Tetralysal

Package leaflet: Information for the patient

Warning! Keep this leaflet. The packaging information in a foreign language.
Tetralysal, 300 mg, hard capsules
Lymecycline
Please read this leaflet carefully before taking 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. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, 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 the microorganism 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 have an irritating effect. 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 of 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 changes in teeth and discoloration of enamel);
• during pregnancy and breastfeeding.

Warning and precautions
Before starting to take 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, you should take plenty of fluids with this medicine.
Rarely, exposure to sunlight or other sources of ultraviolet (UV) radiation may cause skin reactions (phototoxic effects) while taking this medicine. This effect has been observed after administration of high doses of the medicine (1200 mg/day) and simultaneous intense exposure to UV radiation (sunbathing, sunbeds). During treatment, it is advisable to avoid sunlight and other sources of ultraviolet radiation (e.g. sunbeds).
If skin changes occur, especially redness or blisters, you should contact your doctor immediately, as this may be the beginning of rare but serious, life-threatening skin complications.
If diarrhoea occurs during treatment or several weeks after stopping treatment, you should contact your doctor immediately. Diarrhoea may be a symptom of pseudomembranous colitis caused by toxins produced by excessive growth of the bacterium Clostridium difficile in the intestine.
The inflammation may be mild or severe. Mild cases usually resolve after discontinuation of the medicine.
In more severe cases, your doctor may prescribe metronidazole or vancomycin.
Do not take drugs that inhibit peristalsis or other constipating agents.
If the patient suffers from myasthenia gravis (a disease characterized by muscle weakness), symptoms of this condition may worsen during treatment with lymecycline. Caution should be exercised when using Tetralysal 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 this may cause kidney damage.
This medicine should be used with particular caution in patients with impaired kidney or liver function.
You should talk to your doctor, even if 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 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 exclusively in adults.
Tell your doctor if you are taking any of the following medicines:

• anticoagulants, 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,
• diuretics (medicines that increase urine production).

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 any of the following products:

• antacids,
• products containing iron,
• antiepileptic medicines, 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. Tell 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), cytostatics, oral antidiabetic drugs, and glucocorticosteroids.
It may interfere with the determination of catecholamines and glucose (by reduction methods) in urine, giving falsely elevated results.
Tetralysal with food and drink
See section 3.
Pregnancy and breastfeeding
Tetralysal must not be used during pregnancy and while breastfeeding. The use of medicines such as tetracyclines may affect the normal development of growing teeth and cause permanent tooth discoloration.
If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
Driving and operating machinery
Tetralysal has no influence on the ability to drive or operate machinery.
Tetralysal contains quinoline yellow (E 104)
This medicine may cause allergic reactions.

3. How to use Tetralysal

This medicine should always be used as directed by the physician. In case of 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 a large amount of water while sitting in an upright position to avoid
esophageal injury. 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 continue taking Tetralysal.
Use in children
Tetralysal should not be used in children under 8 years of age.
Taking more Tetralysal than recommended
Overdose of this medicine 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 treatment
Do not discontinue treatment prematurely, 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 any medicine, Tetralysal may cause adverse reactions, although not everyone experiences them.
The adverse reactions listed below are categorized according to 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
• Intestinal inflammation
• 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)
• Itching, rash, or urticaria
• Sudden, severe generalized allergic reactions associated with malaise
• Blastomycosis, candidiasis (yeast infection)
• Vaginitis
• Increased intracranial pressure
• Dizziness
• Photosensitivity (increased sensitivity to sunlight)
• 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 headaches 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. With tetracyclines, mild intracranial hypertension has been reported, which may manifest 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 (elevated levels of nitrogen-containing compounds in the blood), which may be exacerbated 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 those 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, Office for Registration 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 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Tetralysal contains

• The active substance is lymecycline. One hard capsule contains 408 mg of lymecycline, equivalent to 300 mg of tetracycline.
• Other components of the medicine are: magnesium stearate, colloidal hydrated silica.
• Gelatin 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 red-yellow hard capsules.
Pack sizes: 16 or 28 capsules.
For further information, contact the responsible party or 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in France, the country of export: 34009 367 598 0 0
Parallel Import Licence Number: 262/22