Tetralysal

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Tetralysal, 300 mg, hard capsules
Lymecycline
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Tetralysal is and what it is used for
2. Important information before taking Tetralysal
3. How to take Tetralysal
4. Possible side effects
5. How to store Tetralysal
6. Contents of the pack and other information

1. What Tetralysal is and what it is used for

Tetralysal is an antibiotic belonging to the tetracycline group. In the treatment of acne, it acts:

• antibacterially against Propionibacterium acnes;
• anti-inflammatory (by inhibiting the activity of certain types of white blood cells);
• by inhibiting a bacterial enzyme responsible for producing free fatty acids, which are irritant. This leads to a reduction in the number of inflammatory skin lesions.

Indications for the use of Tetralysal:

• moderate to severe common acne with inflammatory lesions such as papules, pustules, nodules, cysts, and infiltrates;
• rosacea.

2. Important information before using Tetralysal

When not to use Tetralysal:

• if the patient is allergic (hypersensitive) to lymecycline or any of the other ingredients of the medicine (listed in section 6);
• if the patient is allergic to other antibiotics of the tetracycline group;
• if the patient is taking medicines called retinoids (used in the treatment of skin diseases);
• in children under 8 years of age (due to the risk of permanent changes in teeth and discoloration of enamel);
• during pregnancy and breastfeeding.

Warnings and precautions
Before starting Tetralysal, discuss this with your doctor.
You should stop taking Tetralysal if you experience severe headaches.
Taking Tetralysal may cause irritation and ulceration of the oesophagus; to avoid this, drink plenty of fluids when taking this medicine.
In case of strong exposure to sunlight or other sources of ultraviolet (UV) radiation, Tetralysal may very rarely cause skin reactions (phototoxic effect). Such an effect has been observed after administration of high doses of the medicine (1200 mg/day) and simultaneous strong exposure to UV radiation (sunbathing, solarium). However, during treatment it is advisable to avoid sunlight and other sources of ultraviolet radiation (e.g. solarium).
If skin changes occur, especially redness or blisters, consult a doctor immediately, as this may be the beginning of rare, life-threatening severe skin complications.
If diarrhoea occurs during treatment or several weeks after stopping the medicine, seek medical advice immediately. Diarrhoea may be a sign of pseudomembranous colitis caused by toxins from excessive growth of the bacterium Clostridium difficile in the intestines.
The inflammation may be mild or severe. Mild cases usually resolve after discontinuation of the medicine. In more severe cases, the doctor may prescribe metronidazole or vancomycin. Do not take drugs that inhibit peristalsis or have constipating effects.
If the patient suffers from myasthenia gravis (a disease characterised by muscle weakness), symptoms of this disease may worsen during treatment with lymecycline. Exercise caution when using Tetralysal in patients with myasthenia gravis.
If the patient suffers from systemic lupus erythematosus, they should consult a doctor before using this medicine.
Do not take expired medicine, as it may cause kidney damage.
Tetralysal should be used with particular caution in patients with impaired kidney or liver function.
Talk to your doctor, even if any of the above conditions occurred in the past.

Children and adolescents
Tetralysal should not be given to children under 8 years of age due to the risk of permanent tooth discoloration and inhibition of enamel development.

Tetralysal and other medicines
Tell your doctor about all medicines you are currently using, have recently used, or plan to use.
Studies on the interaction between lymecycline and other medicines have been conducted exclusively in adults.
Inform your doctor if you are taking any of the following medicines:

• blood-thinning medicines, e.g. warfarin
• medicines for treating HIV, e.g. didanosine
• other medicines for treating acne
• other antibiotics, including penicillins
• oral retinoids and products containing vitamin A (above 10,000 IU/day): risk of intracranial hypertension
• medicines that increase urine production – diuretics

Inform your doctor if you are taking any medicines containing lithium, as this medicine may increase lithium blood levels.
Do not take the following medicines at the same time as Tetralysal, as they may affect its proper action. Wait at least 2 hours before or after taking Tetralysal before taking the following products:

• antacids
• iron-containing products
• medicines for epilepsy, including barbiturates, e.g. phenobarbital, phenytoin, carbamazepine
• medicines that reduce stomach acid, e.g. cimetidine and ranitidine
• antacids (hydroxides and salts of magnesium, aluminium, and calcium), activated charcoal, cholestyramine, bismuth chelates, sucralfate.

The use of methoxyflurane in combination with Tetralysal is not recommended due to the risk of fatal kidney poisoning. Inform your doctor if you have a planned procedure requiring anaesthesia, as tetracyclines should not be used with certain types of anaesthetic agents.
Tetralysal may enhance the effect of oral anticoagulants (coumarin derivatives), cytostatics, oral antidiabetic drugs, and glucocorticoids.
It may interfere with the determination of catecholamines and glucose (by reduction methods) in urine, leading to falsely elevated results.

Tetralysal with food and drink
See section 3.

Pregnancy and breastfeeding
Tetralysal must not be used during pregnancy and breastfeeding. The use of medicines such as tetracyclines may affect the normal development of teeth and cause permanent tooth discoloration.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.

Driving and operating machinery
Tetralysal has no influence on the ability to drive or operate machinery.

3. How to use Tetralysal

This medicine should always be used exactly as your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist.

Adults
The recommended dose is:

• for the treatment of acne vulgaris: 300 mg (one Tetralysal capsule) once daily for 12 weeks;
• for the treatment of rosacea: initially 600 mg (one Tetralysal capsule twice daily) for 10 days, followed by 300 mg (one Tetralysal capsule) once daily for a period of 3 to 6 months.

Swallow the capsules with a full glass of water while sitting in an upright position to avoid damage to the oesophagus. Taking the medicine with food, including milk, does not significantly affect its absorption.

Capsules containing 150 mg of the active substance are also available.

Your doctor will inform you how long you should continue taking Tetralysal.

Use in children
Tetralysal must not be used in children under 8 years of age.

Taking more Tetralysal than recommended
Overdosing may cause liver damage. If you have taken more than the recommended dose, seek immediate medical advice.

Missed dose of Tetralysal
Do not take a double dose to make up for a missed dose.

Stopping Tetralysal treatment
Do not stop treatment too early, as symptoms may return. Always consult your doctor if you are considering stopping the medicine.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Tetralysal may cause adverse reactions, although not everyone experiences them.
The adverse reactions listed below are categorized by frequency of occurrence.
Common (occurring in 1 to 10 out of 100 patients)

• Nausea
• Abdominal pain
• Diarrhea
• Headache

Frequency not known (frequency cannot be estimated from available data)

• Changes in blood cell count
• Visual disturbances*
• Double vision
• Permanent loss of vision
• Inflammation of the tongue
• Inflammation of the intestine
• Vomiting
• Upper abdominal pain
• Inflammation of the small intestine and colon
• Pseudomembranous colitis
• Pancreatitis
• Fever
• Yellowing of the skin or eyes (jaundice)
• Hepatitis
• Changes in laboratory test results (blood tests, liver enzyme tests)
• Allergic reactions (itching of the facial skin, including around the eyes and mouth)
• Skin itching, rash, or urticaria
• Sudden, serious generalized allergic reactions associated with malaise
• Blastomycosis, candidiasis (yeast infection)
• Vaginitis
• Increased intracranial pressure
• Dizziness
• Photosensitivity
• Toxic epidermal necrolysis
• Development of pimples or skin peeling over large areas, ulceration or lesions around the mouth, lips, genital or anal areas (Stevens-Johnson syndrome)
• Depression
• Nightmares

*Clinical symptoms such as visual disturbances or headaches may be caused by increased intracranial pressure. If symptoms of increased intracranial pressure occur during treatment with lymecycline, the medicine should be discontinued. Mild intracranial hypertension has been reported during treatment with tetracyclines, which may present as headache, vomiting, visual disturbances including blurred vision, scotoma (dark spots or flashes in the visual field), diplopia (double vision), or permanent vision loss.
Additionally, the following adverse reactions may occur during treatment with other medicines belonging to the same group as Tetralysal (tetracyclines):

• Tooth discoloration and enamel hypoplasia if the medicine is administered to children under 8 years of age;
• changes in blood test results (reduced number of red blood cells, increased number of certain types of white blood cells);
• hyperazotemia (excessively high concentration of nitrogen compounds in the blood), which may be intensified by concomitant use of diuretics.

Cases of systemic lupus erythematosus and pancreatitis associated with tetracycline treatment have been observed.
Tetralysal should be discontinued if symptoms of increased intracranial pressure occur.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Tetralysal

Keep this medicine out of 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 the stated month.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Tetralysal contains

• The active substance is limecycline. One hard capsule contains 408 mg of limecycline, equivalent to 300 mg of tetracycline.
• Other components of the medicine: magnesium stearate, colloidal anhydrous silica.
• Capsule shell: gelatin, titanium dioxide (E 171), erythrosine (E 127), quinoline yellow (E 104), indigotine (E 132).

What Tetralysal looks like and contents of the pack
Tetralysal is available as hard, red-yellow capsules.
Pack sizes: 16 or 28 capsules.
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in France, the country of export:
Galderma International
Tour Europlaza - La Défense 4
20, avenue André Prothin
92927 La Défense Cedex
France

Manufacturer:
Sophartex
21 Rue Du Pressoir
28500 Vernouillet
France

Parallel Importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czesky Těšín
Czech Republic

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland

Euceryn Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
Wł. Żeleńskiego 45
31-353 Kraków
Poland

Marketing Authorisation Number in France, the country of export:
34009 367 598 0 0
367 598-0
367 597-4
34009 367 597 4 9

Parallel Import Authorisation Number: 224/23