8 mm

30 mm

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.

This medicine 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 this medicine work together to lower blood pressure further than if either was given alone.

This medicine 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 this medicine

Do not take this medicine

•    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 medicine

•    if you are more than 3 months pregnant. (It is also better to avoid this medicine 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 mellitus or impaired kidney function and you are treated with blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before taking this medicine 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 this medicine"

You must tell your doctor if you think you are (or might become) pregnant. This medicine 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 this medicine)

•    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 this medicine. This could be a sign that you are developing glaucoma, increased pressure in your eye(s). You should discontinue treatment with this medicine and seek medical attention.

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

Children and adolescents

This medicine should not be given to children and adolescents (under 18 years).

Taking other medicines

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 this medicine may have an effect on other medicines. Preparations containing lithium should not be taken with this medicine 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 this medicine" 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.

Taking with food and drink

This medicine can be taken with or without food.

Due to the hydrochlorothiazide contained in this medicine 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 this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of this medicine. This medicine 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

Tell your doctor if you are breast-feeding or about to start breastfeeding. This medicine 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. This medicine 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.

This medicine 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.

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 this medicine is one or two tablets a day. It will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.    g

Your doctor will instruct you how to switch from the previous treatment to this medicine.

Use in children and adolescents

This medicine should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

Route and method of administration

This medicine is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take this medicine 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 this medicine until your doctor tells you otherwise.

The score line on 300/25 mg tablet is not intended for breaking the tablet.

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

If you take more of this medicine than you should

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

If you forget to take this medicine

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.

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.

Stop taking this medicine and contact your doctor immediately if you notice any of the below side effects:

•    Rare cases of allergic skin reactions (rash, hives), as well as localised swelling of the face, lips and/or tongue, shortness of breath

•    Rapid heart beat (tachycardia) or altered heart beat

•    Kidney problems -symptoms include nausea, vomiting, changes in urine output, fatigue, weakness, loss of appetite, difficulty in breathing

•    Liver problems e.g. hepatitis and jaundice (symptoms include abdominal pain, dark urine, feeling sick, yellowing of the skin and whites of eyes)

•    Inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting

•    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

•    Lung problems including pneumonia or build-up of fluid in the lungs

•    Serious skin reactions like toxic epidermal necrolysis 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

Side effects reported in clinical studies for patients treated with

irbesartan and hydrochlorothiazide 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 cause you problems, talk to your

doctor.

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

•    diarrhoea

•    low blood pressure

•    fainting

•    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 cause you problems, talk to your doctor.

Post-marketing side effects

Some undesirable effects have been reported since marketing of irbesartan and hydrochlorothiazide. Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, increased level of potassium in your blood.

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; sleep disorders; depression; blurred vision; increased sensitivity of the skin to the sun; inflammation of blood vessels; weakness and muscle spasm; 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 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.

•    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.

•    Do not store above 30°C. Store in the original package in order to protect from light and moisture.

•    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 this medicine contains

•    The active substances are irbesartan and hydrochlorothiazide.

•    Each tablet of 150/12.5 mg contains 150 mg irbesartan and

12.5    mg hydrochlorothiazide.

•    Each tablet of 300/12.5 mg contains 300 mg irbesartan and

12.5    mg hydrochlorothiazide.

•    Each tablet of 300/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.

•    The other ingredients are:

Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, poloxamer pregelatinised maize starch.

Film-coating (150/12.5 mg, 300/12.5 mg): Hypromellose, Titanium dioxide (E171), Purified stearic acid, Microcrystalline cellulose, Iron oxide yellow (E172), Iron oxide red (E172). Film-coating (300/25 mg): Hypromellose, Titanium dioxide (E171), Purified stearic acid, Microcrystalline cellulose, Iron oxide red (E172), Iron oxide black (E172).

What these tablets look like and contents of the pack

•    150/12.5 mg: Light pink, oblong, biconvex film-coated tablets

•    300/12.5 mg: Light pink, oblong, biconvex film-coated tablets

•    300/25 mg: Pink, oblong, biconvex, film-coated tablets with a scoreline on one side and plain on the other side.

•    This medicine is available in blister packs of 14, 28, 56 or 98 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire, HP4 1EG,

United Kingdom

Telephone: 0044 (0)1442 200922 Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

Irbesartan and Hydrochlorothiazide 150/12.5 mg film-coated tablets; PL 17907/0517 Irbesartan and Hydrochlorothiazide 300/12.5 mg film-coated tablets; PL 17907/0518 Irbesartan and Hydrochlorothiazide 300/25 mg film-coated tablets; PL 17907/0519

This leaflet was last revised in March 2016.

To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, email) above.

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