Irbesartan and hydrochlorothiazide Aurobindo: detailed information

Patient Information Leaflet: Information for the User

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

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Irbesartan and Hydrochlorothiazide Aurobindo is and what it is used for
What you need to know before taking Irbesartan and Hydrochlorothiazide Aurobindo
How to take Irbesartan and Hydrochlorothiazide Aurobindo
Possible side effects
How to store Irbesartan and Hydrochlorothiazide Aurobindo
Contents of the pack and other information

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

Irbesartan and Hydrochlorothiazide Aurobindo 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 located in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, resulting in relaxation of the blood vessels and a lowering of blood pressure. Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that increase urine production, thereby lowering blood pressure.
The two active substances in Irbesartan and Hydrochlorothiazide Aurobindo work together to lower blood pressure to a greater extent than either medicine alone.
Irbesartan and Hydrochlorothiazide Aurobindo is used to treat high blood pressure when treatment with either irbesartan or hydrochlorothiazide alone has not adequately controlled your blood pressure.

2. What you should know before taking Irbesartan and Hydrochlorothiazide Aurobindo

Do not take Irbesartan and Hydrochlorothiazide Aurobindo:

if you are allergic to irbesartan or to any of the other ingredients of this
medicine (listed in section 6);
if you are allergic to hydrochlorothiazide or to any sulfonamide-derived medicine;
if you are more than 3 months pregnant (Irbesartan and Hydrochlorothiazide Aurobindo should also be avoided in early pregnancy – see section on Pregnancy);
if you have severe liver or kidney problems;
if you have difficulty passing urine;
if your doctor finds that you have persistently high calcium levels or low potassium levels in the blood;
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Irbesartan and Hydrochlorothiazide Aurobindo, especially if you are in any of the following situations:

if you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Irbesartan and Hydrochlorothiazide Aurobindo;
if you are experiencing excessive vomiting or diarrhoea;
if you have kidney problems or have had a kidney transplant;
if you have heart problems;
if you have liver problems;
if you have diabetes;
if you have lupus erythematosus (also known as lupus or SLE);
if you have primary hyperaldosteronism (a condition involving excessive production of the hormone aldosterone, leading to sodium retention and consequently increased blood pressure);
if you are taking any of the following medicines for high blood pressure:
- an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;
- aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also the section “Do not take Irbesartan and Hydrochlorothiazide Aurobindo”.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant).
Irbesartan and Hydrochlorothiazide Aurobindo is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby (see section on Pregnancy).
You should also inform your doctor:

if you are on a low-salt diet;
if you experience symptoms such as excessive 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 Aurobindo);
if you notice an increased, abnormally rapid sensitivity of the skin to sunlight, with symptoms of sunburn (such as redness, itching, swelling, blistering);
if you are scheduled for surgery or require anaesthetics;
if you experience changes in vision or pain in one or both eyes while taking Irbesartan and Hydrochlorothiazide Aurobindo. This could be a sign of developing glaucoma, an increase in pressure inside the eye. You should stop taking Irbesartan and Hydrochlorothiazide Aurobindo and seek immediate medical attention.

The hydrochlorothiazide contained in this medicine may lead to a positive result in anti-doping tests.
Caution for athletes: this product contains substances prohibited in doping. Any use differing from the recommended dosage regimen or route of administration is prohibited.
Children and adolescents
Irbesartan and Hydrochlorothiazide Aurobindo must not be given to children and adolescents (under 18 years of age).
Other medicines and Irbesartan and Hydrochlorothiazide Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diuretics such as hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide Aurobindo may interact with other medicines. Preparations containing lithium must not be taken together with Irbesartan and Hydrochlorothiazide Aurobindo without close medical supervision.
Your doctor may consider it necessary to adjust the dose and/or take additional precautions:

if you are taking an ACE inhibitor or aliskiren (see also sections “Do not take Irbesartan and Hydrochlorothiazide Aurobindo” and “Warnings and precautions”)

You may need blood tests if you are taking:

potassium supplements,
salt substitutes containing potassium,
potassium-sparing medicines or other diuretics,
certain laxatives,
medicines for the treatment of gout,
therapeutic vitamin D supplements,
medicines to control heart rhythm,
medicines for diabetes (oral antidiabetic drugs or insulin),
carbamazepine (a medicine used to treat epilepsy).

It is also important to inform your doctor if you are taking other medicines to lower blood pressure, steroids, anticancer medicines, painkillers, medicines for arthritis, or bile acid sequestrants such as cholestyramine or colestipol to reduce blood cholesterol.
Irbesartan and Hydrochlorothiazide Aurobindo with food and drink and alcohol
Irbesartan and Hydrochlorothiazide Aurobindo can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide Aurobindo, drinking alcohol during treatment may increase the likelihood of dizziness when standing up, especially when moving from a sitting to an upright position.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbesartan and Hydrochlorothiazide Aurobindo before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Irbesartan and Hydrochlorothiazide Aurobindo is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or plan to start breast-feeding. Irbesartan and Hydrochlorothiazide Aurobindo is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies on the effects on the ability to drive or use machines have been conducted. It is unlikely that Irbesartan and Hydrochlorothiazide Aurobindo affects the ability to drive or use machines. However, dizziness or fatigue may occasionally occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or operating machinery.
Irbesartan and Hydrochlorothiazide contains
Irbesartan and Hydrochlorothiazide contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Irbesartan and Hydrochlorothiazide Aurobindo

Take this medicine exactly as prescribed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose of Irbesartan and Hydrochlorothiazide Aurobindo is one or two tablets
per day. Irbesartan and Hydrochlorothiazide Aurobindo will be prescribed by your doctor
if your previous treatment has not sufficiently lowered your blood pressure. Your doctor will
inform you how to switch from your previous treatment to Irbesartan and Hydrochlorothiazide Aurobindo.
Method of administration
Irbesartan and Hydrochlorothiazide Aurobindo is for oral use. Swallow the tablets with a
sufficient amount of liquid (for example, a glass of water). You may take Irbesartan and
Hydrochlorothiazide Aurobindo with or without food. Try to take your daily dose at approximately the same time each day. It is important to continue treatment with Irbesartan and
Hydrochlorothiazide Aurobindo unless otherwise instructed by your doctor.
Maximum blood pressure lowering effect is achieved after 6–8 weeks of starting treatment.
If you take more Irbesartan and Hydrochlorothiazide Aurobindo than you should
If you accidentally take too many tablets, contact your doctor immediately.
Children must not take Irbesartan and Hydrochlorothiazide Aurobindo
Irbesartan and Hydrochlorothiazide Aurobindo must not be given to children under
18 years of age. If a child ingests any tablets, contact your doctor immediately.
If you forget to take Irbesartan and Hydrochlorothiazide Aurobindo
If you accidentally miss a daily dose, take the next dose as usual. Do not take a double
dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will
experience them. Some of these effects may be serious and may require medical
attention.
Rare cases of allergic skin reactions (rash, urticaria) as well as localized swelling of the
face, lips and/or tongue have been reported in patients treated with irbesartan.
If you experience any of these symptoms or have difficulty breathing , stop taking
Irbesartan and Hydrochlorothiazide Aurobindo 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

In clinical studies, the side effects reported in patients treated with
Irbesartan/Hydrochlorothiazide were:

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

nausea, vomiting
abnormal urination
fatigue
dizziness (also when standing up from a lying or sitting position)
blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase) or substances that measure kidney function (blood urea nitrogen, creatinine)
If any of these side effects cause you problems , consult your doctor.

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

diarrhoea
low blood pressure
fainting
increased heart rate
flushing
swelling
sexual dysfunction (problems related to sexual performance)
blood tests may show decreased levels of potassium and sodium in the blood

Unknown frequency side effects (frequency cannot be estimated from available data):

non-melanoma skin cancer and lip cancer

If any of these side effects cause you problems , consult your doctor.
Side effects reported since marketing of Irbesartan and Hydrochlorothiazide
Since the launch of Irbesartan and Hydrochlorothiazide on the market, some side effects
have been reported. The side effects with unknown frequency include: headache,
tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, abnormal liver
function, impaired kidney function, increased potassium levels in the blood, allergic
reactions such as rash, urticaria, 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 with all combinations of two active substances, side effects associated with each
individual component cannot be ruled out.

Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain and decreased platelet count
(blood cells essential for blood clotting) 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 characterized by
severe pain in the upper abdomen, often with nausea and vomiting; sleep disturbances;
depression; blurred vision; deficiency of white blood cells which may lead to frequent
infections; fever; decreased platelet count (a component essential for blood clotting),
reduction in red blood cells (anaemia) characterized by tiredness, headache,
shortness of breath during physical activity, dizziness and pallor; kidney disease;
lung problems including pneumonia or fluid accumulation in the lungs; increased
sensitivity of the skin to sunlight; inflammation of blood vessels; skin disease
characterized by peeling of the skin over the entire body; cutaneous lupus erythematosus,
identified by a skin rash that may appear on the face, neck or scalp; allergic reactions;
muscle weakness and spasms; altered heart rate; drop in blood pressure upon changing
body position; swelling of the salivary glands; elevated blood sugar levels, sugar in the
urine; increased levels of certain types of fat in the blood; elevated levels of uric acid 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 experience any side effect, including those not listed in this leaflet, speak to your
doctor or pharmacist. You can also report side effects directly via the national reporting
system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store Irbesartan and Hydrochlorothiazide Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Irbesartan and Hydrochlorothiazide Aurobindo contains

The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
The other ingredients are:
Tablet core: monohydrate lactose, sodium starch glycolate (type A), povidone K30, anhydrous colloidal silica, talc, sodium stearate fumarate.
Coating:
Film-coated tablets 150 mg/12.5 mg and 300 mg/12.5 mg
monohydrate lactose
hypromellose (E464)
titanium dioxide (E171)
macrogol 4000
yellow iron oxide (E172)
red iron oxide (E172)
Film-coated tablets 300 mg/25 mg
hypromellose (E464)
titanium dioxide (E171)
macrogol 4000
red iron oxide (E172)
black iron oxide (E172)

Description of the appearance of Irbesartan and Hydrochlorothiazide Aurobindo and contents of the pack
Film-coated tablet.
150 mg/12.5 mg
Film-coated tablets, peach-coloured, biconvex, oval-shaped, with "H 35" engraved on one side and smooth on the other.
300 mg/12.5 mg
Film-coated tablets, peach-coloured, biconvex, oval-shaped, with "H 36" engraved on one side and smooth on the other.
300 mg/25 mg
Film-coated tablets, pink-coloured, biconvex, oval-shaped, with "H 37" engraved on one side and smooth on the other.
The tablets are available in blister packs made of polyamide/aluminum/PVC/aluminum foil, and in HDPE white opaque bottles with white opaque polypropylene caps.
Pack sizes:
Blister packs: 1, 14, 28, 30, 56, 90, 98, 100 and 500 tablets.
Bottle packs: 30 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe 102,
21047 Saronno (VA)
Italy

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD
United Kingdom

This medicinal product is authorized in the European Economic Area Member States under the following names:
France: Irbesartan/Hydrochlorothiazide Arrow 150mg/12.5mg, 300 mg/12.5 mg & 300 mg/25 mg, film-coated tablets
Germany: Irbesartan/Hydrochlorothiazide Aurobindo 150 mg/12.5 mg, 300 mg/12.5 mg & 300 mg/25 mg Filmtabletten
Italy: Irbesartan and Hydrochlorothiazide Aurobindo
Malta: Irbesartan/Hydrochlorothiazide Aurobindo 150 mg/12.5 mg, 300 mg/12.5 mg & 300 mg/25 mg film-coated tablets
Netherlands: Irbesartan/Hydrochlorothiazide Aurobindo 150 mg/12.5 mg, 300 mg/12.5 mg & 300 mg/25 mg filmomhulde tabletten
Poland: Irbesartan/Hydrochlorothiazide Aurobindo
Portugal: Irbesartan + Hidroclorotiazida Aurobindo
Spain: Irbesartán/Hidroclorotiazida Aurobindo 150 mg/12.5 mg, 300 mg/12.5 mg & 300 mg/25 mg comprimidos recubiertos con película EFG
United Kingdom: Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg, 300 mg/12.5 mg & 300 mg/25 mg Film-coated Tablets