Losartankalium/HCT 100/12,5 mg ratiopharm, filmomhulde tabletten

1. WHAT 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 kidneys pass more water and salt. This also helps to reduce blood pressure.

It is indicated for the treatment of essential hypertension (high blood pressure).

2. BEFORE YOU TAKE

Do NOT take <Losartan Potassium / Hydrochlorothiazide>

• if you are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other ingredients in this medicine
• if you 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)
• if you are more than 3 months pregnant (It is also better to avoid <Losartan Potassium / Hydrochlorothiazide> in early pregnancy - see “Pregnancy and breast-feeding”)
• 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 low potassium, low sodium or high calcium levels which cannot be corrected by treatment
• if you are suffering from gout.

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Losartan Potassium / Hydrochlorothiazide 100 mg / 12.5 mg Film-coated Tablets

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Take special care with <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 and breast-feeding”).’

It is important to tell your doctor before taking <Losartan Potassium / Hydrochlorothiazide>: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 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 erythematodus)
• 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 aldesterone by the adrenal gland, caused by an abnormality within the gland)
• if your liver function is impaired (see "Do not take <Losartan Potassium / Hydrochlorothiazide>").

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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, glycyrrhizin (found in liquorice), 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,
• arthritis medicines,
• resins used for high cholesterol, such as colestyramine,

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• medicines which relax your muscles,
• sleeping tablets,
• opioid medicines such as morphine,
• 'pressor amines' such as adrenaline or other drugs from the same group.

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.

Taking <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

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 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.

Tell your doctor if you are breast-feeding or about to start breast-feeding. <Losartan Potassium / Hydrochlorothiazide> is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.

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

Use in children and adolescents

There is no experience with the use of <Losartan Potassium / Hydrochlorothiazide> in children. Therefore, it should not be given to children.

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.

Important information about some of the ingredients of <Losartan Potassium / Hydrochlorothiazide>

<Losartan Potassium / Hydrochlorothiazide> contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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3. HOW TO TAKE

Always take <Losartan Potassium / Hydrochlorothiazide> exactly as your doctor has told you. Your doctor will decide on the appropriate dose of <Losartan Potassium / Hydrochlorothiazide> depending on your condition and whether you are taking other medicines. It is important to continue taking <Losartan Potassium / Hydrochlorothiazide> for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

High blood pressure

The usual dose of <Losartan Potassium / Hydrochlorothiazide> for most patients with high blood pressure is 1 tablet of Losartan Potassium / Hydrochlorothiazide 50 mg/12.5 mg per day to control blood pressure over the 24-hour period. This can be increased to 1 tablet once daily of <Losartan Potassium / Hydrochlorothiazide> 100 mg/12.5 mg or 2 tablets once daily of Losartan Potassium / hydrochlorothiazide 50 mg/12.5 mg or changed to 1 tablet daily of Losartan Potassium / Hydrochlorothiazide 100 mg/25 mg (a stronger strength) per day. The maximum daily dose is 2 tablets per day of Losartan Potassium / Hydrochlorothiazide 50 mg/12.5 mg or 1 tablet daily of Losartan Potassium / Hydrochlorothiazide 100 mg/25 mg film-coated tablets.

For doses not realisable/practicable with this strength, other strengths are available.

For oral administration

If you take more <Losartan Potassium / Hydrochlorothiazide> than you should

In case of an overdose, contact your doctor immediately so that medical attention may be given promptly. Overdosage can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forget to take <Losartan Potassium / Hydrochlorothiazide>

Try to take <Losartan Potassium / Hydrochlorothiazide> daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, <Losartan Potassium / Hydrochlorothiazide> can cause side effects, although not everybody gets them.

If you experience the following, stop taking <Losartan Potassium / Hydrochlorothiazide> and tell your doctor immediately or go to the casualty department of your nearest hospital:

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

This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than 1 out of 1,000 patients. You may need urgent medical attention or hospitalisation.

The following side effects have been reported:

Common (affecting 1 to 10 users in 100):

• Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder,
• Diarrhoea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,

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Losartan Potassium / Hydrochlorothiazide 100 mg / 12.5 mg Film-coated Tablets

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• Weakness, tiredness, chest pain,
• Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels.

Uncommon (affecting 1 to 10 users in 1,000):

• Anaemia, red or brownish spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of the hands and feet and stomach pain), bruising, reduction in white blood cells, clotting problems and bruising,
• Loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, sleepiness, memory impairment,
• Pins and needles or similar sensations, pain in the extremities, trembling, migraine, fainting,
• Blurred vision, burning or stinging in the eyes, conjunctivitis, worsening eyesight, seeing things in yellow,
• Ringing, buzzing, roaring or clicking in the ears,
• Low blood pressure, which may be associated with changes in posture (feeling light-headed or weak when you stand up, angina (chest pain), abnormal heartbeat, cerebrovascular accident (TIA, “mini-stroke”), heart attack, palpitations,
• Inflammation of blood vessels, which is often associated with a skin rash or bruising,
• Sore throat, breathlessness, bronchitis, pneumonia, water on the lungs (which causes difficulty breathing), nosebleed, runny nose, congestion,
• Constipation, wind, stomach upsets, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
• Hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss,
• Pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination including at night, abnormal kidney function including inflammation of the kidneys, urinary infection, sugar in the urine,
• Decreased sexual appetite, impotence,
• Swelling of the face, fever.

Rare (affecting 1 to 10 users in 10,000)

• Hepatitis (inflammation of the liver), abnormal liver function tests.

Not known (cannot be estimated from the available data)

• Muscle wasting (rhabdomyolysis)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE

Keep out of the reach and sight of children.

Do not use <Losartan Potassium / Hydrochlorothiazide>after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package in order to protect from moisture.

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.

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Losartan Potassium / Hydrochlorothiazide 100 mg / 12.5 mg Film-coated Tablets

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What <Losartan Potassium / Hydrochlorothiazide> contains

• The active substances are losartan potassium and hydrochlorothiazide. Each film-coated tablet contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
• The other ingredients are lactose monohydrate, starch pregelatinised, cellulose microcrystalline and magnesium stearate in the tablet core and poly(vinyl alcohol) part-hydrolyzed, titanium dioxide (E171), macrogol 3350 and talc in the film-coating.

What <Losartan Potassium / Hydrochlorothiazide> looks like and contents of the pack

• Film-coated tablet
• White, biconvex, oval-shaped film-coated tablet debossed "LH" on one side and plain on the other
• Available in blisters 14, 15, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 280 film-coated tablets. 50x1 unit dose (hospital pack) film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Vergunninghouder ratiopharm Nederland B.V. Florapark 4

2012 HK Haarlem Nederland

Fabrikanten

TEVA UK Ltd

Brampton Road, Hampden Park,

Eastbourne, East Sussex, BN22 9AG

Engeland

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Nederland

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hongarije

Teva Czech Industries s.r.o. Ostravská 29, c.p. 305

747 70 Opava, Komárov Tsjechië

TEVA PHARMA, S.L.U.

C/ C, n° 4, Poligono Industrial Malpica,

Zaragoza, 50016 Zaragoza

Spanje

In het register ingeschreven onder nummer:

RVG 109787

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Losartan Potassium / Hydrochlorothiazide 100 mg / 12.5 mg Film-coated Tablets

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<This medicinal product is authorised in the Member States of the EEA under the following names:>

<{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}> <[To be completed nationally]>

This leaflet was last approved in mei 2012

<[To be completed nationally]>

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