Novothiral

Leaflet accompanying the packaging: patient information

Novothyral, 100 µg + 20 µg, tablets
Levothyroxine sodium + Liothyronine sodium

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

1. What is Novothyral and what is it used for

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

• substitution treatment of 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, primarily after thyroidectomy.

2. Important information before taking Novothyral

When not to take Novothyral

Do not take Novothyral:

• if you are allergic to levothyroxine sodium, liothyronine sodium, or any of the other ingredients of this medicine (listed in section 6);
• if you have untreated hypopituitarism or hyperthyroidism;
• if you have adrenal cortical insufficiency and are not receiving appropriate replacement therapy.

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

Warnings and precautions

Before starting to take Novothyral, consult your doctor or pharmacist.
Thyroid hormones should not be used to reduce weight. Taking them will not reduce weight 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 exclude the presence of the following diseases or to treat them: coronary insufficiency, angina pectoris, atherosclerosis, arterial 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 Novothyral, tell your doctor if you have adrenal cortical insufficiency.
In case of secondary hypothyroidism, before starting replacement therapy, it is necessary to clarify its cause and, if necessary, start appropriate replacement therapy for adrenal cortical insufficiency.
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, in order 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, a disturbance of thyroid hormone balance 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. Tell your doctor if you experience any side effects, as it may be necessary to increase or decrease the dose.
If you are to undergo laboratory tests to check thyroid hormone levels, you should inform your doctor or laboratory staff if you are currently taking or have recently taken biotin (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. Your doctor may recommend stopping biotin before undergoing laboratory tests. It is also important to remember that other products you are taking, such as multivitamins or supplements for hair, skin, and nails, may also contain biotin. This may affect laboratory test results. If you are taking such products, inform your doctor or laboratory staff (see "Novothyral and other medicines").

Novothyral contains lactose and sodium

One tablet contains 65.88 mg of lactose monohydrate. If you have previously been diagnosed with intolerance to some sugars, you should consult your 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 medicines are given in the section "Novothyral and other medicines".

Novothyral 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 you are to undergo laboratory tests for thyroid hormone levels. 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 in diabetic patients, it is necessary to regularly monitor blood sugar levels, especially at the beginning of thyroid hormone treatment, and adjust the dosage of the antidiabetic medicine if necessary.
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 into the central nervous system and gastrointestinal tract, especially in the elderly. Therefore, it is necessary to regularly monitor blood coagulation parameters at the beginning of treatment (or when changing the dose) and during combination therapy. If necessary, the doctor will adjust the dose of the anticoagulant medicine.
Protease inhibitors
Protease inhibitors (e.g., ritonavir, indinavir, lopinavir) may affect the effect of levothyroxine.
It is recommended to closely monitor thyroid hormone levels. If necessary, the doctor will adjust the dose of Novothyral.

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 an increase in fT4 levels.
Phenytoin
Phenytoin may affect the effect of levothyroxine by displacing it from protein binding and thus increasing fT4 and fT3 levels. Phenytoin accelerates the metabolism of levothyroxine in the liver. It is recommended to closely monitor thyroid function parameters.
Rapid intravenous administration of phenytoin may lead to increased levels of free levothyroxine and liothyronine in the serum, 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 reduce the absorption of levothyroxine in the intestine and make it less effective. If you are taking levothyroxine while being treated with proton pump inhibitors, your doctor should monitor thyroid function and adjust the dose of Novothyral if necessary.
Orlistat
When taking orlistat (a medicine used to treat obesity), stopping treatment, or changing orlistat treatment, you should inform your doctor, as more frequent monitoring and dose adjustment may be necessary. Taking Novothyral and orlistat at the same time may cause hypothyroidism and (or) worsen hypothyroidism control.
Sewelamer
Sewelamer may reduce the absorption of levothyroxine, so it is recommended to monitor patients for changes in thyroid function at the beginning or end of combination treatment with these medicines and adjust the dose of Novothyral if necessary.
Tyrosine kinase inhibitors
Tyrosine kinase inhibitors (e.g., imatinib, sunitinib) may reduce the effectiveness of levothyroxine.
Therefore, it is recommended to monitor patients for changes in thyroid function at the beginning or end of combination treatment with these medicines and adjust the dose of Novothyral if necessary.
Cholestyramine, colestypol
Cholestyramine or colestypol inhibit the absorption of thyroid hormones. Therefore, Novothyral 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 medicines containing aluminum, iron-containing medicines, calcium-containing medicines: Novothyral should be taken at least 2 hours before taking these medicines, as they may otherwise reduce the effect of Novothyral.
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 the case of nodular goiter with possible unrecognized autonomous thyroid function.
Sertraline, chloroquine/proguanil
These substances reduce the effectiveness of thyroid hormones and cause an increase in TSH levels in the 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), medicines containing St. John's Wort (some herbal medicines), may increase the hepatic clearance of levothyroxine, leading to a decrease in thyroid hormone levels in the serum.
Estrogens
During the use of estrogen-containing contraceptives or postmenopausal hormone replacement therapy, the need for thyroid hormones may increase.

Novothyral with food and drink

The total 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 reduce the absorption of Novothyral in the intestine. Therefore, it may be necessary to adjust the dose of Novothyral, especially at the beginning 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 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 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 during 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 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 will have any effect on the ability to drive and use machines.

3. How to take Novothyral

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
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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, the 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 per day.
Adolescents and adults:½ - 2 tablets of Novothyral per day.
Usually, the initial dose is ½ tablet of Novothyral per day. Depending on individual tolerance, the daily dose is increased every two weeks by ½ tablet of Novothyral.
In children and patients at risk, Novothyral should be dosed very carefully.
The doctor should recommend a small initial dose and gradually increase it at longer intervals, frequently monitoring thyroid hormone levels.
For adolescents and adults, the following dosing recommendations apply.
Treatment of non-toxic goiter
½ - 1 tablet of Novothyral per day.
Prevention of goiter recurrence after resection
½ - 1 tablet of Novothyral per day.
Postoperative state after malignant thyroid tumor surgery

• 1 - 2 tablets of Novothyral 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, it is also necessary to administer a higher dose of levothyroxine and a lower dose of liothyronine than usual.
The longer the hypothyroidism has lasted and the older the patient, the more cautiously substitution therapy should be started, as it may lead to an exacerbation of angina pectoris symptoms in coronary artery disease or the occurrence of cardiac arrhythmias.
In case of coronary artery disease, heart failure, and cardiac arrhythmias of the tachycardia type, it is essential to avoid hyperthyroidism, even to a slight degree, caused by pharmacotherapy, and therefore, in such cases, frequent clinical and laboratory checks should be performed.
The total 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 case of hypothyroidism and thyroidectomy due to malignant thyroid tumor, treatment is usually carried out for life, while in case of goiter with euthyroidism and prevention of goiter recurrence, treatment is carried out for a period of several months to a lifetime.

Taking a higher dose of Novothyral than recommended

If you have taken a higher dose of the medicine 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, single cases of seizures have been reported when exceeding the individual dose tolerance limit.
Several cases of sudden cardiac death have been reported in individuals who have been abusing levothyroxine for many years.
If you have taken a higher dose than recommended, you may experience symptoms such as tachycardia, anxiety, agitation, and hyperkinesia.
Overdose may cause hyperthyroidism and lead to symptoms of acute psychosis.

Missing a dose of Novothyral

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

4. Possible side effects

Like all medicines, Novothyral can cause side effects, although not everybody gets them.
If Novothyral is taken as directed and clinical and laboratory parameters are monitored, it is not expected that side effects will 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: allergic reactions (rash, urticaria); angioedema (severe allergic reaction involving swelling of the face, tongue, or throat, which may cause difficulty swallowing or breathing). The frequency of these side effects is unknown.
If you experience intolerance to the prescribed dose or overdose, especially if the dose is increased too quickly at the beginning of treatment, you may experience symptoms typical of hyperthyroidism, 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 careful dosing.

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 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
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Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Novothyral

Keep the medicine out of the sight and reach of children.
Do not use Novothyral after the expiry date stated on the packaging after:
Expiry date (EXP). The expiry date refers to the last day of the specified month.
Do not store above 25°C.
To protect from light and moisture, store 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 packaging and other information

What Novothyral contains

• The active substances of the medicine are levothyroxine sodium and liothyronine sodium. Each Novothyral tablet contains: 100 micrograms of levothyroxine sodium and 20 micrograms of liothyronine sodium.
• Other ingredients: lactose monohydrate, cornstarch, gelatin, sodium croscarmellose, magnesium stearate.

What Novothyral looks like and contents of the pack

Novothyral is a white, round tablet with a score line on both sides.
The packaging 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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