Losartan Potassium And Hydrochlorothiazide 100mg/12.5 Mg Film-Coated Tablets
TEVA UK Ref: 231-30-18761-E LEA LOSARTAN HCTZ 100mg/12.5mg F/C TABS TUK Version: 1 30 September 2014
PAGE 1: FRONT FACE (INSIDE OF REEL)
Pharma code 56
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 100 mg/12.5 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FORTHE USER
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.
♦ Ifyou have any further questions, askyour doctoror 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.
♦ Ifyou get any side effects, talkto your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
WHAT IS INTHIS LEAFLET:
1. What Losartan potassium and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets are and what they are used for
2. What you need to know before you take Losartan potassium and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets
3. How to take Losartan potassium and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets
4. Possible side effects
5. How to store Losartan potassium and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets
6. Contents of the pack and other information
WHAT LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 100 mg/12.5 mg FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Losartan Potassium and 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.
It is indicated for the treatment of essential hypertension (high blood pressure).
©WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 100 mg/12.5 mg FILM-COATED TABLETS
Do NOT take Losartan potassium and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets
♦ ifyou are allergic to losartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6)
♦ ifyou 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)
♦ ifyou are more than 3 months pregnant (It is also better to avoid Losartan Potassium and Hydrochlorothiazide in early pregnancy - see "Pregnancy and breast-feeding")
♦ ifyou have severely impaired liverfunction
♦ ifyou have severely impaired kidneyfunction oryour kidneys are not producing any urine
♦ ifyou have low potassium, low sodium or high calcium levels which cannot be corrected by treatment
♦ ifyou are suffering from gout
♦ ifyou have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
You must tell your doctor if you think you are (or might become) pregnant. Losartan Potassium and 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 and breast-feeding").
Talk to your doctor or pharmacist before taking Losartan Potassium and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets
♦ ifyou have previously suffered from swelling ofthe face, lips, throat or tongue
♦ ifyou take diuretics (water pills)
♦ ifyou are on a salt-restricted diet
♦ ifyou have or have had severe vomiting and/or diarrhoea
♦ ifyou have heart failure
♦ ifyou have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney, or you have recently had a kidney transplant
♦ ifyou have narrowing ofthe arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function)
♦ if you have 'aortic or mitral valve stenosis' (narrowing ofthe 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 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 and hydrochlorothiazide tablets
♦ ifyou sufferfrom primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldesterone by the adrenal gland, caused by an abnormality within the gland)
♦ if your liverfunction is impaired (see "Do not take Losartan potassium and Hydrochlorothiazide
100 mg/12.5 mg Film-coatedTablets")
♦ 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 diabetes-related kidney problems
♦ aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information underthe heading 'Do nottake Losartan potassium/Hydrochlorothiazide'.
Children and adolescents
There is no experience with the use of Losartan Potassium and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets in children. Therefore, it should not be given to children.
Other medicines and Losartan Potassium and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Diuretic agents such as the hydrochlorothiazide contained in Losartan Potassium and Hydrochlorothiazide may interact with other medicines. Preparations containing lithium should not be taken with Losartan Potassium and Hydrochlorothiazide 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 fortreatment offungal infections
♦ arthritis medicines
♦ resins used for high cholesterol, such as colestyramine
♦ medicines which relax your muscles
♦ sleeping tablets
♦ opioid medicines such as morphine
♦ pressor amines1 such as adrenaline or other drugs from the same group.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitoror aliskiren (see also information underthe headings 'Do not take Losartan potassium/Hydrochlorothiazide' and 'Warnings and precautions').
Please also inform your doctor you are taking Losartan Potassium and Hydrochlorothiazide if you will be undergoing a radiographic procedure and will be given iodine contrast media.
Losartan potassium and Hydrochlorothiazide
100 mg/12.5 mg Film-coated Tablets with food and drink
You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan Potassium and Hydrochlorothiazide may increase each other's effects. Dietary salt in excessive quantities may counteract the effect of Losartan Potassium and Hydrochlorothiazide. Losartan Potassium and Hydrochlorothiazide 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 or pharmacist for advice before taking this medicine.
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 and 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 and Hydrochlorothiazide. Losartan Potassium and Hydrochlorothiazide is not recommended in early pregnancy, and must not be taken when more than
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3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan Potassium and 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.
Elderly people
Losartan Potassium and 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.
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.
Losartan potassium and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets contains lactose Losartan Potassium and Hydrochlorothiazide contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
©HOW TO TAKE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 100 mg/12.5 mg FILM-COATED 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 and Hydrochlorothiazide depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan Potassium and Hydrochlorothiazide 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 and Hydrochlorothiazide for most patients with high blood pressure is 1 tablet of Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg per day to control blood pressure over the 24-hour period. This can be increased to 1 tablet once daily of Losartan Potassium and Hydrochlorothiazide 100 mg/12.5 mg or 2 tablets once daily of Losartan Potassium and hydrochlorothiazide 50 mg/12.5 mg or changed to 1 tablet daily of Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg (a stronger strength) per day. The maximum daily dose is 2 tablets per day of Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg or 1 tablet daily of Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg film-coated tablets.
For doses not realisable/practicable with this strength, other strengths are available.
For oral administration
If you take more Losartan potassium and Hydrochlorothiazide 100 mg/12.5 mg Film-coated 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 and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets
Try to take Losartan Potassium and Hydrochlorothiazide daily as prescribed. Do not take a double dose to make up for a forgotten dose. Just resume your usual schedule. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets, and tell your doctor immediately or go to the casualty department of your nearest hospital:
♦ A severe allergic reaction (rash, itching, swelling ofthe 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 (may affect up to 1 in 10 people):
♦ 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,chestpain
♦ Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels.
Uncommon (may affect up to 1 in 100 people):
♦ 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 ofappetite, increased uric acid levels orfrank 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
♦ Sorethroat, 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 ofthe 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 ofthe face, fever.
Rare (may affect up to 1 in 1,000 people)
♦ Hepatitis (inflammation of the liver), abnormal liver function tests.
Not known (frequency cannot be estimated from the available data)
♦ Muscle wasting (rhabdomyolysis)
♦ Disturbed taste (dysgeusia).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
HOW TO STORE LOSARTAN AND HYDROCHLOROTHIAZIDE 100 mg/12.5 mg FILM-COATED TABLETS
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 carton and blister after EXPThe expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to protect from moisture.
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 to protect the environment.
FURTHER INFORMATION
What Losartan potassium and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets contain
♦ The active substances are losartan potassium and hydrochlorothiazide. Each film-coated tablet contains 100 mg of losartan potassium and
12.5 mg of hydrochlorothiazide.
♦ The other ingredients are lactose monohydrate, starch pregelatinised, cellulose microcrystalline and magnesium stearate in the tablet core and poly(vinyl alcohol) part-hydrolyzed,titanium dioxide (E171), macrogol 3350 and talc in the film-coating.
What Losartan potassium and Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets look like and contents of the pack
♦ Film-coated tablet
♦ White, biconvex, oval-shaped film-coated tablet debossed "LH" on one side and plain on the other
♦ Available in blisters 14, 28, 30, 56, 60, 90, 98 & 100 Film-coated tablets. 50x1 unit dose (hospital pack) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom. This leaflet was last revised in 09/2014 PL 00289/1354 18761-E
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Version 1.9
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