Elements for a Public Summary

Transcription

1 VI.2 Elements for a Public Summary <Product Name> 25 microgram tablets <Product Name> 50 microgram tablets <Product Name> 75 microgram tablets <Product Name> 100 microgram tablets <Product Name> 125 microgram tablets <Product Name> 150 microgram tablets <Product Name> 175 microgram tablets <Product Name> 200 microgram tablets VI.2.1 Overview of disease epidemiology Hypothyroidism is a disorder in which thyroid gland, a small gland in the neck, is underactive and does therefore not produce enough thyroid hormones. These hormones are called triiodothyronine (T3) and thyroxine (T4). Main symptomps include tiredness, weight gain, depression, dry skin and hair and being sensitive to the cold. A blood test needs to be performed for hypothyroidism to be diagnosed. Prevalence of hypothyroidism worldwide is estimated to be between 2 and 4 in 1000 people. Hypothyroidism is more common in women, although men can be affected as well. Typical treatment involves daily hormonereplacement tablets, called levothyroxine (such as <Product Name>), to increase the thyroxine levels. Most patients require treatment for the rest of their life but this varies greatly. Levothyroxine (such as <Product Name>) may also be used when over-treatment of high thyorid hormone levels (hyperthyroidism) leads to too low levels of thyroid hormones (a pardoxical reaction). Thyroid suppression testing is used to investigate the levels of the thyroid hormones. Triiodothyronine (T3) and thyroxine (T4), as well as thyroid-stimulating hormone (TSH) levels, are tested. Levothyroxine (such as <Product Name>) may be used to determine TSH levels. Patients will receive a dose of levothyroxine and their change in T4 and TSH levels will then be measured. Euthyroid goitre is a swollen thyroid gland which usually manifests as a lump in the neck. It is a symptom of an over- or an under-active thyorid gland, thyroid cancer or idodine deficiency. Tretment will depend on the cause and on the size the lump. If the lump is small and deemed as unproblematic, it may just be monitored at first. If goitre is caused by the lack of thyroid gland hormones, it may be treated with daily hormone-replacement tablets, called levothyroxine (such as <Product Name>), to increase the thyroxine levels. Surgery and radioidoine treatment may be used to remove to goitre if it gets too large and problematic. Levothyroxine (such as <Product Name>) may also be used to prevent relapse of goitre after surgery. Thyroid cancer is cancer of the thyorid gland, a small gland in the neck, which usually manifests as a lump/swelling in the neck. However, a lump in the thyroid does not necessarily mean that you have thyroid cancer - only around 1 in 20 thyroid lumps are cancerous. A sore throat or voice changes are additional symptoms which may occur. Thyorid cancer is a rare cancer, occuring in 1-3% of cancer cases. It usually affectes people between 35 and 39 and those over 70 years of age. Women are 2-3 times more likely to develop thyroid cancer than men. Between 80% and 90% of patients with thyorid cancer will have a normal lifespan.treatment varies but usually includes levothyroxine (such as STADA Arzneimittel AG C O N F I D E N T I A L Page 23 of 47

2 <Product Name>) to suppress cancer growth, surgery to remove the thyroid gland and radiotherapy. VI.2.2 Summary of treatment benefits Levothyroxine, the active substance in <Product Name>, is a synthetic thyroid hormone for the treatment of diseases and dysfunctions of the thyroid gland. It has the same effect as the naturally occurring thyroid hormones. <Product Name> microgram is used to treat benign goitre in patients with normal thyroid function, to prevent recurrence of goitre after surgery, to replace natural thyroid hormones, when your thyroid gland does not produce enough, to suppress tumour growth in patients with thyroid cancer. <Product Name> microgram can also be used to balance thyroid hormone levels, when overproduction of hormones is treated with antithyroid medicines. <Product Name> 100/150/200 microgram may also be used in the testing of your thyroid function. VI.2.3 Unknowns relating to treatment benefits None. STADA Arzneimittel AG C O N F I D E N T I A L Page 24 of 47

3 VI.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability Allergic reactions Condition occuring due to over-active thyroid (Thyrotoxicosis) Serious condition caused by insufficient cortisol hormone levels (Adrenal crisis) Hypersensitivity reactions including rash, itching, shortness of breath, joint pain, general discomfort and swelling may occur with <Product Name> use. Pateinst with an over-active thyroid (thyrotoxicosis), i.e. those in who have high levels of thyroid hormones, should not be taking <Product Name>. <Product Name> increases thyroid hormone levels and will therefore further elevate these is patients with overactive thyroid. <Product Name> is contraindicated in patients with uncorrected adrenal insufficiency (condition in which the adrenal glands do not produce enough steroid hormones, primarily cortisol), as excessive thyroid hormones from <Product Inform your doctor if you have any allergies. Always take this medicine as prescribed by your doctor and as indicated in the Package Leaflet. This will minimise the risk of developing adverse drug reactions. Contact your doctor if you unexplained swelling rash shortness of breath joint pain with overactive thyroid. Contact your doctor if you hyperactivity mood swings difficulty sleeping feeling tired all the time muscle weakness sensitivity to heat and excess sweating unexplained or unexpected weight loss with adrenal insufficiency. Contact your doctor immediatelly if you STADA Arzneimittel AG C O N F I D E N T I A L Page 25 of 47

4 Cardiovascular disorders Name> may precipitate an acute adrenal crisis (a serious condition caused by insufficient cortisol levels) by increasing the elimination of steroids from the body. In patients with cardiovascular problems (e.g. arrhythmias, cardiac failure), increase in thyroid hormones as a result of over-treatment with <Product Name> must be avoided, as it may lead to worsening of these pre-existing cardiovascular problems. nausea or abdominal pain. vomiting. fever. joint pain. loss of appetite. dramatic changes in blood pressure. weakness. chills. with any cardiac problems. Your doctor will perform regular checks of your thyroid hormone levels. Contact your doctor immediatelly if you rapid heart rate shortness of breath weakness. swelling in your legs, ankles and feet (or worsening of the same). Important potential risks Risk Seizures in patients with known history of epilepsy What is known (Including reason why it is considered a potential risk) Patients treated with <Product Name> who have previously been diagnosed with epilepsy may be at an increased risk of developing seizures (fits). Care is required when levothyroxine is administered to patients with known history of epilepsy. Seizures (fits) have been reported rarely in association with the initiation of levothyroxine sodium therapy, and may be related to the effect of thyroid hormone on seizure threshold. Missing information Risk What is known STADA Arzneimittel AG C O N F I D E N T I A L Page 26 of 47

5 None N/A VI.2.5 Summary of risk minimisation measures by safety concern All medicines have a Summary of Product Characteristics (SPC) which provides physicians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations for minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PL). The measures in these documents are known as routine risk minimisation measures. This medicine has no additional risk minimisation measures. VI.2.6 Planned post authorisation development plan No post-authorisation studies have been imposed or are planned. VI.2.7 Summary of changes to the Risk Management Plan over time Not applicable STADA Arzneimittel AG C O N F I D E N T I A L Page 27 of 47