COZAAR 100 mg Film-Coated Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What COZAAR is and what it is used for
2. What you need to know before you take COZAAR
3. How to take COZAAR
4. Possible side effects
5. How to store COZAAR
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 you are more than 3 months pregnant (It is also better to avoid COZAAR in early pregnancy - see Pregnancy),
• if your liver function is severely impaired,
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Talk to your doctor, pharmacist, or nurse before taking COZAAR.

You must tell your doctor if you think you are (or might become) pregnant. COZAAR 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 COZAAR:

• if you have had a history of angioedema (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 COZAAR” 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 COZAAR”.
• if you are taking other medications that may increase serum potassium (see section 2 “Other medicines and COZAAR”).

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

COZAAR is not recommended for use in children suffering from kidney or liver problems, as limited data are available in these patient groups. COZAAR 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 (amiloride, triamteren, spironolactone), or other medicines that may increase serum potassium (e.g., heparin, trimethoprim-containing medicines), as the combination with COZAAR is not advisable.

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

• 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 COZAAR” 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.

COZAAR may be taken with or without food.

Grapefruit juice should be avoided while taking COZAAR.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking COZAAR before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of COZAAR. COZAAR 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. COZAAR 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 new-born, or born prematurely.

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

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

COZAAR 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.

COZAAR 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.

Children below 6 years of age

COZAAR 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 COZAAR). 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 COZAAR 50 mg) once a day. The dose may later be increased to 100 mg losartan (two tablets COZAAR 50 mg or one tablet of COZAAR 100 mg) 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 (one tablet COZAAR 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 COZAAR 50 mg or one tablet each of COZAAR 100 mg and COZAAR 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 COZAAR").

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 COZAAR until your doctor tells you otherwise.

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

If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

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 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 COZAAR 12.5 mg tablet contains 12.5 mg of losartan potassium.

Each COZAAR 50 mg tablet contains 50 mg of losartan potassium.

Each COZAAR 100 mg tablet contains 100 mg of losartan potassium.

The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinised maize starch, magnesium stearate (E572), hyprolose (E463), hypromellose (E464).

COZAAR 12.5 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively.

The COZAAR 12.5 mg tablets also contain carnauba wax (E903), titanium dioxide (E171) and indigo carmine (E132) aluminium lake.

The COZAAR 50 mg tablets also contain carnauba wax (E903) and titanium dioxide (E171).

The COZAAR 100 mg tablets also contain carnauba wax (E903) and titanium dioxide (E171).

COZAAR 12.5 mg is supplied as unscored film-coated tablets containing 12.5 mg of losartan potassium.

COZAAR 50 mg is supplied as scored film-coated tablets containing 50 mg of losartan potassium. The score line is not intended for breaking the tablet.

COZAAR 100 mg is supplied as unscored film-coated tablets containing 100 mg of losartan potassium.

COZAAR is supplied in the following pack sizes:

• COZAAR 12.5 mg - PVC/PE/PVDC blister packages with aluminium foil lidding in packs of 7, 14, 21, 28, 50, 98, 210 or 500 tablets and a unit-dose package of 28 tablets for hospital use. HDPE bottles of 100 tablets.
• COZAAR 50 mg - PVC/PE/PVDC blister packages with aluminium foil lidding in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 or 300 tablets.
• COZAAR 100 mg - PVC/PE/PVDC blister packages with aluminium foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer:

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Member State Invented name

Austria Cosaar 12,5 mg - Filmtabletten

Austria Cosaar 50 mg - Filmtabletten

Austria Cosaar 100 mg - Filmtabletten

Belgium COZAAR 12,5 mg

Belgium COZAAR 50 mg

Belgium COZAAR 100 mg

Bulgaria COZAAR 12,5 mg film-coated tablets

Cyprus COZAAR

Czech Republic COZAAR 50 mg

Czech Republic COZAAR 100 mg

Denmark Cozaar

Finland Cozaar 12,5 mg kalvopäällysteiset tabletit

Finland Cozaar 50 mg kalvopäällysteiset tabletit

Finland Cozaar 100 mg kalvopäällysteiset tabletit

France COZAAR 50 mg scored coated tablets

France COZAAR 100 mg film-coated tablets

Germany LORZAAR PROTECT 100 mg Filmtabletten

Germany LORZAAR PROTECT 50 mg Filmtabletten

Germany LORZAAR START 12,5 mg Filmtabletten

Greece COZAAR

Hungary COZAAR

Iceland COZAAR

Ireland COZAAR 12.5mg film-coated tablets

Ireland COZAAR 50 mg film-coated tablets

Ireland COZAAR 100 mg film-coated tablets

Italy LORTAAN 12,5 mg compresse rivestite con film

Italy LORTAAN 50 mg compresse rivestite con film

Italy LORTAAN 100 mg compresse rivestite con film

Luxembourg COZAAR 12,5 mg

Luxembourg COZAAR 50 mg

Luxembourg COZAAR 100 mg

Malta COZAAR 12,5 mg film-coated tablets

Malta COZAAR 50 mg film-coated tablets

Malta COZAAR 100 mg film-coated tablets

Netherlands COZAAR 12,5 mg

Netherlands COZAAR 50 mg

Netherlands COZAAR 100 mg

Norway Cozaar

Poland COZAAR

Portugal Cozaar

Portugal Cozaar 100 mg

Portugal Cozaar IC

Spain COZAAR 12,5 mg Inicio comprimidos recubiertos con película

Spain COZAAR 50 mg comprimidos recubiertos con película

Spain COZAAR 100 mg comprimidos recubiertos con película

Sweden COZAAR 12,5 mg filmdragerade tabletter

Sweden COZAAR 50 mg filmdragerade tabletter

Member State Invented name

Sweden COZAAR 100 mg filmdragerade tabletter

United Kingdom (Northern Ireland) COZAAR 12,5 mg film-coated tablets

United Kingdom (Northern Ireland) COZAAR 50 mg film-coated tablets

United Kingdom (Northern Ireland) COZAAR 100 mg film-coated tablets