LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 50/12.5MG FILM-COATED TABLETS
Read all of this leaflet carefully before taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
- 1. What Losartan potassium and Hydrochlorothiazide is and what it is used for
- 2. Before you take Losartan potassium and Hydrochlorothiazide
- 3. How to take Losartan potassium and Hydrochlorothiazide
- 4. Possible side effects
- 5. How to store Losartan potassium and Hydrochlorothiazide
- 6. Further information
What Losartan Potassium And Hydrochlorothiazide Is And What It Is Used For
- Losartan potassium and Hydrochlorothiazide is a combination of an angiotensin-II receptor antagonists (losartan) and a diuretic (hydrochlorothiazide).
- Losartan potassium and Hydrochlorothiazide is indicated for the treatment of essential hypertension (high blood pressure).
Before You Take Losartan Potassium And Hydrochlorothiazide
Do not take Losartan potassium and Hydrochlorothiazide
- If you are allergic (hypersensitive) to losartan, hydrochlorothiazide or any of the other ingredients in this medicine
- If you are allergic (hypersensitive) 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 more than 3 months pregnant (it is also better to avoid Losartan potassium and Hydrochlorothiazide tablets in early pregnancy - see pregnancy section)
- If you are breast-feeding
- 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.
Take special care with Losartan potassium and 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 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 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 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 potassium and Hydrochlorothiazide tablets are not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as they 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 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, 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, or 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 when it is planned to apply iodine contrast media about taking Losartan potassium and Hydrochlorothiazide.
Taking Losartan potassium and Hydrochlorothiazide with food and drink
You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan potassium and Hydrochlorothiazide tablets may increase each other’s effects.
Dietary salt in excessive quantities may counteract the effect of Losartan potassium and Hydrochlorothiazide tablets.
Losartan potassium and 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 and Hydrochlorothiazide tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead. Losartan potassium and Hydrochlorothiazide tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as they may cause serious harm to your baby if used after the third month of pregnancy.
Breast feeding:You must not take Losartan potassium and Hydrochlorothiazide if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Use in children and adolescents
There is no experience with the use of Losartan potassium and Hydrochlorothiazide in children. Therefore, Losartan potassium and Hydrochlorothiazide should not be given to children
Use in elderly patients
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.
Important information about some of the ingredients of Losartan potassium and Hydrochlorothiazide tablets
Losartan potassium and 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 medicine.
How To Take Losartan Potassium And Hydrochlorothiazide
Always take Losartan potassium and Hydrochlorothiazide tablets exactly as your doctor has instructed you. 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 usual dose of Losartan potassium and Hydrochlorothiazide for most patients with high blood pressure is 1 tablet of Losartan potassium and Hydrochlorothiazide 50mg/12.5mg per day to control blood pressure over the 24-hour period. This can be increased to 2 tablets once daily of Losartan potassium and Hydrochlorothiazide 50mg/12.5mg Film-Coated Tablets or changed to 1 tablet daily of Losartan potassium and Hydrochlorothiazide 100mg/25mg Film-Coated Tablets (a stronger strength) per day. The maximum daily dose is 2 tablets per day of Losartan potassium and Hydrochlorothiazide 50mg/12.5mg Film-Coated tablets or 1 tablet daily of Losartan potassium and Hydrochlorothiazide 100mg/25mg Film-Coated Tablets
If you take more Losartan potassium and Hydrochlorothiazide 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
Try to take Losartan potassium and Hydrochlorothiazide daily as prescribed. However, if you misss a dose, do not take an extra dose. Just resume your usual schedule.
Possible Side Effects
Like all medicines, Losartan potassium and Hydrochlorothiazide tablets can cause side effects, although not everybody gets them.
If you experience the following, stop taking Losartan potassium and 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 (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 pain, 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
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How To Store Losartan Potassium And Hydrochlorothiazide
Keep out of the reach and sight of children.
Do not use Losartan potassium and Hydrochlorothiazide tablets after the expiry date that is stated on the carton after EXP. The expiry date refers to the last day of the month.
Store Losartan potassium and Hydrochlorothiazide in the original package.
Keep the blister in the outer carton. Do not open the blister pack until you are ready to take the medicine.
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.
Further Information
What Losartan potassium and Hydrochlorothiazide tablets contain
The active ingredients are Losartan potassium and Hydrochlorothiazide. Each tablet contains 50mg of losartan potassium, equivalent to 45,76mg of losartan and 12.5mg of hydrochlorothiazide.
- The other ingredients are
Tablet core:
lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate
Film-coating:
hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), Quinoline Yellow Aluminium Lake (E104), Iron Oxide Yellow (E172) and Iron Oxide Black (E172).
What Losartan potassium and Hydrochlorothiazide looks like and contents of the pack
Losartan potassium and Hydrochlorothiazide 50/12.5mg film-coated tablets are yellow, oval-shaped and plain on both sides.
Losartan potassium and Hydrochlorothiazide 50/12.5mg film-coated tablets are available in blisters of 28 tablets (Aluminium blisters with aluminium foil lidding)
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
Or
This leaflet was last revised in November 2009.
‘Winthrop’ is a registered trademark ©. 2009 Winthrop Pharmaceuticals
319739
No comments:
Post a Comment