Tetralisal

Package Leaflet: Information for the Patient

Tetralysal, 150 mg, Hard Capsules

Lymecycline

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 acts:

• 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 you are allergic (hypersensitive) to lymecycline or any of the other ingredients of the medicine (listed in section 6);
• if you are allergic to other tetracycline antibiotics;
• if you are 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.

You should stop taking Tetralysal if you experience severe headaches.
Taking Tetralysal may cause irritation and esophageal ulceration; to avoid this, you should drink plenty of fluids with this medicine.
In case of intense exposure to sunlight or other sources of ultraviolet radiation (UV),
Tetralysal may very 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 intense exposure to UV radiation (sunbathing, solarium). However, during treatment, it is recommended to avoid sun exposure 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 a rare, life-threatening severe skin complication.
If you experience diarrhea during or after treatment with Tetralysal, you should immediately consult a doctor. Diarrhea can be a symptom of pseudomembranous colitis caused by the toxins of overgrown 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 recommend taking metronidazole or vancomycin.
You should not take medications that inhibit peristalsis or have a constipating effect.
If you have myasthenia gravis (a disease characterized by muscle weakness), lymecycline treatment may exacerbate the symptoms of this disease. You should exercise caution when taking Tetralysal if you have myasthenia gravis.
If you have systemic lupus erythematosus, you should consult your doctor before taking this medicine.
You should not take expired medicine, as it may cause kidney damage.
The medicine should be used with special caution in patients with impaired renal or hepatic function.
You should discuss this with your doctor, even if these 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

Tell your doctor about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Studies on the interaction of lymecycline with other medicines have been conducted only in adults.
Tell your doctor about the following medicines you are taking:

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

Tell 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 with 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 medicines, 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

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

Tetralysal contains 52 mg of lactose in 1 capsule

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

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 (two Tetralysal capsules) per day for 12 weeks;
• for the treatment of rosacea:initially 600 mg (two Tetralysal capsules twice a day) for 10 days, then 300 mg (two Tetralysal capsules) 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 300 mg of the active substance are also available.
Your doctor will inform you how long to take Tetralysal.

Use in children

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

Overdose of Tetralysal

Overdose of the medicine may damage the liver. If you have taken more than the recommended dose, consult your doctor immediately.

Missed 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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Below are the side effects listed by frequency of occurrence.

Frequent (occurring in 1 to 10 in 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
• Glossitis
• Colitis
• 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 peeling of the skin on large areas, ulceration, or changes in the area around the mouth, genitals, and anus (Stevens-Johnson syndrome)
• Depression
• Nightmares

*Clinical symptoms such as vision disturbances or headaches may be caused by increased intracranial pressure. If you experience symptoms of increased intracranial pressure during lymecycline treatment, you should stop taking 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 (elevated levels of nitrogen compounds in the blood), which may be intensified by concurrent use of diuretics.

There have been reports of systemic lupus erythematosus and pancreatitis associated with tetracycline treatment.
You should stop taking Tetralysal if you experience symptoms of increased intracranial pressure.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw, Poland
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tetralysal

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
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 pack and other information

What Tetralysal contains

• The active substance of the medicine is lymecycline. One hard capsule contains 204 mg of lymecycline, equivalent to 150 mg of tetracycline.
• The other ingredients of the medicine are: magnesium stearate, precipitated hydrated silica, corn starch, lactose.
• Hard capsule shell: gelatin, titanium dioxide (E 171), erythrosine (E 127), quinoline yellow (E 104).

What Tetralysal looks like and contents of the pack

Tetralysal is available in the form of yellow-orange hard capsules.
The pack contains 16 capsules.

Marketing authorization holder

Galderma Poland Sp. z o.o.
Puławska Street 145
02-715 Warsaw, Poland
phone: 22 331 21 80

Manufacturer

Laboratoires Sophartex S.A.
21, rue de Pressoir, 28500 Vernouillet
France
Date of last revision of the leaflet:07/2021