Losartan Hydrochlorothiazide 50mg/12.5mg Film-Coated Tablet
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 diabetes or impaired kidney function and you are treated with blood pressure lowering medicine containing aliskiren.
• 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)
- 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 if you have disbetes-related kidney problems.
- aliskiren
• 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.
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).
- Disturbed taste
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 October 2015.