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 following information carefully before using the medicine, as it contains
important information for the patient

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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 irritants. As a result, the number of inflammatory skin lesions is reduced.

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 from the tetracycline group;
• if the patient is taking medicines called retinoids (used in the treatment of skin disorders);
• in children under 8 years of age (due to the risk of permanent tooth discoloration and impaired enamel development);
• during pregnancy and breastfeeding.

Warning and precautions
Before starting treatment with 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 intense exposure to sunlight or other sources of ultraviolet (UV) radiation, Tetralysal may very rarely cause skin reactions (phototoxic reactions). Such effects have been observed after administration of high doses of the drug (1200 mg/day) combined with intense UV exposure (sunbathing, solarium). 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, contact your 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 treatment, seek medical advice immediately. Diarrhoea may be a symptom of pseudomembranous colitis caused by toxins from excessive growth of Clostridium difficile bacteria in the intestine.
The inflammation may be mild or severe. Mild cases usually resolve after discontinuation of the drug.
In more severe cases, your doctor may recommend taking 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 condition may worsen during treatment with lymecycline. Use Tetralysal with caution in patients with myasthenia gravis.
If the patient suffers from systemic lupus erythematosus, they should consult their doctor before using this medicine.
Do not take expired medicine, as it may cause kidney damage.
Use Tetralysal 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 impaired enamel development.
Tetralysal and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
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 vitamin A-containing products (above 10,000 IU/day): risk of intracranial hypertension;
• diuretics (medicines that increase urine production). Inform your doctor if you are taking any lithium-containing medicines, 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 effects of oral anticoagulants (coumarin derivatives), cytostatic drugs, oral antidiabetic drugs, and glucocorticosteroids.
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 growing teeth and cause permanent tooth discoloration.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Driving and operating machinery
Tetralysal does not affect the ability to drive or operate machinery.

3. How to use Tetralysal

This medicine should always be used exactly as prescribed by your doctor. If in doubt, 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 plenty of water while sitting in an upright position to avoid esophageal damage. Concomitant intake of food, including milk, does not significantly affect drug absorption.

Capsules containing 150 mg of the active substance are also available.
Your doctor will inform you how long you should take Tetralysal.
Use in children
Tetralysal must not be used in children under 8 years of age.
Taking more Tetralysal than recommended
Overdose may cause liver damage. If you have taken more than the recommended dose, seek immediate medical advice.
If you miss a dose of Tetralysal
Do not take a double dose to make up for a missed dose.
Stopping Tetralysal
Do not stop treatment too early, as symptoms may recur. 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 counts
• Visual disturbances*
• Double vision
• Permanent loss of vision
• Inflammation of the tongue
• Enteritis
• 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 face, including around the eyes and mouth)
• Skin itching, rash, or urticaria
• Sudden, severe generalized allergic reactions associated with malaise
• Blastomycosis, candidiasis (yeast infection)
• Vaginitis
• Increased intracranial pressure
• Dizziness
• Photosensitivity
• Toxic epidermal necrolysis
• Development of acne 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 headache may be caused by the development of intracranial hypertension. 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 (excess nitrogen-containing compounds in the blood), which may be intensified by concomitant use of diuretics. Cases of systemic lupus erythematosus and pancreatitis associated with tetracycline therapy have been observed.

Treatment with 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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the 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 apply.
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 lymecycline. Each hard capsule contains 408 mg of lymecycline, equivalent to 300 mg of tetracycline.
• Other components of the medicine are: magnesium stearate, colloidal hydrated silica.
• Capsule shell: gelatin, titanium dioxide (E 171), erythrosine (E 127), quinoline yellow (E 104), indigo carmine (E 132).

What Tetralysal looks like and contents of the pack
Tetralysal is available as hard, red-yellow capsules.
Packs contain 16 or 28 capsules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in France, 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warszawa
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. k.
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Marketing Authorisation Numbers in France, country of export: 367 597-4
367 598-0
Parallel Import Licence Number: 244/25