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Irbesartan And Hydrochlorothiazide 300 Mg/12.5 Mg Film-Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Irbesartan and Hydrochlorothiazide 150 mg/12.5 mg film-coated tablets Irbesartan and Hydrochlorothiazide 300 mg/12.5 mg film-coated tablets Irbesartan and Hydrochlorothiazide 300 mg/25 mg film-coated tablets

irbesartan/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2. Before you take Irbesartan and Hydrochlorothiazide

3. How to take Irbesartan and Hydrochlorothiazide

4. Possible side effects

5. How to store Irbesartan and Hydrochlorothiazide

6. Further information

1. WHAT IRBESARTAN AND HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR

Irbesartan and Hydrochlorothiazide 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 and Hydrochlorothiazide work together to lower blood pressure further than if either was given alone.

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

2. BEFORE YOU TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE Do not take Irbesartan and Hydrochlorothiazide

• if you are allergic (hypersensitive) to irbesartan or any of the other ingredients of Irbesartan and Hydrochlorothiazide

• if you are allergic (hypersensitive) 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 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

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

Take special care with Irbesartan and Hydrochlorothiazide Tell your doctor 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).

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

• 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

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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

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.

Taking Irbesartan and Hydrochlorothiazide with food and drink

Irbesartan and Hydrochlorothiazide can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide, 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 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 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. Irbesartan and Hydrochlorothiazide 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. Irbesartan and Hydrochlorothiazide 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 and Hydrochlorothiazide 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.

Important information about some of the ingredients of Irbesartan and Hydrochlorothiazide

Irbesartan and Hydrochlorothiazide 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 medicinal product.

3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE

Always take Irbesartan and Hydrochlorothiazide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

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

Method of administration

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

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

Children should not take Irbesartan and Hydrochlorothiazide

Irbesartan and Hydrochlorothiazide 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

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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Irbesartan and Hydrochlorothiazide 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 and contact your doctor immediately.

Side effects reported in clinical studies for patients treated with irbesartan and hydrochlorothiazide were:

Common side effects (affect 1 to 10 users in 100)

• 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 (affect 1 to 10 users in 1,000)

• 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

Some undesirable effects have been reported since marketing of Irbesartan and Hidroclorotiazida. 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE IRBESARTAN AND HYDROCHLOROTHIAZIDE

Keep out of the sight and reach of children.

Do not use Irbesartan and Hydrochlorothiazide after the expiry date which is stated on the carton and on the blister/label of the bottle after EXP.

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

Store below 30⁰C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Irbesartan and Hydrochlorothiazide contains

150 mg/12.5 mg

• The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan and Hydrochlorothiazide 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.

• The other ingredients are Lactose Monohydrate, Sodium Starch Glycolate (Type A), Povidone (K-30), Silica Colloidal Anhydrous, Talc, Sodium stearyl fumarate, Hypromellose (E464), Titanium dioxide (E171), Macrogol 4000, Iron Oxide Yellow (E172), Iron Oxide Red (E172)

300 mg/12.5 mg

• The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan and Hydrochlorothiazide 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.

300 mg/25 mg

• The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan and Hydrochlorothiazide 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.

What Irbesartan and Hydrochlorothiazide looks like and contents of the pack

Irbesartan and Hydrochlorothiazide 150 mg/12.5 mg film-coated tablets are peach coloured film-coated biconvex oval shaped tablets, debossed with “H 35” on one side and plain on other side.

Irbesartan and Hydrochlorothiazide 300 mg/12.5 mg film-coated tablets are peach coloured film-coated biconvex oval shaped tablets, debossed with “H 36” on one side and plain on other side.

Irbesartan and Hydrochlorothiazide 300 mg/25 mg film-coated tablets are pink coloured film-coated biconvex oval shaped tablets, debossed with “H 37” on one side and plain on other side.

Tablets are available in Polyamide / Aluminium / PVC - Aluminium blister packs and white opaque HDPE bottle with white opaque Polypropylene closure packs.

Pack size:

Blister pack:

150 mg/12.5 mg: 10, 14, 28, 30, 56, 90 and 98 tablets

300 mg/12.5 mg & 300 mg/25 mg: 10, 28, 30, 56, 90 and 98 tablets

Bottle pack:

30 and 90 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland

Manufacturer:

• Pfizer Service Company BVBA, Hoge Wei 10, 1930, Zaventem, Belgium or

• Pfizer PGM, Zone industrielle, 29, route des Industries, 37530 Poce -Sur-Cisse, France

• Pfizer Italia s.r.l., Localita Marino Del Tronto, 63100 - Ascoli Piceno (AP), Italy

This leaflet was revised in 07/2013

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