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

Active substance: LOSARTAN POTASSIUM

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Losartan potassium/Hydrochlorothiazide
50/12.5mg and 100/25mg Tablets
pregnant, as it may cause serious harm to your baby if used at that
stage (see pregnancy section).

Read all of this leaflet carefully before you start taking this
medicine.
• 
Keep this leaflet. You may need to read it again.
•  you have any further questions, ask your doctor or
If
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.
•  any of the side effects gets serious, or if you notice any
If
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
• 
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.



Taking other medicines



P
 lease tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.



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



P
 reparations containing lithium should not be taken with Losartan
HCT tablets without close supervision by your doctor.



S
 pecial 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).














I
 t 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,
• 
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.



P
 lease 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.

In this leaflet:
1 What Losartan HCT tablets are and what they are

used for

2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
1 What Losartan HCT tablets are and what they are

used for




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

2 Before you take











Do not take Losartan HCT tablets if you

•  allergic (hypersensitive) to losartan, hydrochlorothiazide or to
are
any of the other ingredients of Losartan HCT tablets (see section 6
“What Losartan HCT tablets contain”)
•  allergic (hypersensitive) to other sulfonamide-derived
are
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
•  more than 3 months pregnant (it is also better to avoid
are
Losartan HCT tablets in early pregnancy – see pregnancy section)
•  ave severely impaired kidney function or your kidneys are not
h
producing any urine
• 
have low potassium, low sodium or high calcium levels which
cannot be corrected by treatment
•  suffering from gout.
are


Taking Losartan HCT tablets with food and drink




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



Pregnancy and breast-feeding



A
 sk your doctor or pharmacist for advice before taking any
medicines.



Pregnancy



Y
 ou 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



T
 ell 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.




Take special care with Losartan HCT tablets if you





















• 
have previously suffered from swelling of the face, lips, throat or
tongue
• 
take diuretics (water pills)
•  on a salt-restricted diet
are
• 
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)
•  diabetic
are
• 
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).








Use in children and adolescents
T
 here is no experience with the use of Losartan HCT tablets in
children. Therefore, Losartan HCT tablets should not be given to
children.

Use in elderly patients



L
 osartan 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.



Driving and using machines



W
 hen 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.

Y
 ou 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
Continued over page

Continued top of next column
AAAE9155

Losartan Potassium HCT 50mg/12.5mg, 100mg/25mg PIL - UK
item no: AAAE9155

dimensions: 190 x 380

print proof no: 2

pharmacode:

origination date: 07.02.13

min pt size: 8pt

1. black
2.
3.
4.
5.
6.

originated by: SA
approved for print/date

colours/plates:

revision date: 15.02.13

Technical Approval

revised by: sa

date sent: N/A

supplier: Actavis Malta

technically app. date:

Non Printing Colours
1.
2.
3.

3 How to take





A
 lways take Losartan HCT tablets exactly as your doctor has
instructed you. 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.



H
 igh Blood Pressure




T
 he usual dose of Losartan HCT tablets for most patients with
high blood pressure is 1 Losartan HCT 50/12.5mg tablet once
daily to control blood pressure over the 24-hour period. This can
be increased to 2 Losartan HCT 50/12.5mg tablets once daily or
1 Losartan HCT 100/25mg tablet (a stronger strength) once daily.
The maximum daily dose is 2 Losartan HCT 50/12.5mg tablets or 1
Losartan HCT 100/25mg tablet.

 you take more Losartan HCT tablets than you should
If
n case of an overdose, contact your doctor immediately so that
I
medical attention may be given promptly. An overdose can cause
a drop in blood pressure, palpitations, slow pulse, changes in blood
composition and dehydration.
 you forget to take Losartan HCT tablets
If
 ry to take Losartan HCT tablets daily as prescribed. However, if you
T
miss a dose, do not take an extra dose.
Just resume your usual schedule.











Not known (the frequency cannot be estimated from the
available data)
•  bnormal muscle breakdown (rhabdomyolysis) with symptoms
A
such as muscle pain, weakness and swelling which can lead to
kidney problems (urine can become dark)
I
f any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor.

5 How to store


Keep out of the reach and sight of children.



D
 o not use Losartan HCT tablets 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 25°C.
M
 edicines 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

L
 ike all medicines, Losartan HCT tablets can cause side effects,
although not everybody gets them.
I
f you experience the following, stop taking Losartan HCT tablets
and tell your doctor immediately or go to the casualty department
of your nearest hospital:
•  severe allergic reaction (rash, itching, swelling of the face,
A
lips, mouth or throat that may cause difficulty in swallowing or
breathing).
 his is a serious but rare side effect, which affects more than 1 out
T
of 10,000 patients but fewer than 1 out of 1,000 patients. You may
need urgent medical attention or hospitalisation.
T
 he following side effects have been reported:


Common (affecting less than one person in 10 but more than one
person 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 abnormal heart
rhythm), decreased haemoglobin levels.

Uncommon (affecting less than one person in 100 but more than
one person in 1,000):
• 
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,
• 
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,
• 
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, fever.



What Losartan HCT tablets contain



• 
The active substances are losartan potassium and
hydrochlorothiazide.



If you stop taking Losartan HCT tablets
I
f you have any further questions on the use of this product, ask your
doctor or pharmacist.

4 Possible side effects






Rare (more than 1 out of 10000 patients and less than 1 out of 1000
patients):
• 
Hepatitis (inflammation of the liver), abnormal liver function tests

 ach Losartan HCT 50mg/12.5mg tablet contains 50mg losartan
E
potassium and 12.5mg hydrochlorothiazide.



 ach Losartan HCT 100mg/25mg tablet contains 100mg losartan
E
potassium and 25mg hydrochlorothiazide.




• 
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


L
 osartan 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.



L
 osartan 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.




P
 ack sizes
28 film-coated tablets







Marketing Authorisation Holder
A
 ctavis Group PTC ehf
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland







Manufacturer
Actavis hf.
Reykjavíkurvegur 78,
IS-220 Hafnarfjördur
I
celand







Actavis Ltd
BLB 016,
Bulebel Industrial Estate,
Zejtun, ZTN 3000,
Malta

This leaflet was last revised in February 2013




Continued top of next column
AAAE9155

Actavis, Barnstaple, EX32 8NS, UK

Losartan Potassium HCT 50mg/12.5mg, 100mg/25mg PIL - UK
item no: AAAE9155

dimensions: 190 x 380

print proof no: 2

pharmacode:

origination date: 07.02.13

min pt size: 8pt

1. black
2.
3.
4.
5.
6.

originated by: SA
approved for print/date

colours/plates:

revision date: 15.02.13

Technical Approval

revised by: sa

date sent: N/A

supplier: Actavis Malta

technically app. date:

Non Printing Colours
1.
2.
3.

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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