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Irbesartan And Hydrochlorothiazide 150mg / 12.5mg Film-Coated Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

IRBESARTAN AND HYDROCHLOROTHIAZIDE 150mg/I2.5mg, 300mg/lZ5mg and 300mg/25mg

FILM-COATED TABLETS

Irbesartan and 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 and Hydrochlorothiazide Tablets are and what they are used for

2.    What you need to know before you take Irbesartan and Hydrochlorothiazide Tablets

3.    How to take Irbesartan and Hydrochlorothiazide Tablets

4.    Possible side effects

5.    How to store Irbesartan and Hydrochlorothiazide Tablets

6.    Contents of the pack and other information

1.    What Irbesartan and Hydrochlorothiazide Tablets are and what they are used for

The full name of your medicine is Irbesartan and Hydrochlorothiazide 150mg/12.5mg film-coated tablets,

Irbesartan and Hydrochlorothiazide 300mg/12.5mg film-coated tablets and Irbesartan and Hydrochlorothiazide 300mg/25mg film-coated tablets, but within the leaflet it will be referred to as Irbesartan and Hydrochlorothiazide Tablets.

Irbesartan and Hydrochlorothiazide Tablets are a combination of two active substances, irbesartan and hydrochlorothiazide.

Irbesartan belongs to a group of medicines known as angiotensin-ll receptor antagonists. Angiotensin-ll 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-ll 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 and Hydrochlorothiazide Tablets work together to lower blood pressure further than if either was given alone.

Irbesartan and Hydrochlorothiazide Tablets are 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 and Hydrochlorothiazide Tablets

Do not take Irbesartan and Hydrochlorothiazide Tablets:

•    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 and Hydrochlorothiazide Tablets 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 or pharmacist before taking Irbesartan and Hydrochlorothiazide Tablets 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 and Hydrochlorothiazide Tablets”.

You must tell your doctor if you think you are (or might become)


pregnant. Irbesartan and Hydrochlorothiazide 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).

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 and Hydrochlorothiazide Tablets)

•    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 anaesthetics

•    if you have changes in your vision or pain in one or both of your eyes while taking Irbesartan and Hydrochlorothiazide Tablets. This could be a sign that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Irbesartan and Hydrochlorothiazide Tablets 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 and Hydrochlorothiazide Tablets should not be given to children and adolescents (under 18 years).

Other medicines and Irbesartan and Hydrochlorothiazide Tablets

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 and Hydrochlorothiazide Tablets may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan and Hydrochlorothiazide Tablets 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 and Hydrochlorothiazide Tablets” 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 and Hydrochlorothiazide Tablets with food and drink

Irbesartan and Hydrochlorothiazide Tablets can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide Tablets, 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, breast-feeding and fertility Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan and Hydrochlorothiazide Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan and Hydrochlorothiazide Tablets. Irbesartan and Hydrochlorothiazide Tablets are 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

Tell your doctor if you are breast-feeding or about to start breastfeeding. Irbesartan and Hydrochlorothiazide 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, especially if your baby is newborn, or was born


I1


prematurely.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Irbesartan and Hydrochlorothiazide Tablets are 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 and Hydrochlorothiazide Tablets contain 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 medicinal product.

3.    How to take Irbesartan and Hydrochlorothiazide Tablets

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

Dosage

The recommended dose of Irbesartan and Hydrochlorothiazide Tablets is one or two tablets a day. Irbesartan and Hydrochlorothiazide Tablets 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 and Hydrochlorothiazide Tablets.

Method of administration

Irbesartan and Hydrochlorothiazide Tablets are for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan and Hydrochlorothiazide Tablets 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 and Hydrochlorothiazide Tablets 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 and Hydrochlorothiazide Tablets than you should

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

Children should not take Irbesartan and Hydrochlorothiazide Tablets

Irbesartan and Hydrochlorothiazide Tablets 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 and Hydrochlorothiazide Tablets

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 and Hydrochlorothiazide Tablets 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 and Hydrochlorothiazide Tablets 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 and Hydrochlorothiazide Tablets

Some undesirable effects have been reported since marketing of


Irbesartan and Hydrochlorothiazide Tablets. 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 and Hydrochlorothiazide Tablets

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 after EXP. The expiry date refers to the last day of that month.

DO NOT store above 30°C.

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 and Hydrochlorothiazide Tablets contain

•    The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet contains 150mg of irbesartan and

12.5mg of hydrochlorothiazide.

Each film-coated tablet contains 300mg of irbesartan and 12.5mg of hydrochlorothiazide.

Each film-coated tablet contains 300mg of irbesartan and 25mg of hydrochlorothiazide.

•    The other ingredients are:

Core: lactose monohydrate, cellulose, microcrystalline, croscarmellose sodium, hypromellose and magnesium stearate.

Film-coating:

150ma/12.5mq and 300mq/12.5ma

polyvinyl alcohol - part, hydrolised, titanium dioxide (E171), talc (E553b), macrogol 3350, lecithin (soya) (E322), iron oxide red (E172), iron oxide black (E172) and iron oxide yellow (E172).

300ma/25ma

polyvinyl alcohol - part, hydrolised, titanium dioxide (E171), talc (E553b), macrogol 3350, lecithin (soya) (E322), indigo carmine aluminium lake/ FD&C Blue #2 (E172), iron oxide red (E172), iron oxide black (E172) and iron oxide yellow (E172).

What Irbesartan and Hydrochlorothiazide Tablets look like and contents of the pack

Irbesartan and Hydrochlorothiazide 150mg/12.5mg Film-coated tablets and Irbesartan and Hydrochlorothiazide 300mg/12.5mg Film-coated tablets are pink, biconvex and oval-shaped film-coated tablets.

Irbesartan and Hydrochlorothiazide 300mg/25mg Film-coated tablets grey-violet, biconvex and oval-shaped film-coated tablets, with a break-line on one side. The tablet can be divided into equal doses.

Irbesartan and Hydrochlorothiazide Tablets are supplied in blister packs of 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Crescent Pharma Limited

Units 3 & 4, Quidhampton Business Units,

Polhampton Lane, Overton,

Hampshire RG25 3ED United Kingdom

This leaflet was last revised in 04/2016