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

Active substance(s): HYDROCHLOROTHIAZIDE / LOSARTAN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan Potassium/Hydrochlorothiazide 100 mg/12.5 mg 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.

What is in this leaflet:
1.

What Losartan Potassium / Hydrochlorothiazide is and what it is used for

2.

What you need to know before you take Losartan Potassium / Hydrochlorothiazide

3.

How to take Losartan Potassium / Hydrochlorothiazide

4.

Possible side effects

5.

How to store Losartan Potassium / Hydrochlorothiazide

6.

Contents of the pack and other information

1.
WHAT LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE IS
AND WHAT IT IS USED FOR

Losartan Potassium / 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).

2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN
POTASSIUM / HYDROCHLOROTHIAZIDE

Do NOT take Losartan Potassium / Hydrochlorothiazide

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if you are allergic to losartan, hydrochlorothiazide or any of the other ingredients of this
medicine (listed in section 6)

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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)

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if you are more than 3 months pregnant (It is also better to avoid Losartan Potassium /
Hydrochlorothiazide in early pregnancy - see “Pregnancy and breast-feeding”)

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if you have severely impaired liver function

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if you have severely impaired kidney function or your kidneys are not producing any urine

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if you have low potassium, low sodium or high calcium levels which cannot be corrected
by treatment

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if you are suffering from gout.

- if you have diabetes or impaired kidney function and you are treated with a blood pressure
lowering medicine containing aliskiren.

Warnings and precautions
You must tell your doctor if you think you are (or might become) pregnant. Losartan Potassium /
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”).’
Talk to your doctor or pharmacist before taking:Losartan Potassium / Hydrochlorothiazide:
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if you have previously suffered from swelling of the face, lips, throat or tongue

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if you take diuretics (water pills)

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if you are on a salt-restricted diet

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if you have or have had severe vomiting and/or diarrhoea

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if you have heart failure

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if you have narrow arteries to your kidneys (renal artery stenosis) or only have one
functioning kidney, or you have recently had a kidney transplant

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if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to
poor heart function)

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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)

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if you are diabetic

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if you have had gout

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if you have or have had an allergic condition, asthma or a condition that causes joint pain,
skin rashes and fever (systemic lupus erythematodus)

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if you have high calcium or low potassium levels or you are on a low potassium diet

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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

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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)

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if your liver function is impaired (see "Do not take Losartan Potassium /
Hydrochlorothiazide").

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if you 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 potassium / Hydrochlorothiazide’.

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

Other medicines and Losartan Potassium / Hydrochlorothiazide

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 Potassium /
Hydrochlorothiazide may interact with other medicines.

Preparations containing lithium should not be taken with Losartan Potassium /
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
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other medicines to reduce your blood pressure,

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steroids,

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medicines to treat cancer,

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pain killers,

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drugs for treatment of fungal infections,

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arthritis medicines,

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resins used for high cholesterol, such as colestyramine,

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medicines which relax your muscles,

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sleeping tablets,

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opioid medicines such as morphine,

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'pressor amines' such as adrenaline or other drugs from the same group.

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 potassium / Hydrochlorothiazide’ and ‘Warnings and precautions’).

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

Losartan Potassium / Hydrochlorothiazide with food and drink

You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan Potassium /
Hydrochlorothiazide may increase each other’s effects.

Dietary salt in excessive quantities may counteract the effect of Losartan Potassium /
Hydrochlorothiazide.

Losartan Potassium / Hydrochlorothiazide 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.
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 / 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 / Hydrochlorothiazide. Losartan Potassium / 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 /
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.
Older people
Losartan Potassium / Hydrochlorothiazide 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 an automobile or operating dangerous machinery) until
you know how you tolerate your medicine.

Losartan Potassium / Hydrochlorothiazide contains lactose

Losartan Potassium / Hydrochlorothiazide contains lactose monohydrate. If you have been told
by your doctor that you have an intolerance to some sugars, contact your doctor before taking
this medicinal product.

3.
HOW TO TAKE LOSARTAN POTASSIUM /
HYDROCHLOROTHIAZIDE

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

High blood pressure

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

For doses not realisable/practicable with this strength, other strengths are available.

For oral administration

If you take more Losartan Potassium / Hydrochlorothiazide 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 / Hydrochlorothiazide

Try to take Losartan Potassium / Hydrochlorothiazide 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 medicine, 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 Potassium / Hydrochlorothiazide and
tell your doctor immediately or go to the casualty department of your nearest hospital:
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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):
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Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder,

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Diarrhoea, abdominal pain, nausea, indigestion,

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Muscle pain or cramps, leg pain, back pain,

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Insomnia, headache, dizziness,

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Weakness, tiredness, chest pain,

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Increased potassium levels (which can cause an abnormal heart rhythm), decreased
haemoglobin levels.

Uncommon (may affect up to 1 in 100 people):
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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 and bruising,

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Loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels,
abnormal blood electrolyte levels,

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Anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression,
abnormal dreams, sleep disorders, sleepiness, memory impairment,

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Pins and needles or similar sensations, pain in the extremities, trembling, migraine,
fainting,

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Blurred vision, burning or stinging in the eyes, conjunctivitis, worsening eyesight, seeing
things in yellow,

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Ringing, buzzing, roaring or clicking in the ears,

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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,
cerebrovascular accident (TIA, “mini-stroke”), heart attack, palpitations,

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Inflammation of blood vessels, which is often associated with a skin rash or bruising,

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Sore throat, breathlessness, bronchitis, pneumonia, water on the lungs (which causes
difficulty breathing), nosebleed, runny nose, congestion,

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Constipation, wind, stomach upsets, stomach spasms, vomiting, dry mouth, inflammation
of a salivary gland, toothache,

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Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,

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Hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry
skin, flushing, sweating, hair loss,

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Pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle
weakness,

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Frequent urination including at night, abnormal kidney function including inflammation of
the kidneys, urinary infection, sugar in the urine,

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Decreased sexual appetite, impotence,

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Swelling of the face, fever.

Rare (may affect up to 1 in 1,000 people)
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Hepatitis (inflammation of the liver), abnormal liver function tests.

Not known (frequency cannot be estimated from the available data)
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Muscle wasting (rhabdomyolysis)
Disturbed taste (dysgeusia)

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 POTASSIUM /
HYDROCHLOROTHIAZIDE

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 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.

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 to protect the
environment.

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Losartan Potassium / Hydrochlorothiazide contains

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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) parthydrolyzed, titanium dioxide (E171), macrogol 3350 and talc in the film-coating.

What Losartan Potassium / Hydrochlorothiazide looks like and contents of the pack

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Film-coated tablet
White, biconvex, oval-shaped film-coated tablet debossed "LH" on one side and plain on
the other
Available in blisters 14, 15, 28, 30, 50, 56, 60, 84, 90, 98, 100, 280 film-coated tablets. Not
all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG

OR*

Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG

Manufacturer
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary

OR*

Teva Czech Industries s.r.o., Ostravská 29, c.p. 305, 747 70 Opava, Komárov, Czech Republic

This leaflet was last revised in September 2014

PL 00289/1526

* Only the site used for batch release will be listed on the printed mock-up

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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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