Synthroid Tablets

SYNTHROID is used when the thyroid gland does not produce enough hormone (hypothyroidism). It is also used to help decrease the size of enlarged thyroid gland (known as goiter) and as additional treatment of some thyroid cancers.

WARNING: Thyroid hormones, including SYNTHROID, either alone or with other medicines, should not be used for the treatment of obesity or for weight loss as they could produce serious or even life threatening side effects.

Do not take SYNTHROID:

• If you are hypersensitive (allergic) to levothyroxine sodium or any of the other ingredients of SYNTHROID (listed in section 6);
• If you have an overactive thyroid gland (thyrotoxicosis) of any cause;
• If you have uncorrected adrenal gland under-activity.

Warnings and precautions

Take special care with SYNTHROID:

• If you have any heart problems, whether or not you have received treatment for them (especially history of heart attack, heart disease, hardening of the arteries);
• You are elderly;
• You have other medical problems, whether or not you have received treatment for them (especially high blood pressure, osteoporosis, blood clotting disorder, or history of thyroid, adrenal and/or pituitary gland problems);
• You have diabetes, your dose of insulin or oral antidiabetic medicine may need to be changed after starting SYNTHROID. You should monitor your blood and urinary sugar levels as directed by your doctor and report any changes to your doctor immediately;
• You are taking an oral anticoagulant (blood thinner) such as warfarin, your dose may need to be changed after starting SYNTHROID;
• You are taking any other medication (prescription or over-the-counter);
• You are planning to have any kind of surgery (including dental surgery) or emergency treatment. You should inform your doctor or dentist that you are taking SYNTHROID before having any kind of surgery;
• You are a woman on long-term therapy. You may experience decrease in bone density.

Other medicines and SYNTHROID

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Medicines that may interact with SYNTHROID include but are not limited to the following:

Do not share medicines prescribed for you with any other person. Always take SYNTHROID exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are not sure. If you have the impression that the effect of SYNTHROID is too strong or too weak, tell your doctor or pharmacist. Thyroid hormone replacement is usually taken for life. Do not change the amount you take or how often you take it, unless directed to do so by your doctor.

Take SYNTHROID as a single dose, preferably on an empty stomach, one half- to one hour before breakfast. SYNTHROID should be taken with a full glass of water. As food and drink can significantly change the absorption of SYNTHROID, you are advised to take SYNTHROID at the same time every day and be consistent on how you take it with regards to meals [i.e. either always take it on an empty stomach (preferred method) or always take it with food]. The dose of this medicine will be different for different patients. Treatment is usually started with lower doses that are increased a little at a time to prevent side effects.

SYNTHROID can have side effects. Not all side effects are reported for this medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or health care provider for advice.

If any of the following happens, stop taking SYNTHROID and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to SYNTHROID. You may need urgent medical attention or hospitalisation.

Side effects with SYNTHROID are usually related to overdosing. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Chest pain
• Fast or irregular heartbeat

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

• Weight loss or gain
• Sweating
• Nervousness
• Temporary hair loss
• Decrease of bone mineral density
• Diarrhoea
• Vomiting

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 or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of SYNTHROID.

• Store at or below 25 °C.

• Protect from light and moisture.

• Keep well closed.

• KEEP ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN.

• Do not store in the bathroom.

• Do not use after the expiry date stated on the label.

• Keep in the original container.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drain or sewerage systems (e.g. toilets).