Buscofenpocket - remedy against menstrual pains 10 soluble sachets

Product Description

Fast-acting remedy for menstrual pain, easy to swallow, practical and convenient to carry with you when needed.

Indications

BuscofenPocket is an ally when you want to combat pain from:

• Mild-moderate intensity period.
• Headache.
• Toothache.
• Menstrual pain.
• Fever.

Ibuprofen - the active ingredient contained in BuscofenPocket - belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs) which work by modifying the body's response to pain, inflammation and high body temperature.
BuscofenPocket, thanks to its orodispersible sachet format, is easy to swallow and convenient to take on the go and convenient to carry with you as needed.
To be taken without water, with Lemon Flavor.
BuscofenPocket 400 mg, available in packs of 10 orodispersible sachets, is recommended for adults and adolescents with a body weight of 40 kg or more (aged 12 years or over).

Ingredients

Active ingredients: Each single-dose sachet contains ibuprofen 400 mg.
Excipients: Hydrated dextrates, anhydrous citric acid, Acesulfame potassium (E 950), Glycerol distearate (Type I), Lemon flavor 502336 TP0551 (contains corn maltodextrins, alpha-tocopherol (E 307)).

Directions for use and Dosage

Dosage
For short-term use only.
Undesirable effects can be limited by using the lowest effective dose for the shortest duration necessary to control symptoms.
Adults should consult a doctor if symptoms worsen or if the use of the medicine is required for more than 3 days in the case of fever or more than 4 days in the case of pain.
Consult a doctor if symptoms worsen in adolescents over 12 years of age or if the use of this medicine is required for more than 4 days in the case of pain. 3 days.
Adults and adolescents with a body weight of 40 kg or more (aged 12 years or over)
The initial dose is 1 sachet of BuscofenPocket 400 mg.
If necessary, an additional sachet of BuscofenPocket 400 mg can be taken.
The interval between doses should be chosen in line with the symptoms observed and the maximum recommended daily dose.
It should not be less than six hours.
Do not exceed the dose of 1200 mg (3 sachets of BuscofenPocket 400 mg) in 24 hours.
Children under 12 years and adolescents with a body weight of < 40 kg
BuscofenPocket 400 mg is not suitable for children under 12 years and adolescents with a body weight of < 40 kg.
Elderly
In elderly patients, the dosage is the same as that for adults, but greater caution is required.
Impaired liver or kidney function
BuscofenPocket 400 mg is contraindicated in patients with severe liver or kidney impairment.
In patients with mild to moderate impairment of kidney or liver function, a dose reduction is not necessary, however greater caution is required.

Method of administration
Oral use.
Place the oral powder on the tongue, let it dissolve and then swallow it; Water is not necessary.
Taking during meals is recommended, especially for people with a delicate stomach.

Warnings

Caution is required in patients:

• With a history of hypertension and/or heart failure, as fluid retention and edema have been reported in association with NSAID therapy.
• With renal impairment, as further deterioration of renal function may occur.
• With liver dysfunction.
• Who have just undergone major surgery.
• With congenital impairment of porphyrin metabolism (e.g. acute intermittent porphyria).

Undesirable effects may be limited by using the lowest effective dose for the shortest duration necessary to control symptoms.

Respiratory disorders
Bronchospasm may occur in patients with bronchial asthma or allergic disease or with a history of these disorders.
Elderly
The elderly have an increased frequency of adverse reactions to NSAIDs, in particular gastrointestinal bleeding and perforation, which may be fatal.
Gastrointestinal safety
Life-threatening gastrointestinal bleeding, ulceration and perforation have been reported with all NSAIDs at any time during treatment. treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly.
These patients should initiate treatment with the lowest available dose.
For these patients, as well as For patients requiring concomitant use of low-dose aspirin or other drugs likely to increase gastrointestinal risk, combination therapy with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered. Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly during the initial stages of treatment. Caution is advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid. If gastrointestinal bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these disorders may be exacerbated.
Skin reactions
Very rarely, serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of NSAIDs.
Patients appear to be at greatest risk of developing these reactions at the beginning of therapy: in the majority of cases, the reactions occur within the first month of treatment.
Therapy with BuscofenPocket should be discontinued as soon as rashes, mucosal lesions, or any other sign of hypersensitivity appear.
Exceptionally, chickenpox may be the cause of serious infectious complications affecting the skin and soft tissues.
To date, no specific treatment can be given. exclude that NSAIDs contribute to the worsening of these infections.
It is therefore recommended to avoid the use of ibuprofen during chickenpox.
Systemic lupus erythematosus and mixed connective tissue disease
Caution is advised in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease, since may be at increased risk of aseptic meningitis.
Paediatric population
There is a risk of renal impairment in dehydrated adolescents.

For further information, read the package leaflet carefully.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients.
• Patients with a history of bronchospasm, asthma, rhinitis, urticaria or angioedema associated with the intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
• History of gastrointestinal bleeding or perforation related to previous NSAID therapy.
• Presence or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• Haemorrhage cerebrovascular or other active haemorrhage.
• Patients with severe hepatic insufficiency, severe renal insufficiency (glomerular filtration rate less than 30 ml/min) or severe heart failure (NYHA class IV).
• Severe dehydration (due to vomiting, diarrhoea or insufficient fluid intake).
• Haematopoietic disorders of unknown origin, e.g.
  thrombocytopenia.
• During the last trimester of pregnancy.

Interactions

Monitoring of clinical and biological parameters should be considered for patients taking ibuprofen concomitantly with the medicinal products listed below.
The use of ibuprofen in combination with the following medicinal products is not recommended:

• Other NSAIDs, including selective serotonin reuptake inhibitors (SNRIs), cyclooxygenase-2: Use in combination with other NSAIDs, including COX-2 inhibitors, should be avoided due to the potential for additive effects.
  The concomitant use of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding due to the synergistic effect.
• Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased adverse effects.
  Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered concomitantly.
  Although there are uncertainties regarding the extrapolation of these data to the clinical situation, no definitive conclusion can be drawn. exclude the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid.
  Clinically relevant effects are not considered likely in the case of occasional use of ibuprofen.

For further information, read the package leaflet carefully.

Undesirable effects

Gastrointestinal disorders: The most common adverse events are: The most commonly observed reactions are gastrointestinal in nature.
Peptic ulceration, perforation or gastrointestinal bleeding may occur, sometimes with fatal outcome, especially in the elderly.
Following the administration of ibuprofen, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis and exacerbation of colitis and Crohn's disease have been reported.
Less frequently, gastritis has been observed.
Immune system disorders: Hypersensitivity reactions have been reported following treatment with ibuprofen, which may consist of:

• Non-specific allergic reactions and anaphylaxis.
• Respiratory tract reactivity, including asthma, including severe asthma, bronchospasm or dyspnoea.
• Various skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, very rarely, erythema multiforme, bullous dermatoses (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

Infections and infestations: Worsening of the inflammation associated with varicella-zoster virus infection (e.g. development of necrotizing fasciitis) has been described in conjunction with the use of ibuprofen.
This is probably associated with the mechanism of action of NSAIDs.
Therefore, if the patient notices the appearance or worsening of signs of infection while taking ibuprofen, it is recommended to seek medical advice immediately.
It should be investigated whether there is an indication for anti-infective/antibiotic therapy.
Cardiac and vascular disorders: Edema, hypertension and cardiac failure have been reported in association with NSAID therapy.
Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/day), may increase the risk of developing an infection. be associated with a small increased risk of arterial thrombotic events such as myocardial infarction or stroke.
Adverse reactions possibly related to ibuprofen are listed below by frequency and MedDRA system organ class.
Frequency groups are classified according to the following categories:

• very common (> 1/10);
• common (> 1/100 - < 1/10);
• uncommon (> 1/1,000 - < 1/100);
• rare (> 1/10,000 - < 1/1,000);
• very rare (< 1/10,000)
• not known (cannot be estimated from the available data):

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

For further information, read the package leaflet carefully.

Overdose

Toxicity
In children or adults, signs and symptoms of toxicity have generally not been observed at doses below 100 mg/kg.
However, supportive treatment may be necessary in some cases.
Children have been observed to show signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or above.
In adults, the dose-response effect is less clear.
The half-life in overdose is 1.5-3 hours.
Symptoms
Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4-6 hours.
The most common symptoms of overdose are: Commonly reported side effects include nausea, vomiting, abdominal pain, lethargy, and somnolence.
Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsions, and loss of consciousness.
Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, CNS and respiratory depression have also been reported rarely.
Cardiovascular toxicity, including hypotension, bradycardia, and tachycardia, has been reported.
Metabolic acidosis may occur in cases of severe poisoning.
Renal failure and liver damage may occur in cases of significant overdose.
Treatment
There is no specific antidote for ibuprofen overdose.
If the amount ingested in the previous hour exceeds 400 mg/kg, administration of ibuprofen is recommended. Oral administration of activated charcoal or gastric lavage followed by supportive measures.
For more up-to-date information, contact your local poison control center.

Pregnancy and breastfeeding

Pregnancy
Inhibition of prostaglandin synthesis may have adverse effects on pregnancy and/or embryo-fetal development.
Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy.
The risk is believed to increase with dose and duration of therapy.
In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality.
Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
Ibuprofen should not be administered during the first and second trimesters of pregnancy unless absolutely necessary.
If ibuprofen is used by a woman who is attempting to conceive or During the first and second trimester of pregnancy, the dose should be kept as low as possible, and the duration of treatment should be as short as possible.
In the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

• a possible prolongation of bleeding time, an anti-aggregating effect which may increase the risk of pulmonary hypertension;
• a possible prolongation of bleeding time;
• an anti-coagulant effect which may increase the risk of pulmonary hypertension ... occur even at very low doses;
• an inhibition of uterine contractions, resulting in a delay or prolongation of labor.

Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.
Breastfeeding
Only small amounts of ibuprofen and its metabolites are excreted in breast milk.
Since There are no known harmful effects on newborns; it is not usually necessary to stop breastfeeding during short-term use of ibuprofen at the recommended doses.
Fertility
There is some evidence that substances that inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility by affecting ovulation.
This effect is reversible after stopping treatment.

Storage

Do not store above 25°C.
Store in the original package in order to protect from light.

Format

10 orodispersible sachets of 400 mg