Levothiroxine Accord

Package Leaflet: Information for the User

Levothyroxine Accord, 12.5 micrograms, tablets

Levothyroxine Accord, 25 micrograms, tablets

Levothyroxine Accord, 50 micrograms, tablets

Levothyroxine Accord, 75 micrograms, tablets

Levothyroxine Accord, 88 micrograms, tablets

Levothyroxine Accord, 100 micrograms, tablets

Levothyroxine Accord, 112 micrograms, tablets

Levothyroxine Accord, 125 micrograms, tablets

Levothyroxine Accord, 137 micrograms, tablets

Levothyroxine Accord, 150 micrograms, tablets

Levothyroxine Accord, 175 micrograms, tablets

Levothyroxine Accord, 200 micrograms, tablets

Levothyroxine sodium

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents:

• 1. What Levothyroxine Accord is and what it is used for
• 2. Important information before taking Levothyroxine Accord
• 3. How to take Levothyroxine Accord
• 4. Possible side effects
• 5. How to store Levothyroxine Accord
• 6. Package contents and other information

1. What Levothyroxine Accord is and what it is used for

Levothyroxine, the active substance of Levothyroxine Accord, is a synthetic thyroid hormone used to treat thyroid diseases and disorders. It has the same effect as the thyroid hormones that occur naturally in the body. Levothyroxine Accord is used:

• to treat mild goiter in patients with normal thyroid function,
• to prevent goiter recurrence in patients after surgery,
• to supplement the lack of natural thyroid hormones when the thyroid gland does not produce enough hormones,
• to inhibit tumor growth in patients with thyroid cancer.

Levothyroxine Accord 25 micrograms, 50 micrograms, 75 micrograms, 88 micrograms, and 100 micrograms are also used to normalize thyroid hormone levels in patients who are taking antithyroid medications due to excessive thyroid hormone production. Levothyroxine Accord 100 micrograms, 150 micrograms, and 200 micrograms may also be used in tests to assess thyroid function. Levothyroxine Accord, 12.5 micrograms:

• In children with hypothyroidism as an initial dose to replace thyroid hormone.
• In elderly patients, patients with coronary artery disease, and patients with severe or long-standing hypothyroidism as a small initial dose, which should then be gradually increased at longer intervals (e.g., 12.5 micrograms per day every 2 weeks), often monitoring thyroid hormone levels.
• In any patient who requires gradual increase of levothyroxine dose.

2. Important information before taking Levothyroxine Accord

When not to take Levothyroxine Accord

• if you are allergic to levothyroxine sodium or any of the other ingredients of this medicine (listed in section 6),
• if you have untreated adrenal insufficiency or hypopituitarism, or if thyroid hormones are produced in excess (hyperthyroidism),
• if you have acute heart disease (myocardial infarction, myocarditis).
• During pregnancy, Levothyroxine Accord should not be taken with antithyroid medications for the treatment of hyperthyroidism.

Levothyroxine Accord should not be taken in combination with antithyroid medications if you are pregnant (see "Pregnancy and breastfeeding" below).

Warnings and precautions

Before starting treatment with Levothyroxine Accord, tell your doctor if you have any of the following heart diseases:

• insufficient blood flow in the coronary arteries (angina pectoris),
• heart failure,
• rapid and irregular heart rhythm,
• high blood pressure,
• fatty deposits in the arteries (arteriosclerosis),
• if the adrenal glands do not function properly (adrenal insufficiency), and the treatment to supplement the lack of adrenal hormones is insufficient,
• if you are to undergo laboratory tests to check thyroid hormone levels, you should inform your doctor or laboratory staff if you are taking or have recently taken biotin (also known as vitamin H, vitamin B7, or vitamin B8). Biotin may affect the results of laboratory tests. Depending on the type of test, the results may be falsely elevated or falsely decreased due to biotin intake. Your doctor may advise you to stop taking biotin before undergoing laboratory tests. You should also remember that other products you are taking, such as multivitamins or supplements for hair, skin, and nails, may also contain biotin. This may affect the results of laboratory tests. If you are taking such products, you should inform your doctor or laboratory staff (see "Levothyroxine Accord and other medicines").

Treatment of these disorders is necessary before starting treatment with Levothyroxine Accord and before performing a thyroid suppression test. During treatment with Levothyroxine Accord, it is necessary to frequently monitor thyroid hormone levels. If you are unsure whether you have any of the above diseases or if they are not treated, you should consult your doctor. Your doctor will perform the necessary tests to determine if you have any disorders of adrenal or pituitary function or a certain type of thyroid disorder with uncontrolled excessive production of thyroid hormones (autonomous thyroid function), as in such cases, appropriate treatment may be necessary before starting treatment with Levothyroxine Accord and before performing a thyroid suppression test. After starting levothyroxine treatment in premature infants with very low birth weight, it is necessary to regularly monitor blood pressure, as a sudden drop in blood pressure (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. You should consult your doctor if you have any questions about changing medicines. During the transition period, close monitoring of clinical and biochemical parameters is necessary. You should tell your doctor if you experience any side effects, as it may be necessary to increase or decrease the dose.

• if you are in menopause or postmenopause; your doctor may then recommend regular monitoring of thyroid function due to the risk of osteoporosis;
• when changing from one levothyroxine-containing medicine to another. The effects of these medicines may differ slightly, and therefore more frequent monitoring and appropriate dose adjustment may be necessary;
• when starting, stopping, or changing treatment with orlistat (a medicine used to treat obesity); more frequent monitoring and appropriate dose adjustment may be necessary;
• in case of psychotic disorders, your doctor may recommend more frequent monitoring and appropriate dose adjustment;
• if you have adrenal insufficiency (adrenal gland dysfunction).

Changes in thyroid hormone balance may occur when changing from one levothyroxine-containing medicine to another. If you have any questions about changing medicines, you should consult your doctor. Close monitoring of patients (clinical and biological evaluation) is necessary during the transition period. If you experience any side effects, you should consult your doctor, as it may be necessary to increase or decrease the dose.

Levothyroxine Accord and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, as Levothyroxine Accord may affect the action of these medicines:

• antidiabetic medicines (medicines that lower blood sugar levels): Levothyroxine Accord may reduce the effect of antidiabetic medicines, so additional monitoring of blood sugar levels may be necessary, especially at the start of treatment with Levothyroxine Accord. During treatment with Levothyroxine Accord, it may be necessary to adjust the dose of antidiabetic medicine.
• anticoagulant medicines (coumarin derivatives): Levothyroxine Accord may enhance the effect of these medicines, which may increase the risk of bleeding, especially in elderly patients. Therefore, regular monitoring of blood coagulation parameters may be necessary at the start and during treatment with Levothyroxine Accord. During treatment with Levothyroxine Accord, it may be necessary to adjust the dose of anticoagulant medicine from the coumarin derivative group.

It is necessary to ensure that the recommended time intervals are observed when taking any of the following medicines:

• bile acid sequestrants and cholesterol-lowering medicines (cholestyramine or colestipol): Levothyroxine Accord should be taken 4 to 5 hours before taking these medicines, as they may inhibit the absorption of Levothyroxine Accord from the gut;

these medicines may reduce the effect of Levothyroxine Accord, so you should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take:

• propylthiouracil (an antithyroid medicine),
• corticosteroids (anti-allergic and anti-inflammatory medicines),
• beta-adrenergic blockers (medicines that lower blood pressure, also used to treat heart diseases),
• sertraline (an antidepressant),
• chloroquine or proguanil (medicines used to treat or prevent malaria),
• medicines that stimulate certain liver enzymes, such as barbiturates (sedatives, sleeping pills) or carbamazepine (an antiepileptic medicine, also used to treat certain types of pain and mood disorders),
• estrogen-containing medicines, used for hormone replacement therapy during menopause and postmenopause or to prevent pregnancy,
• sevelamer (a medicine that lowers phosphate levels, used in patients with chronic kidney failure),
• tyrosine kinase inhibitors (medicines used to treat cancer),
• orlistat (a medicine used to treat obesity).

These medicines may enhance the effect of Levothyroxine Accord, so you should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take:

• salicylates (medicines used to relieve pain and reduce fever),
• dicumarol (a medicine that reduces blood clotting),
• high doses of furosemide, above 250 mg (a diuretic),
• clofibrate (a medicine that lowers lipid levels in the blood).

These medicines may affect the action of Levothyroxine Accord, so you should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take:

• ritonavir, indinavir, lopinavir (protease inhibitors, medicines used to treat HIV infections),
• phenytoin (an antiepileptic medicine),
• medicines containing St. John's Wort (some herbal medicines),
• proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole, and lansoprazole) used to reduce stomach acid production, which may reduce the absorption of levothyroxine from the gut and make it less effective. If you are taking levothyroxine while being treated with proton pump inhibitors, your doctor should monitor your thyroid function and adjust the dose of Levothyroxine Accord if necessary.

In this situation, regular thyroid hormone testing and dose adjustment may be necessary. If you are taking amiodarone (a medicine used to treat heart rhythm disorders), you should tell your doctor, as this medicine may affect thyroid function. You should tell your doctor about taking Levothyroxine Accord if you need to undergo a diagnostic or imaging test with a contrast agent containing iodine, as this test involves the administration of a substance that affects thyroid function. You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those that are available without a prescription. 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 without consulting a doctor may lead to serious and life-threatening side effects, especially when taking other weight loss medicines. If you are currently taking or have recently taken biotin, you must inform your doctor or laboratory staff if you are to undergo thyroid hormone laboratory tests. Biotin may affect the results of laboratory tests (see "Warnings and precautions").

Levothyroxine Accord with food and drink

If your diet includes soy products, you should tell your doctor, especially if you change the amount of these products you consume. Soy products may reduce the absorption of Levothyroxine Accord from the gut, and therefore, it may be necessary to adjust the dose of Levothyroxine Accord.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Adequate amounts of thyroid hormone are necessary for normal pregnancy. Therefore, during pregnancy, you should continue taking Levothyroxine Accord. During pregnancy, you should not take Levothyroxine Accord if you are taking antithyroid medications (thyreostatics) for the treatment of hyperthyroidism. If necessary, your doctor may adjust the dose. If you become pregnant, you should contact your doctor. There is no evidence that Levothyroxine Accord is harmful to the baby if the mother is breastfeeding and has normal thyroid function. You should not take Levothyroxine Accord if you are breastfeeding and taking antithyroid medications (thyreostatics) for the treatment of hyperthyroidism.

Driving and using machines

Levothyroxine sodium should not affect your ability to drive or use machines.

Important information about some ingredients of Levothyroxine Accord

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free". The 25 micrograms tablet contains orange yellow S (E 110), which may cause allergic reactions. The 75 micrograms tablet contains indigo carmine (E 132) and Allura Red AC (E 129), which may cause allergic reactions. The 88 micrograms tablet contains tartrazine (E 102), which may cause allergic reactions. The 100 micrograms tablet contains tartrazine (E 102) and orange yellow S (E 110), which may cause allergic reactions. The 125 micrograms tablet contains orange yellow S (E 110) and Allura Red AC (E 129), which may cause allergic reactions.

3. How to take Levothyroxine Accord

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will determine the appropriate dose for you individually, based on clinical evaluation and laboratory tests. Treatment usually starts with a small dose, which is increased every 2 to 4 weeks until the full dose, adjusted individually for each patient, is reached. In the first weeks of treatment, laboratory tests will be necessary to allow your doctor to adjust the appropriate dose. If a child is born with a thyroid disease that involves insufficient production of thyroid hormones, it is essential to supplement them quickly. Therefore, your doctor may recommend a higher initial dose of 10 to 15 micrograms per kilogram of body weight per day for the first 3 months. Then, your doctor will adjust the dose individually. Typical dose ranges are shown in the table below. Smaller, individually adjusted doses may be sufficient for:

• elderly patients,
• patients with heart diseases,
• patients with severe or long-standing hypothyroidism,
• patients with small body mass or giant goiter.

Method of administration
Levothyroxine Accord is intended for oral use.
The single daily dose should be taken in the morning, on an empty stomach (at least half an hour before breakfast), preferably with a small amount of liquid, e.g., half a glass of water.
Infants should be given the entire daily dose of Levothyroxine Accord once a day, at least half an hour before the first meal of the day. Immediately before administration, the tablet should be crushed and mixed with a small amount of water, and the resulting suspension, which should be prepared freshly each time, should be given with a small additional amount of liquid.
Duration of treatment
The duration of treatment may vary depending on the reason for taking Levothyroxine Accord. Your doctor will discuss with you individually how long you need to take the medicine. Most patients need to take Levothyroxine Accord for the rest of their lives.

Taking a higher dose of Levothyroxine Accord than recommended

If you take a higher dose than recommended, you may experience symptoms such as rapid heartbeat, nervousness, excitement, or involuntary movements. In patients with neurological disorders, such as epilepsy, single seizures have been observed. In patients with psychotic disorders, symptoms of acute psychosis may occur. In such cases, you should consult your doctor.

Missing a dose of Levothyroxine Accord

Do not take a double dose to make up for a forgotten dose. The next day, take the usual dose of the medicine.
If you are unsure about taking Levothyroxine Accord, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Levothyroxine Accord can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, but severe allergic reactions are rare.
In case of sudden symptoms such as wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, and itching (especially all over the body), you should contact your doctor immediately.
In case of poor tolerance to the prescribed dose or if you take a higher dose of Levothyroxine Accord than recommended, you may experience symptoms similar to hyperthyroidism, especially if the dose is increased too quickly at the start of treatment.
The following side effects have been observed (frequency not known):

• headache, hot flashes, excessive sweating,
• weight loss,
• tremors, nervousness, excitement,
• seizures,
• insomnia,
• rapid heartbeat (tachycardia) or angina pectoris (chest pain with a feeling of pressure in the chest),
• irregular heartbeat, palpitations,
• high blood pressure, heart failure, myocardial infarction,
• shortness of breath (dyspnea),
• increased appetite, nausea, vomiting, diarrhea, abdominal cramps,
• muscle weakness and cramps,
• fever
• in women - menstrual disorders,
• decreased bone density, especially in postmenopausal women who take high doses of the medicine for a long time,
• hyperthyroidism,
• angioedema, rash, urticaria.

If you experience any of the above symptoms, you should contact your doctor. The symptoms usually disappear after adjusting the dose.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 Levothyroxine Accord

Keep this medicine out of the sight and reach of children.
Do not use Levothyroxine Accord after the expiry date stated on the blister, bottle, and carton after EXP. The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C.
HDPE bottle: discard 180 days after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Levothyroxine Accord contains

The active substance is levothyroxine sodium. Each tablet contains 12.5 micrograms, 25 micrograms, 50 micrograms, 75 micrograms, 88 micrograms, 100 micrograms, 112 micrograms, 125 micrograms, 137 micrograms, 150 micrograms, 175 micrograms, or 200 micrograms of levothyroxine sodium.
The other ingredients are microcrystalline cellulose, microcrystalline cellulose (type 112), light magnesium oxide, sodium carboxymethylcellulose (type A), sodium stearyl fumarate.
25 micrograms
Lake Blend LB530006 Orange contains:
Orange yellow S (E 110), aluminum lake
75 micrograms
Lake Blend LB505008 Purple contains:
Indigo carmine (E 132), aluminum lake
Allura Red AC (E 129), aluminum lake
88 micrograms
Lake Blend LB510028 Green contains:
Tartrazine (E 102), aluminum lake
Indigo carmine (E 132), aluminum lake
100 micrograms
Lake Blend LB520044 Yellow contains:
Tartrazine (E 102), aluminum lake
Orange yellow S (E 110), aluminum lake
112 micrograms
Lake Blend LB540042 Pink contains:
Cochineal red A (E 120)
Allura Red AC (E 129), aluminum lake
125 micrograms
Lake Blend LB575003 Brown contains:
Orange yellow S (E 110), aluminum lake
Brilliant blue FCF (E 133), aluminum lake
Allura Red AC (E 129), aluminum lake
137 micrograms
Lake Blend LB505013 Blue contains:
Brilliant blue FCF (E 133), aluminum lake
150 micrograms
Lake Blend LB505010 Blue contains:
Indigo carmine (E 132), aluminum lake
175 micrograms
Lake Blend LB500017 Purple contains:
Cochineal red A (E 120)
Brilliant blue FCF (E 133), aluminum lake
200 micrograms
Lake Blend LB540010 Maroon contains:
Allura Red AC (E 129), aluminum lake

What Levothyroxine Accord looks like and contents of the pack

12.5 micrograms
Orange-colored PVC/EVOH/Aclar/Aluminum blister pack containing 10, 50, 100, or 200 tablets in a carton.
25/50/100 micrograms
Orange-colored PVC/EVOH/Aclar/Aluminum blister pack containing 10, 30, 50, 56, 90, 100, or 200 tablets in a carton.
75/88/112/125/137/150/175/200 micrograms
Orange-colored PVC/EVOH/Aclar/Aluminum blister pack containing 10, 30, 50, 90, 100, or 200 tablets in a carton.
25/50/75/88/100/112/125/137/150/175/200 micrograms
White HDPE bottle with a non-transparent white polypropylene child-resistant closure with an induction seal, containing 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer

Laboratori Fundació Dau
C/C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
96-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country Name of the medicinal product

Netherlands
Levothyroxine Accord 12.5/25/50/75/88/100/112/125/137/150/175/200 microgram tablets
Austria
Levothyroxin natrium Accord 12.5/25/50/75/88/100/112/125/137/150/175/200 micrograms tablets
Estonia
Levothyroxine Accord
Latvia
Levothyroxine Accord 12.5/25/50/75/88/100/112/125/137/150/175/200 micrograms tablets
Lithuania
Levothyroxine Accord 12.5/25/50/75/88/100/112/125/137/150/175/200 micrograms tablets
Poland
Levothyroxine Accord
Cyprus
Levothyroxine Accord 25/50/100 microgram tablets
Greece
Levothyroxine/Accord

• 12.5/25/50/75/88/100/112/125/137/150/175/200 μg tablets

Date of last revision of the package leaflet: November 2024