other hand, the use of NSAIDs has sometimes been related to the appearance of liver symptoms, such as increased transaminases, [JAUNDICE] and [HEPATITIS], which could be serious and even fatal. Due to the risk of toxicity, it is recommended that patients with liver disease use this medication at the lowest effective dose, and periodically check liver function (transaminases, bilirubin) to detect any signs of liver damage. Its use is contraindicated in severe liver failure (Child-Pugh class C) as there are no data on its safety.

- Skin reactions. The use of NSAIDs has caused very rare, but potentially fatal, serious adverse reactions such as exfoliative dermatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome. These adverse reactions usually have an early onset, in the first month of treatment. If symptoms of hypersensitivity, mucosal lesions or skin erythema are observed, treatment will be discontinued.

- [HYPERSENSITIVITY REACTIONS]. The administration of any NSAID has been related to the appearance of allergic reactions. Cases of cross hypersensitivity have been reported between different NSAIDs, as well as between NSAIDs and salicylates, so patients with a history of [ALLERGY TO NSAIDs] other than this active ingredient or [ALLERGY TO SALICYLATES] should use this active ingredient with extreme caution.

It is recommended to avoid its use in those patients in whom a salicylate or an NSAID has previously given rise to severe allergic reactions, including [ASTHMA], [NASAL POLYPS], [ANGIOEDEMA] or [RHINITIS], due to the increased risk of potentially fatal anaphylaxis.

- [ASTHMA]. Asthmatic patients are more likely to experience bronchospasm when taking an NSAID. In addition, they could be more susceptible to anaphylactic symptoms after the administration of an NSAID.

- [ALTERATIONS OF COAGULATION]. NSAIDs have antiplatelet activity, although less than that of acetylsalicylic acid.

- [ASEPTIC MENINGITIS]. Rare cases of aseptic meningitis have been reported in patients with NSAIDs, with fever and coma, probably due to a hypersensitivity reaction, although cross-allergy between NSAIDs has not been found. This meningitis seems to be more frequent in patients with [COLLAGENOSIS] such as [SYSTEMIC LUPUS ERYTHEMATOSO], although it has also been reported in some patients who did not suffer from these pathologies. In NSAID-treated patients who develop symptoms of meningitis, the possibility of aseptic meningitis should be considered.

- Ophthalmological pictures. NSAIDs have been related to the appearance of ocular reactions, such as blurred vision, loss of vision, alteration in color vision, scotoma or retinal alterations.

- [FEMALE INFERTILITY]: Like other NSAIDs, it can decrease female fertility and its use is not recommended in women who wish to become pregnant. In women who have difficulties conceiving or being studied for infertility, the withdrawal of the NSAID should be considered.

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains isomalt. Patients with hereditary [FRUCTOSE INTOLERANCE] should not take this medication.

INTERACTIONS

- NSAIDs, including antiplatelet doses of acetylsalicylic acid. Increases the risk of peptic ulcer and gastric bleeding.

-Aliskiren. Possible reduction of the antihypertensive effect of aliskiren (NSAIDs act on the renin-angiotensin system). In patients with compromised renal function (dehydrated or elderly) deterioration of renal function may be precipitated (possible acute renal failure, usually reversible). Caution, especially in the elderly, monitoring the antihypertensive effect and renal function.

- SSRI antidepressants (fluoxetine, paroxetine, sertraline, citalopram). There is an increased risk of bleeding in general, and gastrointestinal bleeding in particular, especially in the elderly and patients with a history of gastrointestinal bleeding.

- Diuretics. Fflurbiprofen could oppose the diuretic and antihypertensive effects. Periodic blood pressure assessment is recommended.

- Glitazones (pioglitazone, rosiglitazone). Theoretical risk of potentiation of edema that both glitazones and NSAIDs can cause. Caution and monitor possible signs of fluid retention and heart failure (swollen ankles, dyspnea).

- Antiplatelet agents, including pentoxifylline: there is an increased risk of bleeding in general, and gastrointestinal bleeding in particular. Manage with caution.

- Potassium supplements: possible increase in potassium levels, with risk of hyperkalemia.

PREGNANCY

Animal Safety: In rats exposed to doses of 0.4 mg/kg/day or more, during pregnancy, increased

incidence of termination of pregnancy.

Safety in humans: there are data from epidemiological studies that reveal an increased risk of miscarriage, heart malformations, and gastroschisis after taking prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. It seems that the risk increases depending on the dose and the duration of treatment.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to the following situations: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension), and renal dysfunction, which may progress to renal failure with oligo-hydroamniosis. In addition, they can expose the mother and child at the end of pregnancy to the following situations: possible prolongation of bleeding time due to an antiplatelet effect that can occur even at very low doses and inhibition of uterine contractions that can cause a delay or prolongation of labour.

Therefore, this drug is contraindicated during the last trimester. During the first and second trimester of pregnancy, it is only accepted if there are no safer therapeutic alternatives, and the benefits outweigh the possible risks.

Effects on fertility: There is evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may

decrease female fertility by effect on ovulation. This is reversible after stopping treatment.

LACTATION

Safety in animals: no data available.

Safety in humans: Flurbiprofen concentrations in milk have been detected below 0.7% of maternal serum concentrations. It is highly unlikely that the amount excreted will have a negative impact on the nursing infant. However, caution is advised when using in lactating mothers.

CHILDREN

This medicine is indicated in adults and children from 12 years of age.

ADVANCED AGE

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation. There is no recommendation for use in these patients, since there are insufficient data.

ADVERSE REACTIONS

The following adverse reactions are related to the short-term use of flurbiprofen at non-prescription doses.

- Blood: (<0.1%): [ANEMIA]. (<0.01%): hematopoietic disorders, ([HEMOLYTIC ANEMIA], [APLASTIC ANEMIA], [NEUTROPENIA], [THROMBOCYTOPENIA], [AGRANULOCYTOSIS]). The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, unexplained bruising and bleeding.

- Nervous system: (<1%): [HEADACHE] and [DIZZENESS]. (0.1-0.01%): [INSOMNIA]

- Respiratory: (0.1-0.01%): [DYSPNEA]. Exacerbation of [ASTHMA] and [BRONCHIAL SPASM].

- Gastrointestinal: (>10%): Oral discomfort (burning or itching sensation in the mouth). (1-10%): [ABDOMINAL PAIN], [DIARRHEA], [DRY MOUTH], [MOUTH ULCER], [NAUSEA] and oral paresthesia. (<1%): [DYSPEPSIA], [FLATULENCE] and vomiting. (0.1-0.01%): [GASTRIC PERFORATION] and [GASTRIC ULCER] or [DUODENAL ULCER].

- Renal and urinary: (<0.1%): [INTERSTITIAL NEPHRITIS], [NEPHROTIC SYNDROME] and renal failure.

ADVERSE REACTIONS RELATING TO EXCIPIENTS

- This medicine contains isomalt. Daily doses greater than 10 g can produce a certain mild laxative effect and lead to [DIARRHEA].

OVERDOSE

- Symptoms : the symptoms of overdose are unknown, similar drugs have produced gastrointestinal disorders (vomiting, anorexia, abdominal pain), neurological (drowsiness, dizziness, disorientation, headache).

- Measures to be taken : Aspiration and gastric lavage, administration of adsorbent charcoal, urine alkalinization, monitoring and maintenance of vital signs, symptomatic treatment of gastrointestinal irritation, hypotension, respiratory depression and seizures, with monitoring of renal and hepatic functions and detection of possible gastrointestinal bleeding in feces.

Leaflet Lizifen 8.75 Mg 16 Lozenges To Suck (Honey And Lemon Flavor)