LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 50 MG/12.5 MG FILM-COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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PAGE 1: FRONT FACE (INSIDE OF REEL)

LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE 50 mg/12.5 mg
FILM-COATED TABLETS
LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE 100 mg/25 mg
FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION
FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do not
pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

• if you need to have an anaesthetic (even at the
dentist) or before surgery, or if you are going to
have tests to check your parathyroid function, you
must tell the doctor or medical staff that you are
taking Losartan potassium and
Hydrochlorothiazide tablets
• if you suffer from primary hyperaldosteronism (a
syndrome associated with increased secretion of
the hormone aldesterone by the adrenal gland,
caused by an abnormality within the gland)
• you must tell your doctor if you think you are (or
might become) pregnant. Losartan potassium and
Hydrochlorothiazide is not recommended in early
pregnancy, and must not be taken if you are more
than 3 months pregnant, as it may cause serious
harm to your baby if used at that stage (see
pregnancy section).
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.

Diuretic agents such as the hydrochlorothiazide
contained in Losartan potassium and
1. What Losartan potassium and Hydrochlorothiazide Hydrochlorothiazide may interact with other
medicines. Preparations containing lithium should
tablets are and what they are used for
not be taken with Losartan potassium and
2. Before you take Losartan potassium and
Hydrochlorothiazide without close supervision by
Hydrochlorothiazide tablets
your doctor. Special precautionary measures (e.g.
3. How to take Losartan potassium and
blood tests) may be appropriate if you take
Hydrochlorothiazide tablets
potassium supplements, potassium-containing salt
4. Possible side effects
substitutes or potassium-sparing medicines, other
5. How to store Losartan potassium and
diuretics (“water tablets”), some laxatives,
Hydrochlorothiazide tablets
glycyrrhizin (found in liquorice), medicines for the
6. Further information
treatment of gout, medicines to control heart rhythm
or for diabetes (oral agents or insulins). It is also
WHAT LOSARTAN POTASSIUM AND
important for your doctor to know if you are taking
HYDROCHLOROTHIAZIDE TABLETS ARE AND other medicines to reduce your blood pressure,
WHAT THEY ARE USED FOR
steroids, medicines to treat cancer, pain killers, drugs
for treatment of fungal infections or arthritis
Losartan and Hydrochlorothiazide is a combination of medicines, resins used for high cholesterol, such as
an angiotensin II receptor antagonist (losartan) and a colestyramine, medicines which relax your muscles,
diuretic (hydrochlorothiazide).
sleeping tablets; opioid medicines such as morphine,
Losartan and Hydrochlorothiazide is indicated for the ‘pressor amines’ such as adrenaline or other drugs
from the same group; (oral agents for diabetes or
treatment of essential hypertension (high blood
insulins).
pressure).

IN THIS LEAFLET:

Pharma code 123

(Main)

NEW
POSITION
105mm

1

2

BEFORE YOU TAKE LOSARTAN POTASSIUM
AND HYDROCHLOROTHIAZIDE TABLETS

Do NOT take Losartan potassium and
Hydrochlorothiazide tablets:
• if you are allergic (hypersensitive) to losartan,
hydrochlorothiazide or to any of the other
ingredients of this medicine
• if you are allergic (hypersensitive) to other
sulfonamide-derived substances (e.g. other
thiazides, some antibacterial drugs such as
co-trimoxazole, ask your doctor if you are not sure)
• if you are, think you may be or are planning to
become pregnant (see also "Pregnancy and
breast-feeding")
• if you have severely impaired liver function
• if you have severely impaired kidney function or
your kidneys are not producing any urine
• if you have low potassium, low sodium or high
calcium levels which cannot be corrected by
treatment
• if you are suffering from gout
• if you are more than 3 months pregnant. (It is also
better to avoid Losartan potassium and
Hydrochlorothiazide in early pregnancy – see
pregnancy section.).

Please also inform your doctor when it is planned to
apply iodine contrast media about taking Losartan
potassium and Hydrochlorothiazide.
Taking Losartan potassium and Hydrochlorothiazide
tablets with food and drink
You are advised not to drink alcohol whilst taking
these tablets: alcohol and Losartan potassium and
Hydrochlorothiazide tablets may increase each
other’s effects.
Dietary salt in excessive quantities may counteract
the effect of Losartan potassium and
Hydrochlorothiazide tablets.
You should avoid food and drink containing liquorice
as glycyrrhizin, which is found in liquorice, may
cause abnormal blood electrolyte levels.
Losartan potassium and Hydrochlorothiazide tablets
may be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or
might become) pregnant. Your doctor will normally
advise you to stop taking Losartan potassium and
Hydrochlorothiazide tablets before you become
pregnant or as soon as you know you are pregnant
and will advise you to take another medicine instead
of Losartan potassium and Hydrochlorothiazide
tablets. Losartan potassium and Hydrochlorothiazide
Take special care with Losartan potassium and
tablets is not recommended during pregnancy, and
Hydrochlorothiazide tablets:
must not be taken when more than 3 months
• if you have previously suffered from swelling of
pregnant, as it may cause serious harm to your baby
the face, lips, throat or tongue
if used after the third month of pregnancy.
• if you take diuretics (water pills)
Breast-feeding
• if you are on a salt-restricted diet
Tell your doctor if you are breast-feeding or about to
• if you have or have had severe vomiting and/or
start breast-feeding. Losartan potassium and
diarrhoea
Hydrochlorothiazide tablets are not recommended
• if you have heart failure
for mothers who are breast-feeding, and your doctor
• if you have narrow arteries to your kidneys (renal
may choose another treatment for you if you wish to
artery stenosis) or only have one functioning
breast-feed.
kidney, or you have recently had a kidney transplant Use in children and adolescents
• if you have narrowing of the arteries
There is no experience with the use of Losartan
(atherosclerosis), angina pectoris (chest pain due
potassium and Hydrochlorothiazide in children.
to poor heart function)
Therefore, Losartan potassium and
Hydrochlorothiazide should not be given to children.
• if you have 'aortic or mitral valve stenosis'
Use in elderly patients
(narrowing of the valves of the heart) or
Losartan potassium and Hydrochlorothiazide works
'hypertrophic cardiomyopathy' (a disease causing
equally well in and is equally well tolerated by most
thickening of heart muscle)
older and younger adult patients. Most older patients
• if you are diabetic
require the same dose as younger patients.
• if you have had gout
Driving and using machines
• if you have or have had an allergic condition,
When you begin treatment with this medication, you
asthma or a condition that causes joint pain, skin
should not perform tasks which may require special
rashes and fever (systemic lupus erythematosus).
attention (for example, driving an automobile or
• if you have high calcium or low potassium levels
operating dangerous machinery) until you know how
or you are on a low potassium diet
you tolerate your medicine.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

• Ringing, buzzing, roaring or clicking in the ears
Important information about some of the ingredients
of Losartan potassium and Hydrochlorothiazide Tablets • Low blood pressure, which may be associated with
changes in posture (feeling light-headed or weak
Losartan potassium and Hydrochlorothiazide tablets
when you stand up), angina (chest pain), abnormal
contain lactose. If you have been told by your doctor
heartbeat, cerebrovascular accident (TIA,
that you have an intolerance to some sugars, contact
“mini-stroke”), heart attack, palpitations
your doctor before taking this medicinal product.
• Inflammation of blood vessels, which is often
associated with a skin rash or bruising
HOW TO TAKE LOSARTAN POTASSIUM AND
• Sore throat, breathlessness, bronchitis, pneumonia,
HYDROCHLOROTHIAZIDE TABLETS
water on the lungs (which causes difficulty
breathing), nosebleed, runny nose, congestion
Always take Losartan potassium and
• Constipation, wind, stomach upsets, stomach
Hydrochlorothiazide tablets exactly as your doctor
spasms, vomiting, dry mouth, inflammation of a
has told you. Your doctor will decide on the
salivary gland, toothache
appropriate dose of Losartan potassium and
• Jaundice (yellowing of the eyes and skin),
Hydrochlorothiazide depending on your condition
inflammation of the pancreas
and whether you are taking other medicines. It is
important to continue taking Losartan potassium and • Hives, itching, inflammation of the skin, rash,
redness of the skin, sensitivity to light, dry skin,
Hydrochlorothiazide for as long as your doctor
flushing, sweating, hair loss
prescribes it in order to maintain smooth control of
• Pain in the arms, shoulders, hips, knees or other
your blood pressure.
joints, joint swelling, stiffness, muscle weakness
High blood pressure
• Frequent urination including at night, abnormal
The usual dose of Losartan potassium and
kidney function including inflammation of the
Hydrochlorothiazide for most patients with high
kidneys, urinary infection, sugar in the urine
blood pressure is 1 tablet of Losartan potassium and • Decreased sexual appetite, impotence
Hydrochlorothiazide 50 mg/12.5 mg per day to
• Swelling of the face, fever.
control blood pressure over the 24-hour period. This
Rare (more than 1 out of 10,000 patients and less
can be increased to 2 tablets once daily of
than 1 out of 1,000 patients):
Losartan/Hydrochlorothiazide 50 mg/12.5 mg
• Hepatitis (inflammation of the liver), abnormal
Film-coated tablets or changed to 1 tablet daily of
liver function tests.
Losartan/Hydrochlorothiazide 100 mg/25 mg
Not known (cannot be estimated, more than 1 out of
Film-coated tablets (a stronger strength) per day. The 10,000 patients):
maximum daily dose is 2 tablets per day of
• Abnormal muscle breakdown which can lead to
Losartan/Hydrochlorothiazide
kidney problems.
50 mg/12.5 mg Film-coated tablets or 1 tablet daily of If any of the side effects get serious, or if you notice
Losartan/Hydrochlorothiazide 100 mg/25 mg
any side effects not listed in this leaflet, please tell
Film-coated tablets.
your doctor.
If you take more Losartan potassium and
HOW TO STORE LOSARTAN POTASSIUM
Hydrochlorothiazide tablets than you should
AND HYDROCHLOROTHIAZIDE TABLETS
In case of an overdose, contact your doctor
immediately so that medical attention may be given
Keep out of the reach and sight of children.
promptly. Overdosage can cause a drop in blood
pressure, palpitations, slow pulse, changes in blood
Do not use Losartan potassium and
composition, and dehydration.
Hydrochlorothiazide tablets after the expiry date that
is stated on the carton after EXP The expiry date
.
If you forget to take Losartan potassium and
refers to the last day of the month.
Hydrochlorothiazide tablets
Try to take Losartan/Hydrochlorothiazide tablets daily Do not store above 25° C.
as prescribed. However, if you miss a dose, do not
take an extra dose. Just resume your usual schedule. Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
POSSIBLE SIDE EFFECTS
measures will help to protect the environment.

3

5

4

Like all medicines, Losartan potassium and
Hydrochlorothiazide tablets can cause side effects,
although not everybody gets them.

6

FURTHER INFORMATION

What Losartan potassium and Hydrochlorothiazide
If you experience the following, stop taking Losartan tablets contain:
potassium and Hydrochlorothiazide tablets and tell
• The active ingredients are losartan potassium and
your doctor immediately or go to the casualty
hydrochlorothiazide. Each tablet contains either
department of your nearest hospital:
50 mg of losartan potassium and 12.5 mg of
• A severe allergic reaction (rash, itching, swelling of
hydrochlorothiazide or 100 mg of losartan
the face, lips, mouth or throat that may cause
potassium and 25 mg of hydrochlorothiazide
difficulty in swallowing or breathing).
• The other ingredients are:
Tablet core: lactose monohydrate, cellulose
This is a serious but rare side effect, which affects
microcrystalline (E460a), pregelatinised starch
more than 1 out of 10,000 patients but fewer than 1
(maize), magnesium stearate (E572).
out of 1,000 patients. You may need urgent medical
attention or hospitalisation.
Film-coat: poly(vinyl alcohol), titanium dioxide (E171),
macrogol 3350, talc (E553b), yellow iron oxide (E172).
The following side effects have been reported:
Common (affecting fewer than one person in 10 but
What Losartan potassium and Hydrochlorothiazide
more than one person in 100):
tablets look like and contents of the pack:
• Cough, upper airway infection, congestion in the
• Losartan potassium and Hydrochlorothiazide
nose, sinusitis, sinus disorder
50/12.5 mg Film-Coated Tablets are yellow, oval,
• Diarrhoea, abdominal pain, nausea, indigestion
bi-convex tablets, marked with “5” and “0” on one
• Muscle pain or cramps, leg pain, back pain
side and a score line on both sides.
• Insomnia, headache, dizziness
The score line is only to facilitate breaking for ease of
• Weakness, tiredness, chest pain
swallowing and not to divide into equal doses.
• Increased potassium levels (which can cause an
• Losartan potassium and Hydrochlorothiazide
abnormal heart rhythm), decreased haemoglobin
100/25 mg Film-Coated Tablets are yellow, oval,
levels.
bi-convex tablets marked with “100” on one side
Uncommon (affecting fewer than one person in 100
and smooth on the other side.
but more than one person in 1,000):
• The 50/12.5 mg tablets are available in pack sizes
• Anaemia, red or brownish spots on the skin
of 1, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets,
(sometimes especially on the feet, legs, arms and
calendar packs of 28 tablets and hospital packs of
buttocks, with joint pain, swelling of the hands and
50x1 and 280 (10x28) tablets
feet and stomach pain), bruising, reduction in
• The 100/25 mg tablets are available in pack sizes of
white blood cells, clotting problems and bruising
1, 7, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets,
• Loss of appetite, increased uric acid levels or frank
calendar packs of 7 and 28 tablets and hospital
gout, increased blood sugar levels, abnormal
packs of 50x1 and 280 (10x28) tablets.
blood electrolyte levels
Not all pack sizes may be marketed.
• Anxiety, nervousness, panic disorder (recurring
panic attacks), confusion, depression, abnormal
Marketing Authorisation Holder and Manufacturer
dreams, sleep disorders, sleepiness, memory
Marketing authorisation holder is: TEVA UK Limited,
impairment
Eastbourne, BN22 9AG
• Pins and needles or similar sensations, pain in the Manufacturer is: Teva Pharmaceutical Works Private
extremities, trembling, migraine, fainting
Limited Company, pallagi ut 13, 4042 Debrecen, Hungry
• Blurred vision, burning or stinging in the eyes,
This leaflet was last revised in August 2011
conjunctivitis, worsening eyesight, seeing things
in yellow

PL 00289/0967-0968

12345-A
160 x 323

PAGE 1: FRONT FACE (INSIDE OF REEL)

LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE 50 mg/12.5 mg
FILM-COATED TABLETS
LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE 100 mg/25 mg
FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION
FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do not
pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

• if you need to have an anaesthetic (even at the
dentist) or before surgery, or if you are going to
have tests to check your parathyroid function, you
must tell the doctor or medical staff that you are
taking Losartan potassium and
Hydrochlorothiazide tablets
• if you suffer from primary hyperaldosteronism (a
syndrome associated with increased secretion of
the hormone aldesterone by the adrenal gland,
caused by an abnormality within the gland)
• you must tell your doctor if you think you are (or
might become) pregnant. Losartan potassium and
Hydrochlorothiazide is not recommended in early
pregnancy, and must not be taken if you are more
than 3 months pregnant, as it may cause serious
harm to your baby if used at that stage (see
pregnancy section).
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.

Diuretic agents such as the hydrochlorothiazide
contained in Losartan potassium and
1. What Losartan potassium and Hydrochlorothiazide Hydrochlorothiazide may interact with other
medicines. Preparations containing lithium should
tablets are and what they are used for
not be taken with Losartan potassium and
2. Before you take Losartan potassium and
Hydrochlorothiazide without close supervision by
Hydrochlorothiazide tablets
your doctor. Special precautionary measures (e.g.
3. How to take Losartan potassium and
blood tests) may be appropriate if you take potassium
Hydrochlorothiazide tablets
supplements, potassium-containing salt substitutes
4. Possible side effects
or potassium-sparing medicines, other diuretics
5. How to store Losartan potassium and
(“water tablets”), some laxatives, glycyrrhizin (found
Hydrochlorothiazide tablets
in liquorice), medicines for the treatment of gout,
6. Further information
medicines to control heart rhythm or for diabetes
(oral agents or insulins). It is also important for your
WHAT LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLETS ARE AND doctor to know if you are taking other medicines to
reduce your blood pressure, steroids, medicines to
WHAT THEY ARE USED FOR
treat cancer, pain killers, drugs for treatment of fungal
Losartan and Hydrochlorothiazide is a combination of infections or arthritis medicines, resins used for high
an angiotensin II receptor antagonist (losartan) and a cholesterol, such as colestyramine, medicines which
relax your muscles, sleeping tablets; opioid
diuretic (hydrochlorothiazide).
medicines such as morphine, ‘pressor amines’ such
Losartan and Hydrochlorothiazide is indicated for the as adrenaline or other drugs from the same group;
treatment of essential hypertension (high blood
(oral agents for diabetes or insulins).
pressure).
Please also inform your doctor when it is planned to
BEFORE YOU TAKE LOSARTAN POTASSIUM apply iodine contrast media about taking Losartan
potassium and Hydrochlorothiazide.
AND HYDROCHLOROTHIAZIDE TABLETS

IN THIS LEAFLET:

Pharma code 1710

(Main)

NEW
POSITION
105mm

1

2

Do NOT take Losartan potassium and
Hydrochlorothiazide tablets:
• if you are allergic (hypersensitive) to losartan,
hydrochlorothiazide or to any of the other
ingredients of this medicine
• if you are allergic (hypersensitive) to other
sulfonamide-derived substances (e.g. other
thiazides, some antibacterial drugs such as
co-trimoxazole, ask your doctor if you are not sure)
• if you are, think you may be or are planning to
become pregnant (see also "Pregnancy and
breast-feeding")
• if you have severely impaired liver function
• if you have severely impaired kidney function or
your kidneys are not producing any urine
• if you have low potassium, low sodium or high
calcium levels which cannot be corrected by
treatment
• if you are suffering from gout
• if you are more than 3 months pregnant. (It is also
better to avoid Losartan potassium and
Hydrochlorothiazide in early pregnancy – see
pregnancy section.).

Taking Losartan potassium and Hydrochlorothiazide
tablets with food and drink
You are advised not to drink alcohol whilst taking
these tablets: alcohol and Losartan potassium and
Hydrochlorothiazide tablets may increase each
other’s effects.
Dietary salt in excessive quantities may counteract
the effect of Losartan potassium and
Hydrochlorothiazide tablets.

You should avoid food and drink containing liquorice
as glycyrrhizin, which is found in liquorice, may
cause abnormal blood electrolyte levels.
Losartan potassium and Hydrochlorothiazide tablets
may be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or
might become) pregnant. Your doctor will normally
advise you to stop taking Losartan potassium and
Hydrochlorothiazide tablets before you become
pregnant or as soon as you know you are pregnant
and will advise you to take another medicine instead
of Losartan potassium and Hydrochlorothiazide
tablets. Losartan potassium and Hydrochlorothiazide
Take special care with Losartan potassium and
tablets is not recommended during pregnancy, and
Hydrochlorothiazide tablets:
must not be taken when more than 3 months
• if you have previously suffered from swelling of
pregnant, as it may cause serious harm to your baby
the face, lips, throat or tongue
if used after the third month of pregnancy.
• if you take diuretics (water pills)
Breast-feeding
• if you are on a salt-restricted diet
Tell your doctor if you are breast-feeding or about to
• if you have or have had severe vomiting and/or
start breast-feeding. Losartan potassium and
diarrhoea
Hydrochlorothiazide tablets are not recommended
• if you have heart failure
for mothers who are breast-feeding, and your doctor
• if you have narrow arteries to your kidneys (renal
may choose another treatment for you if you wish to
artery stenosis) or only have one functioning
breast-feed.
kidney, or you have recently had a kidney transplant Use in children and adolescents
• if you have narrowing of the arteries
There is no experience with the use of Losartan
(atherosclerosis), angina pectoris (chest pain due
potassium and Hydrochlorothiazide in children.
to poor heart function)
Therefore, Losartan potassium and
• if you have 'aortic or mitral valve stenosis'
Hydrochlorothiazide should not be given to children.
Use in elderly patients
(narrowing of the valves of the heart) or
Losartan potassium and Hydrochlorothiazide works
'hypertrophic cardiomyopathy' (a disease causing
equally well in and is equally well tolerated by most
thickening of heart muscle)
older and younger adult patients. Most older patients
• if you are diabetic
require the same dose as younger patients.
• if you have had gout
Driving and using machines
• if you have or have had an allergic condition,
When you begin treatment with this medication, you
asthma or a condition that causes joint pain, skin
should not perform tasks which may require special
rashes and fever (systemic lupus erythematosus).
attention (for example, driving an automobile or
• if you have high calcium or low potassium levels
operating dangerous machinery) until you know how
or you are on a low potassium diet
you tolerate your medicine.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

• Ringing, buzzing, roaring or clicking in the ears
Important information about some of the ingredients
of Losartan potassium and Hydrochlorothiazide Tablets • Low blood pressure, which may be associated with
changes in posture (feeling light-headed or weak
Losartan potassium and Hydrochlorothiazide tablets
when you stand up), angina (chest pain), abnormal
contain lactose. If you have been told by your doctor
heartbeat, cerebrovascular accident (TIA,
that you have an intolerance to some sugars, contact
“mini-stroke”), heart attack, palpitations
your doctor before taking this medicinal product.
• Inflammation of blood vessels, which is often
associated with a skin rash or bruising
HOW TO TAKE LOSARTAN POTASSIUM AND
• Sore throat, breathlessness, bronchitis, pneumonia,
HYDROCHLOROTHIAZIDE TABLETS
water on the lungs (which causes difficulty
breathing), nosebleed, runny nose, congestion
Always take Losartan potassium and
• Constipation, wind, stomach upsets, stomach
Hydrochlorothiazide tablets exactly as your doctor
spasms, vomiting, dry mouth, inflammation of a
has told you. Your doctor will decide on the
salivary gland, toothache
appropriate dose of Losartan potassium and
• Jaundice (yellowing of the eyes and skin),
Hydrochlorothiazide depending on your condition
inflammation of the pancreas
and whether you are taking other medicines. It is
important to continue taking Losartan potassium and • Hives, itching, inflammation of the skin, rash,
redness of the skin, sensitivity to light, dry skin,
Hydrochlorothiazide for as long as your doctor
flushing, sweating, hair loss
prescribes it in order to maintain smooth control of
• Pain in the arms, shoulders, hips, knees or other
your blood pressure.
joints, joint swelling, stiffness, muscle weakness
High blood pressure
• Frequent urination including at night, abnormal
The usual dose of Losartan potassium and
kidney function including inflammation of the
Hydrochlorothiazide for most patients with high
kidneys, urinary infection, sugar in the urine
blood pressure is 1 tablet of Losartan potassium and • Decreased sexual appetite, impotence
Hydrochlorothiazide 50 mg/12.5 mg per day to
• Swelling of the face, fever.
control blood pressure over the 24-hour period. This
Rare (more than 1 out of 10,000 patients and less
can be increased to 2 tablets once daily of
than 1 out of 1,000 patients):
Losartan/Hydrochlorothiazide 50 mg/12.5 mg
• Hepatitis (inflammation of the liver), abnormal
Film-coated tablets or changed to 1 tablet daily of
liver function tests.
Losartan/Hydrochlorothiazide 100 mg/25 mg
Not known (cannot be estimated, more than 1 out of
Film-coated tablets (a stronger strength) per day. The 10,000 patients):
maximum daily dose is 2 tablets per day of
• Abnormal muscle breakdown which can lead to
Losartan/Hydrochlorothiazide
kidney problems.
50 mg/12.5 mg Film-coated tablets or 1 tablet daily of If any of the side effects get serious, or if you notice
Losartan/Hydrochlorothiazide 100 mg/25 mg
any side effects not listed in this leaflet, please tell
Film-coated tablets.
your doctor.
If you take more Losartan potassium and
HOW TO STORE LOSARTAN POTASSIUM
Hydrochlorothiazide tablets than you should
AND HYDROCHLOROTHIAZIDE TABLETS
In case of an overdose, contact your doctor
immediately so that medical attention may be given
Keep out of the reach and sight of children.
promptly. Overdosage can cause a drop in blood
pressure, palpitations, slow pulse, changes in blood
Do not use Losartan potassium and
composition, and dehydration.
Hydrochlorothiazide tablets after the expiry date that
is stated on the carton after EXP The expiry date
.
If you forget to take Losartan potassium and
refers to the last day of the month.
Hydrochlorothiazide tablets
Try to take Losartan/Hydrochlorothiazide tablets daily Do not store above 25° C.
as prescribed. However, if you miss a dose, do not
take an extra dose. Just resume your usual schedule. Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
POSSIBLE SIDE EFFECTS
measures will help to protect the environment.

3

5

4

Like all medicines, Losartan potassium and
Hydrochlorothiazide tablets can cause side effects,
although not everybody gets them.

6

FURTHER INFORMATION

What Losartan potassium and Hydrochlorothiazide
If you experience the following, stop taking Losartan tablets contain:
potassium and Hydrochlorothiazide tablets and tell
• The active ingredients are losartan potassium and
your doctor immediately or go to the casualty
hydrochlorothiazide. Each tablet contains either
department of your nearest hospital:
50 mg of losartan potassium and 12.5 mg of
• A severe allergic reaction (rash, itching, swelling of
hydrochlorothiazide or 100 mg of losartan
the face, lips, mouth or throat that may cause
potassium and 25 mg of hydrochlorothiazide
difficulty in swallowing or breathing).
• The other ingredients are:
Tablet core: lactose monohydrate, cellulose
This is a serious but rare side effect, which affects
microcrystalline (E460a), pregelatinised starch
more than 1 out of 10,000 patients but fewer than 1
(maize), magnesium stearate (E572).
out of 1,000 patients. You may need urgent medical
attention or hospitalisation.
Film-coat: poly(vinyl alcohol), titanium dioxide (E171),
macrogol 3350, talc (E553b), yellow iron oxide (E172).
The following side effects have been reported:
Common (affecting fewer than one person in 10 but
What Losartan potassium and Hydrochlorothiazide
more than one person in 100):
tablets look like and contents of the pack:
• Cough, upper airway infection, congestion in the
• Losartan potassium and Hydrochlorothiazide
nose, sinusitis, sinus disorder
50/12.5 mg Film-Coated Tablets are yellow, oval,
• Diarrhoea, abdominal pain, nausea, indigestion
bi-convex tablets, marked with “5” and “0” on one
• Muscle pain or cramps, leg pain, back pain
side and a score line on both sides.
• Insomnia, headache, dizziness
The score line is only to facilitate breaking for ease of
• Weakness, tiredness, chest pain
swallowing and not to divide into equal doses.
• Increased potassium levels (which can cause an
• Losartan potassium and Hydrochlorothiazide
abnormal heart rhythm), decreased haemoglobin
100/25 mg Film-Coated Tablets are yellow, oval,
levels.
bi-convex tablets marked with “100” on one side
Uncommon (affecting fewer than one person in 100
and smooth on the other side.
but more than one person in 1,000):
• The 50/12.5 mg tablets are available in pack sizes
• Anaemia, red or brownish spots on the skin
of 1, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets,
(sometimes especially on the feet, legs, arms and
calendar packs of 28 tablets and hospital packs of
buttocks, with joint pain, swelling of the hands and
50x1 and 280 (10x28) tablets
feet and stomach pain), bruising, reduction in
• The 100/25 mg tablets are available in pack sizes of
white blood cells, clotting problems and bruising
1, 7, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets,
• Loss of appetite, increased uric acid levels or frank
calendar packs of 7 and 28 tablets and hospital
gout, increased blood sugar levels, abnormal
packs of 50x1 and 280 (10x28) tablets.
blood electrolyte levels
Not all pack sizes may be marketed.
• Anxiety, nervousness, panic disorder (recurring
panic attacks), confusion, depression, abnormal
Marketing Authorisation Holder and Manufacturer
dreams, sleep disorders, sleepiness, memory
TEVA UK Limited, Eastbourne, BN22 9AG
impairment
• Pins and needles or similar sensations, pain in the This leaflet was last revised in August 2011
PL 00289/0967-0968
extremities, trembling, migraine, fainting
• Blurred vision, burning or stinging in the eyes,
conjunctivitis, worsening eyesight, seeing things
in yellow
86263-U
160 x 323

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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