Tetralysal 150mg and 300mg Capsule

Infections caused by susceptible strains of pathogens:

• Upper and lower respiratory tract infections
• Sinusitis, pharyngitis, Mycoplasma pneumoniae, psittacosis and chronic bronchitis.
• Genito-urinary tract infections
• Non-specific urethritis (only if the strain is sensitive), lymphogranuloma venereum, chancroid and granuloma inguinale, gonococcal salpingitis, epididymitis, acute epididymo-orchitis, endocervical infections, syphilis and gonorrhoea (in cases of penicillin allergy).
• Soft tissue
• Acne
• Ophthalmic infections
• Trachoma and inclusion conjunctivitis.
• Intestinal infections
• Cholera, Whippleu2019s disease and tropical sprue.
• Miscellaneous infections
• Rickettsial infections, brucellosis, tularemia, actinomycosis, Lyme disease, yaws, relapsing fever, leptospirosis during the early infective phase.

Adults: The recommended dose for acne is 300 mg/day. The usual duration of treatment is 12 weeks. The usual dose for indications other than acne is 300 mg every 12 hours (depending on the severity of the infection). The maximum dose should not exceed 3 g daily for adults and 50 mg/kg body mass per day for children.

Elderly: As for other tetracyclines, no specific dose adjustment is required.

Paediatric population: The safety and efficacy of TETRALYSAL u00ae in children aged under 12 years of age have not been established.

Methods of administration: The capsules should be taken either one hour before meals or two hours after meals with adequate liquid to avoid lodging of capsules in the distal oesophagus as this may result in local corrosive irritation and ulceration.

Hypersensitivity to lymecycline or any other tetracyclines or to any of the excipients listed in section 6.1. In patients with impaired renal function. Should not be given to children younger than 12 years of age as permanent discolouration of the childu2019s teeth and enamel hypoplasia may occur. Should not be given to patients with systemic lupus erythematosus. Concurrent treatment with oral retinoids (see Interaction with other Medications). Pregnancy and breastfeeding.

Use with care in patients with renal or liver function impairment. 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 be taken with TETRALYSAL u00ae (see u2018Posology and method of administrationu2019).

Hepatotoxicity: Overdosage could result in hepatotoxicity. Frail or elderly patients are susceptible to hepatotoxic medicines and antianabolic effects of tetracyclines. Do not use concomitantly with hepatotoxic medicines.

Antibiotic resistance: Prescribers must adhere to the principles of antibiotic stewardship. Prolonged use of broad spectrum antibiotics may result in the appearance of resistant organisms and superinfection.

Phototoxicity: Photosensitivity may occur (see section 4.8 u201cUndesirable Effectsu201d). Due to the risks of photosensitivity, it is recommended to avoid exposure to direct sunlight and ultraviolet light during the treatment which should be discontinued if erythematous cutaneous manifestations occur.

Expired medication: The use of expired tetracyclines may lead to a Fanconi-type syndrome renal tubular acidosis (Pseudo-Fanconi syndrome) which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis, aminoaciduria, hypophosphatemia and hypocalcaemia, readily reversible when treatment is discontinued altogether.

Systemic lupus erythematosus: May cause exacerbations of systemic lupus erythematosus (see Section 4.3).

Myasthenia Gravis: Symptoms of Myasthenia gravis may be aggravated.

Paediatric population: Use in children under the age of 12 years is contraindicated due to the risk of permanent dental staining and enamel hypoplasia (see Section 4.3). Raised intracranial pressure may occur particularly in infants and especially if Vitamin A or other retinoids are given concomitantly.

Preparations containing sodium bicarbonate and iron, magnesium/aluminium and calcium hydroxides, oxides, salts, cholestyramine, bismuth chelate, sucralfate and quinapril may decrease the absorption of lymecycline. Patients should therefore not receive antacid therapy or milk concomitantly. Enzyme inducers such as barbiturates, carbamazepine, phenytoin may accelerate the decomposition of tetracycline due to enzyme induction in the liver thereby decreasing its half-life. These products should not be taken within two hours before or after taking TETRALYSAL u00ae.

Concomitant use of oral retinoids and vitamin A (above 10 000 IU/day) should be avoided as this may increase the risk of benign intracranial hypertension. Doses of anticoagulants may need to be reduced if given concomitantly. Concomitant use of diuretics should be avoided. Penicillin and beta-lactam antibiotics should not be given concomitantly with tetracyclines as antagonism may occur. Tetracyclines may diminish the effectiveness of oral contraceptives. Fatal renal toxicity may follow the concomitant use with methoxyflurane. Concomitant use of lithium may cause an increase in serum lithium levels.

Paediatric population: Interaction studies have only been performed in adults.

TETRALYSAL u00ae should not be used by pregnant or breastfeeding women.

Pregnancy: Lymecycline crosses the placenta and is deposited in foetal bones and teeth. Pregnant women are particularly susceptible to severe tetracycline-induced liver damage.

Breastfeeding: Lymecycline is readily excreted into breast milk.

Fertility: No data on the effect on fertility is available.

TETRALYSAL u00ae is not known to affect the ability to drive or use machines.

Tabulated list of adverse reactions: The most frequently reported adverse events with TETRALYSAL u00ae are gastrointestinal disorders of nausea, abdominal pain, diarrhoea and nervous system disorder of headache. The most serious adverse events reported with TETRALYSAL u00ae are Stevens Johnson syndrome, anaphylactic reaction, angioneurotic oedema and intracranial hypertension.

System Organ Class Frequency Adverse Reaction

• Blood and lymphatic system disorders Unknown Haemolytic anaemia Eosinophilia Neutropenia Thrombocytopenia
• Eye disorders Unknown Visual disturbance
• Gastrointestinal disorders Common (u22651/100 and <1/10) Nausea Abdominal pain Diarrhoea Unknown Epigastralgia (gastrointestinal pain upper) Glossitis Vomiting Enterocolitis
• General disorders and administration site conditions Unknown Pyrexia
• Hepatobiliary disorders Unknown Jaundice Hepatitis
• Immune system disorder Unknown Anaphylactic reaction Hypersensitivity Urticaria Angioneurotic oedema
• Investigations Unknown Transaminases increased Blood alkaline phosphatase increased Blood bilirubin increased
• Nervous system disorders Common (u22651/100 and <1/10) Headache Unknown Dizziness Intracranial hypertension
• Skin and subcutaneous tissues disorders Unknown Erythematous rash Photosensitivity Pruritus Stevens Johnson syndrome
• Psychiatric disorders Unknown Depression Nightmare

Description of selected adverse reactions: Symptoms resulting from the overgrowth of non-susceptible organisms: Overgrowth of Candida albicans in the mouth causes soreness, redness and thrush which may extend into the trachea and bronchi; overgrowth of C. albicans in the bowel results in pruritis ani and vulvovaginitis and there may be overgrowth of resistant coliform organisms, such as Pseudomonas spp. and Proteus spp., causing diarrhoea. Colitis due to Clostridium difficile may occur. Super-infection due to resistant staphylococci may cause fulminating enteritis. Allergic (hypersensitivity) reactions: Allergic reactions to lymecycline and its analogues have been reported. Cross-sensitisation is common. Symptoms include maculopapular rashes, exfoliative dermatitis, exacerbation of systemic lupus erythematosus, pericarditis and Henoch-Schu00f6nlein purpura (anaphylactoid purpura). Photosensitivity of the skin and nails; onycholysis and nail discolouration may occur. Increased severity of uraemia and hepatotoxicity in patients with renal disease given high doses. Vitamin deficiencies may result during prolonged administration. A Jarisch-Herxheimer-like reaction has been reported in patients with relapsing fever treated with tetracycline. In the elderly a negative nitrogen balance may be induced.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: http://www.sahpra.org.za/Publications/Index/8

In overdose, side effects can be precipitated and/or be of increased severity. (See Section 4.8 u201cUndesirable effectsu201d.) If adverse reactions or idiosyncrasy occurs, discontinue medication. Treatment is symptomatic and supportive.