Losartan Potassium/Hydrochlorothiazide 100 Mg/25 Mg Film-Coated Tablets
Package leaflet: Information for the patient
Losartan potassium / Hydrochlorothiazide 50 mg /12.5 mg Film-Coated Tablets Losartan potassium / Hydrochlorothiazide 100 mg /25 mg Film-Coated Tablets
losartan potassium and hydrochlorothiazide
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 please ask your doctor or pharmacist.
• This medicine has been prescribed for 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.
What is in this leaflet:
1. What Losartan potassium / Hydrochlorothiazide is and what it is used for
2. What you need to know 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. Contents of the pack and other information
1. What Losartan potassium / Hydrochlorothiazide 50MG/12.5MG & 100MG/25MG is and what it is used for
Losartan potassium / Hydrochlorothiazide is 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 potassium / Hydrochlorothiazide is indicated for the treatment of essential hypertension (high blood pressure).
2. What you need to know before you take Losartan potassium / Hydrochlorothiazide50MG/12.5MG & 100MG/25MG
Do not take Losartan potassium / Hydrochlorothiazide
- if you are allergic to losartan potassium, to hydrochlorothiazide or to any of the other ingredients in this medicine (listed in section 6)
- if you are allergic 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 in early pregnany - See pregnancy section)
- if you have severely impaired liver function
- if you have a blockage, or reduced flow of bile, such as cholestasis (can be due to impaired liver
function or gallstones) causing jaundice, dark urine, pale stools and itching over the skin
- 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 can not be corrected by treatment
- if you are suffering from gout
- if you have diabetes or impaired kidney function and are taking a medicine called aliskiren to
reduce blood pressure.
Warnings and precautions
You must tell your doctor if you think 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).
It is important to tell your doctor before taking Losartan potassium / Hydrochlorothiazide
- if you have previously suffered from swelling of the face, lips throat or tongue
- if you take diuretics (water tablets)
- if you are on a salt-restricted diet
- if you have or have had severe vomiting and/or diarrhoea or are dehydrated
- if you have heart failure
- if you have cerebrovascular disease (disease of the blood vessels supplying the brain)
- if your liver function is impaired (see section 2 “Do not take Losartan potassium / Hydrochlorothiazide”)
- 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 erythematosus)
- if you have high calcium or low potassium levels or you are on a low potassium diet
- if you have high fat levels in your blood (cholesterol and triglycerides), as the
hydrochlorothiazide in this medicine may cause these to increase .
- 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 your doctor or medical staff that you are taking losartan potassium and hydrochlorothiazde tablets.
- if you 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 of African or Caribbean descent. This medicine may not be as effective for you.
- if you are taking a medicine called aliskiren to reduce blood pressure.
Other medicines and Losartan potassium / Hydrochlorothiazide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Diuretic agents such as the hydrochlorothiazide cointained in Losartan potassium / Hydrochlorothiazide may interact with other medicines.
You should avoid taking Losartan potassium / Hydrochlorothiazide with:
- lithium (used to treat depression),
- potassium supplements, potassium-sparing diuretics (spironolactone, triamterene, amiloride) and potassium salts.
It is also important for your doctor to know if you are taking any of the following medicines. :
• other medicines to reduce your blood pressure such as ACE-inhibitors (e.g. ramipril), methyldopa,
• other diuretics (“water tablets”),
• medicines for the treatment of gout (e.g. probenecid, sulfinpyrazone and allopurinol),
• medicines to control heart rhythm (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide)
• steroids or ACTH (also called corticotropin, a synthetic hormone used to check the function of your adrenal gland)
• medicines to treat cancer (e.g. amifostine, cyclophosphamide, methotrexate),
• pain killers such as non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high dose salicylates (e.g. aspirin),
• drugs for treatment of fungal infections (e.g. fluconazole, amphotericin B by injection),
• arthritis medicines,
• resins used for high cholesterol, such as cholestyramine, colestipol,
• medicines which relax your muscles (e.g. tubocurarine, baclofen),
• sleeping tablets,
• opioid medicines such as morphine,
• ‘pressor amines’ such as adrenaline or other drugs from the same group,
• oral agents for diabetes (e.g. metformin) or insulins,
• medicines to treat neurological disorders such as depression, anxiety, and schizophrenia including tricyclic antidepressants and neuroleptics (such as chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, pimozide, amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol),
• medicines which may give you a dry mouth or blurred vision (e.g. atropine, biperiden)
• medicines for mouth ulcers (e.g. choline salicylate),
• immunosuppressants used for the treatment of auto-immune disorders or following transplant surgery to prevent rejection (e.g. ciclosporin),
• some laxatives (e.g. senna, bisacodyl)
• digoxin or other cardiac glycosides (for the treatment of heart problems),
• bepridil (used to treat angina pectoris),
• cisapride or diphemanil (used to treat gastrointestinal disorders),
• erythromycin by injection (an antibiotic),
• rifampicin (used to treat tuberculosis),
• halofantrine (used to treat certain types of malaria),
• terfenadine or mizolastine (antihistamines for hay fever or allergies),
• pentamidine (used to treat pneumonia),
• vincamine by injection (used to treat memory loss in the elderly),
• calcium including calcium supplements,
• carbamazepine (an antiepileptic).
• glycyrrhizin (found in liquorice and often used in cough medicines if taken in large amounts)
Also inform your doctor you are taking Losartan potassium / Hydrochlorothiazide if you will be undergoing a radiographic procedure and will be given iodine contrast media.
Special precautionary measures (e.g. blood tests) may also be appropriate.
Taking Losartan potassium / Hydrochlorothiazide with food and drink
You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan potassium / Hydrochlorothiazide may increase each other’s effects.
Dietary salt in excessive quantities may counteract the effect of Losartan potassium / Hydrochlorothiazide. Large amounts of glycyrrhizin which is contained in liquorice can affect how well Losartan potassium / Hydrochlorothiazide works.
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.
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 breastfeed, especially if your baby is a newborn, or born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
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. You may feel dizzy or drowsy, especially at the beginning of your treatement or when the dose is increased.
Losartan potassium / Hydrochlorothiazide contains lactose
If you have been told by your doctor that you are lactose intolerant or have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Losartan potassium / Hydrochlorothiazide 50MG/12.5MG & 100MG/25MG
Always take this medicine exactly as your doctor has 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 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.
The recommended 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 / Hydrochlorothiazide 50 mg/12.5 mg Film-coated Tablets or changed to 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-coated Tablets (a stronger strength) per day. The maximum daily dose is 2 tablets per day of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-coated Tablets or 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-coated Tablets.
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.
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.
Taking your medicine
Losartan potassium / Hydrochlorothiazide tablets should be swallowed with a glass of water and can be taken with or without food.
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. Overdose can cause a drop in blood pressure, , fast heart rate, 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 medicine, ask your doctor or pharmacist.
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 / Hydrochlorothiazide tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:
Common (may affect up to 1 in 10people):
• Kidney problems including inflammation of the kidneys and kidney failure,
Uncommon (may affect up to 1 in 100people):
• Angina (chest pain), abnormal heartbeat (fast, slow or irregular), cerebrovascular accident (TIA, “mini-stroke”), heart attack,
• Blood problems including:
o Reduction in white blood cells leading to an increase in infections, o 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), clotting problems and bruising,
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas, Pneumonia, water on the lungs (which causes difficulty breathing),
• If you develop a severe skin rash that causes blistering that can affect the mouth, throat, nose, genitals. This is often accompanied by flu-like symptoms (Toxic Epidermal Necrolysis (TEN)).
Rare (may affect up to 1 in 1,000people):
• A severe allergic reaction (rash, itching, swelling of the face, tongue, lips, mouth or throat that may cause difficulty in swallowing or breathing).
• Hepatitis (inflammation of the liver),
Not known (frequency cannot be estimated from the available data):
• Unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis).
The following other side effects have been reported:
Common (may affect up to 1 in 10people):
• 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 and/or neck pain, dizziness,
• Weakness, tiredness, chest pain,
• Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels,
• Decreased sugar in the blood.
Uncommon (may affect up to 1 in 100people):
• Loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels, low levels of blood sodium and potassium, increase in urea and creatinine levels in the blood,
• 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, vertigo,
• Low blood pressure, which may be associated with changes in posture (feeling light-headed or weak when you stand up), palpitations,
• Inflammation of blood vessels, which is often associated with a skin rash or bruising,
• Sore throat, breathlessness, bronchitis, nosebleed, runny nose, congestion,
• Constipation, wind, stomach upsets, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,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, widespread pain with a heightened and painful response to pressure
• Frequent urination including at night, urinary infection, sugar in the urine,
• Decreased sexual appetite, impotence,
• Swelling of the face, localised swelling, fever.
Rare (may affect up to 1 in 1,000people):
• Abnormal liver function tests
Not known (frequency cannot be estimated from the available data):
• Flu-like symptoms,
• Generally feeling unwell
• Disturbed taste (dysgeusia)
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.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE Losartan potassium / Hydrochlorothiazide 50MG/12.5MG & 100MG/25MG
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
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. Contents of the pack and other information What Losartan potassium / Hydrochlorothiazide contains
The active substances are: losartan potassium and hydrochlorothiazide.
Losartan potassium / Hydrochlorothiazide 50 mg /12.5 mg Film-coated Tablet: contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
Losartan potassium / Hydrochlorothiazide 100 mg /25 mg Film-coated Tablet: contains 100 mg losartan potassium and 25 mg of hydrochlorothiazide.
- The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2 “Hydrochlorothiazide contains lactose”), pregelatinised maize starch, magnesium stearate, hydroxypropylcellulose, hypromellose, titanium dioxide (E171) and yellow iron oxide (E172).
What Losartan potassium / Hydrochlorothiazide looks like and contents of the pack
Losartan potassium / Hydrochlorothiazide 50 mg /12.5 mg Film-Coated Tablets are round, yellow film-coated tablets.
Losartan potassium / Hydrochlorothiazide 100 mg /25 mg Film-Coated Tablets are round, yellow film-coated tablets.
Losartan potassium / Hydrochlorothiazide 50 mg /12.5 mg Film-Coated Tablets are available in blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 tablets and calendar packs containing 28 &
98 tablets.
Losartan potassium / Hydrochlorothiazide 100 mg /25 mg Film-Coated Tablets are available in blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 tablets and calendar packs containing 28 & 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturers:_
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom_
This leaflet was last revised in 06/2014
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