Package leaflet: Information for the patient

TETRALYSAL 150 mg hard capsules, 300 mg hard capsules

Lymecycline
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tetralysal is and what it is used for
What you need to know before taking Tetralysal
How to take Tetralysal
Possible side effects
How to store Tetralysal
Contents of the pack and other information

1. What Tetralysal is and what it is used for

Tetralysal belongs to a group of antibiotic medicines called tetracyclines.
The main use of Tetralysal is to treat moderate to severe acne. Acne appears as
an inflammation of the skin, presenting with papules (small raised skin lesions without pus),
pustules (small skin lesions containing pus), blackheads and pimples.

2. What you need to know before taking Tetralysal

Do not take Tetralysal

If you are allergic to tetracycline-L-methylene lysine (limecycline) or to any of the other ingredients of this medicine (listed in section 6);
Tetralysal is contraindicated in children under 8 years of age due to the risk of permanent discoloration of teeth and enamel.
Tetralysal is contraindicated when used concomitantly with oral retinoids (vitamin A-based products taken by mouth).
Tetralysal is contraindicated during pregnancy and breastfeeding (see section "Special warnings").

Warnings and precautions
Talk to your doctor or pharmacist before taking Tetralysal.
As with other antibiotics, treatment with tetracyclines may lead to secondary bacterial or fungal (mycotic) infections.
In particular, there is a risk of enterocolitis caused by resistant staphylococci (inflammation of the small intestine and colon due to bacteria resistant to the therapeutic action of the drug).
If you undergo prolonged courses of treatment with Tetralysal, your doctor will prescribe periodic checks of blood composition and liver and kidney function.
In susceptible individuals, skin reactions may occur during treatment following exposure to sunlight or sunlamps. If skin redness (cutaneous erythema) appears, you must stop treatment immediately.
If you have renal impairment, inform your doctor before taking Tetralysal and carefully follow the instructions provided.
Before taking Tetralysal, consult your doctor if you suffer from myasthenia gravis (a disease that causes muscle weakness).
Before taking Tetralysal, consult your doctor if you suffer from systemic lupus erythematosus.
Take the medicine with a sufficient amount of water to avoid irritation and ulcers of the oesophagus.
If you take more Tetralysal than you should (overdose), liver problems (hepatotoxicity) may occur.
Do not take Tetralysal after the expiry date, as this could result in a risk of kidney damage (pseudo-Fanconi syndrome).

Children
Tetralysal must not be used in children under 8 years of age due to the risk of permanent discoloration of teeth and enamel.

Other medicines and Tetralysal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not use Tetralysal together with oral vitamin A-based products due to the risk of increased intracranial pressure.
Do not take antacids containing aluminium, calcium, or magnesium, or products containing iron salts, didanosine, activated charcoal, cholestyramine, bismuth chelates, or sucralfate together with Tetralysal, as these reduce the absorption of orally administered tetracyclines.
Do not take together with medicines that increase gastric pH, as they reduce tetracycline absorption.
Avoid concomitant use with penicillins (another type of antibiotic) due to possible interference between the two drugs.
If you are being treated with anticoagulant medicines (medicines to prevent blood clots), inform your doctor, as the dosage may need to be adjusted due to the possible reduction in anticoagulant activity caused by tetracyclines.
Do not take together with antiepileptic medicines, including barbiturates such as phenobarbital, phenytoin, and carbamazepine.
The use of methoxyflurane in combination with Tetralysal is not recommended, as it may cause fatal renal toxicity.
Limecycline (the active ingredient in Tetralysal) may cause false positive results in urine glucose tests.
Inform your doctor if you are taking lithium, as this medicine may increase lithium levels.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
The use of tetracyclines during tooth development (second half of pregnancy) may cause permanent yellow-brown discoloration of the child's teeth. This is particularly observed with prolonged use, but has also been reported after short, repeated treatment courses. For this reason, the use of Tetralysal is contraindicated during pregnancy and breastfeeding.

Fertility
No data are available on effects on fertility.

3. How to take Tetralysal

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for the treatment of acne is 300 mg/day for 12 weeks.
You should take the product with an adequate amount of water to avoid irritation and ulceration of the oesophagus.

Use in children
Tetralysal must not be used in children under 8 years of age due to the risk of permanent discoloration and enamel damage of the teeth.

If you take more Tetralysal than you should
If you have accidentally taken an excessive dose of Tetralysal, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects are listed by frequency:
Common (may affect up to 1 in 10 people):

Headache
Nausea
Abdominal pain
Diarrhoea

Not known (frequency cannot be estimated from the available data):

Enterocolitis (inflammation of the small intestine and colon)
Glossitis (inflammation of the tongue)
Visual disturbances*
Neutropenia (reduction in neutrophils, a type of white blood cells)
Thrombocytopenia (reduction in platelets)
Vomiting
Upper gastrointestinal tract pain (in the stomach)
Fever
Jaundice (yellowing of the skin)
Hepatitis (inflammation of the liver)
Hypersensitivity
Urticaria
Angioneurotic edema (swelling of the eyelids, lips, tongue, genital organs)
Anaphylactic reaction (severe, rapidly developing allergic reaction that may be fatal)
Increased transaminases (liver enzymes in the blood indicating possible liver damage)
Increased alkaline phosphatase (blood enzymes indicating certain diseases)
Increased bilirubin (a substance contained in bile)
Dizziness
Intracranial hypertension (increased pressure within the skull)
Erythematous rash (appearance of red skin lesions)
Photosensitivity reactions during exposure to sunlight or sunbeds
Pruritus (itching)
Stevens-Johnson syndrome (a severe acute hypersensitivity reaction affecting the skin and mucous membranes)
Depression
Nightmares

*(the occurrence of clinical symptoms, including visual disturbances or headache, may be related to intracranial hypertension. If increased intracranial pressure is suspected during treatment with limecycline, administration must be discontinued).
Benign intracranial hypertension has been reported with tetracyclines, with possible symptoms including headache, vomiting, visual disturbances such as blurred vision, scotoma (dark spots or intermittently flickering vision in the visual field), diplopia (double vision), or permanent vision loss.

Additionally:

When administered in children under 8 years of age, permanent discoloration of teeth and enamel abnormalities may occur.
Cases of haemolytic anaemia (low haemoglobin concentration), eosinophilia (increase in certain blood cells), and other blood disorders have been reported.
Cases of non-renal hyperazotemia (increased blood nitrogen levels) may occur due to concomitant use of diuretics (medicines used to increase urine secretion) and tetracyclines.
Treatment with Tetralysal must be discontinued if symptoms suggestive of increased intracranial pressure occur (e.g. vomiting).
Isolated cases of anorexia (loss or reduced appetite) and allergic vasculitis (inflammation of blood vessels) have been reported.
Cases of systemic lupus erythematosus and pancreatitis have been observed, generally attributable to tetracycline therapy.

Following the instructions provided in the leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Tetralysal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The indicated expiry date applies to the product stored in its original, intact packaging and kept under proper storage conditions.
Store this medicine in its original packaging.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tetralysal contains
Each 150 mg capsule contains:
The active substance is tetracycline-L-methylene lysine (licomycin) equivalent to 150 mg of tetracycline base.
The other components are:
Magnesium stearate, levilite, gelatin, glyceryl monooleate.
Each 300 mg capsule contains:
The active substance is tetracycline-L-methylene lysine (licomycin) equivalent to 300 mg of tetracycline base.
The other components are:
Magnesium stearate, hydrated colloidal silica.
Components of the gelatin capsule: gelatin, titanium dioxide (E171), quinoline yellow (E104), erythrosine (E127), indigo carmine (E132).
Description of the appearance of Tetralysal and contents of the pack
150 mg hard capsules
Glass bottle containing 28 capsules.
300 mg hard capsules
Al/PE blister pack containing 4 capsules.
Packs containing 16 or 28 capsules.
Marketing Authorization Holder
Galderma Italia S.p.A. – Registered office Via dell’Annunciata 21 – Milan.
Manufacturer
150 mg hard capsules:
Pfizer Italia S.r.l. – Ascoli Piceno site – Località Marino del Tronto (AP).
300 mg hard capsules:
Sophartex S.A. Laboratoires – Vernouillet (France)
or
Laboratoires Galderma – Alby Sur-Cheran (France)