Eferox

Package Leaflet: Information for the Patient

Eferox,25 micrograms, tablets
Eferox,50 micrograms, tablets
Eferox,75 micrograms, tablets
Eferox,88 micrograms, tablets
Levothyroxine sodium

You should carefully read the contents of this 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 your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What Eferox is and what it is used for

Thyroxine is a hormone produced naturally in the body by the thyroid gland. Levothyroxine sodium is a synthetic form of this hormone.
Eferox is used to supplement the deficiency of thyroid hormone and/or to alleviate diseases and disorders of thyroid function.
Eferox is used:

• to supplement the deficiency of thyroid hormone in all forms of hypothyroidism (hypothyroidism) or after thyroid removal,
• to prevent the recurrence of goiter after goiter removal in patients with normal thyroid function,
• to treat goiter in patients with normal thyroid function,
• as combination therapy with antithyroid drugs in hyperthyroidism, after achieving a normal metabolic state of the thyroid,
• in cases of malignant thyroid cancer, especially after surgical procedures to inhibit tumor growth and as a supplement to the missing thyroid hormone.

2. Important information before taking Eferox

When not to take Eferox

• if you are allergic to levothyroxine or any of the other ingredients of this medicine (listed in section 6);
• if you have untreated hyperthyroidism (hyperthyroidism, thyrotoxicosis);
• if you have adrenal insufficiency (adrenal insufficiency) and you are not receiving appropriate replacement therapy;
• if you have untreated hypopituitarism;
• if you have the following diseases or conditions:
• acute myocardial infarction
• acute myocarditis
• acute pancarditis
• in case of pregnancy, you should not take Eferox at the same time as other medicines for hyperthyroidism (antithyroid drugs).

Before starting treatment with Eferox, the following diseases or conditions must be excluded or treated:

• coronary heart disease;
• chest pain (angina pectoris);
• fatty deposits in the arteries (atherosclerosis);
• high blood pressure (hypertension);
• conditions in which the pituitary gland and/or adrenal glands do not produce enough hormones (hypopituitarism and/or adrenal insufficiency);
• areas in the thyroid gland that produce uncontrolled amounts of thyroid hormone (autonomous thyroid function).

Warnings and precautions

Thyroid hormones are not suitable for use in weight loss. Taking thyroid hormones will not lead to weight loss in patients with normal thyroid hormone levels. Taking additional amounts of thyroid hormones without a doctor's prescription can cause serious, even life-threatening, side effects, especially in combination with other weight loss medications (see section 2: "Eferox and other medicines").
In case of a need to change the medicine to another levothyroxine-containing medicine, an imbalance of thyroid function may occur. If you have any questions about changing the medicine, you should discuss it with your doctor. Patients should be closely monitored (clinically and biologically) during the transition period. You should inform your doctor if you experience any side effects, as this may indicate the need to adjust the dose (increase or decrease the dose).
Before starting treatment with Eferox, you should discuss the following with your doctor or pharmacist:

• if you have been suffering from hypothyroidism for a long time, for example since birth or the disease was discovered in childhood;
• if you have heart disease, including angina pectoris, coronary heart disease, heart failure, arrhythmias, or high blood pressure;
• if you have recently had a heart attack;
• if you are taking anticoagulant medications (e.g., phenprocoumon). The dose of this medicine may need to be adjusted (see section 2: "Eferox and other medicines");
• if you are being treated for diabetes. The dose of your antidiabetic medication may need to be adjusted, as levothyroxine may increase blood sugar levels (see section 2: "Eferox and other medicines");
• if you are in menopause. You should have your thyroid function checked more frequently to avoid increased levothyroxine levels in the blood, which can cause osteoporosis (bone fragility);
• if you have epilepsy (seizures). When starting levothyroxine treatment or rapidly increasing the dose, seizures have been reported to occur rarely;
• if you have myxedema (swelling of the skin and subcutaneous tissue), as the dose of Eferox may need to be reduced;
• if you have small intestine disease, as it may cause absorption disorders (malabsorption syndrome, e.g., celiac disease, lactose intolerance) and may require treatment to ensure that Eferox works properly;
• if you have adrenal insufficiency (adrenal insufficiency), hypopituitarism, or a certain type of thyroid dysfunction with uncontrolled excessive production of thyroid hormones, as in such cases, appropriate treatment is necessary before starting Eferox.

If you are going to have laboratory tests to check your thyroid hormone levels, you should inform your doctor or laboratory staff if you are currently taking or have recently taken biotin (also known as vitamin H, vitamin B7, or vitamin B8). Biotin may affect laboratory test results. Depending on the type of test, the results may be falsely elevated or falsely decreased due to biotin intake. Your doctor may recommend that you stop taking biotin before 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 laboratory test results. If you are taking such products, you should inform your doctor or laboratory staff (see "Warnings and precautions").

You should talk to your doctor if you experience symptoms of psychotic disorders.
When starting levothyroxine treatment in premature infants with very low birth weight, you should regularly check blood pressure, as a sudden drop in blood pressure (so-called circulatory collapse) may occur.
In elderly patients, e.g., those with heart disease, the dose should be adjusted carefully and individually. Your doctor should monitor such patients closely.

Blood Tests

Before starting levothyroxine treatment, your doctor will perform a blood test to check how much thyroxine your thyroid gland produces and what dose of the medicine you will need. After starting treatment, your doctor will recommend regular blood tests to check if the medicine is working properly.

Eferox and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes over-the-counter medicines, herbal medicines, and vitamin supplements. Many other medicines may affect the action of Eferox. Levothyroxine may also affect the action of other medicines.
Before undergoing a test with iodine-based contrast agents, you should inform your doctor that you are taking Eferox.
If you are currently taking or have recently taken biotin, you must inform your doctor and/or laboratory staff if you are to undergo thyroid hormone laboratory tests. Biotin may affect laboratory test results (see "Warnings and precautions").
The following medicines may affect the action of levothyroxine:

• medicines used in epilepsy, such as carbamazepine, phenytoin, primidone, and barbiturates
• medicines containing St. John's wort (some herbal medicines)
• sertraline, lithium - medicines used in depression, mood disorders, and anxiety
• statins, such as simvastatin and lovastatin (medicines used to treat high cholesterol levels in the blood);
• rifampicin - a medicine used to treat infections
• imatinib, sunitinib, 5-fluorouracil - medicines used to treat certain types of cancer
• beta-adrenergic blockers, such as propranolol, atenolol, and sotalol - medicines used to treat high blood pressure and heart disease
• hormonal medicines containing estrogen, used in hormone replacement therapy and hormonal contraception ("the pill")
• hormonal medicines containing androgens, used in hormone replacement therapy

in men

• glucocorticoids, such as cortisol, hydrocortisone, prednisolone, and dexamethasone - medicines used to treat inflammatory conditions
• amiodarone - a medicine used to treat irregular heart rhythm
• anti-inflammatory medicines, such as phenylbutazone or acetylsalicylic acid
• methadone - a medicine used in substitution therapy for opioid dependence
• furosemide - a medicine used to treat high blood pressure or edema
• propylthiouracil - a medicine used to treat hyperthyroidism
• iodide - used to protect the thyroid gland from radiation
• oral contrast agents - taken before some imaging tests to improve visualization of body parts
• chloroquine or proguanil - used in malaria prophylaxis and rheumatic diseases
• ritonavir - a medicine used to control HIV infection and chronic hepatitis C virus infection
• orlistat - a medicine used to treat obesity;
• proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole, and lansoprazole) are 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 Eferox if necessary.

Eferox should be taken at least 4 to 5 hours before taking the following medicines:

• calcium, magnesium, aluminum, or iron supplements, lanthanum
• cholestyramine, colestipol, or clofibrate - medicines used to reduce high cholesterol levels in the blood
• sodium polystyrene sulfonate - used to treat kidney disease
• orlistat - used for weight loss
• cimetidine - used to inhibit excessive stomach acid production
• proton pump inhibitors, such as omeprazole, esomeprazole - medicines used to inhibit excessive stomach acid production
• sucralfate, antacids - used to treat stomach ulcers.

Eferox may affect the action of the following medicines:

• anticoagulant medicines that prevent blood clots, such as warfarin, dicumarol, and phenprocoumon
• medicines used to treat diabetes, such as insulin and metformin
• tricyclic antidepressant medicines, such as amitriptyline, imipramine, and doxepin
• medicines that stimulate the sympathetic nervous system, such as adrenaline (used to treat severe allergic reactions) or phenylephrine (a decongestant found in many cold and flu medicines)
• digoxin - a medicine used to treat heart disease
• phenytoin - a medicine used to treat epilepsy.

Eferox with food and drink

Products and foods containing soy, rich in fiber, may affect the absorption of levothyroxine. Therefore, the dose of levothyroxine may need to be adjusted by your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Continuous treatment with thyroid hormones is particularly important during pregnancy and breastfeeding, and therefore, it must be continued under the supervision of your doctor.
During pregnancy, the need for levothyroxine may increase due to increased estrogen levels (female sex hormone) in the blood. Therefore, thyroid function should be monitored during pregnancy and after childbirth, and the dose of levothyroxine should be adjusted accordingly.
Even when taking high doses of levothyroxine, the amount of thyroid hormone that passes into breast milk during breastfeeding is very small, so it is harmless.
During pregnancy and breastfeeding, suppression tests should not be performed.

Driving and using machines

It is not expected that Eferox will have any effect on the ability to drive or use machines, as the levothyroxine contained in this medicine is identical to the thyroid hormone that occurs naturally in the body.

Eferox contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Eferox

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
In elderly patients, patients with coronary heart disease, and patients with severe or chronic hypothyroidism, thyroid hormone treatment should be started with caution. In these patients, treatment should be started with a small initial dose, which should then be gradually increased over a longer period, with frequent monitoring of thyroid hormone levels. Experience has shown that smaller doses are also sufficient for people with low body weight and patients with large goiters.
Dosage
For individual treatment, Eferox tablets with graduated strengths from 25 to 200 micrograms are available, which means that in most cases, only one tablet per day needs to be taken.
Your doctor will determine the individual dose for you based on the tests and laboratory results. Treatment usually starts with a small dose, which is increased every 2 to 4 weeks until the full dose, adjusted individually for you, is reached. In the first few weeks of treatment, you will be prescribed laboratory tests, which will allow your doctor to adjust the appropriate dose.

Method of administration
The entire daily dose should be taken in the morning, on an empty stomach, at least half an hour before breakfast, as the active substance is better absorbed on an empty stomach than before or after a meal. The tablets should be swallowed whole, without chewing, with a glass of water.
Infants should receive the entire daily dose at least half an hour before the first meal, preferably with a small amount of water to facilitate swallowing. If necessary, the tablet can be divided.
It is not recommended to crush the tablet or prepare a suspension in water or other liquids, as this may lead to incorrect dosing.
Eferox tablets can be divided into equal doses.

Note on dividing the tablet

Place the tablet on a hard, flat surface with the dividing line facing up. To divide the tablet, press your thumb directly on the center of the tablet.

Duration of treatment
The medicine should be taken for as long as your doctor recommends.
If you have hypothyroidism or have had thyroid surgery due to malignant thyroid cancer, you will usually take Eferox for the rest of your life.
In the case of goiter and to prevent the recurrence of goiter, Eferox should be taken for several months or years, or even for the rest of your life.
In combination therapy for hyperthyroidism, Eferox should be taken for as long as you are taking antithyroid medication (thyreostatic).
In the treatment of goiter with normal thyroid function, the medicine should be taken for 6 months to 2 years. If the use of Eferox does not produce the desired results within this period, other treatment options should be considered.

Overdose of Eferox

If you (or someone else) have taken more tablets than you should, or if you suspect that a child has taken any amount of tablets, you should immediately contact your doctor, the emergency department of the nearest hospital, or the poison control center.
Symptoms of overdose may include: excitement, confusion, irritability, fever, chest pain (angina pectoris), rapid or irregular heartbeat, rapid breathing, muscle spasms, headache, anxiety, hyperactivity, flushing, sweating, diarrhea, tremors, difficulty sleeping, anxiety or nervousness, feeling of physical or emotional exhaustion, seizures.
These symptoms may last up to 6 days. You should take the remaining tablets and this leaflet with you, so that the medical staff knows exactly what medicine you have taken.

Missed dose of Eferox

If you miss a dose, you should take your usual dose of the medicine at the next scheduled time. Do not take a double dose to make up for the missed dose. If you are unsure, you should consult your doctor or pharmacist.

Stopping Eferox treatment

To ensure that the treatment is effective, you should regularly take Eferox in the doses prescribed by your doctor. Under no circumstances should you change, stop, or discontinue the prescribed treatment without consulting your doctor, as your symptoms may return.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Eferox can cause side effects, although not everybody gets them.

You should stop taking the tablets and go to the hospital immediately if you experience:

• an allergic reaction, such as: swelling of the face, tongue, lips, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing (angioedema), severe itching of the skin with raised lumps, joint pain, sensitivity to light, general feeling of being unwell (frequency not known). You may need urgent medical attention.

In some patients, a severe reaction to high levels of thyroid hormone may occur. This is called a "thyroid crisis". You should stop taking the tablets and go to the hospital immediately if you experience any of the following symptoms (frequency not known):

• very high fever, rapid heartbeat, irregular heartbeat, low blood pressure, heart failure, jaundice, confusion, seizures, and coma.

You should inform your doctor or pharmacist if you experience any of the following side effects, if they get worse, or if you notice any other side effects not listed in this leaflet.

Most side effects are similar to the symptoms of hyperthyroidism (when the thyroid gland produces too much thyroxine) and are caused by taking too high a dose of the medicine. Symptoms usually disappear after the dose is reduced or the tablets are stopped. You should inform your doctor if you experience any side effects. Your doctor will decide whether to reduce the daily dose or stop the medicine for a few days. However, you should not change the dose of the medicine or stop taking the tablets without consulting your doctor first.
Frequency not known:frequency cannot be estimated from the available data

• increased appetite
• anxiety, excitement, difficulty sleeping (insomnia)
• tremors, headache, seizures
• chest pain (angina pectoris), palpitations, irregular or rapid heartbeat, heart failure, myocardial infarction
• high blood pressure (hypertension), sudden flushing
• shortness of breath (dyspnea)
• diarrhea, feeling of nausea (nausea), vomiting, abdominal pain
• increased sweating, itching, skin rash, hives
• muscle spasms, muscle weakness, joint pain
• decreased bone density (osteoporosis), especially in postmenopausal women taking high doses of the medicine for a long time
• in women: irregular menstrual periods
• fever (high temperature), swelling, general feeling of being unwell
• weight loss
• hyperthyroidism.

Additional side effects in children
Rare:may affect up to 1 in 1,000 people

• increased intracranial pressure in children, which is not caused by a tumor or other diseases (benign intracranial hypertension).

Frequency not known:frequency cannot be estimated from the available data

• slowed or stopped growth in children, due to changes in bone development
• temporary hair loss in children
• skull deformity in infants, caused by premature closure of bone growth plates in children (craniosynostosis)
• heat intolerance.

In case of hypersensitivity to levothyroxine or any of the other ingredients of Eferox, allergic reactions affecting the skin and respiratory tract may occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 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 Eferox

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP. The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Eferox contains

• The active substance of the medicine is anhydrous levothyroxine sodium.

Eferox, 25 micrograms, tablets
Each tablet contains 25 micrograms of anhydrous levothyroxine sodium.
Eferox, 50 micrograms, tablets
Each tablet contains 50 micrograms of anhydrous levothyroxine sodium.
Eferox, 75 micrograms, tablets
Each tablet contains 75 micrograms of anhydrous levothyroxine sodium.
Eferox, 88 micrograms, tablets
Each tablet contains 88 micrograms of anhydrous levothyroxine sodium.

• The other ingredients are: microcrystalline cellulose, cornstarch, heavy magnesium oxide, sodium carboxymethylcellulose (type A), and magnesium stearate.

What Eferox looks like and contents of the package

Eferox: the tablets are white, round, uncoated, divisible by pressure, with a dividing line on one side and a numerical marking corresponding to the strength (i.e., 25, 50, 75, 88) embossed on the other side. The tablets have a diameter of approximately 7 mm and a height of approximately 3 mm.
Eferox 25 micrograms and 50 micrograms are available in blisters containing 15, 20, 25, 30, 50, 60, 84, 90, and 100 tablets in a carton.
Eferox 75 micrograms is available in blisters containing 20, 25, 30, 50, 60, 90, or 100 tablets in a carton.
Eferox 88 micrograms is available in blisters containing 25, 30, 50, 60, 90, or 100 tablets in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw
phone: +48 22 855 40 93

Manufacturer

Aristo Pharma GmbH
Wallenroder Straße 8–10
13435 Berlin
Germany
Lindopharm GmbH
Neustraße 82
40721 Hilden
Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Levothyroxin Aristo 25/50/75/88 Mikrogramm Tabletten
Germany
L-Thyroxin Aristo 25/50/75/88 Mikrogramm Tabletten
Czech Republic
Levothyroxine Aristo 25/50/75/88 mikrogramů tablety
Spain
Levotiroxina Aristo 25/50 microgramos comprimidos EFG
Levotiroxina Aristo 75/88 microgramos comprimidos
Netherlands
Levothyroxinenatrium Aristo 25/50/88 microgram tabletten
Ireland
Levothyroxine sodium Aristo 25/50/75/88 microgram tablets
Poland
Eferox 25/50/75/88 mikrogramów tabletki
Portugal
Eferox 25/50/75/88 microgramas comprimidos
Italy
Levotiroxina DOC 25/50/75 mikrogrammi compresse
Levotiroxina Aristo 88 mikrogrammi compresse
Date of last revision of the leaflet: