Tetralysal Side Effects

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Answer the side-effect intent for tetralysal without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Tetralysal?

Tetralysal contains the active ingredient lymecycline.

• Active ingredient — lymecycline
• Registration number — 57/20.1.1/0408
• Registration holder — Activo Health (Pty) Ltd

It is approved for:

• Upper and lower respiratory tract infections, such as bronchitis and sinusitis
• Urinary tract infections and sexually transmitted diseases
• Soft tissue infections, like acne
• Eye infections
• Infections of the stomach. LYMECYCLINE ACTIVO can also be used to treat other infections caused by suspectable bacteria

Common side effects of Tetralysal

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• swollen face, lips, tongue and throat
• difficulty in breathing
• hives
• blistering or peeling of large areas of skin
• ulcerations or lesions on the mouth, lips, genital or anal regions; or
• yellowing of the skin and eyes (jaundice), dark urine and tiredness which may be symptoms of liver problems
• These are all very serious side effects. If you have them, you may have had a serious reaction to or side effect from LYMECYCLINE ACTIVO. You may need urgent medical attention or hospitalisation. Benign intracranial hypertension has been reported in general with tetracycline therapy. Symptoms may include:
• headache
• vomiting
• visual disturbances (blurred vision, blind spots or double vision); or
• permanent visual loss. If you notice any of the above, stop taking LYMECYCLINE ACTIVO and tell your doctor immediately or go to the casualty department at your nearest hospital
• You may need urgent medical attention. The following side effects are frequently experienced with the use of LYMECYCLINE ACTIVO: Activo Health (Pty) Ltd efjdefbfaegcfe Lymecycline Activo
• nausea (feeling sick)
• abdominal pain
• diarrhoea
• headache. Other side effects with an unknown frequency associated with the use of LYMECYCLINE ACTIVO include:
• changes in the number or type of certain blood cells including red blood cells, white blood cells and/or platelets
• depression and nightmares
• disturbances of eyesight and dizziness
• pain in the upper abdomen, vomiting (being sick) and inflammation of the intestines
• inflammation of the tongue (which may present as swelling, redness or tenderness of the tongue)
• itching, skin rash or hives and increased sensitivity of the skin to sunlight
• nail discolouration, loosening of the nail from the fingers and/or toes
• fever
• changes in some blood tests (tests of liver function). The following side effects may occur during treatment with the tetracycline class of medicines to which LYMECYCLINE ACTIVO belongs (the tetracyclines):
• systemic lupus erythematosus (an allergic condition that causes joint pain, skin rashes or fever)
• inflammation or ulceration of the gullet, causing pain or difficulty swallowing or painful heartburn. Activo Health (Pty) Ltd efjdefbfaegcfe Lymecycline Activo
• difficulty in swallowing
• inflammation of the pancreas or liver, or liver damage
• teeth discolouration
• inflammation or soreness of the tongue, mouth, cheeks, gums or lips
• soreness or itching of the genital area or yeast infection around the anus or genitals
• inflammation and infection of the colon causing diarrhea

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are hypersensitive (allergic) to lymecycline, to other tetracycline antibiotics (such as doxycycline, minocycline, tetracycline, oxytetracycline) or any of the other ingredients of LYMECYCLINE ACTIVO (listed in section 6)
• if you have, or ever had, kidney disease or impaired kidney function
• if you have been diagnosed with systemic lupus erythematosus (an allergic condition that causes joint pain, skin rashes or fever). LYMECYCLINE ACTIVO may worsen this condition
• if you are taking a medicine that contains oral retinoids (for example, isotretinoin and vitamin A) which can also be used to treat acne. Activo Health (Pty) Ltd efjdefbfaegcfe Lymecycline Activo
• if you are pregnant, planning to have a baby or breastfeeding your baby. LYMECYCLINE ACTIVO should not be given to children under the age of 12 years. It is known to cause permanent teeth discolouration, thinning of the tooth enamel and affects bone development

Use with care, and tell your doctor, if

• if you have impaired liver function (liver disease), especially if you are over the age of 65 years
• if you have been diagnosed with myasthenia gravis (a disease that weakens the muscles), because LYMECYCLINE ACTIVO may worsen this condition. The prolonged use of LYMECYCLINE ACTIVO may result in opportunistic infections
• This is an infection that may occur when the immune system is weakened. This includes yeast infections, such as oral thrush and vaginal thrush, and bacterial infections that may cause diarrhoea. You should avoid direct exposure to sunlight and artificial light from sunbeds due to the risk of photosensitivity (skin discomfort experienced when exposed to direct sunlight or artificial sunlight from sunbeds). If you experience skin discomfort, stop taking LYMECYCLINE ACTIVO and contact your health care provider. Taking too much LYMECYCLINE ACTIVO (i.e., taking more than the recommended dose) may cause liver problems. Activo Health (Pty) Ltd efjdefbfaegcfe Lymecycline Activo Do not use expired LYMECYCLINE ACTIVO. This may cause a Fanconi-type syndrome, which is a serious kidney disease. The signs and symptoms of this condition are excessive thirst and urination, nausea and vomiting. The expiry date can be found on the blister packaging and the outer carton. You may develop vitamin deficiencies when using LYMECYCLINE ACTIVO for prolonged periods. Your doctor may advise you to use a vitamin supplement. Take LYMECYCLINE ACTIVO with adequate amounts of water to prevent lodging in the throat. This is to prevent pain, irritation and sores in the throat. Children LYMECYCLINE ACTIVO should not be used in children younger than 12 years because of the risk of permanent changes to children’s teeth and enamel discolouration

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine
• LYMECYCLINE ACTIVO must not be taken if you are pregnant or breastfeeding, because lymecycline affects the developing bones and teeth of your baby
• LYMECYCLINE ACTIVO may cause liver damage in pregnant women
• Activo Health (Pty) Ltd efjdefbfaegcfe Lymecycline Activo Driving or using machines It is not always possible to predict to what extent LYMECYCLINE ACTIVO may interfere with your daily activities
• Do not engage in any activities like driving or using machines until you are aware of the extent to which LYMECYCLINE ACTIVO affects you
• LYMECYCLINE ACTIVO may affect your vision so that you are not able to see as well as before, or it may cause dizziness

Interactions and medicines to check

The approved leaflet names these interactions.

• Antacids (indigestion) remedies that contain aluminium, calcium, magnesium or sodium bicarbonate. Activo Health (Pty) Ltd efjdefbfaegcfe Lymecycline Activo
• Preparations that contain bismuth, cholestyramine or sucralfate
• Quinapril (used to treat high blood pressure)
• Supplements containing aluminium, calcium, iron, magnesium or zinc
• Medicines used for the treatment of epilepsy or seizures (carbamazepine and phenytoin). Wait at least 2 (two) hours before or after taking LYMECYCLINE ACTIVO before you take any of the products listed above. Tell your doctor if you are taking any of the following medicines:
• Oral retinoids (used in the treatment of acne), for example, isotretinoin and vitamin A, which may be included in supplements: a serious side-effect may occur when used with LYMECYCLINE ACTIVO and these medicines should not be used at the same time
• Anticoagulants: LYMECYCLINE ACTIVO may increase the effects of anticoagulants (also called blood thinners) for example, warfarin. Your doctor may need to reduce the dose of anticoagulant
• Diuretics (used to treat kidney disease, heart disease or high blood pressure). This combination should be avoided
• Penicillin: The combination of LYMECYCLINE ACTIVO with medicines that contain the antibiotic penicillin should be avoided
• Oral contraceptives: LYMECYCLINE ACTIVO may decrease the effectiveness of oral contraceptives (also known as ”the pill”) which is used to prevent pregnancy. If you are using an oral contraceptive and have been prescribed Activo Health (Pty) Ltd efjdefbfaegcfe Lymecycline Activo LYMECYCLINE ACTIVO, speak to your health care provider about alternative contraceptive methods
• Methoxyflurane (used in pain management): The combination of LYMECYCLINE ACTIVO with methoxyflurane may cause kidney damage
• Lithium (used for the treatment of depression and bipolar disorder): if used simultaneously, LYMECYCLINE ACTIVO may increase lithium levels. Taking LYMECYCLINE ACTIVO with food and drink LYMECYCLINE ACTIVO should be taken one hour before or two hours after a meal. The absorption of LYMECYCLINE ACTIVO may be affected by milk. Avoid taking milk two hours before or after taking LYMECYCLINE ACTIVO. LYMECYCLINE ACTIVO should be taken with sufficient water to prevent lodging in the throat
• This is to prevent pain, irritation and sores in the throat

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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