T00075-01 Malta Zejtun 190x380 PIL

Losartan potassium/Hydrochlorothiazide 50/12.5mg and 100/25mg 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. See section 4 .

•    The full name of this medicine is Losartan potassium/ Hydrochlorothiazide 50/12.5mg and 100/25mg Tablets but within the leaflet it will be referred to as Losartan HCT tablets.

What is in this leaflet

j What Losartan HCT tablets are and what they are used for

What you need to know before you take Losartan HCT tablets

3j How to take Losartan HCT tablets

3 Possible side effects

~5| How to store Losartan HCT tablets

^1 Contents of the pack and other information

j What Losartan HCT tablets are and what they are used for

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

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

"21 What you need to know before you take Losartan HCT tablets

Do not take Losartan HCT tablets if you

•    are allergic to losartan, hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).

•    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)

•    have severely impaired liver function

•    are more than 3 months pregnant (it is also better to avoid Losartan HCT tablets in early pregnancy - see pregnancy section)

•    have severely impaired kidney function or your kidneys are not producing any urine

•    have low potassium, low sodium or high calcium levels which cannot be corrected by treatment

•    are suffering from gout.

•    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 HCT tablets if you

•    have previously suffered from swelling of the face, lips, throat or tongue

•    take diuretics (water pills)

•    are on a salt-restricted diet

•    have or have had severe vomiting and/or diarrhoea

•    have heart failure

•    have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney, or you have recently had a kidney transplant

•    have narrowing of the arteries (atherosclerosis), angina pectoris

(chest pain due to poor heart function)

•    have'aortic or mitral valve stenosis' (narrowing of the valves of the heart) or 'hypertrophic cardiomyopathy' (a disease causing thickening of heart muscle)

•    have a history of mild to moderate liver impairment

•    are diabetic

•    have had gout

•    have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematosus)

•    have high calcium or low potassium levels or you are on a low potassium diet

•    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 HCT tablets.

•    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).

•    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

Continued top of next column AAAI1571

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 HCT tablets if you”

You must tell your doctor if you think you are (or might become) pregnant. Losartan HCT 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 HCT tablets in children. Therefore, Losartan HCT tablets should not be given to children.

Other medicines and Losartan HCT 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 HCT tablets may interact with other medicines.

Preparations containing lithium should not be taken with Losartan HCT 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).

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 HCT tablets if you” and "Warnings and precautions”).

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 infections, including 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 (epinephrine) or other drugs from the same group.

•    oral agents for diabetes or insulins

•    anticholinergic agents (e.g. atropine, biperiden).

•    antipsychotics

•    antidepressants

•    carbamazepine

Please also inform your doctor you are taking Losartan HCT tablets if you will be undergoing a radiographic procedure and will be given iodine contrast media.

Losartan HCT tablets with food and drink and alcohol

You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan HCT tablets may increase each other's effects. Dietary salt in excessive quantities may counteract the effect of Losartan HCT tablets.

Losartan HCT 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 HCT 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 HCT tablets. Losartan HCT 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 breastfeeding. Losartan HCT 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.

Use in elderly patients

Losartan HCT tablets work equally well in and are equally well tolerated by most older and younger adult patients. Most older patients require the same dose as younger patients.

Continued over page

Driving and using machines

When you begin treatment with this medication, you should not perform tasks which may require special attention (for example, driving a car or operating dangerous machinery) until you know how you tolerate your medicine.

How to take Losartan HCT tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on the appropriate dose of Losartan HCT tablets depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan HCT tablets for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

High Blood Pressure

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

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

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

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

•    Flu-like symptoms and feeling of general discomfort and illness

•    Generally feeling unwell (malaise)

•    Low levels of sodium in the blood (hyponatraemia)

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

•    Disturbed taste (dysgeusia)

•    Dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position,

•    Cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

3 How to store Losartan HCT tablets

If you take more Losartan HCT 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 HCT tablets

Try to take Losartan HCT tablets daily as prescribed. Do not take a double dose to make up for a forgotten dose. Just resume your usual schedule.

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

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 label and carton after EXP. The expiry date refers to the last day of that month.

Store below 25°C.

Do not throw away any 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.

^1 Contents of the pack and other information

3 Possible side effects

Like all medicines, this medicine can cause side effects, although not • The active substances are losartan potassium and everybody gets them.    ^{hydrochlorothiazide}.

If you experience the following, stop taking Losartan HCT tablets 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 (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,

•    Changes in kidney function including kidney failure,

•    Low blood sugar (hypoglycaemia).

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, reduced number of platelets,

•    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, vertigo

•    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, localised swelling (oedema), fever.

Each Losartan HCT 50mg/12.5mg tablet contains 50mg losartan potassium and 12.5mg hydrochlorothiazide.

Each Losartan HCT 100mg/25mg tablet contains 100mg losartan potassium and 25mg 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 HCT tablets look like and contents of the pack

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

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

Pack sizes

28 film-coated tablets

Marketing Authorisation Holder

Actavis Group PTC ehf Reykjavikurvegi 76-78 220 HafnarfjorSur Iceland

Manufacturer

Actavis hf.

Reykjavikurvegur 78,

IS-220 Hafnarfjordur Iceland

Actavis Ltd BLB 016,

Bulebel Industrial Estate,

Zejtun, ZTN 3000,

Malta

This leaflet was last revised in September 2015

If you would like a leaflet with larger text, please contact 01271 385257.