Tetralisal

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Tetralysal

300 mg, hard capsules

Lymecyclinum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tetralysal and what is it 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 is Tetralysal and what is it used for

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

• as an antibacterial agent against the microorganism Propionibacterium acnes;
• as an anti-inflammatory agent (by inhibiting the activity of certain types of white blood cells);
• by inhibiting the bacterial enzyme that produces free fatty acids, which have an irritating effect. This reduces the number of inflammatory lesions on the skin.

Indications for use of Tetralysal:

• common acne of moderate and severe degree, with inflammatory lesions in the form of papules, pustules, nodules, cysts, and infiltrates;
• rosacea.

2. Important information before taking Tetralysal

When not to take 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 in the tetracycline group;
• if the patient is taking retinoids (used to treat skin diseases);
• in children under 8 years of age (due to the risk of permanent tooth discoloration and enamel hypoplasia);
• during pregnancy and breastfeeding.

Warnings and precautions

Before starting treatment with Tetralysal, you should discuss it with your doctor.

You should stop taking Tetralysal if you experience severe headaches.
Taking Tetralysal may cause irritation and esophageal ulceration; to avoid this, you should drink a large amount of fluids with this medicine.
In case of strong exposure to sunlight or other sources of ultraviolet radiation (UV),
the medicine may rarely cause skin reactions (phototoxic effect). Such an effect has been demonstrated after the use of high doses of the medicine (1200 mg/day) and concurrent strong exposure to UV radiation (sunbathing, solarium). However, during treatment, it is recommended to avoid sunlight and other sources of ultraviolet radiation (e.g., solarium).
If skin changes occur, especially redness or blisters, you should immediately consult a doctor, as this may be the beginning of rare, life-threatening severe skin complications.
If diarrhea occurs during treatment or a few weeks after the end of treatment, you should immediately consult a doctor. Diarrhea may be a symptom of pseudomembranous colitis caused by toxins of excessively multiplying bacteria Clostridium difficile.
The inflammation may be mild or severe. Mild cases usually resolve after discontinuation of the medicine.
In more severe cases, the doctor may recommend taking metronidazole or vancomycin.
You should not take medications that inhibit peristalsis or have a constipating effect.
If the patient has myasthenia (a disease characterized by muscle weakness), treatment with lymecycline may exacerbate the symptoms of this disease. You should exercise caution when taking Tetralysal in patients with myasthenia.
If the patient has systemic lupus erythematosus, they should consult a doctor before taking this medicine.
You should not take an expired medicine, as it may cause kidney damage.
The medicine should be used with special caution in patients with impaired kidney or liver function.
You should discuss this with your doctor, even if the above conditions have 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 enamel hypoplasia.

Tetralysal and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Studies on the interaction between lymecycline and other medicines have been conducted only in adults.
You should tell your doctor about the following medicines you are taking:

• blood thinners, e.g., warfarin
• HIV medications, e.g., didanosine
• other acne treatments
• other antibiotics, including penicillins
• oral retinoids and products containing vitamin A (over 10,000 IU/day): risk of increased intracranial pressure
• diuretics

You should inform your doctor if you are taking any medicines containing lithium, as this medicine may increase lithium levels in the blood.
You should not take the following medicines at the same time as Tetralysal, as they may affect the proper functioning of the medicine. You should wait at least 2 hours before or after taking Tetralysal before taking the following types of products:

• antacids
• iron-containing products
• antiepileptics, including barbiturates, e.g., phenobarbital, phenytoin, carbamazepine
• medicines that reduce stomach acid, e.g., cimetidine and ranitidine
• antacids (hydroxides and salts of magnesium, aluminum, 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. Tell your doctor if you have a planned procedure that requires anesthesia, as tetracyclines cannot be used with certain types of anesthetics.
Tetralysal may enhance the effect of oral anticoagulants (coumarin derivatives), cytostatics, oral antidiabetic agents, glucocorticosteroids.
It may interfere with the determination of catecholamines and glucose (reduction methods) in urine, giving falsely elevated results.

Tetralysal with food and drink

See section 3.

Pregnancy and breastfeeding

Tetralysal should not be usedin pregnant or breastfeeding women. The use of tetracycline-like medicines may affect the normal growth of developing teeth and cause permanent tooth discoloration.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine.

Driving and using machines

Tetralysal does not affect the ability to drive or use machines.

3. How to take Tetralysal

This medicine should always be taken according to the doctor's recommendations. If you have any doubts, you should consult a doctor or pharmacist.
Adults
The recommended dose is:

• for the treatment of common acne: 300 mg (one Tetralysal capsule) per day for 12 weeks;
• for the treatment of rosacea: initially 600 mg (one Tetralysal capsule twice a day) for 10 days, and then 300 mg (one Tetralysal capsule) once a day for a period of 3 to 6 months.

Capsules should be swallowed with a large amount of water, sitting upright, to avoid esophageal damage. Concurrent intake of meals, including milk, does not significantly affect the absorption of the medicine.
Capsules containing 150 mg of the active substance are also available.
The doctor will inform the patient how long they should take Tetralysal.

Use in children

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

Use of a higher than recommended dose of Tetralysal

Overdose of the medicine may damage the liver. If a higher dose of the medicine than recommended is taken, you should immediately consult a doctor.

Missed dose of Tetralysal

You should not take a double dose to make up for a missed dose.

Stopping treatment with Tetralysal

Do not stop treatment too early, as symptoms may return. You should always consult a doctor if you are considering stopping treatment with Tetralysal.
If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Tetralysal can cause side effects, although not everybody gets them.

The following side effects are listed according to their frequency of occurrence.

Frequent (occurring in 1 to 10 out of 100 patients)

• Nausea
• Abdominal pain
• Diarrhea
• Headache

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

• Changes in blood cell count
• Vision disturbances*
• Double vision
• Permanent vision loss
• Tongue inflammation
• Enteritis
• Vomiting
• Upper abdominal pain
• Small intestine and colon inflammation
• Pseudomembranous colitis
• Pancreatitis
• Fever
• Jaundice (yellowing of the skin or eyes)
• Hepatitis
• Changes in laboratory test results (blood tests, liver enzyme tests)
• Allergic reactions (itching of the skin of the face, also around the eyes and mouth)
• Itching of the skin, rash, or urticaria
• Sudden, severe allergic reactions of a generalized nature associated with malaise
• Blastomycosis, candidiasis (thrush)
• Vaginitis
• Increased intracranial pressure
• Dizziness
• Sensitivity to sunlight
• Toxic epidermal necrolysis
• Appearance of pimples or skin peeling over large areas, ulceration, or changes in the mouth, lips, genital, and anal areas (Stevens-Johnson syndrome)
• Depression
• Nightmares

*Clinical symptoms such as vision disturbances or headaches may be caused by increased intracranial pressure. If symptoms of increased intracranial pressure occur during treatment with lymecycline, you should stop taking the medicine. During treatment with tetracyclines, mild increased intracranial pressure has been reported, which may manifest as headache, vomiting, vision disturbances, including blurred vision, flashes (dark spots or flashes in the field of vision), diplopia (double vision), or permanent vision loss.
Additionally, the following side effects may occur during treatment with other medicines in the same group as Tetralysal (tetracyclines):

• tooth discoloration and enamel hypoplasia if the medicine is given to children under 8 years of age;
• changes in blood test results (decrease in red blood cell count, increase in certain white blood cell counts);
• hyperazotemia (excessive levels of nitrogen compounds in the blood), which may be intensified by concurrent use of diuretics.

Cases of systemic lupus erythematosus and pancreatitis associated with tetracycline treatment have been observed.
You should stop taking Tetralysal if symptoms of increased intracranial pressure occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Tetralysal

The medicine should be stored in a place that is 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 month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tetralysal contains

• The active substance of the medicine is lymecycline. One hard capsule contains 408 mg of lymecycline, which corresponds to 300 mg of tetracycline.
• The other ingredients of the medicine are: magnesium stearate, colloidal hydrated silica.
• Coating: gelatin, titanium dioxide (E 171), erythrosine (E 127), quinoline yellow (E 104), indigo carmine (E 132).

What Tetralysal looks like and what the pack contains

Tetralysal is available in the form of hard, red-yellow capsules.
The pack contains 16 or 28 capsules.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in France, the country of export: 367 597-4
34009 367 597 4 9
367 598-0
34009 367 598 0 0

Parallel import authorization number: 25/23 Date of approval of the leaflet: 22.02.2023

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