LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 100MG/12.5 MG FILM-COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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PAGE 1: FRONT FACE (INSIDE OF REEL)

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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.










IN THIS LEAFLET:
1. What Losartan Potassium and
Hydrochlorothiazide 100 mg/12.5 mg Film-coated
tablets are and what they are used for
2. Before you take Losartan Potassium and
Hydrochlorothiazide 100 mg/12.5 mg Film-coated
tablets
3. How to take Losartan Potassium and
Hydrochlorothiazide 100 mg/12.5 mg Film-coated
tablets
4. Possible side effects
5. How to store Losartan Potassium and
Hydrochlorothiazide 100 mg/12.5 mg Film-coated
tablets
6. Further information

1

WHAT LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE 100 mg/12.5 mg
FILM-COATED TABLETS ARE AND WHAT
THEY ARE USED FOR

Losartan Potassium and Hydrochlorothiazide is a
combination of an angiotensin II receptor antagonist
(losartan) and a diuretic (hydrochlorothiazide).
Angiotensin II is a substance produced in the body
which binds to receptors in blood vessels, causing
them to tighten. This results in an increase in blood
pressure. Losartan prevents the binding of
angiotensin II to these receptors, causing the blood
vessels to relax which in turn lowers the blood
pressure. Hydrochlorothiazide works by making the
kidneys pass more water and salt. This also helps to
reduce blood pressure.
It is indicated for the treatment of essential
hypertension (high blood pressure).





kidney, or you have recently had a kidney
transplant
if you have narrowing of the arteries
(atherosclerosis), angina pectoris (chest pain due
to poor heart function)
if you have ‘aortic or mitral valve stenosis’
(narrowing of the valves of the heart) or
‘hypertrophic cardiomyopathy’ (a disease causing
thickening of heart muscle)
if you are diabetic
if you have had gout
if you have or have had an allergic condition,
asthma or a condition that causes joint pain, skin
rashes and fever (systemic lupus erythematodus)
if you have high calcium or low potassium levels
or you are on a low potassium diet
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)
if your liver function is impaired (see "Do not take
Losartan Potassium and Hydrochlorothiazide
100 mg/12.5 mg Film-coated tablets").

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
Hydrochlorothiazide may interact with other medicines.
Preparations containing lithium should not be taken
with Losartan Potassium and Hydrochlorothiazide
without close supervision by your doctor.
Special precautionary measures (e.g. blood tests)
may be appropriate if you take potassium
supplements, potassium-containing salt substitutes
or potassium-sparing medicines, other diuretics
(“water tablets”), some laxatives, glycyrrhizin (found
in liquorice), medicines for the treatment of gout,
medicines to control heart rhythm or for diabetes
(oral agents or insulins).

It is also important for your doctor to know if you are
taking
• other medicines to reduce your blood pressure
• steroids
• medicines to treat cancer
• pain killers
• drugs for treatment of fungal infections
• arthritis medicines
BEFORE YOU TAKE LOSARTAN
POTASSIUM AND HYDROCHLOROTHIAZIDE • resins used for high cholesterol, such as
colestyramine
100 mg/12.5 mg FILM-COATED TABLETS
• medicines which relax your muscles
• sleeping tablets
Do NOT take Losartan Potassium and
• opioid medicines such as morphine
Hydrochlorothiazide 100 mg/12.5 mg Film-coated
• 'pressor amines' such as adrenaline or other drugs
tablets
from the same group.
• if you are allergic (hypersensitive) to losartan,
Please also inform your doctor you are taking
hydrochlorothiazide or to any of the other
Losartan Potassium and Hydrochlorothiazide if you
ingredients in this medicine
will be undergoing a radiographic procedure and will
• if you are allergic (hypersensitive) to other
be given iodine contrast media.
sulfonamide-derived substances (e.g. other
thiazides, some antibacterial drugs such as coTaking Losartan Potassium and Hydrochlorothiazide
trimoxazole, ask your doctor if you are not sure)
100 mg/12.5 mg Film-coated tablets with food and
• if you are more than 3 months pregnant (It is also drink
better to avoid Losartan Potassium and
You are advised not to drink alcohol whilst taking
Hydrochlorothiazide in early pregnancy - see
these tablets: alcohol and Losartan Potassium and
“Pregnancy and breast-feeding”)
Hydrochlorothiazide may increase each other’s
• if you have severely impaired liver function
effects.
• if you have severely impaired kidney function or
Dietary salt in excessive quantities may counteract
your kidneys are not producing any urine
the effect of Losartan Potassium and
• if you have low potassium, low sodium or high
Hydrochlorothiazide.
calcium levels which cannot be corrected by
treatment
Losartan Potassium and Hydrochlorothiazide may be
• if you are suffering from gout.
taken with or without food.

2

Take special care with Losartan Potassium and
Hydrochlorothiazide 100 mg/12.5 mg Film-coated
tablets
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 and breast-feeding”).’
It is important to tell your doctor before taking
Losartan Potassium and Hydrochlorothiazide
100 mg/12.5 mg Film-coated tablets:
• if you have previously suffered from swelling of
the face, lips, throat or tongue
• if you take diuretics (water pills)
• if you are on a salt restricted diet
• if you have or have had severe vomiting and/or
diarrhoea
• if you have heart failure
• if you have narrow arteries to your kidneys (renal
artery stenosis) or only have one functioning

Pregnancy and breast-feeding
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 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.
Losartan Potassium and Hydrochlorothiazide is not
recommended in early pregnancy, and must not be
taken when more than 3 months pregnant, as it may
cause serious harm to your baby if used after the
third month of pregnancy.
Tell your doctor if you are breast-feeding or about to
start breast-feeding. Losartan Potassium and
Hydrochlorothiazide is not recommended for
mothers who are breast-feeding, and your doctor
may choose another treatment for you if you wish to
breast-feed.
Ask your doctor or pharmacist for advice before
taking any medicine.

Top of page cut-off to middle of registration mark: 44 mm.

LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE
100 mg/12.5 mg FILM-COATED
TABLETS

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Use in children and adolescents
There is no experience with the use of Losartan
Potassium and Hydrochlorothiazide in children.
Therefore, it should not be given to children.

abnormal heart rhythm), decreased haemoglobin
levels.

Uncommon (affecting 1 to 10 users in 1,000):
• Anaemia, red or brownish spots on the skin
(sometimes especially on the feet, legs, arms and
Use in elderly patients
buttocks, with joint pain, swelling of the hands and
Losartan Potassium and Hydrochlorothiazide works
feet and stomach pain), bruising, reduction in
equally well in and is equally well tolerated by most
white blood cells, clotting problems and bruising
older and younger adult patients. Most older patients
• Loss of appetite, increased uric acid levels or frank
require the same dose as younger patients.
gout, increased blood sugar levels, abnormal
Driving and using machines
blood electrolyte levels
When you begin treatment with this medication, you • Anxiety, nervousness, panic disorder (recurring
should not perform tasks which may require special
panic attacks), confusion, depression, abnormal
attention (for example, driving an automobile or
dreams, sleep disorders, sleepiness, memory
operating dangerous machinery) until you know how
impairment
you tolerate your medicine.
• Pins and needles or similar sensations, pain in the
extremities, trembling, migraine, fainting
Important information about some of the ingredients
• Blurred vision, burning or stinging in the eyes,
of Losartan Potassium and Hydrochlorothiazide
conjunctivitis, worsening eyesight, seeing things
100 mg/12.5 mg Film-coated tablets
in yellow
Losartan Potassium and Hydrochlorothiazide
contains lactose monohydrate. If you have been told • Ringing, buzzing, roaring or clicking in the ears
by your doctor that you have an intolerance to some • Low blood pressure, which may be associated
with changes in posture (feeling light headed or
sugars, contact your doctor before taking this
weak when you stand up), angina (chest pain),
medicinal product.
abnormal heartbeat, cerebrovascular accident
HOW TO TAKE LOSARTAN POTASSIUM
(TIA, “mini-stroke”), heart attack, palpitations
AND HYDROCHLOROTHIAZIDE
• Inflammation of blood vessels, which is often
100 mg/12.5 mg FILM-COATED TABLETS
associated with a skin rash or bruising
• Sore throat, breathlessness, bronchitis,
Always take Losartan Potassium and
pneumonia, water on the lungs (which causes
Hydrochlorothiazide exactly as your doctor has told
difficulty breathing), nosebleed, runny nose,
you. Your doctor will decide on the appropriate dose
congestion
of Losartan Potassium and Hydrochlorothiazide
• Constipation, wind, stomach upsets, stomach
depending on your condition and whether you are
spasms, vomiting, dry mouth, inflammation of a
taking other medicines. It is important to continue
salivary gland, toothache
taking Losartan Potassium and Hydrochlorothiazide
• Jaundice (yellowing of the eyes and skin),
for as long as your doctor prescribes it in order to
inflammation of the pancreas
maintain smooth control of your blood pressure.
• Hives, itching, inflammation of the skin, rash,
redness of the skin, sensitivity to light, dry skin,
High blood pressure
flushing, sweating, hair loss
The usual dose of Losartan Potassium and
• Pain in the arms, shoulders, hips, knees or other
Hydrochlorothiazide for most patients with high
joints, joint swelling, stiffness, muscle weakness
blood pressure is 1 tablet of Losartan Potassium and
• Frequent urination including at night, abnormal
Hydrochlorothiazide 50 mg/12.5 mg per day to
kidney function including inflammation of the
control blood pressure over the 24 hour period. This
kidneys, urinary infection, sugar in the urine
can be increased to 1 tablet once daily of Losartan
• Decreased sexual appetite, impotence
Potassium and Hydrochlorothiazide 100 mg/12.5 mg
• Swelling of the face, fever.
or 2 tablets once daily of Losartan Potassium and
hydrochlorothiazide 50 mg/12.5 mg or changed to
Rare (affecting 1 to 10 users in 10,000)
1 tablet daily of Losartan Potassium and
• Hepatitis (inflammation of the liver), abnormal
Hydrochlorothiazide 100 mg/25 mg (a stronger
liver function tests.
strength) per day. The maximum daily dose is
Not known (cannot be estimated from available data)
2 tablets per day of Losartan Potassium and
• Muscle wasting (rhabdomyolysis).
Hydrochlorothiazide 50 mg/12.5 mg or 1 tablet daily
of Losartan Potassium and Hydrochlorothiazide
If any of the side effects get serious, or if you notice
100 mg/25 mg film-coated tablets.
any side effects not listed in this leaflet, please tell
For doses not realisable/practicable with this strength, your doctor.
other strengths are available.
HOW TO STORE LOSARTAN POTASSIUM
For oral administration.
AND HYDROCHLOROTHIAZIDE

3

5

If you take more Losartan Potassium and
Hydrochlorothiazide 100 mg/12.5 mg Film-coated
tablets than you should
In case of an overdose, contact your doctor
immediately so that medical attention may be given
promptly. Overdosage can cause a drop in blood
pressure, palpitations, slow pulse, changes in blood
composition, and dehydration.
If you forget to take Losartan Potassium and
Hydrochlorothiazide 100 mg/12.5 mg Film-coated
tablets
Try to take Losartan Potassium and
Hydrochlorothiazide daily as prescribed. However, if
you miss a dose, do not take an extra dose. Just
resume your usual schedule.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Losartan Potassium and
Hydrochlorothiazide can cause side effects, although
not everybody gets them.
If you experience the following, stop taking Losartan
Potassium and Hydrochlorothiazide 100 mg/12.5 mg
Film-coated tablets and tell your doctor immediately
or go to the casualty department of your nearest
hospital:
• A severe allergic reaction (rash, itching, swelling
of the face, lips, mouth or throat that may cause
difficulty in swallowing or breathing).
This is a serious but rare side effect, which affects
more than 1 out of 10,000 patients but fewer than 1
out of 1,000 patients. You may need urgent medical
attention or hospitalisation.
The following side effects have been reported:
Common (affecting 1 to 10 users in 100):
• Cough, upper airway infection, congestion in the
nose, sinusitis, sinus disorder
• Diarrhoea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain
• Insomnia, headache, dizziness
• Weakness, tiredness, chest pain
• Increased potassium levels (which can cause an

100 mg/12.5 mg FILM-COATED TABLETS

Keep out of the reach and sight of children.
Do not use Losartan Potassium and
Hydrochlorothiazide after the expiry date which is
stated on the carton and blister after EXP The expiry
.
date refers to the last day of that month.
Do not store above 25°C. Store in the original
package in order to protect from moisture.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6

FURTHER INFORMATION

What Losartan Potassium and Hydrochlorothiazide
100 mg/12.5 mg Film-coated tablets contains
• The active substances are losartan potassium and
hydrochlorothiazide. Each film coated tablet
contains 100 mg of losartan potassium and
12.5 mg of hydrochlorothiazide.
• The other ingredients are lactose monohydrate,
starch pregelatinised, cellulose microcrystalline
and magnesium stearate in the tablet core and
poly(vinyl alcohol) part-hydrolyzed, titanium
dioxide (E171), macrogol 3350 and talc in the filmcoating.
What Losartan Potassium and Hydrochlorothiazide
100 mg/12.5 mg Film-coated tablets looks like and
contents of the pack
• Film-coated tablet
• White, biconvex, oval-shaped film-coated tablet
debossed "LH" on one side and plain on the other
• Available in blisters 14, 28, 30, 56, 60, 90, 98 & 100
Film-coated tablets. 50x1 unit dose (hospital pack)
Film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Brampton Road, Hampden Park,
Eastbourne, East Sussex, BN22 9AG.
This leaflet was last revised in December 2011.
PL 00289/1354

18761-B
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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