50 mg / 12.5 mg and 100 mg / 25 mg film-coated tablets
losartan potassium / hydrochlorothiazide
What Losartan / Hydrochlorothiazide Krka is and what it is used for
Losartan / Hydrochlorothiazide Krka is a combination of an angiotensin II receptor antagonist ( losartan ) and a diuretic ( hydrochlorothiazide ).
Losartan / Hydrochlorothiazide Krka is indicated for the treatment of essential hypertension (high blood pressure ).
Losartan and hydrochlorothiazide contained in Losartan / Hydrochlorothiazide Krka may also be approved for the treatment of other conditions not mentioned in this information. Ask your doctor, pharmacist or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Losartan / Hydrochlorothiazide Krka
Do not use Losartan / Hydrochlorothiazide Krka
- if you are allergic to losartan , hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6)
- during the last 6 months of pregnancy. (even earlier in pregnancy you should avoid Losartan / Hydrochlorothiazide Krka, see section Pregnancy and breast-feeding )
- if you have severe hepatic impairment, bile stasis or other disease that blocks the bile ducts
- if you have severe renal impairment (ie creatinine clearance less than 30 ml / min)
- 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
- 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 Krka:
- 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 (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 had an allergic condition, asthma or a condition that causes joint pain, rash and fever ( SLE , systemic lupus erythematosus)
- if you have high calcium levels or low potassium levels or are on a low potassium 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 to check 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 secrete too much of the hormone et aldosterone , caused by a disorder of the adrenal gland)
- 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 Krka
- 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 Krka. This can lead to permanent vision loss, if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at greater risk of developing this.
- 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
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading ” Do not take Losartan / Hydrochlorothiazide Krka “.
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Losartan / Hydrochlorothiazide Krka is not recommended during early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects (see section Pregnancy and breastfeeding).
Older
Losartan / Hydrochlorothiazide Krka 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 in the treatment of Losartan / Hydrochlorothiazide Krka in children. Losartan / Hydrochlorothiazide Krka should therefore not be given to children.
Other medicines and Losartan / Hydrochlorothiazide Krka
Talk to your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diuretics such as hydrochlorothiazide in Losartan / Hydrochlorothiazide Krka may interact with other medicines.
Medicines containing lithium should not be taken with Losartan / Hydrochlorothiazide Krka without the close supervision of your doctor.
Special precautions (eg blood tests) are appropriate if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, other diuretics ( diuretics ), certain laxatives, medicines to treat gout, medicines to control your heart rhythm, or to treat diabetes (both insulin and oral medicines). It is also important for your doctor to know if you are taking other antihypertensive drugs, steroids, anti-cancer drugs, painkillers, anti-fungal drugs, anti-arthritis drugs, resins for high cholesterol such as cholestyramine, muscle relaxants, sleeping pills, opioid medicines such as morphine, pressor amines such as adrenaline or other medicines within the same group of medicines (oral diabetes medicines or insulin ).
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 Krka ” and ” Warnings and precautions “).
Also, tell your doctor that you are taking Losartan / Hydrochlorothiazide Krka if you are going to have an X-ray examination with an iodinated contrast medium.
Losartan / Hydrochlorothiazide Krka with food, drink and alcohol
Alcohol should be avoided while you are taking these tablets. Alcohol and Losartan / Hydrochlorothiazide Krka may enhance each other’s effects.
An excess of salt in the diet can counteract the effect of Losartan / Hydrochlorothiazide Krka.
Losartan / Hydrochlorothiazide Krka 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
Contact your doctor if you think you are (or might become) pregnant during treatment. Usually, your doctor suggests that you stop taking Losartan / Hydrochlorothiazide Krka before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Losartan / Hydrochlorothiazide Krka should not be used in early pregnancy and should not be used 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 Krka is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breastfeed your baby, especially if your baby is newborn or born prematurely.
Driving and using machines
When starting treatment with this medicine, you should not perform any 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 attention. 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 Krka 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 use Losartan / Hydrochlorothiazide Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will decide on the appropriate dose of Losartan / Hydrochlorothiazide Krka, depending on your medical condition and whether you are taking other medicines. You must continue to take Losartan / Hydrochlorothiazide Krka according to your doctor’s prescription to maintain even control of your blood pressure.
If you use more Losartan / Hydrochlorothiazide Krka than you should
High blood pressure
The usual maintenance dose for most patients with high blood pressure is a Losartan / Hydrochlorothiazide Krka 50 mg / 12.5 mg tablet once daily to monitor blood pressure over 24 hours. Your doctor may increase the dose one to two tablets once a day or change it to a tablet daily of Losartan / Hydrochlorothiazide Krka 100 mg / 25 mg film-coated tablets (higher strength). The maximum daily dose is two tablets of Losartan / Hydrochlorothiazide Krka 50 mg / 12.5 mg film-coated tablets or one tablet of Losartan / Hydrochlorothiazide Krka 100 mg / 25 mg film-coated tablets.
In case of overdose, contact your doctor immediately so that care can be given immediately. Symptoms of overdose include a drop in blood pressure, palpitations, slow heart rate, changes in blood composition, and dehydration.
If you forget to use Losartan / Hydrochlorothiazide Krka
Try to take Losartan / Hydrochlorothiazide Krka as prescribed . Do not take a double dose to make up for a forgotten dose, but take the next dose as usual.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, stop taking Losartan / Hydrochlorothiazide Krka and talk to your doctor immediately or seek medical advice:
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth, or throat, which can cause difficulty swallowing and breathing).
This is a serious but rare side effect, occurring in more than 1 in 10,000 and less than 1 in 1,000 users. You may need emergency medical care or hospitalization.
The following side effects have been reported:
Common ( may affect up to 1 in 10 people):
- cough, upper respiratory tract infection, nasal congestion, sinusitis , sinus problems
- diarrhea, abdominal pain, nausea, indigestion
- muscle aches or cramps, leg pain, back pain
- insomnia, headache, dizziness
- weakness, fatigue, chest pain
- increased potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels
Uncommon ( may affect up to 1 in 100 people):
- anemia , red or brown skin spots (in some cases especially on the feet, legs, arms and buttocks, with joint pain, swelling of the hands and feet and stomach pain), bruising, decreased white blood cell count , coagulation problems and bruising
- loss of appetite, increased levels of uric acid or gout , increased blood sugar levels, disturbed salinity in the blood
- anxiety, nervousness, panic disorder (recurrent panic attacks), confusion, depression, altered dream pattern, sleep disorders, drowsiness, impaired memory
- numbness and tingling or similar sensations, pain in the extremities , tremors, migraines , fainting
- blurred vision, burning sensation in the eyes, conjunctivitis in the eye, decreased visual acuity , yellowing
- ringing, buzzing, roaring or clicking in the ears
- low blood pressure , which may be associated with posture (feeling dizzy or weak when standing up), angina (chest pain), irregular heartbeat, cerebrovascular event ( TIA , “mini-stroke”), heart attack, palpitations
- inflammation of blood vessels, which is often associated with skin rashes or bruising
- sore throat, shortness of breath, bronchitis , pneumonia , water in the lungs (causing difficulty breathing), nosebleeds, runny nose, nasal congestion
- constipation, flatulence, stomach upset, stomach spasms, vomiting, dry mouth, salivary gland inflammation , toothache
- jaundice (yellow whites of the eyes and skin), pancreatitis
- hives, itching , dermatitis, rash, flushing, photosensitivity, dry skin, hot flashes, sweating, hair loss
- pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness
- frequent urination including at night, renal impairment including nephritis, urinary tract infection, sugar in the urine
- decreased sexual desire, impotence
- facial swelling, fever
Rare ( may affect up to 1 in 1,000 people):
- hepatitis ( inflammation of the liver), abnormal liver function tests
No known frequency (can not be calculated from the available data):
- skin and lip cancer (Non- melanoma skin cancer)
- rhabdomyolysis
- taste change ( dysgeusia )
- impaired vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma )
How to store Losartan / Hydrochlorothiazide Krka
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 30 ° C. Store in the original package. Moisture sensitive.
HDPE tablet jar:
The shelf life of broken packaging is 100 days.
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 pack and other information
Content declaration
The active substances are losartan potassium and hydrochlorothiazide.
50 mg / 12.5 mg: Each film-coated tablet contains 50 mg of losartan potassium equivalent to 45.76 mg of losartan and 12.5 mg of hydrochlorothiazide .
100 mg / 25 mg : Each film-coated tablet contains 100 mg of losartan potassium equivalent to 91.52 mg of losartan and 25 mg of hydrochlorothiazide .
The other ingredients are pregelatinized maize starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate in the tablet core, hypromellose, macrogol, quinoline yellow (E104), talc, titanium dioxide (E171) in the film coating. See section 2 “Losartan / Hydrochlorothiazide Krka contains lactose”.
What the medicine looks like and contents of the pack
Losartan / Hydrochlorothiazide Krka 50 mg / 12.5 mg: yellow, oval, biconvex, film-coated tablets with the partial notch on one side, 6 mm x 12 mm (oval-shaped), thickness 3.8 – 4.7 mm. The breaker is not for dividing the tablet into equal doses, but only for easier swallowing.
Losartan / Hydrochlorothiazide Krka 100 mg / 25 mg: yellow, oval, biconvex, film-coated tablets, tablet size is 8 mm x 15 mm, thickness 5.1–6.1 mm.
The tablets are supplied in packs containing:
50 mg / 12.5 mg: 10, 14, 28, 30, 56, 60, 84, 90, 98 and 112 film-coated tablets in clear Al / PVC / PVDC blister packs.
100 mg / 25 mg: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 112 film-coated tablets in clear Al / PVC / PVDC blister packs, in a carton.
50 mg / 12.5 mg: 100 film-coated tablets in a white plastic tablet jar with a white, sealed screw cap.
100 mg / 25 mg: 100 film-coated tablets in a white plastic tablet jar with a white, sealed screw cap, in a carton.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer:
50 mg / 12.5 mg and 100 mg / 25 mg
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
50 mg / 12.5 mg
KRKA-POLSKA Sp. z oo, ul. Równoległa 5, 02-235 Warsaw, Poland