Irbesartan and Hydrochlorothiazide Tablets USP 75mg/6.25mg

Irbesartan and Hydrochlorothiazide Tablets USP 75mg/6.25mg
Irbesartan and Hydrochlorothiazide Tablets USP 150mg/12.5mg
Irbesartan and Hydrochlorothiazide Tablets USP 300mg/12.5mg
Irbesartan and Hydrochlorothiazide Tablets USP 300mg/25mg

Package Leaflet: Information for the patient

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 is and what it is used for
2. What you need to know 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. Contents of the pack and other 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 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

Do not take Irbesartan and Hydrochlorothiazide

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 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 and Hydrochlorothiazide 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.
if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan and Hydrochlorothiazide.

Your doctor may check your kidney function, blood pressure, and the number of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading ?Do not take Irbesartan and Hydrochlorothiazide?.

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

Other medicines and Irbesartan and Hydrochlorothiazide

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 may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan and Hydrochlorothiazide 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? 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 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, especially 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 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 are 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 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 prematurely.

Driving and using machines

Irbesartan and Hydrochlorothiazide are unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during the treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Irbesartan and Hydrochlorothiazide 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

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 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 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 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 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 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 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

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, 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, severe allergic reactions (anaphylactic shock), and decrease in the number of platelets (a blood cell essential for the clotting of the blood) have 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.

Not known (frequency cannot be estimated from the available data): skin and lip cancer (non-melanoma skin cancer).

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.

5. HOW TO STORE IRBESARTAN AND HYDROCHLOROTHIAZIDE

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 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 Irbesartan and Hydrochlorothiazide contains

The active substances are irbesartan and hydrochlorothiazide.

a) Each film-coated tablet contains:
Irbesartan USP 75mg
Hydrochlorothiazide USP 6.25mg

b) Each film-coated tablet contains:
Irbesartan USP 150mg.
Hydrochlorothiazide USP 12.5mg

c) Each film-coated tablet contains:
Irbesartan USP 300mg
Hydrochlorothiazide USP 12.5mg

d) Each film-coated tablet contains:
Irbesartan USP 300mg
Hydrochlorothiazide USP 25mg

The other ingredients are:

Tablet core: Lactose monohydrate, Microcrystalline cellulose, Croscarmellose sodium, Hypromellose

Silicon dioxide, Magnesium stearate

Film-coating: Lactose monohydrate, Hypromellose, Titanium dioxide, Macrogol, Red and yellow ferric oxides & Carnauba wax.

What Irbesartan and Hydrochlorothiazide looks like and contents of the pack

Irbesartan and Hydrochlorothiazide tablets are peach, biconvex, oval-shaped.

Tablets are available in PVC/Aluminium Blister Pack.

Pack Size of: 7, 14, 28, 30, 50, 60, 90, 100 and 500 tablets.

Not all pack sizes may be marketed.

7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)