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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents:

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

Levothyroxine, the active substance of Levothyroxine Accord, is a synthetic thyroid hormone intended for the treatment of 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 drugs due to excessive thyroid hormone production. Levothyroxine Accord 100 micrograms, 150 micrograms, and 200 micrograms may also be used in tests evaluating 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 prolonged 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 controlling 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 the patient is allergic to levothyroxine sodium or any of the other ingredients of this medicine (listed in section 6.),
• if the patient has untreated adrenal insufficiency or pituitary insufficiency, or if thyroid hormones are produced in excess (hyperthyroidism),
• if the patient has acute heart disease (myocardial infarction, myocarditis).
• During pregnancy, Levothyroxine Accord should not be taken with antithyroid drugs for the treatment of hyperthyroidism.

Levothyroxine Accord should not be taken in combination with antithyroid drugs if the patient is pregnant (see "Pregnancy and breastfeeding" below).

Warnings and precautions

Before starting treatment with Levothyroxine Accord, the patient should inform their doctor about 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,
• fat deposits in the arteries (arteriosclerosis),
• if the adrenal glands do not function properly (adrenal insufficiency), and the treatment supplementing the lack of adrenal hormones is insufficient,
• if the patient is to undergo laboratory tests to check thyroid hormone levels, the patient should inform their 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 that the patient stop taking biotin before undergoing laboratory tests. It should also be noted that other products taken by the patient, such as multivitamins or supplements for hair, skin, and nails, may also contain biotin. This may affect laboratory test results. If the patient is taking such products, they should inform their 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, frequent monitoring of thyroid hormone levels is necessary. In case of doubts about the presence of any of the above diseases or if they are not treated, the patient should consult their doctor. The doctor will perform the necessary tests to determine if the patient has adrenal or pituitary disorders or a certain type of thyroid disorder with uncontrolled excessive thyroid hormone production (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 disruption of thyroid hormone balance may occur. The patient should consult their doctor if they have any questions about changing medicines. During the transition period, close monitoring of clinical and biochemical parameters is necessary. The patient should inform their doctor if they experience any side effects, as it may be necessary to increase or decrease the dose.

Levothyroxine Accord and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, as Levothyroxine Accord may affect the action of these medicines:

• antidiabetic medicines (medicines that lower blood sugar levels): Levothyroxine Accord may weaken the action of antidiabetic medicines, so additional blood sugar level controls may be necessary, especially at the beginning of treatment with Levothyroxine Accord. During treatment with Levothyroxine Accord, it may be necessary to change the dose of antidiabetic medicine;
• anticoagulant medicines (coumarin derivatives): Levothyroxine Accord may enhance the action 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 beginning and during treatment with Levothyroxine Accord. During treatment with Levothyroxine Accord, it may be necessary to change the dose of anticoagulant medicine from the coumarin derivative group.

The patient should ensure that the recommended time intervals are followed 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 weaken the action of Levothyroxine Accord, so the patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take:

• propylthiouracil (an antithyroid medicine),
• glucocorticoids (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),
• medicines containing estrogens, used in hormone replacement therapy during menopause and after menopause 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 action of Levothyroxine Accord, so the patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take:

• salicylates (medicines used to relieve pain and reduce fever),
• dicumarol (a medicine that lowers blood clotting),
• furosemide in high doses, 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 the patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take:

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

In this situation, it may be necessary to regularly perform thyroid hormone tests and change the dose of the medicine. If the patient is taking amiodarone (a medicine used to treat heart rhythm disorders), they should inform their doctor, as this medicine may affect thyroid function. The patient should inform their doctor about taking Levothyroxine Accord if they need to undergo a diagnostic or imaging test with a contrast agent containing iodine, as this test involves the administration of an injection that affects thyroid function. The patient should inform their doctor or pharmacist about all medicines they are currently 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 the patient is currently taking or has recently taken biotin, they must inform their doctor or laboratory staff if they are to undergo thyroid hormone laboratory tests. Biotin may affect laboratory test results (see "Warnings and precautions").

Levothyroxine Accord with food and drink

If the patient's diet includes soy products, they should inform their doctor, especially if they change the amount of these products they consume. Soy products may reduce the absorption of Levothyroxine Accord from the gut, and it may be necessary to modify the dose of Levothyroxine Accord accordingly.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. The proper amount of thyroid hormone is necessary for a normal pregnancy. Therefore, during pregnancy, the patient should continue taking Levothyroxine Accord. During pregnancy, Levothyroxine Accord should not be taken if the patient is taking antithyroid drugs for the treatment of hyperthyroidism. If necessary, the doctor may adjust the dose. If the patient becomes pregnant, they should contact their doctor. There is no evidence that Levothyroxine Accord is harmful to the baby if the mother is breastfeeding and has normal thyroid function. Levothyroxine Accord should not be taken if the patient is breastfeeding and taking antithyroid drugs for the treatment of hyperthyroidism.

Driving and using machines

Levothyroxine sodium should not affect the patient's ability to drive or operate 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 microgram tablet contains orange yellow S (E 110), which may cause allergic reactions. The 75 microgram tablet contains indigo carmine (E 132) and Allura Red AC (E 129), which may cause allergic reactions. The 88 microgram tablet contains tartrazine (E 102), which may cause allergic reactions. The 100 microgram tablet contains tartrazine (E 102) and orange yellow S (E 110), which may cause allergic reactions. The 125 microgram tablet contains orange yellow S (E 110) and Allura Red AC (E 129), which may cause allergic reactions.

3. How to take Levothyroxine Accord

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are not sure, they should ask their doctor or pharmacist. The doctor will determine the appropriate dose for each patient 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 is reached, which is adjusted individually for each patient. In the first weeks of treatment, laboratory tests will be necessary to allow the doctor to adjust the appropriate dose. If a child is born with a thyroid disease characterized by insufficient hormone production, it is essential to supplement them quickly. Therefore, the 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, the doctor will adjust the dose individually. Typical dose ranges are presented in the table below. Smaller, individually adjusted doses may be sufficient for:

• elderly patients,
• patients with heart diseases,
• patients with severe or prolonged hypothyroidism,
• patients with low body weight 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 at one time, 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. The doctor will discuss with each patient how long they 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

In case of taking a higher dose than recommended, the patient 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, the patient should consult their doctor.

Missing a dose of Levothyroxine Accord

The patient should not take a double dose of the medicine to make up for a missed dose. The next day, they should take their usual dose of the medicine.
In case of doubts about taking Levothyroxine Accord, the patient should consult their 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. If the patient experiences sudden symptoms such as wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, and itching (especially all over the body), they should contact their doctor immediately. In case of poor tolerance to the recommended dose or taking a higher dose of Levothyroxine Accord than recommended, the patient may experience symptoms similar to hyperthyroidism, especially if the dose is increased too quickly at the beginning 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 heart rhythm, 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 the patient experiences any of the above symptoms, they should contact their doctor. The symptoms usually disappear after changing the dose.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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, it is possible to gather more information on the safety of the medicine.

5. How to store Levothyroxine Accord

The medicine should be stored 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. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Package contents and other information

What Levothyroxine Accord contains

The active substance of Levothyroxine Accord 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. The 25 microgram tablet contains Lake Blend LB530006 Orange, which includes orange yellow S (E 110) and aluminum lake. The 75 microgram tablet contains Lake Blend LB505008 Purple, which includes indigo carmine (E 132) and aluminum lake, and Allura Red AC (E 129) and aluminum lake. The 88 microgram tablet contains Lake Blend LB510028 Green, which includes tartrazine (E 102) and aluminum lake, and indigo carmine (E 132) and aluminum lake. The 100 microgram tablet contains Lake Blend LB520044 Yellow, which includes tartrazine (E 102) and aluminum lake, and orange yellow S (E 110) and aluminum lake. The 112 microgram tablet contains Lake Blend LB540042 Pink, which includes carmine (E 120) and Allura Red AC (E 129) and aluminum lake. The 125 microgram tablet contains Lake Blend LB575003 Brown, which includes orange yellow S (E 110) and aluminum lake, Brilliant Blue FCF (E 133) and aluminum lake, and Allura Red AC (E 129) and aluminum lake. The 137 microgram tablet contains Lake Blend LB505013 Blue, which includes Brilliant Blue FCF (E 133) and aluminum lake. The 150 microgram tablet contains Lake Blend LB505010 Blue, which includes indigo carmine (E 132) and aluminum lake. The 175 microgram tablet contains Lake Blend LB500017 Purple, which includes carmine (E 120) and Brilliant Blue FCF (E 133) and aluminum lake. The 200 microgram tablet contains Lake Blend LB540010 Maroon, which includes Allura Red AC (E 129) and aluminum lake.

What Levothyroxine Accord looks like and contents of the pack

12.5 micrograms
White, round, flat, uncoated tablets with "P" and "13" embossed on one side and smooth on the other side. The diameter of the tablet is approximately 7 mm.
25 micrograms
Orange, round, flat, uncoated tablets with a score line on both sides and "P" and "1" embossed on one side and smooth on the other side. The diameter of the tablet is approximately 7 mm. The tablet can be divided into equal doses.
50 micrograms
White, round, flat, uncoated tablets with a score line on both sides and "P" and "2" embossed on one side and smooth on the other side. The diameter of the tablet is approximately 7 mm. The tablet can be divided into equal doses.
75 micrograms
Purple, round, flat, uncoated tablets with a score line on both sides and "P" and "3" embossed on one side and smooth on the other side. The diameter of the tablet is approximately 7 mm. The tablet can be divided into equal doses.
88 micrograms
Green, round, flat, uncoated tablets with a score line on both sides and "P" and "4" embossed on one side and smooth on the other side. The diameter of the tablet is approximately 7 mm. The tablet can be divided into equal doses.
100 micrograms
Yellow, round, flat, uncoated tablets with a score line on both sides and "P" and "14" embossed on one side and smooth on the other side. The diameter of the tablet is approximately 7 mm. The tablet can be divided into equal doses.
112 micrograms
Pink, round, flat, uncoated tablets with a score line on both sides and "P" and "6" embossed on one side and smooth on the other side. The diameter of the tablet is approximately 7 mm. The tablet can be divided into equal doses.
125 micrograms
Brown, round, flat, uncoated tablets with a score line on both sides and "P" and "7" embossed on one side and smooth on the other side. The diameter of the tablet is approximately 7 mm. The tablet can be divided into equal doses.
137 micrograms
Turquoise, round, flat, uncoated tablets with a score line on both sides and "P" and "8" embossed on one side and smooth on the other side. The diameter of the tablet is approximately 7 mm. The tablet can be divided into equal doses.
150 micrograms
Blue, round, flat, uncoated tablets with a score line on both sides and "P" and "9" embossed on one side and smooth on the other side. The diameter of the tablet is approximately 7 mm. The tablet can be divided into equal doses.
175 micrograms
Lilac, round, flat, uncoated tablets with a score line on both sides and "P" and "10" embossed on one side and smooth on the other side. The diameter of the tablet is approximately 7 mm. The tablet can be divided into equal doses.
200 micrograms
Pink, round, flat, uncoated tablets with a score line on both sides and "P" and "11" embossed on one side and smooth on the other side. The diameter of the tablet is approximately 7 mm. The tablet can be divided into equal doses.
12.5 micrograms
Orange-colored blister pack containing 10, 50, 100, or 200 tablets in a carton.
25/50/100 micrograms
Orange-colored 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 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 white, non-transparent polypropylene child-resistant closure and 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
Lithuania
Levothyroxine Accord 12.5/25/50/75/88/100/112/125/137/150/175/200 micrograms tablets
Latvia
Levothyroxine Accord 12.5/25/50/75/88/100/112/125/137/150/175/200 micrograms tablets
Greece
Levothyroxine/Accord 12.5/25/50/75/88/100/112/125/137/150/175/200 micrograms tablets

• Cyprus
  Levothyroxine Accord 25/50/100 microgram tablets

Date of last revision of the package leaflet: November 2024