PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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 you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

-    The full name of the medicinal product is Losartan potassium/Hydrochlorothiazide 50 mg/12.5 mg film-coated tablets and Losartan potassium/Hydrochlorothiazide 100 mg/25 mg film-coated tablets but within the leaflet it will be referred to as Losartan potassium/Hydrochlorothiazide tablets.

What is in this leaflet:

1.    What Losartan potassium/Hydrochlorothiazide tablets are and what they are used for

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

3.    How to take Losartan potassium/Hydrochlorothiazide tablets

4.    Possible side effects

5.    How to store Losartan potassium/Hydrochlorothiazide tablets

6.    Contents of the pack and other Information

1.    What Losartan potassium/Hydrochlorothiazide tablets are and what they are used for

Losartan potassium/Hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).

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

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

Do not take Losartan potassium/Hydrochlorothiazide tablets

•    if you are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other ingredients of this medicine (see section 6 “What Losartan potassium/Hydrochlorothiazide tablet contains”).

•    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 have severely impaired liver function

•    if you are more than 3 months pregnant (it is also better to avoid Losartan potassium/Hydrochlorothiazide tablets in early pregnancy - see pregnancy section)

•    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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Losartan potassium/Hydrochlorothiazide tablets

•    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).

You must tell your doctor if you think you are (or might become) pregnant. Losartan potassium/Hydrochlorothiazide tablets are 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).

Children and adolescents

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

Older people

Losartan potassium/Hydrochlorothiazide tablets 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.

Other medicines and Losartan potassium/Hydrochlorothiazide tablets

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 tablets may interact with other medicines.

Preparations containing lithium should not be taken with Losartan potassium/Hydrochlorothiazide tablets 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,

•    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 tablets if you will be undergoing a radiographic procedure and will be given iodine contrast media.

Losartan potassium/Hydrochlorothiazide tablets with food and drink

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

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

Losartan potassium/Hydrochlorothiazide tablets may be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 tablets 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 tablets. Losartan potassium/Hydrochlorothiazide tablets are not recommended 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 tablets are not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.

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.

3.    How to take Losartan potassium/Hydrochlorothiazide tablets

Always take Losartan potassium/Hydrochlorothiazide tablets exactly as your doctor has instructed you. Your doctor will decide on the appropriate dose of Losartan potassium/Hydrochlorothiazide tablets depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan potassium/Hydrochlorothiazide tablets 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 tablets 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 2 tablets once daily of losartan / hydrochlorothiazide 50 mg/12.5 mg film-coated tablets or changed to 1 tablet daily of losartan / hydrochlorothiazide 100 mg/25 mg film-coated tablets (a stronger strength) per day. The maximum daily dose is 2 tablets per day of losartan / hydrochlorothiazide 50 mg/12.5 mg film-coated tablets or 1 tablet daily of losartan / hydrochlorothiazide 100 mg/25 mg film-coated tablets.

If you take more Losartan potassium/Hydrochlorothiazide tablets than you should:

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

If you forget to take Losartan potassium/Hydrochlorothiazide tablets

Try to take Losartan potassium/Hydrochlorothiazide tablets daily as prescribed. However, if you miss a dose, do not take an extra dose.

Just resume your usual schedule.

If you stop taking Losartan potassium/Hydrochlorothiazide tablets

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

4.    Possible side effects

Like all medicines, Losartan potassium/Hydrochlorothiazide tablets can cause side effects, although not everybody gets them.

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

Rare (may affect up to 1 in 1000 people)

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

The following side effects have been reported:

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

•    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,

•    Weakness, tiredness, chest pain,

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

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

•    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 (may affect up to 1 in 1000 people)

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

Not known (the frequency cannot be estimated from the available data)

•    Abnormal muscle breakdown (rhabdomyolysis) with symptoms such as muscle pain, weakness and swelling which can lead to kidney problems (urine can become dark)

Reporting of side effects

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

You can also report side effects directly via the Yellow Card Scheme,

Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine

5.    How to store Losartan potassium/Hydrochlorothiazide tablets

Keep this medicine out of the sight and reach of children.

Do not use Losartan potassium/Hydrochlorothiazide tablets after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Blister: Store below 25°C.

Tablet container: Store below 30°C.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Losartan potassium/Hydrochlorothiazide tablet contains

•    The active substances are losartan potassium and hydrochlorothiazide. Each Losartan potassium/Hydrochlorothiazide 50 mg/12.5 mg tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide. Each Losartan potassium/Hydrochlorothiazide 100 mg/25 mg tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.

•    The other ingredients are:

Tablet core: mannitol (E421), microcrystalline cellulose, croscarmellose sodium, povidone (K-30), magnesium stearate.

Film-coating: hypromellose (3cP, 50cP), hydroxypropylcellulose, titanium dioxide (E171), macrogol 400.

What Losartan potassium/Hydrochlorothiazide tablet looks like and contents of the pack

Losartan potassium/Hydrochlorothiazide 50 mg/12.5 mg tablets are white, round, biconvex, 8 mm film-coated tablets, scored on both sides, with side scores. “LH1” is marked on one side.

Losartan potassium/Hydrochlorothiazide 100 mg/25 mg tablets are white, round, biconvex, 10 mm film-coated tablets, scored on both sides, with side scores. “LH2” is marked on one side.

Pack sizes

Blister packs and tablet containers:

Blister: 10, 14, 20, 28, 30, 50, 56, 60, 98 or 100 film-coated tablets Tablet container: 100, 250 or 500 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aptil Pharma Limited

9th Floor, CP House, 97-107 Uxbridge Road, Ealing, London, W5 5TL

Manufacturer

Actavis Group hf.

Reykjavikurvegur 78, 220 Hafnafjordur, Iceland

This leaflet was last revised in December 2013.    LLOSXY-02