LOSARB PLUS Film-coated tablet Ref.[2791] Active ingredients: Hydrochlorothiazide Losartan

Take special care with Losarb Plus

• 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 you think that you are (or might become) pregnant. You must tell your doctor as Losarb Plus is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section Pregnancy and breastfeeding).

Use in children and adolescents

Important information about some of the ingredients of Losarb Plus

Losarb Plus 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 medicine.
Use in children and adolescents

There is no experience in children and adolescents. Therefore, Losarb Plus should not be given to children and adolescents.

Use in elderly patients

Losarb Plus 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.

If you forget to take Losarb Plus

Try to take Losarb Plus 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.

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 Losarb Plus may interact with other medicines. Preparations containing lithium should not be taken with Losarb Plus 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 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; (oral agents for diabetes or insulins).

Please also inform your doctor when it is planned to apply iodine contrast media about taking Losarb Plus.

Taking Losarb Plus with food and drink

You are advised not to drink alcohol whilst taking these tablets: alcohol and Losarb Plus tablets may increase each other’s effects.

Dietary salt in excessive quantities may counteract the effect of Losarb Plus tablets.

Losarb Plus tablets may be taken with or without food.

Important information about some of the ingredients of Losarb Plus

Losarb Plus 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 medicine.

Pregnancy and breast-feeding

You must tell your doctor if you think that you are (or might become) pregnant. Usually, your doctor will advise you to take another medicine instead of Losarb Plus, as Losarb Plus is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.

Appropriate antihypertensive drug must usually replace (the product) before starting a pregnancy.

The product should not be used during the 2nd and 3rd trimester of pregnancy.

Your doctor will normally advise you to stop taking Losarb Plus as soon as you know you are pregnant.

If you become pregnant during therapy with (the product), please inform and see your physician without delay.

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

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. 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.

POSSIBLE SIDE EFFECTS

Like all medicines, Losarb Plus can cause side effects, although not everybody gets them.

If you experience the following, stop taking Losarb Plus 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.

Side effects are listed below with frequencies defined as:

Common: affects 1 to 10 users in 100 Uncommon: affects 1 to 10 users in 1,000 Rare: affects 1 to 10 users in 10,000

Common:

• 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:

• 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:

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

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