LOSARTAN HYDROCHLOROTHIAZIDE 100MG/25MG FILM-COATED TABLET

Active substance: LOSARTAN POTASSIUM

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PATIENT INFORMATION LEAFLET

LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE
50mg/12.5mg AND 100mg/25mg FILM-COATED TABLETS

Losartan potassium and hydrochlorothiazide
Read all of this leaflet carefully before taking this medicine.





Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your 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 your medicine is and what it is used for
2. What you need to know before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of pack and other information

1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
The name of your medicine is Losartan potassium/Hydrochlorothiazide 50mg/12.5mg or
100mg/25mg Film-coated Tablets. Your medicine is referred to as Losartan
potassium/Hydrochlorothiazide Tablets or “your medicine” throughout this leaflet.
Losartan potassium/Hydrochlorothiazide Tablets contain medicines called losartan potassium
and hydrochlorothiazide. Both of these medicines reduce blood pressure.



Losartan potassium belongs to a class of medicines known as angiotensin II receptor
antagonists. Losartan potassium helps blood vessels relax and so lowers blood
pressure.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also
known as “water tablets”). Hydrochlorothiazide works by making the kidneys pass
more water and salt and this leads to a reduction in blood pressure.

Losartan potassium/Hydrochlorothiazide Tablets are used to treat high blood pressure not
adequately controlled by either losartan potassium or hydrochlorothiazide when taken on their
own.

People with high blood pressure often do not notice any signs of this problem. Many may feel
quite normal. High blood pressure increases the workload of the heart and may damage
arteries. High blood pressure increases the risk of heart attacks, stroke and kidney failure.
Lowering your blood pressure reduces the risk of developing these disorders.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE YOUR MEDICINE
DO NOT take Losartan potassium/Hydrochlorothiazide Tablets if you:








are allergic (hypersensitive) to losartan potassium, hydrochlorothiazide or any of the
other ingredients in this medicine
are allergic (hypersensitive) to other sulphonamide-derived substances (e.g. other
thiazides, some anti-bacterial drugs such as co-trimoxazole) - ask your doctor if you
are not sure
are more than 3 months pregnant – it is also better to avoid Losartan
potassium/Hydrochlorothiazide Tablets in early pregnancy – see “Pregnancy and
breast-feeding” section
have severe liver problems
have severe kidney problems or your kidneys are not producing any urine
have low potassium, low sodium or high calcium levels which cannot be corrected by
treatment
are suffering from gout

Take special care with Losartan potassium/Hydrochlorothiazide Tablets
It is important to tell your doctor before taking this medicine if you:

















have previously suffered from swelling of the face, lips, throat or tongue
take diuretics (“water tablets”)
are on a salt-restricted diet
have severe vomiting and/or diarrhoea
have heart failure
have mild to moderate liver problems
have narrow arteries to your kidneys (renal artery stenosis) or only have one
functioning kidney or you have recently had a kidney transplant
have narrowing of the arteries to the heart (artherosclerosis), or suffer from angina
pectoris (chest pain due to poor heart function); or have thickening of the heart
muscle (hypertrophic cardiomyopathy)
are diabetic, as your antidiabetic medicine dose may need to be changed
have had gout
have or have had an allergic condition or asthma
have had a condition that causes joint pain, skin rashes and fever (systemic lupus
erythematosus (SLE))
have high calcium or low potassium levels
are on a low potassium diet
need to have an anaesthetic before surgery (even at the dentist)
are going to have tests to check your parathyroid gland, you must tell the doctor or
medical staff that you are taking Losartan potassium/Hydrochlorothiazide Tablets






suffer from primary hyperaldosteronism (a syndrome associated with increased
secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality
within the gland)
have become pregnant or are planning to become pregnant
have an intolerance to some sugars as this medicine contains lactose monohydrate
have ‘aortic or mitral valve stenosis’ (narrowing of the valves of the heart)

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.
The effect of the treatment can be influenced if Losartan potassium/Hydrochlorothiazide
Tablets are taken together with certain other medicines. It may be necessary to change the
dose, to take other precautions, or in some cases to stop taking one of the medicines.
This especially applies to the following medicines:





























lithium, a medicine used to treat mental health (your doctor will need to monitor you
closely)
medicines that may affect blood potassium levels e.g. potassium supplements,
potassium-containing salt substitutes, diuretics (“water tablets”) e.g. spironolactone
corticosteroids used for inflammation
some laxatives
medicines for the treatment of gout (e.g. allopurinol, probenecid, sulfinpyrazone)
calcium supplements
bepridil, a medicine used for angina
cisapride, a medicine used for reflux disease
diphemanil, a medicine used to slow down gastric motility
halofantrine, a medicine used to treat malaria
mizolastine and terfenadine, anti-histamine medicines used to treat allergies
pentamidine, a medicine used to treat pneumonia
any medicines for the treatment of diabetes (taken by mouth or injection) e.g.
metformin, insulin
any other medicines that lower your blood pressure such as methyldopa, vincamine
antidepressants, tranquilizers, barbiturates
some antipsychotics, e.g. pimozide, haloperidol
medicines used in cancer therapy e.g. amifostine, methotrexate, cyclophosphamide
medicines used to control muscle spasms e.g. baclofen
opioid medicines such as codeine and morphine
noradrenaline or adrenaline, medicines used in medical emergencies
pain killers and arthritis medicines known as “NSAIDS”
medicines used at the time of an operation e.g. anaesthetics, tubocurarine or atropine
biperiden, used in Parkinson’s disease
cholestyramine and colestipol (medicines used to treat high cholesterol)
ciclosporin, a medicine used to prevent rejection of an organ transplant
some antibiotics e.g. rifampicin, fluconazole, amphotericin, erythromycin
any sedative, including alcohol (see below)
carbamazepine, a medicine used to treat epileptic seizures

Laboratory tests
If you are going to have special x-rays that make use of iodine contrast media then please tell
your doctor you are taking Losartan potassium/Hydrochlorothiazide Tablets. Increase in
cholesterol and triglyceride levels may be associated with hydrochlorothiazide therapy.
Taking 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.
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 Tablets are 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.
Breast-feeding
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.
Driving and using machines
Losartan potassium/Hydrochlorothiazide Tablets may cause dizziness or drowsiness. When
you begin treatment with this medicine, you should not perform tasks that may need special
attention (e.g. driving a car or operating dangerous machinery) until you know how you react
to your medicine.
Important information about some of the ingredients in your medicine
Losartan potassium/Hydrochlorothiazide Tablets contain 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 YOUR MEDICINE
Always take your medicine exactly as your doctor has instructed you. 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

your medicine for as long as your doctor prescribes it in order to maintain smooth control of
your blood pressure.
Swallow the tablets with a glass of water.
Losartan potassium/Hydrochlorothiazide Tablets may be taken with or without food.

DOSAGE
Adults (including the elderly)
The usual dose for most patients with high blood pressure is 50mg/12.5mg per day.
This can be increased to 100mg/25mg per day.
The maximum daily dose is 100mg/25mg.
If you take more of your medicine than you should
If you take more tablets than you should, contact your doctor immediately so that medical
attention may be given promptly. An overdose can cause a drop in blood pressure,
palpitations, slow pulse rate and dehydration.
If you forget to take your medicine
Try to take your medicine daily as prescribed. However, if you miss a dose, DO NOT take an
extra dose. Just resume your usual schedule.
If you stop taking your medicine
Stopping treatment with Losartan potassium/Hydrochlorothiazide Tablets may cause your
blood pressure to get worse. Do not stop taking your medicine unless your doctor tells you to.
DOSAGE
Adults (including the elderly)
The usual dose for most patients with high blood pressure is 50mg/12.5mg per day.
This can be increased to 100mg/25mg per day.
The maximum daily dose is 100mg/25mg.
If you take more of your medicine than you should
If you take more tablets than you should, contact your doctor immediately so that medical
attention may be given promptly. An overdose can cause a drop in blood pressure,
palpitations, slow pulse rate and dehydration.
If you forget to take your medicine
Try to take your medicine daily as prescribed. However, if you miss a dose, DO NOT take an
extra dose. Just resume your usual schedule.
If you stop taking your medicine
Stopping treatment with Losartan potassium/Hydrochlorothiazide Tablets may cause your
blood pressure to get worse. Do not stop taking your medicine unless your doctor tells you to.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Losartan potassium/Hydrochlorothiazide Tablets may cause side effects,
although not everybody gets them.
STOP taking Losartan potassium/Hydrochlorothiazide Tablets and contact your doctor
immediately or go to the nearest hospital casualty department if you develop any of the
following symptoms:








a sudden life-threatening allergic reaction with rash, itching or hives on the skin,
swelling of the face, lips, tongue or other parts of the body, shortness of breath,
wheezing or trouble breathing
severe skin reaction which starts with painful red areas, then large blisters and ends
with the peeling of layers of skin. Fever and chills, aching muscles and generally
feeling unwell, accompany this.
heart attack (symptoms include sudden chest pain typically radiating from the left
arm or left hand side of the neck, shortness of breath, nausea, vomiting, palpitations,
sweating and anxiety
stroke or “mini” stroke (symptoms can include collapse, numbness or weakness of the
arms or legs, headache, dizziness and confusion, visual disturbance, difficulty with
swallowing, slurred speech and loss of speech)
angina (pain or uncomfortable feeling in the chest, often spreading to the shoulder
and back)
sudden attack of unconsciousness
hepatitis – liver disease with nausea, vomiting, loss of appetite, feeling generally
unwell, fever, itching, yellowing of the skin and eyes and dark coloured urine

The following side effects have been reported.
Common: affecting less than 1 person in 10







cough, inflammation or infection of the upper airways, congestion in the nose, sinus
pain
diarrhoea, stomach pain, nausea (feeling sick), indigestion
muscle pain or cramps, leg pain, back pain, chest pain
sleep disturbances, insomnia
headache, dizziness
weakness, tiredness

Uncommon: affecting less than 1 person in 100








anaemia causing tiredness, headaches, shortness of breath, dizziness or looking pale
small bleeds under the skin (symptoms may include joint pain and stomach pain)
lack of white blood cells leading to increased susceptibility to infection with fever,
chills, sore throat or mouth ulcers
low blood platelet count, which may lead to bleeding or bruising more easily than
normal
loss of appetite
swollen joints, gout
anxiety, feeling of panic, confusion, depression, abnormal dreams, drowsiness






















difficulty with memory
nervousness, pins and needles, numbness or weakness of the arms and legs,
trembling, fainting, migraine
visual disturbance (e.g. blurred vision, decrease in sharpness of vision, visual defect
in which objects appear to have a yellowish hue), burning/ stinging in the eye,
conjunctivitis (inflammation of the lining of the eye)
low blood pressure (may cause light headedness on standing)
spinning sensation, tinnitus (buzzing sounds in ears)
pain in the breast bone, palpitations (increased awareness of the heartbeat), changes
in heartbeat (fast, slow, irregular, or dangerously fast heartbeat)
inflammation of small blood vessels
sore throat, inflammation of the throat and larynx, difficulty breathing, bronchitis,
nose bleed, runny nose, congestion in the chest and lungs
pneumonia, inflammation of the lungs, fluid retention on the lungs, breathing
difficulties
constipation, flatulence, stomach discomfort/ irritation, vomiting (being sick), dental
pain, dry mouth, inflammation of the salivary glands, swollen face
pancreatitis (inflammation of the pancreas gland causing severe upper stomach pain
and vomiting)
hair loss, skin rash, dry skin, skin flush, reddening of the skin, increased sensitivity of
skin to light, itch, hives, sweating
arm pain, joint swelling, joint pain, bone pain, knee pain, shoulder pain, stiffness,
arthritis, hip pain, chronic widespread pain, muscle weakness
urinary infection, kidney problems that may become severe
increased frequency of needing to pass urine including passing urine during the night
sugar (glucose) in the urine
decreased sex drive, decreased sexual performance
fever
changes in blood test results of salt balance (disturbed salt balance may be associated
with nausea, tiredness, muscle weakness, muscle spasms, confusion, convulsions)
rise in blood sugar (diabetic patients may need to adjust treatment)

Rare: affecting less than 1 person in 1,000



high potassium levels in the blood (symptoms may include feeling unwell,
palpitations and muscle weakness)
disturbance in liver function (this will show up in a blood test)

Unknown: the frequency 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)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 YOUR MEDICINE
Do not use your medicine after the expiry date shown on the carton. The expiry date refers to
the last day of that month.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
There are no special requirements to store the tablets at a particular temperature.
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. CONTENTS OF PACK AND OTHER INFORMATION
What your medicine contains
The active substances are losartan potassium and hydrochlorothiazide.
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg contains 50mg of losartan potassium
and 12.5mg of hydrochlorothiazide.
Losartan potassium/Hydrochlorothiazide 100mg/25mg contains 100mg of losartan potassium
and 25mg of hydrochlorothiazide.

Losartan potassium/Hydrochlorothiazide 50mg/12.5mg and 100mg/25mg Tablets contain the
following inactive ingredients: microcrystalline cellulose, lactose monohydrate,
pregelatinized maize starch, magnesium stearate, hydroxypropylcellulose, hypromellose,
titanium dioxide (E171), talc and yellow iron oxide (E172).
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg contains 4.24mg (0.108 mEq) of
potassium.
Losartan potassium/Hydrochlorothiazide 100 mg/25mg contains 8.48 mg (0.216 mEq) of
potassium.
What your medicine looks like and contents of the pack
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg is supplied as yellow, oblong, scored
on one side film-coated tablets.
Losartan potassium/Hydrochlorothiazide 100mg/25mg is supplied as yellow, round, scored on
one side film-coated tablets.
The score line is only to help breaking for ease of swallowing and not to divide into equal
doses.
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg and 100mg/25mg are supplied in
blister packs of 28 film-coated tablets.

Marketing Authorisation Holder
Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK
Losartan potassium/Hydrochlorothiazide 100mg/25mg : PL 20395/0108
And Losartan potassium/Hydrochlorothiazide 50mg/12.5mg : PL 20395/0109

This leaflet was last prepared in February 2014.

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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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