Tifactor

Italy
Brand name Tifactor
Form solution, oral
Active substance / Dosage
LEVOTHYROXINE SODIUM
Prescription type Prescription only
ATC code
H03AA01
Registration number 045995
Manufacturer I.B.N. SAVIO S.R.L

Table of Contents

Package leaflet: Information for the user

TIFACTOR 25 mcg/5 ml oral solution

Levothyroxine sodium
Please 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 questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What TIFACTOR is and what it is used for
  2. What you need to know before taking TIFACTOR
  3. How to take TIFACTOR
  4. Possible side effects
  5. How to store TIFACTOR
  6. Contents of the pack and other information

1. What TIFACTOR is and what it is used for

TIFACTOR contains the active substance levothyroxine sodium.
It is used to treat hypothyroidism, a condition in which the thyroid gland is underactive and does not produce
sufficient thyroxine to meet the body's needs.
TIFACTOR is also used to treat thyroid cancer and non-toxic diffuse goitre or Hashimoto's thyroiditis, conditions in which the thyroid gland enlarges, causing a swelling in the front part of the neck.

2. What you need to know before taking TIFACTOR

Do not take TIFACTOR

  • if you are allergic to sodium levothyroxine, sodium methyl parahydroxybenzoate, or to any of the other ingredients of this medicine (listed in section 6).
  • if you have adrenal insufficiency and do not have adequate corticosteroid coverage.
  • if you have recently had a heart attack (acute myocardial infarction), inflammation of the heart muscle (acute myocarditis), or inflammation of the sac surrounding the heart (acute pancarditis).
  • if you are pregnant, do not take this medicine in combination with other medicines used to treat hyperthyroidism (see section on Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before taking TIFACTOR.

  • if you have heart disease, circulatory problems, or high blood pressure.
  • if you have an overactive thyroid (hyperthyroidism), underactive adrenal glands, diabetes, or have had an underactive thyroid for some time.

Children
Partial hair loss may occur during the first few months of treatment, but this effect is temporary and hair usually regrows subsequently.
Extreme caution must be exercised when starting levothyroxine therapy in premature neonates with low birth weight. Due to immature adrenal function, circulatory collapse may occur (see section 4, "Possible side effects").

Other medicines and TIFACTOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
TIFACTOR may interfere with the action of certain other drugs, and some drugs may affect TIFACTOR. In particular, inform your doctor or pharmacist if you are taking the following medicines:

  • medicines to prevent blood clotting (e.g. warfarin)
  • medicines for depression (e.g. sertraline, imipramine, amitriptyline)
  • medicines for epilepsy (e.g. phenytoin, phenobarbital, carbamazepine)
  • medicines for diabetes
  • rifampicin (for infections, particularly tuberculosis)
  • digoxin or amiodarone (for heart conditions)
  • propranolol (for high blood pressure), lovastatin (for high cholesterol), phenylbutazone, or aspirin
  • estrogens, estrogen-containing products, or oral contraceptives, androgens, or corticosteroids
  • other medicines, including those purchased without a prescription
  • sucralfate, cimetidine, or aluminum hydroxide (for stomach ulcers)
  • colestyramine or colesevelam (to reduce cholesterol levels), sodium polystyrene sulfonate, calcium carbonate, or iron supplements.

TIFACTOR may be taken with these medicines, but not at the same time.

  • chloroquine or proguanil (for prevention of malaria)
  • protease inhibitors (e.g. ritonavir, indinavir, lopinavir) used to treat HIV
  • sevelamer (used to treat high phosphate levels in patients with kidney failure)
  • tyrosine kinase inhibitors (e.g. imatinib, sunitinib) used to treat cancer
  • propylthiouracil (used to treat hyperthyroidism)
  • beta-blockers (used to treat high blood pressure and heart problems)
  • sympathomimetic agents (steroid hormones used to treat adrenal insufficiency and other conditions)
  • glucocorticoids (steroid hormones used to treat adrenal insufficiency and other conditions)
  • iodine-containing contrast agents (used to enhance visibility of blood vessels and organs during radiographic procedures)
  • orlistat (a medicine used to treat obesity)

If you are admitted to hospital for surgery, inform the anaesthetist or medical staff that you are taking TIFACTOR. It may interact with an anaesthetic (ketamine) that may be administered before surgery.

TIFACTOR with food and drinks
Products containing soy (especially soy-based supplements) may interact with levothyroxine; consult your doctor or pharmacist.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.

TIFACTOR contains sodium methyl parahydroxybenzoate (E219)

  • It may cause allergic reactions (including delayed reactions).
    TIFACTOR contains glycerol
    It may cause headache, gastrointestinal disturbances, and diarrhoea.
    TIFACTOR contains less than 1 mmol (23 mg) of sodium per 5 ml, i.e. essentially 'sodium-free'.

3. How to take TIFACTOR

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the daily dose based on your condition. Your doctor will perform regular blood tests to monitor your response to treatment.
If you switch from the oral solution to the tablet form of levothyroxine or from the tablet form to the oral solution of levothyroxine, your doctor will monitor you more closely. The same applies when switching between different brands of oral solutions containing levothyroxine.

Usual daily doses:
Adults and children over 12 years of age:
The initial dose is 50–100 micrograms (mcg) per day, increasing by 25–50 mcg every 3–4 weeks until the correct dose for your condition is reached. The usual maintenance dose is 100–200 mcg per day.
For diffuse non-toxic goitre or Hashimoto's thyroiditis, the recommended dose is 50–200 micrograms (mcg) per day.
For the treatment of thyroid cancer, the recommended dose is 150–300 micrograms (mcg) per day.

Elderly patients (over 50 years of age):
The initial dose is 12.5 micrograms (mcg) per day, increasing by 12.5 mcg every 4 weeks until the correct dose is achieved. The usual final dose ranges from 50 to 200 mcg per day. This dose also applies to patients with severe hypothyroidism and those with heart disease.

Children under 12 years of age:
The dose for children depends on age, weight, and the condition being treated. Your child will be monitored to ensure they receive the correct dose. Give this medicine to your child at least one hour before their first meal of the day.

Congenital hypothyroidism in children:
Initially, 10–15 micrograms/kg body weight per day for the first 3 months. The dose will then be adjusted based on response to treatment.

Acquired hypothyroidism in children:
Initially, 12.5–50 micrograms per day. The dose should be gradually increased every 2–4 weeks depending on response to treatment.

Use the oral dosing syringe provided to deliver the specific dose – see instructions below. The syringe can be used to measure the dose by drawing up the liquid to the correct mark on the syringe. For example, if your dose is 50 micrograms per day, the corresponding volume will be:
For the 25 micrograms/5 ml strength: 2 x 5 ml (10 ml in total)

How to use the oral dosing syringe:

  1. Shake the bottle well, making sure the cap is securely tightened on the bottle.
  2. Remove the cap. Note: Keep the cap nearby to close the bottle after each use.
  3. Push the plastic adapter firmly into the neck of the bottle. Note: The adapter must remain in the bottle at all times.
  4. Take the syringe and check that the plunger is fully pushed down.
  5. Hold the bottle upright and firmly insert the oral dosing syringe into the plastic adapter.
  6. Invert the entire bottle with the syringe upside down.
  7. Slowly pull the plunger down fully so that the syringe fills with medicine. Push the plunger up to expel any large air bubbles that may be trapped in the oral dosing syringe.
  8. Then slowly pull the plunger back to the volume required for your dose.
  9. Turn the entire bottle with the syringe upright and remove the syringe from the bottle.
  10. The medicine can now be swallowed directly from the oral dosing syringe. Make sure you are sitting upright and slowly push the plunger to allow you to swallow the dose comfortably.
  11. Replace the child-resistant cap after use, leaving the adapter in place.
  12. Cleaning: After use, clean the outside of the syringe with a clean, dry cloth.

Method of administration
TIFACTOR must be swallowed. You must take TIFACTOR on an empty stomach, usually before breakfast.

Duration of treatment
If you are being treated for hypothyroidism, diffuse non-toxic goitre, or Hashimoto's thyroiditis, treatment is generally lifelong.

If you take more TIFACTOR than you should
If you accidentally take too high a dose of this medicine, call your doctor immediately or go to the nearest hospital emergency department. Symptoms of overdose include fever, irregular heartbeat, muscle weakness, headache, restlessness, hot flushes, sweating, and diarrhoea. Always bring the remaining medicine, container, and label with you so that the medicine can be identified.

If you forget to take TIFACTOR
If you forget to take your medicine, take the missed dose as soon as you remember, then take the next dose at your usual time. Do not take a double dose at the same time to make up for a forgotten dose. If you have missed several doses, inform your doctor at your next check-up or blood test.

If you stop taking TIFACTOR
For your treatment to be effective, you must take TIFACTOR regularly at the dose prescribed by your doctor. Under no circumstances should you change, suspend, or stop the prescribed treatment without first discussing it with your doctor. Symptoms of the disease may return if you stop or discontinue treatment prematurely. The nature of these symptoms depends on the underlying condition.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
These usually occur only if you are taking too high a dose.
If you experience any of the following symptoms, stop taking TIFACTOR immediately and contact your
doctor or go to the nearest hospital emergency department.

  • Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
  • Hives (urticaria)
  • Fainting
  • Yellowing of the skin and eyes, also known as jaundice

These side effects are very serious. If you experience any of these symptoms, you may be having a severe allergic reaction to TIFACTOR. You may require urgent medical attention or hospitalization. All of these side effects are very rare.

Inform your doctor if you notice any of the following effects:
Rapid or irregular heartbeat, palpitations, chest pain, muscle cramps or weakness, headache, restlessness, excitability, hot flushes, circulatory collapse in premature infants with low birth weight (see section 2), sweating, diarrhoea, vomiting, fever, menstrual disturbances, high blood pressure in the brain, tremor, drowsiness, heat intolerance, and excessive weight loss. Skin rash, itching and swelling may also occur.

Very rarely, if an especially excessive dose of TIFACTOR has been taken either as a single dose or over many years, heart failure may occur, and cases of coma and death have been reported.
If you feel unwell in any other way, inform your doctor as soon as possible.

Additional side effects in children
Children may experience hair loss at the beginning of treatment; however, this is usually temporary and hair regrows.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TIFACTOR

Keep this medicine out of the sight and reach of children.
Expiry date
Dispose of any remaining medicine 2 months after opening.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Storage conditions
Do not store above 25°C.
Keep in the original packaging to protect the medicine from light.
Do not use this medicine if you notice any changes in its appearance or smell. Consult your pharmacist.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What TIFACTOR contains

  • The active substance is levothyroxine sodium. Each 5 ml of oral solution contains levothyroxine equivalent to 25 micrograms (mcg) of anhydrous sodium levothyroxine.
  • The other components are glycerol, monohydrate citric acid, sodium methyl parahydroxybenzoate (E219) and purified water.

Description of the appearance of TIFACTOR and contents of the pack
TIFACTOR is a clear, colourless liquid. Each bottle contains 75 ml or 100 ml of levothyroxine oral solution.
TIFACTOR is available in packs containing one or two glass bottles, each filled with 75 ml of oral solution, or one glass bottle filled with 100 ml of oral solution.
A 5 ml syringe is also included to help you measure the dose.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
I.B.N. Savio S.r.l
Via del Mare, 36
Pomezia (RM)
Manufacturer
GALENICA PHARMACEUTICAL INDUSTRY S.A.
3rd km Old National Road Chalkida ‐ Athens
Glifa Chalkida Eubia, 34100, Greece
Package leaflet: information for the user

TIFACTOR 50 mcg/5 ml oral solution

Levothyroxine sodium
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What TIFACTOR is and what it is used for
  2. What you need to know before taking TIFACTOR
  3. How to take TIFACTOR
  4. Possible side effects
  5. How to store TIFACTOR
  6. Package contents and other information

1. What TIFACTOR is and what it is used for

TIFACTOR contains the active substance levothyroxine sodium.
It is used to treat hypothyroidism, a condition in which the thyroid gland is underactive and does not produce sufficient thyroxine to meet the body's needs.
TIFACTOR is also used to treat thyroid cancer and non-toxic diffuse goitre or Hashimoto's thyroiditis, conditions in which the thyroid gland enlarges, causing a swelling in the front part of the neck.

2. What you should know before taking TIFACTOR

Do not take TIFACTOR

  • if you are allergic to sodium levothyroxine, sodium methyl parahydroxybenzoate, or to any of the other ingredients of this medicine (listed in section 6).
  • if you have adrenal insufficiency and do not have adequate corticosteroid coverage.
  • if you have recently had a heart attack (acute myocardial infarction), inflammation of the heart muscle (acute myocarditis), or inflammation of the sac surrounding the heart (acute pancarditis).
  • if you are pregnant, do not take this medicine in combination with other medicines used to treat hyperthyroidism (see section on Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before taking TIFACTOR if:

  • you have a heart disease, circulation problems, or high blood pressure.
  • you have an overactive thyroid (hyperthyroidism), underactive adrenal gland, diabetes, or have had an underactive thyroid for some time.

Children
Partial hair loss may occur during the first few months of treatment, but this effect is temporary and hair usually regrows afterwards.
Extreme caution must be exercised when initiating levothyroxine therapy in premature infants with low birth weight. Due to immature adrenal function, circulatory collapse may occur (see section 4 “Possible side effects”).

Other medicines and TIFACTOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
TIFACTOR may interfere with the action of certain other drugs, and some drugs may affect TIFACTOR. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

  • medicines to prevent blood clotting (e.g. warfarin)
  • medicines for depression (e.g. sertraline, imipramine, amitriptyline)
  • medicines for epilepsy (e.g. phenytoin, phenobarbital, carbamazepine)
  • medicines for diabetes
  • rifampicin (for infections, particularly tuberculosis)
  • digoxin or amiodarone (for heart conditions)
  • propranolol (for high blood pressure), lovastatin (for high cholesterol), phenylbutazone, or aspirin
  • estrogens, estrogen-containing products or oral contraceptives, androgens, or corticosteroids
  • other medicines, including those purchased without a prescription
  • sucralfate, cimetidine, or aluminium hydroxide (for stomach ulcers)
  • colestyramine or colesevelam (to reduce cholesterol levels), sodium polystyrene sulfonate, calcium carbonate, or iron supplements.

TIFACTOR may be taken with these medicines but not at the same time.

  • chloroquine or proguanil (for prevention of malaria)
  • protease inhibitors (e.g. ritonavir, indinavir, lopinavir) used to treat HIV
  • sevelamer (used to treat high phosphate levels in patients with renal failure)
  • tyrosine kinase inhibitors (e.g. imatinib, sunitinib) used to treat cancer
  • propylthiouracil (used to treat hyperthyroidism)
  • beta-blockers (used to treat high blood pressure and heart problems)
  • sympathomimetic agents (steroid hormones used to treat adrenal insufficiency and other conditions)
  • glucocorticoids (steroid hormones used to treat adrenal insufficiency and other conditions)
  • iodine-containing contrast agents (used to enhance visibility of blood vessels and organs during radiographic procedures)
  • orlistat (a medicine used to treat obesity)

If you are admitted to hospital for surgery, inform the anaesthetist or medical staff that you are taking TIFACTOR. It may interact with an anaesthetic (ketamine) that might be administered before surgery.

TIFACTOR with food and drinks
Products containing soy (especially soy-based supplements) may interact with levothyroxine. Please consult your doctor or pharmacist.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.

TIFACTOR contains sodium methyl parahydroxybenzoate (E219)

  • It may cause allergic reactions (including delayed reactions).
    TIFACTOR contains glycerol
    It may cause headache, gastrointestinal disturbances, and diarrhoea.
    TIFACTOR contains less than 1 mmol (23 mg) of sodium per 5 ml, i.e. essentially ‘sodium-free’.

3. How to take TIFACTOR

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Your doctor will decide the daily dose based on your condition. Your doctor will perform regular
blood tests at scheduled intervals to monitor your response to treatment.
If you switch from the oral solution to levothyroxine tablets or from levothyroxine tablets to the oral
solution, your doctor will monitor you more closely. The same applies when switching between different
brands of oral solutions containing levothyroxine.

Usual daily doses: Adults and children above 12 years of age:
The initial dose is 50–100 micrograms (mcg) per day, increased by 25–50 mcg every 3–4
weeks until the appropriate dose for your condition is reached. The usual maintenance dose is
100–200 mcg per day.
For non-toxic diffuse goitre or Hashimoto's thyroiditis, the recommended dose is 50–200 micrograms
(mcg) per day.
For the treatment of thyroid cancer, the recommended dose is 150–300 micrograms (mcg) per
day.

Elderly patients (over 50 years of age):
The initial dose is 12.5 micrograms (mcg) per day, increased by 12.5 mcg every 4 weeks until
the correct dose is achieved. The usual final dose ranges between 50 and 200 mcg per day. This dose also applies to patients with severe hypothyroidism and those with heart disease.

Children under 12 years of age:
The dose for children depends on age, body weight, and the condition being treated. Your child will be
monitored to ensure they are receiving the correct dose. Give this medicine to your child at least
one hour before their first meal of the day.

Congenital hypothyroidism in children:
Initially, 10–15 micrograms/kg body weight per day for the first 3 months. The dose will then
be adjusted according to response to treatment.

Acquired hypothyroidism in children:
Initially, 12.5–50 micrograms per day. The dose should be gradually increased every 2–4
weeks depending on response to treatment.

Use the oral dosing syringe provided to deliver the prescribed dose – see instructions below. The syringe can be used to measure the dose by drawing up the liquid to the correct mark on the syringe. For example, if your dose is 50 micrograms per day, the corresponding volume will be:
For the 50 microgram/5 ml strength: 5 ml

How to use the oral dosing syringe:

  1. Shake the bottle well, making sure the cap is tightly secured on the bottle.
  2. Remove the cap. Note: Keep the cap nearby to close the bottle after each use.
  3. Push the plastic adapter firmly into the neck of the bottle. Note: The adapter must remain in the bottle at all times.
  4. Take the syringe and ensure the plunger is fully depressed.
  5. Hold the bottle upright and firmly insert the oral dosing syringe into the plastic adapter.
  6. Invert the entire bottle with the syringe facing downward.
  7. Slowly pull the plunger down to fill the syringe with medicine. Push the plunger up to expel any large air bubbles trapped in the oral dosing syringe.
  8. Then slowly pull the plunger back to the mark corresponding to the required dose.
  9. Turn the entire bottle upright with the syringe pointing upward and remove the syringe from the bottle.
  10. The medicine can now be swallowed directly from the oral dosing syringe. Make sure you are sitting in an upright position and slowly press the plunger to allow yourself to swallow the dose.
  11. Replace the child-resistant cap after use, leaving the adapter in place.
  12. Cleaning: After use, clean the outside of the syringe with a clean, dry cloth.

Method of administration
TIFACTOR must be swallowed. You must take TIFACTOR on an empty stomach, usually before breakfast.

Duration of treatment
If you are being treated for hypothyroidism, non-toxic diffuse goitre, or Hashimoto's thyroiditis, treatment is generally lifelong.

If you take more TIFACTOR than you should
If you accidentally take too much medicine, contact your doctor immediately or go to the nearest hospital emergency department. Symptoms of overdose include fever, irregular heartbeat, muscle spasms, headache, restlessness, hot flushes, sweating, and diarrhoea. Always bring the remaining medicine, container, and label with you so that the medicine can be identified.

If you forget to take TIFACTOR
If you forget to take your dose, take it as soon as you remember, then take your next dose at the usual time. Do not take a double dose at the same time to make up for the missed dose. If you have missed several doses, inform your doctor at your next check-up or blood test.

If you stop taking TIFACTOR
For your treatment to be effective, you must take TIFACTOR regularly at the dose prescribed by your doctor. Under no circumstances should you change, suspend, or stop your prescribed treatment without first discussing it with your doctor. Symptoms of the disease may return if you stop or discontinue treatment prematurely. The nature of these symptoms depends on the underlying condition.

If you have any questions about 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.
These usually occur only if you are taking too high a dose.
If you experience any of the following symptoms, stop taking TIFACTOR and contact your doctor
immediately or go to the nearest hospital emergency department.

  • Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
  • Hives (urticaria)
  • Fainting
  • Yellowing of the skin and eyes (also known as jaundice)

These side effects are very serious. If you experience any of these symptoms, you may be having a severe allergic reaction to TIFACTOR. You may require urgent medical attention or hospitalisation. All of these various side effects are very rare.

Inform your doctor if you notice any of the following effects:
Rapid or irregular heartbeat, palpitations, chest pain, muscle cramps or weakness, headache, restlessness, excitability, hot flushes, circulatory collapse in premature newborns with low birth weight (see section 2), sweating, diarrhoea, vomiting, fever, menstrual disorders, high blood pressure in the brain, tremor, drowsiness, heat intolerance, and excessive weight loss. Skin rash, itching and swelling may also occur.
Very rarely, if a particularly excessive dose of TIFACTOR has been taken either as a single overdose or over many years, heart failure may occur, and cases of coma and death have been reported.
If you feel unwell in any other way, inform your doctor as soon as possible.

Additional side effects in children
Children may experience hair loss at the beginning of treatment; however, this is usually temporary and hair regrows.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TIFACTOR

Keep this medicine out of the sight and reach of children.
Expiry date
Dispose of any remaining medicine 2 months after opening.
Do not use this medicine after the expiry date stated on the label and on the carton after EXP. The expiry date refers to the last day of that month.
Storage conditions
Do not store above 25°C.
Keep in the original packaging to protect the medicine from light.
Do not use this medicine if you notice any changes in its appearance or odour. Consult your pharmacist.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What TIFACTOR contains

  • The active substance is levothyroxine sodium. Each 5 ml of oral solution contains levothyroxine equivalent to 50 micrograms (mcg) of anhydrous sodium levothyroxine.
  • The other ingredients are glycerol, citric acid monohydrate, sodium methyl parahydroxybenzoate (E219) and purified water.

Description of the appearance of TIFACTOR and contents of the pack
TIFACTOR is a clear, colourless liquid. Each bottle contains 75 ml or 100 ml of levothyroxine oral solution. TIFACTOR is available in packs containing one or two glass bottles, each filled with 75 ml of oral solution, or one glass bottle filled with 100 ml of oral solution. A 5 ml syringe is also included to help you measure the dose.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
I.B.N. Savio S.r.l
Via del Mare, 36
Pomezia (RM)
Manufacturer
GALENICA PHARMACEUTICAL INDUSTRY S.A.
3rd km Old National Road Chalkida ‐ Athens
Glifa Chalkida Eubia, 34100, Greece

Patient Information Leaflet

TIFACTOR 100 mcg/5 ml oral solution

Levothyroxine sodium
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What TIFACTOR is and what it is used for
  2. What you need to know before taking TIFACTOR
  3. How to take TIFACTOR
  4. Possible side effects
  5. How to store TIFACTOR
  6. Package contents and other information

1. What TIFACTOR is and what it is used for

TIFACTOR contains the active substance levothyroxine sodium.
It is used to treat hypothyroidism, a condition in which the thyroid gland is underactive and does not produce sufficient thyroxine to meet the body's needs.
TIFACTOR is also used to treat thyroid cancer and non-toxic diffuse goitre or Hashimoto's thyroiditis, conditions in which the thyroid gland enlarges, causing swelling in the front part of the neck.

2. What you need to know before taking TIFACTOR

Do not take TIFACTOR

  • if you are allergic to sodium levothyroxine, sodium methyl parahydroxybenzoate, or to any of the other ingredients of this medicine (listed in section 6).
  • if you have adrenal insufficiency and do not have adequate corticosteroid coverage.
  • if you have recently had a heart attack (acute myocardial infarction), inflammation of the heart muscle (acute myocarditis), or inflammation of the sac surrounding the heart (acute pancarditis).
  • if you are pregnant, do not take this medicine in combination with other medicines used to treat hyperthyroidism (see section on Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before taking TIFACTOR.

  • if you have heart disease, circulatory problems, or high blood pressure.
  • if you have an overactive thyroid (hyperthyroidism), underactive adrenal glands, diabetes, or have had an underactive thyroid for some time.

Children
Partial hair loss may occur during the first months of treatment, but this effect is temporary and hair usually regrows later.
Extreme caution must be exercised when starting levothyroxine therapy in premature infants with low birth weight. Due to immature adrenal function, circulatory collapse may occur (see section 4, “Possible side effects”).

Other medicines and TIFACTOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
TIFACTOR may interfere with the action of certain other drugs, and some medicines may affect TIFACTOR. In particular, inform your doctor or pharmacist if you are taking the following medicines:

  • medicines to prevent blood clotting (e.g. warfarin)
  • medicines for depression (e.g. sertraline, imipramine, amitriptyline)
  • medicines for epilepsy (e.g. phenytoin, phenobarbital, carbamazepine), or
  • medicines for diabetes
  • rifampicin (for infections, particularly tuberculosis)
  • digoxin or amiodarone (for heart conditions)
  • propranolol (for high blood pressure), lovastatin (for high cholesterol), phenylbutazone, or aspirin
  • estrogens, estrogen-containing products or oral contraceptives, androgens, or corticosteroids
  • other medicines, including those purchased without prescription
  • sucralfate, cimetidine, or aluminum hydroxide for stomach ulcers
  • colestyramine or colesevelam to reduce cholesterol levels, sodium polystyrene sulfonate, calcium carbonate, or iron supplements.

TIFACTOR may be taken with these medicines but not at the same time.

  • chloroquine or proguanil for prevention of malaria
  • protease inhibitors (e.g. ritonavir, indinavir, lopinavir) used to treat HIV
  • sevelamer (used to treat high phosphate levels in patients with kidney failure)
  • tyrosine kinase inhibitors (e.g. imatinib and sunitinib) used to treat cancer
  • propylthiouracil (used to treat hyperthyroidism)
  • beta-blockers (used to treat high blood pressure and heart problems)
  • sympathomimetic agents (steroid hormones used to treat adrenal insufficiency and other diseases)
  • glucocorticoids (steroid hormones used to treat adrenal insufficiency and other diseases)
  • iodine-containing contrast agents (used to enhance visibility of blood vessels and organs during radiographic procedures)
  • orlistat (a medicine used to treat obesity)

If you are admitted to hospital for surgery, inform the anaesthetist or medical staff that you are taking TIFACTOR. It may interact with an anaesthetic (ketamine) that may be administered before surgery.

TIFACTOR with food and drinks
Products containing soy (especially soy-based supplements) may interact with levothyroxine; consult your doctor or pharmacist.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.

TIFACTOR contains sodium methyl parahydroxybenzoate (E219)

  • It may cause allergic reactions (including delayed reactions).
    TIFACTOR contains glycerol
    It may cause headache, gastrointestinal disturbances, and diarrhoea.
    TIFACTOR contains less than 1 mmol (23 mg) of sodium per 5 ml, i.e. essentially 'sodium-free'.

3. How to take TIFACTOR

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the daily dose based on your condition. Your doctor will perform regular blood tests to monitor your response to treatment.
If you switch from the oral solution to the tablet form of levothyroxine, or from the tablet form to the oral solution of levothyroxine, your doctor will monitor you more closely. The same applies when switching between different brands of oral solutions containing levothyroxine.

Usual daily doses: Adults and children over 12 years of age:
The initial dose is 50–100 micrograms (mcg) per day, increased by 25–50 mcg every 3–4 weeks until the correct dose for your condition is reached. The usual maintenance dose is 100–200 mcg per day.
For diffuse non-toxic goitre or Hashimoto's thyroiditis, the recommended dose is 50–200 micrograms (mcg) per day.
For the treatment of thyroid cancer, the recommended dose is 150–300 micrograms (mcg) per day.

Elderly patients (over 50 years of age):
The initial dose is 12.5 micrograms (mcg) per day, increased by 12.5 mcg every 4 weeks until the correct dose is achieved. The usual final dose ranges from 50 to 200 mcg per day. This dose also applies to patients with severe hypothyroidism and those with heart disease.

Children under 12 years of age:
The dose for children depends on age, body weight, and the condition being treated. Your child will be monitored to ensure they are receiving the correct dose. Give this medicine to your child at least one hour before their first meal of the day.

Congenital hypothyroidism in children:
Initially, 10–15 micrograms/kg body weight per day for the first 3 months. The dose will then be adjusted based on response to treatment.

Acquired hypothyroidism in children:
Initially, 12.5–50 micrograms per day. The dose should be gradually increased every 2–4 weeks depending on response to treatment.

Use the oral dosing syringe provided to deliver the specific dose – see instructions below. The syringe can be used to measure the dose by drawing up the liquid to the appropriate mark on the syringe. For example, if your dose is 50 micrograms per day, the corresponding volume will be:
For the 100 micrograms/5 ml strength: 2.5 ml

How to use the oral dosing syringe:

  1. Shake the bottle well, making sure the cap is securely tightened on the bottle.
  2. Remove the cap. Note: Keep the cap nearby to close the bottle after each use.
  3. Push the plastic adapter firmly into the neck of the bottle. Note: The adapter must remain in the bottle at all times.
  4. Take the dosing syringe and ensure the plunger is fully pushed down.
  5. Hold the bottle upright and firmly insert the oral dosing syringe into the plastic adapter.
  6. Invert the entire bottle with the syringe upside down.
  7. Slowly pull the plunger down to fill the syringe with medicine. Push the plunger up to expel any large air bubbles trapped in the oral dosing syringe.
  8. Then slowly pull the plunger back to the volume required for your dose.
  9. Turn the entire bottle with the syringe upright and remove the syringe from the bottle.
  10. The medicine can now be taken directly from the oral dosing syringe. Make sure you are sitting in an upright position and slowly push the plunger to allow you to swallow the dose.
  11. Replace the child-resistant cap after use, leaving the adapter in place.
  12. Cleaning: After use, clean the outside of the syringe with a clean, dry cloth.

Method of administration
TIFACTOR must be swallowed. You must take TIFACTOR on an empty stomach, usually before breakfast.

Duration of treatment
If you are being treated for hypothyroidism, diffuse non-toxic goitre, or Hashimoto's thyroiditis, treatment is generally lifelong.

If you take more TIFACTOR than you should
If you accidentally take too much medicine, call your doctor immediately or go to the nearest hospital emergency department. Symptoms of overdose include fever, irregular heartbeat, muscle weakness, headache, restlessness, hot flushes, sweating, and diarrhoea. Always bring the remaining medicine, container, and label with you so the medicine can be identified.

If you forget to take TIFACTOR
If you forget to take your medicine, take the next dose as soon as you remember, then take the following dose at your usual time. Do not take a double dose at the same time to make up for a forgotten dose. If you have missed several doses, inform your doctor at your next check-up or blood test.

If you stop taking TIFACTOR
For your treatment to be effective, you must take TIFACTOR regularly at the dose prescribed by your doctor. Do not under any circumstances change, suspend, or stop your prescribed treatment without first discussing it with your doctor. Symptoms of the disease may return if you stop or discontinue treatment prematurely. The nature of these symptoms depends on the underlying condition.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These usually occur only if you are taking too high a dose.
If you experience any of the following symptoms, stop taking TIFACTOR immediately and contact your doctor
or go to the nearest hospital emergency department.

  • Swelling of hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
  • Hives
  • Fainting
  • Yellowing of the skin and eyes, also known as jaundice

These side effects are very serious. If you experience these symptoms, you may be having a severe allergic reaction to TIFACTOR. You may require urgent medical attention or hospitalization. All of these side effects are very rare.
Inform your doctor if you notice any of the following side effects:
Rapid or irregular heartbeat, palpitations, chest pain, muscle cramps or weakness, headache, restlessness, excitability, flushing, circulatory collapse in premature infants with low birth weight (see section 2), sweating, diarrhoea, vomiting, fever, menstrual problems, increased blood pressure in the skull, tremor, drowsiness, heat intolerance and excessive weight loss. Skin rash, itching and swelling may also occur.
Very rarely, if a particularly excessive dose of TIFACTOR has been taken either as a single overdose or over many years, heart failure may occur, and cases of coma and death have been reported.
If you do not feel well in any other way, inform your doctor as soon as possible.
Additional side effects in children
Children may experience hair loss at the beginning of treatment; however, this is usually temporary and hair regrows.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TIFACTOR

Keep this medicine out of the sight and reach of children.
Expiry date
Discard any remaining medicine 2 months after opening.
Do not use this medicine after the expiry date which is stated on the label and on the carton after
EXP. The expiry date refers to the last day of that month.
Storage conditions
Do not store above 25°C.
Keep in the original packaging to protect the medicine from light.
Do not use this medicine if you notice any changes in the appearance or smell of the medicine. Discuss this with your pharmacist.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TIFACTOR contains

  • The active substance is levothyroxine sodium. Each 5 ml of oral solution contains levothyroxine equivalent to 100 micrograms (mcg) of anhydrous sodium levothyroxine.
  • The other ingredients are glycerol, citric acid monohydrate, sodium methyl parahydroxybenzoate (E219) and purified water.

Description of the appearance of TIFACTOR and contents of the pack
TIFACTOR is a clear, colourless liquid. Each bottle contains 75 ml or 100 ml of levothyroxine oral solution. TIFACTOR is available in packs containing one or two glass bottles, each filled with 75 ml of oral solution, or one glass bottle filled with 100 ml of oral solution.
A 5 ml syringe is also included to help you measure the dose.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
I.B.N. Savio S.r.l
Via del Mare, 36
Pomezia (RM)
Manufacturer
GALENICA PHARMACEUTICAL INDUSTRY S.A.
3rd km Old National Road Chalkida ‐ Athens
Glifa Chalkida Eubia, 34100, Greece