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

Active substance(s): HYDROCHLOROTHIAZIDE / LOSARTAN POTASSIUM

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Package leaflet: information for the user

Losartan potassium/Hydrochlorothiazide
100/12.5mg Film-coated Tablets
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. See section 4.
• The full name of this medicine is Losartan potassium/
Hydrochlorothiazide 100mg/12.5mg Film-coated
Tablets but within the leaflet it will be referred to as
Losartan HCT tablets.

What is in this leaflet
1 What Losartan HCT tablets are and what
they are used for
2 What you need to know before you take
Losartan HCT tablets
3 How to take Losartan HCT tablets
4 Possible side effects
5 How to store Losartan HCT tablets
6 Contents of the pack and other information
1 What Losartan HCT tablets are and what

they are used for

Losartan HCT tablets are a combination of an angiotensin
II receptor antagonist (losartan) and a diuretic
(hydrochlorothiazide).
Losartan HCT tablets are indicated for the treatment of
essential hypertension (high blood pressure).

2 What you need to know before you take

Losartan HCT tablets

Do not take Losartan HCT tablets if you

• are allergic to losartan, hydrochlorothiazide or to any of
the other ingredients of this medicine (listed in section 6).
• are allergic (hypersensitive) to other sulfonamidederived substances (e. g. other thiazides, some
antibacterial drugs such as co-trimoxazole, ask your
doctor if you are not sure)
• have severely impaired liver function
• are more than 3 months pregnant (it is also better
to avoid Losartan HCT tablets in early pregnancy - see
pregnancy section)
• have severely impaired kidney function or your kidneys
are not producing any urine
• have low potassium, low sodium or high calcium
levels which cannot be corrected by treatment
• are suffering from gout.
• have diabetes or impaired kidney function and you
are treated with a blood pressure lowering medicine
containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Losartan
HCT tablets if you
• have previously suffered from swelling of the face, lips,
throat or tongue
• take diuretics (water pills)
• are on a salt-restricted diet
• have or have had severe vomiting and/or diarrhoea
• have heart failure
• have narrow arteries to your kidneys (renal artery
stenosis) or only have one functioning kidney, or you
have recently had a kidney transplant
• have narrowing of the arteries (atherosclerosis), angina
pectoris (chest pain due to poor heart function)
• have ‘aortic or mitral valve stenosis’ (narrowing of the
valves of the heart) or ‘hypertrophic cardiomyopathy’
(a disease causing thickening of heart muscle)
• have a history of mild to moderate liver impairment
• are diabetic
• have had gout
• have or have had an allergic condition, asthma or a
condition that causes joint pain, skin rashes and fever
(systemic lupus erythematosus)
• have high calcium or low potassium levels or you are on
a low potassium diet
• 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
• suffer from primary hyperaldosteronism (a syndrome
associated with increased secretion of the hormone
Continued top of next column
AAAI1572

aldesterone by the adrenal gland, caused by an
abnormality within the gland).
• are taking any of the following medicines used to treat
high blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril,
ramipril), in particular if you have diabetes-related
kidney problems
- aliskiren
Your doctor may check your kidney function, blood
pressure and the amount of electrolytes (e.g. potassium) in
your blood at regular intervals.
See also information under the heading “Do not take
Losartan HCT tablets if you”
You must tell your doctor if you think you are (or
might become) pregnant. Losartan HCT tablets are 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).

Children and adolescents

There is no experience with the use of Losartan HCT tablets
in children. Therefore, Losartan HCT tablets should not be
given to children.

Other medicines and Losartan HCT tablets

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Diuretic agents such as the hydrochlorothiazide contained
in Losartan HCT tablets may interact with other medicines.
Preparations containing lithium should not be taken with
Losartan HCT tablets 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 potassiumsparing 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).
Your doctor may need to change your dose and/or to take
other precautions:
- If you are taking an ACE-inhibitor or aliskiren (see also
information under the headings “Do not take Losartan
HCT tablets if you” and “Warnings and precautions”).
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 infections, including fungal
infections
• arthritis medicines
• resins used for high cholesterol, such as colestyramine
• medicines which relax your muscles

• sleeping tablets
• opioid medicines such as morphine
• “pressor amines” such as adrenaline or other drugs from

the same group.

• oral agents for diabetes or insulins
• anticholinergic agents (e.g. atropine, biperiden).
• antipsychotics
• antidepressants
• carbamazepine

Please also inform your doctor you are taking Losartan HCT
tablets if you will be undergoing a radiographic procedure
and will be given iodine contrast media.

Losartan HCT tablets with food and drink and
alcohol

You are advised not to drink alcohol whilst taking these
tablets: alcohol and Losartan HCT tablets may increase
each other’s effects.
Dietary salt in excessive quantities may counteract the
effect of Losartan HCT tablets.
Losartan HCT tablets may be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

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 HCT 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
HCT tablets. Losartan HCT tablets are not recommended
during 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.
Continued over page

Breastfeeding

Tell your doctor if you are breast-feeding or about to start
breast-feeding. Losartan HCT tablets are not recommended
for mothers who are breast-feeding, and your doctor may
choose another treatment for you if you wish to breastfeed.

Use in elderly patients

Losartan HCT tablets works equally well in and is equally
well tolerated by most older and younger adult patients.
Most older patients require the same dose as younger
patients.

Driving and using machines

When you begin treatment with this medication, you
should not perform tasks which may require special
attention (for example, driving a car or operating
dangerous machinery) until you know how you tolerate
your medicine.

3 How to take Losartan HCT tablets

Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure. Your doctor will decide on the appropriate dose of
Losartan HCT tablets depending on your condition and
whether you are taking other medicines. It is important to
continue taking Losartan HCT tablets for as long as your
doctor prescribes it in order to maintain smooth control of
your blood pressure.

High Blood Pressure

The recommended usual dose of Losartan HCT tablets
for most patients with high blood pressure is 1 tablet of
Losartan HCT 50mg/12.5mg per day to control blood
pressure over the 24-hour period. This can be increased
to 2 tablets once daily of losartan/hydrochlorothiazide
50mg/12.5mg film-coated tablets or changed to 1 tablet
daily of losartan/hydrochlorothiazide 100mg/25mg
film-coated tablets (a stronger strength) per day. The
maximum daily dose is 2 tablets per day of losartan/
hydrochlorothiazide 50mg/12.5mg film-coated tablets or 1
tablet daily of losartan/hydrochlorothiazide 100mg/25mg
film-coated tablets.
Losartan HCT 100mg/12.5mg is available for patients who
need additional blood pressure control after being titrated
to 100mg of losartan.

If you take more Losartan HCT tablets than you
should

In case of an overdose, contact your doctor immediately
so that medical attention may be given promptly. An
overdose can cause a drop in blood pressure, palpitations,
slow pulse, changes in blood composition, and
dehydration.

If you forget to take Losartan HCT tablets

Try to take Losartan HCT tablets daily as prescribed. Do not
take a double dose to make up for a forgotten 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, this medicine can cause side effects,
although not everybody gets them.
If you experience the following, stop taking Losartan
HCT 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 (may affect up to 1 in 10 people)
• 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 abnormal
heart rhythm), decreased haemoglobin levels,
• Changes in kidney function including kidney failure,
• Low blood sugar (hypoglycaemia).
Uncommon (may affect up to 1 in 100 people)
• Anaemia, red or brownish spots on the skin (sometimes
especially on the feet, legs, arms and buttocks, with
joint pain, swelling of the hands and feet and stomach
pain), bruising, reduction in white blood cells, clotting
problems, reduced number of platelets,
• Loss of appetite, increased uric acid levels or frank gout,
increased blood sugar levels, abnormal blood electrolyte
levels
• Anxiety, nervousness, panic disorder (recurring panic
attacks), confusion, depression, abnormal dreams, sleep
disorders, sleepiness, memory impairment
• Pins and needles or similar sensations, pain in the
extremities, trembling, migraine, fainting
• Blurred vision, burning or stinging in the eyes,
conjunctivitis, worsening eyesight, seeing things in
yellow
• Ringing, buzzing, roaring or clicking in the ears, vertigo
• Low blood pressure, which may be associated with
changes in posture (feeling light-headed or weak when
you stand up), angina (chest pain), abnormal heartbeat,
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cerebrovascular accident (TIA, “mini-stroke”), heart attack,
palpitations
• Inflammation of blood vessels, which is often associated
with a skin rash or bruising
• Sore throat, breathlessness, bronchitis, pneumonia,
water on the lungs (which causes difficulty breathing),
nosebleed, runny nose, congestion
• Constipation, wind, stomach upsets, stomach spasms,
vomiting, dry mouth, inflammation of a salivary gland,
toothache
• Jaundice (yellowing of the eyes and skin), inflammation
of the pancreas
• Hives, itching, inflammation of the skin, rash, redness of
the skin, sensitivity to light, dry skin, flushing, sweating,
hair loss
• Pain in the arms, shoulders, hips, knees or other joints,
joint swelling, stiffness, muscle weakness
• Frequent urination including at night, abnormal kidney
function including inflammation of the kidneys, urinary
infection, sugar in the urine
• Decreased sexual appetite, impotence
• Swelling of the face, localised swelling (oedema), fever.
Rare (may affect up to 1 in 1,000 people)
• Hepatitis (inflammation of the liver), abnormal liver
function tests
Not known (frequency cannot be estimated from the
available data)
• Flu-like symptoms and feeling of general discomfort and
illness
• Generally feeling unwell (malaise)
• Low levels of sodium in the blood (hyponatraemia)
• Abnormal muscle breakdown (rhabdomyolysis) with
symptoms such as muscle pain, weakness and swelling
which can lead to kidney problems (urine can become
dark)
• Disturbed taste (dysgeusia)
• Dose-related orthostatic effects such as lowering of blood
pressure appearing when rising from a lying or sitting
position,
• Cutaneous lupus erythematosus, which is identified by a
rash that may appear on the face, neck, and scalp.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Losartan HCT tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the label and carton after EXP. The expiry date
refers to the last day of that month.
Store below 30°C and store in the original packaging in
order to protect from moisture.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6 Contents of the pack and other information
What Losartan HCT tablets contain
• The active substances are losartan potassium and

hydrochlorothiazide.
Each Losartan HCT 100mg/12.5mg tablet contains 100mg
losartan potassium and 12.5mg hydrochlorothiazide.
• The other ingredients are:
• Tablet core: mannitol (E421), microcrystalline cellulose,
croscarmellose sodium, povidone (K-30), magnesium
stearate.
• Film-coating: Hypromellose (6cP), macrogol 8000, yellow
iron oxide (E172), talc, titanium dioxide (E171).

What Losartan HCT tablets looks like and
contents of the pack

Losartan HCT 100mg/12.5mg tablets are yellow, round,
biconvex, 10mm film-coated tablets. “LH3” is marked on
one side. The tablets are not scored.
Pack sizes
28 film-coated tablets
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjördur
Iceland
Manufacturer
Actavis hf.
Reykjavikurvegur 78
220 Hafnarfjördur
Iceland
Actavis Ltd.
BLB 016, Bulebel Industrial Estate,
Zejtun, ZTN 3000,
Malta
This leaflet was last revised in September 2015

Actavis, Barnstaple, EX32 8NS, UK

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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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