Tetralisal

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Tetralysal, 300 mg, Hard Capsules

Lymecyclinum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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, pharmacist, or nurse. 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 irritate the skin. This reduces the number of inflammatory lesions on the skin.

Indications for the use of Tetralysal:

• common acne of moderate and severe intensity, 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 tetracycline antibiotics;
• 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, discuss it with your doctor.

Stop taking Tetralysal if you experience severe headaches.
Taking Tetralysal may cause irritation and esophageal ulceration; to avoid this, drink plenty of fluids with the 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 shown after taking 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, seek medical attention immediately, as this may be the beginning of rare, life-threatening severe skin complications.
If diarrhea occurs during or after treatment with the medicine, seek medical attention immediately. Diarrhea may be a sign of pseudomembranous colitis caused by toxins of excessively multiplying bacteria Clostridium difficilein the intestines.
Colitis can 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 medications that slow down bowel movements or have a constipating effect.
If the patient has myasthenia gravis (a disease characterized by muscle weakness), lymecycline treatment may exacerbate the symptoms of this disease. Caution should be exercised when using Tetralysal in patients with myasthenia gravis.
If the patient has systemic lupus erythematosus, they should consult their doctor before taking this medicine.
Do not take expired medicine, as it may cause kidney damage.
The medicine should be used with special caution in patients with impaired kidney or liver function.
Consult your doctor, even if the above conditions have occurred in the past.

Children and adolescents

Do not give Tetralysal to children under 8 years of age, due to the risk of permanent tooth discoloration and enamel hypoplasia.

Tetralysal and other medicines

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.
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.

Inform your doctor if you are taking any medicines containing lithium, as this medicine may increase lithium levels in the blood.
Do not take the following medicines at the same time as Tetralysal, as they may affect the proper functioning of the medicine. 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.

Using 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 drugs, 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 must not be takenby women during pregnancy or breastfeeding. 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 their doctor before taking this medicine.

Driving and using machines

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

Tetralysal contains quinoline yellow (E 104)

The medicine may cause allergic reactions.

3. How to take Tetralysal

This medicine should always be taken as directed by your doctor. If you are unsure, consult your 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, then 300 mg (one Tetralysal capsule) once a day for a period of 3 to 6 months.

Swallow the capsules with a large amount of water, sitting upright, to avoid esophageal damage. 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 to take Tetralysal.

Use in children

Tetralysal must not be taken by children under 8 years of age.

Taking more than the recommended dose of Tetralysal

Overdose of the medicine may damage the liver. If you have taken more than the recommended dose, seek medical attention immediately.

Missing a dose of Tetralysal

Do 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. Always consult your doctor if you are considering stopping treatment with Tetralysal.
If you have any further doubts about taking this medicine, consult your 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 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
• Vision disturbances*
• Double vision
• Permanent vision loss
• Glossitis
• 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
• Formation of pimples or peeling of the skin 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 lymecycline treatment, discontinue the medicine. During tetracycline treatment, 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 types of white blood cells);
• hyperazotemia (excessive levels of nitrogen compounds in the blood), which may be intensified by concurrent use of diuretics.

Systemic lupus erythematosus and pancreatitis have been observed in patients treated with tetracyclines.
Discontinue Tetralysal if symptoms of increased intracranial pressure occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Tetralysal

Keep the 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 month.
No special precautions for storage are necessary.
Medicines should not be disposed of via wastewater or household waste. 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, equivalent to 300 mg of tetracycline.
• The other ingredients of the medicine are: magnesium stearate, colloidal hydrated silica.
• The 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 in the form of red-yellow hard capsules.
The pack contains 16 or 28 capsules.
For more detailed information, consult the marketing authorization holder or 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
French marketing authorization number: 34009 367 598 0 0

Parallel import authorization number: 262/22 Date of leaflet approval: 29.06.2022

[Information about the trademark]