IRBESARTAN 150 mg /12.5 Mg Film-Coated Tablets

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1. IRBESARTAN E IDROCLOROTIAZIDE ALTER 150 mg/12,5 mg film-coated tablets
2. IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/12,5 mg film-coated tablets
3. IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/25 mg film-coated tablets
   1. WHAT IS IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER
   3. HOW TO TAKE IRBESARTAN E IDROCLOROTIAZIDE ALTER
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER
   6. PACKAGE CONTENTS AND OTHER INFORMATION
4. IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/12,5 mg film-coated tablets
5. IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/12,5 mg film-coated tablets

IRBESARTAN E IDROCLOROTIAZIDE ALTER 150 mg/12,5 mg film-coated tablets

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IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/12,5 mg film-coated tablets

film

IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/25 mg film-coated tablets

Irbesartan/idroclorotiazide
Generic medicine

Read this leaflet carefully before you start taking the medicine because 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 pass it on to others even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What IRBESARTAN E IDROCLOROTIAZIDE ALTER is and what it is used for
• 2. What you need to know before you take IRBESARTAN E IDROCLOROTIAZIDE ALTER
• 3. How to take IRBESARTAN E IDROCLOROTIAZIDE ALTER
• 4. Possible side effects
• 5. How to store IRBESARTAN E IDROCLOROTIAZIDE ALTER
• 6. Contents of the pack and other information

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

IRBESARTAN E IDROCLOROTIAZIDE ALTER is a combination of two active substances:
irbesartan and hydrochlorothiazide.
Irbesartan belongs to a group of drugs known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body
that binds to its receptors, located in blood vessels, causing a narrowing of
the latter. This leads to an increase in blood pressure. Irbesartan prevents the
binding of angiotensin-II to these receptors, causing a relaxation of the blood
vessels and a lowering of blood pressure.
Hydrochlorothiazide belongs to a group of medicines (so-called thiazide diuretics)
that determine an increased production of urine with a consequent lowering
of blood pressure.
The two active ingredients of IRBESARTAN E IDROCLOROTIAZIDE ALTER work together
determining a lowering of blood pressure values that is greater than that caused
by the individual drugs administered separately.

IRBESARTAN E IDROCLOROTIAZIDE ALTER is used to treat high blood pressurewhen
treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled
your blood pressure.

2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER

Do not take IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER

• if you are allergicto irbesartan or any of the ingredients of this medicine (listed in section 6).
• if you are allergicto hydrochlorothiazide or any medicines derived from sulfonamides
• if you are pregnant for more than 3 months(it is best to avoid taking IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER even in the early stages of pregnancy - see section “Pregnancy”)
• if you have serious problems with your liver or kidneys
• if you have difficulty urinating
• if your doctor finds that you have a persistently high level of calcium or a low level ofpotassium in your blood
• if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Warnings and precautions
Talk to your doctorbefore taking IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER if you
are in any of the following conditions:

• excessive vomiting or diarrhea
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER
• if you suffer from kidney disordersor have had a kidney transplant
• if you suffer from heart disorders
• if you suffer from liver disorders
• 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, subsequently, 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), especially if you suffer from kidney problems related to diabetes.
• aliskiren
• If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If, after taking Irbesartan and Hydrochlorothiazide Alter, you experience shortness of breath or severe difficulty breathing, consult a doctor immediately

The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated in the section “Do not take IRBESARTAN AND
HYDROCHLOROTHIAZIDE ALTER”
You must tell your doctor if you think you may be pregnant (or if there is a possibility
of becoming pregnant). IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER is not
recommended in the early stages of pregnancy and should not be taken if you are
pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (see the section “Pregnancy”).

Also, tell your doctor:

• if you are following a low-salt diet
• if you have symptoms such as excessive thirst, dry mouth, general weakness, drowsiness,muscle pain or cramps, nausea, vomiting,or a heartbeat that is excessivelyfastwhich may indicate an excessive effect of hydrochlorothiazide (contained in IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER)
• if you have noticed an increase, faster than normal, in skin sensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, rash)
• if you are to undergo surgeryor receive anesthesia
• if you have a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a period ranging from a few hours to weeks after taking IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may be at a higher risk of developing this disorder. You should stop IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER and consult your doctor.

For those who play sports: the use of the drug without a therapeutic need constitutes
doping and may still result in positive doping tests.

Children and adolescents
IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER should not be given to children and
adolescents (under 18 years of age).

Other medicines and IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Diuretic medicines like hydrochlorothiazide contained in IRBESARTAN AND
HYDROCHLOROTHIAZIDE ALTER can have an effect on other medicines. Preparations
containing lithium should not be taken with IRBESARTAN AND
HYDROCHLOROTHIAZIDE ALTER unless under strict medical supervision.
The doctor may need to adjust the dose and/or take other
precautions if you are taking an ACE inhibitor or aliskiren (see the section “Do not take IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER” and “Warnings and
precautions”).

You may need blood tests if you are using:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing diuretics or other diuretics
• some laxatives
• medicines for the treatment of gout
• vitamin D supplements
• medicines to control the heartbeat
• medicines for diabetes (oral or insulin).
• carbamazepine (a medicine for the treatment of epilepsy).

It is also important to tell your doctor if you are taking other medicines to lower your
blood pressure, steroids, cancer medicines, pain medicines, for
arthritis or colestyramine and colestipol to lower cholesterol levels in the blood.

IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER with food, drinks and alcohol
IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER can be taken with or without food.
Due to the hydrochlorothiazide contained in IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER, if
you drink alcohol during therapy with this medicine, while standing, you may have a
feeling of greater dizziness, especially when moving from a sitting to an upright
position.

Pregnancy, breastfeeding and fertility
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility
of becoming pregnant); your doctor will usually advise you to stop
taking IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER before becoming
pregnant or as soon as you find out you are pregnant and will advise you to take another
medicine instead of IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER. IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER is not
recommended in the early stages of pregnancy and should not be taken if you are
pregnant for more than 3 months as it can cause serious harm to the baby if taken after
the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. IRBESARTAN AND
HYDROCHLOROTHIAZIDE ALTER is not recommended for women who are breastfeeding and
your doctor may choose another treatment for you if you wish to breastfeed, especially
if the baby is newborn or premature.

Driving and using machines
Studies have not been conducted on the ability to drive vehicles and use machines.
It is unlikely that IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER will affect your ability
to drive vehicles or use machines.
However, dizziness or fatigue may occasionally occur during
treatment for high blood pressure. If this happens to you, talk to your doctor before driving
vehicles or using machines.

IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER contains lactose and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially ‘sodium-free’.

3. HOW TO TAKE IRBESARTAN E IDROCLOROTIAZIDE ALTER

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.

Dosage
The recommended dose of IRBESARTAN E IDROCLOROTIAZIDE ALTER 150 mg/12.5 mg is one or two tablets a day.
The recommended dose of IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/12.5 mg is one tablet a day.
The recommended dose of IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/25 mg is one tablet a day.
IRBESARTAN E IDROCLOROTIAZIDE ALTER will be prescribed by your doctor if previous therapy has not sufficiently reduced your blood pressure. The doctor will advise you on how to switch from previous treatment to treatment with IRBESARTAN E IDROCLOROTIAZIDE ALTER.

Method of administration
IRBESARTAN E IDROCLOROTIAZIDE ALTER is for oral use. Swallow the tablets with a sufficient amount of liquid (for example a glass of water). You can take IRBESARTAN E IDROCLOROTIAZIDE ALTER with or without food. You should try to take the medicine at the same time each day. It is important to continue therapy unless otherwise indicated by your doctor.
The maximum blood pressure lowering effect should be achieved after 6-8 weeks from the start of treatment.

If you take more IRBESARTAN E IDROCLOROTIAZIDE ALTER than you should
If you accidentally take too many tablets, contact your doctor immediately.

Children should not take IRBESARTAN E IDROCLOROTIAZIDE ALTER
IRBESARTAN E IDROCLOROTIAZIDE ALTER should not be given to children under 18 years of age. If a child swallows tablets, contact your doctor immediately.

If you forget to take IRBESARTAN E IDROCLOROTIAZIDE ALTER
If you forget to take a dose of the medicine, continue with therapy as normal.
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, IRBESARTAN E IDROCLOROTIAZIDE ALTER can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.
In patients treated with irbesartan, rare cases of allergic skin reactions (rash, urticaria) have been reported, as well as localized swelling of the face, lips
and/or tongue. If you have any of the above symptoms or if you have difficulty breathing,
stop taking IRBESARTAN E IDROCLOROTIAZIDE ALTER and contact
your doctor immediately.
The frequency of the following listed side effects is defined using the following
convention:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people.
Very rare: may affect less than 1 in 10,000 people
The side effects reported in clinical studies in patients treated with IRBESARTAN E
IDROCLOROTIAZIDE were:

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

• nausea/vomiting
• urinary disorders
• fatigue
• dizziness (even when moving from a sitting or lying position to an upright position)
• blood tests may show an increase in the levels of an enzyme that measures muscle and cardiac function (creatine kinase) or an increase in the levels of substances that measure kidney function (azotemia, creatinine).

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

• diarrhea
• hypotension
• weakness
• fast heartbeat
• hot flushes
• swelling
• sexual dysfunction (problems with sexual activity)
• blood tests may show a decrease in potassium and sodium levels in the blood.

Very rare side effects may affect less than 1 in 10,000 people

• Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Side effects reported after marketing authorization of IRBESARTAN E
IDROCLOROTIAZIDE ALTER
Since marketing authorization of IRBESARTAN E IDROCLOROTIAZIDE ALTER, some side effects have been
reported. Side effects with unknown frequency are:
headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain,
abnormal liver function and renal dysfunction, high potassium levels in the
blood and allergic reactions (rash, urticaria, localized 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 any combination of two active substances, side effects associated with
each of the components cannot be ruled out.

Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain and
decreased number of platelets (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; lack of white blood cells,
which can lead to frequent infections, fever; decreased number of platelets
(essential component for blood clotting); decreased number of red blood cells (anemia) characterized by fatigue, headache, shortness of breath
during exercise, dizziness and pale appearance; kidney problems; lung problems
including pneumonia or increased fluid in the lungs; increased sensitivity of the skin
to the sun; inflammation of blood vessels; a skin disorder characterized by
shedding of the skin all over the body; lupus erythematosus, identified by a rash
that can appear on the face, neck and scalp; allergic reactions; weakness
and muscle spasm; altered heartbeat; lowering of blood pressure
following a change in body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increases in certain types
of fat in the blood; high uric acid levels in the blood, which can cause gout;
skin cancer and lip cancer (non-melanoma skin cancer) (frequency not
known); rapid onset of distance vision impairment (myopia) (frequency
not known), blurred vision or eye pain due to increased pressure
(possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma (frequency not known).
It is known that the side effects associated with hydrochlorothiazide may increase with
higher doses of hydrochlorothiazide.

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this
medicine.

5. HOW TO STORE IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER

Keep out of sight and reach of children.
Do not use IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER after the expiry date stated
on the package and blister after Exp. The expiry date refers to the last day of
the month.
Do not store at a temperature above 30°C.
Store in the original packaging to protect it from moisture.
Do not dispose of any medicine in wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What IRBESARTAN E IDROCLOROTIAZIDE ALTER contains

• The active ingredients are: irbesartan and hydrochlorothiazide. Each film-coated tablet of IRBESARTAN E IDROCLOROTIAZIDE ALTER 150 mg/12.5 mg contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet of IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/12.5 mg contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet of IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/25 mg contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
• The excipients are: Tablet core:Lactose Monohydrate, Microcrystalline Cellulose, Hydroxypropylmethylcellulose, Croscarmellose Sodium), Aerosil 200 (Colloidal Silicon Dioxide), Magnesium Stearate, Coating:Hypromellose, Titanium Dioxide, Triacetin, Red and Yellow Iron Oxide.

Description of the appearance of IRBESARTAN E IDROCLOROTIAZIDE ALTER and package contents
IRBESARTAN E IDROCLOROTIAZIDE ALTER 150 mg/12.5 mg film-coated tablets
are salmon pink in color, round, without a fracture line, film-coated, with a
diameter of 11 mm
IRBESARTAN E IDROCLOROTIAZIDE ALTER 150 mg/12.5 mg film-coated tablets
are supplied in packs containing blisters of 14 or 28 tablets.

IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/12,5 mg film-coated tablets

are yellow ochre, oblong, without a fracture line, film-coated,
with dimensions of 17.0 mm x 7.5 mm

IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/12,5 mg film-coated tablets

are supplied in packs containing blisters of 14 or 28 tablets
IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/25 mg film-coated tablets
are salmon pink, oblong, without a fracture line, film-coated, with
dimensions of 17.0 mm x 7.5 mm.
IRBESARTAN E IDROCLOROTIAZIDE ALTER 300 mg/25 mg film-coated tablets
are supplied in packs containing blisters of 14, 28 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
LABORATORI ALTER srl
Via Egadi, 7
20144 Milan

Manufacturer:
Laboratorios Alter, S.A.
c/ Mateo Inurria, 30 - 28036 Madrid – Spain