LEVOTHYROXINE TABLETS 100 MICROGRAMS - patient leaflet, side effects, dosage

Patient Information Leaflet

Levothyroxine Tablets BP 25, 50 & 100 micrograms

WHAT YOU NEED TO KNOW ABOUT LEVOTHYROXINE TABLETS

Please read this leaflet carefully before you start to take your tablets. It contains important information. If you are not sure about anything, or you want to know more, ask your doctor or a pharmacist. Keep this leaflet safe, as you may want to read it again. Your tablets are called Levothyroxine Tablets BP and they are part of a group of drugs known as thyroid hormones. Normally the thyroid gland in the body makes enough thyroid hormone but, if it does not, Levothyroxine Tablets provide the balance.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

• 1. What Levothyroxine Tablets are and what they are used for

• 2. Before you take Levothyroxine Tablets

• 3. How to take Levothyroxine Tablets

• 4. Possible side effects

• 5. How to store Levothyroxine Tablets

• 6. Further Information

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

The active ingredient in Levothyroxine Tablets is Levothyroxine Sodium. Levothyroxine Tablets are available in three different strengths. Levothyroxine Tablets are used to treat hypothyroidism, a condition in which the thyroid gland is underactive and so does not make enough thyroxine for the body's needs. Levothyroxine Tablets are also used to treat thyroid cancer and diffuse non-toxic goiter or Hashimoto's thy­roiditis, conditions in which the thyroid gland becomes enlarged causing a swelling in the front of the neck.

2. Before you take Levothyroxine Tablets

– think you may be allergic to Levothyroxine or to any of the other ingredients of Levothyroxine Tablets. (These are listed in section 6).

Please tell your doctor before you start to take Levothyroxine Tablets if you:

• – think you may be allergic to Levothyroxine Sodium or to any of the other ingredients of Levothyroxine Tablets (these are listed in Section 6.)

• – are pregnant, may become pregnant or are breast-feeding

• – have heart disease

• – have problems with your circulation

• – have high blood pressure

• – are suffering from an overactive thyroid gland (hyperthyroidism)

• – are suffering from an underactive adrenal gland

• – are suffering from diabetes

• – have had an underactive thyroid gland for some time.

Are you taking other medicines ? Some medicines can interfere with your treatment. Tell your doctor if you are taking any of the following:

• – medicines to stop your blood clotting (for example Warfarin)

• – medicines for depression (for example Imipramine, Amitriptyline)

• – medicines for epilepsy (for example Phenytoin, Phenobarbital, Carbamazepine, Primadone)

• – medicines for diabetes

• – Sucralfate, Cimetidine or aluminium hydroxide for a stomach ulcer, Colestyramine to lower your cholesterol levels, calcium carbonate or iron supplements. Levothyroxine Tablets can be taken with these medicines but not at the same time. Your doctor or pharmacist will advise you

• – Rifampicin (for infections particularly tuberculosis), Digoxin or Amiodarone (for your heart), Propranolol (for high blood pressure), Lovastatin (for high cholesterol levels) or Phenylbutazone

• – Aspirin (anti-inflammatory medicines)

• – Estrogen, estrogen containing products

• – oral contraceptives

• – androgens or corticosteroids

• – any other medicines including ones that you have bought for yourself without a prescription.

These tablets contain lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking these tablets.

If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking. Levothyroxine Tablets may react with an anaesthetic (Ketamine) which you may be given before an operation.

3. how to take levothyroxine tablets

The doctor will decide what dose of Levothyroxine Tablets you should take. Always take the tablets exactly as your doctor has told you to. The dose will be on the pharmacist's label. Check the label carefully. It should tell you how many tablets to take and how often. If you are not sure, ask your doctor or pharmacist. Your doctor will take regular blood samples at regular intervals to monitor your response to treatment.

Swallow the tablets whole with water. You should take your tablets as single dose on an empty stomach, usually before breakfast.

The following doses are intended as a guide:

Adults and children over 12 years: The starting dose is 50 to 100 micrograms (mcg) a day, increasing by 25 to 50 mcg every 3–4 weeks, until you are taking the right amount for your condition. The usual maintenance dose is 100 to 200 mcg daily.

Older patients (over 50 years of age): The starting dose is 25 mcg a day, increasing by 25 mcg every 4 weeks until the correct dose is obtained. The usual final dose is between 50 and 200 mcg daily. This dose also applies to patients with severe hypothyroidism, and to those with heart disease.

Children under 12 years: The dose for children depends on their age, weight and the condition being treated. Your child will be monitored to make sure he/she gets the right dose. Give your child this medicine at least half an hour before the first meal of the day.

Congenital hypothyroidism in infants: Initially 10 to 50 micrograms/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 50 micrograms a day. The dose should be increased gradually every 2 to 4 weeks depending on response to treatment.

Use in children: For young children, your doctor is likely to prescribe Levothyroxine Oral Solution instead of tablets.

If you forget to take a dose at the right time, take it as soon as you remember. Do not take two doses together. If it is almost time to take the next dose, wait until then and then carry on as before. If you have forgotten several doses tell your doctor when you have your next check-up or blood test.

It can be dangerous to stop taking your tablets without your doctor's advice.

What to do if you take too many tablets – It is important not to take too many tablets. Contact your nearest hospital casualty department or a doctor for advice if you have swallowed too many tablets or if you think a child has swallowed any. Take this leaflet, and any tablets that you still have to show the doctor.

4. possible side effects

Like all medicines, Levothyroxine Tablets can cause side effects, although not everybody gets them. These usually only happen if the dose you are taking is too high.

Tell your doctor if you get: rapid or irregular heart beats, palpitations, chest pain, muscle cramps or weakness, headache, restlessness, excitability, flushing, sweating, diarrhoea, vomiting, fever, tremor, sleeplessness, heat intolerance and excessive weight loss. Rash, itching and puffiness may also occur.

Very rarely, if far too many tablets have been taken in one go or over many years, serious heart problems have been reported. If you feel unwell in any other way, tell your doctor as soon as you can. Children may have some hair loss at the beginning of treatment, however this is usually temporary and the hair returns.

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. You can also report side effects directly via the Yellow Card Scheme Website or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store levothyroxine tablets

Store the tablets in their original pack away from direct light. Store below 25°C.

Keep this medicine out of the sight and reach of children.

Do not take the tablets after the expiry date which is printed on the carton and label.

You should take any tablets that are out of date or which you no longer need back to your pharmacist.

6. Further Information

There are three strengths of Levothyroxine Tablets, 25 micrograms (mcg), 50 mcg and 100 mcg.

Levothyroxine Tablets contain the active ingredient Levothyroxine Sodium.

Each tablet contains Levothyroxine Sodium equivalent to Levothyroxine Sodium Anhydrous 25 mcg, 50 mcg or 100 mcg (active ingredient); and lactose, sucrose, maize starch and magnesium stearate (other ingredients).

Levothyroxine Tablets are white and come in packs of 28, 500 or 1000 tablets.

The 25 mcg tablets are engraved E 902 on one side and plain on the other.

The 50 mcg tablets are engraved E 905 on one side and plain on the other.

The 100 mcg tablets are engraved E 907 on one side and plain on the other.

The Marketing Authorisation Holder is:

RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Swe­den

The Manufacturer is:

Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, Lancashire, OL7 9RR, UK.

This leaflet was last revised in 11/2020.

3