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

Active substance: LOSARTAN POTASSIUM

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Losartan Potassium / Hydrochlorothiazide 100 mg / 12.5 mg Film-coated Tablets

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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.
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. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1.
What Losartan Potassium / Hydrochlorothiazide is and what it is used for
2.
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.
Further 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.

BEFORE YOU TAKE LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE

Do NOT take Losartan Potassium / Hydrochlorothiazide
-

if you are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other
ingredients in this medicine
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)
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”)
if you have severely impaired liver function
if you have severely impaired kidney function or your kidneys are not producing any urine
if you have low potassium, low sodium or high calcium levels which cannot be corrected by
treatment
if you are suffering from gout.

Take special care with Losartan Potassium / Hydrochlorothiazide
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
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Losartan Potassium / Hydrochlorothiazide 100 mg / 12.5 mg Film-coated Tablets

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than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see
“Pregnancy and breast-feeding”).’
It is important to tell your doctor before taking Losartan Potassium / Hydrochlorothiazide: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
if you have heart failure
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 erythematodus)
if you have high calcium or low potassium levels or you are on a low potassium diet
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
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)
if your liver function is impaired (see "Do not take Losartan Potassium / Hydrochlorothiazide").
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
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
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 or other drugs from the same group.
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Losartan Potassium / Hydrochlorothiazide 100 mg / 12.5 mg Film-coated Tablets

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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.
Taking 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
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.
Use in children and adolescents
There is no experience with the use of Losartan Potassium / Hydrochlorothiazide in children.
Therefore, it should not be given to children.
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.
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.
Important information about some of the ingredients of Losartan Potassium /
Hydrochlorothiazide
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 Losartan Potassium / Hydrochlorothiazide exactly as your doctor has told you. 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
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Losartan Potassium / Hydrochlorothiazide 100 mg / 12.5 mg Film-coated Tablets

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Potassium / 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 / 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. However, if you miss a
dose, do not take an extra dose. Just resume your usual schedule.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Losartan Potassium / Hydrochlorothiazide 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:
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 (affecting 1 to 10 users 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.

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Losartan Potassium / Hydrochlorothiazide 100 mg / 12.5 mg Film-coated Tablets

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Uncommon (affecting 1 to 10 users 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.
Rare (affecting 1 to 10 users in 10,000)
Hepatitis (inflammation of the liver), abnormal liver function tests.
Not known (cannot be estimated from the available data)
Muscle wasting (rhabdomyolysis)
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 / HYDROCHLOROTHIAZIDE

Keep out of the reach and sight of children.
Do not use Losartan Potassium / Hydrochlorothiazideafter 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.
Medicines 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.

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Losartan Potassium / Hydrochlorothiazide 100 mg / 12.5 mg Film-coated Tablets

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FURTHER 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) part-hydrolyzed, 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 March 2012

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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