LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE 50 MG/12.5MG TABLETS

Active substance: LOSARTAN POTASSIUM

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Package leaflet: Information for the user
Losartan Potassium / Hydrochlorothiazide 50 mg/12.5 mg Tablets
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, pharmacist or nurse.
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, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
What is in this leaflet:
1.
What Losartan Potassium / Hydrochlorothiazide Tablets are and what they are used for
2.
What you need to know before you take Losartan Potassium /Hydrochlorothiazide Tablets
3.
How to take Losartan Potassium / Hydrochlorothiazide Tablets
4.
Possible side effects
5.
How to store Losartan Potassium / Hydrochlorothiazide Tablets
6.
Contents of the pack and other information

1.

What Losartan Potassium / Hydrochlorothiazide tablets are and what they are used
for

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

2.

What you need to know before you take Losartan Potassium / Hydrochlorothiazide
tablets

Do not take Losartan Potassium / Hydrochlorothiazide Tablets
-

-

if you are allergic to losartan, hydrochlorothiazide or any of the other ingredients in 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 more than 3 months pregnant. (It is also better to avoid Losartan Potassium /
Hydrochlorothiazide Tablets in early pregnancy – see pregnancy section.),
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.

Warnings and precautions
You must tell your doctor if you think you are (or might become) pregnant. Losartan Potassium /
Hydrochlorothiazide Tablets are not recommended in early pregnancy, and must not be taken if
you are more than 3 months pregnant, as they may cause serious harm to your baby if used at that
stage (see pregnancy section).
Tell your doctor, pharmacist or nurse before taking Losartan Potassium / Hydrochlorothiazide
Tablets:
-

-

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 / 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).

Other medicines and Losartan Potassium / Hydrochlorothiazide Tablets
Tell your doctor, pharmacist or nurse if you are taking or have recently taken any other
medicines.
Diuretic agents such as the hydrochlorothiazide contained in Losartan Potassium /
Hydrochlorothiazide Tablets may interact with other medicines. Preparations containing lithium
should not be taken with Losartan Potassium / Hydrochlorothiazide Tablets 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 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 Tablets.
Losartan Potassium / Hydrochlorothiazide Tablets with food and drink
You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan Potassium /
Hydrochlorothiazide Tablets may increase each other’s effects.
Dietary salt in excessive quantities may counteract the effect of Losartan Potassium /
Hydrochlorothiazide Tablets.
Losartan Potassium / Hydrochlorothiazide Tablets 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, pharmacist or nurse for advise before taking this medicine.
Pregnancy
Your doctor will normally advise you to stop taking Losartan Potassium / Hydrochlorothiazide
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 Potassium / Hydrochlorothiazide Tablets. Losartan
Potassium / Hydrochlorothiazide Tablets are not recommended in early pregnancy, and must not
be taken when more than 3 months pregnant, as they 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 Potassium /
Hydrochlorothiazide 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Children and adolescents
There is no experience with the use of Losartan Potassium / Hydrochlorothiazide Tablets in
children. Therefore, Losartan Potassium / Hydrochlorothiazide Tablets should not be given to
children.
Use in elderly patients
Losartan Potassium / Hydrochlorothiazide 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
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.

3.

How to take losartan potassium / hydrochlorothiazide tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure. Your doctor will decide on the appropriate dose of
Losartan Potassium / Hydrochlorothiazide Tablets depending on your condition and whether you
are taking other medicines. It is important to continue taking Losartan Potassium /
Hydrochlorothiazide Tablets for as long as your doctor prescribes it in order to maintain smooth
control of your blood pressure.
High Blood Pressure
The recommended dose of Losartan Potassium / Hydrochlorothiazide Tablets for most patients
with high blood pressure is 1 tablet of Losartan Potassium / Hydrochlorothiazide Tablets 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 Tablets or
changed to 1 tablet daily of Losartan Potassium / Hydrochlorothiazide 100 mg/25 mg Tablets (a
stronger strength) per day. The maximum daily dose is 2 tablets per day of Losartan Potassium /
Hydrochlorothiazide 50 mg/12.5 mg Tablets or 1 tablet daily of Losartan Potassium /
Hydrochlorothiazide 100 mg/25 mg Tablets.

If you take more Losartan Potassium / 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 / Hydrochlorothiazide Tablets:
Try to take Losartan Potassium / 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, this medicine can cause side effects, although not everybody gets them.
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 10000 patients and less than 1 out of 1000 patients)
- Hepatitis (inflammation of the liver), abnormal liver function tests
Not known (cannot be estimated from the available data)
- Abnormal muscle breakdown (rhabdomyolysis) with symptoms such as muscle pain,
weakness and swelling which can lead to kidney problems (urine can become dark)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects
not listed in this leaflet.

5.

How to store Losartan Potassium / Hydrochlorothiazide tablets

Keep this medicine out of the sight and reach of children.

Store below 30ºC.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry
date refers to the last day of the month.
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.

FURTHER INFORMATION

What Losartan Potassium / Hydrochlorothiazide Tablets contain:
The active ingredients (which make the medicine work) are 50mg of losartan potassium and
12.5mg of hydrochlorothiazide
The other ingredients are mannitol, microcrystalline cellulose, croscarmellose sodium, povidone,
magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), macrogol.
Each tablet contains 4.24mg (0.108 mmol) of potassium
What Losartan Potassium / Hydrochlorothiazide Tablets look like and contents of the pack:
Losartan Potassium / Hydrochlorothiazide Tablets are white, round, scored, biconvex, film-coated
tablets.
The tablets are provided in blister packs and bottles of 14, 28, 30, 50, 56, 98, 100 and 280
tablets.*
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Medis ehf, Reykjavikurvegur 78, 220 Hafnarfjordur, Iceland
Manufacturer:
Actavis hf, Reykjavikurvegur 78, PO Box 420, IS-222 Hafnarfjordur, Iceland

This leaflet was last revised in 06/2012

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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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