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• leaflet CONSILIENT HEALTH_PL 01656-0069
• leaflet MAH GENERIC_PL 01656-0069
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ANVERSO:

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan potassium/Hydrochlorothiazide 50 mg/12.5 mg fllm-coated tablets Losartan potassium/Hydrochlorothiazide 100 mg/25 mg fllm-coated tablets

Losartan potassium / Hydrochlorothiazide

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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Losartan potassium/Hydrochlorothiazide is and what it is used for

2.    What you need to know before you take Losartan potassium / Hydrochlorothiazide

3.    How    to    take    Losartan    potassium    /

Hydrochlorothiazide

4.    Possible side effects

5.    How    to    store    Losartan    potassium    /

Hydrochlorothiazide

6.    Contents of th pack and other information

1. What Losartan potassium / Hydrochlorothiazide is and what it is used for

Losartan potassium / Hydrochlorothiazide is 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 kidney pass more water and salt. This also helps to reduce blood pressure.

Losartan potassium / Hydrochlorothiazide is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before you take Losartan potassium / Hydrochlorothiazide

Do    not    take Losartan potassium /

Hydrochlorothiazide

•    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

sulphonamide derived substances (e.g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure).

•    If    you have low potassium, low

sodium or high calcium levels which cannot be corrected by treatment.

•    If you are suffering from gout

•    If    you are more than 3 months

pregnant. (It is also better to avoid Losartan potassium / Hydrochlorothiazide in early pregnancy - see Pregnancy section.)

•    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 diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions

Talk to your doctor or pharmacist before taking Losartan potassium / Hydrochlorothiazide You must tell your doctor if you think you are (or might become) pregnant. Losartan potassium / Hydrochlorothiazide is 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 section).

It is important to tell your doctor before taking Losartan potassium / 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 your liver function is impaired (see section 2 “Do not take Losartan potassium / Hydrochlorothiazide)

•    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 aldosterone by the adrenal gland, caused by an abnormality within the gland).

• if you are taking any of the following medicines used to treat high blood pressure:

-    an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.

-    aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Losartan potassium / Hydrochlorothiazide”

Children and adolescent

There is no experience with the use of Losartan potassium / Hydrochlorothiazide in children. Therefore, Losartan potassium / Hydrochlorothiazide should not be given to children and teenagers.

Other medicines and Losartan potassium / Hydrochlorothiazide

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

Diuretic agents such as the hydrochlorothiazide contained in Losartan potassium / Hydrochlorothiazide may interact with other medicines.

Preparations containing lithium should not be taken with Losartan potassium / 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 cholestyramine, 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 you are taking Losartan potassium / Hydrochlorothiazide if you will be undergoing a radiographic procedure and will be given iodine contrast media.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Losartan potassium / Hydrochlorothiazide” and “Warnings and precautions”

Losartan potassium / Hydrochlorothiazide with food and drink

You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan potassium / Hydrochlorothiazide may increase each other’s effects.

Dietary salt in excessive quantities may counteract the effect of Losartan potassium / Hydrochlorothiazide.

Losartan potassium / Hydrochlorothiazide 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 / Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan potassium / Hydrochlorothiazide. Losartan potassium / Hydrochlorothiazide is not recommended in during 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 potassium / Hydrochlorothiazide is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed.

Use in elderly patients

Losartan potassium / 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.

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