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

Active substance: LOSARTAN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan Potassium/Hydrochlorothiazide
50 mg/12.5 mg film-coated tablets
Losartan potassium/Hydrochlorothiazide

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).
Losartan Potassium/Hydrochlorothiazide 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 and/or hydrochlorothiazide or any of the other ingredients of Losartan
Potassium/Hydrochlorothiazide;
• if you are more than 3 months pregnant. (It is also better to avoid Losartan Potassium/Hydrochlorothiazide in early pregnancy
– see pregnancy section.);
• if you have severely impaired liver function; cholestasis and biliary obstructive disorders
• if you have severely impaired kidney function (i.e. creatinine clearance <30 ml/min)
• if 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
• 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).
You must tell your doctor if you think that you are (or might become) pregnant. Losartan Potassium/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:
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, 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 amines’ such
as adrenaline or other drugs from the same group; (oral agents for diabetes or insulins).
Please also inform your doctor when it is planned to apply iodine contrast media about taking Losartan Potassium/
Hydrochlorothiazide.
Taking Losartan Potassium/Hydrochlorothiazide with food and drink:
This medicinal product may be taken with or without food.
You are advised not to drink alcohol whilst taking these tablets: alcohol and losartan potassium and hydrochlorothiazide tablets
may increase each other’s effects.
Dietary salt in excessive quantities may counteract the effect of losartan potassium and hydrochlorothiazide tablets.
Pregnancy and breast-feeding
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 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.
Breastfeeding
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, especially if your baby is newborn, or was born prematurely.
Use in children and adolescents
There is no experience with the use of Losartan Potassium/Hydrochlorothiazide in children. Therefore, Losartan Potassium/
Hydrochlorothiazide 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:
This product 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 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 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
2 tablets once daily of Losartan Potassium/Hydrochlorothiazide 50 mg/12.5 mg film-coated tablets or changed to 1 tablet daily of
Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg film-coated tablets (a stronger strength) per day. The maximum daily
dose is 2 tablets per day of Losartan Potassium/Hydrochlorothiazide 50 mg/12.5 mg film-coated tablets or 1 tablet daily of
Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg film-coated tablets.
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.
The frequency of side effects is classified in following categories







Very common
Common
Uncommon
Rare
Very rare
Not known

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from available data

If you experience the following, stop taking Losartan Potassium/Hydrochlorothiazide 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.
The 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.
Rare (more than 1 out of 10,000 patients and less than 1 out of 1,000 patients)
- Hepatitis (inflammation of the liver), abnormal liver function tests
Not known (frequency cannot be estimated from available data)
- Rhabdomyolisis
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.
5. STORING LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE
Keep out of the reach and sight of children.
Do not use Losartan Potassium/Hydrochlorothiazide after 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 30°C. Store in the original blister 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.
6. FURTHER INFORMATION
What Losartan Potassium/Hydrochlorothiazide contains
• The active substances are losartan potassium and hydrochlorothiazide. Each film-coated tablet contains 50 mg losartan
potassium, equivalent to 45.76 mg losartan and 12.5 mg hydrochlorothiazide.
• The other ingredients are:
in the core – pregelatinised maize starch; microcrystalline cellulose; lactose monohydrate; magnesium stearate; in the coating
– hypromellose; macrogol 4000; quinoline yellow (E104); talc; titanium dioxide (E171).
What Losartan Potassium/Hydrochlorothiazide looks like and contents of the pack
Losartan Potassium/Hydrochlorothiazide tablets are yellow, oval, moderately biconvex, film-coated tablets with one-sided
halving score, tablet dimension 6 mm x 12 mm (oval shape) thickness 3.8 – 4.7 mm. The score line is only to facilitate breaking for
ease of swallowing and not to divide into equal doses.
Tablets are supplied in cartons containing 10, 14, 28, 30, 56, 60, 84, 90 and 98 film-coated tablets in Al/PVC/PVDC transparent
blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Krka d.d., Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer: 1. Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

2. TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Distributed by: Consilient Health (UK) Ltd, 500 Chiswick High Road, London, W4 5RG.
This leaflet was last revised 02/2012
P0148

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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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