Levothyroxine accord

Package leaflet: Information for the user

Levothyroxine Accord, 12.5 micrograms, tablets
Levothyroxine Accord, 25 micrograms, tablets
Levothyroxine Accord, 50 micrograms, tablets
Levothyroxine Accord, 75 micrograms, tablets
Levothyroxine Accord, 88 micrograms, tablets
Levothyroxine Accord, 100 micrograms, tablets
Levothyroxine Accord, 112 micrograms, tablets
Levothyroxine Accord, 125 micrograms, tablets
Levothyroxine Accord, 137 micrograms, tablets
Levothyroxine Accord, 150 micrograms, tablets
Levothyroxine Accord, 175 micrograms, tablets
Levothyroxine Accord, 200 micrograms, tablets
Levothyroxinum natricum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Levothyroxine Accord is and what it is used for
2. Important information before taking Levothyroxine Accord
3. How to take Levothyroxine Accord
4. Possible side effects
5. How to store Levothyroxine Accord
6. Contents of the pack and other information

1. What Levothyroxine Accord is and what it is used for

Levothyroxine, the active substance in Levothyroxine Accord, is a synthetic thyroid hormone used to treat diseases and disorders of thyroid function. It has the same action as the thyroid hormones naturally present in the body. Levothyroxine Accord is used:

• for the treatment of mild goitre in patients with normal thyroid function,
• to prevent recurrence of goitre in patients after surgery,
• to replace deficient natural thyroid hormones when the thyroid gland does not produce sufficient amounts,
• to suppress tumour growth in patients with thyroid cancer.

Levothyroxine Accord 25 micrograms, 50 micrograms, 75 micrograms, 88 micrograms, and 100 micrograms is also used to normalize thyroid hormone levels in patients who are receiving antithyroid drugs due to excessive production of thyroid hormones.
Levothyroxine Accord 100 micrograms, 150 micrograms, and 200 micrograms may also be used in tests assessing thyroid function.
Levothyroxine Accord 12.5 micrograms:

• In children with hypothyroidism, as an initial dose providing thyroid hormone replacement.
• In elderly patients, in patients with ischaemic heart disease, and in patients with severe or long-standing hypothyroidism, as a low initial dose which should then be gradually increased at longer intervals (e.g. by 12.5 micrograms daily every 2 weeks), with frequent monitoring of thyroid hormone levels.
• In any patient requiring gradual dose escalation of levothyroxine.

2. Important information before using Levothyroxine Accord

When not to use Levothyroxine Accord

• if the patient is allergic to sodium levothyroxine or any of the other ingredients of this medicine (listed in section 6),
• if the patient has untreated adrenal or pituitary insufficiency, or if thyroid hormones are being produced in excess (hyperthyroidism),
• if the patient has an acute heart condition (myocardial infarction, inflammation of the heart).
• During pregnancy, Levothyroxine Accord must not be used concomitantly with antithyroid drugs in the treatment of hyperthyroidism.

Levothyroxine Accord should not be used in combination with antithyroid drugs if
the patient is pregnant (see section "Pregnancy and breastfeeding" below).
Warnings and precautions
Before starting treatment with Levothyroxine Accord, inform your doctor if the patient has any of
the following heart conditions:

• inadequate blood flow in the blood vessels of the heart (angina pectoris),
• heart failure,
• rapid or irregular heartbeat,
• arterial hypertension,
• fatty deposits in the arteries (atherosclerosis),
• if the adrenal glands are not functioning properly (adrenal insufficiency), and replacement therapy for adrenal hormone deficiency is insufficient,
• if laboratory tests to measure thyroid hormone levels are to be performed, the patient should inform the doctor or laboratory staff about current or recent use of biotin (also known as vitamin H, vitamin B7 or vitamin B8). Biotin may affect laboratory test results. Depending on the type of test, results may be falsely elevated or falsely decreased due to biotin intake. The doctor may advise the patient to discontinue biotin before laboratory testing. It is also important to remember that other products the patient may be taking, such as multivitamin preparations or supplements for hair, skin and nails, may also contain biotin. This may affect laboratory test results. If the patient is taking such products, they should inform the doctor or laboratory staff (please refer to the information in the section "Levothyroxine Accord with other medicines").

Treatment of these disorders is necessary before starting treatment with Levothyroxine Accord and
before performing a thyroid suppression test. During treatment with Levothyroxine Accord,
frequent monitoring of thyroid hormone levels is required. If there is any uncertainty about whether
the patient has any of the above-mentioned conditions or if these conditions are untreated, consult a doctor.
The doctor will perform appropriate tests to determine whether the patient has adrenal or pituitary
dysfunction, or a certain type of thyroid dysfunction involving uncontrolled overproduction of thyroid
hormones (autonomous thyroid function), as appropriate treatment may be necessary before
starting Levothyroxine Accord and before performing a thyroid suppression test.
After starting levothyroxine treatment in preterm infants with very low birth weight, blood pressure
should be monitored regularly, as a sudden drop in blood pressure (called circulatory collapse) may occur.
When switching from one medicine to another containing levothyroxine, thyroid hormone imbalance
may occur. Consult a doctor if the patient has any questions about changing medicines. Close monitoring
of clinical and biochemical parameters is necessary during the transition period. Inform the doctor if any
adverse effects occur, as dose adjustment may be required.
Talk to the doctor:

• if the patient is peri- or postmenopausal; the doctor may recommend regular monitoring of thyroid function due to the risk of osteoporosis;
• when switching from one levothyroxine-containing medicine to another; the effects of these medicines may differ slightly, so more frequent monitoring and dose adjustment may be necessary;
• when starting, stopping, or changing treatment with orlistat (a medicine used in the treatment of obesity); more frequent monitoring and dose adjustment may be necessary;
• in case of psychotic disorders, the doctor may recommend more frequent monitoring and dose adjustment;
• if the patient has adrenal insufficiency (adrenal cortex insufficiency).

Thyroid dysfunction may occur when switching from one levothyroxine-containing medicine to another.
If there are any questions about changing medicines, consult a doctor. Close monitoring of patients
(clinical and biological evaluation) is necessary during the transition period. If any adverse effects occur,
consult a doctor, as dose increase or decrease may be necessary.
Levothyroxine Accord with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take, because Levothyroxine Accord may affect the action
of these medicines:

• antidiabetic medicines (medicines that lower blood sugar levels): Levothyroxine Accord may reduce the effectiveness of antidiabetic medicines, so additional blood glucose monitoring may be necessary, especially at the beginning of treatment with Levothyroxine Accord. During treatment with Levothyroxine Accord, a change in the dose of antidiabetic medicine may be required;
• anticoagulant medicines (coumarin derivatives): Levothyroxine Accord may enhance the effect of these medicines, increasing the risk of bleeding, especially in elderly patients. Therefore, regular monitoring of blood coagulation parameters may be necessary at the beginning and during treatment with Levothyroxine Accord. During treatment with Levothyroxine Accord, a change in the dose of coumarin-derived anticoagulant medicine may be required.

Ensure that the recommended time intervals are observed when taking any of the following medicines:

• bile acid sequestrants and cholesterol-lowering medicines (cholestyramine or colestipol): Levothyroxine Accord should be taken 4 to 5 hours before taking these medicines, as
  they may inhibit the absorption of Levothyroxine Accord from the intestines;

• antacids (used to relieve indigestion), sucralfate (used in the treatment of gastric and intestinal ulcers), other medicines containing aluminium, medicines containing iron, medicines containing calcium: Levothyroxine Accord should be taken at least 2 hours before taking these medicines, otherwise they may reduce the effectiveness of Levothyroxine Accord.

The above-mentioned medicines may reduce the effectiveness of Levothyroxine Accord, therefore inform
the doctor or pharmacist about all medicines currently taken or recently taken, as well as any planned
medicines:

• propylthiouracil (an antithyroid medicine),
• glucocorticosteroids (anti-allergic and anti-inflammatory medicines),
• beta-blockers (medicines that lower blood pressure, also used in the treatment of heart diseases),
• sertraline (an antidepressant),
• chloroquine or proguanil (medicines used in the treatment or prevention of malaria),
• medicines that induce certain liver enzymes, such as barbiturates (sedatives, hypnotics) or carbamazepine (an anticonvulsant used also for certain types of pain and mood disorders),
• medicines containing oestrogens, used in hormone replacement therapy during and after menopause or for contraception,
• sevelamer (a medicine that reduces phosphate levels, used in patients with chronic kidney failure),
• tyrosine kinase inhibitors (medicines used in cancer treatment),
• orlistat (a medicine used in the treatment of obesity).

The above-mentioned medicines may enhance the effect of Levothyroxine Accord, therefore inform the doctor
or pharmacist about all medicines currently taken or recently taken, as well as any planned medicines:

• salicylates (medicines used to relieve pain and reduce fever),
• dicoumarol (a medicine that reduces blood clotting),
• high-dose furosemide, above 250 mg (a diuretic),
• clofibrate (a medicine that reduces blood lipid levels).

The above-mentioned medicines may affect the action of Levothyroxine Accord, therefore inform the doctor
or pharmacist about all medicines currently taken or recently taken, as well as any planned medicines:

• ritonavir, indinavir, lopinavir (protease inhibitors, medicines used in the treatment of HIV infections),
• phenytoin (an anticonvulsant),
• medicines containing St. John's wort (some herbal medicines),
• proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazol, rabeprazole and lansoprazole) used to reduce stomach acid production, which may impair levothyroxine absorption from the intestine and make it less effective. If the patient is taking levothyroxine during treatment with proton pump inhibitors, the doctor should monitor thyroid function and adjust the dose of Levothyroxine Accord if necessary.

In this case, regular thyroid hormone testing and dose adjustment may be necessary.
If the patient is taking amiodarone (a medicine used to treat heart rhythm disorders), inform the doctor,
as this medicine may affect thyroid function.
Inform the doctor about taking Levothyroxine Accord if a diagnostic or imaging test involving an iodine-containing contrast agent is required, as this test involves an injection that may affect thyroid function.
Inform the doctor or pharmacist about all medicines currently or recently taken, including those available
without a prescription.
Thyroid hormones should not be used for weight reduction. Taking them will not lead to weight loss if
thyroid hormone levels are maintained at appropriate levels. Increasing the dose without consulting
a doctor may lead to severe and life-threatening adverse effects, especially when combined with other
weight-loss medicines.
If the patient is currently or has recently taken biotin, they must inform the doctor or laboratory staff
if thyroid hormone laboratory tests are to be performed. Biotin may affect laboratory test results (see
"Warnings and precautions").
Levothyroxine Accord with food and drink
If the diet includes soy-containing products, inform the doctor, especially if the amount of such products
consumed changes. Soy-containing products may reduce the absorption of Levothyroxine Accord from
the small intestine, so dose adjustment of Levothyroxine Accord may be necessary.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant,
she should consult a doctor or pharmacist before using this medicine.
Appropriate levels of thyroid hormone are essential for a healthy pregnancy. Therefore, treatment with
Levothyroxine Accord should be continued during pregnancy. Levothyroxine Accord must not be used
during pregnancy if the patient is taking antithyroid drugs (medicines used to treat excessive thyroid
hormone levels). If necessary, the doctor may adjust the dose.
If pregnancy occurs, contact the doctor.
There is no evidence that using Levothyroxine Accord in breastfeeding women harms the infant with
a normally functioning thyroid. Levothyroxine Accord must not be used if the patient is breastfeeding and
taking antithyroid drugs (medicines used to treat hyperthyroidism).
Driving and operating machinery
Sodium levothyroxine should not affect the ability to drive or operate machinery.
Important information about certain ingredients of Levothyroxine Accord
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered
"sodium-free".
25 microgram tablet: The medicine contains sunset yellow FCF, which may cause allergic reactions.
75, 112, 200 microgram tablets: The medicine contains Allura red AC, which may cause allergic reactions.
88 microgram tablet: The medicine contains tartrazine, which may cause allergic reactions.
100 microgram tablet: The medicine contains tartrazine and sunset yellow FCF, which may cause
allergic reactions.
125 microgram tablet: The medicine contains sunset yellow FCF and Allura red AC, which may cause
allergic reactions.

3. How to use Levothyroxine Accord

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
Your doctor will individually determine the appropriate dose for each patient based on clinical evaluation
and laboratory tests. Treatment usually starts with a low dose, which is increased every 2 to 4
weeks until the full, individually adjusted dose is reached.
During the first weeks of treatment, laboratory tests will be necessary to allow your doctor to adjust
the appropriate dose.
If a child is born with a thyroid disease involving insufficient production of thyroid hormones, it is important to quickly supplement them. Therefore, your doctor may recommend a higher initial dose
of 10 micrograms to 15 micrograms per kg body weight per day for the first 3 months.
Afterwards, your doctor will adjust the dose individually.
Typical dosage ranges are shown in the table below. Lower, individually adjusted doses may be sufficient for patients:

• of advanced age,
• with heart disease,
• with severe or long-standing hypothyroidism,
• with low body weight or with giant goitre.

Method of administration
Levothyroxine Accord is intended for oral use.
The single daily dose should be taken in the morning on an empty stomach (at least half an hour before breakfast), preferably with a small amount of liquid, e.g. half a glass of water.

For infants, the entire daily dose of Levothyroxine Accord should be administered once daily, at least half an hour before the first meal of the day. Immediately before administration, the tablet should be crushed and mixed with a small amount of water. The resulting suspension, which should always be freshly prepared, should be administered together with a small additional amount of liquid.

Duration of treatment
The duration of treatment may vary depending on the reason for which Levothyroxine Accord is used. The physician will discuss individually with each patient how long the treatment should last. Most patients need to take Levothyroxine Accord for life.

Use of a higher than recommended dose of Levothyroxine Accord
If a higher than recommended dose is taken, symptoms such as rapid heartbeat, restlessness, agitation, or involuntary movements may occur. In patients with pre-existing neurological disorders, such as epilepsy, single seizure episodes have been observed. In patients with psychotic disorders, symptoms of acute psychosis may occur. In such cases, consult a physician immediately.

Missed dose of Levothyroxine Accord
Do not take a double dose to make up for a missed dose. On the following day, resume taking the usual prescribed dose.

If there are any doubts regarding the use of Levothyroxine Accord, consult a physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
All medicines can cause allergic reactions, but serious allergic reactions are rare.
If sudden symptoms occur, such as: wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash and itching (especially affecting the whole body), contact a doctor immediately.
If the recommended dose is poorly tolerated or if an overdose of Levothyroxine Accord is taken, symptoms similar to hyperthyroidism may occur, particularly if the dose is increased too rapidly at the beginning of treatment.

The following adverse effects have been observed (frequency unknown):

• headache, hot flushes, excessive sweating,
• weight loss,
• tremor, restlessness, agitation,
• convulsions,
• insomnia,
• rapid heartbeat (tachycardia) or angina pectoris (chest pain with a feeling of pressure in the chest),
• irregular heart rhythm, palpitations,
• high blood pressure (hypertension), heart failure, heart attack,
• shortness of breath,
• increased appetite, nausea, vomiting, diarrhoea, abdominal cramps,
• muscle weakness and muscle cramps,
• fever,
• in women – menstrual disorders,
• decreased bone density, particularly in postmenopausal women who take high doses of the medicine for a long time,
• hyperthyroidism,
• angioedema, rash, urticaria.

If any of the above symptoms occur, contact a doctor. Symptoms usually resolve after adjusting the dose.
Reporting adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Levothyroxine Accord

Keep this medicine out of the sight and reach of children.
Do not use Levothyroxine Accord after the expiry date stated on the blister,
bottle, and cardboard package after EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
HDPE bottle: discard 180 days after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist what to do with medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Levothyroxine Accord contains
The active substance is sodium levothyroxine. Each tablet contains 12.5 micrograms,
25 micrograms, 50 micrograms, 75 micrograms, 88 micrograms, 100 micrograms,
112 micrograms, 125 micrograms, 137 micrograms, 150 micrograms, 175 micrograms or
200 micrograms of sodium levothyroxine.
The other ingredients are: microcrystalline cellulose, microcrystalline cellulose (type 112), magnesium oxide, light, sodium carboxymethylstarch (type A), sodium stearyl fumarate.

25 micrograms
Lake Blend LB530006 Orange contains:
Orange Yellow (E 110), aluminium lake

75 micrograms
Lake Blend LB505008 Purple contains:
Indigo Carmine (E 132), aluminium lake
Allura Red AC (E 129), aluminium lake

88 micrograms
Lake Blend LB510028 Green contains:
Tartrazine (E 102), aluminium lake
Indigo Carmine (E 132), aluminium lake

100 micrograms
Lake Blend LB520044 Yellow contains:
Tartrazine (E 102), aluminium lake
Orange Yellow (E 110), aluminium lake

112 micrograms
Lake Blend LB540042 Pink contains:
Carmine (E 120)
Allura Red AC (E 129), aluminium lake

125 micrograms
Lake Blend LB575003 Brown contains:
Orange Yellow (E 110), aluminium lake
Brilliant Blue FCF (E 133), aluminium lake
Allura Red AC (E 129), aluminium lake

137 micrograms
Lake Blend LB505013 Blue contains:
Brilliant Blue FCF (E 133), aluminium lake

150 micrograms
Lake Blend LB505010 Blue contains:
Indigo Carmine (E 132), aluminium lake

175 micrograms
Lake Blend LB500017 Purple contains:
Carmine (E 120)
Brilliant Blue FCF (E 133), aluminium lake

200 micrograms
Lake Blend LB540010 Maroon contains:
Allura Red AC (E 129), aluminium lake

What Levothyroxine Accord looks like and contents of the pack
12.5 micrograms
Round, flat, uncoated white tablets, embossed with "P" and "13" on one side and smooth on the other. Tablet diameter approximately 7 mm.

25 micrograms
Round, flat, uncoated orange tablets, with a breakline on both sides and embossed with "P" and "1" on one side and smooth on the other. Tablet diameter approximately 7 mm.
The tablet can be divided into equal doses.

50 micrograms
Round, flat, uncoated white tablets, with a breakline on both sides and embossed with "P" and "2" on one side and smooth on the other. Tablet diameter approximately 7 mm.
The tablet can be divided into equal doses.

75 micrograms
Round, flat, uncoated purple tablets, with a breakline on both sides and embossed with "P" and "3" on one side and smooth on the other. Tablet diameter approximately 7 mm.
The tablet can be divided into equal doses.

88 micrograms
Round, flat, uncoated olive-green tablets, with a breakline on both sides and embossed with "P" and "4" on one side and smooth on the other. Tablet diameter approximately 7 mm.
The tablet can be divided into equal doses.

100 micrograms
Round, flat, uncoated yellow tablets, with a breakline on both sides and embossed with "P" and "14" on one side and smooth on the other. Tablet diameter approximately 7 mm.
The tablet can be divided into equal doses.

112 micrograms
Round, flat, uncoated pink tablets, with a breakline on both sides and embossed with "P" and "6" on one side and smooth on the other. Tablet diameter approximately 7 mm.
The tablet can be divided into equal doses.

125 micrograms
Round, flat, uncoated brown tablets, with a breakline on both sides and embossed with "P" and "7" on one side and smooth on the other. Tablet diameter approximately 7 mm.
The tablet can be divided into equal doses.

137 micrograms
Round, flat, uncoated turquoise tablets, with a breakline on both sides and embossed with "P" and "8" on one side and smooth on the other. Tablet diameter approximately 7 mm.
The tablet can be divided into equal doses.

150 micrograms
Round, flat, uncoated blue tablets, with a breakline on both sides and embossed with "P" and "9" on one side and smooth on the other. Tablet diameter approximately 7 mm.
The tablet can be divided into equal doses.

175 micrograms
Round, flat, uncoated lilac tablets, with a breakline on both sides and embossed with "P" and "10" on one side and smooth on the other. Tablet diameter approximately 7 mm.
The tablet can be divided into equal doses.

200 micrograms
Round, flat, uncoated pink tablets, with a breakline on both sides and embossed with "P" and "11" on one side and smooth on the other. Tablet diameter approximately 7 mm.
The tablet can be divided into equal doses.

12.5 micrograms
Orange-coloured PVC/EVOH/Aclar/Aluminium blister containing 10, 50, 100 or 200 tablets in a cardboard box.

25/50/100 micrograms
Orange-coloured PVC/EVOH/Aclar/Aluminium blister containing 10, 30, 50, 56, 90, 100 or 200 tablets in a cardboard box.

75/88/112/125/137/150/175/200 micrograms
Orange-coloured PVC/EVOH/Aclar/Aluminium blister containing 10, 30, 50, 90, 100 or 200 tablets in a cardboard box.

25/50/75/88/100/112/125/137/150/175/200 micrograms
White, opaque HDPE bottle with white, opaque polypropylene child-resistant closure and induction seal, containing 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Tel: + 48 22 577 28 00

Manufacturer
LABORATORI FUNDACIÓ DAU
C/C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50 Street
96-200 Pabianice

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

| Country | Name of the medicinal product | |--------|-------------------------------| | Netherlands | Levothyroxine Accord 12.5/25/50/75/88/100/112/125/137/150/175/200 microgram tablets | | Austria | Levothyroxin natrium Accord 12.5/25/50/75/88/100/112/125/137/150/175/200 microgram tablets | | Estonia | Levothyroxine Accord | | Latvia | Levothyroxine Accord 12.5/25/50/75/88/100/112/125/137/150/175/200 mikrogrami tabletes | | Lithuania | Levothyroxine Accord 12.5/25/50/75/88/100/112/125/137/150/175/200 mikrogramų tabletės | | Poland | Levothyroxine Accord | | Cyprus | Levothyroxine Accord 25/50/100 microgram tablets | | Greece | Levothyroxine/Accord 12.5/25/50/75/88/100/112/125/137/150/175/200 μg tablets |