Levothiroxine Accord

Leaflet attached to the packaging: 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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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 packaging 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 the growth of tumors 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 that 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 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 increase of levothyroxine dose.

2. Important information before taking Levothyroxine Accord

When not to take Levothyroxine Accord

• During pregnancy, Levothyroxine Accord should not be taken with antithyroid drugs to treat 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 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, it is necessary to frequently check thyroid hormone levels. In case of doubts about whether the patient has 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 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 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 tell their doctor if they experience any side effects, as it may be necessary to increase or decrease the dose.

• in case of changing one levothyroxine-containing medicine to another levothyroxine-containing medicine. The effects of these medicines may differ slightly, and therefore, more frequent monitoring and dose adjustment may be necessary;
• in case of starting or stopping orlistat treatment or changing orlistat treatment (a medicine used to treat obesity); more frequent monitoring and dose adjustment may be necessary;
• in case of psychotic disorders, the doctor may recommend more frequent monitoring and dose adjustment;

Disruption of thyroid hormone balance may occur when changing the levothyroxine-containing medicine to another levothyroxine-containing medicine. If the patient has any questions about changing the medicine, they should consult their doctor. Close monitoring of the patient (clinical and biological assessment) is necessary during the transition period. If any side effects occur, the patient should consult their doctor, 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 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 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 observed when taking any of the following medicines:

• bile acid sequestrants and cholesterol-lowering medicines (cholestyramine or colestypol): 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 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:

• 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 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 action of Levothyroxine Accord, so 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:

• salicylates (medicines used to relieve pain and lower fever),
• dicumarol (a medicine that lowers blood coagulation),
• 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 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:

• ritonavir, indinavir, lopinavir (protease inhibitors, medicines used to treat HIV infection),
• 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 gut and make it less effective. If the patient takes levothyroxine while being treated with proton pump inhibitors, the doctor should monitor 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 the patient is taking amiodarone (a medicine used to treat heart rhythm disorders), they should tell their doctor, as this medicine may affect thyroid function. The patient should tell 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 tell 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 severe 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 the results of laboratory tests (see "Warnings and precautions").

Levothyroxine Accord with food and drink

If the patient's diet includes soy products, they should tell 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 therefore, it may be necessary to adjust the dose of Levothyroxine Accord.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, 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 (thyreostatics). If necessary, the doctor may adjust the dose. If the patient becomes pregnant, they should contact their doctor. There is no evidence that taking Levothyroxine Accord during breastfeeding harms the baby with normal thyroid function. Levothyroxine Accord should not be taken if the patient is breastfeeding and taking antithyroid drugs (thyreostatics).

Driving and operating machinery

Levothyroxine sodium should not affect the ability to drive and operate machinery.

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 "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

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The doctor will determine the appropriate dose for each patient based on clinical assessment 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 the 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, 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 following symptoms may occur: rapid heartbeat, restlessness, 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 the 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. If the patient has poor tolerance to the recommended dose or takes a higher dose of Levothyroxine Accord than recommended, they 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, restlessness, 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 dose adjustment.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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. 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 sight and reach of children. Do not take 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. 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. Contents of the packaging 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 orange yellow S (E 110). The 75 microgram tablet contains indigo carmine (E 132) and Allura red AC (E 129). The 88 microgram tablet contains tartrazine (E 102). The 100 microgram tablet contains tartrazine (E 102) and orange yellow S (E 110). The 125 microgram tablet contains orange yellow S (E 110) and Allura red AC (E 129).

What Levothyroxine Accord looks like and contents of the pack

12.5 micrograms
Round, flat, uncoated tablets, white, with a score line on one side and "P" and "13" embossed on the other side. Diameter of the tablet is about 7 mm.
25 micrograms
Round, flat, uncoated tablets, orange, with a score line on both sides and "P" and "1" embossed on one side and plain on the other side. Diameter of the tablet is about 7 mm. The tablet can be divided into equal doses.
50 micrograms
Round, flat, uncoated tablets, white, with a score line on both sides and "P" and "2" embossed on one side and plain on the other side. Diameter of the tablet is about 7 mm. The tablet can be divided into equal doses.
75 micrograms
Round, flat, uncoated tablets, purple, with a score line on both sides and "P" and "3" embossed on one side and plain on the other side. Diameter of the tablet is about 7 mm. The tablet can be divided into equal doses.
88 micrograms
Round, flat, uncoated tablets, olive green, with a score line on both sides and "P" and "4" embossed on one side and plain on the other side. Diameter of the tablet is about 7 mm. The tablet can be divided into equal doses.
100 micrograms
Round, flat, uncoated tablets, yellow, with a score line on both sides and "P" and "14" embossed on one side and plain on the other side. Diameter of the tablet is about 7 mm. The tablet can be divided into equal doses.
112 micrograms
Round, flat, uncoated tablets, pink, with a score line on both sides and "P" and "6" embossed on one side and plain on the other side. Diameter of the tablet is about 7 mm. The tablet can be divided into equal doses.
125 micrograms
Round, flat, uncoated tablets, brown, with a score line on both sides and "P" and "7" embossed on one side and plain on the other side. Diameter of the tablet is about 7 mm. The tablet can be divided into equal doses.
137 micrograms
Round, flat, uncoated tablets, turquoise, with a score line on both sides and "P" and "8" embossed on one side and plain on the other side. Diameter of the tablet is about 7 mm. The tablet can be divided into equal doses.
150 micrograms
Round, flat, uncoated tablets, blue, with a score line on both sides and "P" and "9" embossed on one side and plain on the other side. Diameter of the tablet is about 7 mm. The tablet can be divided into equal doses.
175 micrograms
Round, flat, uncoated tablets, lilac, with a score line on both sides and "P" and "10" embossed on one side and plain on the other side. Diameter of the tablet is about 7 mm. The tablet can be divided into equal doses.
200 micrograms
Round, flat, uncoated tablets, pink, with a score line on both sides and "P" and "11" embossed on one side and plain on the other side. Diameter of the tablet is about 7 mm. The tablet can be divided into equal doses.
12.5 micrograms
Orange blister pack containing 10, 50, 100, or 200 tablets in a carton.
25/50/100 micrograms
Orange 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 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 leaflet: November 2024