Losartan potassium 25 mg film-coated tablets

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

• if you are allergic to losartan or 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 potassium 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 potassium.

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

It is important to tell your doctor before taking Losartan potassium:

• if you have had a history of angiooedema (swelling of the face, lips, throat, and/or tongue) (see also 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 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 potassium" 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 increased secretion of the 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 potassium”

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

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.

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

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

• 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.

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.

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 potassium” and “Warnings and precautions”)

Losartan potassium may be taken with or without food.

Ask your doctor or pharmacist for advice before taking any 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 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. Losartan potassium 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.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan potassium 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 newborn, or was born prematurely.

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

Losartan potassium 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 intolerance to some sugars, contact your doctor before taking this medicinal product.

Children below 6 years of age

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

Losartan tablets 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 (one tablet Losartan potassium 12.5 mg) 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 potassium 50 mg or one tablet each of Losartan potassium 100 mg and Losartan potassium 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 potassium").

The tablets should be swallowed 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 potassium until your doctor tells you otherwise.

If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately. Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.

Do not take a double dose to make up for a forgotten dose.

If you accidentally miss a daily dose, just take the next dose as normal.

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 Yellow Card Scheme, Website: 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.

• The active substance is losartan potassium. Each film-coated tablet contains 12.5 mg, 25 mg, 50 mg or 100 mg losartan potassium, equivalent to 11.4 mg, 22.9 mg, 45.8 mg and 91.5 mg losartan respectively.
• The other ingredients of Losartan potassium 12.5 mg/25 mg are: maize starch, pregelatinised maize starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, cellactose (powdered cellulose and lactose monohydrate) in the tablet core and hypromellose, talc, propylene glycol, titanium dioxide (E171) and quinoline yellow (E104) in the film coating.
• The other ingredients of Losartan potassium 50 mg/100 mg are: maize starch, pregelatinised maize starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, cellactose (powdered cellulose and lactose monohydrate) in the tablet core and hypromellose, talc, propylene glycol and titanium dioxide (E171) in the film coating.
  See section 2 " Losartan potassium contains lactose".

Losartan potassium 12.5 mg: Oval, convex, yellow, film-coated tablet.

Losartan potassium 25 mg: Oval, convex, yellow, film-coated, one-side-scored tablet. The tablet can be divided into equal doses.

Losartan potassium 50 mg: Round, convex, white film-coated, one-side-scored tablet with bevelled edges. The score line is not intended for breaking the tablet.

Losartan potassium 100 mg: Oval, convex, white film-coated tablet.

Losartan potassium 12.5 mg/25 mg/50 mg/100 mg

PVC/PVDC blister of transparent foil, with aluminium foil used for covering; box.

Pack sizes:

Losartan potassium 12.5 mg: 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets

Losartan potassium 25 mg: 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets

Losartan potassium 50 mg: 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets

Losartan potassium 100 mg: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets.

Losartan potassium 50 mg

Polyethylene (HDPE) tablet container with polypropylene closure. Polyethylene dessicator filled with silica gel.

Pack size: 250 film-coated tablets.

Polyethylene (HDPE) tablet container with a tamper-evident polypropylene (PP) closure

Losartan potassium 12.5 mg: 250 film-coated tablets, in a carton box.

Losartan potassium 100 mg: 100 film-coated tablets, in a carton box.

Not all the pack sizes may be marketed.