LEVOTIROXINA 25 MICROGRAMMI Coated tablet

Зміст інструкції

1. Levotiroxina DOC 25 micrograms tablets, 50 micrograms tablets, 75 micrograms tablets, 100 micrograms tablets, 125 micrograms tablets, 150 micrograms tablets
   1. What is Levotiroxina DOC and what is it used for
   2. What you need to know before taking Levotiroxina DOC
   3. How to take Levotiroxina DOC
   4. Possible side effects
   5. How to store Levotiroxina DOC
   6. Package contents and other information

Levotiroxina DOC 25 micrograms tablets, 50 micrograms tablets, 75 micrograms tablets, 100 micrograms tablets, 125 micrograms tablets, 150 micrograms tablets

Levotiroxina DOC 200 micrograms tablets
Generic medicine

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Levotiroxina DOC is and what it is used for
• 2. What you need to know before you take Levotiroxina DOC
• 3. How to take Levotiroxina DOC
• 4. Possible side effects
• 5. How to store Levotiroxina DOC
• 6. Contents of the pack and other information

1. What is Levotiroxina DOC and what is it used for

Thyroxine is a hormone that is produced naturally in the body by the thyroid gland. Sodium levothyroxine is a synthetic version of this hormone.
Levotiroxina DOC is used to replace the missing hormone and/or to rest the thyroid
gland.
Levotiroxina DOC is used:

• to replace the missing hormone in all forms of reduced thyroid function (hypothyroidism) or after removal of the thyroid gland,
• to prevent the recurrence of new goiters after surgical removal in patients with normal thyroid function,
• to treat non-malignant goiter (benign struma) in patients with normal thyroid function. Levotiroxina DOC 25 micrograms
• as additional therapy in the antithyroid treatment of an overactive thyroid, after reaching a normal metabolic state,
• for malignant thyroid tumors, in particular after surgical intervention to suppress new tumor growth and to compensate for the lack of hormone
• thyroid. Levotiroxina DOC 50 micrograms
• as additional therapy in the antithyroid treatment of an overactive thyroid, after reaching a normal metabolic state,
• for malignant thyroid tumors, in particular after surgical intervention to suppress new tumor growth and to compensate for the lack of thyroid hormone.

Levotiroxina DOC 75 micrograms

• as additional therapy in the antithyroid treatment of an overactive thyroid, after reaching a normal metabolic state,
• for malignant thyroid tumors, in particular after surgical intervention to suppress new tumor growth and to compensate for the lack of thyroid hormone. Levotiroxina DOC 100 micrograms
• as additional therapy in the antithyroid treatment of an overactive thyroid, after reaching a normal metabolic state,
• for malignant thyroid tumors, in particular after surgical intervention to suppress new tumor growth and to compensate for the lack of thyroid hormone,
• in the thyroid suppression test. Levotiroxina DOC 125 micrograms
• for malignant thyroid tumors, in particular after surgical intervention to suppress new tumor growth and to compensate for the lack of thyroid hormone.

Levotiroxina DOC 150 micrograms

• for malignant thyroid tumors, in particular after surgical intervention to suppress new tumor growth and to compensate for the lack of thyroid hormone.
• in the thyroid suppression test. Levotiroxina DOC 175 micrograms
• for malignant thyroid tumors, in particular after surgical intervention to suppress new tumor growth and to compensate for the lack of thyroid hormone.

Levotiroxina DOC 200 micrograms

• for malignant thyroid tumors, in particular after surgical intervention to suppress new tumor growth and to compensate for the lack of thyroid hormone,
• in the thyroid suppression test.

2. What you need to know before taking Levotiroxina DOC

Do not take Levotiroxina DOC

• if you are allergic to levothyroxine or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from untreated hyperthyroidism (hyperthyroidism, thyrotoxicosis);
• if you suffer from inactive adrenal glands (adrenal insufficiency) and do not have adequate replacement treatment;
• if you suffer from untreated pituitary insufficiency;
• if you have acute heart disease (heart attack or inflammation of the heart muscle);
• if you are pregnant Levotiroxina DOC should not be taken at the same time as other medicines directed against an overactive thyroid (antithyroid medicines).

Before starting treatment with Levotiroxina DOC, it is necessary to exclude or treat the following disorders or conditions:

• coronary heart disease,
• chest pain with a feeling of tightness in the chest (angina pectoris),
• deposits of fat in the arteries (arteriosclerosis)
• high blood pressure (hypertension),
• a condition in which the pituitary gland and the adrenal cortex do not produce a sufficient amount of hormones (pituitary and/or adrenal insufficiency),
• areas of the thyroid that produce uncontrolled amounts of thyroid hormone (thyroid autonomy).

Warnings and precautions
Thyroid hormones are not indicated to achieve weight loss. Taking thyroid hormones will not reduce weight if the level of thyroid hormone in the blood is within the normal range.
If you increase the dose without appropriate medical advice, serious or even life-threatening side effects may occur, especially in association with certain medicines for weight loss (see section 2 “Other medicines and Levotiroxina DOC”).
If it is necessary to change your medicine to another containing levothyroxine, a thyroid imbalance may occur. Talk to your doctor if you have questions about how to change the medicine. Accurate monitoring (clinical and biological) is necessary during the transition period. You must inform your doctor if you experience side effects, as this may indicate that the dose needs to be increased or decreased.
Consult your doctor or pharmacist before taking Levotiroxina DOC,

• if you have suffered from a reduction in thyroid function for a long time, i.e. from birth or acquired during childhood;
• if you suffer from heart problems including angina pectoris, coronary heart disease, weakness of the heart muscle (heart failure), heart rhythm disorders or hypertension or arteriosclerosis,
• if you have recently had a heart attack;
• if you are taking medicines to prevent blood clotting (e.g. phenprocoumon). It may be necessary to adjust the dose of this medicine (see section 2. “Other medicines and Levotiroxina DOC”),
• if you are being treated for diabetes. It may be necessary to adjust the dose of your antidiabetic medicine as levothyroxine can increase blood sugar levels (see section 2. “Other medicines and Levotiroxina DOC”),
• if you have entered menopause. Your thyroid function should be checked more frequently to avoid an increase in levothyroxine levels in the blood, which can cause osteoporosis (brittle bones);
• if you suffer from epilepsy (seizures). Rarely, epileptic seizures have been reported at the start of treatment with levothyroxine or when the dose was increased rapidly.
• if you suffer from myxedema (swelling of the skin and subcutaneous tissue), as it may be necessary to reduce the dosage of Levotiroxina DOC;
• if you suffer from a disease of the small intestine, as this can also inhibit the absorption of the drug (malabsorption syndromes, e.g. celiac disease, lactose intolerance). These conditions must be treated to ensure the effectiveness of therapy with Levotiroxina DOC;
• if you suffer from a reduction in adrenal gland function (adrenal insufficiency), a pituitary gland dysfunction or a thyroid gland dysfunction with uncontrolled production of thyroid hormones, because this must be checked medically before starting to take Levotiroxina DOC;
• if you are about to undergo laboratory tests to monitor thyroid hormone levels, you should inform the doctor and/or laboratory personnel that you are taking or have recently taken biotin (also known as vitamin H, vitamin B7 or vitamin B8). Biotin can affect the results of laboratory tests. Depending on the test, the results may be falsely high or falsely low due to biotin. The doctor may ask you to stop taking biotin before performing the laboratory tests. You should also know that other products you may be taking, such as multivitamin complexes or hair, skin and nail supplements, may contain biotin. This could affect the results of laboratory tests. Inform your doctor and/or laboratory personnel if you are taking such products (please note the information in the section Other medicines and Levotiroxina DOC).

Talk to your doctor if you experience signs of psychotic disorders.
Blood pressure will be checked regularly when starting treatment with levothyroxine in premature infants with very low birth weight, as a rapid drop in blood pressure (circulatory collapse) may occur.
In the elderly, the dose should be carefully and individually adjusted, for example in patients with heart problems and should be monitored by the doctor.

Blood tests
Before starting to take levothyroxine, the doctor will perform a blood test to see how much thyroxine the thyroid gland produces and what dose of medicine is needed. Once you start taking the medicine, the doctor will ask you to have regular blood tests to see how the medicine is working.

Other medicines and Levotiroxina DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes over-the-counter medicines, herbal remedies and vitamin supplements.
Many medicines affect the action of levothyroxine. The effects of other medicines can also be affected by levothyroxine. If you are about to undergo a test with iodinated contrast agents, you must inform the doctor that you are taking Levotiroxina.
If you are taking or have recently taken biotin, you must inform your doctor and/or laboratory personnel when you are about to undergo laboratory tests to monitor thyroid hormone levels. Biotin can affect the results of laboratory tests (see the section “Warnings and precautions”).
The following medicines can affect the action of levothyroxine:

• medicines for epilepsy or seizures such as carbamazepine, phenytoin, primidone and barbiturates
• products containing St John's wort (a herbal medicine).
• sertraline, lithium - used to treat depression, mood and anxiety disorders
• statins such as simvastatin and lovastatin (used to treat high cholesterol levels in the blood),
• rifampicin - used to treat infections
• imatinib, sunitinib, 5-fluorouracil - used to treat some types of cancer
• betablockers such as propranolol, atenolol and sotalol - used for the treatment of hypertension and heart problems
• medicines containing estrogens for hormone replacement therapy (HRT) and for contraception (“the pill”)
• medicines containing androgens for male hormone replacement therapy
• glucocorticoids such as cortisone, hydrocortisone, prednisolone and dexamethasone - used for the treatment of inflammation
• amiodarone - used for the treatment of irregular heartbeat
• anti-inflammatory drugs such as phenylbutazone or acetylsalicylic acid
• methadone - used for opioid substitution therapy
• furosemide - used for the treatment of hypertension or edema
• propylthiouracil - used for hyperthyroidism
• iodide - used to protect the thyroid gland from radiation
• oral contrast agents - taken before some radiological examinations to make parts of the body more visible during the scan,
• chloroquine/proguanil - used for malaria prophylaxis and in rheumatic diseases
• ritonavir - used to control HIV and hepatitis C viruses
• weight loss medicines (e.g. orlistat)
• proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole and lansoprazole) are used to reduce the amount of acid produced by the stomach, which can decrease the absorption of levothyroxine from the intestine and therefore make it less effective. If you are taking levothyroxine during treatment with proton pump inhibitors, your doctor should monitor your thyroid function and may need to adjust the dose of Levotiroxina DOC.

Levotiroxina DOC must be taken at least 4-5 hours before taking the following medicines:

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

The following medicines can be affected by levothyroxine:

• anticoagulant medicines to prevent blood clots such as warfarin, dicoumarol and phenprocoumon
• medicines for the treatment of diabetes such as insulin and metformin
• tricyclic antidepressants such as amitriptyline, imipramine and dosulepine
• medicines that stimulate the sympathetic nervous system such as adrenaline (used for the treatment of severe allergic reactions) or phenylephrine (a decongestant used in many treatments for flu and colds)
• digoxin - used to treat heart problems- phenytoin - antiepileptic medicine

Levotiroxina DOC with food and drink
Products containing soy and high-fiber foods can affect the absorption of levothyroxine. As a result, your doctor may need to adjust the dose of levothyroxine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Continuous treatment with thyroid hormones is particularly important during pregnancy and breastfeeding and should therefore be continued under the supervision of the treating doctor.
The need for levothyroxine may increase during pregnancy due to the increase in the blood levels of estrogens (female sex hormones). During and after pregnancy, it is therefore advisable to monitor thyroid function and possibly correct the dose of levothyroxine.
Even during therapy with high doses of levothyroxine, the amount of thyroid hormone that passes into breast milk during breastfeeding is very low and therefore harmless.
Suppression tests should not be performed during pregnancy and breastfeeding.

Driving and using machines
Levotiroxina DOC is not expected to affect the ability to drive and operate machinery, as levothyroxine is identical to the naturally occurring thyroid hormone.

Levotiroxina DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Levotiroxina DOC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
In elderly patients, in patients with coronary heart disease and in patients with severely or
chronically hypoactive thyroid function, particular attention is required at the beginning of treatment with
thyroid hormones. This means that a low initial dose must be chosen, gradually increased and
at longer time intervals, with frequent monitoring of thyroid hormones.
Experience has shown that a lower dose is sufficient even in patients with reduced body weight
and in patients with large goiters.
Dosage
For individual treatment, tablets with dosages between 25 and 200
micrograms of Levotiroxina are available, which means that in most cases only
one tablet should be taken per day.
The doctor will determine your individual dose based on examinations and laboratory tests. In general, you
start with a low dose, which is increased every 2-4 weeks, until the full
individual dose is reached. During the first few weeks of treatment you will undergo laboratory tests in order to
adjust the dose.

How to administer
The total daily dose is taken in the morning, on an empty stomach, at least half an hour before
breakfast, as the active ingredient is better absorbed on an empty stomach than during or after
a meal. The tablets must be swallowed whole, without being chewed, with a glass
of water.
Infants receive the total daily dose at least half an hour before the first meal of the day,
preferably with water to facilitate swallowing. If necessary, the tablet can be
divided.
It is not recommended that the tablets be crushed and dispersed in water or other liquids, which
could lead to inaccuracies in administration.
Levotiroxina DOC tablets can be divided into equal doses.

Notice on divisibility
Place the tablet with the score line facing up on a
flat, hard surface. To divide the tablet, press straight down with your thumb
in the center of the tablet.
Duration of administration
You must take this medicine for as long as your doctor tells you to.
If you have a thyroid gland that is not functioning properly or have undergone surgery
on the thyroid for a malignant tumor, you will probably take Levotiroxina for life.
For benign goiter and for the prevention of recurrent goiter growth, you should take
Levotiroxina for a period ranging from several months to a few years or even for the rest of your
life.
In supportive therapy for the treatment of hyperthyroidism, you should take levothyroxine for
the entire duration of treatment with a thyrostatic drug.
For the treatment of benign goiter with normal thyroid function, a treatment period of
6 months to 2 years is necessary. If treatment with Levotiroxina DOC has not produced the desired
results within this period, other therapeutic options should be considered.
To perform thyroid suppression tests, 150 or -200 micrograms of
Levotiroxina DOC are taken daily for 14 days.

If you take more Levotiroxina DOC than you should
If you (or someone else) take more tablets than intended, or think a child may have ingested some, contact your doctor immediately, the nearest hospital emergency room or the
poison control center. Signs of an overdose may include: agitation, feeling confused,
feeling irritable, fever, chest pain (angina), fast or irregular heartbeat,
rapid breathing, muscle cramps, headache, restlessness, hyperactivity flushing,
sweating, dilated pupils, and diarrhea, tremor, difficulty sleeping, anxiety or nervousness, feeling
tired, emotionality, seizures. These signs may take up to 6 days to appear. Bring
exactly what you have taken.

If you forget to take Levotiroxina DOC
If you forget a dose, take the usual dose when the next dose is due. Do not take a
double dose to make up for missed doses. If in doubt, ask your doctor or pharmacist.

If you stop taking Levotiroxina DOC

These tablets are for long-term treatment. You may need to take them for the
rest of your life. Do not stop taking the tablets unless your doctor has told you to
do so.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking the tablets and go to hospital immediately if you have:

• an allergic reaction such as swelling of the face, tongue, lips and/or throat and/or difficulty swallowing or hives with potential difficulty breathing (angioedema), severe itching on the skin with raised bumps, joint pain, sensitivity to the sun, a general feeling of being unwell (frequency not known). Urgent medical attention may be needed.

Some patients may experience a severe reaction to high levels of thyroid hormone. This is
called "thyrotoxic crisis". Stop taking the tablets and go to hospital if you experience any of the
following symptoms (frequency not known):

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

Tell your doctor or pharmacist if any of these side effects persist,
worsen or if you notice any other side effects not listed.
Most side effects are similar to the symptoms of hyperthyroidism (where the thyroid
gland produces too much thyroxine) and are due to the fact that the dose of the medicine is too high. They
usually disappear after reducing the dose or stopping the tablets. Tell your
doctor if side effects occur. He/she will decide whether the daily dose needs to be reduced
or whether you should stop taking the tablets for a few days. However, you should not change the
dose or stop the tablets without first talking to your doctor.

Not known:frequency cannot be estimated based on available data

• increased appetite
• restlessness, excitability, difficulty sleeping (insomnia)
• tremor, headache, seizure
• chest pain (angina pectoris), strong, irregular or fast heartbeat, heart failure, heart attack
• high blood pressure (hypertension), hot flushes
• shortness of breath (dyspnea)
• diarrhea, vomiting, feeling unwell (nausea), stomach pains
• increased sweating, itching, rash, hives muscle cramps, muscle weakness, joint pain
• A decrease in bone density (osteoporosis), especially in women who have reached menopause and are taking high doses for long periods
• in women: irregular periods
• fever (high temperature), swelling (edema), general feeling of being unwell
• weight loss
• overactive thyroid (hyperthyroidism)

Further side effects in children

Rare:may affect up to 1 in 1,000 people

• increased pressure around the brain in children that is not caused by a tumor or other diseases (benign intracranial hypertension)

Not known:frequency cannot be estimated based on available data

• growth in children may slow down or stop due to changes in bone growth
• temporary hair loss in children
• deformity of the skull in newborns caused by the premature closure of the joints of the skull bone (craniosynostosis)
• intolerance to heat

In case of hypersensitivity to levothyroxine or any of the other components of Levotiroxina
DOC, allergic reactions of the skin and the respiratory tract may occur.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Levotiroxina DOC

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 pack after “Exp.”. The expiry
date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levotiroxina DOC contains

• The active ingredient is levothyroxine sodium anhydrous. Levotiroxina DOC 25 micrograms tablets Each tablet contains 25 micrograms of levothyroxine sodium anhydrous.

Levotiroxina DOC 50 micrograms tablets
Each tablet contains 50 micrograms of levothyroxine sodium anhydrous.
Levotiroxina DOC 75 micrograms tablets
Each tablet contains 75 micrograms of levothyroxine sodium anhydrous.
Levotiroxina DOC 100 micrograms tablets
Each tablet contains 100 micrograms of levothyroxine sodium anhydrous.
Levotiroxina DOC 125 micrograms tablets
Each tablet contains 125 micrograms of levothyroxine sodium anhydrous.
Levotiroxina DOC 150 micrograms tablets
Each tablet contains 150 micrograms of levothyroxine sodium anhydrous.
Levotiroxina DOC 200 micrograms tablets
Each tablet contains 200 micrograms of levothyroxine sodium anhydrous.

• The other ingredients are microcrystalline cellulose, corn starch, heavy magnesium oxide, Sodium Carboxymethylcellulose type A and vegetable magnesium stearate.

Description of the appearance of Levotiroxina DOC and contents of the pack
Levotiroxina DOC are white, circular, uncoated, biconvex tablets
(divisible tablets) with a score line on one side and the dosage (25, 50, 75, 100, 125, 150 or

• 200) printed on the other. The tablets have a diameter of approximately 7 mm and a height of approximately 3 mm. Levotiroxina DOC 25 micrograms, 50 micrograms, 100 micrograms and 200 micrograms tablets are packaged in a blister pack of 15, 20, 25, 30, 50, 60, 84, 90 and 100 tablets. Levotiroxina DOC 75 micrograms, 125 micrograms and 150 micrograms tablets are packaged in a blister pack of 20, 25, 30, 50, 60, 90 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici Srl
Via Turati 40
20121 Milan
Italy

Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: Levothyroxin Aristo 25/50/100/200 Microgram Tablets
Czech Republic: Levothyroxine Aristo 25/50/100/200 micrograms tablets
Germany: L-Thyroxin Aristo 25/50/100/200 Microgram Tablets
Finland: Levothyroxine Aristo 25/50/100/200 microgram tablets
Ireland: Levothyroxine sodium Aristo25/50/100/200 microgram tablets
Italy: Levotiroxina DOC 25/50/100/200 micrograms tablets
Netherlands: Levothyroxinenatrium Aristo 25/50/100/200 microgram tablets
Poland: Eferox 25/50/100/200 micrograms tablets
Portugal: Levotiroxina Aristo25/50/100/200 micrograms tablets
Spain: Levotiroxina Aristo 25/50/100/200 micrograms tablets EFG
Sweden: Levothyroxine Aristo 25/50/100/200 microgram tablets