Eferox

Patient Information Leaflet: Eferox

Eferox,112 micrograms, tablets
Eferox,125 micrograms, tablets
Eferox,137 micrograms, tablets
Eferox,175 micrograms, tablets
Levothyroxine sodium

Read this leaflet carefully before taking Eferox, as it contains important information for you.

• You should 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 only. 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. Important information before taking 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 thyroid gland diseases and disorders.
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 relapse of goiter after goiter removal in patients with normal thyroid function,
• to treat benign (non-cancerous) goiter in patients with normal thyroid function,
• in the treatment of malignant thyroid cancer, especially after surgical procedures to inhibit tumor growth and as a replacement for 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 (overactive thyroid);
• if you have untreated adrenal insufficiency (adrenal gland disorder) and you are not receiving appropriate replacement therapy;
• if you have untreated hypopituitarism (pituitary gland disorder);
• if you have any of 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 anti-thyroid medicines (thyrostatic drugs).

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

• coronary artery disease;
• angina pectoris;
• atherosclerosis;
• 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 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 when combined 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, 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 artery 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 medicine 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 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 gland disorder), pituitary gland disorder, or a certain type of thyroid disorder with uncontrolled excessive production of thyroid hormones, as in such cases, appropriate treatment is necessary before starting Eferox.

Before starting Eferox, you should discuss the following with your doctor or pharmacist:

• 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 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. This may affect laboratory test results. If you are taking such products, you should inform your doctor or laboratory staff (see "Warnings and precautions" and 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 such 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 supplements. 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 levels)
• 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

Medicines that may affect the action of levothyroxine include:

• 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 omeprazol, esomeprazol, pantoprazol, rabeprazol, and lanzoprazol) 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 omeprazol, esomeprazol - 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 doxulepine
• 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 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 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 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 and 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

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
The tablets are available in strengths of 25 to 200 micrograms, which means that in most cases, you will only need to take one tablet per day.
Your doctor will determine the individual dose for you based on the results of your tests and laboratory results. 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 undergo 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 their daily dose at least half an hour before their first meal, preferably with a small amount of water to make it easier to swallow. 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.
The tablets of Eferox can be divided into equal doses.

Tablet division

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 benign goiter and to prevent relapse 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 (thyrostatic drugs).
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.

Overdose of Eferox

If you (or someone else) have taken too many tablets, or if a child has taken any, you should 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 which 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, as symptoms may recur.
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 bumps, 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, known as 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.

Tell 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 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 first consulting your doctor.
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, 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 Drug Safety of the 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 which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Store in a cool, dry place, below 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. Contents of the pack and other information

What Eferox contains

• The active substance 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.

• The other ingredients are: microcrystalline cellulose, maize starch, 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 line 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 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 112/125/137/175 micrograms tablets
Germany
L-Thyroxin Aristo 112/125/137/175 micrograms tablets
Czech Republic
Levothyroxine Aristo 112/125/137/175 micrograms tablets
Spain
Levotiroxina Aristo 112/125/137/175 micrograms tablets
Netherlands
Levothyroxine sodium Aristo 112/125/137/175 micrograms tablets
Ireland
Levothyroxine sodium Aristo 112/125/137/175 micrograms tablets
Poland
Eferox 112/125/137/175 micrograms tablets
Portugal
Eferox 112/125/137/175 micrograms tablets
Italy
Levotiroxina DOC 125 micrograms tablets
Levotiroxina Aristo 112, 137, 175 micrograms tablets
Date of last revision of the leaflet: