Doxytet Side Effects

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

What is Doxytet?

Doxytet contains the active ingredient Doxycycline.

• Active ingredient — Doxycycline
• Registration number — 31/20.1.1/0425; 31/20.1.2/0425
• Registration holder — Biotech Laboratories (Pty) Ltd

It is approved for:

• DOXYCYCLINE BIOTECH 100 is a broad-spectrum tetracycline antibiotic and may be used to treat a wide range of infections caused by bacteria: − Respiratory tract infections such as sinusitis, inflammation of the pharynx, lung infection caused by Mycoplasma, parrot fever and chronic bronchitis
• S4 − Urinary tract infections
• − Sexually transmitted diseases
• − Infections of the eye

Common side effects of Doxytet

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.

Frequent side effects

• headache
• feeling or being sick
• eat disorder
• reddish-purple spots on the lower extremities, swollen and sore joints, abdominal pain or bloody urine
• hives
• swelling of the legs and arms

Less frequent side effects

• vaginal infection, vaginitis
• thrush of the vagina or mouth
• blood disorders, these are due to changes in numbers of different cell types in the blood. Symptoms may include tiredness, easy bruising or infections
• discolouration of thyroid tissue (does not affect thyroid function)
• inherited blood disorder (porphyria) and urine discolouration is a symptom
• eating disorder (loss of appetite)
• increased pressure in the skull (severe headaches, blurred and/or double vision, blind spots), permanent loss of vision
• bulging fontanelles (soft spot on head) of infants
• anxiety
• tinnitus (ringing noise in ear)
• skin reddening (flushing)
• heartburn
• pancreatitis (manifested by severe upper abdominal pain)
• difficulty swallowing, stomach pain, diarrhoea
• inflammation and/or ulcers of the gullet (symptoms may include sore mouth, indigestion)
• oral thrush (redness and soreness)
• inflammation of the tongue
• soreness and itching of the rectal and/or genital area
• inflammation around the vagina
• inflammation and damage to the liver
• abnormal liver function tests
• redness and peeling of the skin (dermatitis exfoliative)
• detachment of the nail from finger bed
• aches in the joints or muscles
• increased urea in the blood

Frequency unknown side effects

• vitamin deficiencies may occur
• discolouration of teeth. The use of expired DOXYCYCLINE BIOTECH 100 may lead to a Fanconi-type syndrome which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glycosuria, acidosis, aminoaciduria, hypophosphatemia and hypocalcaemia

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 doxycycline hyclate, other tetracyclines or any of the other ingredients of DOXYCYCLINE BIOTECH 100 (listed in section 6)
• if you have some form of kidney (renal) disease
• if you are pregnant or breastfeeding your baby
• if you are pregnant, you are more susceptible to severe doxycycline-induced liver damage
• if you are younger than 12 years of age as permanent discoloration of teeth may occur
• if you have an inflammatory disease of connective tissue (systemic lupus erythematosus)

Use with care, and tell your doctor, if

• if you are likely to be exposed to direct sunlight or ultraviolet light, or if you are already sunburned
• if you have any liver disease or are taking medicine which affect your liver
• if you have severe kidney problems
• if you experience severe skin reactions such as erythema multiforme (circular, irregular red patches), Stevens-Johnson syndrome (rash with flushing, fever, blisters or ulcers), toxic epidermal necrolysis (reddening, peeling and swelling that resembles burns)
• if you have diarrhoea or usually get diarrhoea when you take antibiotics or have suffered from problems with your stomach or intestines. If you develop severe or prolonged or bloody diarrhoea during or after using DOXYCYCLINE BIOTECH 100 tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics
• if you suffer from porphyria (a deficiency of specific enzymes within the body causing an increase of substances called porphyrins)
• are taking oral retinoids as there is a higher risk of suffering from increased pressure in your skull (severe headache with change in vision) when taken with DOXYCYCLINE BIOTECH 100
• if you are frail or elderly
• if you have a vaginal infection or blood infection caused by fungus
• if you have a stomach ulcer or vomits the contents of the stomach with dark blood, oesophagitis (inflammation of the oesophagus or gullet)
• if you have some form of sexual transmitted disease (e.g., syphilis)
• if you suffer from myasthenia gravis, a condition characterised by muscle weakness, difficulty chewing and swallowing and slurred speech
• if you suffer from systemic lupus erythematous (an inflammatory disease of connective tissue), see “Do not take DOXYCYCLINE BIOTECH 100”
• if you experience shaking chills, a rise in temperature, and intensification of skin rashes known as the Jarisch–Herxheimer reaction (JHR) within 24 hours after antibiotic treatment of the spirochetal infections such as syphilis, Lyme disease, leptospirosis, and relapsing fever (RF), these symptoms are consequence of antibiotic treatment of spirochete infections and usually self-limiting. Children DOXYCYCLINE BIOTECH 100 should not be used in children under 12 years of age

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 healthcare provider for advice before taking this medicine
• Do not take DOXYCYCLINE BIOTECH 100 if you are pregnant or breastfeeding your baby

Interactions and medicines to check

The approved leaflet names these interactions.

• medicines such as antacids containing aluminium, calcium or magnesium or other medicines containing iron, bismuth or zinc salts. Do not take at the same time as DOXYCYCLINE BIOTECH 100 as absorption of DOXYCYCLINE BIOTECH 100 may be reduced
• warfarin or other anticoagulants (to stop blood clotting)
• medicines to treat epilepsy such as phenobarbital, carbamazepine, primidone and phenytoin may interact with the metabolism of DOXYCYCLINE BIOTECH 100
• penicillin should not be used with DOXYCYCLINE BIOTECH 100 as it may block the action of DOXYCYCLINE BIOTECH 100
• DOXYCYCLINE BIOTECH 100 may diminish the effectiveness of the pill (oral contraceptives)
• methoxyflurane (an anaesthetic), if you need an operation, tell your doctor or dentist that you are taking DOXYCYCLINE BIOTECH 100
• alcohol may decrease the amount of time it takes for DOXYCYCLINE BIOTECH 100 to lose half of its strength in blood plasma
• ciclosporin (used following organ transplants) should be monitored appropriately
• rifampicin (tuberculosis treatment) may interact with DOXYCYCLINE BIOTECH 100. This may result in a sub-therapeutic effect of DOXYCYCLINE BIOTECH 100 (the dosage administered at too low a level to treat the disease)
• isotretinoin or other systemic retinoids (used to treat severe acne). DOXYCYCLINE BIOTECH 100 with food, drink and alcohol You should not drink alcohol whilst taking DOXYCYCLINE BIOTECH 100, alcohol may reduce the effect of your medicine. Swallow the tablets whole with a full glass of water. You should take the tablets either sitting down or standing up and well before you go to bed for the night. It is important not to lie down for at least thirty minutes after taking DOXYCYCLINE BIOTECH 100

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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