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

Active substance(s): HYDROCHLOROTHIAZIDE / LOSARTAN POTASSIUM

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T00075-01 Malta Zejtun 190x380 PIL

Package leaflet: information for the user

Losartan potassium/Hydrochlorothiazide
50/12.5mg and 100/25mg 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 50/12.5mg and 100/25mg Tablets
but within the leaflet it will be referred to as Losartan HCT
tablets.

What is in this leaflet

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

1 What Losartan HCT tablets are and what they are

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

2 What you need to know before you take Losartan

Diuretic agents such as the hydrochlorothiazide contained in
Losartan HCT tablets may interact with other medicines.

used for

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

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, potassiumcontaining 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).
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”).

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 sulfonamide-derived
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 HCT tablets.
• 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).
• are taking any of the following medicines used to treat high blood
pressure:
- a n ACE-inhibitor (for example enalapril, lisinopril, ramipril), in
particular if you have diabetes-related kidney problems
- aliskiren

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AAAI1571

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 (epinephrine) 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.

Breastfeeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. 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 breast-feed.




Use in elderly patients

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



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T00075-01 Malta Zejtun 190x380 PIL




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.

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

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.

Store below 25°C.

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.

If you have any further questions on the use of this product, ask your
doctor or pharmacist.

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.

6 Contents of the pack and other information

4 Possible side effects



What Losartan HCT tablets contain

Like all medicines, this medicine can cause side effects, although not
everybody gets them.



• The active substances are losartan potassium and
hydrochlorothiazide.

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.

Each Losartan HCT 50mg/12.5mg tablet contains 50mg losartan
potassium and 12.5mg hydrochlorothiazide.
Each Losartan HCT 100mg/25mg tablet contains 100mg losartan
potassium and 25mg hydrochlorothiazide.




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, 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.

• The other ingredients are:
• Tablet core: mannitol (E421), microcrystalline cellulose,
croscarmellose sodium, povidone (K-30), magnesium stearate.
• Film-coating: hypromellose (3cP, 50cP), hydroxypropylcellulose,
titanium dioxide (E171), macrogol 400.

What Losartan HCT tablets look like and contents of the
pack

Losartan potassium/Hydrochlorothiazide 50mg/12.5mg tablets are
white, round, biconvex, 8mm film-coated tablets, scored on both
sides, with side scores. “LH1” is marked on one side.
Losartan potassium/Hydrochlorothiazide 100mg/25mg tablets are
white, round, biconvex, 10mm film-coated tablets, scored on both
sides, with side scores. “LH2” is marked on one side.



Pack sizes
28 film-coated tablets

Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis hf.
Reykjavíkurvegur 78,
IS-220 Hafnarfjördur
Iceland
Actavis Ltd
BLB 016,
Bulebel Industrial Estate,
Zejtun, ZTN 3000,
Malta


This leaflet was last revised in September 2015



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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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