Losartan potassium 100 mg Tablet

• 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.

1. What Losartan is and what it is used for
2. What you need to know before you take Losartan
3. How to take Losartan
4. Possible side effects
5. How to store Losartan
6. Contents of the pack and other information

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6),
• if your liver function is severely impaired,
• if you are more than 3 months pregnant (it is also better to avoid losartan in early pregnancy - see “Pregnancy” section),
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Talk to your doctor or pharmacist before taking Losartan.

You must tell your doctor if you think you are (or might become) pregnant. Losartan 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” section).

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Losartan. Your doctor will decide on further treatment. Do not stop taking Losartan on your own.

It is important to tell your doctor before taking Losartan:

• if you have had a history of angioedema (swelling of the face, lips, throat, and/or tongue) (see section 4 “Possible side effects”),
• if you suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body,
• if you receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction leading to an extreme loss of fluid and salt in your body (see section 3 “Dosage in special patient groups”),
• if you are known to have a narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently,
• if your liver function is impaired (see sections 2 “Do not take Losartan” and 3 “Dosage in special patient groups”),
• if you suffer from heart failure with or without renal impairment or concomitant severe life-threatening cardiac arrhythmias. Special caution is necessary when you are treated with a ß-blocker concomitantly,
• if you have problems with your heart valves or heart muscle,
• if you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain),
• if you suffer from primary hyperaldosteronism (a syndrome associated with increase secretion of hormone aldosterone by the adrenal gland, caused by an abnormality within the gland),
• if you 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

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”.

• if you are taking other medications that may increase serum potassium (see section 2 “Other medicines and Losartan”).

Losartan has been studied in children. For more information, talk to your doctor.

Losartan is not recommended for use in children suffering from kidney or liver problems, as limited data are available in these patient groups.

Losartan is not recommended for use in children under 6 years old, as it has not been shown to work in this age group.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Tell your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines such as certain diuretics (amiloride, triamteren, spironolactone), or other medicines that may increase serum potassium (e.g., heparin, trimethoprim-containing medicines), as the combination with Losartan is not advisable.

Take particular care if you are taking the following medicines while under treatment with Losartan:

• other blood pressure lowering medicines as they may additionally reduce your blood pressure. Blood pressure may also be lowered by one of the following drugs/class of drugs: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory drugs such as indomethacin, including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood pressure lowering effect of losartan.

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” and “Warnings and precautions”).

If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.

Lithium-containing medicines should not be taken in combination with losartan without close supervision by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.

Losartan may be taken with or without food.

Grapefruit juice should be avoided while taking Losartan.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor 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 before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan. Losartan 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.

Breast feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn, or born prematurely.

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

Losartan is unlikely to affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Children below 6 years of age

Losartan is not recommended for use in children under 6 years old, as it has not been shown to work in this age group.

Children aged 6 - 18 years old

The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight administered once a day (up to 25 mg of losartan). The doctor may increase the dose if blood pressure is not controlled.

Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.

Adult patients with high blood pressure and Type 2 diabetes

Treatment usually starts with 50 mg losartan (two Losartan 25 mg tablets or one Losartan 50 mg tablet) once a day. The dose may later be increased to 100 mg losartan (two Losartan 50 mg tablets or one Losartan 100 mg tablet) once daily depending on your blood pressure response.

Losartan may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg losartan once a day. Generally, the dose should be increased weekly step-by-step (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, 150 mg daily during the fifth week) up to the maintenance dose as determined by your physician. A maximum dose of 150 mg losartan (for example, three tablets of Losartan 50 mg or one tablet each of Losartan 100 mg and Losartan 50 mg) once daily may be used.

In the treatment of heart failure, losartan is usually combined with a diuretic (medicine that increases the amount of water that you pass out through your kidneys) and/or digitalis (medicine that helps to make the heart stronger and more efficient) and/or a beta-blocker.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with liver impairment, or in patients over the age of 75 years. The use of losartan is not recommended in patients with severe hepatic impairment (see section “Do not take Losartan”).

The tablets should be swallowed whole with a glass of water. You should try to take your daily dose at about the same time each day. It is important that you continue to take Losartan until your doctor tells you otherwise.

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

Symptoms of overdose include: low blood pressure, increased heartbeat, possibly decreased heartbeat.

Take it as soon as you remember, unless it is time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

Do not stop taking Losartan without talking to your doctor.

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

Common (may affect up to 1 in 10 people)

• dizziness
• low blood pressure (especially after excessive loss of water from the body within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics),
• dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position,
• debility,
• fatigue,
• too little sugar in the blood (hypoglycaemia),
• too much potassium in the blood (hyperkalaemia),
• changes in kidney function including kidney failure,
• reduced number of red blood cells (anaemia),
• increase in blood urea, serum creatinine and serum potassium in patients with heart failure.

Uncommon (may affect up to 1 in 100 people)

• sleepiness (somnolence)
• headache
• sleep disorders
• feeling of increased heart rate (palpitations)
• severe chest pain (angina pectoris)
• shortness of breath (dyspnoea)
• abdominal pain
• obstipation
• diarrhoea
• nausea
• vomiting
• hives (urticaria)
• itching (pruritus)
• rash
• localised swelling (oedema)
• cough.

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

• hypersensitivity
• angioedema
• inflammation of blood vessels (vasculitis including Henöch-Schonlein purpura)
• numbness or tingling sensation (paraesthesia)
• fainting (syncope)
• very rapid and irregular heartbeat (atrial fibrillation)
• brain attack (stroke)
• inflammation of the liver (hepatitis)
• elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment
• intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

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

• reduced number of thrombocytes
• migraine
• liver function abnormalities
• muscle and joint pain
• flu-like symptoms
• back pain and urinary tract infection
• increased sensitivity to the sun (photosensitivity)
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis)
• impotence
• inflammation of the pancreas (pancreatitis)
• low levels of sodium in the blood (hyponatraemia)
• depression
• generally feeling unwell (malaise)
• ringing, buzzing, roaring, or clicking in the ears (tinnitus)
• disturbed taste (dysgeusia).

Side effects in children are similar to those seen in adults.

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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Each film-coated tablet contains 25 mg, 50 mg or 100 mg of losartan potassium

The other ingredients are : microcrystalline cellulose (E460), dibasic calcium phosphate, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate.

The film-coating contains hypromellose (E464), lactose monohydrate, titanium dioxide (E171), polyethylene glycol 4000 and sodium citrate dihydrate.

• Losartan potassium 25 mg are white, round shaped film-coated tablets, diameter 6.5 mm, debossed with L25 on one side and plain on other side.
• Losartan potassium 50 mg are white, oval shaped film-coated tablets with central break line on one side and L50 on the other side. Length: 11.5 mm. Breadth: 6mm.
• Losartan potassium 100 mg are white, oval shaped film-coated tablets debossed with L100 on one side and plain on the other side. Length: 13.4 mm. Breadth: 6.6 mm.

Losartan is available in:

• Losartan 25 mg tablets are available in blister packs of 7 or 28 tablets.
• Losartan 50 mg tablets are available in blister packs of 7, 10, 14, 28, 30, 56, 84, 90, 98, 280 or 500 tablets.
• Losartan 100 mg tablets are available in blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 or 280 tablets.

Not all pack sizes may be marketed.