Levothyroxine Tablets BP 150 micrograms Taj Pharma

Levothyroxine Tablets BP 25/50/100/150/200 micrograms Taj Pharma

1.Name of the medicinal product
Levothyroxine Tablets BP 25/50/100/150/200 micrograms Taj Pharma

2.Qualitative and quantitative composition

a) Levothyroxine Tablets BP 25µg
Each tablet contains
Anhydrous Levothyroxine Sodium    25µg
Excipients                                          q.s.

b) Levothyroxine Tablets BP 50µg
Each tablet contains
Anhydrous Levothyroxine Sodium    50µg
Excipients                                          q.s.

c) Levothyroxine Tablets BP 100µg
Each tablet contains
Anhydrous Levothyroxine Sodium   100µg
Excipients                                         q.s.

d) Levothyroxine Tablets BP 150µg
Each tablet contains
Anhydrous Levothyroxine Sodium  150µg
Excipients                                           q.s.

e) Levothyroxine Tablets BP 200µg
Each tablet contains
Anhydrous Levothyroxine Sodium  200µg
Excipients                                   q.s.

Excipient with known effect:

Each tablet contains lactose and sodium.

For the full list of excipients, see section 6.1.

3.Pharmaceutical form

White uncoated tablets.

4.Clinical particulars

4.1 Therapeutic indications

Recommended clinical indications:

1. control of hypothyroidism,
2. congenital hypothyroidism in infants
3. acquired hypothyroidism in children
4. juvenile myxoedema.

4.2 Posology and method of administration

Posology

In younger patients, and in the absence of heart disease, a serum Levothyroxine (T4) level of 70 to 160 nanomols per litre, or a serum thyrotrophin level of less that 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 100 micrograms daily, preferably taken before breakfast or the first meal of the day. Adjust at three to four week intervals by 50 micrograms until normal metabolism is steadily maintained. The final daily dose may be up to 100 to 200 micrograms.

Elderly: As for patients aged over 50 years.

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

Patients over 50 years with cardiac disease

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

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 150 micrograms 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 15 micrograms 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 12.5-50 micrograms 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.

Juvenile myxoedema in children

The initial recommended dosage is 25 micrograms daily. In such conditions, the daily dose may be increased by 25 micrograms 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.

Method of Administration

For oral administration.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

Levothyroxine 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 treatment, and it is advisable to start corticosteroid therapy before giving levothyroxine to such patients.

Levothyroxine 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 treatment in order to detect changes consistent with ischaemia in which case, levothyroxine 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.

Subclinical hyperthyroidism may be associated with bone loss. To minimise the risk of osteoporosis, dosage of levothyroxine 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 is administered to patients with known history of epilepsy. Seizures have been reported rarely in association with the initiation of levothyroxine sodium therapy and may be related to the effect of thyroid hormone on seizure threshold.

Levothyroxine Tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

Interactions affecting other drugs:

Levothyroxine 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 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 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 therapy.

Beta Blockers: levothyroxine (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:

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 dosage requirements.

Effects of Levothyroxine may be decreased by concomitant sertraline.

Absorption of levothyroxine (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 (thyroxine) accelerated by rifampicin, barbituarates, and primidone. (may increase requirements for levothyroxine (thyroxine) in hypothyroidism)

Imatinib: plasma concentration of levothyroxine (thyroxine) possibly reduced by imatinib.

Beta blockers may decrease the peripheral conversion of levothyroxine to triiodothyronine.

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

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-binding globulins.

Anti-obesity drugs such as orlistat may decrease levothyroxine 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 therapy.

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

4.6 Fertility, pregnancy and lactation

Pregnancy

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

4.7 Effects on ability to drive and use machines

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

4.8 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)

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. Healthcare professionals are asked to report any suspected adverse reactions.

4.9 Overdose

Symptoms

In most cases there will be no features. Signs of an overdose may include: fever, chest pain (angina), racing or irregular heartbeat, muscle cramps, headache, restlessness, flushing, sweating, diarrhoea, tremor, insomnia and hyperpyrexia. These signs can take up to 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.

5.Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Thyroid hormones, ATC Code: H03AA01

Levothyroxine Tablets contain the hydrated form of Levothyroxine sodium which is used for the treatment of hypothyroidism. The thyroid gland is dependent upon 2 active principles for its main hormone activity these are Levothyroxine (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 these hormones is to increase the rate of cell metabolism. Levothyroxine is deiodinated in peripheral tissues to form Tri-iodothyronine which is thought to be the active tissue form of thyroid hormone. Tri-iodothyronine is certainly more rapid acting and has a shorter duration of action than Levothyroxine.

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

5.2 Pharmacokinetic properties

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

5.3 Preclinical safety data

No further data of relevance.

6.Pharmaceutical particulars

6.1 List of excipients

Also contains: lactose, magnesium stearate, maize starch, pregelatinised maize starch, stearic acid.

6.2 Incompatibilities

None known.

6.3 Shelf life

Three years from the date of manufacture (polyethylene containers and amber glass bottles)

Two years from date of manufacture (blisters)

Two years from date of manufacture (polypropylene containers)

6.4 Special precautions for storage

Blister packs:

Do not store above 25°C.

Store in the original package.

Keep container in the outer carton.

Polypropylene containers, polyethylene containers and amber glass bottles:

Do not store above 25°C.

Store in the original container.

Keep the container tightly closed.

6.5 Nature and contents of container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps.

The product may also be supplied in blister packs in cartons:

1. a) Carton: Printed carton manufactured from white folding box board.
2. b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M²PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 7s, 14s, 28s, 56s, 84s, 100s, 250s, 500s, 1000s.

The product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 25,000

6.6 Special precautions for disposal and other handling

Not applicable.

7. 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 BP 25/50/100/150/200 micrograms Taj Pharma

(Levothyroxine)

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• Thyroxine is a hormone produced by the thyroid gland. Levothyroxine is used to replace thyroxine in people whose thyroid gland does not work properly. You will usually need to take this medicine for the rest of your life and must not stop taking it, or change the dose, without speaking to your doctor first.
• This medicine can affect the way other medicines work (See Section 2 ‘Taking other medicines’). If you take medicines to control diabetes or warfarin to prevent blood clots, the dose may need to be adjusted by your doctor when you start taking levothyroxine tablets.
• You will start off taking a low dose of this medicine (See Section 3 ’How to take’). Your doctor will then increase the dose gradually at 3-4 week intervals until your thyroxine levels are corrected. This will help to reduce the chance of side effects.
• You will need regular blood tests whilst you are taking this medicine.
• These tablets can be taken by both adults and children. If you are giving this medicine to your child make sure you know how many and when to give the tablets (See Section 3 ’How to take’) and what side effects to look out for (See Section 4 ’Possible side effects’).

1. What Levothyroxine tablets are and what they are used for

Thyroxine is a hormone which is produced naturally in the body by the thyroid gland.

Levothyroxine 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 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 you need.

2 What you need to know before you take Levothyroxine tablets

Do not take Levothyroxine tablets if you:

• are allergic to levothyroxine or any of the other ingredients of this medicine (listed in section 6)
• suffer from an overactive thyroid gland that produces too much thyroid hormone (thyrotoxicosis)
• 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 or pharmacist before taking Levothyroxine tablets if you:

• have suffered with an underactive thyroid gland for a long time
• suffer from heart problems including angina, coronary artery disease or high blood pressure
• are being treated for diabetes. The dose of your anti-diabetic medicine may need to be changed as levothyroxine can raise blood sugar levels
• are over 50 years of age.

Blood tests

Before you start taking levothyroxine 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 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 works. The effects of other drugs may also be affected by levothyroxine.

The following may affect the way that levothyroxine 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
• colestyramine 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:

• 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 (epinephrine -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
• propranolol –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.

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 whilst you are pregnant, particularly in the first three months of your pregnancy

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product, as it contains lactose.

Levothyroxine tablets are essentially ‘sodium-free’

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Levothyroxine tablets

Always take this medicine exactly as your doctor 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 – 100 micrograms every day. Your doctor may increase the dose you take every 3 – 4 weeks by 50 micrograms until your thyroxine levels are correct. Your final daily dose may be up to 100 – 200 micrograms daily.

Patients over 50 years of age

The recommended starting dose will be no more than 50 micrograms every day.

The dose may then be increased by 50 micrograms every 3 – 4 weeks until your thyroxine levels are correct. Your final daily dose will be between 50 – 200 micrograms daily.

Patients over 50 years with heart problems

The recommended starting dose will be 25 micrograms every day or 50 micrograms every other day. The dose may be increased by 25 micrograms every 4 weeks until your thyroxine levels are correct. Your final daily dose will usually be between 50 – 200 micrograms daily.

Use in children and adolescents

For young children, your doctor is likely to prescribe Levothyroxine 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 – 15 micrograms/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 – 50 micrograms per day. The dose should be increased gradually 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 25 micrograms every day. The dose will then be increased by 25 micrograms 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 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 any, 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 know exactly what you have taken.

If you forget to take Levothyroxine 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 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 or pharmacist.

4.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 throxine 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 joins 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.

5. How to store Levothyroxine tablets

• Keep this medicine out of the sight and reach of children.
• Do not store above 25ºC. Store in the original package. Keep container in the outer carton.
• Do not use this medicine after the expiry date which is stated on the label/carton/bottle. The expiry date refers to the last day of that month.
• 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 to protect the environment.

6.Contents of the pack and other information

What Levothyroxine tablets contain

• The active substance (the ingredient that makes the tablets work) is anhydrous levothyroxine sodium.

Each tablet contains
Levothyroxine Tablets BP 25/50/100/150/200 micrograms.

• The other ingredients are lactose, magnesium stearate, maize starch, stearic acid and pregelatinised maize starch.

What Levothyroxine tablets look like and contents of the pack
25/50/100/150/200 microgram tablets are white, circular, biconvex, uncoated tablets.

Pack size is 28 and 1000 tablets

7. 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