Losartan Potassium / Hydrochlorothiazide 50 Mg /12.5 Mg Film-Coated Tablets
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Losartan potassium/Hydrochlorothiazide 50 mg/12.5 mg film-coated tablets Losartan potassium/Hydrochlorothiazide 100 mg/12.5 mg film-coated tablets Losartan potassium/Hydrochlorothiazide 100 mg/25 mg film-coated tablets
losartan potassium / 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, 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 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 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/Hydrochlorothiazide Do not take Losartan potassium/Hydrochlorothiazide
• if you are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other ingredients in this medicine (listed in section 6).
• if you 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)
• if you are more than 3 months pregnant. (It is also better to avoid Losartan potassium/Hydrochlorothiazide in early pregnancy - See Pregnancy.)
• if you have severely impaired liver function
• 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 cannot be corrected by treatment
• if you are suffering from gout
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
Warnings and precautions:
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 pills)
• if you are on a salt-restricted diet
• if you have or have had severe vomiting and/or diarrhoea
• if you have heart failure
• if your liver function is impaired (see section 2 "Do not take Losartan potassium/Hydrochlorothiazide " and 3 "Dosage in special patient groups"
• 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 erythematodus)
• 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.
• 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 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 under the heading “Do not take Losartan potassium/Hydrochlorothiazide”.
Take special care with Losartan potassium/Hydrochlorothiazide
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).
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.
Other medicines and Losartan potssium/hydrochlorothiazide
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Losartan potassium/Hydrochlorothiazide” and “Warnings and Precautions”).
Diuretic agents such as the hydrochlorothiazide contained in Losartan potassium/Hydrochlorothiazide may interact with other medicines.
Preparations containing lithium should not be taken with Losartan potassium/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, 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 for treatment of fungal infections
• arthritis medicines
• resins used for high cholesterol, such as colestyramine
• medicines which relax your muscles
• sleeping tablets
• opioid medicines such as morphine
• ‘pressor amines’ such as adrenaline or other drugs from the same group
• oral agents for diabetes or insulins
Please 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.
Taking Losartan potassium/Hydrochlorothiazide 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.
Losartan potassium/Hydrochlorothiazide tablets may be taken with or without food.
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 breast feed. Especially if your baby is a newborn, or born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
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/ Hydrochlorothiazide contains Lactose
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 Losartan potassium/Hydrochlorothiazide
Always take Losartan potassium/Hydrochlorothiazide exactly as your doctor has instructed 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.
High Blood Pressure
The usual 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 potassium/Hydrochlorothiazide 50 mg/12.5 mg or changed to 1 tablet daily of Losartan potassium/Hydrochlorothiazide 100 mg/25 mg (a stronger strength) per day. The maximum daily dose is 2 tablets per day of Losartan potassium/Hydrochlorothiazide 50 mg/12.5 mg or 1 tablet daily of Losartan potassium/Hydrochlorothiazide 100 mg/25 mg.
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, palpitations, 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, Losartan potassium/Hydrochlorothiazide tablets can cause side effects, although not everybody gets them.
If you experience the following, stop taking Losartan potassium/Hydrochlorothiazide tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:
A severe allergic reaction (rash, itching, swelling of the 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 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, dizziness,
• Weakness, tiredness, chest pain,
• Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels.
Uncommon (may affect up to 1 in 100people):
• 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 of appetite, increased uric acid levels or frank 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, “ministroke”), heart attack, palpitations,
• Inflammation of blood vessels, which is often associated with a skin rash or bruising,
• Sore throat, 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 of the 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 of the face, fever.
Rare (may affect up to 1 in 1,000people)
• Hepatitis (inflammation of the liver), abnormal liver function tests
Other side effects with unknown frequency (cannot be estimated from the available data):
• Unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis)
• Disturbed taste (dysgeusia)
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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 Losartan posttasium/Hydrochlorothiazide Keep this medicine out of the sight and reach of children.
Do not use Losartan potassium/Hydrochlorothiazide after the expiry date which is stated on the blister, carton/label. The expiry date refers to the last day of that month.
Store below 250C.
Do not throw away any medicines via waste water or household waste. Ask you 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 tablets contain 50 mg of losartan potassium and
12.5 mg of hydrochlorothiazide as the active ingredients.
Losartan potassium/Hydrochlorothiazide 100 mg/12.5 mg tablets contain 100 mg of losartan potassium and
12.5 mg of hydrochlorothiazide as the active ingredients.
Losartan potassium/Hydrochlorothiazide 100 mg/25 mg tablets contain 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.
The other ingredients are cellulose microcrystalline, lactose monohydrate, starch pregelatinised, silica colloidal anhydrous, magnesium stearate.
Tablet coat: Hydroxypropyl cellulose (E463), hypromellose 6cp (E464), titanium dioxide (E171), quinoline yellow aluminium lake (E104) [only in 50 mg/12.5 mg & 100 mg/25 mg].
What Losartan potassium/Hydrochlorothiazide looks like and contents of the pack
Film-coated tablets
Losartan potassium/Hydrochlorothiazide 50 mg/12.5 mg
Yellow coloured, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘48’ on the other side.
Losartan potassium/Hydrochlorothiazide 100 mg/12.5 mg
White, Oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘F’ on one side and ‘74’ on the other side.
Losartan potassium/Hydrochlorothiazide 100 mg/25 mg
Yellow coloured, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘49’ on the other side.
Losartan potassium/Hydrochlorothiazide tablets are available in packs of PVC/Aclar - Aluminium foil blisters and HDPE bottle packs.
Pack sizes:
Blister pack: 14, 28, 30, 50, 56, 60, 90, 98, 100, 280 and 500 film-coated tablets Bottle pack: 14, 100 and 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000 Malta