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SPC, UK: TETRACYCLINE Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

TETRACYCLINE TABLETS BP 250mg.

Qualitative and quantitative composition

Each tablet contains 250mg Tetracycline Hydrochloride PhEur. Excipients with known effect: Sunset yellow FCF aluminium lake (E110). For the full list of excipients, see section 6.1.

Pharmaceutical form

Orange film-coated tablets. Orange, circular, biconvex film-coated tablets, impressed C on one face and the identifying letters TE on the reverse.

Therapeutic indications

Tetracycline is a bacteriostatic broad-spectrum antibiotic, active against a wide variety of Gram-positive and Gram-negative organisms. Infections caused by tetracycline-sensitive organisms include: Respiratory ...

Posology and method of administration

Posology Tetracycline should be given one hour before or two hours after meals, since food and some dairy products interfere with absorption. Therapy should be continued for up to three days after symptoms ...

Contraindications

Hypersensitivity to the active substance, any of the tetracyclines or to any of the excipients listed in section 6.1. Chronic renal/hepatic dysfunction; Renal impairment, particularly if severe; Systemic ...

Special warnings and precautions for use

Tetracycline drugs may cause permanent tooth discolouration (yellow-grey-brown), if administered during tooth development, in the last half of pregnancy and in infancy up to twelve years of age (see sections ...

Interaction with other medicinal products and other forms of interaction

The absorption of tetracycline from the gastrointestinal tract is impaired by the concomitant administration of di and trivalent cations such as iron, calcium, aluminium, magnesium, bismuth and zinc salts. ...

Pregnancy and lactation

Pregnancy Not to be used in pregnancy unless essential to the patients welfare. Tetracyclines cross the placenta and may have toxic effects on foetal tissues, particularly on skeletal development (see ...

Effects on ability to drive and use machines

None known.

Undesirable effects

The following convention has been utilised for the classification of frequency. Very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10,000 and <1/1000); very rare (<1/10,000); ...

Overdose

Symptoms: There may be nausea and vomiting. Crystalluria and haematuria may occur following very large doses. Hypersensitivity reactions may occur. Treatment: There is no specific antidote. Gastric decontamination ...

Pharmacodynamic properties

Pharmacotherapeutic group: Tetracycline hydrochloride is a broad-spectrum bacteriostatic antibiotic ATC code: D06AA04 Tetracyclines are taken up into sensitive bacterial cells by an active transport process. ...

Pharmacokinetic properties

Absorption Most tetracyclines are incompletely absorbed from the gastrointestinal tract, about 60-80% of a dose of tetracycline usually being available. The degree of absorption is diminished by the presence ...

Preclinical safety data

Not applicable.

List of excipients

The tablet contains: Sodium lauryl sulfate Hydroxypropylcellulose (E463) Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate The coating contains: Methylhydroxypropylcellulose (E464) Propylene ...

Incompatibilities

None known.

Shelf life

Shelf-life: Three years from the date of manufacture (tablet containers & caps/bottles & screw caps). Three years from the date of manufacture (blisters). Shelf-life after dilution/reconstitution: Not ...

Special precautions for storage

Do not store above 25°C. Keep the container tightly closed (polypropylene containers). Store in the original package (blisters).

Nature and contents of container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative ...

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization number(s)

PL 0142/0373

Date of first authorization / renewal of the authorization

25.05.2001

Date of revision of the text

09/10/2019

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