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LOSARTAN/HYDROCHLOROTHIAZIDE 100 MG/25 MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / LOSARTAN POTASSIUM

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Package leaflet: Information for the user
Losartan/Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets
Losartan/Hydrochlorothiazide 100 mg/25 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/Hydrochlorothiazide is and what it is used for
2.
What you need to know before you take Losartan/Hydrochlorothiazide
3.
How to take Losartan/Hydrochlorothiazide
4.
Possible side effects
5.
How to store Losartan/Hydrochlorothiazide
6.
Contents of the pack and other information

1.

What Losartan/Hydrochlorothiazide is and what it is used for

Losartan/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/Hydrochlorothiazide is indicated for the treatment of essential hypertension (high blood
pressure).

2.

What you need to know before you take Losartan/Hydrochlorothiazide

Do not take Losartan/Hydrochlorothiazide
if you are allergic to losartan, hydrochlorothiazide or any of the other ingredients of this
medicine (listed in section 6).
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, think you may be or are planning to become pregnant (see section 2"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
if you are more than 3 months pregnant. (It is also better to avoid this medicine in early
pregnancy – see section 2 "Pregnancy and breast-feeding")
if you 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/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 your liver function is impaired (see section 2 “Do not take Losartan/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 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/Hydrochlorothiazide.
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).
you must tell your doctor if you think you are (or might become) pregnant.
Losartan/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 section 2 "Pregnancy and breast-feeding").
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
diabetes-related 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/Hydrochlorothiazide‟.

Children and adolescents
There is no experience with the use of Losartan potassium and Hydrochlorothiazide in children.
Therefore, Losartan/Hydrochlorothiazide should not be given to children.
Elderly patients
Losartan potassium and 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.
Other medicines and Losartan/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 this medicine may interact with other
medicines. Preparations containing lithium should not be taken with this medicine 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
or arthritis medicines, resins used for high cholesterol, such as colestyramine, medicines which relax
your muscles, sleeping tablets; opioid medicines such as morphine, „pressor aminies‟ such as
adrenaline or other drugs from the same group; oral agents for diabetes 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/Hydrochlorothiazide‟ and „Warnings and precautions‟).
Please also inform your doctor when it is planned to apply iodine contrast media about taking
Losartan/Hydrochlorothiazide.
Losartan/Hydrochlorothiazide with food, drink and alcohol
You are advised not to drink alcohol whilst taking these tablets: alcohol and
Losartan/Hydrochlorothiazide may increase each other‟s effects.
Dietary salt in excessive quantities may counteract the effect of Losartan/Hydrochlorothiazide.
You should avoid food and drink containing glycyrrhizin, which is found in liquorice, may cause
abnormal blood electrolyte levels.
Losartan/Hydrochlorothiazide 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/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/Hydrochlorothiazide. Losartan/Hydrochlorothiazide 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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding.
Losartan/Hydrochlorothiazide are not recommended for mothers who are breast-feeding, and your
doctor may choose another treatment for you if you wish to breast-feed.
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.
Losartan/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 medicinal product.

3.

How to take Losartan/Hydrochlorothiazide

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 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/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 tablet or 1 tablet daily of
Losartan/Hydrochlorothiazide 100 mg/25 mg Film-coated tablets.
If you take more Losartan/Hydrochlorothiazide than you should
In case of an overdose, contact your doctor immediately so that medical attention may be given
promptly. Overdose with Losartan/Hydrochlorothiazide can cause a drop in blood pressure,
palpitations, slow pulse, changes in blood composition, and dehydration.
If you forget to take Losartan/Hydrochlorothiazide
Try to take Losartan/Hydrochlorothiazide daily as prescribed. Do not take a double dose to make up
for a forgotten dose.
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 the following, stop taking Losartan/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 (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
Too low sugar in the blood (hypoglycemia)
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 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, 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
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
Unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis)
Low levels of sodium in the blood (hyponatremia)
Generally feeling unwell (malaise)
Disturbed taste (dysgeusia)

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/Hydrochlorothiazide

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 after EXP. The expiry date
refers to the last day of that month.
Do not store above 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.

6.

Contents of the pack and other information

What Losartan/Hydrochlorothiazide Film-coated Tablets contains
The active substances are losartan potassium and hydrochlorothiazide.
Each Losartan/Hydrochlorothiazide 50 mg/12.5 mg Film-coated Tablet contains 50 mg of
losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide.
Each Losartan/Hydrochlorothiazide 100 mg/25 mg Film-coated Tablet contains 100 mg of
losartan (as potassium salt) and 25 mg of hydrochlorothiazide.
The other ingredients are
Tablet core: lactose monohydrate, cellulose microcrystalline, pregelatinised starch (maize),
magnesium stearate.
Film-coat: poly(vinyl alcohol), titanium dioxide, macrogol 3350, talc, yellow iron oxide (E172).
What Losartan/Hydrochlorothiazide looks like and contents of the pack
Losartan/Hydrochlorothiazide 50 mg/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.
Losartan/Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets are yellow, oval, bi-convex
tablets marked with “1” and “00” 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.

The 50 mg/12.5 mg tablets are available in pack sizes of 14,28, 30, 56, 60, 90, 98 & 100 filmcoated tablets, hospital packs of 50x1 film-coated tablets.
The 100 mg/25 mg tablets are available in pack sizes of 14,28, 30, 56, 60, 90, 98 & 100 filmcoated tablets, hospital packs of 50x1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, UK

*OR
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
*OR
TEVA SANTE, Rue Bellocier, 89100 Sens, France
*OR
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
*OR
TEVA PHARMA, S.L.U., C/ C, n° 4, Poligono Industrial Malpica, Zaragoza, 50016, Zaragoza, Spain
*OR
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren-Weiler, Germany
This leaflet was last revised in 09/2014
PL 00289/1646
PL 00289/1647
* Only the actual site of batch release will appear on the printed version of the leaflet

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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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