Losartan Potassium/Hydrochlorothiazide 100mg/25mg Film-Coated Tablets
- pins and needles or similar sensations, pain or numbness in the extremities, trembling
- migraine, fainting
- blurred vision, burning or stinging in the eyes, conjunctivitis, worsening eyesight, seeing things in yellow
- ringing, buzzing or clicking in the ears
- low blood pressure, feeling light headed or weak when you stand up
- angina (heaviness or tightness in the chest along with heart pain), abnormal heartbeat, stroke, heart attack, heart palpitations, change in heart rhythm
- sore throat, nosebleed, runny nose
- swelling of the face, fever
- breathlessness, bronchitis, pneumonia, fluid on the lungs
- constipation, wind, stomach upsets, stomach spasms, vomiting
- dry mouth, inflammation of saliva glands, dental pain
- hives, itchy rash, inflammation or redness of the skin, dry skin,
- sensitivity to light, flushing, sweating, hair loss
- pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness
- frequent urination including at night, urinary infection, sugar in the urine
- abnormal kidney function including inflammation of the kidneys and kidney failure
- decreased sexual appetite, impotence
- anaemia, abnormal breakdown of red blood cells, lower white blood cell count, bone marrow failure
- gout, excess of uric acid in the blood
- mild increase in urea and creatine serum levels
Rare side effects (affects 1 to 10 users in 10,000):
- hepatitis (inflammation of the liver), abnormal liver function tests
- high levels of potassium
- rapid swelling of the skin or mucous membranes such as the eyes and mouth
Very Rare (affects less than 1 user in 10,000):
- increase in hepatic enzymes and bilirubin
The following side effects have also been reported but the frequency is not known:
- changes in liver function
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.
Reporting of side effects
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: "http://www.mhra.gov.uk/yellowcard"www.mhra.gov.uk/yellowcard.
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.
Do not store above 30°C.
Medicines should not be disposed of 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 PACK AND OTHER 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: microcystalline cellulose (E460), magnesium stearate (E572), lactose monohydrate, pregelatinized starch.
Tablet film coating: hypromellose (E464), titanium dioxide (E171), margol/PEG 400, iron oxide yellow, indigo carmine aluminium lake (E132)
What Losartan HCT tablets look like and contents of the pack
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg tablets are Yellow, round film-coated tablets, scored on one sides.
Losartan potassium/Hydrochlorothiazide 100mg/25mg tablets are Yellow, oblong film-coated tablets, scored on one sides.
They come in blisters of: 7, 10, 14, 28, 30, 50, 56, 90, 98. (Not all pack sizes may be marketed)
Marketing Authorisation Holder and Manufacturer
Medreich PLC, Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail: info@medreich.co.uk
Losartan potassium/Hydrochlorothiazide 50/12.5 mg: PL 21880/0143 Losartan potassium/Hydrochlorothiazide 100/25 mg: PL 21880/0144
This leaflet was last revised in 01/2014.
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Package leaflet: Information for the user
Losartan Potassium/Hydrochlorothiazide
50/12.5mg and 100/25mg Film-Coated Tablets
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 HCT tablets are and what they are used for
2. What you need to know before you take these tablets
3. How to take the tablets
4. Possible side effects
5. How to store
6. Contents of pack and other information
1. WHAT LOSARTAN HCT TABLETS ARE AND WHAT THEY ARE USED FOR
Losartan Potassium/Hydrochlorothiadise tablets (from here on called Losartan HCT tablets) are 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 HCT tablets are indicated for the treatment of essential hypertension (high blood pressure).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THESE TABLETS Do not take Losartan HCT tablets if you:
- are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other ingredients listed in section 6.
- 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.
- suffer from high calcium, low potassium or low sodium levels in your blood that does not respond to treatment.
- have severely impaired liver function or blockage of bile ducts.
- are suffering from gout.
- are more than 3 months pregnant (it is also better to avoid Losartan HCT tablets in early pregnancy. See ‘Pregnancy and Breastfeeding')
- have severely impaired kidney function or your kidneys are not producing any urine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Losartan HCT tablets if you:
- have, or have a history of, angio-oedema (swelling of the face, lips, throat, and/or tongue)
- are suffering from severe sickness (vomiting) or diarrhoea
- take or have recently taken other diuretics (water tablets)
- are on a low salt diet
- have high calcium or low potassium levels
- have progressive liver disease (cirrhosis) or mild to moderate liver impairment
- suffer from reduced kidney function, kidney failure, have only one functioning kidney or have received a kidney transplant
- have narrowing (stenosis) or blockage of the blood vessels leading to your kidneys
- have increased secretion of the hormone aldesterone by the adrenal gland (primary hyperaldosteronism)
- suffer from reduced blood supply to the heart (coronary heart disease) or reduced blood circulation in the brain (cerebrovascular disease)
- suffer from heart failure, with or without kidney problems
- have narrowing of the valves of the heart (aortic or mitral valve stenosis)
- suffer from thickening of the heart muscle (hypertrophic cardiomyopathy)
- have an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematosus)
- have diabetes
- are having tests related to your parathyroid gland function
- you will be undergoing a radiographic procedure and are required to take an iodine contrast media
- are of Afro-Caribbean origin then these tablets may not be suitable for you as they may not be as effective as they should be
If any of these points apply to you, do not take this medicine until you have talked to your doctor or pharmacist. You may need to be given a different medicine or the dose may need to be changed.
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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 and Breastfeeding section).
Other medicines and Losartan HCT tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Take particular care if you are taking any of the following:
- other blood pressure lowering medicines as they may additionally reduce your blood pressure e.g. valsartan or telmisartan
- diuretics (water tablets), e.g. bendroflumethiazide, indapamide, spironolactone
- other medicines to lower blood pressure, e.g. amlodipine, felodipine, lercanidipine, methyldopa
- medicines for high blood pressure called ACE inhibitors, e.g. enalapril, lisinopril, ramipril
- medicines for heart conditions and high blood pressure called beta-blockers e.g. atenolol, bisoprolol, sotalol
- medicines to treat irregular heart rate, such as quinidine and amiodarone
- medicines for heart failure, e.g. digoxin
- tricyclic antidepressants, e.g. amitriptyline, trazodone, lofepramine
- medicines to treat psychiatric conditions such as schizophrenia and bipolar disorder, e.g. flupentixol, chlorpromazine, olanzapine, risperidone, lithium
- medicines to relax your muscles, including baclofen
- cancer treatments, including amifostine
- medicines which can increase or retain potassium levels, e.g. potassium supplements, salt substitutes, heparin or potassium sparing medicines
- medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that reduce inflammation and pain, e.g. aspirin, ibuprofen, indometacin, naproxen, celecoxib
- medicines used to treat gout, e.g. allopurinol and probenecid
- rifampicin (an antibiotic used to treat tuberculosis)
- medicines to treat fungal infections, including fluconazole
- methotrexate (used to treat cancers, arthritis and psoriasis)
- medicines used to treat arthritis
- medicines that suppress the immune system, e.g. ciclosporin
- epilepsy medication, e.g. carbamazepine
- steroids, e.g. prednisolone, hydrocortisone
- medicines used to treat high cholesterol, e.g. colestyramine
- adrenaline (epinephrine) or other similar medicines that cause a rise in blood pressure
- opioid pain-killer medicines, e.g. dihydrocodeine, morphine
- sleeping tablets
- calcium supplements
Taking Losartan HCT tablets with food and drink
The tablets should be taken with a glass of water. They may be taken with or without food.
Do not drink alcohol whilst taking these tablets as alcohol and Losartan HCT tablets may increase each other's effects.
High levels of salt in your diet may stop Losartan HCT tablets from working properly so avoid eating too much salty 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.
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 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 during 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.
Breastfeeding
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 breastfeed.
Driving and using machines
Losartan HCT tablets can cause dizziness or drowsiness in some people, particularly at the start of treatment or if your dose is increased. If you experience these symptoms contact your doctor before driving or operating machinery.
Losartan HCT tablets contain Lactose
Losartan HCT tablets contain lactose monohydrate. If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE THE TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will decide on the appropriate dose of Losartan HCT tablets depending on your condition and whether you are taking other medicines.
The recommended dose is one Losartan HCT 50/12.5 mg tablet once daily. This dose may be increased to two 50/12.5 mg tablets once daily, or one 100/25 mg tablet once daily, in patients who do not respond to the lower dose. The maximum daily dose is two Losartan HCT 50/12.5mg tablets or one Losartan HCT 100/25mg tablet. The maximum blood-pressure lowering effect should be reached 3 - 4 weeks after beginning treatment.
Swallow this medicine with a glass of water. This medicine may be taken with or without food.
Other dosage information
• Kidney impairment - No change of dosage is required in patients with moderate kidney impairment. This medicine is not recommended for dialysis patients or patients with severe kidney impairment.
• Liver impairment - A lower dose may be considered if you have mild to moderate hepatic impairment. This medicine is not recommended for patients with severe liver impairment.
• Reduced blood volume - Blood volume and/or sodium depletion should be corrected prior to taking this medicine in patients with a reduced blood volume.
• Children and adolescents - This medicine should not be given to children or adolescents under 18 years of age.
• Elderly patients - This medicine is suitable for elderly patients, however the dose should be decreased in elderly patients over 75 years of age.
If you take more Losartan HCT tablets than you should
If you take more Losartan HCT tablets than you should, contact your doctor or pharmacist immediately. If possible take the tablets or box with you. Symptoms of overdose are low blood pressure, heart palpitations or a slow pulse, needing to pass urine more frequently and dehydration.
If you forget to take Losartan HCT tablets
If you miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Losartan HCT tablets
It is important to continue taking Losartan tablets for as long as your doctor prescribes it in order to maintain control of your blood pressure.
If you have the impression that the effect of Losartan is too strong or too weak, please talk to your doctor or pharmacist.
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.
Serious side effects
Stop taking this medicine and contact your doctor or hospital emergency department IMMEDIATELY if you develop any of the following symptoms:
- swelling of the face, lips, mouth or throat, difficulty breathing or swallowing, rash or itching. These could be a sign of a severe allergic reaction.
- yellowing of the eyes and skin (jaundice). This could be a sign of serious liver problems including hepatitis.
- severe abdominal pain with fever and swelling. This could be a sign of inflammation of the pancreas.
Stop taking the tablets and seek immediate medical advice if the above symptoms occur.
Other side effects
The following side effects may also occur:
Common side effects (affects 1 to 10 users in 100):
- cough, upper airway infection, congestion in the nose, inflammation or pain of the sinuses
- diarrhoea, abdominal pain, nausea, indigestion
- muscle pain or cramps, leg pain, back pain
- insomnia (difficulty sleeping)
- headache, dizziness (vertigo)
- chest pain
- weakness, tiredness
- increased potassium levels, reduction of red blood cells, decreased haemoglobin levels
Uncommon side effects (affects 1 to 10 users in 1,000):
- red or brownish spots on the skin with joint pain, stomach pain or swelling of the hands and feet, bruising
- skin rash, bruising or red/purplish discolouration of the skin produced by small bleeding vessels near the surface
- anorexia (weight loss), increased blood sugar levels, abnormal blood electrolyte levels
- anxiety, nervousness, panic attacks, confusion, depression
- abnormal dreams, sleep disorders, sleepiness, memory impairment
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