Tertroxin Tablets

TERTROXIN 20 μg belongs to a group of medicines called thyroid preparations. TERTROXIN 20 μg is a form of thyroxine which is quick acting and long lasting. Thyroxine is a hormone produced by the thyroid gland in the neck which controls many body functions. TERTROXIN 20 μg is used in the treatment of:

• Coma due to myxoedema (severe hypothyroidism where you produce very low levels of thyroid hormones),
• Management of severe chronic thyroid deficiency,
• Hypothyroid states arising in treatment of thyrotoxicosis (an overactive thyroid gland that produces too much thyroid hormones),
• In thyrotoxicosis as additional treatment to carbimazole.

Do not take TERTROXIN 20 μg:

• If you are hypersensitive (allergic) to liothyronine sodium or any of the other ingredients of TERTROXIN 20 μg (listed in section 6).
• If you have angina (severe pain in the chest) or any heart and blood vessel disorder.
• If you have untreated hyperthyroidism (overactive thyroid).
• If you suffer from a condition called Addison's disease (condition where your adrenal gland does not produce enough steroid hormones).

Warnings and precautions

Take special care with TERTROXIN 20 μg:

• If you have diabetes and are using antidiabetic medicines.
• If you have a condition where your adrenal glands do not produce enough of the hormone called cortisol (adrenocortical insufficiency).
• If you suffer from a condition called myxoedema (swelling of the skin and underlying tissues giving a waxy consistency, typical of patients with underactive thyroid glands).
• If you suffer from prolonged hypothyroidism (a condition in which the thyroid gland doesn't produce enough thyroid hormone).
• If you are using medication that prevents blood clotting.
• If you suffer from chest pain, fast heartbeat or excessive sweating.
• If you are an elderly person.

TERTROXIN 20 μg should not be used in the management of obesity as this may produce serious or life-threatening adverse effects.

Children and adolescents

A condition called craniosynostosis, where the sutures of the skull close too early causing problems with normal brain and skull growth, may occur in infants given high doses of thyroid hormones. Partial hair loss can also occur in children in the first few months of thyroid therapy, but their hair may grow back.

Other medicines and TERTROXIN 20 μg

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor if you are taking any of the following:

• Medicines used to thin your blood and to prevent blood clots e.g. aspirin.
• Anticonvulsants (e.g. carbamazepine, primidone or phenytoin) used to prevent convulsions (fits).
• Medicines used during anaesthesia such as ketamine.
• Oral contraceptives or other estrogen containing products.
• Medicines called digoxin used to treat heart conditions such as heart failure or amiodarone, used to treat irregular heartbeats.
• Colestyramine which reduces the level of cholesterol (fats) in the blood.
• Tricyclic antidepressants (e.g. amitriptyline or imipramine) used to treat depression.
• Insulin and other treatments for diabetes.

Do not share medicines prescribed for you with any other person. Always take TERTROXIN 20 μg exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will prescribe an individualised dose for your specific condition. Your doctor will tell you how long your treatment with TERTROXIN 20 μg will last. If you have the impression that the effect of TERTROXIN 20 μg is too strong or too weak, tell your doctor or pharmacist.

If you take more TERTROXIN 20 μg than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. The following signs and symptoms indicate over dosage, and usually disappear when the dose is reduced, or treatment is withdrawn for a day or two; chest pain, irregular or abnormal heartbeat (cardiac dysrhythmias), feeling like your heart is racing (palpitation), and cramps in skeletal muscle; also, fast heartbeat (tachycardia), diarrhoea, restlessness, irritability, nervousness, excitability, headache, reddening of the skin (flushing), sweating, excessive loss of weight and muscular weakness. Congestive heart failure (when the heart muscle doesn't pump blood as well as it should) may be induced or aggravated.

If you forget to take TERTROXIN 20 μg

Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of TERTROXIN 20 μg, take the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take several doses, contact your doctor without delay.

TERTROXIN 20 μg can have side effects. Not all side effects reported for TERTROXIN 20 μg are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TERTROXIN 20 μg, please consult your healthcare provider for advice. If any of the following happens, stop taking TERTROXIN 20 μg and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing as you could be suffering from a condition called myxoedema,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to TERTROXIN 20 μg. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Irregular heartbeat, abnormal heart beats, increased rate of heartbeat,
• Squeezing, pressure, heaviness, tightness or pain in the chest (anginal pain).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• Cramps in the skeletal muscle, muscle weakness,
• excessive loss of weight,
• the inability to rest or relax or excitability,
• headache,
• reddening of the face and/or neck (flushing),
• frequent/loose watery stools (diarrhoea),
• sweating.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to:

SAHPRA: via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088 /+27(0)11 239 - 6200

By reporting side effects, you can help provide more information on the safety of TERTROXIN 20 μg.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light. Keep in original packaging until required for use.

• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).