TICHE 13 MICROGRAMMI Soft capsules

Содержание инструкции

1. TICHE 13 micrograms soft capsules, 25 micrograms soft capsules, 50 micrograms soft capsules, 75 micrograms soft capsules, 88 micrograms soft capsules
   1. WHAT TICHE IS AND WHAT IT IS USED FOR
   2. BEFORE TAKING TICHE
   3. HOW TO TAKE TICHE
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TICHE
   6. FURTHER INFORMATION

TICHE 13 micrograms soft capsules, 25 micrograms soft capsules, 50 micrograms soft capsules, 75 micrograms soft capsules, 88 micrograms soft capsules

TICHE 100 micrograms soft capsules
TICHE 112 micrograms soft capsules
TICHE 125 micrograms soft capsules
TICHE 137 micrograms soft capsules
TICHE 150 micrograms soft capsules
TICHE 175 micrograms soft capsules
TICHE 200 micrograms soft capsules
Sodium levothyroxine

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What TICHE is and what it is used for
• 2. Before you take TICHE
• 3. How to take TICHE
• 4. Possible side effects
• 5. How to store TICHE
• 6. Further information

1. WHAT TICHE IS AND WHAT IT IS USED FOR

The active ingredient of TICHE is sodium levothyroxine (T4), a synthetic thyroid hormone, whose
structure and action are identical to the natural thyroid hormone.
TICHE 25 - 200 is used

• In the replacement therapy of thyroid hormone in case of hypothyroidism;
• for the prevention of recurrent goiter after surgical intervention, in patients with normal thyroid function;
• for the treatment of benign goiter in patients with normal thyroid function;
• for the suppression of renewed thyroid (malignant) tumor growth, particularly after surgical intervention, and as a substitute for thyroid hormone deficiency;
• as accompanying therapy in the treatment of hyperthyroidism;
• in the thyroid suppression test.

TICHE 13 is used

• in children as an initial dose in the replacement therapy of thyroid hormone in case of hypothyroidism,
• in elderly patients, in patients with coronary artery disease and in those with severe or chronic hypothyroidism as a minimum initial dose which, subsequently, must be slowly increased and

at
prolonged intervals (e.g. a gradual increase of the dose of 13 mcg every 14 days) with
frequent monitoring of thyroid hormone levels;

• in any patient in whom it is necessary to gradually increase the dose of levothyroxine.

2. BEFORE TAKING TICHE

Do not take TICHE

• if you are allergic (hypersensitive) to levothyroxine sodium or any of the other ingredients of TICHE;
• if you have recently had a heart attack, acute inflammation of the heart muscle and/or acute inflammation of all layers of the heart wall (pancarditis);
• if you are pregnant and are taking medications for an overactive thyroid (thyreostatics) at the same time (see “Pregnancy and breastfeeding”);
• if you suffer from untreated adrenal insufficiency (adrenal failure), untreated pituitary gland dysfunction (pituitary insufficiency) and/or untreated overactive thyroid gland;
• if you are unable to swallow a soft capsule whole.

Pay particular attention with TICHE
if you suffer from any of the following heart conditions:

• high blood pressure,
• fast or irregular heartbeat,
• fat deposits on the artery walls (atherosclerosis),
• chest pain with a feeling of tightness (angina pectoris),
• insufficient blood flow to the coronary arteries (coronary insufficiency).

These conditions must be treated with medications before taking TICHE and, while taking
TICHE, the levels of thyroid hormones must be checked frequently.
Tell your doctor if you suspect you have any of the above conditions or if you have been
diagnosed with one of them and it has not yet been treated.
If you are about to undergo laboratory tests to monitor thyroid hormone levels, you should
inform your 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. Your doctor may ask you to stop taking biotin
before undergoing 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 may affect the results of laboratory tests. Inform your doctor and/or
laboratory personnel if you are taking such products (please refer to the information in the Taking TICHE with other medicinessection).

Before treatment

• Your doctor will perform tests to check if you suffer from a disorder of the adrenal gland, pituitary gland or thyroid gland caused by the overproduction and uncontrolled production of thyroid hormones (thyroid autonomy), as this condition must be treated with medication before taking TICHE.
• Tell your doctor if you are currently in menopause or post-menopause. Regarding the risk of osteoporosis, it may be necessary to regularly check thyroid function.
• Some heart conditions must be treated before taking TICHE; read the information in the “Pay particular attention with TICHE” section carefully.
• If you have an altered blood glucose level (diabetes) or if you are taking medications that help to thin the blood, read the “Taking TICHE with other medicines” section carefully.
• If you are switching to another product containing levothyroxine, a thyroid imbalance may occur. Consult your doctor for any questions regarding the change of medication. Careful monitoring (biological and clinical) is necessary during the transition period. Consult your doctor if you experience any side effects, as the dose may need to be increased or decreased in such cases.
• Do not take TICHE to lose weight. If your thyroid hormone levels in the blood are within the normal range, taking additional thyroid hormones will not lead to weight loss. Taking additional thyroid hormones without specific consultation with your doctor can cause serious or even life-threatening side effects, especially if taken together with other weight-loss substances.

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.

Elderly patients
Careful dosage and frequent medical checks are necessary in elderly patients.

Taking TICHEwith other medicines
Taking other medicines together with TICHE can affect its action or that of the other
medicine. Make sure your doctor is aware of the medicines you are taking.
Do not take other medicines while taking TICHE unless you have first informed your doctor
or pharmacist and asked for their advice, including those obtained without a prescription.

Inform your doctor if you are taking the following medicines.

• Medicines to lower blood sugar (antidiabetics):TICHE may reducethe effect of the antidiabetic medicine you are taking. Additional tests may be necessary to measure blood sugar levels, especially at the beginning of therapy with TICHE. During treatment with TICHE, the dosage of the antidiabetic medicine may need to be adjusted.
• Medicines that help to thin the blood (coumarin derivatives): TICHE may increasethe effect of these medicines. Regular monitoring of blood coagulation may be necessary, especially at the beginning of therapy with TICHE. During treatment with TICHE, the dosage of the coumarin medicine may need to be adjusted.
• Propylthiouracil(medicine for the treatment of hyperthyroidism),
• Glucocorticoids(anti-allergic and anti-inflammatory medicines),
• Beta-blockers(medicines to reduce blood pressure, also used in the treatment of heart disease),
• Sertraline(medicine for the treatment of depression),
• Chloroquine or proguanil(medicine for the prevention or treatment of malaria),
• Medicines for the treatment of epilepsy, such as carbamazepine, phenytoin, phenobarbital, primidone,
• Medicines containing estrogensused for hormone replacement therapy during or after menopause or as contraceptives,
• Salicylates(medicines used to relieve pain or lower fever),
• Dicoumarol(medicine used to inhibit blood coagulation),
• Furosemideat high doses of 250 mg or more (medicine used to increase urine production),
• Clofibrate(medicine used to reduce fats in the blood),
• Amiodarone(medicine for the treatment of heart rhythm disorders),
• Sevelamer(medicine used in patients undergoing dialysis or with chronic non-dialyzed kidney disease),
• Orlistat (e.g. alli)(medicine used for weight loss)
• Products containing St. John's wort(a herbal medicine);
• Proton pump inhibitors: 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 TICHE;
• Biotin: If you are taking or have recently taken biotin, you should 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 “ Pay particular attention with TICHE” section).

May affect the way levothyroxine works:

• Ritonavir,used to control HIV and chronic hepatitis C viruses .

If you are taking any of the following medicines, make sure you respect the recommended time interval:

• Antacids(medicines used to relieve stomach symptoms and heartburn), sucralfate(for the treatment of peptic ulcers) and medicines containing aluminum,iron or calcium carbonate: take TICHE at least 2 hours beforeany of these medicines, as the effect of TICHE may be reduced.
• Medicines used to bind bile acids and lower high cholesterol levels (such as cholestyramineor colestipol): take TICHE 4 - 5 hours beforethese medicines, as they can inhibit the absorption of TICHE in the intestine.

Also be careful when taking TICHE with other medicines:
If you are going to have an X-ray examination or other diagnostic tests using
a contrast agent, tell your doctor that you are taking TICHE, as the substance to be injected
may affect thyroid function.

Taking TICHE with food and drink
Tell your doctor if you consume soy products, especially if you change the proportion of the amount
of soy products in your diet. Soy products can reduce the absorption of
levothyroxine in the intestine; for this reason, the dose of TICHE may need to be
adjusted.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

• Treatment with TICHE is particularly important during pregnancy and, therefore, should not be discontinued. This is essential for the normal development of the unborn child. Consult your doctor, as the dose of levothyroxine may need to be adjusted, as your requirement may increase during pregnancy. Thyroid function should be carefully monitored.
• TICHE should not be used during pregnancy together with medicines for the treatment of hyperthyroidism (thyreostatics). During pregnancy, hyperthyroidism should be treated exclusively with low-dose thyreostatics (see “Do not take TICHE”).

Breastfeeding

• TICHE can be used during breastfeeding. There is no information to suggest that the use of TICHE by women during breastfeeding could harm the baby with normal thyroid function. TICHE should not be used during breastfeeding together with medicines for the treatment of hyperthyroidism (thyreostatics).

Driving and using machines
There is no evidence to suggest that TICHE limits the ability to drive vehicles or use
machinery, as levothyroxine is identical to natural thyroid hormone.

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

3. HOW TO TAKE TICHE

Always take TICHE exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
The doctor will determine the individual dose based on the results of laboratory tests.

Dosage
For individual treatment, soft capsules of TICHE are available with a variable content of 13 to 200 micrograms of sodium levothyroxine, so that you can take one capsule per day.

Adults

• Treatment of thyroid gland hypofunction: Initially, adults should take 25-50 micrograms of sodium levothyroxine per day. The doctor may prescribe increasing this dose by 25-50 micrograms of sodium levothyroxine every two to four weeks, up to a daily dose of 100-200 micrograms of sodium levothyroxine (equivalent to 1 - 2 soft capsules of TICHE).
• Prevention of recurrent goiter after surgical removal and treatment of benign goiter: the daily dose is 75-200 micrograms of sodium levothyroxine.
• Supportive therapy in the treatment of hyperthyroidism with thyostatic drugs: the daily dose is 50-100 micrograms of sodium levothyroxine.
• After surgery on the thyroid for malignant thyroid tumor: The daily dose is 150-300 micrograms of sodium levothyroxine.

To start treatment and increase the dose in adults, as well as for the treatment of children, it is recommended to use, where indicated, a dosage form with the lowest content of active ingredient.

Elderly patients, patients with coronary heart disease and patients with severe or chronic hypothyroidism
Treatment with thyroid hormones should be started with particular caution. This means that a low initial dose should be selected, gradually increased at prolonged intervals, with frequent monitoring by laboratory tests.

Children

• TICHE is not indicated in children who are unable to swallow a whole capsule. TICHE is not indicated in children under 6 years of age.
• In children, treatment should be started with a daily dose of 13-50 micrograms of sodium levothyroxine. In long-term treatment, the dose depends on the age and body surface area of the individual child, along with other factors. The individual dose is determined by the doctor.

Inform your doctor or pharmacist if you feel that the effects of TICHE are too strong or too weak.

How to take the medicine

• Swallow the capsule whole with an adequate amount of liquid (e.g. half a glass of water)
• Take the full daily dose in the morning, on an empty stomach, at least half an hour before breakfast. Absorption of the active ingredient is better on an empty stomach, rather than after a meal. The soft capsules of TICHE must not be crushed before taking them, nor can they be suspended or dissolved in water.

Duration of treatment
Take this medicine for as long as prescribed by your doctor.

• If you have thyroid gland hypofunction or have undergone surgery for a malignant thyroid tumor, you will generally need to take TICHE for life.
• For benign goiter and prevention of recurrent goiter, you should take TICHE for a period ranging from several months or years for the rest of your life.
• In supportive therapy for the treatment of hyperthyroidism, you should take TICHE for as long as you take the thyostatic medicine.
• For the treatment of benign goiter with normal thyroid function, a treatment period of between 6 months and 2 years is necessary. If treatment with TICHE has not produced the desired result within this period, other therapeutic options should be considered.

If you take more TICHE than you should
If you take a higher dose than prescribed, symptoms of hyperthyroidism may appear, such as palpitations, anxiety, agitation, excessive sweating or tremor (see “4. Possible side effects”). In these cases, contact your doctor.

If you forget to take TICHE
If you forget to take a dose, do not take it when you remember, skip it and take the normal dose the next day, as usual.

If you stop taking TICHE
TICHE must be taken regularly at the dose prescribed by your doctor for the therapy to be effective. Do not change, stop or suspend treatment without consulting your doctor. A suspension or temporary interruption may cause the symptoms to reappear.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, TICHE can cause side effects, although not everybody gets them.
If you take the prescribed dose of TICHE and attend your doctor's appointments for laboratory tests,
no side effects are expected. In fact, levothyroxine, the active substance of TICHE, is identical
to the natural thyroid hormone.
The following side effects may occur with frequency not known: angioedema, skin rash, urticaria
If you take more TICHE than prescribed or if you do not tolerate the dose (e.g. if the dose has been increased
too quickly), symptoms characteristic of hyperthyroidism may occur, such as:

• weight loss, increased appetite,
• tremors in the fingers, agitation, insomnia, headache, increased intracranial pressure with swelling of the eyes (especially in children),
• palpitations, heart rhythm disturbances, in particular acceleration, chest pain with a feeling of constriction (angina pectoris),
• increased blood pressure,
• vomiting, diarrhea,
• weakness and muscle cramps,
• irregular menstruation,
• excessive sweating, hair loss, feeling of warmth (facial flushing), fever. If any of the above symptoms occur, inform your doctor. They may decide to interrupt treatment for a few days, or to reduce the dose until the side effects disappear.

In case of hypersensitivity,allergic reactions may affect the skin and breathing. In
this case, seek immediate medical attention.
Inform your doctor or pharmacist.

Reporting of side effects
If you get any side effects, even those 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 provide more information on the safety
of this medicine.

5. HOW TO STORE TICHE

Keep out of the sight and reach of children.
Do not use TICHE after the expiry date stated on the outer packaging after the wording EXP. The
expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.

6. FURTHER INFORMATION

What TICHE contains
The active ingredient is sodium levothyroxine.
1 soft capsule of TICHE 13 micrograms contains 13 micrograms of sodium levothyroxine.
1 soft capsule of TICHE 25 micrograms contains 25 micrograms of sodium levothyroxine.
1 soft capsule of TICHE 50 micrograms contains 50 micrograms of sodium levothyroxine.
1 soft capsule of TICHE 75 micrograms contains 75 micrograms of sodium levothyroxine.
1 soft capsule of TICHE 88 micrograms contains 88 micrograms of sodium levothyroxine.
1 soft capsule of TICHE 100 micrograms contains 100 micrograms of sodium levothyroxine.
1 soft capsule of TICHE 112 micrograms contains 112 micrograms of sodium levothyroxine.
1 soft capsule of TICHE 125 micrograms contains 125 micrograms of sodium levothyroxine.
1 soft capsule of TICHE 137 micrograms contains 137 micrograms of sodium levothyroxine.
1 soft capsule of TICHE 150 micrograms contains 150 micrograms of sodium levothyroxine.
1 soft capsule of TICHE 175 micrograms contains 175 micrograms of sodium levothyroxine.
1 soft capsule of TICHE 200 micrograms contains 200 micrograms of sodium levothyroxine.
The excipients are:
gelatin, glycerol, purified water.

Description of the appearance of TICHE and contents of the pack
TICHE are oval, round soft capsules, amber in colour.
Each capsule is marked with an identifying (letter) mark for the dosage.
The TICHE 13 micrograms soft capsules are identified by the letter “A”.
The TICHE 25 micrograms soft capsules are identified by the letter “E”.
The TICHE 50 micrograms soft capsules are identified by the letter “G”.
The TICHE 75 micrograms soft capsules are identified by the letter “H”.
The TICHE 88 micrograms soft capsules are identified by the letter “J”.
The TICHE 100 micrograms soft capsules are identified by the letter “K”.
The TICHE 112 micrograms soft capsules are identified by the letter “M”.
The TICHE 125 micrograms soft capsules are identified by the letter “N”.
The TICHE 137 micrograms soft capsules are identified by the letter “P”.
The TICHE 150 micrograms soft capsules are identified by the letter “S”.
The TICHE 175 micrograms soft capsules are identified by the letter “U”.
The TICHE 200 micrograms soft capsules are identified by the letter “Y”.
TICHE is packaged in PVC-polychlorotrifluoroethylene (PCTFE)/aluminium/aluminium blisters in
packs of 30, 50 or 100 soft capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi

Manufacturer responsible for batch release
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi