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

Active substance: LOSARTAN POTASSIUM

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TEVA UK Ref:

231-30-86263-X LEA LOSARTAN POTASSIUM AND HCTZ A/S TAB TUK

Version:

1

23 April 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

Read all of this leaflet carefully before you start
taking this medicine.
or pharmacist.
pass it on to others. It may harm them, even if
their symptoms are the same as yours.

syndrome associated with increased secretion of
the hormone aldesterone by the adrenal gland,
caused by an abnormality within the gland)
might become) pregnant. Losartan potassium and
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).
Taking other medicines
or have recently taken any other medicines, including
medicines obtained without a prescription.
contained in Losartan potassium and
Hydrochlorothiazide may interact with other

not be taken with Losartan potassium and
Hydrochlorothiazide without close supervision by
your doctor. Special precautionary measures (e.g.
IN THIS LEAFLET:
blood tests) may be appropriate if you take potassium
supplements, potassium-containing salt substitutes
1. What Losartan potassium and Hydrochlorothiazide
or potassium-sparing medicines, other diuretics
tablets are and what they are used for
(“water tablets”), some laxatives, glycyrrhizin (found
2. Before you take Losartan potassium and
in liquorice), medicines for the treatment of gout,
Hydrochlorothiazide tablets
medicines to control heart rhythm or for diabetes
3. How to take Losartan potassium and
(oral agents or insulins). It is also important for your
Hydrochlorothiazide tablets
doctor to know if you are taking other medicines to
4. Possible side effects
reduce your blood pressure, steroids, medicines to
5. How to store Losartan potassium and
treat cancer, pain killers, drugs for treatment of fungal
Hydrochlorothiazide tablets
infections or arthritis medicines, resins used for high
6. Further information
cholesterol, such as colestyramine, medicines which
relax your muscles, sleeping tablets; opioid
WHAT LOSARTAN POTASSIUM AND
medicines such as morphine, ‘pressor amines’ such
HYDROCHLOROTHIAZIDE TABLETS ARE AND as adrenaline or other drugs from the same group;
WHAT THEY ARE USED FOR
(oral agents for diabetes or insulins).
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

1

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

2

BEFORE YOU TAKE LOSARTAN POTASSIUM
AND HYDROCHLOROTHIAZIDE TABLETS

apply iodine contrast media about taking Losartan
potassium and Hydrochlorothiazide.
Taking Losartan potassium and Hydrochlorothiazide
tablets with food and drink
You are advised not to drink alcohol whilst taking
these tablets: alcohol and Losartan potassium and
Hydrochlorothiazide tablets may increase each
other’s effects.

the effect of Losartan potassium and
Hydrochlorothiazide tablets.
You should avoid food and drink containing liquorice
hydrochlorothiazide or to any of the other
as glycyrrhizin, which is found in liquorice, may
ingredients of this medicine
cause abnormal blood electrolyte levels.
Losartan potassium and Hydrochlorothiazide tablets
sulfonamide-derived substances (e.g. other
may be taken with or without food.
thiazides, some antibacterial drugs such as
co-trimoxazole, ask your doctor if you are not sure) Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or
might become) pregnant. Your doctor will normally
breast-feeding”)
advise you to stop taking Losartan potassium and
Hydrochlorothiazide tablets before you become
pregnant or as soon as you know you are pregnant
your kidneys are not producing any urine
and will advise you to take another medicine instead
of Losartan potassium and Hydrochlorothiazide
calcium levels which cannot be corrected by
tablets. Losartan potassium and Hydrochlorothiazide
treatment
tablets 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
better to avoid Losartan potassium and
if used after the third month of pregnancy.
Hydrochlorothiazide in early pregnancy – see
pregnancy section).
Breast-feeding
Tell your doctor if you are breast-feeding or about to
Take special care with Losartan potassium and
start breast-feeding. Losartan potassium and
Hydrochlorothiazide tablets:
Hydrochlorothiazide tablets are not recommended
for mothers who are breast-feeding, and your doctor
the face, lips, throat or tongue
may choose another treatment for you if you wish to
breast-feed.
Use in children and adolescents
diarrhoea
There is no experience with the use of Losartan
potassium and Hydrochlorothiazide in children.
Therefore, Losartan potassium and
artery stenosis) or only have one functioning
Hydrochlorothiazide should not be given to children.
kidney, or you have recently had a kidney transplant
Use in elderly patients
Losartan potassium and Hydrochlorothiazide works
(atherosclerosis), angina pectoris (chest pain due
equally well in and is equally well tolerated by most
to poor heart function)
Do NOT take Losartan potassium and
Hydrochlorothiazide tablets:

(narrowing of the valves of the heart) or

require the same dose as younger patients.
Driving and using machines

thickening of heart muscle)

asthma or a condition that causes joint pain, skin
rashes and fever (systemic lupus erythematosus)
or you are on a low potassium diet
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

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.
Important information about some of the ingredients
of Losartan potassium and Hydrochlorothiazide Tablets
Losartan potassium and Hydrochlorothiazide tablets
contain lactose. If you have been told by your doctor
that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

Top of page cut-off to middle of registration mark: 44 mm.

LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE 50 mg/12.5 mg
FILM-COATED TABLETS
LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE 100 mg/25 mg
FILM-COATED TABLETS

TEVA UK Ref:

231-30-86263-X LEA LOSARTAN POTASSIUM AND HCTZ A/S TAB TUK

Version:

1

PAGE 2: REAR FACE (OUTSIDE OF REEL)

3

HOW TO TAKE LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLETS

Always take Losartan potassium and
Hydrochlorothiazide tablets exactly as your doctor
has told you. Your doctor will decide on the
appropriate dose of Losartan potassium and
Hydrochlorothiazide depending on your condition
and whether you are taking other medicines. It is
important to continue taking Losartan potassium and
Hydrochlorothiazide for as long as your doctor
prescribes it in order to maintain smooth control of
your blood pressure.
High blood pressure
The usual dose of Losartan potassium and
Hydrochlorothiazide for most patients with high
blood pressure is 1 tablet of Losartan potassium and
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
Losartan/Hydrochlorothiazide 50 mg/12.5 mg
Film-coated Tablets or changed to 1 tablet daily of
Losartan/Hydrochlorothiazide 100 mg/25 mg
Film-coated Tablets (a stronger strength) per day. The
maximum daily dose is 2 tablets per day of
Losartan/Hydrochlorothiazide 50 mg/12.5 mg
Film-coated Tablets or 1 tablet daily of
Losartan/Hydrochlorothiazide 100 mg/25 mg
Film-coated Tablets.
If you take more Losartan potassium and
Hydrochlorothiazide tablets 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 and
Hydrochlorothiazide tablets
Try to take Losartan/Hydrochlorothiazide tablets daily
as prescribed. However, if you miss a dose, do not
take an extra dose. Just resume your usual schedule.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Losartan potassium and
Hydrochlorothiazide tablets can cause side effects,
although not everybody gets them.
If you experience the following, stop taking Losartan
potassium and Hydrochlorothiazide tablets and tell
your doctor immediately or go to the casualty
department of your nearest hospital:
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 (affecting fewer than one person in 10 but
more than one person in 100):
nose, sinusitis, sinus disorder

abnormal heart rhythm), decreased haemoglobin
levels.
Uncommon (affecting fewer than one person in 100
but more than one person in 1,000):
(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
gout, increased blood sugar levels, abnormal
blood electrolyte levels
panic attacks), confusion, depression, abnormal
dreams, sleep disorders, sleepiness, memory
impairment
extremities, trembling, migraine, fainting

inflammation of the pancreas
redness of the skin, sensitivity to light, dry skin,
flushing, sweating, hair loss
joints, joint swelling, stiffness, muscle weakness
kidney function including inflammation of the
kidneys, urinary infection, sugar in the urine

Rare (more than 1 out of 10,000 patients and less
than 1 out of 1,000 patients):
liver function tests.
Not known (cannot be estimated, more than 1 out of
10,000 patients):
kidney problems.
If 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 LOSARTAN POTASSIUM
AND HYDROCHLOROTHIAZIDE TABLETS

Keep out of the reach and sight of children.
Hydrochlorothiazide tablets after the expiry date that
refers to the last day of the month.

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

What Losartan potassium and Hydrochlorothiazide
tablets contain:
hydrochlorothiazide. Each tablet contains either
50 mg of losartan potassium and 12.5 mg of
hydrochlorothiazide or 100 mg of losartan
potassium and 25 mg of hydrochlorothiazide.
Tablet core: lactose monohydrate, cellulose
microcrystalline (E460a), pregelatinised starch
(maize), magnesium stearate (E572).
Film-coat: poly (vinyl alcohol), titanium dioxide (E171),
macrogol 3350, talc (E553b), yellow iron oxide (E172).
What Losartan potassium and Hydrochlorothiazide
tablets look like and contents of the pack:
50/12.5 mg Film-coated Tablets are yellow, oval,
bi-convex tablets, marked with “5” and “0” on one
side and a score line on both sides.
The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.
100/25 mg Film-coated Tablets are yellow, oval,
bi-convex tablets, debossed "1" and "00" on one
side and breakline on both sides.
The breakline is only to facilitate breaking for ease
of swallowing and not to divide into equal doses.
of 1, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets,
calendar packs of 28 tablets and hospital packs of
50x1 and 280 (10x28) tablets.
100 and 250 tablets.
1, 7, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets,
calendar packs of 7 and 28 tablets and hospital
packs of 50x1 and 280 (10x28) tablets.
30 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in 04/2014

conjunctivitis, worsening eyesight, seeing things
in yellow
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
associated with a skin rash or bruising
Sore throat, breathlessness, bronchitis, pneumonia,
water on the lungs (which causes difficulty
breathing), nosebleed, runny nose, congestion
spasms, vomiting, dry mouth, inflammation of a
salivary gland, toothache

86263-X
160 x 323

23 April 2014

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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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