Eferox

Leaflet accompanying the packaging: patient information

Eferox,112 micrograms, tablets
Eferox,125 micrograms, tablets
Eferox,137 micrograms, tablets
Eferox,175 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 as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Eferox and what is it 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 packaging and other information

1. What is Eferox and what is it 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 a deficiency of thyroid hormone and/or to alleviate diseases and disorders of thyroid function.
Eferox is used:

• to supplement a deficiency of thyroid hormone in all forms of hypothyroidism (hypothyroidism) or after thyroid removal,
• to prevent relapses of goiter after goiter removal in patients with normal thyroid function,
• to treat benign (non-malignant) goiter in patients with normal thyroid function,
• in cases of malignant thyroid cancer, especially after surgical procedures to inhibit tumor growth and as a supplement to replace missing thyroid hormone.

2. Important information before taking Eferox

When not to take Eferox

• if the patient is allergic to levothyroxine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has untreated hyperthyroidism (hyperthyroidism, thyrotoxicosis);
• if the patient has adrenal insufficiency (adrenal failure) and the patient is not receiving appropriate replacement therapy;
• if the patient has untreated hypopituitarism;
• if the patient has the following diseases or conditions:
• acute myocardial infarction
• acute myocarditis
• acute pancarditis
• in case of pregnancy, it is not recommended to 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").
If it is necessary to change the medicine to another levothyroxine-containing medicine, a disruption of thyroid function balance may occur. If you have any questions about switching medicines, 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 Eferox, you should discuss the following with your doctor or pharmacist:

• if the patient has been suffering from hypothyroidism for a long time, for example since birth or the disease was discovered in childhood;
• if the patient has heart disease, including angina pectoris, coronary heart disease, heart failure, arrhythmias, or high blood pressure, or atherosclerosis;
• if the patient has recently had a heart attack;
• if the patient is taking anticoagulant medications (e.g., phenprocoumon). The dose of this medicine may need to be adjusted (see section 2: "Eferox and other medicines");
• if the patient is being treated for diabetes. The dose of the antidiabetic medication may need to be adjusted, as levothyroxine may increase blood sugar levels (see section 2: "Eferox and other medicines");
• if the patient is in menopause. It is necessary to monitor thyroid function more frequently to avoid increased levothyroxine levels in the blood, which can cause osteoporosis (bone fragility);
• if the patient has epilepsy (seizures). When starting levothyroxine treatment or rapidly increasing the dose, seizures have been reported to occur rarely;
• if the patient has edema (swelling of the skin and subcutaneous tissue), as the dose of Eferox may need to be reduced;
• if the patient has 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 the patient has adrenal insufficiency (adrenal failure), 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.

Before starting Eferox, the patient should inform their doctor or pharmacist if they are taking or have recently taken any other medicines, including those without a prescription, herbal medicines, and vitamin preparations. Many other medicines can affect the action of Eferox. Levothyroxine can also affect the action of other medicines.
Before undergoing a test using iodine-based contrast agents, the patient should inform their doctor about taking Eferox.
If the patient is currently taking or has recently taken biotin, they must inform their doctor and/or laboratory staff if they are to undergo thyroid hormone laboratory tests. Biotin can affect laboratory test results (see "Warnings and precautions"
The following medicines can 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
• glucocorticosteroids, 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 addiction
• 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 during the test
• 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 can weaken the absorption of levothyroxine from the intestine and make it less effective. If the patient is taking levothyroxine while being treated with proton pump inhibitors, the doctor should monitor 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 antidepressants, 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, high in fiber, may affect the absorption of levothyroxine. Therefore, there may be a need to adjust the dose of levothyroxine by the attending physician.

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.
Continuous treatment with thyroid hormones is particularly important during pregnancy and breastfeeding, and therefore, it must be continued under the supervision of the attending physician.
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 both during and after pregnancy, and the dose of levothyroxine should be adjusted accordingly.
Even during treatment with high doses of levothyroxine, the amount of thyroid hormone passing into breast milk during breastfeeding is very small, so it is harmless.
During pregnancy and breastfeeding, suppression tests should not be performed.

Driving and operating machinery

It is not expected that Eferox will have any effect on the ability to drive and operate machinery, 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 the medicine is considered "sodium-free".

3. How to take Eferox

This medicine should always be taken exactly as prescribed 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 at longer intervals, 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.
Dosing
For individual treatment, Eferox tablets with graduated strengths from 25 to 200 micrograms are available, which means that in most cases, only one tablet needs to be taken per day.
The doctor will determine the individual dose for the patient 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 the patient, is reached. In the first weeks of treatment, the patient will be prescribed laboratory tests, which will allow the 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 tablet division

Place the tablet on a hard, flat surface
with the dividing groove 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 prescribed by the doctor.
If the patient has hypothyroidism or has undergone thyroid surgery due to malignant thyroid cancer, they will usually take Eferox for life.
In the case of benign goiter and to prevent relapses of goiter, Eferox should be taken for several months or years, or even for life.
In supportive therapy for hyperthyroidism, Eferox should be taken for as long as the antithyroid medicine (thyrostatic) is taken.
In the treatment of benign 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.

Using more than the recommended dose of Eferox

If the patient (or someone else) has swallowed more tablets than they should, or if there is a suspicion that a child has taken any amount of tablets, they should immediately contact a doctor, the emergency department of the nearest hospital, or a 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 can see exactly what medicine the patient has taken.

Missing a dose of Eferox

If a dose is missed, the patient should take their usual dose at the next dose time. They should not take a double dose to make up for the missed dose. If they are unsure, they should consult their doctor or pharmacist.

Stopping Eferox treatment

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

4. Possible side effects

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

The patient should stop taking the tablets and go to the hospital immediately if they 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 bumps, joint pain, increased sensitivity to sunlight, general malaise (frequency not known). The patient may need emergency medical attention.

In some patients, a severe reaction to high thyroid hormone levels may occur, known as a "thyroid crisis". The patient should stop taking the tablets and go to the hospital immediately if they 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.

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

Most side effects are similar to 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. The patient should inform their doctor if they experience any side effects. The doctor will decide whether to reduce the daily dose or stop the medicine for a few days. However, the patient should not change the dose of the medicine or stop taking the tablets without consulting their 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 malaise
• weight loss
• hyperthyroidism.

Additional side effects in children
Rarely:may affect up to 1 in 1,000 patients

• 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, caused by 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 side effects occur, including any not listed in this leaflet, the patient should tell their 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:
Aleje Jerozolimskie 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, more information can be collected on the safety of the 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 pack and carton after: EXP. The expiry date refers to the last day of the month stated.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Eferox contains

• The active substance of Eferox is levothyroxine sodium anhydrous.

Eferox, 112 micrograms, tablets
Each tablet contains 112 micrograms of levothyroxine sodium anhydrous.
Eferox, 125 micrograms, tablets
Each tablet contains 125 micrograms of levothyroxine sodium anhydrous.
Eferox, 137 micrograms, tablets
Each tablet contains 137 micrograms of levothyroxine sodium anhydrous.
Eferox, 175 micrograms, tablets
Each tablet contains 175 micrograms of levothyroxine sodium anhydrous.

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

What Eferox looks like and contents of the pack

Eferox: the tablets are white, round, uncoated, divisible by pressure, with a dividing groove on one side and a numerical marking corresponding to the strength (i.e., 112, 125, 137, 175) embossed on the other side. The tablets are approximately 7 mm in diameter and 3 mm in height.
Eferox 125 micrograms is available in blisters containing 20, 25, 30, 50, 60, 90, or 100 tablets in a carton.
Eferox 112 micrograms, 137 micrograms, and 175 micrograms are 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 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 112/125/137/175 Mikrogramm Tabletten
Germany
L-Thyroxin Aristo 112/125/137/175 Mikrogramm Tabletten
Czech Republic
Levothyroxine Aristo 112/125/137/175 mikrogramů tablety
Spain
Levotiroxina Aristo 112/125/137/175 microgramos comprimidos
Netherlands
Levothyroxinenatrium Aristo 112/125/137/175 microgram tabletten
Ireland
Levothyroxine sodium Aristo 112/125/137/175 microgram tablets
Poland
Eferox 112/125/137/175 mikrogramów tabletki
Portugal
Eferox 112/125/137/175 microgramas comprimidos
Italy
Levotiroxina DOC 125 mikrogrammi compresse
Levotiroxina Aristo 112, 137, 175 mikrogrammi compresse
Date of last revision of the leaflet: