1. Name of the medicinal product
  2. Levothyroxine Tablets USP 25mcg Taj Pharma
    Levothyroxine Tablets USP 50mcg Taj Pharma
    Levothyroxine Tablets USP 75mcg Taj Pharma
    Levothyroxine Tablets USP 88mcg Taj Pharma
    Levothyroxine Tablets USP 100mcg Taj Pharma
    Levothyroxine Tablets USP 112mcg Taj Pharma
    Levothyroxine Tablets USP 125mcg Taj Pharma
    Levothyroxine Tablets USP 137mcg Taj Pharma
    Levothyroxine Tablets USP 150mcg Taj Pharma
    Levothyroxine Tablets USP 175mcg Taj Pharma
    Levothyroxine Tablets USP 200mcg Taj Pharma
    Levothyroxine Tablets USP 300mcg Taj Pharma

    1. Qualitative and quantitative composition

    a) Levothyroxine Tablets USP 25mcg Taj Pharma
    Each uncoated tablet contains:
    Levothyroxine sodium anhydrous USP 25mcg.
    Excipients: Q.S.

    b) Levothyroxine Tablets USP 50mcg Taj Pharma
    Each uncoated tablet contains:
    Levothyroxine sodium anhydrous USP 50mcg.
    Excipients: Q.S.

    c) Levothyroxine Tablets USP 75mcg Taj Pharma
    Each uncoated tablet contains:
    Levothyroxine sodium anhydrous USP 75mcg.
    Excipients: Q.S.

    d) Levothyroxine Tablets USP 88mcg Taj Pharma
    Each uncoated tablet contains:
    Levothyroxine sodium anhydrous USP 88mcg.
    Excipients: Q.S.

    e) Levothyroxine Tablets USP 100mcg Taj Pharma
    Each uncoated tablet contains:
    Levothyroxine sodium anhydrous USP 100mcg.
    Excipients: Q.S.

    f) Levothyroxine Tablets USP 112mcg Taj Pharma
    Each uncoated tablet contains:
    Levothyroxine sodium anhydrous USP 112mcg.
    Excipients: Q.S.

    g) Levothyroxine Tablets USP 125mcg Taj Pharma
    Each uncoated tablet contains:
    Levothyroxine sodium anhydrous USP 125mcg.
    Excipients: Q.S.

    h) Levothyroxine Tablets USP 137mcg Taj Pharma
    Each uncoated tablet contains:
    Levothyroxine sodium anhydrous USP 137mcg.
    Excipients: Q.S.

    i) Levothyroxine Tablets USP 150mcg Taj Pharma
    Each uncoated tablet contains:
    Levothyroxine sodium anhydrous USP 150mcg.
    Excipients: Q.S.

    j) Levothyroxine Tablets USP 175mcg Taj Pharma
    Each uncoated tablet contains:
    Levothyroxine sodium anhydrous USP 175mcg.
    Excipients: Q.S.

    k) Levothyroxine Tablets USP 200mcg Taj Pharma
    Each uncoated tablet contains:
    Levothyroxine sodium anhydrous USP 200mcg.
    Excipients: Q.S.

    l) Levothyroxine Tablets USP 300mcg Taj Pharma
    Each uncoated tablet contains:
    Levothyroxine sodium anhydrous USP 300mcg.
    Excipients: Q.S.

    Excipients with known effect
    Lactose 30.49mg per tablet

    For the full list of excipients, see section 6.1.

    1. Pharmaceutical form

    Uncoated Tablet

    1. Clinical particulars
    • Therapeutic indications

    Recommended clinical indications: Control of hypothyroidism, congenital hypothyroidism in infants, acquired hypothyroidism in children and juvenile myxoedema.

    • Posology and method of administration

    Posology

    In younger patients, and in the absence of heart disease, a serum Levothyroxine Taj Pharma (T4) level of 70 to 160 nanomols per litre, or a serum thyrotrophin level of less than 5 milli-units per litre should be targeted. A pre-therapy ECG is valuable because ECG changes due to hypothyroidism may be confused with ECG evidence of cardiac ischaemia. If too rapid an increase in metabolism is produced (causing diarrhoea, nervousness, rapid pulse, insomnia, tremors, and sometimes anginal pain where there is latent cardiac ischaemia,) dosage must be reduced, or withheld, for a day or two, and then re-started at a lower dose level.

    Adults: Initially 50 to 100mcg daily (2 to 4 tablets daily), preferably taken before breakfast or your first meal of the day. Adjust at three to four week intervals by 50mcg until normal metabolism is steadily maintained. The final daily dose may be up to 100 to 200mcg.

    Elderly: As for patients aged over 50 years.

    For patients over 50 years, initially, it is not advisable to exceed 50mcg daily. In this condition, the daily dose may be increased by 50mcg at intervals of every 3-4 weeks, until stable thyroxine levels are attained. The final daily dose may be up to 50 to 200mcg.

    Patients over 50 years with cardiac disease:

    Where there is cardiac disease, 25mcg daily or 50mcg on alternate days is more suitable. In this condition, the daily dosage may be increased by 25 microgram increments at intervals of every 4 weeks, until stable thyroxine levels are attained. The final daily dose may be up to 50 to 200mcg.

    For patients aged over 50 years, with or without cardiac disease, clinical response is probably a more acceptable criteria of dosage rather that serum levels.

    Paediatric population

    The maintenance dose is generally 100 to 150mcg per m² body surface area. The dose for children depends on their age, weight and the condition being treated. Regular monitoring using serum TSH levels, as in adults, is required to make sure he/she gets the right dose. Infants should be given the total daily dose at least half an hour before the first meal of the day.

    Congenital hypothyroidism in infants:

    For neonates and infants with congenital hypothyroidism, where rapid replacement is important, the initial recommended dosage is 10 to 15mcg per kg BW per day for the first 3 months. Thereafter, the dose should be adjusted individually according to the clinical findings and thyroid hormone and TSH values.

    Acquired hypothyroidism in children:

    For children with acquired hypothyroidism, the initial recommended dosage is 12.5-50mcg per day. The dose should be increased gradually every 2 to 4 weeks according to the clinical findings and thyroid hormone and TSH values until the full replacement dose is reached.

    Infants should be given the total daily dose at least half an hour before the first meal of the day.

    Juvenile myxoedema in children:

    The initial recommended dosage is 25mcg daily. In such conditions, the daily dose may be increased by 25mcg at intervals of every 2 – 4 weeks, until mild symptoms of hyperthyroidism is seen. The dose will then be reduced slightly.

    In children under 5 years of age, the administration of whole tablets is not recommended. It is also not recommended that tablets are crushed and dispersed in water or other liquids, owing to limited solubility which could lead to dosing inaccuracy. In this age group it is preferable to administer an approved oral solution of Levothyroxine Taj Pharma

    Method of administration

    Oral

    • Contraindications
    • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
    • Thyrotoxicosis
    • Adrenal gland disorder or adrenal insufficiency

    Special warnings and precautions for use

    Levothyroxine Taj Pharma should be introduced very gradually in patients aged over 50 years (see section 4.2) and those with long standing hypothyroidism to avoid any sudden increase in metabolic demands.

    Patients with panhypopituitarism or other causes predisposing to adrenal insufficiency may react to Levothyroxine Taj Pharma treatment, and it is advisable to start corticosteroid therapy before giving Levothyroxine Taj Pharma to such patients.

    Levothyroxine Taj Pharma sodium should be used with caution in patients with cardiovascular disorders, including angina, coronary artery disease, hypertension, and in the elderly who have a greater likelihood of occult cardiac disease.

    To minimise the risk of adverse effects of undetected overtreatment, such as atrial fibrillation and fractures associated with low serum levels of thyroid stimulating hormone (TSH) in older patients, it is important to monitor serum TSH and adjust the dose accordingly during long term use.

    In individuals suspected to have cardiovascular disease or to be at high risk, it is important to perform an ECG prior to commencement of Levothyroxine Taj Pharma treatment in order to detect changes consistent with ischaemia in which case, Levothyroxine Taj Pharma should be initiated at a low dose, followed by cautious dose escalation to avoid worsening of ischaemia or precipitation of an infarct.

    Special care is needed for the elderly and for patients with symptoms of myocardial insufficiency, or ECG evidence of myocardial infarction.

    Thyroid replacement therapy may cause an increase in dosage requirements of insulin or other anti-diabetic therapy (such as metformin). Care is needed for patients with diabetes mellitus, and diabetes insipidus.

    See note above regarding withdrawal of treatment.

    Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

    Subclinical hyperthyroidism may be associated with bone loss. To minimise the risk of osteoporosis, dosage of Levothyroxine Taj Pharma sodium should be titrated to the lowest possible effective level.

    Parents of children receiving thyroid agent should be advised that partial loss of hair may occur during the first few months of therapy, but this effect is usually transient and subsequent regrowth usually occurs.

    Care is required when Levothyroxine Taj Pharma is administered to patients with known history of epilepsy. Seizures have been reported rarely in association with the initiation of Levothyroxine Taj Pharma sodium therapy and may be related to the effect of thyroid hormone on seizure threshold.

    • Interaction with other medicinal products and other forms of interaction

    Interactions affecting other drugs:

    Levothyroxine Taj Pharma increases the effect of anticoagulants (Warfarin) and it may be necessary to reduce the anticoagulation dosage if excessive, hypoprothrombinaemia and bleeding are to be avoided.

    Blood sugar levels are raised and dosage of anti-diabetic agents may require adjustment.

    Tricyclic anti-depressants (e.g. amitriptyline, imipramine, dosulepin) response may be accelerated because Levothyroxine Taj Pharma increases sensitivity to catecholamines; concomitant use may precipitate cardiac arrhythmias.

    The effects of sympathomimetic agents (e.g. adrenaline or phenylephrine) are also enhanced

    Cardiac glycosides: If Levothyroxine Taj Pharma therapy is initiated in digitalised patients, the dose of digitalis may require adjustment. Hyperthyroid patients may need their digoxin dosage gradually increased as treatment proceeds because initially patients are relatively sensitive to digoxin.

    NSAIDs: False low plasma concentrations have been observed with concurrent anti-inflammatory treatment such as phenylbutazone or acetylsalicylic acid and Levothyroxine Taj Pharma therapy.

    Beta Blockers: Levothyroxine Taj Pharma (thyroxine) accelerates metabolism of propranolol, atenolol and sotalol.

    General anaesthetics: Isolated reports of marked hypertension and tachycardia have been reported with concurrent ketamine administration.

    Interactions affecting Levothyroxine Taj Pharma:

    Amiodarone may inhibit the de iodination of thyroxine to tri iodothyronine resulting in a decreased concentration of tri iodothyronine, thereby reducing the effects of thyroid hormones.

    Anti-convulsants, such as carbamazepine and phenytoin, enhance the metabolism of thyroid hormones and may displace them from plasma proteins.

    Initiation or discontinuation of anti-convulsant therapy may alter Levothyroxine Taj Pharma dosage requirements.

    Effects of Levothyroxine Taj Pharma may be decreased by concomitant sertraline.

    Absorption of Levothyroxine Taj Pharma (thyroxine) possibly reduced by antacids, proton pump inhibitors, calcium salts, cimetidine, oral iron, sucralfate, colestipol, polystyrene sulphonate resin and cholestyramine (administration should be separated by 4-5 hours).

    Metabolism of Levothyroxine Taj Pharma (thyroxine) accelerated by rifampicin, barbituarates, and primidone. (may increase requirements for Levothyroxine Taj Pharma (thyroxine) in hypothyroidism)

    Imatinib: plasma concentration of Levothyroxine Taj Pharma (thyroxine) possibly reduced by imatinib.

    Beta blockers may decrease the peripheral conversion of Levothyroxine Taj Pharma to triiodothyronine.

    Lipid regulating drugs: Lovastatin has been reported to cause one case each of hypothyroidism and hyperthyroidism in two patients taking Levothyroxine Taj Pharma.

    Sex Hormones: Oestrogen, oestrogen containing product (including hormone replacement therapy) and oral contraceptives may increase the requirement of thyroid therapy dosage. Conversely, androgens and corticosteroids may decrease serum concentrations of Levothyroxine Taj Pharma-binding globulins.

    Anti-obesity drugs such as orlistat may decrease Levothyroxine Taj Pharma absorption which may result in hypothyroidism (monitor for changes in thyroid function).

    A number of drugs may affect thyroid function tests and this should be borne in mind when monitoring a patient on Levothyroxine Taj Pharma therapy.

    Post-marketing cases have been reported indicating a potential interaction between ritonavir containing products and Levothyroxine Taj Pharma. Thyroid- stimulating hormone (TSH) should be monitored in patients treated with Levothyroxine Taj Pharma at least the first month after starting and /or ending ritonavir treatment.

    • Fertility, pregnancy and lactation

    Pregnancy

    The safety of Levothyroxine Taj Pharma treatment during pregnancy is not known, but any possible risk of foetal abnormalities should be weighed against the risk to the foetus of untreated hypothyroidism.

    Breast-feeding

    Levothyroxine Taj Pharma is excreted in breast milk in low concentrations, and it is contentious whether this can interfere with neonatal screening.

    • Effects on ability to drive and use machines

    Levothyroxine Taj Pharma has no or negligible influence on the ability to drive and use machines.

    • Undesirable effects

    Side-effects are usually indicative of excessive dosage and usually disappear on reduction of dosage or withdrawal of treatment for a few days. Adverse reactions listed below have been observed during clinical studies and/or during marketed use and are based on clinical trial data and classified according to MedDRA System Organ Class. Frequency categories are defined according to the following convention:

    Not known (cannot be estimated from the available data)

    System organ class Frequency Undesirable effects
    Immune system disorders Not known Hypersensitivity reaction,
    Endocrine disorders Not known Thyrotoxic crisis1
    Psychiatric disorders Not known Restlessness, agitation, insomnia
    Nervous system disorders Not known Tremor,
    Cardiac disorders Not known Angina pectoris, arrhythmia, palpitations, tachycardia
    Vascular disorders Not known Flushing,
    Respiratory, thoracic and mediastinal disorders Not known Dyspnoea
    Gastrointestinal disorders Not known Diarrhoea, vomiting
    Skin and subcutaneous tissue disorders Not known Hyperhidrosis, rash, pruritus
    Musculoskeletal and connective tissue disorder Not known Arthralgia, muscle spasm, muscular weakness,
    Reproductive system disorders Not known Menstruation irregular
    General disorders and administration site conditions Not known Headache, pyrexia, malaise, oedema
    Investigations Not known Weight decreased

    1Some patients may experience a severe reaction to high levels of thyroid hormone. This is called a “thyroid crisis” with any of the following symptoms: Hyperpyrexia, tachycardia, arrhythmia, hypotension, cardiac failure, jaundice, confusion, seizure and coma

    Paediatric population

    Heat intolerance, transient hair loss, benign intracranial hypertension, craniostenosis in infants and premature closure of epiphysis in children.

    Reporting of suspected adverse reactions:

    Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

    • Overdose

    Symptoms

    In most cases there will be no features. Signs of an overdose may include: chest pain (angina), tachycardia or arrythmia, muscle cramps, headache, restlessness, flushing, sweating, diarrhoea, tremor, insomnia and hyperpyrexia. These signs can take upto 5 days to appear. Atrial fibrillation may develop. Convulsions occurred in one child. There may be increased toxicity in those with pre-existing heart disease.

    Management:

    Give oral activated charcoal if more than 10mg has been ingested by an adult or more than 5mg by a child, within 1 hour. If more than 10mg has been ingested by an adult or more than 5mg by a child, take blood 6-12 hours after ingestion for measurement of the free thyroxine concentration. The analysis does not need to be done urgently but can wait until the first working day after the incident. Patients with normal free thyroxine concentrations do not require follow up. Those with high concentrations should have outpatient review 3-6 days after ingestion to detect delayed onset hyperthyroidism. Features of clinical hyperthyroidism should be controlled with beta-blockers, e.g. propranolol

    1. Pharmacological properties

    5.1 Pharmacodynamic properties

    Pharmacotherapeutic group: Thyroid hormones

    Levothyroxine Taj Pharma is a tablet containing Levothyroxine Taj Pharma sodium used for the treatment of hypothyroidism. The thyroid gland is dependent upon 2 active principles for it’s main hormone activity these are Levothyroxine Taj Pharma (tetraiodothyronine) and Tri-iodothyronine (see Goodman and Gilman, 1985). These closely related iodine containing amino acids are incorporated into the glycoprotein thyroglobulin. The chief action of Levothyroxine Taj Pharma is to increase the rate of cell metabolism. Levothyroxine Taj Pharma is deiodinated in peripheral tissues to form triiodothyronine which is thought to be the active tissue form of thyroid hormone. Triiodothyronine has a rapid action but a shorter duration of activity than Levothyroxine Taj Pharma.

    The chief action of Levothyroxine Taj Pharma is to increase the rate of cell metabolism.

    5.2 Pharmacokinetic properties

    Levothyroxine Taj Pharma sodium is incompletely and variably absorbed from the gastrointestinal tract. It is almost completely bound to plasma proteins and has a half-life in the circulation of about a week in healthy subjects, but longer in patients with myxoedema.

    A large portion of the Levothyroxine Taj Pharma leaving the circulation is taken up by the liver. Part of a dose of Levothyroxine Taj Pharma is metabolised to triiodothyronine. Levothyroxine Taj Pharma is excreted in the urine as free drug, deiodinated metabolites and conjugates. Some Levothyroxine Taj Pharma is excreted in the faeces. There is limited placental transfer of Levothyroxine Taj Pharma.

    5.3 Preclinical safety data

    No further data of relevance

    1. Pharmaceutical particulars
      • List of excipients

    Sodium citrate
    Lactose
    Maize starch
    Powdered acacia
    Magnesium stearate

    • Incompatibilities

    None known

    • Shelf life

    24 months

    • Special precautions for storage

    Do not store above 25°C
    Store in the original package in order to protect from light and moisture

    • Nature and contents of container

    Polypropylene container with tamper-evident low density polyethylene lid, containing 28, 56, 100, 112, 500 or 1000 tablets
    Aluminium foil with PVC/PVdC film blisters containing 28, 56 or 112 tablets

    Not all pack sizes may be marketed.

    • Special precautions for disposal and other handling

    No special requirements for disposal.
    Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

    Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825) Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com

    Levothyroxine Tablets USP 125mcg Taj Pharma

     Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

    • Keep this leaflet. You may need to read it again.
    • If you have any further questions, ask your doctor, pharmacist or nurse.
    • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
    • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4

    What is in this leaflet:

    1. What Levothyroxine Taj Pharma Sodium Tablets are and what they are used for
    2. What you need to know before you take Levothyroxine Taj Pharma Sodium Tablets
    3. How to take Levothyroxine Taj Pharma Sodium Tablets
    4. Possible side effects
    5. How to store Levothyroxine Taj Pharma Sodium Tablets
    6. Contents of the pack and other information

    1. WHAT LEVOTHYROXINE TAJ PHARMA SODIUM TABLETS ARE AND WHAT THEY ARE USED FOR

    Thyroxine is a hormone which is produced naturally in the body by the thyroid gland. Levothyroxine Taj Pharma is a synthetic version of this hormone. Thyroxine controls how much energy your body uses. When the thyroid gland does not produce enough

    thyroxine (a condition known as hypothyroidism), many of the body’s functions slow down. Some of the most common symptoms of hypothyroidism are:

    • tiredness
    • weight gain
    • feeling depressed

    Levothyroxine Taj Pharma Sodium tablets are used to replace the thyroxine that your thyroid gland cannot produce and prevent the symptoms of hypothyroidism. Before starting your treatment your doctor will carry out a blood test to work out how much Levothyroxine Taj Pharma you need.

    1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOTHYROXINE TAJ PHARMA SODIUM TABLETS

    Do not take Levothyroxine Taj Pharma Sodium tablets

    • if you are allergic to Levothyroxine Taj Pharma or any of the other ingredients of this medicine (listed in section 6)
    • if you suffer from an overactive thyroid gland that produces too much thyroid hormone (thyrotoxicosis)
    • if you have any condition that affects your adrenal glands (your doctor will be able to advise you if you are not sure).

    If any of these apply to you, do not take this medicine and go back to your doctor to discuss your treatment.

    Warnings and precautions

    Talk to your doctor, pharmacist or nurse before taking Levothyroxine Taj Pharma Sodium Tablets

    • if you have suffered with an under active thyroid gland for a long time
    • if you suffer from heart problems including angina, coronary artery disease or high blood pressure
    • if you are being treated for diabetes. The dose of your antidiabetic medicine may need to be changed as Levothyroxine Taj Pharma can raise blood sugar levels
    • if you are over 50 years of age.

    Blood tests:

    Before you start taking Levothyroxine Taj Pharma your doctor will do a blood test to see how much thyroxine your thyroid gland is making and what dose of the medicine you will need. Once you start taking the medicine your doctor will want you to have regular blood tests to see how well the medicine is working.

    Other medicines and Levothyroxine Taj Pharma Sodium Tablets:

    Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes over the counter medicines, herbal remedies and vitamin supplements. Many medicines affect the way Levothyroxine Taj Pharma works. The effects of other drugs may also be affected by Levothyroxine Taj Pharma.

    The following may affect the way that Levothyroxine Taj Pharma works:

    • medicines for epilepsy such as carbamazepine, phenytoin, primidone and barbiturates
    • sertraline – used to treat depression and anxiety disorders
    • antacids – used to treat indigestion
    • medicines containing calcium salts
    • cimetidine – used to reduce excess stomach acid
    • proton pump inhibitors such as omeprazole, lansoprazole and pantoprazole – used to reduce the amount of acid produced by the stomach
    • sucralfate – used to treat and prevent stomach and duodenal ulcers
    • cholestyramine and colestipol – used to treat high level of fat in the blood
    • polystyrene sulphone resin – used to reduce high levels of potassium in the blood
    • medicines containing iron that are taken by mouth
    • rifampicin – used to treat infections
    • imatinib – used to treat certain types of cancer
    • beta blockers such as atenolol and sotalol – used to treat high blood pressure and heart problems
    • oestrogen containing medicines for hormone
    • replacement therapy (HRT) and contraception (the ‘pill’)
    • androgen containing medicines for male hormone replacement therapy
    • corticosteroids such as hydrocortisone and prednisolone – used to treat inflammation
    • amiodarone – used to treat an irregular heart beat
    • orlistat – used to treat obesity
    • Ritonavir – used to control HIV and chronic hepatitis C virus.
    • The following may be affected by Levothyroxine Taj Pharma:
    • anticoagulant medicines to prevent blood clots such as warfarin
    • medicines to treat diabetes such as insulin and metformin
    • tricyclic antidepressants such as amitriptyline, imipramine and dosulepin
    • medicines that stimulate the sympathetic nervous system such as adrenaline (used to treat severe allergic reactions) or phenylephrine (a decongestant found in many cold and flu treatments)
    • digoxin – used to treat heart problems
    • anti-inflammatory medicines such as phenylbutazone or aspirin
    • propanolol – used to treat high blood pressure and heart problems
    • ketamine – used as an anaesthetic. If you need to have an operation, please tell your doctor or anaesthetist that you are taking Levothyroxine Taj Pharma.

    Pregnancy and breast-feeding:

    If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you should continue treatment with Levothyroxine Taj Pharma whilst you are pregnant, particularly in the first three months of your pregnancy.

    Driving and using machines

    This medicine should not affect your ability to drive and use machines.
    Levothyroxine Taj Pharma Sodium Tablets contain lactose:

    This medicine also contains lactose, a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

    1. HOW TO TAKE LEVOTHYROXINE TAJ PHARMA SODIUM TABLETS

    Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. You may be taking this medicine for the rest of your life.

    Your dose will be decided by your doctor and will depend on the results of your blood tests. The dose you should take will be on the label attached by your pharmacist. Swallow the tablets with plenty of water. You should usually take your tablets before breakfast or your first meal of the day.

    Adults:

    The recommended starting dose is 50 – 100mcg every day. Your doctor may increase the dose you take every 3 – 4 weeks by 50mcg until your thyroxine levels are correct. Your final daily dose may be up to 100 – 200mcg daily.

    Patients over 50 years of age:

    The recommended starting dose will be no more than 50mcg every day. The dose may then be increased by 50mcg every 3 – 4 weeks until your thyroxine levels are correct. Your final daily dose will be between 50 – 200mcg daily.

    Patients over 50 years of age with heart problems:

    The recommended starting dose will be 25mcg every day or 50mcg every other day. The dose may be increased by 25mcg every 4 weeks until your thyroxine levels are correct.

    Your final daily dose will usually be between 50 – 200mcg daily.

    Use in children and adolescents:

    For young children, your doctor is likely to prescribe
    Levothyroxine Taj Pharma Oral Solution instead of tablets

    Congenital hypothyroidism in infants:

    This is a condition where your baby has been born with a thyroid gland that does not produce enough thyroxine. The starting dose is 10 -15mcg/kg bodyweight per day for the first three months. The dose will then be adjusted depending on how your baby responds to the treatment.

    Acquired hypothyroidism in children:

    This is a condition where your child’s thyroid gland stops working properly because it has been attacked by their immune system, e.g. in children with an autoimmune disease or following a viral infection. The starting dose is 12.5 – 50mcg per day. The dose will then be increased every 2 –

    4 weeks depending on how your child responds to the medicine.

    Juvenile myxoedema:

    This is a condition where children and adolescents develop severe hypothyroidism (produce very low levels of thyroid hormones). The starting dose is 25mcg every day.

    The dose will then be increased by 25mcg every 2 – 4 weeks until your child shows mild symptoms of hyperthyroidism (a condition where the thyroid gland produces too much thyroxine). The dose will then be reduced slightly.

    If you take more Levothyroxine Taj Pharma Sodium Tablets than you should:

    If you (or someone else) swallow a lot of the tablets at the same time, or you think a child may have swallowed some, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose may include: fever, chest pain (angina), racing or irregular heartbeat, muscle cramps, headache, restlessness, flushing, sweating and

    diarrhoea. These signs can take up to 5 days to appear. Take any remaining tablets and this leaflet with you so that the medical staff knows exactly what you have taken.

    If you forget to take Levothyroxine Taj Pharma Sodium Tablets:

    If you forget to take a dose take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose. If you forget to give your child their dose, contact your doctor or pharmacist for further advice.

    If you stop taking Levothyroxine Taj Pharma Sodium Tablets:

    These tablets are for long term use. You may need to take them for the rest of your life. Do not stop taking the tablets unless your doctor has told you to do so.

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

    1. POSSIBLE SIDE EFFECTS

    Like all medicines, this medicine can cause side effects, although not everybody gets them.

    Stop taking the tablets and go to hospital at once if you have:

    • a rare allergic reaction such as swelling of the face, tongue, lips and throat, difficulty breathing, severe itching of your skin with raised lumps, joint pain, sensitivity to the sun, general feeling of being unwell. You may need urgent medical attention.

    Some patients may experience a severe reaction to high levels of thyroid hormone. This is called a “thyroid crisis” and you should contact your doctor immediately if you have any of the following symptoms:

    • very high temperature; fast heart rate; irregular heartbeat; low blood pressure; heart failure; jaundice; confusion; fits and coma.

    Tell your doctor or pharmacist if any of the following side effects continue, get worse or if you notice any other side effects not listed.

    Most of the side effects are similar to the symptoms of hyperthyroidism (where the thyroid gland makes too much thyroxine) and are due to your dose of the medicine being too high. They will usually disappear after reducing the dose or stopping the tablets. However, you must not change the dose or stop the tablets without talking to your doctor first.

    Not known (frequency cannot be estimated from the

    available data)

    • headache
    • flushing
    • high temperature, sweating
    • weight loss
    • tremor, restlessness, excitability, difficulty sleeping (insomnia)
    • increased pressure around the brain in children that is not caused by a tumour or other diseases (benign intracranial hypertension)
    • chest pain (angina), pounding, irregular or fast heartbeat
    • diarrhoea, vomiting
    • muscle cramps, muscle weakness
    • deformity of the skull in infants caused by the early closure of joints in the skull bone (craniostenosis)
    • growth in children may slow or stop due to changes in bone growth
    • irregular periods
    • intolerance to heat
    • temporary hair loss in children.

    Reporting of side effects:

    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

    1. HOW TO STORE LEVOTHYROXINE TAJ PHARMA SODIUM TABLETS

    Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

    Do not store above 25°C. Store in the original package in order to protect from light and moisture.

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

    1. CONTENTS OF THE PACK AND OTHER INFORMATION

    What Levothyroxine Taj Pharma Sodium Tablets contain:

    • The active substance is anhydrous Levothyroxine Taj Pharma sodium.
    • Each tablet contains 25mcg, 50mcg, 75mcg, 88mcg, 100mcg, 112mcg, 125mcg, 137mcg, 150mcg, 175mcg, 200mcg and 300mcg of anhydrous Levothyroxine Taj Pharma sodium.
    • The other ingredients are sodium citrate, lactose, maize starch, acacia powder and magnesium stearate.

    What Levothyroxine Taj Pharma Sodium Tablets and contents of the pack:

    They are packed in a blister pack of 28, 56 or 112 tablets and polypropylene containers of 28, 56, 100, 112, 500 or 1000 tablets.

    Not all pack sizes may be marketed.

    Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825) Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com