Puran T4 (levothyroxine sodium): full package insert, how to take, contraindications, side effects.

The information presented here is based on the original medicine leaflet, ensuring the accuracy and reliability of the data.

We recommend that you read it carefully. If you have any questions, consult your doctor or pharmacist for expert advice.

Indications of the Drug

Hypothyroidism Treatment

This medication is indicated for hormone replacement or supplementation in patients with hypothyroidism, i.e. insufficient production of hormones by the thyroid gland. It is suitable for treating hypothyroidism in several situations:

• Cretinism: A condition that occurs during infancy or breastfeeding due to a deficiency of thyroid hormones during the fetal stage.
• Myxedema: Characterized by dry skin, swollen lips, and a thickened nose, associated with hypothyroidism.
• Common Hypothyroidism: Can be used in patients of any age, including children, adults, the elderly and during pregnancy.
• Primary Hypothyroidism: Resulting from reduced thyroid function or after total or partial removal of the thyroid gland, with or without goiter.
• Secondary or Tertiary Hypothyroidism: Resulting from dysfunctions in the pituitary gland or hypothalamus.

TSH suppression

The medicine is also used to suppress pituitary TSH (thyroid-stimulating hormone) in the treatment or prevention of several conditions, including:

• Euthyroid goiters: Includes thyroid nodules, subacute or chronic lymphocytic thyroiditis (such as Hashimoto's thyroiditis), and follicular and papillary thyroid carcinomas that are thyrotropin-dependent.

Diagnosis of Hyperthyroidism

This medicine helps in the diagnosis of suspected mild hyperthyroidism or in the detection of an autonomous thyroid gland, through suppression tests.

How does PURAN T4 work?

THE PURAN T4 contains levothyroxine, a substance that is a hormone normally produced by the thyroid gland.

This medicine is used to replace or supplement insufficient production of this hormone in the body, helping to maintain hormonal balance in patients with thyroid hormone deficiency.

What should I know before using?

Heart disease:

If you have heart problems such as angina, heart attack, high blood pressure, heart failure or any cardiovascular disorder, tell your doctor. In these cases, levothyroxine should be used with extreme caution, starting with lower doses and increasing gradually.

Elderly patients:

Special attention should be given to elderly patients, especially those with goiter, history of myocardial infarction, angina pectoris, heart failure or cardiac arrhythmias (heart rhythm irregularities).
heartbeat) with tachycardia (accelerated heart rate).

In elderly patients and those with long-standing hypothyroidism, levothyroxine should be introduced very gradually. This is necessary to avoid a sudden increase in metabolic demands, which could cause complications due to the body's limited adaptation to new energy needs.

Problems with the adrenal and pituitary glands:

Thyroid hormone replacement therapy can trigger problems with the adrenal or pituitary glands if not treated appropriately with corticosteroids.

Premature newborns:

In low-weight premature newborns, the introduction of levothyroxine must be done with extreme caution due to the risk of circulatory collapse.

History of epilepsy:

If you have a history of epilepsy, caution should be exercised when administering levothyroxine as there is an increased risk of seizures.

Hypersensitivity reactions:

Serious allergic reactions (which can be life-threatening) may occur and may occur immediately or appear days after starting treatment. If you experience allergic symptoms, seek immediate medical attention.

Bone mineral density:

Long-term use of levothyroxine may be associated with loss of bone density, increasing the risk of osteoporosis and fractures, especially in postmenopausal women using suppressive doses of TSH after treatment for thyroid carcinoma.

Use for Weight Loss

This medication should not be used for weight loss, as it can cause serious health problems and even death if used in doses higher than those recommended. In patients with normal thyroid hormone levels (euthyroid), the usual doses are not effective for weight loss.

Diabetes care

Patients with diabetes mellitus or diabetes insipidus require additional and special care when using levothyroxine.

Dosage adaptation

Levothyroxine dosage should be adjusted based on thyroid function tests and monitoring of clinical symptoms. It is essential to adapt the dosage according to the test results and the patient's clinical response.

Monitoring and drug interactions

Patients taking levothyroxine should be closely monitored, especially if they are taking medications that may influence thyroid function, such as amiodarone, tyrosine kinase inhibitors, salicylates, and high-dose furosemide.

Risk of osteoporosis in postmenopausal women

Postmenopausal women at increased risk of osteoporosis should have their levothyroxine dosage adjusted to the lowest effective level possible to minimize the risk of bone fractures.

Pregnancy and breastfeeding

Levothyroxine treatment does not need to be adjusted during pregnancy. However, tell your doctor if you suspect you are pregnant or if you are breastfeeding.

Levothyroxine crosses the placental barrier in limited amounts, and its use has not been shown to have adverse effects on the fetus. Maintaining thyroid hormone levels within the normal range is crucial for the health of the pregnant woman and the fetus.

Both TSH (thyroid-stimulating hormone) and thyroid hormone levels should be monitored periodically, and treatment adjusted as necessary.

Levothyroxine should not be used as an adjunctive treatment for hyperthyroidism during pregnancy, as it may increase the need for antithyroid medications, which cross the placental barrier and may cause hypothyroidism in the fetus.

Hyperthyroidism during pregnancy should be treated with low doses of a single antithyroid agent.

The use of levothyroxine does not interfere with lactation. Only a small amount of the drug is excreted in breast milk, and breastfeeding can continue normally during treatment.

Levothyroxine can be used during pregnancy and lactation, as long as it is under medical supervision.

Changes in the ability to drive and operate machinery

There is no evidence that levothyroxine affects the ability to drive or operate machinery.

Recent laboratory tests and exams

If you are having lab tests to monitor your thyroid hormone levels, tell your doctor and the lab professional if you have recently taken biotin (vitamin H, B7, or B8).

Biotin may alter test results, making them falsely low or high. Your doctor may recommend that you stop taking biotin before testing.

Other products, such as multivitamins or hair, skin, and nail supplements, may also contain biotin and affect test results. Tell your doctor and/or lab professional about the use of these products.

Interactions with other medicines

Effects of PURAN T4 on other medicines

Oral Anticoagulants
Thyroid hormones, such as levothyroxine, may potentiate the effects of oral anticoagulants, such as dicumarol and warfarin. Patients taking anticoagulants should be carefully monitored when initiating or adjusting therapy with thyroid agents, and the dosage of the oral anticoagulant may need to be adjusted.

Oral Antidiabetics and Insulin
Levothyroxine may cause an increase in blood glucose. For diabetic patients, this may require adjustments in the dose of oral antidiabetic drugs or insulin. This effect occurs because thyroid hormones influence hepatic insulin sensitivity, which is crucial for inhibiting hepatic gluconeogenesis.

Other Medicines
Tell your doctor if you are using any other medicines, especially blood thinners, oral contraceptives, cholestyramine, aspirin, antidiabetics or antidepressants.

Effects of other medicines on PURAN T4

Enzyme Inducing Drugs
Medications such as rifampin, carbamazepine, phenytoin, barbiturates, and St. John's wort (Hypericum perforatum) may increase hepatic elimination of thyroid hormone, resulting in decreased blood concentrations. Patients on thyroid hormone therapy may require dosage adjustments if these medications are administered concomitantly.

Proton Pump Inhibitor Medications
Medicines such as omeprazole, esomeprazole, pantoprazole, rabeprazole, and lansoprazole can reduce the absorption of levothyroxine from the intestine, making it less effective. Your doctor should monitor your thyroid function and adjust your levothyroxine dose if necessary.

Amiodarone
Amiodarone may inhibit the peripheral conversion of levothyroxine T4 to T3, resulting in decreased serum T3 concentration and increased serum TSH level.

Glucocorticoids, Propylthiouracil and Beta-Sympatholytics
Medications such as glucocorticoids, propylthiouracil and beta-sympatholytics (especially propranolol) inhibit the peripheral conversion of levothyroxine (T4) to T3, which may lead to a reduction in serum T3 concentration.

Protease Inhibitors
Protease inhibitors, such as lopinavir/ritonavir, may reduce the therapeutic effect of levothyroxine. Clinical symptoms and thyroid function tests should be monitored carefully, and dose adjustments may be necessary.

Tyrosine Kinase Inhibitors
Tyrosine kinase inhibitors, such as imatinib, sunitinib, or sorafenib, may reduce the efficacy of levothyroxine. Clinical symptoms and thyroid function should be monitored carefully, and dose adjustments may be necessary.

Estrogens
Oral contraceptives and other estrogens can increase thyroxine binding, leading to misdiagnosis and mistreatment.

Salicylates
Doses greater than 2 g/day may temporarily increase thyroid hormone levels, followed by a reduction in total T4 and free T4 levels by 20–30%.

Furosemide
High doses of furosemide (>80 mg intravenously) may cause a transient increase in free T4 and a reduction in total T4 due to changes in renal function and serum albumin concentration. This effect is not observed at usual doses.

Clofibrate
Clofibrate can act as a microsomal enzyme inducer, altering the metabolism of thyroid hormones and reducing free T4 and T3 levels.

Antidiabetics
Levothyroxine may reduce the hypoglycemic (blood sugar-lowering) effect of oral antidiabetic agents such as metformin, glimepiride, and glibenclamide, as well as insulin. Monitoring blood glucose levels and adjusting the dose of antidiabetic agents may be necessary.

Iodinated Contrast Media
Some iodinated contrast media (such as iopanoic acid and sodium ipodate) can temporarily interfere with thyroid function, reducing the secretion of thyroid hormones and causing hypothyroidism.

Orlistat
Hypothyroidism or reduced control of hypothyroidism may occur when levothyroxine and orlistat (used to treat obesity) are taken at the same time, due to decreased absorption of levothyroxine.

Semaglutide
If you are taking levothyroxine and semaglutide (an antidiabetic medicine) at the same time, this may affect your levothyroxine levels. Your doctor may need to monitor your thyroid levels and adjust your PURAN T4 dose as needed.

Medicines taken by mouth that may reduce the absorption of PURAN T4

• Ion Exchange Resins
  Resins such as cholestyramine, sevelamer, and polystyrene calcium sulfate may decrease the absorption of levothyroxine by binding to thyroid hormones in the gastrointestinal tract. It is recommended that the administration of these medications be separated from levothyroxine to minimize this interaction.
• Bile Acid Sequestrant
  Colesevelam may reduce the absorption of levothyroxine. To avoid this interference, it is recommended to take levothyroxine at least 4 hours before consuming colesevelam.
• Gastrointestinal Tract Medications
  Substances such as sucralfate, antacids, and calcium carbonate may interfere with the absorption of levothyroxine in the gastrointestinal tract. These medications should be administered separately from levothyroxine.
• Iron Salts
  Ferrous sulfate may reduce the absorption of levothyroxine. It is best to space out the administration of iron salts and levothyroxine to avoid this interaction.

Food

• Soy
  In neonates treated with levothyroxine and fed a soy-based diet, an increase in TSH levels may occur. Levothyroxine doses may need to be adjusted to maintain normal serum T4 and TSH levels. Continuous monitoring of these levels is essential during and after the introduction of soy into the diet.
• Coffee
  Avoid taking PURAN T4 with coffee, as this can decrease the absorption of levothyroxine from the intestine and reduce its effectiveness. Wait half an hour to an hour after taking PURAN T4 before consuming coffee. To optimize absorption, take PURAN T4 on an empty stomach, preferably 30 minutes to 1 hour before or 2 hours after breakfast or any meal.

Always inform your doctor or dentist about any other medication you are taking. Do not use medication without medical advice, as this may pose risks to your health.

Where and how should I store it?

Storage: Keep PURAN T4 at room temperature, between 15 and 30 ºC. Store the medicine away from light and moisture. Keep PURAN T4 in its original packaging. Keep PURAN T4 in its original packaging.

Expiration Date: Do not use the medicine after the expiration date. Check the batch number, manufacturing date and expiration date on the packaging.

Aspect: Before using, check the appearance of the medicine. If the tablet is within the expiration date, but you notice any change in its appearance, consult a pharmacist to find out if it can still be used.

Description: The tablet is round, white, flat, beveled and has the corresponding concentration (12.5; 25; 37.5; 50; 62.5; 75; 88; 100; 112; 125; 150; 175; 200 or 300) engraved on both sides.

Ingredients and formulation

PURAN T4 is available in the following presentations with packaging of 30 tablets:

When should I not use Puran T4?

PURAN T4 should not be used under the following conditions:

• Allergy to any component of the formula.
• Recent myocardial infarction.
• Untreated thyrotoxicosis, a condition resulting from elevated levels of thyroid hormones.
• Decompensated adrenal insufficiency, which is a problem in the glands located above the kidneys.
• Untreated hyperthyroidism.

There are no specific contraindications related to age groups (age).

How to use Puran T4? (instruction)

PURAN T4 doses vary according to the severity of hypothyroidism, the patient's age and individual tolerance. To adjust the dosage, it is recommended to measure T3, T4 and TSH before starting treatment.

Route of administration:

Take the tablets with liquid, orally.

There are no studies on the administration of PURAN T4 by non-recommended routes. Therefore, to ensure safety and efficacy, administration must be exclusively oral., or as directed by your physician.

Adult use

Hypothyroidism: Start with a low dose of 50 mcg/day, which can be increased according to the patient's response and cardiovascular condition. The initial dose can be increased by 25 mcg every 2 to 3 weeks until the desired effect is achieved. In patients with long-standing hypothyroidism and possible cardiovascular alterations, the initial dose should be even lower (25 mcg/day). The maintenance dose usually ranges from 75 to 125 mcg/day, but some patients may require up to 200 mcg/day. Most patients do not require doses higher than 150 mcg/day. Lack of response to doses of 200 mcg/day may indicate malabsorption, non-adherence to treatment, or misdiagnosis.

TSH suppression (thyroid cancer), nodules, euthyroid goiters: The average suppressive dose is 2.6 mcg/kg/day for 7 to 10 days. This dose usually normalizes T3 and T4 levels and reduces the action of TSH. Levothyroxine should be used with caution in patients with suspected independent thyroid gland, since exogenous hormones may add to endogenous hormones.

Pediatric use

Newborns: The initial dose is 5 to 6 mcg/kg/day, adjusted according to the dosage of circulating hormones.

Children: The dose is usually 3 mcg/kg/day, adjusted according to the results of hormone tests.

Elderly patients

For elderly patients, PURAN T4 therapy should begin with low doses (25-50 mcg/day) due to possible cardiovascular impairment.

How to take

The tablets should be taken on an empty stomach, 30 minutes to 1 hour before or 2 hours after breakfast or food intake, to increase absorption.

For children who have difficulty swallowing tablets, they can be crushed and dissolved in a small amount of water.

This suspension can be given with a spoon or dropper and can also be mixed with small amounts of food (such as cereal and juice). The prepared suspension should not be stored for later use.

• Do not stop treatment without consulting your doctor.
• Do not break, open or chew the tablets.
• Follow your doctor's instructions regarding times, doses and duration of treatment.

What to do if I forget to use it?

If you forget to take a dose of PURAN T4, take it as soon as you remember. However, if it is close to the time of your next dose, wait and take the next dose at the correct time.

Do not take two doses at once to make up for the missed dose.

If you have any questions or need help, talk to your pharmacist, doctor or dentist.

Puran T4 Side Effects and Adverse Reactions

In general, the side effects of levothyroxine are related to excessive use of the medication and can cause symptoms of hyperthyroidism (excessive production of hormones by the thyroid gland).

Very common reactions

(more than 10% of patients)

• Palpitations (sensation of heartbeat).
• Insomnia (difficulty sleeping).
• Headache.

Common reactions

(between 1% and 10% of patients)

• Tachycardia (accelerated heart rate).
• Nervousness.
• Hyperthyroidism (effects usually disappear when the dosage is reduced or treatment is stopped)

Unknown reactions

(cannot be estimated from the data collected)

• Immune system: Hypersensitivity.
• Cardiac: Heart arrhythmias (irregular heartbeats) and chest pain (angina).
• Skin and subcutaneous: Swelling (angioedema), rash, hives (itchy rash), excessive sweating (sweating).
• Psychiatric: Agitation and excitement.
• Musculoskeletal and connective tissue: Muscle weakness, cramps and osteoporosis (weak bones) in high doses and prolonged use, especially in postmenopausal women.
• Vascular: Sudden sensation of heat (hot flushes) and circulatory collapse (the heart and vessels are not able to irrigate all the body's tissues with sufficient oxygen) in premature neonates.
• Reproductive and breast: Menstrual irregularities
• Gastrointestinal: Diarrhea and vomiting.
• Weight loss
• Nervous system: Tremors and increased intracranial pressure characterized by headache, nausea, visual changes and tinnitus (pressure in the skull), benign particularly in children
• Intolerance to heat and fever.
• Allergic: Skin rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue.

If you notice any adverse reactions, inform your doctor, dentist or pharmacist. It is also important to report these effects to the customer service department of the company responsible for the medication.

What to do if you use more than the recommended amount?

If someone uses more PURAN T4 than indicated, the following may occur:

• Thyroid storm: Severe crisis due to excess thyroid hormones in the blood.
• Seizures: Sudden and involuntary muscle contractions.
• Cardiac arrhythmias: Irregular heartbeat.
• Reduced cardiac function: Weaker heartbeat.
• Coma and death: In extreme cases.

Treatment:

• Acute Overdose: It can be treated with activated charcoal to reduce the absorption of the drug in the stomach.
• Symptomatic Treatment: Beta blockers may help control symptoms of hyperactivity.
• Plasma Filtration: In severe cases, it may be necessary to separate and remove the plasma from the blood.

Follow-up: Overdose may require monitoring by up to 6 days, as symptoms may last due to the gradual conversion of the drug into its active form.

Seek Help: If you suspect an overdose, seek medical help immediately and take the medicine packaging or leaflet with you, if possible. For further guidance, call 0800 722 6001.

Download the original manufacturer's leaflet:

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Sources and bibliography:

This article was extracted from the manufacturer's original package insert. Sanofi Medley Pharmaceutical, in August 2024, under technical supervision of the responsible pharmacist.

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