50 mg / 12.5 mg and 100 mg / 25 mg film-coated tablets
losartan potassium / hydrochlorothiazide
What Losartan / Hydrochlorothiazide Teva is and what it is used for
Losartan / Hydrochlorothiazide Teva is a combination of an angiotensin II receptor antagonist ( losartan ) and a diuretic ( hydrochlorothiazide ).
Losartan / Hydrochlorothiazide Teva is used for treating essential hypertension (high blood pressure ).
Losartan potassium/hydrochlorothiazide contained in Losartan / Hydrochlorothiazide Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Losartan / Hydrochlorothiazide Teva
Do not take Losartan / Hydrochlorothiazide Teva
- if you are allergic to losartan , hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to other sulfonamide derivatives (eg other thiazides or certain antibacterial drugs such as the combination trimethoprim and sulfamethoxazole; consult your doctor if you are unsure)
- if you have severe hepatic impairment
- if you have severe renal impairment or if your kidneys do not produce any urine
- if you have low potassium or sodium levels or high calcium levels that cannot be corrected by treatment
- if you have gout
- during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Losartan / Hydrochlorothiazide Teva, see section 2 Pregnancy, breast-feeding and fertility ).
- if you have diabetes or renal impairment and are being treated with a blood pressure lowering medicine containing aliskiren
Warnings and cautions
Talk to your doctor or pharmacist before taking Losartan / Hydrochlorothiazide Teva:
- if you have previously experienced swelling of the face, lips, throat and / or tongue
- if you are being treated with diuretics ( diuretics )
- if you eat a low-salt diet
- you have or have been ill with vomiting and / or diarrhea
- if you have heart failure
- if you have a narrowing of the blood vessels leading to your kidneys (renal artery stenosis) or just have a functioning kidney, or if you have recently had a kidney transplant
- if you have narrowing of your arteries (arterosclerosis), angina pectoris (chest pain due to impaired heart function)
- if you have aortic or mitral valve stenosis (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease that enlarges the heart muscle)
- if you have diabetes
- if you have had gout
- if you have or have had an allergic condition, asthma or a condition that causes joint pain, rash and fever ( SLE , systemic lupus erythematosus)
- if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses , may increase the risk of certain types of skin and lip cancer (non- melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Losartan / Hydrochlorothiazide Teva.
- if you have high calcium or low potassium levels or are on a potassium-sparing diet
- if you are going to undergo anesthesia (even at the dentist) or before a surgical procedure, or if you are going to have a test for your parathyroid function. You should then tell your doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets
- if you suffer from primary hyperaldosteronism (a syndrome in which your adrenal glands produce too much of the hormone et aldosterone , caused by a disorder of the adrenal gland)
- You must tell your doctor if you think you are (or might become) pregnant.Losartan / Hydrochlorothiazide Teva is not recommended during early pregnancy and should not be taken during the last 6 months of pregnancy as it may harm your baby at that stage (see section 2 Pregnancy, breast-feeding and fertility )
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (eg enalapril , lisinopril, ramipril), especially if you have diabetes-related kidney problems.
- aliskiren
- if you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within hours to weeks after taking Losartan / Hydrochlorothiazide Teva. This can lead to permanent visual impairment if left untreated. You may be at a higher risk of developing this if you have previously had an allergic reaction to penicillin or sulfonamides .
Older
Losartan / Hydrochlorothiazide Teva has an equivalent effect and is just as well tolerated in the elderly as in adolescents. Most elderly patients need the same dose as younger patients.
Children and young people
There is no experience with the use of losartan potassium and hydrochlorothiazide in children. Therefore, Losartan / Hydrochlorothiazide Teva should not be given to children.
Other medicines and Losartan / Hydrochlorothiazide Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diuretics, such as hydrochlorothiazide in these tablets, may interact with other medicines. Medicines containing lithium should not be taken with Losartan / Hydrochlorothiazide Teva without close medical supervision. Special precautions (eg blood tests) may be necessary if you are taking potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines, other diuretics ( diuretics ), certain laxatives, glycyrrhizin (found in licorice), medicines used to treat gout, medicines to treat heart rhythm disorders or diabetes medications (tablets or insulin). It is also important that your doctor knows if you are taking other antihypertensive drugs, steroids, cancer drugs, pain medications, antifungal medicines, medicines for arthritis, resins used for high cholesterol such as cholestyramine, muscle relaxants, sleeping pills, opioid drugs such as morphine, ‘pressor amines such as adrenaline or other drugs within the same drug group.
Your doctor may need to change your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Losartan / Hydrochlorothiazide Teva” and “Warnings and precautions”).
Also, tell your doctor that you are taking Losartan / Hydrochlorothiazide Teva before a scheduled examination with iodinated contrast media.
Losartan / Hydrochlorothiazide Teva with food, drink and alcohol
You should not drink alcohol while taking these tablets: alcohol and Losartan / Hydrochlorothiazide Teva may enhance each other’s effects.
Too much salt in the diet can counteract the effects of Losartan / Hydrochlorothiazide Teva.
You should avoid foods and beverages that contain licorice, as glycyrrhizin contained in licorice can cause abnormal levels in the blood salt balance.
Losartan / Hydrochlorothiazide Teva can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you suspect you may be pregnant or may become pregnant. Usually, your doctor will suggest that you stop taking Losartan / Hydrochlorothiazide Teva and start another treatment before you become pregnant or as soon as you know you are pregnant. Losartan / Hydrochlorothiazide Teva is not recommended in early pregnancy and should not be taken during the last 6 months of pregnancy as this medicine may cause birth defects.
Breast-feeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Losartan / Hydrochlorothiazide Teva is not recommended for breastfeeding mothers. Your doctor may recommend an alternative treatment if you want to breastfeed.
Driving and using machines
When starting treatment with this medicine, you should not perform actions that may require sharp attention (such as driving a motor vehicle or performing dangerous work) until you know how well you tolerate your medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Losartan / Hydrochlorothiazide Teva contains 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 / Hydrochlorothiazide Teva
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will decide on the appropriate dose of Losartan / Hydrochlorothiazide Teva, depending on your medical condition and whether you are taking other medicines. You must continue to take Losartan / Hydrochlorothiazide Teva according to your doctor’s prescription to maintain even control of your blood pressure.
High blood pressure The
recommended maintenance dose for most patients is one Losartan / Hydrochlorothiazide Teva 50 mg / 12.5 mg tablet once daily to monitor blood pressure over 24 hours. Dose one can be increased to two tablets once daily of Losartan / Hydrochlorothiazide Teva 50 mg / 12.5 mg film-coated tablets or changed to one tablet of Losartan / Hydrochlorothiazide Teva 100 mg / 25 mg film-coated tablets (a stronger strength) once daily. The maximum daily dose is two Losartan / Hydrochlorothiazide Teva 50 mg / 12.5 mg film-coated tablets or one Losartan / Hydrochlorothiazide Teva 100 mg / 25 mg film-coated tablet once daily.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Losartan / Hydrochlorothiazide Teva and contact a doctor or emergency department immediately at the nearest hospital if you experience any of the following symptoms:
Severe allergic reaction (rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing and difficulty breathing).
This is a serious but rare side effect, occurring in more than 1 in 10,000 patients but in less than 1 in 1,000 patients. In this case, you may need immediate medical or hospital care.
The following side effects have been reported:
Common (may affect up to 1 in 10 people):
- Cough, upper respiratory tract infection, nasal congestion, sinusitis, other sinus disease
- Diarrhea, stomach pain, nausea, indigestion
- Muscle aches or cramps, leg pain, back pain
- Insomnia, headache, dizziness
- Weakness, fatigue, chest pain
- Elevated potassium levels (which may cause abnormal heart rhythms), decreased hemoglobin levels
Uncommon (may affect up to 1 in 100 people):
- Anemia ( anemia ), red or brownish spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and stomach pain), bruising, reduction in white blood cells , clotting problems and bruising
- Loss of appetite, increased amount of uric acid or gout , elevated blood sugar levels, abnormal levels in the salt balance of the blood
- Anxiety, nervousness, panic disorder (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory disorders
- Ants crawling or similar sensations, pain in arms and legs, tremors, migraines , fainting
- Blurred vision, burning or stinging pain in the eyes, eye inflammation ( conjunctivitis ), impaired visual acuity , yellowing
- Ear ringing, wheezing, howling / clicking sound in the ears
- Low blood pressure , which can occur in connection with a change in posture (feeling of dizziness or weakness when you stand up), angina (chest pain), abnormal heartbeat, disorders of the cerebral circulation ( TIA , mini- stroke ), heart attack, palpitations
- Inflammation of the blood vessels, often with rash or bruising
- Sore throat, shortness of breath, inflammation of the trachea, pneumonia , water in the lungs (which causes difficulty breathing), nosebleeds, runny nose, nasal congestion
- Constipation, gas problems, indigestion, stomach cramps, vomiting, dry mouth , salivary gland inflammation, toothache
- Jaundice (yellowing of the skin and whites of the eyes), inflammation of the pancreas
- Hives , itching , inflammation of the skin, rash, redness, photosensitivity, dry skin, redness, sweating, hair loss
- Pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness
- Frequent bladder emptying (even at night), abnormal kidney function, including inflammation of the kidneys, urinary tract infection, sugar in the urine
- Reduced sex drive, impotence
- Swelling of the face, fever
Rare (affects up to 1 in 10,000 users)
- Hepatitis, abnormalities in liver function tests
No known frequency (can not be calculated from the available data)
- Abnormal muscle breakdown that can lead to kidney problems
- Taste changes ( dysgeusia )
- Skin and lip cancer (non- melanoma skin cancer)
- Impaired vision or pain in your eyes due to increased pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma ).
How to store Losartan / Hydrochlorothiazide Teva
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 carton and blister after EXP. The expiration date is the last day of the specified month.
Do not store above 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.
Contents of the package and other information
Content declaration
- The active substances are losartan potassium and hydrochlorothiazide . Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide . Each tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide .
- The other ingredients are
Tablet core: lactose monohydrate , microcrystalline cellulose (E460a), pregelatinized maize starch, magnesium stearate (E572)
Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide.
What the medicine looks like and contents of the pack
- Losartan / Hydrochlorothiazide Teva 50 mg / 12.5 mg film-coated tablets are yellow, oval, biconvex tablets marked with “5” and “0” on one side and a score line on both sides.
The tablet can be divided into two equal doses . - Losartan / Hydrochlorothiazide Teva 100 mg / 25 mg film-coated tablets are yellow, oval, biconvex tablets debossed with “1” and “00” on one side and a score line on both sides.
The tablet can be divided into two equal doses . - 50 mg / 12.5 mg tablets are sold in packs containing 1, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets, calendar packs containing 28 tablets and hospital packs containing 50×1 and 280 ( 10×28) tablets. HDPE cans with screw caps with safety closure: 100 and 250 tablets.
- 100 mg / 25 mg tablets are sold in packs containing 1, 7, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets, calendar packs containing 7 and 28 tablets and hospital packs containing 50×1 and 280 (10×28) tablets. HDPE cans with screw caps with safety closure: 30 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Pharmachemie BV
Haarlem, Netherlands
Teva Pharmaceutical Works Private Limited Company
Debrecen, Hungary
Teva Czech Industries sro
Opava, Czech Republic
Merckle GmbH
Blaubeuren, Germany
Teva Pharma SLU
Zaragoza, Spain