TETRALYSAL Hard capsule (2020)
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Περιεχόμενα
1. Name of the medicinal product
Tetralysal 300 mg Hard Capsules.
2. Qualitative and quantitative composition
Each capsule contains 408 mg of Lymecycline equivalent to 300 mg tetracycline base. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule. Hard gelatin capsule, red cap and yellow body.
4.1. Therapeutic indications
Tetralysal is indicated for the treatment of infections caused by tetracycline sensitive organisms (please see section 4.4 and 5.1) including the following: Acne Ear, nose and throat infections Acute exacerbation ...
4.2. Posology and method of administration
Adults The usual dosage for the chronic treatment of acne is 1 capsule daily (300 mg/day): treatment should be continued for at least 8 weeks. For other infections, the usual dosage is 1 capsule b.d. (600 ...
4.3. Contraindications
Hypersensitivity to the active substance or any other tetracycline or to any of the excipients listed in section 6.1. Its use is contraindicated in patients with overt renal insufficiency and in children ...
4.4. Special warnings and precautions for use
Oesophageal irritation and ulceration Solid dosage forms of the tetracyclines may cause oesophageal irritation and ulceration. To avoid oesophageal irritation and ulceration, adequate fluids (water) should ...
4.5. Interaction with other medicinal products and other forms of interaction
Simultaneous administration of iron preparations and anti-acids, magnesium/aluminium and calcium hydroxides, oxides, salts, cholestyramine, bismuth chelates, sucralfate and quinapril may decrease cycline ...
4.6. Fertility, pregnancy and lactation
Tetracyclines are selectively absorbed by developing bones and teeth and may cause dental dyschromia and enamel hypoplasia (see section 4.3). Pregnancy Tetracyclines readily cross the placental barrier. ...
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.
4.8. Undesirable effects
Tabulated list of adverse reactions The most frequently reported adverse events with Tetralysal are gastrointestinal disorders of nausea, abdominal pain, diarrhoea and nervous system disorder of headache. ...
4.9. Overdose
Symptoms Acute overdosage is rare with antibiotics and there is no specific treatment. Management Supportive measure should be instituted as required and a high fluid intake maintained.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Tetracyclines <b>ATC code:</b> J01AA04 Mode of action Tetracyclines provide bacteriostatic action at the available plasma and tissue concentrations and are effective against ...
5.2. Pharmacokinetic properties
Lymecycline is more readily absorbed from the gastro-intestinal tract than tetracycline, with a peak serum concentration of approximately 2mg/L after 3 hours following a 300 mg dose. In addition, similar ...
5.3. Preclinical safety data
No specific information is presented given the vast experience gained with the use of tetracyclines in humans over the last forty years.
6.1. List of excipients
Magnesium stearate Colloidal hydrated silica <u>The capsule shells contain:</u> Gelatin Titanium dioxide (E171) Erythrosine (E127) Quinoline yellow (E104) Indigotine (E132)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years (unopened).
6.4. Special precautions for storage
<u>Aluminium and polyethylene strips:</u> Do not store above 25°C. Store in the original container. <u>Aluminium-PVC/PVDC calendar blister strips:</u> Do not store above 25°C. Keep container in the outer ...
6.5. Nature and contents of container
Aluminium-PVC/PVDC calendar blister strips of 14 capsules; two strips per carton, pack size = 28 capsules or Aluminium and polyethylene strips 28 or 56 capsule pack size. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK
8. Marketing authorization number(s)
PL 10590/0019
9. Date of first authorization / renewal of the authorization
29<sup>th</sup> September 1995
10. Date of revision of the text
26<sup>th</sup> June 2020
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