STREPSILS INTENSIVE Lozenge (2021)
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Περιεχόμενα
1. Name of the medicinal product
Strepsils Intensive 8.75 mg Lozenges.
2. Qualitative and quantitative composition
Active Ingredient flurbiprofen 8.75mg <u>Excipients with known effects:</u> Glucose 1.069 g/lozenge. Total maximum daily dose (MDD) is 5.345 g. Sucrose 1.407 g/lozenge. Total MDD is 7.035 g. Invert Sugar ...
3. Pharmaceutical form
Lozenge. Clear, round lozenge.
4.1. Therapeutic indications
For the symptomatic relief of sore throats. Strepsils Intensive Lozenges are indicated in adults and adolescents over 12 years of age.
4.2. Posology and method of administration
Posology Treatment should be administered for the shortest duration necessary to control symptoms. It is recommended that this product should be used for a maximum of three days. Adults One lozenge sucked/dissolved ...
4.3. Contraindications
Hypersensitivity to flurbiprofen or any of the excipients listed in section 6.1. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, bronchospasm or urticaria) ...
4.4. Special warnings and precautions for use
Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms (See section 4.2, and GI and cardiovascular risks below). If the symptoms ...
4.5. Interaction with other medicinal products and other forms of interaction
<b>Flurbiprofen should be avoided in combination with:</b> Other NSAIDS including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of ...
4.6. Fertility, pregnancy and lactation
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Dizziness, drowsiness and visual disturbances are possible undesirable side effects after taking NSAIDs. If affected, ...
4.8. Undesirable effects
Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of: Non-specific allergic reactions and anaphylaxis, Respiratory tract reactivity comprising asthma, aggravated ...
4.9. Overdose
Symptoms Most patients who have ingested clinically important amounts of NSAIDs will develop symptoms of overdose that may include nausea, vomiting, epigastric pain, gastrointestinal irritation or more ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Respiratory System; Throat preparations; Other throat preparations. <b>ATC Code:</b> R02AX01 Flurbiprofen is a propionic acid derivative NSAID which acts through inhibition ...
5.2. Pharmacokinetic properties
Absorption Flurbiprofen 8.75mg lozenges dissolve over 5-12 minutes and the flurbiprofen is readily absorbed, with detection in the blood at 5 minutes and plasma concentrations peaking at 40-45 minutes ...
5.3. Preclinical safety data
There are no preclinical data of relevance additional to information already included in other relevant sections.
6.1. List of excipients
Macrogol 300 Potassium Hydroxide Lemon Flavour (butylated hydroxyanisole (E320), citral, citronellol, d-Limonene, farnesol, geraniol and linalool) Levomenthol Liquid Glucose (wheat starch containing gluten, ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
Lozenges are packed in blisters made up of white opaque 250micron Polyvinyl Chloride (PVC), coated with 40gsm or 90gsm Polyvinylidene Chloride (PVDC); heat sealed to 20 microns Aluminium lidding material ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PA0979/041/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 07 March 2003 Date of last renewal: 07 March 2008
10. Date of revision of the text
February 2021
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