Novothiral 75

Package Leaflet: Information for the Patient

Novothyral 75, 75 µg + 15 µg, tablets
Levothyroxine sodium + Liothyronine sodium

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Novothyral 75 and what is it used for
• 2. Important information before taking Novothyral 75
• 3. How to take Novothyral 75
• 4. Possible side effects
• 5. How to store Novothyral 75
• 6. Contents of the pack and other information

1. What is Novothyral 75 and what is it used for

The thyroid hormones in Novothyral 75 have the same effect as the natural hormones produced by the thyroid gland. Thyroid hormones affect growth, development, and metabolism. Novothyral 75 is used in the following cases:

• Substitution treatment for hypothyroidism of any origin:
• Primary hypothyroidism (congenital or acquired, e.g., after surgical operations, radiation, or medication),
• Secondary hypothyroidism;
• In a state of euthyroidism:
• Prevention of recurrent goiter after its resection,
• Treatment of non-toxic goiter;
• Suppressive and substitution treatment in malignant thyroid tumors, mainly after thyroidectomy.

2. Important information before taking Novothyral 75

When not to take Novothyral 75

Do not take Novothyral 75:

Therapy with Novothyral 75 should not be started in case of myocardial infarction, acute myocarditis, and acute pericarditis. During pregnancy, it is contraindicated to take levothyroxine/liothyronine and a thyroid inhibitor at the same time.

Warnings and precautions

Before starting treatment with Novothyral 75, consult your doctor or pharmacist. Thyroid hormones should not be used to reduce weight. Taking them will not lead to weight loss if thyroid hormones are at the proper level. Increasing the dose of the medicine without consulting a doctor may lead to severe and life-threatening side effects. It is not recommended to take high doses of levothyroxine in combination with certain weight loss medications, such as amfepramone, catherine, and phenylpropanolamine, due to the possible increased risk of severe and life-threatening side effects. Before starting treatment, it is necessary to rule out the presence of the following diseases or to treat them: coronary insufficiency, angina pectoris, atherosclerosis, hypertension, hypopituitarism, or adrenal cortical insufficiency, autonomous thyroid function. In case of psychotic symptoms, the doctor may recommend more frequent checks and appropriate dose adjustment. In patients with coronary insufficiency, heart failure, or cardiac arrhythmias of the tachycardia type, even slight hyperthyroidism caused by the medicine should be avoided. In such cases, thyroid hormone levels should be frequently monitored (see dosage instructions). Before starting treatment with Novothyral 75, tell your doctor if you have adrenal cortical insufficiency. In case of secondary hypothyroidism, the cause should be clarified before starting replacement therapy, and if necessary, appropriate replacement therapy for adrenal cortical insufficiency should be initiated. If autonomous thyroid function is suspected, the doctor will prescribe a TRH test or a scintigraphic examination with thyroid function inhibition. In the treatment of levothyroxine/liothyronine in women with hypothyroidism in the postmenopausal period, who are at increased risk of osteoporosis, to avoid exceeding physiological levels of levothyroxine/liothyronine, thyroid function should be closely monitored. Levothyroxine/liothyronine should not be used in patients with hyperthyroidism, except for combination therapy in the treatment of hyperthyroidism with thyroid inhibitors. When starting treatment with levothyroxine in premature infants with very low birth weight, blood pressure should be regularly monitored, as a sudden drop in blood pressure (so-called circulatory collapse) may occur. If it is necessary to change the medicine to another levothyroxine-containing medicine, thyroid hormone imbalance may occur. Consult your doctor if you have any questions about changing medicines. During the transition period, close monitoring of clinical and biochemical parameters is required. If any side effects occur, consult your doctor, as it may be necessary to increase or decrease the dose. If laboratory tests are to be performed to check thyroid hormone levels, the patient should inform the doctor or laboratory staff about current or recent biotin intake (also known as vitamin H, vitamin B7, or vitamin B8). Biotin may affect laboratory test results. Depending on the type of test, the results may be falsely elevated or decreased due to biotin intake. The doctor may recommend stopping biotin intake before performing laboratory tests. It should also be remembered that other products taken by the patient, such as multivitamins or supplements for hair, skin, and nails, may also contain biotin, which can affect laboratory test results. If the patient is taking such products, they should inform their doctor or laboratory staff (see "Novothyral 75 and other medicines").

Novothyral 75 contains lactose and sodium

One tablet contains 65.91 mg of lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free". Instructions for diabetic patients and patients taking anticoagulant medications are provided in the "Novothyral 75 and other medicines" section.

Novothyral 75 and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. If you are currently taking or have recently taken biotin, you must inform your doctor or laboratory staff if thyroid hormone laboratory tests are to be performed. Biotin may affect laboratory test results (see "Warnings and precautions").
Antidiabetic medicines (medicines that lower blood sugar levels)
Thyroid hormones may reduce the effect of antidiabetic medicines, so diabetic patients should regularly monitor their blood sugar levels, especially at the start of thyroid hormone treatment, and adjust their antidiabetic medicine dosage as needed.
Anticoagulant medicines (coumarin derivatives)
Levothyroxine/liothyronine may enhance the effect of anticoagulant medicines by displacing them from protein binding, which may increase the risk of bleeding in the central nervous system and gastrointestinal tract, especially in the elderly. Therefore, regular monitoring of blood coagulation parameters is necessary at the start of treatment (or when changing the dose) and during combination therapy. If necessary, the doctor will adjust the anticoagulant medicine dosage.
Protease inhibitors
Protease inhibitors (e.g., ritonavir, indinavir, lopinavir) may affect levothyroxine levels. Close monitoring of thyroid hormone levels is recommended. If necessary, the doctor will adjust the Novothyral 75 dosage.

The following medicines enhance the effect of thyroid hormones

Salicylates, dicumarol, furosemide, clofibrate
Salicylates, dicumarol, high-dose furosemide (250 mg), clofibrate, and other substances may displace levothyroxine/liothyronine from protein binding, which may lead to increased free T4 levels.
Phenytoin
Phenytoin may affect levothyroxine levels by displacing it from protein binding and increasing free T4 and free T3 levels. Phenytoin accelerates levothyroxine metabolism in the liver. Close monitoring of thyroid parameters is recommended. Rapid intravenous administration of phenytoin may lead to increased free levothyroxine and liothyronine levels in the blood, as well as an increased risk of cardiac arrhythmias in individual cases.

The following medicines reduce the effect of thyroid hormones

Proton pump inhibitors
Proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole, and lansoprazole) are used to reduce stomach acid production, which may decrease levothyroxine absorption in the intestine and make it less effective. If you are taking levothyroxine during treatment with proton pump inhibitors, your doctor should monitor thyroid function and adjust the Novothyral 75 dosage if necessary.
Orlistat
When taking orlistat (a medicine used to treat obesity), if treatment is discontinued or changed, you should inform your doctor, as closer monitoring and dose adjustment may be necessary. Concurrent use of Novothyral 75 and orlistat may cause hypothyroidism and (or) worsen hypothyroidism control.
Sevelamer
Sevelamer may decrease levothyroxine absorption, so monitoring of patients for changes in thyroid function at the start or end of concurrent treatment with these medicines is recommended, and the Novothyral 75 dosage should be adjusted if necessary.
Tyrosine kinase inhibitors
Tyrosine kinase inhibitors (e.g., imatinib, sunitinib) may decrease levothyroxine effectiveness. Therefore, monitoring of patients for changes in thyroid function at the start or end of concurrent treatment with these medicines is recommended, and the Novothyral 75 dosage should be adjusted if necessary.
Cholestyramine, colestipol
Cholestyramine or colestipol inhibits thyroid hormone absorption. Therefore, Novothyral 75 should be taken 4 to 5 hours before taking these products. Antacids (used to relieve heartburn), sucralfate (used to treat stomach and intestinal ulcers), other aluminum-containing medicines, iron-containing medicines, and calcium-containing medicines: Novothyral 75 should be taken at least 2 hours before taking these medicines, as they may otherwise reduce the effect of Novothyral 75.
Propylthiouracil, glucocorticoids, beta-sympatholytics, amiodarone, and iodine-containing contrast agents
These substances inhibit the conversion of T4 to T3 in peripheral tissues. Due to the high iodine content, amiodarone may cause both hyperthyroidism and hypothyroidism. Particular caution is recommended in cases of nodular goiter with possible unrecognized autonomous thyroid function.
Sertraline, chloroquine/proguanil
These substances decrease the effectiveness of thyroid hormones and cause increased TSH levels in serum.
Medicines that induce liver enzymes
Medicines that induce liver enzymes, such as barbiturates (sedatives, sleep aids), carbamazepine (an antiepileptic medicine also used to alleviate certain types of pain and control mood disorders), and St. John's Wort (some herbal medicines), may increase the hepatic clearance of levothyroxine, leading to decreased thyroid hormone levels in the blood.
Estrogens
During the use of estrogen-containing contraceptives or postmenopausal hormone replacement therapy, the need for thyroid hormones may increase.

Novothyral 75 with food and drink

The entire daily dose should be taken in the morning on an empty stomach, half an hour before breakfast, without chewing the tablet, with a small amount of liquid (e.g., half a glass of water).
Soy products
Soy products may decrease the absorption of Novothyral 75 in the intestine. Therefore, it may be necessary to adjust the Novothyral 75 dosage, especially at the start or after stopping soy-containing products.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine. The decision to take this medicine during pregnancy or breastfeeding will be made by your doctor. Levothyroxine treatment should be continued consistently, especially during pregnancy and breastfeeding.
Pregnancy
During pregnancy, it may be necessary to increase the dose of the medicine. Pregnant women should monitor their TSH levels during each trimester of pregnancy.

Excessive levels of thyroid hormones during pregnancy may have a negative effect on the fetus and postnatal development.

Novothyral 75 is a combination medicine containing levothyroxine and liothyronine. Liothyronine is not recommended during pregnancy. If you plan to become pregnant or become pregnant, your doctor will change the treatment to levothyroxine alone if possible.
Breastfeeding
Levothyroxine/liothyronine passes into breast milk during breastfeeding; however, the levels achieved with recommended therapeutic doses are not sufficient to cause hyperthyroidism or inhibit TSH secretion in the child.

Driving and using machines

No studies have been conducted on the effect of Novothyral 75 on the ability to drive and use machines. However, since levothyroxine and liothyronine are identical to those occurring naturally, it is not expected that Novothyral 75 would have any effect on the ability to drive and use machines.

3. How to take Novothyral 75

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. There are individual differences in the effectiveness and tolerance of thyroid hormones, so clinical observation of the patient and monitoring of thyroid hormone levels are crucial for treatment (liothyronine, TSH). If side effects occur, your doctor will reduce the daily dose or interrupt the administration of the medicine for a few days. As soon as the side effects disappear, treatment can be continued with caution, dosing the medicine carefully. The following doses are recommended (orientative values). Hypothyroidism
Children aged 4 to 12 years:½ - 1 tablet of Novothyral 75 per day.
Adolescents and adults:½ - 2 tablets of Novothyral 75 per day. The usual starting dose is ½ tablet of Novothyral 75 per day. Depending on individual tolerance, the daily dose is increased every two weeks by ½ tablet of Novothyral 75. In children and patients at risk, Novothyral 75 should be dosed very carefully. The doctor should recommend a small starting dose and gradually increase it over a longer period, frequently monitoring thyroid hormone levels. For adolescents and adults, the following dosing recommendations apply. Treatment of non-toxic goiter ½ - 1 tablet of Novothyral 75 per day. Prevention of goiter recurrence after resection ½ - 1 tablet of Novothyral 75 per day. Postoperative treatment for malignant thyroid tumors

• 2 - 3 tablets of Novothyral 75 per day.

Elderly patients, those with low body weight, and patients with large nodular goiter, according to experience, require a lower total dose. In elderly patients, a higher dose of levothyroxine and a lower dose of liothyronine should be administered than usual. The longer the hypothyroidism has lasted and the older the patient, the more cautiously substitution therapy should be started, as individual cases may lead to an exacerbation of angina pectoris symptoms in coronary artery disease or the occurrence of cardiac arrhythmias. In cases of coronary artery disease, heart failure, and cardiac arrhythmias of the tachycardia type, hyperthyroidism should be avoided at all costs, even if it is slight, and caused by pharmacotherapy. Therefore, frequent clinical and laboratory checks should be performed in such cases. The entire daily dose should be taken in the morning on an empty stomach, half an hour before breakfast, without chewing the tablet, with a small amount of liquid. In cases of hypothyroidism and thyroidectomy due to malignant thyroid tumors, treatment is usually lifelong, while in cases of goiter with euthyroidism and prevention of goiter recurrence, treatment may last from several months to a lifetime, depending on individual circumstances.

Taking a higher dose of Novothyral 75 than recommended

If you have taken a higher dose than recommended, consult your doctor or pharmacist immediately. Overdose may cause a significant increase in metabolism. Description of typical symptoms: see section 4. In predisposed patients, individual cases of seizures have been reported when the individual dose tolerance limit is exceeded. Several cases of sudden cardiac death have been reported in people who have been abusing levothyroxine for many years. If a higher dose than recommended is taken, symptoms such as tachycardia, anxiety, agitation, and hyperkinesia may occur. Overdose may cause hyperthyroidism and lead to symptoms of acute psychosis.

Missing a dose of Novothyral 75

Do not take a double dose to make up for a missed dose of Novothyral 75. If you miss a dose of Novothyral 75, consult your doctor.

4. Possible side effects

Like all medicines, Novothyral 75 can cause side effects, although not everybody gets them. If Novothyral 75 is taken as recommended and clinical and laboratory parameters are monitored, no side effects are expected to occur. Stop taking the medicine and consult your doctor or go to the emergency department of the nearest hospital immediately if you experience sudden symptoms of hypersensitivity to the ingredients of Novothyral 75: allergic reactions (rash, urticaria); angioedema (a severe allergic reaction that includes swelling of the face, tongue, or throat, which can cause difficulty swallowing or breathing). The frequency of these side effects is unknown. If individual cases of intolerance to the prescribed dose or overdose occur, especially if the dose is increased too quickly at the start of treatment, symptoms typical of hyperthyroidism may occur, such as cardiac arrhythmias (including atrial fibrillation and extrasystoles), tachycardia (rapid heart rate), palpitations, angina pectoris, headache, weakness, and muscle cramps, hot flashes, fever, vomiting, menstrual disorders, pseudo-tumor cerebri, tremors, restlessness, insomnia, excessive sweating, weight loss, diarrhea. If you experience any of the above side effects, consult your doctor as soon as possible, who will decide whether to interrupt treatment for a few days or reduce the daily dose of the medicine until the symptoms disappear. After the side effects disappear, treatment can be continued with caution, dosing the medicine carefully.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Novothyral 75

Keep this medicine out of the sight and reach of children. Do not use Novothyral 75 after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated. Do not store above 25°C. To protect from light and moisture, keep in the outer packaging. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Novothyral 75 contains

• The active substances of the medicine are levothyroxine sodium and liothyronine sodium. Each tablet of Novothyral 75 contains 75 micrograms of levothyroxine sodium and 15 micrograms of liothyronine sodium.
• Other ingredients: lactose monohydrate, cornstarch, gelatin, sodium croscarmellose, magnesium stearate.

What Novothyral 75 looks like and contents of the pack

Novothyral 75 is a white, round tablet with a score line on both sides. On the upper surface of the tablet, the marking EM 44 is embossed. The pack contains 50 or 100 tablets.

Marketing authorization holder

Merck Sp. z o.o., Al. Jerozolimskie 142B, 02-305 Warsaw, Poland, tel.: +48 22 53 59 700, logo of the marketing authorization holder

Manufacturer

Merck Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany

Date of last revision of the leaflet:

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