Eferox

Package Leaflet: Information for the Patient

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

Read this leaflet carefully before taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, 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. Contents of the pack and other information

1. What Eferox is and what it is used for

Thyroxine is a hormone produced naturally by the thyroid gland. Levothyroxine sodium is a synthetic form of this hormone.
Eferox is used to replace the lack of thyroid hormone and/or to treat diseases and disorders of the thyroid gland.
Eferox is used:

• to replace the lack of thyroid hormone in all forms of hypothyroidism (underactive thyroid) or after removal of the thyroid gland,
• to prevent recurrence of goiter after goiter removal in patients with normal thyroid function,
• to treat goiter (non-cancerous) in patients with normal thyroid function,
• in the case of malignant thyroid cancer, especially after surgical procedures to inhibit tumor growth and as a supplement to replace the 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 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, do not take Eferox at the same time as other medicines for hyperthyroidism (anti-thyroid drugs).

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

• coronary heart disease;
• angina pectoris;
• arteriosclerosis;
• hypertension;
• conditions in which the pituitary gland and/or adrenal glands do not produce enough hormones (hypopituitarism and/or adrenal insufficiency);
• autonomous thyroid function in patients, where areas of the thyroid gland produce uncontrolled amounts of thyroid hormone.

Warnings and precautions

Thyroid hormones are not suitable for weight loss. Taking thyroid hormones will not lead to weight loss in patients with normal thyroid hormone levels. Taking extra 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 change of medication to another levothyroxine-containing medicine, an imbalance of thyroid function may occur. If you have any questions about changing your medication, 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 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 hypertension;
• 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 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 malabsorption of the medicine (malabsorption syndrome, e.g., celiac disease, lactose intolerance) and may require treatment to ensure that Eferox works properly;
• if you have adrenal insufficiency (adrenal gland disorder), pituitary dysfunction, or a certain type of thyroid dysfunction with uncontrolled excessive production of thyroid hormones, as in such cases, appropriate treatment must be initiated before starting Eferox;
• if you are to undergo laboratory tests to check 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 advise you to stop taking biotin before undergoing 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. This may affect laboratory test results. If you are taking such products, you should inform your doctor or laboratory staff (see "Warnings and precautions" in section 2: "Eferox and other medicines").

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, blood pressure should be monitored regularly, 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. 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 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

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take or use. This includes non-prescription medicines, herbal medicines, and vitamin preparations. Many other medicines may affect the action of Eferox. Levothyroxine may also affect the action of other medicines.
Before undergoing a test using 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 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)
• 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 visibility 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
• 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, the dose of levothyroxine may need to be adjusted by the treating 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, it 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 both during and after pregnancy, and the levothyroxine dose 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

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

Take this medicine always 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 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 slowly increased at longer intervals, with frequent monitoring of thyroid hormone levels. Experience has shown that smaller doses are also sufficient in patients with low body weight and in patients with large goiters.
Dosage
For individual treatment, Eferox tablets are available in graduated strengths from 25 to 200 micrograms, 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 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.

Caution when dividing the tablet

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 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 non-cancerous goiter and to prevent recurrence of goiter, Eferox should be taken for several months or years, or even for the rest of your life.
In supportive therapy for hyperthyroidism, Eferox should be taken for as long as you are taking anti-thyroid medication (thyreostatic).
In the treatment of non-cancerous 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.
To perform thyroid function suppression tests, you should take 150 or 200 micrograms of Eferox per day for 14 days.

Overdose of Eferox

If you (or someone else) have taken more tablets than you should, or if you think a child has taken some, contact your doctor, the emergency department of the nearest hospital, or the poison control center immediately.
Symptoms of overdose may include: excitement, confusion, irritability, fever, chest pain (angina pectoris), rapid or irregular heartbeat, rapid breathing, muscle spasms, headache, restlessness, hyperactivity, flushing, sweating, diarrhea, tremors, difficulty sleeping, restlessness or nervousness, feeling of physical or emotional exhaustion, seizures.
These symptoms may last up to 6 days. You should bring any remaining tablets and this leaflet with you, so that medical personnel can accurately determine what medicine 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 that the treatment is effective, 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, otherwise, symptoms may recur.
If you have any further questions about the use of 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, increased 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 or if they get worse or if you 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. 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
• restlessness, 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, 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 you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
You can also report side effects 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 and carton after EXP. The expiry date refers to the last day of that 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. This will help protect the environment.

6. Contents of the pack and other 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, cornstarch, heavy magnesium oxide, 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 dividing groove 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
tel: +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 micrograms tablets
Germany
L-Thyroxin Aristo 150/200 micrograms tablets
Czech Republic
Levothyroxine Aristo 150/200 micrograms tablets
Finland
Levothyroxine Aristo 200 micrograms tablets
Spain
Levotiroxina Aristo 150/200 micrograms tablets
Netherlands
Levothyroxine sodium Aristo 200 micrograms tablets
Ireland
Levothyroxine sodium Aristo 150/200 micrograms tablets
Poland
Eferox 150/200 micrograms tablets
Portugal
Eferox 150/200 micrograms tablets
Sweden
Levothyroxine Aristo 150/200 micrograms tablets
Italy
Levotiroxina DOC 150/200 micrograms tablets
Date of last revision of the leaflet: