Losartan / Hydrochlorothiazide Sandoz | Losartan potassium / hydrochlorothiazide | uses, dose and side effects

Losartan potassium belongs to a group of medicines called angiotensin II receptor antagonists. These allow the blood vessels to relax, which in turn lowers blood pressure.

Hydrochlorothiazide belongs to a group of medicines called diuretics ( diuretic tablets). Hydrochlorothiazide helps the kidneys get rid of more water and salt, which also lowers blood pressure.

These tablets are used to treat high blood pressure. Tablets containing both losartan potassium and hydrochlorothiazide are a suitable alternative for those who would otherwise have been treated with losartan potassium and hydrochlorothiazide in separate tablets. Losartan / Hydrochlorothiazide Sandoz 100 mg / 12.5 mg is available for patients who need additional blood pressure monitoring and who are already taking either losartan 100 mg or hydrochlorothiazide.

Losartan potassium and hydrochlorothiazide contained in Losartan / Hydrochlorothiazide Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. 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 Sandoz

Do not take Losartan / Hydrochlorothiazide Sandoz

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 sulfonamide derivatives (eg other thiazides , certain antibacterial drugs such as the combination trimethoprim and sulfamethoxazole. Ask your doctor if you are unsure.)
if you are pregnant and have been pregnant for more than 3 months. (It is also better to avoid Losartan / Hydrochlorothiazide Sandoz during early pregnancy – see section Pregnancy)
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
if you have diabetes or renal impairment and are being treated with a blood pressure lowering medicine containing aliskiren.

If you think any of the above conditions apply to you, contact your doctor or pharmacist.

Warnings and cautions

Talk to your doctor or pharmacist before taking Losartan / Hydrochlorothiazide Sandoz.

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Losartan / Hydrochlorothiazide Sandoz is not recommended during early pregnancy and should not be used if more than 3 months have passed since pregnancy can cause serious birth defects (see section Pregnancy).

It is important to tell your doctor before starting treatment with Losartan / Hydrochlorothiazide Sandoz if you:

have previously experienced swelling of the face, lips, throat or tongue
taking diuretics ( diuretic tablets)
eat low-salt diets
have or have had severe vomiting and / or diarrhea
have heart failure
have hepatic impairment (see section 2 “Do not take Losartan / Hydrochlorothiazide Sandoz”)
have narrowing of the blood vessels leading to your kidneys (renal artery stenosis) or if you have only one functioning kidney , or if you have recently had a kidney transplant
receive hemodialysis treatment
has constriction in the artery engines (atherosclerosis), angina (chest pain due to poor heart function)
have narrowing of the heart valves ( aortic or mitral valve stenosis) or a disease that enlarges the heart muscle ( hypertrophic cardiomyopathy )
are diabetic r
have had gout
have or have had an allergic condition, asthma or a condition that causes joint pain, rash and fever ( SLE , systemic lupus erythematosus )
have high calcium – or low potassium levels or if you are on a potassium-sparing diet
should undergo anesthesia (even at the dentist) or before a surgical procedure, or if you should undergo a test for your parathyroid function. In this case, you must tell your doctor or healthcare professional that you are taking Losartan / Hydrochlorothiazide Sandoz.
have 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)
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 Sandoz.
may have 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 a few hours to weeks after taking Losartan / Hydrochlorothiazide Sandoz. Untreated, it can lead to permanent visual impairment. If you have previously had a penicillin and sulfonamide allergy, you may be at a higher risk for 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 Sandoz”.

Children and young people

The safety and efficacy of Losartan / Hydrochlorothiazide Sandoz in children and adolescents below 18 years have not been established. Losartan / Hydrochlorothiazide Sandoz should not be used in children and adolescents.

Other medicines and Losartan / Hydrochlorothiazide Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Your doctor may need to change your dose and/or take other precautions if you are using the following medicines:

lithium (a medicine used to treat mania or depression )
potassium supplements
salt substitutes containing potassium
potassium-sparing drugs
other diuretics ( diuretic tablets )
certain laxatives
drugs used in the treatment of gout
drugs to adjust the heart rhythm
drugs against diabetes (medicines taken by mouth or insulin )
drugs used to lower blood pressure et
steroid is
drugs used in the treatment of cancer
painkillers
medicines for arthritis
medicines used to treat fungal infections
resins used in high cholesterol (eg cholestyramine)
muscle relaxing drugs
sleeping pills
opioid is (eg morphine)
drugs called pressoramines (eg adrenaline )
glycyrrizine (found in licorice)
ACE inhibitors or aliskiren (see also the information under the headings “Do not take Losartan / Hydrochlorothiazide Sandoz” and “Warnings and precautions”).

Also, tell your doctor that you are taking Losartan / Hydrochlorothiazide Sandoz if you are having an X-ray and are taking iodine contrast media.

Losartan / Hydrochlorothiazide Sandoz with food and drink

Alcohol should be avoided while you are taking these tablets. Alcohol and Losartan / Hydrochlorothiazide Sandoz may enhance each other’s effects.

An excess of salt in the diet can counteract the effect of Losartan / Hydrochlorothiazide Sandoz.

Losartan / Hydrochlorothiazide Sandoz can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually, your doctor will advise you to stop taking Losartan / Hydrochlorothiazide Sandoz before pregnancy or as soon as you know you are pregnant and instead recommend another medicine. Losartan / Hydrochlorothiazide Sandoz is not recommended for use in pregnant women and should not be used if more than 3 months after pregnancy, as it may cause serious harm to the baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breastfeeding or planning to start breastfeeding. Losartan / Hydrochlorothiazide Sandoz is not recommended for breastfeeding and your doctor may choose another treatment if you want to breastfeed your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

When starting treatment with this medicine, you should not perform actions that may require sharpened attention (eg 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. The description 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 Sandoz contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.

How to take Losartan / Hydrochlorothiazide Sandoz

Always take Losartan / Hydrochlorothiazide Sandoz 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 Sandoz, depending on your medical condition and whether you are taking other medicines. You must continue to take Losartan / Hydrochlorothiazide Sandoz as prescribed by your doctor to maintain even control of your blood pressure.

Take the tablet with a glass of water. The tablet can be taken with or without food.

Use for adults

The usual dose is 1 tablet daily.

Use for the elderly

Dose adjustment is usually not necessary in the elderly.

Use in patients with renal impairment and during hemodialysis

In the case of moderate renal impairment, no dose adjustment is usually required. Do not use Losartan / Hydrochlorothiazide Sandoz if you have severe renal impairment.

Losartan / Hydrochlorothiazide Sandoz is not recommended for patients receiving hemodialysis.

Use in patients with hepatic impairment

Losartan / Hydrochlorothiazide Sandoz should be used with caution in patients who have had mild to moderate hepatic impairment. Do not use Losartan / Hydrochlorothiazide Sandoz if you have severe hepatic impairment (see section 2. “Do not take Losartan / Hydrochlorothiazide Sandoz”).

Use for children and adolescents

Losartan / Hydrochlorothiazide Sandoz should not be given to children and adolescents under 18 years of age.

Use for black patients

Dose adjustment may be required as Losartan / Hydrochlorothiazide Sandoz may be less effective in black patients than in non-black patients.

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 Sandoz and talk to your doctor immediately or go to the nearest emergency department:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing).

This is a serious but rare side effect that occurs in more than 1 patient in 10,000 but less than 1 patient in 1,000. You may need emergency medical care or hospitalization.

The following side effects have been reported:

Common (may affect up to 1 in 10 people):

coughing, infection of the upper airways, nasal congestion, sinusitis, sinus disorder
diarrhea, stomach pain, nausea, indigestion
muscle aches or cramps, pain in the legs or back
insomnia, headache, dizziness
weakness, fatigue, chest pain
increased potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels
changes in renal function, including renal failure
too low blood sugar ( hypoglycaemia ).

Uncommon (may affect up to 1 in 100 people):

anemia , red or brownish spots on the skin (sometimes especially on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and stomach pain), bruising, decreased number of white blood cells , coagulation problems, decreased number of platelets
loss of appetite, high uric acid levels in the blood or gout , high blood sugar levels, abnormal salt balance in the blood
anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, deviant dreams, sleep disturbance, drowsiness, memory loss
numbness and tingling or similar sensations, pain in arms and legs, tremors, migraines , fainting
blurred vision, burning sensation or tingling in the eyes, conjunctivitis of the eye, impaired visual acuity , yellowing
ringing, buzzing, howling or clicking in the ears, dizziness
low blood pressure , which can be caused by changes in posture (you feel dizzy or weak when standing up), angina (chest pain), abnormal heart rate , cardiovascular event ( TIA , “ministroke”), heart attack, palpitations
inflammation of the blood vessels, which is often associated with skin rashes or bruising
sore throat, shortness of breath, bronchitis , pneumonia , water in the lungs (causing shortness of breath), nosebleeds, runny nose, nasal congestion
constipation, difficult-to-treat constipation, gas, upset stomach, stomach cramps, vomiting, dry mouth , inflammation of the salivary glands, toothache
jaundice (yellow eyes and yellow skin), pancreatitis
hives, itching , inflammation of the skin, rash, redness of the skin, photosensitivity, Lyell’s syndrome (skin that looks like it has been burnt and flaky), dry skin, flushing (heat sensation, redness of the skin), sweating, hair loss
pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness
urinary incontinence (even at night), abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine
decreased sexual desire, impotence
facial swelling, local swelling ( edema ), fever.

Rare (may affect up to 1 in 1,000 people):

hepatitis ( inflammation of the liver), abnormal liver function values.

Has been reported (occurs in the unknown number of users):

flu-like symptoms
unexplained muscle pain with dark (tea-colored) urine ( rhabdomyolysis )
low levels of sodium in the blood ( hyponatremia )
general malaise
taste disorders ( dysgeusia )
skin and lip cancer (non- melanoma skin cancer)
nearsightedness
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 Sandoz

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/jar/blister after EXP. The expiration date is the last day of the specified month.

Blister: Do not store above 25 ° C. Store in the original package. HDPE can: Do not store above 25 ° C. Store in the original package. Close the jar tightly. Moisture sensitive.

Shelf life of the medicine after opening:

Jar: 6 months

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.

One film-coated tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide .

Other ingredients are:

Tablet core: microcrystalline cellulose with silica, croscarmellose sodium, silica, colloidal anhydrous silica, magnesium stearate.

Film coating: hypromellose, hydroxypropyl cellulose, titanium dioxide (E171).

What the medicine looks like and contents of the pack

Losartan / Hydrochlorothiazide Sandoz are white, round, biconvex, film-coated tablets marked with 100 and 12.5 on one side.

The film-coated tablets are packaged in OPA / Alu / PVC / Alu-blister or ACLAR / PVC / Alu-blister and stored in a carton or packed in HDPE jars with PP screw caps. The HDPE can contain silica gel as a desiccant (to absorb moisture) either in the plastic screw cap or in a capsule/bag. Do not swallow the capsule/bag with silica gel.

Blisters: 7, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets

Jar: 100 and 250 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Lek Pharmaceuticals dd Verovskova 57, SI-1526 Ljubljana, Slovenia

Lek SA, Ul. Domaniewska 50 C, 02-672 Warsaw, Poland

Lek SA, Ul. Podlipie 16 C, 95010 Strykow, Poland

Salutas Pharma GmbH, Otto von Guericke Allee 1, 39179 Barleben, Germany

Lek Pharmaceuticals dd, Trimline 2 D, 9220 Lendava, Slovenia