LEVOTIROXINA 25 MICROGRAMS Coated tablet

Зміст інструкції

1. Levotiroxina Abdi 25 micrograms tablets, 50 micrograms tablets, 75 micrograms tablets, 100 micrograms tablets, 125 micrograms tablets, 150 micrograms tablets, 175 micrograms tablets
   1. What is Levotiroxina Abdi and what is it used for
   2. What you need to know before taking Levotiroxina Abdi
   3. How to take Levotiroxina Abdi
   4. Possible side effects
   5. How to store Levotiroxina Abdi
   6. Package Contents and Other Information

Levotiroxina Abdi 25 micrograms tablets, 50 micrograms tablets, 75 micrograms tablets, 100 micrograms tablets, 125 micrograms tablets, 150 micrograms tablets, 175 micrograms tablets

Levotiroxina Abdi 200 micrograms tablets
levothyroxine sodium
Generic medicine

Read this leaflet carefully before you start to take this medicine because 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 their symptoms are the same as yours, 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 Abdi is and what it is used for
• 2. What you need to know before you take Levotiroxina Abdi
• 3. How to take Levotiroxina Abdi
• 4. Possible side effects
• 5. How to store Levotiroxina Abdi
• 6. Contents of the pack and other information

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

Levothyroxine, the active substance contained in Levotiroxina Abdi, is a synthetic thyroid hormone that
is used for the treatment of thyroid diseases and dysfunctions. Its effect is identical to
that of hormones produced naturally by the thyroid.
Levotiroxina Abdi is used

• for the treatment of benign goiter in patients with normal thyroid function,
• to prevent the recurrence of goiter after surgical intervention,
• for the replacement of natural thyroid hormones when the thyroid does not produce enough,
• to suppress tumor growth in patients with thyroid cancer.

Levotiroxina Abdi 25 micrograms, 50 micrograms, 75 micrograms and 100 micrograms are also used
to balance the levels of thyroid hormones when excessive production of hormones is treated
with antithyroid medications.
Levotiroxina Abdi 100 micrograms, 150 micrograms and 200 micrograms can also be
used in thyroid function tests.

2. What you need to know before taking Levotiroxina Abdi

Do not take Levotiroxina Abdi
if you have any of the following conditions:

• allergy (hypersensitivity) to the active ingredient or any of the other ingredients of Levotiroxina Abdi (listed in section 6),
• untreated pituitary gland dysfunction or a disease associated with excessive production of

thyroid hormones (untreated hyperthyroidism),

• reduced function of the adrenal glands (adrenal insufficiency) without adequate replacement treatment,
• acute heart disease (myocardial infarction or heart inflammation).

Do not take Levotiroxina Abdi with other antithyroid medicines if you are pregnant
(see section “Pregnancy and breastfeeding” below).

Warnings and precautions
Talk to your doctor or pharmacist before taking Levotiroxina Abdi

• if you have any of the following heart diseases:
• insufficient blood supply to the heart vessels (angina pectoris),
• heart failure,
• fast and irregular heartbeat,
• high blood pressure,
• fat deposits in the arteries (arteriosclerosis),
• if you have reduced activity of the adrenal glands (adrenal insufficiency).

These conditions must be kept under medical control before starting to take
Levotiroxina Abdi or undergoing a thyroid suppression test. During treatment with
Levotiroxina Abdi, you should undergo frequent checks of your thyroid hormone levels. If you are not
sure whether any of these conditions apply to you or you are not under treatment, consult your doctor.
The doctor will check if you have dysfunction of the adrenal glands or the pituitary gland or a
thyroid dysfunction with excessive and uncontrolled production of thyroid hormones (thyroid autonomy), as these conditions must be kept under medical control before starting to
take Levotiroxina Abdi or undergoing a thyroid suppression test.
Blood pressure will be regularly monitored when treatment with levothyroxine is
started in premature infants with very low birth weight, as a rapid drop in
blood pressure (circulatory collapse) may occur.
Switching to another medicine containing levothyroxine, if necessary, may lead to thyroid imbalances. If you have any questions about how to switch to another medicine, ask your doctor. Careful monitoring (clinical and
biological) is necessary during the transition period. Tell your doctor if you experience any undesirable effect, as this may
indicate that the dose needs to be increased or decreased.
Talk to your doctor

• if you are in menopause or postmenopause. Your doctor may need to regularly check your thyroid function due to the risk of osteoporosis
• before starting or stopping taking orlistat or changing your orlistat treatment (a medicine used to treat obesity; more frequent monitoring and dose adjustment may be necessary)
• if you experience signs of psychotic disorders (more frequent monitoring and dose adjustment may be necessary) Thyroid hormones should not be used for weight reduction. Taking thyroid hormones will not reduce weight if your thyroid hormone levels are normal. Serious or even life-threatening side effects may occur if the dose is increased without being expressly recommended by your doctor. Thyroid hormones should not be taken in high doses together with some weight-reducing medicines, such as amfepramone, cathine and phenpropanolamine, as this may increase the risk of serious or even life-threatening side effects.

Other medicines and Levotiroxina Abdi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the
following medicines, as Levotiroxina Abdi may change their effects:

• Antidiabetic medicines (medicines that reduce blood glucose levels): Levotiroxina Abdi may reduce the effect of antidiabetic medicines, so more frequent checks of blood glucose levels may be necessary, especially at the beginning of treatment with Levotiroxina Abdi. During the intake of Levotiroxina Abdi, an adjustment of the dose of the antidiabetic medicine may be necessary.
• Cumarin derivatives (medicines used to prevent blood clotting): Levotiroxina Abdi may intensify the effect of these medicines, increasing the risk of bleeding events, especially in the elderly. At the beginning and during treatment with Levotiroxina Abdi, regular checks of blood coagulation values may be necessary. During the intake of Levotiroxina Abdi, an adjustment of the dose of the coumarin medicine may be necessary.

Make sure to respect the recommended time intervals if you need to take any of the
following medicines:

• Medicines used to bind bile acids and to reduce high cholesterol (such as cholestyramine or colestipol): make sure to take Levotiroxina Abdi 4-5 hours before these medicines, as they can block the absorption of Levotiroxina Abdi in the intestine.
• Antacids (for stomach acidity), sucralfate (for stomach or intestinal ulcers), other medicines containing aluminium, medicines containing iron, medicines containing calcium: make sure to take Levotiroxina Abdi at least 2 hours before these medicines, as they may otherwise reduce the effect of Levotiroxina Abdi. Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines, as they can reduce the effect of Levotiroxina Abdi:
• propylthiouracil (antithyroid medicine),
• glucocorticoids (anti-allergic and anti-inflammatory medicines),
• beta-blockers (medicines used to reduce blood pressure and for the treatment of heart diseases),
• sertraline (antidepressant medicine),
• chloroquine or proguanil (medicines used for the prevention or therapy of malaria),
• medicines that activate certain liver enzymes, such as barbiturates (sedatives, sleeping pills) or carbamazepine (antiepileptic medicine, also used to modify some types of pain and to control mood disorders),
• medicines containing oestrogens used for hormone replacement therapy during and after menopause or to prevent pregnancy,
• sevelamer (medicine that binds phosphate, used for the treatment of patients with chronic renal insufficiency),
• tyrosine kinase inhibitors (anticancer and anti-inflammatory medicines),
• orlistat (medicine used for the treatment of obesity).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the
following medicines, as they can intensify the effect of Levotiroxina Abdi:

• salicylates (medicines used to relieve pain and reduce fever),
• dicoumarol (medicine used to prevent blood clotting),
• furosemide (diuretic medicine) at high doses (250 mg),
• clofibrate (medicine used to reduce lipids in the blood).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the
following medicines, as they may change the effect of Levotiroxina Abdi:

• ritonavir, indinavir, lopinavir (protease inhibitors, medicines used to treat HIV infection),
• phenytoin (antiepileptic medicine).

Regular checks of thyroid hormone parameters may be necessary. An adjustment of the dose of Levotiroxina Abdi may be necessary.
Tell your doctor if you are taking amiodarone (medicine used for the treatment of irregular heartbeat), as this medicine can affect the function and activity of the thyroid.
If you are going to undergo diagnostic tests or scans in which contrast agents containing
iodine are used, tell your doctor that you are taking Levotiroxina Abdi, as you may receive an injection that
can affect thyroid function.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those obtained without a prescription.

Levotiroxina Abdi with food and drink
Tell your doctor if you consume products containing soy, especially if you change the amount. The
products containing soy can reduce the absorption of Levotiroxina Abdi from the intestine and, therefore,
an adjustment of the dose of Levotiroxina Abdi may be necessary.

Pregnancy and breastfeeding
If you are pregnant, continue to take Levotiroxina Abdi. Consult your doctor as
you may need to adjust the dose.
If you are taking Levotiroxina Abdi together with other antithyroid medicines for the treatment of excessive
production of thyroid hormones, your doctor will advise you to stop taking Levotiroxina
Abdi if you become pregnant.
If you are breastfeeding, continue to take Levotiroxina Abdi as recommended by your doctor. The amount
of substance excreted in breast milk is so low that it will not have any effects on the baby.

Driving and operating machinery
No studies have been conducted on the effects of levothyroxine on the ability to drive and operate
machinery.
Levotiroxina Abdi is not expected to impair the ability to drive and operate machinery, as
levothyroxine is identical to the hormone produced naturally by the thyroid.

Levotiroxina Abdi contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

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

3. How to take Levotiroxina Abdi

Take Levotiroxina Abdi following the instructions of your doctor or pharmacist exactly. If you
have any doubts, consult your doctor or pharmacist.
The doctor will determine the individual dose based on tests and laboratory analyses.
Generally, you start with a low dose, which is increased every 2-4 weeks until reaching
the final individual dose. In the first few weeks of treatment, laboratory tests will be performed to
adjust the dose.
If your child was born with hypothyroidism, the doctor may recommend starting treatment with
a higher dose, as rapid replacement is important. The recommended initial dosage is
10-15 micrograms per kg of body weight for the first 3 months. Subsequently, the doctor will adjust
the dose individually.
The usual dosage range is shown in the table below. A lower individual dose may be sufficient

• if you are an elderly patient,
• if you have heart problems,
• if you have severe or long-lasting hypothyroidism,
• if you have a low body weight or a large goiter.

* Levotiroxina Abdi 125 micrograms, 150 micrograms, 175 micrograms or
200 micrograms tablets are not suitable for the lowest dosage range reported here, but the doctor
may prescribe Levotiroxina Abdi tablets with a lower dosage.
Method of administration
Levotiroxina Abdi is for oral use. Take a single daily dose on an empty stomach in the morning
(at least half an hour before breakfast), preferably with some liquid, for example with
half a glass of water.
Newborns can receive the entire daily dose of Levotiroxina Abdi at least half an hour before
the first meal of the day. Immediately before use, crush the tablet, mix it with some
water and administer it to the child with a little more liquid. Always prepare the mixture at
the time of need.
Duration of treatment
The duration of treatment may vary depending on the condition for which Levotiroxina
Abdi is used. Therefore, the doctor will tell you how long you will need to continue taking it. Most
patients need to take Levotiroxina Abdi for life.

If you take more Levotiroxina Abdi than you should
If you have taken a higher dose than prescribed, you may experience symptoms such as a fast
heartbeat, anxiety, agitation or involuntary movements. In patients with neurological disorders such as
epilepsy, seizures may occur in isolated cases. In patients at risk
of psychotic disorders, symptoms of acute psychosis may occur. If any of these
conditions occur, consult your doctor.

If you forget to take Levotiroxina Abdi
Do not take a double dose to make up for a missed tablet, but take the normal dose the next day.
If you have any questions about the use of Levotiroxina Abdi, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Levotiroxina Abdi can cause side effects, although not everybody gets them.
If you take more Levotiroxina Abdi than prescribed or if you do not tolerate the prescribed dose (for example, if the
dose is increased rapidly), you may experience one or more of the following side effects:
irregular or fast heartbeat, chest pain, headache, muscle weakness or cramps,
hot flushes (feeling of heat and redness in the face), fever, vomiting, menstrual disorders, pseudotumor
cerebri (increased intracranial pressure), tremor, restlessness, sleep disturbances, sweating,
weight loss, diarrhea.
If you experience any of these side effects, contact your doctor. The doctor may decide to
interrupt therapy for a few days or reduce the daily dose until the side effects
resolve.
Allergic reactions to any of the components of Levotiroxina Abdi are possible (see
section 6 “What Levotiroxina Abdi contains”). The frequency of these effects is unknown. Allergic
reactions may include skin rash, hives and swelling of the face or throat (angioedema).
In this case, seek immediate medical attention.

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

5. How to store Levotiroxina Abdi

Keep this medicine out of the sight and reach of children.
Do not use Levotiroxina Abdi after the expiry date which is stated on the blister and the package after
“Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater 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 Abdi contains

• The active ingredient is levothyroxine sodium.
• Each Levotiroxina Abdi 25 micrograms tablet contains 25 micrograms of levothyroxine sodium.
• Each Levotiroxina Abdi 50 micrograms tablet contains 50 micrograms of levothyroxine sodium.
• Each Levotiroxina Abdi 75 micrograms tablet contains 75 micrograms of levothyroxine sodium.
• Each Levotiroxina Abdi 100 micrograms tablet contains 100 micrograms of levothyroxine sodium.
• Each Levotiroxina Abdi 125 micrograms tablet contains 125 micrograms of levothyroxine sodium.
• Each Levotiroxina Abdi 150 micrograms tablet contains 150 micrograms of levothyroxine sodium.
• Each Levotiroxina Abdi 175 micrograms tablet contains 175 micrograms of levothyroxine sodium.
• Each Levotiroxina Abdi 200 micrograms tablet contains 200 micrograms of levothyroxine sodium.
• The other ingredients are corn starch, sodium croscarmellose, gelatin, lactose monohydrate and magnesium stearate.

Description of the appearance of Levotiroxina Abdi and package contents
Levotiroxina Abdi 25 micrograms tablets are white and round, with “25” engraved on one
side and a “+” shaped mark on the other side.
Levotiroxina Abdi 50 micrograms tablets are white and round, with “50” engraved on one
side and a “+” shaped mark on the other side.
Levotiroxina Abdi 75 micrograms tablets are white and round, with “75” engraved on one
side and a “+” shaped mark on the other side.
Levotiroxina Abdi 100 micrograms tablets are white and round, with “100” engraved on one
side and a “+” shaped mark on the other side.
Levotiroxina Abdi 125 micrograms tablets are white and round, with “125” engraved on one
side and a “+” shaped mark on the other side.
Levotiroxina Abdi 150 micrograms tablets are white and round, with “150” engraved on one
side and a “+” shaped mark on the other side.
Levotiroxina Abdi 175 micrograms tablets are white and round, with “175” engraved on one
side and a “+” shaped mark on the other side.
Levotiroxina Abdi 200 micrograms tablets are white and round, with “200” engraved on one
side and a “+” shaped mark on the other side.
The tablets are supplied in PVC/PE/PVDC/aluminium blisters of 50 and 100 tablets in cartons.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim, Germany

Manufacturer
Interpharma Services Ltd.
43A Cherni Vrach Blvd. 1407- Sofia
Bulgaria
Flavine Pharma France
3 Voie d’Allemagne
13127 Vitrolles
France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Netherlands: Levothyroxine Abdi