What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 18909/0381, PL 18909/0382.


Losartan potassium / hydrochlorothiazide 50 mg/12.5 mg and 100 mg/25 mg Film-coated Tablets (Arrow)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan potassium / hydrochlorothiazide 50 mg/12.5 mg Film-coated Tablets

(50 mg losartan potassium and 12.5 mg hydrochlorothiazide)

Losartan potassium / hydrochlorothiazide 100 mg/25 mg Film-coated Tablets

(100 mg losartan potassium and 25 mg hydrochlorothiazide)

Read all of this leaflet carefully before you start taking this medicine.

  • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.What Losartan potassium / hydrochlorothiazide Film-coated Tablets are and what they are used for
2.Before you take Losartan potassium / hydrochlorothiazide Film-coated Tablets
3.How to take Losartan potassium / hydrochlorothiazide Film-coated Tablets
4.Possible side effects
5.How to store Losartan potassium / hydrochlorothiazide Film-coated Tablets
6.Further information

1.WHAT LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

Losartan potassium / hydrochlorothiazide Film-coated Tablets are a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).

Losartan potassium / hydrochlorothiazide Film-coated Tablets are indicated for the treatment of essential hypertension (high blood pressure).

2.BEFORE YOU TAKE LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE FILM-COATED TABLETS

Do not take Losartan potassium / hydrochlorothiazide Film-coated Tablets

  • if you are allergic (hypersensitive) to losartan potassium, 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 Film-coated Tablets 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 low potassium, low sodium or high calcium levels which cannot be corrected by treatment
  • if you are suffering from gout.

Take special care with Losartan potassium / hydrochlorothiazide Film-coated 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 /hydrochlorothiazide Film-coated 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 that you are (or might become) pregnant. Losartan potassium / hydrochlorothiazide Film-coated 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).

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 hydrochlorothiazide present in Losartan potassium / hydrochlorothiazide Film-coated Tablets may interact with other medicines. Preparations containing lithium should not be taken with Losartan potassium / hydrochlorothiazide Film-coated 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, medicines for the treatment of gout, medicines to control heart rhythm or for diabetes (oral agents or insulins), medicines containing glycyrrhizin (found in liquorice). 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 that you are taking Losartan potassium / hydrochlorothiazide Film-coated Tablets if you will be given iodine contrast media.

Taking Losartan potassium / hydrochlorothiazide Film-coated Tablets with food and drink

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

Dietary salt in excessive quantities may counteract the effect of Losartan potassium / hydrochlorothiazide Film-coated Tablets. Also avoid eating natural liquorice.

Losartan potassium / hydrochlorothiazide Film-coated Tablets may be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think that 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 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 Film-coated 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 children and adolescents

There is no experience in children and adolescents. Therefore, Losartan potassium / hydrochlorothiazide Film-coated Tablets should not be given to children and adolescents.

Use in elderly patients

Losartan potassium / hydrochlorothiazide Film-coated 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.

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.

Important information about some of the ingredients of Losartan potassium / hydrochlorothiazide Film-coated Tablets

Losartan potassium / hydrochlorothiazide Film-coated Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.HOW TO TAKE LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE FILM-COATED TABLETS

Always take Losartan potassium / hydrochlorothiazide Film-coated Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will decide on the appropriate dose of Losartan potassium / hydrochlorothiazide Film-coated Tablets depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan potassium / hydrochlorothiazide Film-coated Tablets for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

The tablet should be swallowed with a glass of water. The tablets can be taken with or without food.

High Blood Pressure

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

Use in children and adolescents

There is no experience in children and adolescents. Therefore, Losartan potassium / hydrochlorothiazide Film-coated Tablets should not be given to children and adolescents.

If you take more Losartan potassium / hydrochlorothiazide Film-coated Tablets 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 Film-coated Tablets

Try to take Losartan potassium / hydrochlorothiazide Film-coated 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.

4.POSSIBLE SIDE EFFECTS

Like all medicines, Losartan potassium / hydrochlorothiazide Film-coated Tablets can cause side effects, although not everybody gets them.

If you experience the following, stop taking Losartan potassium / hydrochlorothiazide Film-coated 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:

Very common: affects more than 1 user in 10

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

Very rare: affects less than 1 user in 10,000

Not known: frequency cannot be estimated from the available data

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 in 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.

Not known:

  • muscle weakness, painful muscles or muscle breakdown (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 or pharmacist.

5.HOW TO STORE LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE FILM-COATED TABLETS

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

Do not use Losartan potassium / hydrochlorothiazide Film-coated Tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

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.

6.FURTHER INFORMATION

What Losartan potassium / hydrochlorothiazide Film-coated Tablets contain

The active substances are losartan potassium and hydrochlorothiazide.

Losartan potassium / hydrochlorothiazide 50 mg/12.5 mg Film-coated Tablets

Each Tablet contains 50 mg of losartan potassium equivalent to 45.8 mg of losartan and 12.5 mg of hydrochlorothiazide.

Losartan potassium / hydrochlorothiazide 100 mg/25 mg Film-coated Tablets

Each Tablet contains 100 mg of losartan potassium equivalent to 91.6 mg of losartan and 25 mg of hydrochlorothiazide.

The other ingredients are microcrystalline cellulose (E460(i)), lactose monohydrate, pregelatinised maize starch, sodium starch glycolate type A, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose 6cp(E464), titanium dioxide (E171).

What Losartan potassium / hydrochlorothiazide Film-coated Tablets look like and the contents of the pack

50 mg/12.5 mg: White, oblong, biconvex tablets measuring approximately 13.7 × 6.7 mm with a scoreline on both sides.

The scoreline is to facilitate breaking for ease of swallowing and not to divide into equal doses.

100 mg/25 mg: White, oblong, biconvex tablets measuring approximately 15.3 × 6.7 mm with a scoreline on both sides.

The tablet can be divided into equal halves.

Tablets are provided in PVC/PE/PVDC/Aluminium blisters.

Pack sizes: 7, 10, 14, 20, 28, 30, 56, 60, 90, 98, 112 film-coated tablets

Not all pack sizes may be marketed

Marketing Authorisation Holder

Arrow Generics Limited
Unit 2
Eastman Way
Stevenage
Herts
SG1 4SZ

Manufacturer

Specifar S.A., 1
28 Octovriou str.
123 51 Ag. Varvara
Athens
Greece

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

Denmark: Tanlozid

Germany: Losar-Q comp 50mg/12.5mg Filmtabletten

Losar-Q comp 100mg/25mg Filmtabletten

The Netherlands: Kaliumlosartan + HCTZ Arrow 50mg/12,5mg filmomhulde tabletten

Kaliumlosartan + HCTZ Arrow 100mg/25mg filmomhulde tabletten

Norway: Losartan/Hydroklortiazid Arrow

Poland: Losartan + HCT Arrow

Sweden: Tanlozid 50mg/12.5mg & 100mg/25mg filmdragerade tabletter

This leaflet was last revised in 02/2012

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