Eferox

Patient Information Leaflet: Eferox

Eferox,150 micrograms, tablets
Eferox,200 micrograms, tablets
Levothyroxine sodium

Important information about Eferox

• Please read this leaflet carefully before taking Eferox.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Eferox is and what it is used for
• 2. Before you take Eferox
• 3. How to take Eferox
• 4. Possible side effects
• 5. How to store Eferox
• 6. Further information

1. What Eferox is and what it is used for

Thyroxine is a hormone that is produced naturally in the body by the thyroid gland. Levothyroxine sodium is a synthetic form of this hormone.
Eferox is used to replace the thyroid hormone when the thyroid gland does not produce enough, and to treat various thyroid disorders.

• to replace thyroid hormone in all forms of hypothyroidism (underactive thyroid) or after removal of the thyroid gland,
• to prevent recurrence of goiter in patients with normal thyroid function after goiter removal,
• to treat benign goiter in patients with normal thyroid function,
• to treat malignant thyroid cancer, especially after surgical procedures to inhibit tumor growth and as a replacement for missing thyroid hormone,
• in thyroid function suppression tests.

2. Before you take 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 (overactive thyroid),
• if you have untreated adrenal insufficiency (adrenal gland disorder) and are not receiving appropriate replacement therapy,
• if you have untreated hypopituitarism (pituitary gland disorder),
• if you have any of the following conditions:
• acute myocardial infarction (heart attack)
• acute myocarditis (inflammation of the heart muscle)
• acute pancarditis (inflammation of all layers of the heart)
• if you are pregnant and taking Eferox with other anti-thyroid medications.

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

• coronary artery disease,
• angina pectoris (chest pain),
• arteriosclerosis (hardening of the arteries),
• hypertension (high blood pressure),
• conditions where the pituitary gland and/or adrenal glands do not produce enough hormones (hypopituitarism and/or adrenal insufficiency),
• autonomous thyroid function (where the thyroid gland produces excess hormone).

Warnings and precautions

Thyroid hormones should not be used to treat obesity. Taking thyroid hormones will not help you lose weight if your thyroid hormone levels are normal.
Taking extra thyroid hormones without a doctor's prescription can cause serious, life-threatening side effects, especially when combined with other weight-loss medications (see section 2: "Eferox and other medicines").
If you need to switch to a different levothyroxine medicine, you may experience a disruption in your thyroid function. If you have any questions about switching, discuss them with your doctor. You will need to be closely monitored (clinically and biochemically) during the transition period.
Tell your doctor if you experience any side effects, as this may indicate a need to adjust your dose (increase or decrease).

• if you have been hypothyroid for a long time, for example since birth or childhood,
• if you have heart disease, including angina, coronary artery 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 medication may need to be adjusted (see section 2: "Eferox and other medicines"),
• if you are being treated for diabetes. The dose of your anti-diabetic medication may need to be adjusted, as levothyroxine can increase blood sugar levels (see section 2: "Eferox and other medicines"),
• if you are menopausal. 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 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 malabsorption of the medicine (e.g., celiac disease, lactose intolerance) and may require treatment to ensure Eferox works properly,
• if you have adrenal insufficiency (adrenal gland disorder), hypopituitarism (pituitary gland disorder), or certain thyroid function disorders with uncontrolled excess hormone production, as treatment with Eferox may need to be initiated or adjusted,
• 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 can 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 advise you to stop taking biotin before laboratory tests. You should also be aware that other products you are taking, such as multivitamins or supplements for hair, skin, and nails, may also contain biotin, which can affect laboratory test results. If you are taking such products, you should inform your doctor or laboratory staff (see section 2: "Eferox and other medicines").

Tell your doctor if you experience any symptoms of psychotic disorders.
When starting levothyroxine treatment in premature infants with very low birth weight, blood pressure should be monitored regularly, as a sudden drop in blood pressure (so-called circulatory collapse) may occur.
In elderly patients, especially those with heart disease, the dose should be adjusted carefully and individually. The doctor should monitor these patients.

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 Eferox 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

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those without a prescription, herbal medicines, and vitamin supplements. Many other medicines can affect the action of Eferox, and levothyroxine can also affect the action of other medicines.
Before undergoing a test with iodine-based contrast agents, 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 going to have laboratory tests for thyroid hormones. Biotin can affect laboratory test results (see "Warnings and precautions").

• medicines used to treat epilepsy, such as carbamazepine, phenytoin, primidone, and barbiturates
• medicines containing St. John's Wort (some herbal medicines)
• sertraline, lithium - medicines used to treat depression, mood disorders, and anxiety
• statins, such as simvastatin and lovastatin (medicines used to treat high cholesterol)
• rifampicin - a medicine used to treat infections
• imatinib, sunitinib, 5-fluorouracil - medicines used to treat certain types of cancer
• beta-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 for men
• corticosteroids, 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 to treat 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 visibility of body parts
• chloroquine or proguanil - used to prevent malaria and rheumatic diseases
• ritonavir - a medicine used to control HIV infection and chronic hepatitis C
• orlistat - a medicine used to treat obesity
• proton pump inhibitors (such as omeprazol, esomeprazol, pantoprazol, rabeprazol, and lansoprazol) - used to reduce stomach acid production, which can decrease levothyroxine absorption 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 adjust 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 lower high cholesterol
• sodium polystyrene sulfonate - used to treat kidney disease
• orlistat - used for weight loss
• cimetidine - used to reduce stomach acid production
• proton pump inhibitors, such as omeprazol, esomeprazol - medicines used to reduce 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 conditions
• phenytoin - a medicine used to treat epilepsy

Eferox with food and drink

Products and foods containing soy, high in fiber, may affect levothyroxine absorption. 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Continuous treatment with thyroid hormones is particularly important during pregnancy and breastfeeding, and therefore must be continued under medical supervision.
During pregnancy, the need for levothyroxine may increase due to increased estrogen levels in the blood. Therefore, thyroid function should be monitored during and after pregnancy, and the dose of levothyroxine adjusted as necessary.
Even when taking high doses of levothyroxine, the amount of thyroid hormone that passes into breast milk during breastfeeding is very small and harmless.
During pregnancy and breastfeeding, thyroid function suppression tests should not be performed.

Driving and using machines

Eferox is not expected to affect your ability to drive or use machines, as the levothyroxine in this medicine is identical to the thyroid hormone that occurs naturally in the body.

Eferox contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Eferox

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
In elderly patients, patients with coronary artery 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 slowly 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.

Dosage

For individual treatment, Eferox tablets are available in strengths of 25 to 200 micrograms, which means that in most cases, only one tablet needs to be taken per day.
Your doctor will determine your individual dose based on the results of your tests and laboratory tests. Treatment usually starts with a small dose, which is increased every 2 to 4 weeks until the full dose, tailored to your individual needs, is reached. In the first few weeks of treatment, you will be asked to have laboratory tests, which will allow your doctor to adjust the correct 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 their daily dose at least half an hour before their 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.

Tablet division

Place the tablet on a hard, flat surface with the score 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 your thyroid gland removed due to malignant thyroid cancer, you will usually take Eferox for the rest of your life.
In the case of benign goiter and to prevent recurrence 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 you are taking anti-thyroid medication (thyreostatic medication).
In the treatment of benign goiter with normal thyroid function, the medicine should be taken for 6 months to 2 years. If Eferox does not produce the desired results within this period, other treatment options should be considered.
To perform thyroid function suppression tests, 150 or 200 micrograms of Eferox should be taken per day for 14 days.

Overdose of Eferox

If you (or someone else) have taken too many tablets, or if a child has taken any, contact your doctor, the emergency department of your nearest hospital, or the national poison control center immediately.
Symptoms of overdose may include: restlessness, confusion, irritability, fever, chest pain (angina), rapid or irregular heartbeat, rapid breathing, muscle cramps, headache, anxiety, agitation, flushing, sweating, diarrhea, tremors, difficulty sleeping, anxiety or nervousness, feeling of fatigue, physical or emotional exhaustion, seizures.
These symptoms may last up to 6 days. Take any remaining tablets and this leaflet with you to the hospital so that the medical staff knows exactly what you have taken.

Missed dose of Eferox

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

Stopping Eferox treatment

To ensure effective treatment, you should regularly take Eferox in the doses prescribed by your doctor. In no case should you change, stop, or discontinue the prescribed treatment without consulting your doctor, as your symptoms may return.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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 sunlight, 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, known as a "thyroid crisis". 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.

Tell your doctor or pharmacist if you experience any of the following side effects:

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 Eferox. Symptoms usually disappear after the dose is reduced or the tablets are stopped. Tell 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, do 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, restlessness, difficulty sleeping (insomnia)
• tremors, headache, seizures
• chest pain (angina), palpitations, irregular or rapid heartbeat, heart failure, myocardial infarction
• high blood pressure (hypertension), sudden flushing
• shortness of breath (dyspnea)
• diarrhea, nausea (nausea), vomiting, abdominal pain
• increased sweating, itching, skin rash, hives
• muscle cramps, muscle weakness, joint pain
• decreased bone density (osteoporosis), especially in postmenopausal women taking high doses of Eferox 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
• craniosynostosis (premature closure of the skull bones) in infants, due to premature closure of the bone growth plates
• 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, tell your doctor or 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:
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

Keep this medicine out of the 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.
Do not store above 30°C.
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. Further information

What Eferox contains

• The active substance is levothyroxine sodium anhydrous.

Eferox, 150 micrograms, tablets
Each tablet contains 150 micrograms of levothyroxine sodium anhydrous.
Eferox, 200 micrograms, tablets
Each tablet contains 200 micrograms of levothyroxine sodium anhydrous.

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

What Eferox looks like and contents of the pack

Eferox: tablets are white, round, uncoated, divisible by pressure, with a score line on one side and a numerical marking corresponding to the strength (i.e., 150 or 200) embossed on the other side. The tablets are approximately 7 mm in diameter and 3 mm in height.
Eferox 150 micrograms is available in blisters containing 20, 25, 30, 50, 60, 90, or 100 tablets in a carton.
Eferox 200 micrograms is available in blisters containing 15, 20, 25, 30, 50, 60, 84, 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 150/200 Mikrogramm Tabletten
Germany
L-Thyroxin Aristo 150/200 Mikrogramm Tabletten
Czech Republic
Levothyroxine Aristo 150/200 mikrogramů tablety
Finland
Levothyroxine Aristo 200 mikrog tablettia
Spain
Levotiroxina Aristo 150/200 microgramos comprimidos
Netherlands
Levothyroxinenatrium Aristo 200 microgram tabletten
Ireland
Levothyroxine sodium Aristo 150/200 microgram tablets
Poland
Eferox 150/200 mikrogramów tabletki
Portugal
Eferox 150/200 microgramas comprimidos
Sweden
Levothyroxine Aristo 150/200 mikrogram tabletter
Italy
Levotiroxina DOC 150/200 mikrogrammi compresse
Date of last revision of the leaflet: