Losartan Potassium/Hydrochlorothiazide 100/25mg Film-Coated Tablets
Package leaflet: Information for the patient
Losartan potassium/ hydrochlorothiazide 100mg/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, 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.
What is in this leaflet:
1. What Losartan potassium/ hydrochlorothiazide 100mg/25 mg film- coated tablets are and what they are used for
2. What you need to know before you take Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets
3. How to take Losartan potassium/ hydrochlorothiazide 100mg/25 mg film- coated tablets
4. Possible side effects
5. How to store Losartan potassium/ hydrochlorothiazide 100mg/25 mg film- coated tablets
6. Contents of the pack and other information
1. What Losartan potassium / hydrochlorothiazide 100/25mg film- coated tablets are and what they are used for
Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablet 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 100mg/25 mg film-coated tablet is indicated for the treatment of essential hypertension (high blood pressure).
2. What you need to know before you take losartan potassium / hydrochlorothiazide 100/25mg film-coated tablets
Do not take Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets:
• if you are allergic to losartan, hydrochlorthiazide or any of the other ingredients of this medicine
(listed in section 6)
• if you are allergic to other sulphonamide derived substances (e.g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure)
• if you are allergic to peanut or soya, do not use this medicinal product.
• if you are more than 3 months pregnant. (It is also better to avoid losartan potassium/hydrochlorothiazide 100mg/25mg film-coated tablets in early pregnancy - see Pregnancy section)
• if you have severely impaired liver function
• if you have severely impaired kidney function or your kidneys are not producing any urine
• if you are suffering from gout
• if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment.
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
Warnings and precautions
Talk to your doctor or pharmacist before taking Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets.
It is important to tell your doctor before taking Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets:
• 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 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 or have had kidney function impairment
• 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 low potassium diet
• 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 your liver function is impaired (see section 2 “Do not take Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets”).
• 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 100mg/25 mg film-coated tablets”.
You must tell your doctor if you think you are (or might become) pregnant. Losartan potassium /hydrochlorothiazide 100 mg/25 mg film coated tablet 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 100mg/25 mg film-coated tablets in children. Therefore, Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets should not be given to children.
Other medicines and Losartan potassium/ hydrochlorothiazide 100mg/25mg film-coated tablets:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Diuretic agents such as the hydrochlorothiazide contained in Losartan potassium/ hydrochlorothiazide 100/25mg film-coated tablets may interact with other medicines.
Preparations containing lithium should not be taken with Losartan potassium/ hydrochlorothiazide 100/25mg film-coated tablets 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 (e.g. spironolactone, triamterene, amiloride), calcium supplements, other diuretics (water tablets), some laxatives, 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) or for diabetes (oral agents or insulins).
It is also important for your doctor to know if you are taking
• Drugs for treatment of infections (e.g., fluconazole, amphotericin B IV, rifampicin, erythromycin IV, pentamidine)
• Drugs to treat malaria (e.g., halofantrin)
• Medicines to treat hay fever (e.g., mizolastin, terfinadine)
• Painkillers (e.g., non-steroidal anti-inflammatory agents)
• Anti-inflammatory medicines (e.g., high doses of salicylates)
• Sleeping tablets (e.g., barbiturates)
• Opiod medicines such as morphine
• Resins used for high cholesterol such as colestyramine and colestipol
• Medicines used for various brain disorders (e.g., vincamine IV)
• Medicines used to treat seizures (e.g., carbamazepine)
• Steroids
• Other medicines to reduce your blood pressure (e.g., methyldopa)
• Medicines used to treat depression (e.g, tricyclic antidepressants)
• A protective medicine used during cancer treatment (e.g., amifostine)
• ACE (angiotensin-converting enzyme) inhibitors (for the treatment of blood pressure, certain heart conditions, kidney disease in patients with diabetes) - Concomitant treatment should be limited to individually defined cases with close monitoring of renal function
• Antipsychotics (e.g., thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol)
• Medicines to treat cancer (e.g., cyclophosphamide)
• Arthritis medicines (e.g., methotrexate)
• Medicines used to treat stomach problems (e.g., cisapride, diphemanil)
• Medicines which relax your muscles (e.g., tubocurarine, baclofene)
• Anticholinergic agents that decrease gastrointestinal motility and stomach emptying rate (e.g., atropine and biperiden)
• ’Pressor amines’ such as adrenaline or other drugs from the same group
• Medicines to treat heart problems (e.g., digitalis glycosides, bepridil)
• Cyclosporin (used to suppress immune system in organ transplant and certain type of cancer patients)
• Glycyrrhizin, sweet-tasting compound, found in liquorice root
Please also inform your doctor if you are taking Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets and you will be undergoing a radiographic procedure and will be given iodine contrast media.
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 100mg/25 mg film-coated tablets” and “Warnings and precautions”).
Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets with food, drink and alcohol
You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan potassium/hydrochlorothiazide 100mg/25 mg film-coated tablets may increase each other’s effect.
Dietary salt in excessive quantities may counteract the effect of Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets.
Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated 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 100mg/25 mg film- coated tablets 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 100 mg/25 mg film-coated tablets. Losartan potassium/ hydrochlorothiazide 100 mg/25 mg film- coated tablets is not recommended during 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablet is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed.
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 HCTZ 100/25mg Film- coated tablets contains 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 100/25mg 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/ hydrochlorothiazide 100mg/ 25mg film-coated tablets depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan potassium/ hydrochlorothiazide 100mg/ 25mg film-coated tablets for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
High blood pressure
The recommended dose for most patients with high blood pressure is 1 tablet of Losartan potassium / hydrochlorothiazide 50/12.5mg Film- coated tablets per day to control blood pressure over the 24-hour period.
This can be increased to 2 tablets once daily of Losartan potassium/ hydrochlorothiazide 50mg/12.5 mg film-coated tablets or changed to 1 tablet daily of Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets (a stronger strength) per day.
The maximum daily dose is 2 tablets per day of Losartan potassium/ hydrochlorothiazide 50mg/12.5 mg film-coated tablets or 1 tablet daily of Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets.
Use in children
Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets should not be given to children.
Use in elderly patients
Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets 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.
Method of administration
Swallow these tablets whole with water. You can take tablets with or without food.
Duration of treatment
You should take Losartan HCTZ 100/25mg Film-coated tablets for as long as your doctor tells you to.
If you take more Losartan potassium/ hydrochlorothiazide 100mg/25 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/ hydrochlorothiazide 100mg/25 mg film-coated tablets
Try to take Losartan potassium/ hydrochlorothiazide 100 mg/25 mg film- coated tablets as prescribed. If you miss a dose, just resume your usual schedule. Do not take a double dose to make up for a forgotten dose.
If you stop taking Losartan HCTZ 100/25mg film-coated tablets
Take your tablets as directed and for as long as directed. Do not stop taking them even if you feel better, as otherwise the symptoms may return. Do not stop taking your medicine suddenly unless told to do so by your doctor.
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.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
Serious side effects
If you experience the following, stop taking Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:
Rare
• A severe allergic reaction (rash, itching, rapid swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing, fainting which are the symptoms of anaphylactic reaction)
• Rapid swelling of the face, lips, throat and/ or tongue, breathing difficulties and fainting which are symptoms of angioedema
Uncommon
• Severe skin reactions with redness, blisters, sores or ulceration. If you have any of them, you may have had a serious allergic 5 to Losartan HCTZ 100/25MG Film-coated tablets.
Not known
• Inflammation of the pancreas, which causes severe pain in the abdomen and back These are serious side effects. You may need urgent medical attention or hospitalisation.
Other side effects
The following side effects have been reported:
Common:
• 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
• Changes in kidney function including kidney failure
• Too low sugar in the blood (hypoglycaemia).
Uncommon:
• 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, reduced number of platelets
• 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, vertigo
• Abnormal heartbeat, cerebrovascular accident (TIA, “mini-stroke”), 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 cause difficulty breathing), nosebleed, runny nose, congestion
• Constipation, obstipation, wind, stomach upsets, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache
• Jaundice (yellowing of the eyes and skin)
• 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 tract infection, sugar in the urine
• Decreased sexual appetite, impotence
• Swelling of the face, localised swelling (oedema), fever
• Mild increase in urea and creatinine levels in blood.
Rare side effects:
• Hepatitis (inflammation of the liver, abnormal liver function tests.
Not known:
• Flu-like symptoms
• Unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis)
• Low levels of sodium in the blood (hyponatraemia)
• Generally feeling unwell (malaise)
• Disturbed taste (dysgeusia)
• Skin reaction called cutaeneous lupus erythematosus
• Low blood pressure, which may be associated with changes in posture (feeling light- headed or weak when you stand up
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 potassium/hydrochlorothiazide 100/25mg 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 blister and carton after EXP. The expiry date refers to the last day of that month.
Store in the original package to protect from light. This medicinal product does not require any special temperature conditions
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.
6. Contents of the pack and other information
What Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets contains
The active substances are losartan potassium and hydrochlorothiazide.
Each tablet contains 100mg of losartan potassium and 25mg of hydrochlorothiazide.
The other ingredients are:
Tablet core: Microcrystalline cellulose, Lactose Anhydrous, Pregelatinised Maize Starch,
Magnesium Stearate, Colloidal anhydrous silica, Talc,
Tablet coating: Opadry Amb (Yellow) (Composition:Polyvinyl alcohol,Titanium dioxide, Talc, Lecithin (Soya), Quinoline yellow aluminium lake, Xanthan gum)
What Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets looks like and contents of the pack’
Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets are yellow coloured, circular, biconvex, film-coated tablets debossed with ”LH2” on one side and plain on the other side
Losartan potassium/ hydrochlorothiazide 100mg/25 mg film-coated tablets are available in the following pack sizes: 10/20/28/30/56/98/100
Not all pack sizes may be marketed.
Losartan potassium/ hydrochlorothiazide film-coated tablets are available in two strengths: 50/12.5 mg and 100/25 mg.
Marketing Authorisation Holder:
Ranbaxy (UK) Limited 5th floor, Hyde Park, Hayes 3 11 Millington Road Hayes, UB3 4AZ United Kingdom
Manufacturer:
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH Hoofddorp, The Netherlands Terapia S.A., 124 Fabricii Street , 400 632 Cluj Napoca, Romania
This medicinal product is authorised in the Member States under the following names: Austria: Losartan/HCT Ranbaxy 100 mg/25mg Filmtabletten
Italy: LOSARTAN E IDROCLOROTIAZIDE RANBAXY 100 mg + 25 mg compresse
rivestite con film
Poland: SORTABAX HCT
United Kingdom: Losartan potassium/hydrochlorothiazide 100mg/25mg film-coated tablets