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.

Table of Contents of the Package Leaflet:

• 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. Contents of the pack 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 balance 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 to assess thyroid function. Levothyroxine Accord, 12.5 micrograms:

• In children with hypothyroidism as an initial dose to replace thyroid hormone.
• In the elderly, in patients with coronary artery disease, and in 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 while controlling thyroid hormone levels.
• In any patient who requires gradual dose increase of levothyroxine.

2. Important information before taking Levothyroxine Accord

When not to take Levothyroxine Accord

• 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 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,
• fat 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,

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 these diseases or if they are not treated, consult your doctor. Your doctor will perform the necessary tests to determine if you have 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. Consult your doctor if you have any questions about changing medicines. During the transition period, close monitoring of clinical and biochemical parameters is necessary. Tell your doctor if you experience any side effects, 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 weaken the action of antidiabetic medicines, so additional monitoring of blood sugar levels 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 the elderly. 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.

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

• bile acid-binding medicines 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 intestines;

These medicines may weaken the action of Levothyroxine Accord, so 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),
• 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 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 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),
• 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 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 weaken the absorption of levothyroxine from the intestine 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 modify 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), tell your doctor, as this medicine may affect thyroid function. Tell your doctor if you are 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 an injection that affects thyroid function. 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 lose weight. Taking them will not cause 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 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, 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 small intestine, and it may be necessary to adjust the dose of Levothyroxine Accord accordingly.

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 thyroid hormone levels are necessary for a normal pregnancy. Therefore, during pregnancy, you should continue taking Levothyroxine Accord. During pregnancy, do not take Levothyroxine Accord if you are taking antithyroid drugs for the treatment of hyperthyroidism. If necessary, your doctor may adjust the dose. If you become pregnant, 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. Do not take Levothyroxine Accord if you are breastfeeding and taking antithyroid drugs 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 of the 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

Take this medicine always 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 each patient 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:

• the elderly,
• patients with heart disease,
• patients with severe or prolonged hypothyroidism,
• patients with a small body mass or giant goiter.

Method of administration
Levothyroxine Accord is intended for oral use.
Take the single daily dose 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. Your doctor will discuss with you individually how long you should take the medicine. Most patients need to take Levothyroxine Accord for the rest of their lives.

Take more Levothyroxine Accord than prescribed

If you take more Levothyroxine Accord than prescribed, you may experience symptoms such as rapid heartbeat, nervousness, agitation, 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, consult your doctor.

Miss a dose of Levothyroxine Accord

Do not take a double dose of the medicine to make up for a missed dose. The next day, take the usual dose of the medicine.
In case of doubts about taking Levothyroxine Accord, 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. If you experience sudden symptoms such as wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, and itching (especially all over the body), contact your doctor immediately.
In case of poor tolerance to the prescribed dose or if you take more Levothyroxine Accord than prescribed, you 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, agitation,
• 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 these symptoms, 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, 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 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. Contents of the pack 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
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 white, non-transparent 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
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
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