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.
5-POSOLOGY
Always take UBSA-THYROX
®
exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist, if you are not
sure.
In general, you start with a low dose, which is increased every 2 - 4
weeks, until your full individual dose is reached. During the initial
weeks of treatment, you will have appointments for laboratory
tests in order to adjust the dose.
If your baby is born with hypothyroidism your doctor may
recommend to start with a higher dose because a rapid
replacement is important. The initial recommended dosage is 10
to 15 micrograms per kg body weight for the first 3 months.
Thereafter, your doctor will adjust the dose individually. The usual
dose range is shown in the table below.
A lower individualized dose may be sufficient:
- If you are an elderly patient,
- If you have heart problems,
- If you have severe or long-standing thyroid sub-function,
- If you have low weight or a large goitre.
Administration
UBSA-THYROX
®
is meant for oral use.
Take a single daily dose on an empty stomach in the morning (at
least half an hour before breakfast), preferably with a little liquid,
for example with half a glass of water. Infants may receive the
entire daily dose of UBSA-THYROX
®
at least half an hour before the
first meal of the day. Immediately before use, crush the tablet and
mix it with some water and give it to the child with some more
liquid. Always prepare the mixture freshly.
Duration of treatment
Duration of treatment may vary depending on the condition for
which you use UBSA-THYROX
®
. Your doctor will therefore discuss
with you how long you need to take it. Most patients need to take
UBSA-THYROX
®
for their lifetime.
If you take more UBSA-THYROX
®
than you should
If you have taken a higher dose than prescribed, you may
experience symptoms such as rapid heart beat, anxiety,
agitation or unintended movements. In patients with a disorder
affecting the neurological system such as epilepsy, seizures may
occur in isolated cases. In patients at risk of psychotic disorders,
symptoms of acute psychosis may occur. If any of this happens,
contact your doctor.
If you forget to take UBSA-THYROX
®
Do not take a double dose to make up for a forgotten tablet, but
take the normal dose the following day.
If you have any further questions on the use of UBSA-THYROX
®
,
ask your doctor or pharmacist
6- DRUG INTERACTIONS
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any of the following medicines, because
UBSA-THYROX
®
may influence their effect:
-Anti-diabetic medicines (blood-sugar-lowering medicines):
UBSA-THYROX
®
may reduce the effect of your anti-diabetic
medicine, so you may need additional checks of your blood
sugar levels, especially at the start of UBSA-THYROX
®
treatment.
While you are taking UBSA-THYROX
®
, adjustment of the dose of
your anti-diabetic medicine may be necessary.
- Coumarin derivatives (medicines used to prevent blood
clotting): UBSA-THYROX
®
may intensify the effect of these
medicines, which
may increase the risk of bleeding events,
especially in elderly people. You may need regular checks of
your blood clotting values, at the start of and during UBSA-THY-
ROX
®
treatment. While you are taking UBSA-THYROX
®
,
adjustment of the dose of your coumarin medicine may be
necessary.
Make sure that you stick to the recommended time intervals, if
you need to take any of the following medicines:
- Medicine used to bind bile acids and to lower high cholesterol
(such as cholestyramine or cholestipol): Make sure that you take
UBSA-THYROX
®
4 - 5 hours before these medicines, because
they may block the uptake of UBSA-THYROX
®
from the intestine.
- Antacids (for the relief of acid indigestion), sucralfate (for
ulcers of the stomach or intestine), other aluminium-containing
medicines, iron-containing medicines, calcium-containing
medicines: Make sure that you take UBSA-THYROX
®
at least 2
hours before these medicines, because otherwise they may
reduce the effect of UBSA-THYROX
®
.
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any of the following medicines, because they
may reduce the effect of UBSA-THYROX
®
:
- Propylthiouracil (antithyroid medicine),
-Glucocorticoids (anti-allergic and anti-inflammatory
medicines),
- Beta-blockers (blood-pressure-lowering medicines also used
to treat heart diseases),
- Sertraline (antidepressive medicine),
-Chloroquine, or proguanil (medicine to prevent or treat
malaria),
-Medicines activating certain liver enzymes such as
barbiturates (sedatives, sleeping pill) or carbamazepine
(anti-epileptic medicine, also used to modify some types of pain
and to control mood disorders),
-Oestrogen-containing medicines used for hormone
replacement during and after
the menopause or for prevention
of pregnancy,
- Sevelamer (phosphate binding drug, used to treat patients
with chronic renal failure),
- Tyrosine kinase inhibitors (anti-cancer and anti-inflammatory
medicines).
- orlistat (medication to treat obesity)
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any of the following medicines, because
they may intensify the effect of UBSA-THY-
ROX
®
:
- Salicylates (medicine used to relief pain
and to reduce fever),
- Dicumarol (medicine to prevent blood
clotting),
- Furosemide in high doses of 250 mg
(diuretic medicine),
- Clofibrate (blood-lipid-lowering
medicine).
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any of the following medicines, because
they may influence the effect of
UBSA-THYROX
®
:
- Ritonavir, indinavir, lopinavir (protease
inhibitors, medicines to treat HIV
infection),
- Phenytoin (anti-epileptic medicine). You
may need regular checks of your thyroid
hormone parameters.
An adjustment of your dose of UBSA-THY-
ROX
®
may be necessary.
Tell your doctor, if you are taking
amiodarone (medicine used to treat
irregular heart beat), because this
medicine may influence the function and
activity of your thyroid gland.
If you need to have a diagnostic test or
scan with iodine–containing contrast
media, tell your doctor that you take
UBSA-THYROX
®
, because you may
receive an injection that may influence
your thyroid function.
7- WARNING AND PRECAUTIONS
Do not take UBSA-THYROX
®
if you have any of the following:
- Allergy (hypersensitivity) to the active
substance or to any of the other
ingredients of
UBSA-THYROX
®
(listed
in section 2).
- Untreated dysfunction of the adrenal
gland, pituitary gland or excessive
overproduction of thyroid hormones
(thyreotoxicosis).
- Acute heart disease (myocardial
infarction or heart inflammation).
Do not take UBSA-THYROX
®
together with
antithyroid medicines if you are pregnant
(see section Pregnancy and breast-feed-
ing below).
Talk to your doctor or pharmacist before
taking UBSA-THYROX
®
if you have any of
the following heart diseases:
- Insufficient blood flow in the blood
vessels of the heart (angina pectoris),
- Heart failure,
- Rapid and irregular heart beat,
- High blood pressure,
-Fatty deposits in your arteries
Levothyroxine sodium 50/100 mcg tablets
1-FORM AND PRESENTATION
UBSA-THYROX
®
(50mcg,100mcg) are yellow, round shaped, flat, break
line on one side tablets. Box of 100 tablets.
2- COMPOSITION
Each tablet of UBSA-THYROX
®
50 mcg contains Levothyroxine
sodium 50mcg.
Each tablet of UBSA-THYROX
®
100mcg contains Levothyroxine
sodium 100mcg.
Inactive ingredients: lactose, microcrystalline cellulose PH 102,
sodium sulfite, isopropyl alcohol, croscarmellose sodium, sodium
carbonate anhydrous, sodium citrate, talc, magnesium stearate,
colloidal silicon dioxide, quinoline yellow lake.
3-PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: Thyroid hormones
ATC-Code: H03A A01
The synthetic levothyroxine contained in UBSA-THYROX
®
is
identical in effect with the naturally occurring major hormone
secreted by the thyroid. It is converted to T3 in peripheral organs
and, like the endogenous hormone, develops its specific effects
at the T3 receptors. The body is not able to differentiate between
endogenous and exogenous levothyroxine.
Pharmacokinetics properties
Following oral administration, the onset of action is seen after 3-5
days. Levothyroxine exhibits an extremely high binding to specific
transport proteins of about 99.97 %. Due to its high protein binding
levothyroxine undergoes neither hemodialysis nor hemoperfu-
sion. The half-life of levothyroxine is on average 7 days. Thyroid
hormones are metabolized mainly in the liver, kidneys, brain and
muscles. The metabolites are excreted with urine and feces.
4- THERAPEUTIC INDICATIONS
UBSA-THYROX
®
25 - 200 microgram:
- Treatment of benign euthyroid goitre.
-Prophylaxis of relapse after surgery for euthyroid goitre,
depending on the post-operative hormone status.
- Substitution therapy in hypothyroidism.
- Suppression therapy in thyroid cancer.
UBSA-THYROX
®
25 – 100 microgram:
- Concomitant supplementation during anti-thyroid drug
treatment of hyperthyroidism
UBSA-THYROX
®
100/150/200 microgram:
- Diagnostic use for thyroid suppression testing
Use of UBSA-THYROX
The recommended daily dose of UBSA-THYROX
to treat benign goitre in pa ents
with normal thyroid func on
75 - 200 microgram
to prevent recurrence of goitre
a er surgery
75 - 200 microgram
to replace natural thyroid
hormones, when your thyroid
gland does not produce enough
- ini
al dose
- maintenance dose
adults
25 - 50 microgram
100 - 200 microgram
children
12.5 – 50 microgram
100 – 150 microgram per m²
of body surface
to replace natural thyroid
hormones, when your thyroid
gland does not produce enough
- ini
al dose
- maintenance dose
adults
25 - 50 microgram
100 - 200 microgram
children
12.5 – 50 microgram
100 – 150 microgram per m²
of body surface
- suppress tumour growth in
pa ents with thyroid cancer
150 - 300 microgram
to balance thyroid hormone
levels, when overproduc on of
hormones is treated with an
-
thyroid medicines
50 - 100 microgram
-to test thyroid func on
100 micrograms: 200
microgram (2 tablets) star ng
2 weeks before the test
150 micrograms: Star
ng 4
weeks before the test 75
microgram (½ tablet) for two
weeks, then 150 micrograms
(1 tablet) un l the test
5-POSOLOGY
Always take UBSA-THYROX® exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist, if you are not
sure.
In general, you start with a low dose, which is increased every 2 - 4
weeks, until your full individual dose is reached. During the initial
weeks of treatment, you will have appointments for laboratory
tests in order to adjust the dose.
If your baby is born with hypothyroidism your doctor may
recommend to start with a higher dose because a rapid
replacement is important. The initial recommended dosage is 10
to 15 micrograms per kg body weight for the first 3 months.
Thereafter, your doctor will adjust the dose individually. The usual
dose range is shown in the table below.
A lower individualized dose may be sufficient,
- If you are an elderly patient,
- If you have heart problems,
- If you have severe or long-standing thyroid sub-function,
- If you have low weight or a large goitre.
Administration
UBSA-THYROX® is meant for oral use.
Take a single daily dose on an empty stomach in the morning (at
least half an hour before breakfast), preferably with a little liquid,
for example with half a glass of water. Infants may receive the
entire daily dose of UBSA-THYROX® at least half an hour before the
first meal of the day. Immediately before use, crush the tablet and
mix it with some water and give it to the child with some more
liquid. Always prepare the mixture freshly.
Duration of treatment
Duration of treatment may vary depending on the condition for
which you use UBSA-THYROX®. Your doctor will therefore discuss
with you
how long you need to take it. Most patients need to take
UBSA-THYROX® for their lifetime.
If you take more UBSA-THYROX® than you should
If you have taken a higher dose than prescribed, you may
experience symptoms such as rapid heart beat, anxiety,
agitation or unintended movements. In patients with a disorder
affecting the neurological system such as epilepsy, seizures may
occur in isolated cases. In patients at risk of psychotic disorders,
symptoms of acute psychosis may occur. If any of this happens,
contact your doctor.
If you forget to take UBSA-THYROX®
Do not take a double dose to make up for a forgotten tablet, but
take the normal dose the following day.
If you have any further questions on the use of UBSA-THYROX®,
ask your doctor or pharmacist
6- DRUG INTERACTIONS
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any of the following medicines, because
UBSA-THYROX® may influence their effect:
-Anti-diabetic medicines (blood-sugar-lowering medicines):
UBSA-THYROX® may reduce the effect of your anti-diabetic
medicine, so you may need additional checks of your blood
sugar levels, especially at the start of UBSA-THYROX® treatment.
While you are taking UBSA-THYROX®, adjustment of the dose of
your anti-diabetic medicine may be necessary.
- Coumarin derivatives (medicines used to prevent blood
clotting): UBSA-THYROX® may intensify the effect of these
medicines, which may increase the risk of bleeding events,
especially in elderly people. You may need regular checks of
your blood clotting values, at the start of and during UBSA-THY-
ROX® treatment.
While you are taking UBSA-THYROX®,
adjustment of the dose of your coumarin medicine may be
necessary.
Make sure that you stick to the recommended time intervals, if
you need to take any of the following medicines:
- Medicine used to bind bile acids and to lower high cholesterol
(such as cholestyramine or cholestipol): Make sure that you take
UBSA-THYROX® 4 - 5 hours before these medicines, because
they may block the uptake of UBSA-THYROX® from the intestine.
- Antacids (for the relief of acid indigestion), sucralfate (for
ulcers of the stomach or intestine), other aluminium-containing
medicines, iron-containing medicines, calcium-containing
medicines: Make sure that you take UBSA-THYROX® at least 2
hours before these medicines, because otherwise they may
reduce the effect of UBSA-THYROX®.
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any of the following medicines, because they
may reduce the effect of UBSA-THYROX®:
- Propylthiouracil (antithyroid medicine),
- Glucocorticoids (anti-allergic and anti-inflammatory
medicines),
- Beta-blockers (blood-pressure-lowering medicines also used
to treat heart diseases),
- Sertraline (antidepressive medicine),
- Chloroquine, or proguanil (medicine to prevent or treat
malaria),
- Medicines activating certain liver enzymes such as
barbiturates (sedatives, sleeping pill) or carbamazepine
(anti-epileptic medicine, also used to modify some types of pain
and to control mood disorders),
- Oestrogen-containing medicines used for hormone
replacement during and after the menopause or for prevention
of pregnancy,
- Sevelamer (phosphate binding drug, used to treat patients
with chronic renal failure),
- Tyrosine kinase inhibitors (anti-cancer and anti-inflammatory
medicines).
- orlistat (medication to treat obesity)
Tell your doctor or pharmacist if you
are
taking, have recently taken or might take
any of the following medicines, because
they may intensify the effect of UBSA-THY-
ROX® :
- Salicylates (medicine used to relief pain
and to reduce fever),
- Dicumarol (medicine to prevent blood
clotting),
- Furosemide in high doses of 250 mg
(diuretic medicine),
- Clofibrate (blood-lipid-lowering
medicine).
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any of the following medicines, because
they may influence the effect of
UBSA-THYROX® :
- Ritonavir, indinavir, lopinavir (protease
inhibitors, medicines to treat HIV
infection),
- Phenytoin (anti-epileptic medicine). You
may need regular checks of your thyroid
hormone parameters.
An adjustment of your dose of UBSA-THY-
ROX® may be necessary.
Tell your doctor, if you are taking
amiodarone (medicine used to treat
irregular heart beat), because this
medicine may influence the function and
activity of your thyroid gland.
If you need to have a diagnostic test or
scan with iodine–containing contrast
media, tell your doctor that you take
UBSA-THYROX®, because you may
receive an injection that may influence
your thyroid function.
7- WARNING AND PRECAUTIONS
Do not take UBSA-THYROX®
if you have any of the following:
- Allergy (hypersensitivity) to the active
substance or to any of the other
ingredients of UBSA- THYROX® (listed
in section 2),
- Untreated dysfunction of the adrenal
gland, pituitary gland or excessive
overproduction of thyroid hormones
(thyreotoxicosis),
- Acute heart disease (myocardial
infarction or heart inflammation).
Do not take UBSA-THYROX® together with
antithyroid medicines if you are pregnant
(see
section Pregnancy and breast-feed-
ing below).
Talk to your doctor or pharmacist before
taking UBSA-THYROX® if you have any of
the following heart diseases:
- Insufficient blood flow in the blood
vessels of the heart (angina pectoris),
- Heart failure,
- Rapid and irregular heart beat,
- High blood pressure,
- Fatty deposits in your arteries
1-FORM AND PRESENTATION
UBSA-THYROX®(strengths) are yellow, round shaped, flat, break
line on one side tablets. Box of 100 tablets.
2- COMPOSITION
Each tablet of UBSA-THYROX® 50 mcg contains Levothyroxine
sodium 50mcg
Each tablet of UBSA-THYROX® 100mcg contains Levothyroxine
sodium 100mcg
Inactive ingredients: lactose, microcrystalline cellulose PH 102,
sodium sulfite, isopropyl alcohol, croscarmellose sodium, sodium
carbonate anhydrous, sodium citrate, talc, magnesium stearate,
colloidal silicon dioxide, lake quinoline yellow.
3-PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: Thyroid hormones
ATC-Code: H03A A01
The synthetic levothyroxine contained in UBSA-THYROX® is
identical in effect with the naturally occurring major hormone
secreted by the thyroid. It is converted to T3 in peripheral organs
and, like the endogenous hormone, develops its specific effects
at the T3 receptors. The body is not able to differentiate between
endogenous and exogenous levothyroxine.
Pharmacokinetics properties
Following oral administration, the onset of action is seen after 3-5
days. Levothyroxine exhibits an extremely high binding to specific
transport proteins of about 99.97 %. Due to its high protein binding
levothyroxine undergoes neither hemodialysis nor hemoperfu-
sion. The half-life of levothyroxine is on average 7 days. Thyroid
hormones are metabolized mainly in the liver, kidneys, brain and
muscles. The metabolites are excreted with urine and feces.
4- THERAPEUTIC INDICATIONS
UBSA-THYROX® 25 - 200 microgram:
- Treatment of benign euthyroid goitre
- Prophylaxis of relapse after surgery for euthyroid goitre,
depending on the post-operative hormone status
- Substitution therapy in hypothyroidism
- Suppression therapy in thyroid cancer
UBSA-THYROX® 25 – 100 microgram:
- Concomitant supplementation during anti-thyroid drug
treatment of hyperthyroidism
UBSA-THYROX® 100/150/200 microgram:
- Diagnostic use for thyroid suppression testing
(arteriosclerosis).
They must be under medical control before
you start taking UBSA-THYROX® or before a thyroid suppression
test is performed. You must have frequent checks of your thyroid
hormone levels while you are on UBSA-THYROX®. If you are not
sure whether any of these conditions applies to you, or if you do
not receive treatment, contact your doctor.
Your doctor will investigate if you have a dysfunction of the
adrenal or pituitary gland or a dysfunction of the thyroid gland
with uncontrolled overproduction of thyroid hormones (thyroid
autonomy), because this must be medically controlled before you
start taking UBSA-THYROX® or before a thyroid suppression test is
performed.
Blood pressure will be regularly monitored when levothyroxine
treatment is started in very low birth weight preterm neonates
because
rapid fall in blood pressure
(known as circulatory collapse) may occur.
Thyroid imbalance may occur if you need to change your
medication to another levothyroxine containing product. Talk to
your doctor if you have any questions about changing your
medication. A close monitoring (clinical and biological) is
required during the transition period. You should tell your doctor if
you get any side effects as this may indicate that your dose needs
to be adjusted up or down.
Speak to your doctor,
- If you are in the menopause or post-menopausal; your doctor
may need to check your thyroid function regularly because of the
risk of osteoporosis.
- Before you start or stop taking orlistat, or change the treatment
with
orlistat (medication to treat obesity; you may need closer
monitoring and dose adjustment)
- If you experience signs of psychotic disorders (you may need
closer monitoring and dose adjustment)
Thyroid hormones should not be used for weight reduction. Intake
of thyroid hormones will not reduce your weight, if your thyroid
hormone level is in a normal range. Serious or even life-threaten-
ing side effects may occur if you increase the dose without
special advice from your doctor.
High doses of thyroid hormones should not be taken together with
certain medicines for weight reduction, such as amfepramone,
cathine and phenylpropanolamine, as the risk of serious or even
life-threatening side effects may increase.
8- SPECIAL POPULATION
Pregnant and Breastfeeding
If you are pregnant continue taking UBSA-THYROX® . Speak to your
doctor, because the dose may need to be changed. If you have
taken UBSA-THYROX® together with an antithyroid medicine to
treat an overproduction of thyroid hormones, your doctor will
advise you to stop UBSA-THYROX® treatment when you become
pregnant.
If you are breast-feeding, continue taking UBSA-THYROX® as
advised by your doctor. The amount of drug that is excreted into
the breast milk is so small that it will not affect the child.
Driving and using machines
No studies on the effects on the ability to drive and use machines
have been performed. It is not expected that UBSA-THYROX® has
any influence on the ability to drive and use machines, because
levothyroxine is identical to the naturally occurring thyroid
hormone
9-ADVERSE REACTIONS
Like all medicines, UBSA-THYROX® can cause side effects,
although not everybody gets them.
You may experience one or more of the following side effects if
you take more UBSA-THYROX® than prescribed, or if you do not
tolerate your prescribed dose (e.g. when the dose is increased
quickly): Irregular or rapid heart beat, chest pain, headache,
muscle weakness or cramps, flushing (warmth and redness of the
face), fever, vomiting, disorders of menstruation, pseudotumor
cerebri (increased pressure in the head), trembling, restlessness,
sleep disturbances, sweating, weight loss, diarrhoea.
If you experience any of these side effects, contact your doctor.
Your doctor may decide to interrrupt the therapy for several days
or to reduce the daily dose until the side effects have
disappeared.
Allergic reactions to any of the ingredients of UBSA-THYROX® are
possible (see section 2). Allergic reactions may include rash,
urticaria and swelling of the face or throat
(angio-oedema). If this happens, contact your doctor
immediately
10-STORAGE CONDITIONS
Keep this medicine out of the reach of children.
Store in a dry place below 30 C.
Do not use UBSA-THYROX after the expiry date, which is stated on
the blister and the carton.
Keep the blisters in the outer carton, in order to protect from light.
11-MANUFACTURER
Hiral Lab Ltd. 265, Sisona Bhagwanpur,
Roorke,Dist Haridwar 247661
Marketing Authorisation Holder, Packed by
(arteriosclerosis).
They must be under medical control before
you start taking UBSA-THYROX
®
or before a thyroid suppression
test is performed. You must have frequent checks of your thyroid
hormone levels while you are on UBSA-THYROX
®
. If you are not
sure whether any of these conditions applies to you, or if you do
not receive treatment, contact your doctor.
Your doctor will investigate if you have a dysfunction of the
adrenal or pituitary gland or a dysfunction of the thyroid gland
with uncontrolled overproduction of thyroid hormones (thyroid
autonomy), because this must be medically controlled before you
start taking UBSA-THYROX
®
or before a thyroid suppression test is
performed.
Blood pressure will be regularly monitored when levothyroxine
treatment is started in very low birth weight preterm neonates
because
rapid fall in blood pressure
(known as circulatory collapse)
Thyroid imbalance may occur if you need to change your
medication to another levothyroxine containing product. Talk to
your doctor if you have any questions about changing your
medication. A close monitoring (clinical and biological) is
required during the transition period. You should tell your doctor if
you get any side effects as this may indicate that your dose needs
to be adjusted up or down.
Speak to your doctor,
- If you are in the menopause or post-menopausal; your doctor
may need to check your thyroid function regularly because of the
risk of osteoporosis.
- Before you start or stop taking orlistat, or change
the treatment
with orlistat (medication to treat obesity; you may need closer
monitoring and dose adjustment)
- If you experience signs of psychotic disorders (you may need
closer monitoring and dose adjustment)
Thyroid hormones should not be used for weight reduction. Intake
of thyroid hormones will not reduce your weight, if your thyroid
hormone level is in a normal range. Serious or even life-threaten-
ing side effects may occur if you increase the dose without
special advice from your doctor.
High doses of thyroid hormones should not be taken together with
certain medicines for weight reduction, such as amfepramone,
cathine and phenylpropanolamine, as the risk of serious or even
life-threatening side effects may increase.
8- SPECIAL POPULATION
Pregnant and Breastfeeding
If you are pregnant continue taking UBSA-THYROX
®
. Speak to your
doctor, because the dose may need to be changed. If you have
taken UBSA-THYROX
®
together with an antithyroid medicine to
treat an overproduction of thyroid hormones, your doctor will
advise you to stop UBSA-THYROX
®
treatment when you become
pregnant.
If you are breast-feeding, continue taking UBSA-THYROX
®
as
advised by your doctor. The amount of drug that is excreted into
the breast milk is so small that it will not affect the child.
Driving and using machines
No studies on the effects on the ability to drive and use machines
have been performed. It is not expected that UBSA-THYROX
®
has
any influence on the ability to drive and use machines, because
levothyroxine is identical to the
naturally occurring thyroid
hormone
9-ADVERSE REACTIONS
Like all medicines, UBSA-THYROX
®
can cause side effects,
although not everybody gets them.
You may experience one or more of the
following side effects if
you take more UBSA-THYROX
®
than prescribed, or if you do not
tolerate your prescribed dose (e.g. when the dose is increased
quickly): Irregular or rapid heart beat, chest pain, headache,
muscle weakness or cramps, flushing (warmth and redness of the
face), fever, vomiting, disorders of menstruation, pseudotumor
cerebri (increased pressure in the head), trembling, restlessness,
sleep disturbances, sweating, weight loss, diarrhoea.
If you experience any of these side effects, contact your doctor.
Your doctor may decide to interrrupt the therapy for several days
or to reduce the daily dose until the side effects have
disappeared.
Allergic reactions to any of the ingredients of UBSA-THYROX
®
are
possible (see section 2). Allergic reactions may include rash,
urticaria and swelling of the face or throat
(angio-oedema).
10-STORAGE CONDITIONS
Keep this medicine out of the reach of children.
Store in a dry place below 30 C.
Do not use UBSA-THYROX after the expiry date, which is stated on
the blister and the carton.
Keep the blisters in the outer carton, in order to protect from light.
11-MANUFACTURER
Hiral Lab Ltd. 265, Sisona Bhagwanpur,
Roorke,Dist Haridwar 247661, India.
Marketing Authorisation Holder and Secondary Packed by:
Date of Revision: October 07, 2025
Council of Arab Health Ministers
Union of Arab pharmacists
This is a medicine:
- A medicine is a product which
affects your health and its consump-
tion contrary to instructions is
dangerous for you.
- Follow strictly the doctor's
prescription, the method of use and
the instructions of the pharmacist who
dispensed the medicine.
- The doctor and the pharmacist are
the experts in medicine, their benefits
and risks.
- Do not by yourself interrupt the
period of treatment prescribed.
- Do not repeat the same prescription
without consulting your doctor.
- Keep all medicine out of reach of
children.
PI039/01
may occur.
if this happens, contact your doctor immediately
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