Tetralysal

• Antibiotic
• Used to treat bacterial infections
• Capsules for oral use
• Finish the course completely
• Not to be used while pregnant or breastfeeding

Tetralysal (active substance: lymecycline) belongs to a group of medicines called tetracycline antibiotics. This medicine kills certain bacteria and is used to treat bacterial infections such as:

• Severe cases of acne and rosacea.
• Respiratory tract infections.
• Urinary tract infection.
• Genital infection.
• Bile duct infection.
• Eye infection.

Tetracycline capsules should be taken with a full glass of water while standing or sitting upright. This will prevent irritation in your mouth and throat. Take the capsule before a meal. It is important that you finish the course.

This medicine makes the skin more sensitive to UV radiation. You should avoid direct exposure to sunlight or artificial sunlight from sunbeds. If skin irritation occurs, stop the treatment immediately and call your doctor.

Dosage

Dosage varies per person and is determined by a doctor for each specific patient depending on the symptoms. The general dosage guidelines are as follows:

Adults and adolescents aged 12 and above:

• For acne: 300 mg a day. The usual treatment period is 12 weeks. The dose may be decreased to one 300mg capsule taken every other day.
• For other indications: 300 mg in the morning and evening.

A course normally lasts at least eight days, sometimes a number of weeks. Your doctor will tell you how long you need to use this medicine.

Tetralysal should not be used in children under the age of 12.

Alcohol/driving

This medicine does not interact with alcohol or impair your ability to drive safely.

If you use too much/forget to use/stop using Tetralysal

If you take more Tetralysal capsules than you were told to, consult your doctor or pharmacist.

If you forget to take a dose of Tetralysal, skip the missed dose. Do not take a double dose to make up for the forgotten one.

Do not stop using Tetralysal without talking to your doctor. Stopping early could cause the infection to return.

Tetralysal is not suitable for everyone. Do not use this medicine if:

• You are allergic to lymecycline or any other ingredient in this medicine (see section ‘What Tetralysal contains’);
• You are allergic to other tetracycline antibiotics.
• You have hepatic impairment or renal insufficiency (failure of liver and kidney function).
• Tetralysal must not be given to children under eight years of age because of the risk of permanent alterations of tooth and enamel discolouration.
• You are pregnant or breastfeeding.
• You are currently being treated with oral retinoids (a form of Vitamin A acid). See also section ‘What Tetralysal contains’.

When should this medicine be used with caution?

In some cases you should talk to your doctor or pharmacist before or while taking this medicine. For example, if:

• You experience new infections during your treatment with Tetralysal.
• You suffer from myasthenia gravis (a disease that weakens the muscles).
• You suffer from systemic lupus erythematosus (a chronic autoimmune connective tissue disorder).
• You start experiencing persistent headaches of varying intensity with nausea and possibly other symptoms, such as visual disturbances (blurred vision, blind spots or double vision). This could be attributed to increased pressure in the brain (intracranial hypertension). You should stop taking Tetralysal if there is any evidence of pressure increase in the brain.

For more warnings, please see the package leaflet.

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant or breastfeeding.

Other medicines and Tetralysal

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

The following additional warnings apply when using Tetralysal in combination with other medicines:

• Tell your doctor if you are taking other products that could be harmful to the liver or kidneys.
• If you are taking medicines to thin your blood the dose of anticoagulant medicine may need to be adjusted.
• Tell your doctor if you will undergo an operation, treatment or test under local or general anaesthesia in the near future. Tetralysal should not be used with methoxyflurane.
• Tetralysal may interfere with laboratory urine tests.
• Concomitant use of diuretics could lead to an increased level of certain decomposition products in the blood.
• Do not take the following medicines at the same time as your Tetralysal as these could affect how well your medicine works: indigestion remedies, supplements containing calcium, aluminium, magnesium, zinc or iron, products containing active charcoal, bismuth or chelates, H2 antihistamines, antiseizure medicines (for epilepsy) such as phenytoin, barbiturates and carbamazepine.
• Avoid use with penicillin (and other types of antibiotics) for the possible interference between the two products.
• Tetralysal should not be used in combination with oral retinoids or doses of more than 10,000 IU/day of Vitamin A (taken by mouth or injected) as this increases the risk of intracranial hypertension (see also section 'When not to use Tetralysal’).
• You should tell your doctor if you are taking any treatment with lithium.

For more information on warnings, see the package leaflet. If you have any questions or are unsure, consult your doctor before taking this medicine.

Like all medicines, this medicine can cause side effects, although some people may not experience any. Side effects that are known to be associated with Tetralysal include:

Common (may affect up to 1 in 10 people):

• Headache.
• Gastrointestinal symptoms (nausea, diarrhoea, stomach ache).

Other side effects that may occur (frequency unknown):

• Neutropenia (reduced numbers of neutrophils, a type of white blood cells), thrombocytopaenia (reduced numbers of blood palates), blood values which deviate from normal which may or may not be caused by concomitant use of diuretics.
• Hypersensitivity, hives (urticaria), allergic reactions, anaphylactic reaction.
• Dizziness, increased pressure in the brain, visual disturbances.
• Inflammation or soreness of the tongue, inflammation of the small intestine and colon, vomiting, upper abdominal pain.
• Hepatitis, jaundice.
• Skin reactions such as redness, rash, increased sensitivity of the skin to sunlight, itching, blistering or scaling of large parts of the skin (StevensJohnson syndrome).
• Depression.
• Nightmares.
• Fever.
• High transaminase levels (this may be a sign of liver damage), high alkaline phosphatase (ALP) levels (this may be a sign of a liver problem or a bone disorder), high bilirubin levels (stored in the gallbladder).

See the package leaflet for a complete list of side effects. Consult your doctor or pharmacist if you experience these or other side effects.

The active substance is lymecycline. Each capsule contains 300 mg lymecycline.

Read the package leaflet before use. The official package leaflet of Tetralysal is available for download here.