Package leaflet: Information for the patient

Irbesartan/Hydrochlorothiazide Liconsa 150 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide Liconsa 300 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide Liconsa 300 mg/25 mg tablets

Irbe sartan/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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.

What is in this leaflet

1.    What Irbesartan/Hydrochlorothiazide Liconsa is and what it is used for

2.    What you need to know before you take Irbesartan/Hydrochlorothiazide Liconsa

3.    How to take Irbesartan/Hydrochlorothiazide Liconsa

4.    Possible side effects

5.    How to store Irbesartan/Hydrochlorothiazide Liconsa

6.    Contents of the pack and other information

1.    What Irbesartan/Hydrochlorothiazide Liconsa is and what it is used for

Irbesartan/Hydrochlorothiazide Liconsa is a combination of two active substances, irbesartan and hydrochlorothiazide.

Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin- II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.

Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.

The two active ingredients in Irbesartan/Hydrochlorothiazide Liconsa work together to lower blood pressure further than if either was given alone.

Irbesartan/Hydrochlorothiazide Liconsa is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.

2.    What you need to know before you take Irbesartan/Hydrochlorothiazide Liconsa Do not take Irbesartan/Hydrochlorothiazide Liconsa

•    if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6)

•    if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines

•    if you are more than 3 months pregnant. (It is also better to avoid Irbesartan/Hydrochlorothiazide Liconsa in early pregnancy - see pregnancy section)

•    if you have severe liver or kidney problems

•    if you have difficulty in producing urine

•    if your doctor determines that you have persistently high calcium or low potassium levels in your blood

•    if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions

Talk to your doctor before taking Irbesartan/Hydrochlorothiazide Liconsa and if any of the following apply to you:

• if you get excessive vomiting or diarrhoea

• if you suffer from kidney problems or have a kidney transplant

• if you suffer from heart problems

• if you suffer from liver problems

•    if you suffer from diabetes

•    if you suffer from lupus erythematosus (also known as lupus or SLE)

•    if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).

•    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 Irbesartan/Hydrochlorothiazide Liconsa”.

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan/Hydrochlorothiazide Liconsa 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).

You should also tell your doctor:

•    if you are on a low-salt diet

•    if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Liconsa)

•    if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal

•    if you are going to have an operation (surgery) or be given anaestheticsif you have changes in your vision or pain in one or both of your eyes while taking Irbesartan/Hydrochlorothiazide Liconsa. This could be a sign that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Irbesartan/Hydrochlorothiazide Liconsa treatment and seek medical attention.

The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.

Children and adolescents

Irbesartan/Hydrochlorothiazide Liconsa should not be given to children and adolescents (under 18 years). Other medicines and Irbesartan/Hydrochlorothiazide Liconsa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Diuretic agents such as the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Liconsa may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan/Hydrochlorothiazide Liconsa without close supervision by your doctor.

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 Irbesartan/Hydrochlorothiazide Liconsa” and “Warnings and precautions”).

You may need to have blood checks if you take:

•    potassium supplements

•    salt substitutes containing potassium

•    potassium sparing medicines or other diuretics (water tablets)

•    some laxatives

•    medicines for the treatment of gout

•    therapeutic vitamin D supplements

•    medicines to control heart rhythm

•    medicines for diabetes (oral agents or insulins)

•    carbamazepine (a medicine for the treatment of epilepsy).

It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines, or colestyramine and colestipol resins for lowering blood cholesterol.

Irbesartan/Hydrochlorothiazide Liconsa with food and drink

Irbesartan/Hydrochlorothiazide Liconsa can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Liconsa if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will normally advise you to stop taking <product> before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan/Hydrochlorothiazide Liconsa. Irbesartan/Hydrochlorothiazide Liconsa. 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.

Breast-feeding

Irbesartan/Hydrochlorothiazide Liconsa 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.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Irbesartan/Hydrochlorothiazide Liconsa is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Irbesartan/Hydrochlorothiazide Liconsa contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

3. How to take Irbesartan/Hydrochlorothiazide Liconsa

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

Only for Irbesartan/hydrochlorothiazide 150 mg/12.5 mg tablets: The recommended dose of Irbesartan/Hydrochlorothiazide Liconsa is one or two tablets a day. Only for Irbesartan/hydrochlorothiazide 300 mg /12.5 mg and 300 mg /25 mg tablets: The recommended dose of Irbesartan/Hydrochlorothiazide Liconsa is one tablet a day.

Irbesartan/Hydrochlorothiazide Liconsa will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. Your doctor will instruct you how to switch from the previous treatment to Irbesartan/Hydrochlorothiazide Liconsa.

Method of administration

Irbesartan/Hydrochlorothiazide Liconsa is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan/Hydrochlorothiazide Liconsa with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan/Hydrochlorothiazide Liconsa until your doctor tells you otherwise.

The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.

If you take more Irbesartan/Hydrochlorothiazide Liconsa than you should

If you accidentally take too many tablets, contact your doctor immediately.

Children should not take Irbesartan/Hydrochlorothiazide Liconsa

Irbesartan/Hydrochlorothiazide Liconsa should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you forget to take Irbesartan/Hydrochlorothiazide Liconsa

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 dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

Rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan.

If you get any of the above symptoms or get short of breath, stop taking Irbesartan/Hydrochlorothiazide Liconsa and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention: Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Irbesartan/Hydrochlorothiazide Liconsa were:

Common side effects (may affect up to 1 in 10 people):

•    nausea/vomiting

•    abnormal urination

•    fatigue

•    dizziness (including when getting up from a lying or sitting position)

•    blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).

•    If any of these side effects causes you problems, talk to your doctor.

Uncommon side effects (may affect up to 1 in 100 people):

•    diarrhoea

•    low blood pressure

•    fainting

•    heart rate increased

•    flushing

•    swelling

•    sexual dysfunction (problems with sexual performance)

•    blood tests may show lowered levels of potassium and sodium in your blood.

If any of these side effects causes you problems, talk to your doctor.

Side effects reported since the launch of Irbesartan/Hydrochlorothiazide Liconsa

Some undesirable effects have been reported since marketing of Irbesartan/Hydrochlorothiazide Liconsa. Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

As for any combination of two active substances, side effects associated with each individual component cannot be excluded.

Side effects associated with irbesartan alone

In addition to the side effects listed above, chest pain has also been reported.

Side effects associated with hydrochlorothiazide alone

Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.

It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

Reporting of side effects

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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Irbesartan/Hydrochlorothiazide Liconsa

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

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Irbesartan/Hydrochlorothiazide Liconsa contains

•    The active substances are Irbesartan and hydrochlorothiazide.

Each tablet of Irbesartan/Hydrochlorothiazide Liconsa 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.

Each tablet of Irbesartan/Hydrochlorothiazide Liconsa 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.

Each tablet of Irbesartan/Hydrochlorothiazide Liconsa 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.

•    The other ingredients are: povidone, magnesium stearate, Cellulose microcrystalline, lactose monohydrate, sodium croscarmellose, Sillica, colloidal anhydrous, hydrogenated castor oil and maize starch.

What Irbesartan/Hydrochlorothiazide Liconsa looks like and contents of the pack

Irbesartan/Hydrochlorothiazide LiconsaIrbesartan/Hydrochlorothiazide Liconsa 150 mg /12.5 mg tablets are white, cylindrical, biconvex tablets, embossed 1H1 on one side.

Irbesartan/Hydrochlorothiazide Liconsa 300 mg /12.5 mg tablets are white, oblong, biconvex tablets, embossed 1H12 on one side.

Irbesartan/Hydrochlorothiazide Liconsa 300 mg /25 mg tablets are white, oblong, biconvex tablets, embossed 1H25 on one side.

Irbesartan/Hydrochlorothiazide Liconsa 150 mg /12.5 mg, 300 mg /12.5 mg and 300 mg /25 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorios LICONSA, S.A.

Gran Via Carlos III, 98, 7th floor

08028 Barcelona

Spain

Manufacturers:

LABORATORIOS LICONSA S.A.

Avd. Miralcampo, 7

Avda. Miralcampo, no 7

Poligono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

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

The Netherlands Irbesartan/Hydrochloorthiazide Liconsa 150 mg /12.5 mg, 300 mg /12.5 mg, 300/25 mg tablet

Austria    Irbesartan/Hydrochloorthiazide Liconsa 150 mg /12.5 mg, 300 mg /12.5 mg, 300/25

mg tabletten

Germany    Irbesartan/Hydrochloorthiazide Heumann 150 mg /12.5 mg, 300 mg /12.5 mg,

300/25 mg

Irbesartan/Hydrochloorthiazide Liconsa 150 mg /12.5 mg, 300 mg /12.5 mg, 300/25

This leaflet was last revised in 11/2014