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

Active substance(s): HYDROCHLOROTHIAZIDE / LOSARTAN POTASSIUM

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Package leaflet: Information for the patient

Losartan Potassium/
Hydrochlorothiazide
100 mg/12.5 mg
Film-coated Tablets
(losartan potassium/hydrochlorothiazide)

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.
Losartan Potassium/Hydrochlorothiazide 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

• if you are allergic to losartan, hydrochlorothiazide
or to any of the other ingredients of this medicine
(listed in section 6)
• if you are allergic 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 have severely impaired liver function
• if you have a blockage, or reduced flow of bile, such
as cholestasis (which can be due to impaired liver
function or gallstones) causing jaundice, dark urine,
pale stools and itching of the skin
• 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/
Hydrochlorothiazide in early pregnancy – see
Pregnancy section)
• if you have severely impaired kidney function or
your kidneys are not producing any urine.
• 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 section).
It is important to tell your doctor before taking
Losartan Potassium/Hydrochlorothiazide
• 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 or are dehydrated
• if you have heart failure
• if you have cerebrovascular disease (disease of the
blood vessels supplying the brain)
• if your liver function is impaired (see section 2 “Do
not take Losartan Potassium/Hydrochlorothiazide”)
• 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
• 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 erythematosus)
• if you have high calcium or low potassium levels or
you are on a low potassium diet
• if you have high fat levels in your blood (cholesterol
and triglycerides), as the hydrochlorothiazide in
this medicine may cause these to increase
• 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

Losartan Potassium Hydrochlorothiazide

Description 100 mg / 12.5 mg 28
Component Type Leaflet
Affiliate Item Code 1015228
Superceded Affiliate Item Code 852581
TrackWise PR No. 1015228
MA No. N/A
Packing Site/Printer N/A
Supplier Code 50062268

Pharma Code 5011
SAP No. N/A
Vendor Job No. 293211
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

• if you suffer from primary hyperaldosteronism (a
syndrome associated with increased secretion of
the hormone aldosterone by the adrenal gland,
caused by an abnormality within the gland)
• if you are of African or Caribbean descent. You
may experience a weaker blood pressure lowering
effect of this medicine.
• 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 diabetesrelated 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”

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.
You should avoid taking Losartan Potassium/
Hydrochlorothiazide with:
• lithium (used to treat depression),
• potassium supplements, potassium-sparing
diuretics (spironolactone, triamterene, amiloride)
and potassium salts.
It is also important for your doctor to know if you
are taking:
• other medicines to reduce your blood pressure
such as ACE-inhibitors (e.g. ramipril), methyldopa
• other diuretics (“water tablets”)
• medicines for the treatment of gout (e.g.
probenecid, sulfinpyrazone and allopurinol)
• medicines to control heart rhythm (e.g. quinidine,
hydroquinidine, disopyramide, amiodarone, sotalol,
dofetilide, ibutilide)
• steroids or ACTH (also called corticotropin, a
synthetic hormone used to check the function of
your adrenal gland)
• medicines to treat cancer (e.g. amifostine,
cyclophosphamide, methotrexate)
• pain killers such as non-steroidal anti-inflammatory
drugs (e.g. ibuprofen) or high dose salicylates
(e.g. aspirin)
• medicines for treatment of fungal infections (e.g.
fluconazole, amphotericin B by injection)
• arthritis medicines
• resins used for high cholesterol, such as
cholestyramine, colestipol
• medicines which relax your muscles (e.g.
tubocurarine)
• sleeping tablets
• opioid medicines such as morphine
• ‘pressor amines’ such as adrenaline or other
medicines from the same group
• oral agents for diabetes (e.g. metformin) or insulins
• medicines to treat neurological disorders such as
depression, anxiety, and schizophrenia including
tricyclic antidepressants and neuroleptics (such as
chlorpromazine, cyamemazine, levomepromazine,
thioridazine, trifluoperazine, pimozide, amisulpride,
sulpiride, sultopride, tiapride, haloperidol, droperidol)
• medicines which may give you a dry mouth or
blurred vision (e.g. atropine, biperiden)
• medicines for mouth ulcers (e.g. choline salicylate)
• immunosuppressants used for the treatment of
auto-immune disorders or following transplant
surgery to prevent rejection (e.g. ciclosporin)
• some laxatives (e.g. senna, bisacodyl), some
laxatives (e.g. senna, bisacodyl)
• digoxin or other cardiac glycosides (for the
treatment of heart problems)
• bepridil (used to treat angina pectoris)
• cisapride or diphemanil (used to treat
gastrointestinal disorders)
• erythromycin by injection (an antibiotic)
• rifampicin (used to treat tuberculosis)
• halofantrine (used to treat certain types of malaria)
• terfenadine or mizolastine (antihistamines for hay
fever or allergies)
• pentamidine (used to treat pneumonia)
• vincamine by injection (used to treat memory loss
in the elderly)
• calcium including calcium supplements
• carbamazepine (an antiepileptic)
• glycyrrhizin (found in liquorice root and often used
in cough medicines) if taken in large amounts.
Also inform your doctor if you are taking Losartan
Potassium/Hydrochlorothiazide and you will be
undergoing a radiographic procedure and will be
given iodine contrast media.
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”).
Special precautionary measures (e.g. blood tests) may
also be appropriate.

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

Dietary salt in excessive quantities may counteract
the effect of Losartan Potassium/Hydrochlorothiazide
tablets. Large amounts of glycyrrhizin which is
contained in liquorice and some cough medicines
can affect how well Losartan Potassium/
Hydrochlorothiazide works.

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

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

50062268

Date: 13 Oct 2016
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1

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1/2

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Dimensions 170 x 480 mm

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another medicine instead of Losartan Potassium/
Hydrochlorothiazide. Losartan Potassium/
Hydrochlorothiazide is 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.

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, especially if your baby
is a newborn, or born prematurely.

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. You may feel dizzy or
drowsy, especially at the beginning of your treatment
or when the dose is increased.

Losartan Potassium/Hydrochlorothiazide
contains lactose

If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.

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
this medicine for as long as your doctor prescribes
it in order to maintain smooth control of your
blood pressure.
High Blood Pressure
The recommended dose 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 2 tablets once daily of
50 mg/12.5 mg or changed to 1 tablet daily of
100 mg/25 mg per day. The maximum daily dose is
2 tablets per day of 50 mg/12.5 mg or 1 tablet daily of
100 mg/25 mg.

Use in elderly patients

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.

• W
 eakness, tiredness, chest pain
• Increased potassium levels (which can cause
an abnormal heart rhythm), decreased
haemoglobin levels
• Decreased sugar in the blood (hypoglycaemia).
Uncommon (may affect up to 1 in 100 people):
• 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 sensation, numbness or weakness
of the arms and legs, tremor, 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,
dizziness and spinning sensation (vertigo)
• Low blood pressure, which may be associated with
changes in posture (feeling light-headed or weak
when you stand up), palpitations, changes in the
rhythm or rate of the heart beat (arrhythmias)
• Inflammation of blood vessels, which is often
associated with a skin rash or bruising
• Sore throat breathlessness, bronchitis, water on
the lungs (which causes difficulty breathing),
nosebleed, runny nose, congestion
• Constipation, severe constipation (obstipation),
wind, swelling and inflammation of the stomach
lining (gastritis), stomach upsets, stomach spasms,
vomiting, dry mouth, inflammation of a salivary
gland, toothache
• 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
or cramps
• Frequent urination including at night, urinary tract
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):
• Abnormal liver function tests.
Not known (frequency cannot be estimated from the
available data):
• Flu-like symptoms
• Low levels of sodium in the blood (hyponatraemia)
• Generally feeling unwell (malaise)
• Disturbed taste (dysgeusia).

Reporting of side effects

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

If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via 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.

If you take more Losartan Potassium/
Hydrochlorothiazide than you should

5. How to store Losartan Potassium/
Hydrochlorothiazide

Use in children and adolescents

In case of an overdose, contact your doctor
immediately so that medical attention may be
given promptly. Overdose can cause a drop in blood
pressure, fast heart rate, 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 any of the following serious
side effects, stop taking Losartan Potassium/
Hydrochlorothiazide tablets and tell your doctor
immediately or go to the casualty department of
your nearest hospital:
Common (may affect up to 1 in 10 people):
• Abnormal kidney function including inflammation
of the kidneys and kidney failure.
Uncommon (may affect up to 1 in 100 people):
• Angina (chest pain), abnormal heartbeat,
cerebrovascular accident (Transient ischaemic
attack (TIA), “mini-stroke”), heart attack
• Blood problems including:
* reduction in white blood cells leading to an
increase in infections
* anaemia, red or brownish spots on the skin
(especially on the feet, legs, arms and buttocks,
with joint pain, swelling of the hands and feet and
stomach pain), clotting problems and bruising
• Jaundice (yellowing of the eyes and skin),
inflammation of the pancreas, pneumonia, water
on the lungs (which causes difficulty breathing)
• Severe skin reaction associated with painful red
areas, large blisters, peeling of layers of skin. This is
accompanied by fevers and chills, aching muscles
and generally feeling unwell (toxic epidermal
necrolysis).
Rare (may affect up to 1 in 1,000 people):
• A severe allergic reaction (rash, itching, swelling
of the face, tongue, lips, mouth or throat that
may cause difficulty in swallowing or breathing)
(anaphylactic reaction)
• Hepatitis (inflammation of the liver).

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, blister and bottle after EXP.
The expiry date refers to the last day of that month.
Losartan Potassium/Hydrochlorothiazide does not
require any special storage conditions.
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 Potassium/Hydrochlorothiazide
film-coated tablets contain
The active substances are losartan potassium
and hydrochlorothiazide. Each tablet contains
100 mg of losartan potassium and 12.5 mg of
hydrochlorothiazide.

The other ingredients are: cellulose microcrystalline,
lactose monohydrate (see section 2 “Losartan
Potassium/Hydrochlorothiazide contains lactose”),
starch pregelatinized (maize), magnesium stearate,
hydroxypropyl cellulose and titanium dioxide.
Losartan Potassium/Hydrochlorothiazide
100 mg/12.5 mg also contains: Hypromellose 6cP.

What Losartan Potassium/Hydrochlorothiazide
film-coated tablets look like and contents of
the pack

Losartan Potassium/Hydrochlorothiazide
100 mg/12.5 mg is supplied as white to off white,
oval, biconvex film-coated tablets, debossed with ‘M’
on one side of the tablet and ‘LH5’ on the other side.
Losartan Potassium/Hydrochlorothiazide film-coated
tablets are supplied in white, opaque blisters in
pack sizes of 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90,
98, 100, 112, 280 and 500 tablets, calendar pack of
28 tablets and in opaque plastic bottles in pack sizes
of 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan
Potters Bar, Hertfordshire, EN6 1TL
United Kingdom

Manufacturers:

Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland

Not known (frequency cannot be estimated from the
available data):
• Unexplained muscle pain with dark (tea-coloured)
urine (rhabdomyolysis).

Generics [UK] Limited, Station Close, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom

The following other side effects have been reported:

This leaflet was last revised in October 2016.

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
• Difficulty sleeping (insomnia), headache, dizziness

Losartan Potassium Hydrochlorothiazide

Description 100 mg / 12.5 mg 28
Component Type Leaflet
Affiliate Item Code 1015228
Superceded Affiliate Item Code 852581
TrackWise PR No. 1015228
MA No. N/A
Packing Site/Printer N/A
Supplier Code 50062268

Pharma Code 5011
SAP No. N/A
Vendor Job No. 293211
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Mylan Hungary Kft., H-2900, Komárom, Mylan utca 1,
Hungary

1015228
50062268

Date: 13 Oct 2016
No. of colours
Colours

1

Time: 11:20
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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