Levothyroxine Actavis

Levothyroxine sodium.

Each tablet contains either 50micrograms or 100micrograms of anhydrous levothyroxine sodium.
Excipients/Inactive Ingredients: The other ingredients are lactose, magnesium stearate, maize starch, stearic acid and pregelatinised maize starch.

Levothyroxine belongs to a group of medicines called thyroid hormones, which are used to treat hypothyroidism (underactive thyroid gland).

Always take Levothyroxine tablets exactly as advised by the doctor. If the patient is not sure, check with the doctor or pharmacist.
Swallow the tablets with water, before food.
Doses: Adults: Initially 50-100micrograms a day increased by 50micrograms every 3-4 weeks up to a maximum of 150-300micrograms a day, until normal metabolism is maintained.
Patients over 50 years: lnitially no more than 50micrograms a day should be taken.
Patients over 50 years with heart disease: 25micrograms a day or 50micrograms every other day should be taken, this may be increased by 25micrograms a day every 4 weeks.
Children under 12 years: The dose for children depends on their age, weight and the condition being treated. The child will be monitored to make sure he/she gets the right dose. Give the child this medicine at least half an hour before the first meal of the day.
Congenital hypothyroidism in infants: Initially 10 to 15micrograms/kg body weight a day for the first 3 months. The dose will then be adjusted depending on response to treatment.
Acquired hypothyroidism in children: Initially 12.5 to 50micrograms a day. The dose should be increased gradually every 2 to 4 weeks depending on response to treatment.
If required the tablets can be dissolved in 10 to 15ml of drinkable water and given freshly prepared with some more liquid (5 to 10ml).
Juvenile myxoedema: Initially 25micrograms a day, increased by 25micrograms every 2-4 weeks until mild toxic symptoms appear, the dose will then be reduced slightly.
In children over 1 year, initially 2.5-5micrograms per kg of bodyweight a day should be taken.
If the patient forgets to take the tablets: The patient should not take a double dose to make up for a forgotten dose. If the patient forgets to take a dose he/she should take it as soon as he/she remembers it and then take the next dose at the right time.
If the patient stops taking the tablets: The patient should talk to the doctor before he/she stops taking the tablets and follow their advice.

If the patient (or someone else) swallows a lot of the tablets at the same time, or the patient thinks a child may have swallowed any, contact the nearest hospital casualty department or tell the doctor immediately. Symptoms of an overdose include: Mild to moderate overdose: fever, angina, a racing heart, irregular heart beats, muscle cramps, headache, restlessness, flushing, sweating, diarrhoea.
Severe overdose: thyroid crisis including irregular heart beats, heart failure, collapse, coma, death.
Signs and symptoms of increased thyroid hormone levels may not be seen for up to 5 days.

Do not take Levothyroxine tablets and tell the doctor if: allergic (hypersensitive) to anhydrous levothyroxine sodium or any other ingredients in Levothyroxine tablets (see Description); suffering from a condition that produces excessive quantities of thyroid hormone (thyrotoxicosis); suffering from untreated adrenal problems.

Check with the doctor or pharmacist before taking Levothyroxine tablets if the patient: has any heart problems or has had a heart attack; suffers from high blood pressure; is elderly or has severe long term hypothyroidism (underactive thyroid gland); is suffering from a condition caused by an underactive adrenal gland such as panhypopituitarism; has diabetes.
Sugar intolerance: If the patient has been told by the doctor that he/she has an intolerance to some sugars, contact the doctor before taking this medicine, as it contains lactose.
Effects on bone mineral density: In women, long-term levothyroxine sodium therapy has been associated with increased bone resorption, thereby decreasing bone mineral density, especially in post-menopausal women on greater than replacement doses or in women who are receiving suppressive doses of levothyroxine sodium. The increased bone resorption may be associated with increased serum levels and urinary excretion of calcium and phosphorus, elevations in bone alkaline phosphatase and suppressed serum parathyroid hormone levels. Therefore, it is recommended that patients receiving levothyroxine sodium be given the minimum dose necessary to achieve a desired clinical and biochemical response.

If the patient is pregnant particularly in the first three months, planning to become pregnant or is breast-feeding she should tell the doctor or pharmacist before taking this medicine.

Like all medicines, Levothyroxine tablets can cause side effects, although not everybody gets them. Please tell the doctor or pharmacist if the patient notices any of the following effects or any effects not listed.
Tell the doctor if the patient notices any of the following side effects: Allergic reactions: including a rash which may be itchy or swelling.
The following side effects may be due to high doses and usually disappear after reducing the dose or stopping the tablets. Tell the doctor if the patient notices: Heart: a racing heart, irregular heart beats, palpitations, anginal pain.
Central nervous system: headache, restlessness, excitability, difficulty in sleeping, flushing, sweating, fever, involuntary shakiness, heat intolerance.
Stomach and intestines: diarrhoea, being sick, excessive weight loss.
Muscle and bone: muscle cramps, muscular weakness.
Other: partial hair loss during first few months of therapy.

Please tell the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription. Especially: medicines to treat diabetes (e.g. insulin, metformin); medicines to control the heart rate such as digoxin; tricyclic antidepressants (e.g. amitriptyline, dosulepin); medicines that stimulate the sympathetic nervous system such as adrenaline (epinephrine); anticoagulants (used to thin the blood) such as warfarin, dicoumarol, acenocoumarol, phenindione; sodium polystyrene sulphonate (used to treat kidney disease); colesytramine (used to treat diarrhoea); medicines to treat stomach ulcers such as sucralfate, cimetidine; aluminium hydroxide (used to treat heartburn); medicines containing calcium carbonate; "iron" tablets (containing ferrous sulphate); medicines to treat epilepsy such as carbamazepine, phenytoin, phenobarbital, primidone; rifampicin (used to treat serious infections); aspirin and phenylbutazone (medicines to reduce inflammation); propranolol (a beta-blocker); medicines containing oestrogen (e.g. HRT, oral contraceptives - "the pill"); amiodarone (used to treat some heart conditions); ketamine (an anaesthetic); lovastatin or colesevelam (used to reduce cholesterol); orlistat (used to aid weight loss); corticosteroids (e.g. hydrocortisone, prednisolone); medicines containing testosterone and mesterolone.
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.

Do not store above 25°C. Store in the original package.
Keep container in the outer carton.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Thyroid Hormones

H03AA01 - levothyroxine sodium ; Belongs to the class of thyroid hormones.

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