1 What Losartan HCT tablets are and what they are used for
Losartan HCT tablets are a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).
Losartan HCT tablets are indicated for the treatment of essential hypertension (high blood pressure).
2 Before you take
Do not take Losartan HCT tablets if you
- are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other ingredients of Losartan HCT tablets (see section 6 “What Losartan HCT tablets contain”)
- 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)
- have severely impaired liver function
- are more than 3 months pregnant (it is also better to avoid Losartan HCT tablets in early pregnancy – see pregnancy section)
- have severely impaired kidney function or your kidneys are not producing any urine
- have low potassium, low sodium or high calcium levels which cannot be corrected by treatment
- are suffering from gout.
Take special care with Losartan HCT tablets if you
- have previously suffered from swelling of the face, lips, throat or tongue
- take diuretics (water pills)
- are on a salt-restricted diet
- have or have had severe vomiting and/or diarrhoea
- have heart failure
- 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 (atherosclerosis), angina pectoris (chest pain due to poor heart function)
- have ‘aortic or mitral valve stenosis’ (narrowing of the valves of the heart) or ‘hypertrophic cardiomyopathy’ (a disease causing thickening of heart muscle)
- are diabetic
- have had gout
- have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematosus)
- have high calcium or low potassium levels or you are on a low potassium diet
- 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 HCT tablets.
- suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldesterone by the adrenal gland, caused by an abnormality within the gland).
You must tell your doctor if you think you are (or might become) pregnant. Losartan HCT tablets are 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).
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.
Diuretic agents such as the hydrochlorothiazide contained in Losartan HCT tablets may interact with other medicines.
Preparations containing lithium should not be taken with Losartan HCT 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, 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,
- 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 (epinephrine) or other drugs from the same group.
Please also inform your doctor you are taking Losartan HCT tablets if you will be undergoing a radiographic procedure and will be given iodine contrast media.
Taking Losartan HCT tablets with food and drink
You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan HCT tablets may increase each other’s effects.
Dietary salt in excessive quantities may counteract the effect of Losartan HCT tablets.
Losartan HCT tablets may be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicines.
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Losartan HCT 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 HCT tablets. Losartan HCT 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.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan HCT tablets are 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 newborn, or was born prematurely.
Use in children and adolescents
There is no experience with the use of Losartan HCT tablets in children. Therefore, Losartan HCT tablets should not be given to children.
Use in elderly patients
Losartan HCT tablets work 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 a car or operating dangerous machinery) until you know how you tolerate your medicine.
3 How to take
Always take Losartan HCT tablets exactly as your doctor has instructed you. Your doctor will decide on the appropriate dose of Losartan HCT tablets depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan HCT tablets 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 HCT tablets for most patients with high blood pressure is 1 Losartan HCT 50/12.5mg tablet once daily to control blood pressure over the 24-hour period. This can be increased to 2 Losartan HCT 50/12.5mg tablets once daily or 1 Losartan HCT 100/25mg tablet (a stronger strength) once daily. The maximum daily dose is 2 Losartan HCT 50/12.5mg tablets or 1 Losartan HCT 100/25mg tablet.
If you take more Losartan HCT tablets than you should
In case of an overdose, contact your doctor immediately so that medical attention may be given promptly. An overdose can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition and dehydration.
If you forget to take Losartan HCT tablets
Try to take Losartan HCT tablets daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule.
If you stop taking Losartan HCT tablets
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, Losartan HCT tablets can cause side effects, although not everybody gets them.
If you experience the following, stop taking Losartan HCT 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 (affecting less than one person in 10 but more than one person in 100):
- 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 (affecting less than one person in 100 but more than one person in 1,000):
- 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, “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 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 (more than 1 out of 10000 patients and less than 1 out of 1000 patients):
- Hepatitis (inflammation of the liver), abnormal liver function tests
Not known (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)
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5 How to store
Keep out of the reach and sight of children.
Do not use Losartan HCT tablets after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
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 Further information
What Losartan HCT tablets contain
- The active substances are losartan potassium and hydrochlorothiazide.
Each Losartan HCT 50mg/12.5mg tablet contains 50mg losartan potassium and 12.5mg hydrochlorothiazide.
Each Losartan HCT 100mg/25mg tablet contains 100mg losartan potassium and 25mg hydrochlorothiazide.
- The other ingredients are:
- Tablet core: mannitol (E421), microcrystalline cellulose, croscarmellose sodium, povidone (K-30), magnesium stearate.
- Film-coating: hypromellose (3cP, 50cP), hydroxypropylcellulose, titanium dioxide (E171), macrogol 400.
What Losartan HCT tablets look like and contents of the pack
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg tablets are white, round, biconvex, 8mm film-coated tablets, scored on both sides, with side scores. “LH1” is marked on one side.
Losartan potassium/Hydrochlorothiazide 100mg/25mg tablets are white, round, biconvex, 10mm film-coated tablets, scored on both sides, with side scores. “LH2” is marked on one side.
28 film-coated tablets
Marketing Authorisation Holder
Actavis Group PTC ehf
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