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

Active substance: LOSARTAN POTASSIUM

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pins and needles or similar sensations, pain or numbness in the extremities,
trembling
migraine, fainting
blurred vision, burning or stinging in the eyes, conjunctivitis, worsening
eyesight, seeing things in yellow
ringing, buzzing or clicking in the ears
low blood pressure, feeling light headed or weak when you stand up
angina (heaviness or tightness in the chest along with heart pain), abnormal
heartbeat, stroke, heart attack, heart palpitations, change in heart rhythm
sore throat, nosebleed, runny nose
swelling of the face, fever
breathlessness, bronchitis, pneumonia, fluid on the lungs
constipation, wind, stomach upsets, stomach spasms, vomiting
dry mouth, inflammation of saliva glands, dental pain
hives, itchy rash, inflammation or redness of the skin, dry skin,
sensitivity to light, flushing, sweating, hair loss
pain in the arms, shoulders, hips, knees or other joints, joint swelling,
stiffness, muscle weakness
frequent urination including at night, urinary infection, sugar in the urine
abnormal kidney function including inflammation of the kidneys and kidney
failure
decreased sexual appetite, impotence
anaemia, abnormal breakdown of red blood cells, lower white blood cell
count, bone marrow failure
gout, excess of uric acid in the blood
mild increase in urea and creatine serum levels

Rare side effects (affects 1 to 10 users in 10,000):
- hepatitis (inflammation of the liver), abnormal liver function tests
- high levels of potassium
- rapid swelling of the skin or mucous membranes such as the eyes and mouth
Very Rare (affects less than 1 user in 10,000):
- increase in hepatic enzymes and bilirubin
The following side effects have also been reported but the frequency is not
known:
- changes in liver function
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.
Reporting of side effects
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via
the Yellow Card Scheme, website:
"http://www.mhra.gov.uk/yellowcard"www.mhra.gov.uk/yellowcard.
5. HOW TO STORE
Keep out of the reach and sight of children.
Do not use Losartan HCT tablets after the expiry date which is stated on the label
and carton after EXP The expiry date refers to the last day of that month.
.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help to protect the environment.

Package leaflet: Information for the user

Losartan Potassium/Hydrochlorothiazide
50/12.5mg and 100/25mg Film-Coated 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 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.
In this leaflet:
1. What Losartan HCT tablets are and what they are used for
2. What you need to know before you take these tablets
3. How to take the tablets
4. Possible side effects
5. How to store
6. Contents of pack and other information
1. WHAT LOSARTAN HCT TABLETS ARE AND WHAT THEY ARE USED FOR
Losartan Potassium/Hydrochlorothiadise tablets (from here on called Losartan
HCT tablets) are 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 HCT tablets are indicated for the treatment of essential hypertension
(high blood pressure).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THESE TABLETS
Do not take Losartan HCT tablets if you:
- are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the
other ingredients listed in section 6.
- 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.
- suffer from high calcium, low potassium or low sodium levels in your blood
that does not respond to treatment.
- have severely impaired liver function or blockage of bile ducts.
- are suffering from gout.
- are more than 3 months pregnant (it is also better to avoid Losartan HCT
tablets in early pregnancy. See ‘Pregnancy and Breastfeeding’)
- have severely impaired kidney function or your kidneys are not producing
any urine.

This leaflet was last revised in 01/2014.

Warnings and precautions
Talk to your doctor or pharmacist before taking Losartan HCT tablets if you:
- have, or have a history of, angio-oedema (swelling of the face, lips, throat,
and/or tongue)
- are suffering from severe sickness (vomiting) or diarrhoea
- take or have recently taken other diuretics (water tablets)
- are on a low salt diet
- have high calcium or low potassium levels
- have progressive liver disease (cirrhosis) or mild to moderate liver
impairment
- suffer from reduced kidney function, kidney failure, have only one
functioning kidney or have received a kidney transplant
- have narrowing (stenosis) or blockage of the blood vessels leading to your
kidneys
- have increased secretion of the hormone aldesterone by the adrenal gland
(primary hyperaldosteronism)
- suffer from reduced blood supply to the heart (coronary heart disease) or
reduced blood circulation in the brain (cerebrovascular disease)
- suffer from heart failure, with or without kidney problems
- have narrowing of the valves of the heart (aortic or mitral valve stenosis)
- suffer from thickening of the heart muscle (hypertrophic cardiomyopathy)
- have an allergic condition, asthma or a condition that causes joint pain,
skin rashes and fever (systemic lupus erythematosus)
- have diabetes
- are having tests related to your parathyroid gland function
- you will be undergoing a radiographic procedure and are required to take an
iodine contrast media
- are of Afro-Caribbean origin then these tablets may not be suitable for you
as they may not be as effective as they should be

POM

If any of these points apply to you, do not take this medicine until you have talked
to your doctor or pharmacist. You may need to be given a different medicine or
the dose may need to be changed.
This section is continued overleaf →

6. CONTENTS OF PACK AND OTHER INFORMATION
What Losartan HCT tablets contain
The active substances are losartan potassium and hydrochlorothiazide.
Each Losartan HCT 50mg/12.5mg tablet contains 50mg losartan potassium and
12.5mg hydrochlorothiazide.
Each Losartan HCT 100mg/25mg tablet contains 100mg losartan potassium
and 25mg hydrochlorothiazide.
The other ingredients are:
Tablet core: microcystalline cellulose (E460), magnesium stearate (E572),
lactose monohydrate, pregelatinized starch.
Tablet film coating: hypromellose (E464), titanium dioxide (E171), margol/PEG
400, iron oxide yellow, indigo carmine aluminium lake (E132)
What Losartan HCT tablets look like and contents of the pack
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg tablets are Yellow,
round film-coated tablets, scored on one sides.
Losartan potassium/Hydrochlorothiazide 100mg/25mg tablets are Yellow,
oblong film-coated tablets, scored on one sides.
They come in blisters of: 7, 10, 14, 28, 30, 50, 56, 90, 98. (Not all pack sizes
may be marketed)
Marketing Authorisation Holder and Manufacturer
Medreich PLC, Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK
E-mail: info@medreich.co.uk
Losartan potassium/Hydrochlorothiazide 50/12.5 mg: PL 21880/0143
Losartan potassium/Hydrochlorothiazide 100/25 mg: PL 21880/0144

You must tell your doctor if you think you are (or might become) pregnant.
Losartan HCT tablets are 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 and Breastfeeding section).
Other medicines and Losartan HCT tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Take particular care if you are taking any of the following:
- other blood pressure lowering medicines as they may additionally reduce
your blood pressure e.g. valsartan or telmisartan
- diuretics (water tablets), e.g. bendroflumethiazide, indapamide, spironolactone
- other medicines to lower blood pressure, e.g. amlodipine, felodipine,
lercanidipine, methyldopa
- medicines for high blood pressure called ACE inhibitors, e.g. enalapril,
lisinopril, ramipril
- medicines for heart conditions and high blood pressure called beta-blockers
e.g. atenolol, bisoprolol, sotalol
- medicines to treat irregular heart rate, such as quinidine and amiodarone
- medicines for heart failure, e.g. digoxin
- tricyclic antidepressants, e.g. amitriptyline, trazodone, lofepramine
- medicines to treat psychiatric conditions such as schizophrenia and bipolar
disorder, e.g. flupentixol, chlorpromazine, olanzapine, risperidone, lithium
- medicines to relax your muscles, including baclofen
- cancer treatments, including amifostine
- medicines which can increase or retain potassium levels, e.g. potassium
supplements, salt substitutes, heparin or potassium sparing medicines
- medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that
reduce inflammation and pain, e.g. aspirin, ibuprofen, indometacin,
naproxen, celecoxib
- medicines used to treat gout, e.g. allopurinol and probenecid
- rifampicin (an antibiotic used to treat tuberculosis)
- medicines to treat fungal infections, including fluconazole
- methotrexate (used to treat cancers, arthritis and psoriasis)
- medicines used to treat arthritis
- medicines that suppress the immune system, e.g. ciclosporin
- epilepsy medication, e.g. carbamazepine
- steroids, e.g. prednisolone, hydrocortisone
- medicines used to treat high cholesterol, e.g. colestyramine
- adrenaline (epinephrine) or other similar medicines that cause a rise in blood
pressure
- opioid pain-killer medicines, e.g. dihydrocodeine, morphine
- sleeping tablets
- calcium supplements
Taking Losartan HCT tablets with food and drink
The tablets should be taken with a glass of water. They may be taken with or
without food.
Do not drink alcohol whilst taking these tablets as alcohol and Losartan HCT
tablets may increase each other’s effects.
High levels of salt in your diet may stop Losartan HCT tablets from working
properly so avoid eating too much salty 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 HCT 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 HCT tablets. Losartan HCT tablets
are not recommended during 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 HCT tablets are not recommended for mothers who are breast-feeding,
and your doctor may choose another treatment for you if you wish to breastfeed.
Driving and using machines
Losartan HCT tablets can cause dizziness or drowsiness in some people,
particularly at the start of treatment or if your dose is increased. If you
experience these symptoms contact your doctor before driving or operating
machinery.
Losartan HCT tablets contain Lactose
Losartan HCT tablets contain lactose monohydrate. If you have been told by a
doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. HOW TO TAKE THE TABLETS
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 of Losartan HCT tablets
depending on your condition and whether you are taking other medicines.
The recommended dose is one Losartan HCT 50/12.5 mg tablet once daily. This
dose may be increased to two 50/12.5 mg tablets once daily, or one 100/25 mg
tablet once daily, in patients who do not respond to the lower dose. The
maximum daily dose is two Losartan HCT 50/12.5mg tablets or one Losartan
HCT 100/25mg tablet. The maximum blood-pressure lowering effect should be
reached 3 – 4 weeks after beginning treatment.
Swallow this medicine with a glass of water. This medicine may be taken with or
without food.
Other dosage information
• Kidney impairment - No change of dosage is required in patients with
moderate kidney impairment. This medicine is not recommended for dialysis
patients or patients with severe kidney impairment.
• Liver impairment - A lower dose may be considered if you have mild to
moderate hepatic impairment. This medicine is not recommended for patients
with severe liver impairment.
• Reduced blood volume - Blood volume and/or sodium depletion should be
corrected prior to taking this medicine in patients with a reduced blood
volume.
• Children and adolescents - This medicine should not be given to children or
adolescents under 18 years of age.
• Elderly patients - This medicine is suitable for elderly patients, however the
dose should be decreased in elderly patients over 75 years of age.
If you take more Losartan HCT tablets than you should
If you take more Losartan HCT tablets than you should, contact your doctor or
pharmacist immediately. If possible take the tablets or box with you. Symptoms
of overdose are low blood pressure, heart palpitations or a slow pulse, needing
to pass urine more frequently and dehydration.
If you forget to take Losartan HCT tablets
If you miss a daily dose, just take the next dose as normal. Do not take a double
dose to make up for a forgotten tablet.
If you stop taking Losartan HCT tablets
It is important to continue taking Losartan tablets for as long as your doctor
prescribes it in order to maintain control of your blood pressure.
If you have the impression that the effect of Losartan is too strong or too weak,
please talk to your doctor or pharmacist.
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.
Serious side effects
Stop taking this medicine and contact your doctor or hospital emergency
department IMMEDIATELY if you develop any of the following symptoms:
- swelling of the face, lips, mouth or throat, difficulty breathing or swallowing,
rash or itching. These could be a sign of a severe allergic reaction.
- yellowing of the eyes and skin (jaundice). This could be a sign of serious
liver problems including hepatitis.
- severe abdominal pain with fever and swelling. This could be a sign of
inflammation of the pancreas.
Stop taking the tablets and seek immediate medical advice if the above
symptoms occur.
Other side effects
The following side effects may also occur:
Common side effects (affects 1 to 10 users in 100):
- cough, upper airway infection, congestion in the nose, inflammation or pain
of the sinuses
- diarrhoea, abdominal pain, nausea, indigestion
- muscle pain or cramps, leg pain, back pain
- insomnia (difficulty sleeping)
- headache, dizziness (vertigo)
- chest pain
- weakness, tiredness
- increased potassium levels, reduction of red blood cells, decreased
haemoglobin levels
Uncommon side effects (affects 1 to 10 users in 1,000):
- red or brownish spots on the skin with joint pain, stomach pain or swelling
of the hands and feet, bruising
- skin rash, bruising or red/purplish discolouration of the skin produced by
small bleeding vessels near the surface
- anorexia (weight loss), increased blood sugar levels, abnormal blood
electrolyte levels
- anxiety, nervousness, panic attacks, confusion, depression
- abnormal dreams, sleep disorders, sleepiness, memory impairment
This section is continued overleaf →
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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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