TETRALYSAL Hard capsule Ref.[27953] Active ingredients:

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 this medicinal product (see section Posology and method of administration).

Caution should be exercised if the product is administered to patients with impaired renal or hepatic functions.

Hepatotoxicity

Overdosage could result in hepatotoxicity

Antibiotic resistance

Prolonged use of broad spectrum antibiotics may result in the appearance of resistant organisms and superinfection.

Phototoxicity

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 can lead to renal tubular acidosis (Pseudo-Fanconi syndrome) readily reversible when treatment is discontinued altogether.

Systemic lupus erythematosus

May cause exacerbation of systemic lupus erythematosus.

Myasthenia Gravis

Can cause weak neuromuscular blockade so should be used with caution in Myasthenia Gravis.

Hepatic impairment

Care should be exercised when administering tetracyclines to patients with hepatic impairment.

Paediatric population

The product should not be used in children below 12 years of age due to the risk of permanent dental staining and enamel hypoplasia (see Contraindications).

Simultaneous administration of iron preparations and anti-acids, magnesium/aluminium and calcium hydroxides, oxides, salts, cholestyramine, bismuth chelates, sucralfate and quinapril may decrease cycline absorption. 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 300.

Some adverse effects are reported with tetracycline therapy in general in case of combination with lithium; an interaction between lithium and the tetracycline class is a recognised interaction. A combination of lymecycline with lithium may cause an increase in serum lithium levels.

Unlike earlier tetracyclines, absorption of Tetralysal 300 is not significantly impaired by moderate amounts of milk.

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. An increase in the effects of anticoagulants may occur with tetracyclines with an increased risk of haemorrhage. Concomitant use of diuretics should be avoided.

Bacteriostatic medicinal products including lymecycline may interfere with the bacteriocidal action of penicillin and beta-lactam antibiotics. It is advisable that tetracycline-class drugs and penicillin should not therefore be used in combination.

Tetracyclines and methoxyflurane used in combination have been reported to result in fatal renal toxicity.

Paediatric population

Interaction studies have only been performed in adults.

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. Therefore, Tetralysal 300 should not be administered to pregnant women.

Breastfeeding

Tetracyclines are distributed into milk. Therefore, Tetralysal 300 should not be administered to breast-feeding women (risk of enamel hypoplasia or dental dyschromia in the infant) (see section 4.3).

Fertility

No data on the effect on fertility is available.

No studies on the effects on the ability to drive and use machines have been performed.

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. The most serious adverse events reported with Tetralysal are Stevens Johnson syndrome, anaphylactic reaction, angioneurotic oedema and intracranial hypertension.

Description of selected adverse reactions

^* The manifestation of clinical symptoms, including vision disorders, or headache, must suggests the possibility of a cranial hypertension diagnosis. If increased intracranial pressure is suspected during treatment with Tetralysal, administration should be stopped.

Benign intracranial hypertension and bulging fontanelles in infants were reported with tetracyclines with possible symptoms of headaches, vomiting, visual disturbances including blurring of vision, scotomata, diplopia or permanent visual loss.

The following adverse effects were reported with tetracyclines in general and may occur with Tetralysal: dysphagia, oesophagitis, oesophageal ulceration, systemic lupus erythematosus, pancreatitis, teeth discolouration, hepatitis, hepatic failure. Dental dyschromia and/or enamel hypoplasia may occur if the product is administered in children younger than 8 years of age.

As with all antibiotics overgrowth of non susceptible organisms may cause candidiasis, pseudomembranous colitis (Clostridium Difficile overgrowth), glossitis, stomatitis, vaginitis or staphyloccocal enterocolitis.

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 Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.