L Thyroxin 75 mcg. 50 tablets

What is L-Thyroxine 75 Berlin-Hemi and what it is used for
L-Thyroxine 75 Berlin-Hemi is a medicinal product that contains thyroid hormone levothyroxine as an active substance. It has the same effect as the hormone formed naturally.
You are taking L-Tyroxin 75 Berlin-Hemi to replace the missing thyroid hormone and / or relieve your thyroid gland.

L-Tyroxin 75 Berlin-Hemi is used for:

replacement (substitution) of missing thyroid hormone in all types of decreased thyroid function (hypothyroidism);
prevention of recurrent throat (thyroid enlargement) after a throat operation under normal thyroid function;
treatment of benign thrush in normal thyroid function;
accompanying treatment for increased thyroid function with thyreostatics (medicines that suppress thyroid function) once a normal metabolic status has been achieved;
malignant thyroid tumor, primarily after surgery to suppress tumor growth and replace the missing thyroid hormone.
L-Tyroxin 75 Berlin-Hemi is administered to all age groups.

2. What you need to know before you take L-Tyroxin 75 Berlin-Hemi
Do not take L-Tyroxin 75 Berlin-Hemi:

if you are allergic (hypersensitive) to levothyroxine sodium or any of the other ingredients of this medicine (described in Section 6);
if you have any of the following conditions or any of the following conditions:
untreated elevated thyroid function;
untreated adrenal insufficiency;
untreated pituitary insufficiency if this leads to insufficient adrenal cortex requiring treatment;
a recent heart attack;
acute inflammation of the heart muscle (myocarditis);
acute inflammation of all layers of the wall of the heart (pancarditis).
If you are pregnant, you should not take L-Tyroxin 75 Berlin-Hemi together with medicines that suppress increased thyroid function (so-called thyreostatic) (see also "Pregnancy and breast-feeding").

Before starting treatment with L-Tyrosine 75 Berlin-Hemi, the following diseases or conditions should be excluded or treated:

coronary heart disease;
pain in the heart with a feeling of tightness (angina pectoris);
high blood pressure;
pituitary and / or adrenal insufficiency;
presence of areas of the thyroid gland that uncontrollably produce thyroid hormones (autonomic function of the thyroid gland).
Warnings and precautions

If you have had a heart attack or have coronary heart disease, heart muscle weakness, heart rhythm disorders (tachycardia) or inflammation of the heart muscle that is not acute or have suffered prolonged thyroid function: in these cases, to avoid too high levels of the hormone in the blood. For this reason thyroid hormone levels should be monitored more frequently. Ask your doctor if you experience mild symptoms of increased thyroid function associated with L-Tyroxine 75 Berlin-Hemi (see section 4 "Possible side effects");
If you suffer from decreased thyroid function due to pituitary disease. In this case you may also have an adrenal cortex insufficiency that your doctor should first treat (hydrocortisone treatment);
If there are suspected that there are areas in the thyroid gland that uncontrollably produce hormones. This has to be assessed by further studies of thyroid function before initiation of treatment;
In postmenopausal women with a higher risk of bone destruction (osteoporosis). Thyroid function should be controlled more often by your doctor to avoid elevated levels of thyroid hormones in the blood;
If you are a diabetic or are being treated with certain anti-coagulant drugs (eg dicumarol). Please refer to the section "Other medicines and L-Tyrosine 75 Berlin-Hemi";
If you are treated with sevelamer due to high levels of phosphate in the blood, if you are a dialysis patient, your doctor will monitor certain blood parameters for the effectiveness of levothyroxine (see also "Other medicines and L-Tyrosine 75 Berlin-Hemy").
Ask your doctor or pharmacist for advice before taking L-Tyroxine 75 Berlin Hemi.

Incorrect use
You should not take L-Tyroxin 75 Berlin-Hemi to reduce your body weight. If thyroid hormone levels in the blood are normal, supplemental thyroid hormone intake will not lead to a reduction in body weight. Additional intake may lead to undesirable or even life-threatening reactions, especially in combination with certain weight loss medications.

Change of therapy
If you are already being treated with L-Tyroxin 75 Berlin-Hemi, the change in therapy with another thyroid hormone should only be performed with physician follow-up and blood counts.

Elderly patients
Patients
Other Drugs and L-Tyroxin 75 Berlin-Hemi
Please tell your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines.

L-Thyroxine 75 Berlin-Hemi affects the effects of the following drugs or groups:

Antidiabetic medicines (medicines that lower blood sugar). If you are a diabetic, you should regularly monitor your blood sugar levels, especially at the beginning of your thyroid hormone treatment. Your doctor should adjust the dose of the medicine to lower your blood sugar, as levothyroxine may reduce the blood glucose lowering effect;
Coumarin derivatives (anticoagulants). When co-administering L-Tyrosine 75 Berlin-Hemi and coumarin derivatives (eg dicumarol), you should regularly monitor blood clotting. Your doctor should reduce the dose of anticoagulant as levothyroxine may increase the effect of the anti-clotting agents.
The effect of L-Thyroxine 75 Berlin-Hemi is affected by other medicines such as:

Blood lipid lowering drugs, medicines to reduce elevated potassium levels in the blood (ion exchange resins). Medicines to lower blood lipid levels (eg cholestyramine, cholestypol, colesevelam) or medicines to reduce elevated levels of potassium in the blood (calcium or sodium salts of polystyrene sulfonic acid) are administered 4 to 5 hours after L- Tyroxin 75 Berlin-Hemi. Otherwise, these drugs will inhibit the uptake of levothyroxine from the gut and thus reduce its effectiveness;
Sevelamer and lanthanum carbonate. Sevelamer and lanthanum carbonate (medicines to lower elevated blood phosphate levels in hemodialysis patients) are likely to reduce levotiroxine uptake and effectiveness. Your doctor will monitor thyroid function more often (see also section "Warnings and Precautions");
Aluminum-containing medicines that bind to stomach acid, iron-containing medicinal products, calcium-containing medicines. Take L-Tyroxin 75 Berlin-Hemi at least 2 hours before the aluminum-containing medicines that bind to stomach acid (antacids, sucralphate), iron-containing or calcium-containing medicines. Otherwise, these drugs will prevent the absorption of levothyroxine from the small intestine and thus reduce its effectiveness;
Propylthiouracil, glucocorticoids, beta-blockers. Propylthiouracil, glucocorticoids (adrenal hormones, cortisone) and beta-blockers (medicines that lower heart rate and lower blood pressure) inhibit the conversion of levothyroxine to the more active form of lyothyronine, and thus may reduce the effectiveness of L-Tyroxin 75 Berlin-Hemi;
Amiodarone, iodine-containing contrast media. Amiodarone (a medicine for the treatment of disturbed heart rhythm) and iodine-containing contrast media (certain drugs used in X-ray diagnosis) can lead to both increased and decreased thyroid function due to high iodine content. Particular caution should be exercised in the nodule if unidentified areas of the thyroid gland that uncontrollably form thyroid hormones (autonomy) are present. Your doctor will adjust the dose of L-Tyroxin 75 Berlin-Hemi if necessary;
The following drugs may increase the effect of L-Tyroxin 75 Berlin-Hemy:
salicylates (medicines against high temperature and pain);
dicumarol (anticoagulants);
high doses of furosemide (250 mg) (a medicine to increase urine output);
clofibrate (a medicine for lowering lipid levels in the blood);
phenytoin (a medicine to treat seizures, a medicine to treat heart rhythm disturbances);
Birth medications or hormone replacement therapy. If you are taking estrogen-containing hormonal contraceptives or postmenopausal hormone replacement therapy, the need for levothyroxine may be increased;
Sertraline, chloroquine / proguanil. Sertraline (an anti-depressant drug) and chloroquine / proguanil (medicines against malaria and rheumatic diseases) decrease the effectiveness of levothyroxine;
Barbiturates, rifampicin, carbamazepine. Barbiturates (medicines to treat seizures, anesthesia, certain sleeping medicines), rifampicin (antibiotic) and carbamazepine (a medicine to treat seizures) may reduce the effect of levothyroxine;
Protease inhibitors (medicines to treat HIV-infections). If you take both levothyroxine and protease inhibitors (lopinavir, ritonavir), your doctor should carefully monitor your symptoms and monitor the thyroid function. Levothyroxine may decrease its effect with lopinavir / ritonavir co-administration;
Tyrosine kinase inhibitors (imatinib and sunitinib). Treatment with imatinib or sunitinib (medicines for the treatment of chronic myeloid leukemia)
Pregnancy, breastfeeding and fertility
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Proper thyroid hormone treatment is especially important during pregnancy and breastfeeding. Therefore, treatment should be consistent and under the supervision of your treating physician. Despite widespread use during pregnancy, no adverse effects on pregnancy and on the health of the fetus or the newborn have been identified so far.
Thyroid function should be monitored during and after pregnancy. Your doctor may need to adjust the dose because pregnancy may require levotiroxine to increase due to elevated estrogen levels (female sex hormone).
During pregnancy, you should not take L-Tyroxin 75 Berlin-Hemi together with medicines that suppress the increased thyroid function (thyreostatics) as higher doses of thyreostatic will be needed. Thyroidists, unlike levothyroxine, can reach the placental circulation of the fetus and may lead to reduced thyroid function in the fetus. If you suffer from increased thyroid function, your doctor should treat you with extremely low doses of thyreostatin during pregnancy.
The amount of thyroid hormones that pass into breast milk is very low, even with high doses of levothyroxine, and is therefore harmless.
There are no scientific data on fertility impairment in men and women. There are no suspicions or evidence of the existence of a disability.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.

3. How to take L-Tyroxin 75 Berlin-Hemi
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The daily dose you need will be determined by your doctor according to the results of the studies.

Dosage
For individual treatment, divisible tablets with different concentrations of the active substance, e.g. for initial treatment, dose escalation in adult patients, and for the treatment of children.

Depending on the symptoms, your doctor will follow these recommendations:

For treatment of a reduced-function thyroid gland, the starting dose for adult patients is 25-50 micrograms of levothyroxine sodium per day. On recommendation of the physician, this dose may be increased at intervals of 2 to 4 weeks from 25-50 micrograms of levothyroxine sodium to a daily dose of 100-200 micrograms of levothyroxine sodium;
To prevent re-throat after throat surgery and to treat benign thrush, 75-200 micrograms of levothyroxine sodium are taken daily;
For concomitant therapy, 50-100 micrograms of levothyroxine sodium per day is used to treat thyroid increased thyroid function;
Following thyroid surgery due to a malignant thyroid tumor, the daily dose is 150-300 micrograms levothyroxine sodium (equivalent to 2 to 4 L-Tyroxine 75 Berlin-Hemi tablets).
A lower dose of thyroid hormones may be sufficient.

Use in children with decreased thyroid function (congenital or acquired hypothyroidism)
The maintenance dose for long-term treatment of a thyroid gland with reduced function (congenital or acquired hypothyroidism) is usually 100-150 micrograms levothyroxine per m2 body surface area per day. In neonates and infants with congenital reduced thyroid function, rapid hormone replacement therapy is especially important for normal mental and physical development. The initial recommended dose is 10-15 micrograms levothyroxine per kilogram of body weight per day for the first three months. The doctor will then adjust the daily dose individually according to clinical results (especially thyroid hormone levels in the blood).
In children with acquired decreased thyroid function, the initial recommended dose is 12.5-50 micrograms levothyroxine per day. The doctor will increase your daily dose gradually, every 2-4 weeks, until the full replacement dose is reached, especially taking into account thyroid hormone levels in the blood.

Elderly patients, coronary heart disease patients, patients with impaired thyroid function
In the elderly, in coronary heart disease patients and in patients with severe or prolonged thyroid function, treatment with thyroid hormones should be initiated with caution (a low starting dose that increases slowly and at long intervals with regular thyroid hormone monitoring).

Low-weight and high-necked patients
Experience has shown that lower doses are also sufficient in patients with low body weight and in patients with enlarged thyroid gland.

Instructions for dividing the tablets
The tablet can be divided into equal doses.
Place item
Duration of treatment
L-Thyroxine 75 Berlin-Hemy is generally accepted for life under reduced thyroid function and after thyroid surgery due to a malignant tumor. In case of benign tiredness or to prevent recurrence, it is taken for several months or years for life. In the accompanying treatment of elevated thyroid function, L-Tyroxin 75 Berlin-Hemy is used while using thyrothetics (medicines that suppress the increased thyroid function). A benign throat with normal thyroid function requires treatment from 6 months to 2 years. If treatment with L-Tyrosine 75 Berlin-Hemi has not produced the desired effect for this period, your doctor will consider other treatment options.

If you take more than the required dose of L-Tyroxin 75 Berlin-Hemi
Symptoms of overdose are described in section 4 "Possible side effects". Please inform your doctor if you experience these complaints.

If you forget to take L-Tyroxin 75 Berlin-Hemi
If you take too little or miss a dose at any time, do not take a double dose to make up for it. Continue with the normal dosing regimen.

If you stop taking L-Tyroxin 75 Berlin-Hemi
Successful treatment requires the regular dose of your L-Tyroxin 75 Berlin-Hemi prescribed by your doctor. Under no circumstances should you change, interrupt, or stop treatment with L-Thyroxine 75 Berlin-Hemi earlier, as your complaints may recur.

If you have any further questions on the use of this medicine, please ask your doctor or pharmacist.

4. Possible side effects
If you use this medicine correctly, ie if you strictly follow your doctor's prescription and the recommended dose, the onset of side effects is unlikely.

Dose intolerance, overdose
If, in individual cases, the dose is not tolerated or in the case of an overdose, especially if the dose is increased very rapidly at the beginning of treatment, typical symptoms of a severely elevated thyroid function may occur, for example:

palpitations;
abnormal heart rhythm, especially rapid heart beat (tachycardia);
pain accompanied by chest tightness (angina pectoris);
muscle weakness and muscle cramps;
hot flashes, excessive sweating;
tremor (tremor);
anxiety, insomnia;
diarrhea, weight loss;
headache;
menstrual cycle disorders.
Elevated temperature, vomiting, and increased cerebral blood pressure (especially in children) may also occur as atypical symptoms.

Hypersensitivity to the active substance or to any of the other ingredients of L-Tyrosine 75 Berlin-Hemi
In case of hypersensitivity to levothyroxine or any of the other ingredients of L-Tyroxin 75 Berlin-Hemi, allergic reactions to the skin and to the respiratory tract may occur. If you experience hypersensitivity reactions, stop taking the medicine and go to the doctor immediately.
Tell your doctor about the side effects that occurred. He or she will decide whether to reduce the daily dose or to interrupt the intake for a few days. Once the symptoms have resolved, treatment can be restarted with careful dosing.
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet.
How to Store L-Thyroxine 75 Berlin-Hemi
Keep out of the reach of children!
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What contains L-Tyroxin 75 Berlin-Hemi
The active substance is levothyroxine sodium x H 2 O (levothyroxine sodium x H 2 O). One tablet contains 79.8-85.2 micrograms levothyroxine sodium x H2O (equivalent to 75 micrograms levothyroxine sodium).
The other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycollate (type A) (Ph.Eur.), Dextrin (from corn starch), long chain glycerides.

What L-Thyroxine 75 Berlin-Hemi looks like and what the package contains
L-Tyroxin 75 Berlin-Hemi are almost white to slightly beige, round, slightly rounded tablets scored on one side and marked "75" on the other side.
The tablet can be divided into two equal doses.
L-Tyrosine 75 Berlin-Hemi is in original 25, 50 or 100 tablets.
Not all pack sizes may be marketed.

 

 

 

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