IRBESARTAN 150 mg /12.5 Mg Tabletka Powlekana

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1. Irbesartan e Idroclorotiazide Pensa 150 mg/12,5 mg tablets, 300 mg/12,5 mg tablets, 300 mg/25 mg tablets
   1. What is Irbesartan and Hydrochlorothiazide Pensa and what it is used for
   2. What you need to know before taking Irbesartan and Idroclorotiazide Pensa
   3. How to take Irbesartan and Hydrochlorothiazide Pensa
   4. Possible side effects
   5. How to store Irbesartan and Hydrochlorothiazide Pensa
   6. Contents of the pack and other information

Irbesartan e Idroclorotiazide Pensa 150 mg/12,5 mg tablets, 300 mg/12,5 mg tablets, 300 mg/25 mg tablets

Generic medicine
Irbesartan/hydrochlorothiazide

Readcarefullythisleafletbeforetakingthismedicinebecauseitcontains
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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Irbesartan and Hydrochlorothiazide Pensa 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 the
blood vessels, causing a narrowing of these vessels. 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 and Hydrochlorothiazide Pensa work together determining a
lowering of blood pressure values that is greater than that caused by the individual
drugs administered separately.

Irbesartan and Hydrochlorothiazide Pensa is used to treat high blood pressurewhen irbesartan or
hydrochlorothiazide alone have not been able to adequately control blood pressure.

2. What you need to know before taking Irbesartan and Idroclorotiazide Pensa

Do not take Irbesartan and Idroclorotiazide Pensa

• If you are allergicto the active ingredients, to any medicines derived from sulfonamides, or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant for more than 3 months(it is best to avoid taking Irbesartan and Idroclorotiazide Pensa even in the early stages of pregnancy - see section “Pregnancy”)
• If you have serious problems with your liveror kidneys
• If you have difficulty urinating
• If your doctor determines that you have a persistently high level of calcium or a low level of potassiumin your blood
• If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine

that lowers your blood pressure, containing aliskiren

Warnings and precautions
Talk to your doctorbefore taking Irbesartan and Idroclorotiazide Pensa if you are in any of the
following conditions:

• if you experience excessive vomiting or diarrhea
• if you suffer from kidney problems, or have had a kidney transplant
• if you suffer from heart problems
• if you suffer from liver problems
• if you suffer from diabetes
• if you develop low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and pounding heartbeat), especially if you are being treated for 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 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 some types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Irbesartan and Idroclorotiazide Pensa
• if you have a decrease in vision or eye pain. These may 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 Idroclorotiazide Pensa. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may have a higher risk of developing this disorder.
• if you have had breathing problems or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Irbesartan and Idroclorotiazide Pensa, 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 under "Do not take Irbesartan and Idroclorotiazide Pensa".
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Irbesartan and Idroclorotiazide Pensa is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months, as it may
cause serious harm to the baby if taken during this period (see 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 excessively fast heartbeat that may indicate an
  excessive effect of hydrochlorothiazide (contained in Irbesartan and Idroclorotiazide Pensa)
• if you have noticed an increase in skin sensitivity to the sun with symptoms of
  sunburn (such as redness, itching, swelling, rash) that occur more quickly than usual
• if you are to undergo surgery or must take anesthetics
• if you experience a change in vision or pain in one or both eyes while taking

Irbesartan and Idroclorotiazide Pensa. This could be a sign that glaucoma, an increase in eye pressure, is developing. You should stop taking Irbesartan and Idroclorotiazide Pensa and consult your doctor.
Hydrochlorothiazide, contained in this medicine, can give positive results in doping tests.

Children and adolescents
Irbesartan and Idroclorotiazide Pensa should not be given to children and adolescents (under
18 years of age).

Other medicines and Irbesartan and Idroclorotiazide Pensa
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 Idroclorotiazide Pensa
can have an effect on other medicines. Preparations containing lithium should not be taken
together with Irbesartan and Idroclorotiazide Pensa, unless under strict medical control.
The doctor may need to adjust the dose and/or take other precautions:
if you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not take
Irbesartan and Idroclorotiazide Pensa" and "Warnings and precautions”).

You may need blood tests if you are using:

• potassium supplements
• salt substitutes that contain potassium
• potassium-sparing diuretics or other diuretics
• some laxatives
• medicines for the treatment of gout
• vitamin D supplements
• medicines to control your heartbeat
• medicines for diabetes (oral medicines such as repaglinide 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 Idroclorotiazide Pensa with food, drinks and alcohol
Irbesartan and Idroclorotiazide Pensa can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbesartan and Idroclorotiazide Pensa, if you drink alcohol during
therapy with this medicine, you may feel more dizzy when standing up, 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 Idroclorotiazide Pensa 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
Idroclorotiazide Pensa. Irbesartan and Idroclorotiazide Pensa is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months as it may
cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Irbesartan and Idroclorotiazide
Pensa 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 performed on the ability to drive and use machines. It is unlikely
that Irbesartan and Idroclorotiazide Pensa will affect the ability to drive and 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 using machines.

Irbesartan and Idroclorotiazide Pensa contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking
this medicine.

Irbesartan and idroclorotiazide Pensa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Irbesartan and Hydrochlorothiazide Pensa

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

Dosage of Irbesartan and Hydrochlorothiazide Pensa 150 mg/12.5 mg
The recommended dose of Irbesartan and Hydrochlorothiazide Pensa 150 mg/12.5 mg is one tablet per day. Irbesartan and Hydrochlorothiazide Pensa 150 mg/12.5 mg 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 Irbesartan and Hydrochlorothiazide Pensa.
If this dose does not help you reduce your blood pressure as required, your doctor may prescribe Irbesartan and Hydrochlorothiazide Pensa 300 mg/12.5 mg.

Dosage of Irbesartan and Hydrochlorothiazide Pensa 300 mg/12.5 mg
The recommended dose of Irbesartan and Hydrochlorothiazide Pensa 300 mg/12.5 mg is one tablet per day.
Irbesartan and Hydrochlorothiazide Pensa 300 mg/12.5 mg will be prescribed by your doctor if previous therapy has not sufficiently reduced your blood pressure. The doctor will advise you how to switch from previous treatment to Irbesartan and Hydrochlorothiazide Pensa.
If this dose does not help you reduce your blood pressure as required, your doctor may prescribe Irbesartan and Hydrochlorothiazide Pensa 300 mg/25 mg.

Dosage of Irbesartan and Hydrochlorothiazide Pensa 300 mg/25 mg
The recommended dose of Irbesartan and Hydrochlorothiazide Pensa 300 mg/25 mg is one tablet per day.
This dose should not be increased.
Irbesartan and Hydrochlorothiazide Pensa 300 mg/25 mg will be prescribed by your doctor if previous therapy has not sufficiently reduced your blood pressure. The doctor will advise you how to switch from previous treatment to Irbesartan and Hydrochlorothiazide Pensa.
If this dose does not help you reduce your blood pressure as required, your doctor will prescribe additional treatment.

Method of administration
Irbesartan and Hydrochlorothiazide Pensa is for oral use. Swallow the tablets with a sufficient amount of liquid (for example a glass of water). You can take Irbesartan and Hydrochlorothiazide Pensa with or without food. You should try to take the medicine at the same time each day. It is important to continue the 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 and Hydrochlorothiazide Pensa than you should
If you accidentally take too many tablets, contact your doctor immediately.

Children should not take Irbesartan and Hydrochlorothiazide Pensa
Irbesartan and Hydrochlorothiazide Pensa 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 and Hydrochlorothiazide Pensa
If you forget to take a dose of the medicine, continue the therapy normally. Do not take a double dose to make up for the missed dose.
If you have any doubts 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.
In patients treated with irbesartan, rare cases of allergic skin reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported. If you experience anyof the above symptoms or have difficulty breathing, stop taking Irbesartan and
Idroclorotiazide Pensa and contact your doctor immediately.
If you notice any of the following side effects, immediately stop treatment with Irbesartan and
Idroclorotiazide Pensa and contact your doctor immediately or go to the nearest hospital emergency room.

Uncommon (may affect up to 1 in 100 people):
yellowing of the skin and whites of the eyes.

Other possible side effects
Side effects reported in clinical studies for patients treated with a combination of
irbesartan/idroclorotiazide are:

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

• feeling unwell/general malaise (nausea, vomiting)
• urinary disorders
• feeling tired (fatigue)
• dizziness (even when moving from a sitting or lying position to an upright position)
• blood tests may show an increase in the level of an enzyme that measures how muscles and heart are working (creatine kinase) or substances that measure how the kidneys are working (blood urea nitrogen, creatinine).

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

• orthostatic dizziness
• diarrhea
• low blood pressure, syncope, tachycardia, edema
• weakness
• increased heart rate
• hot flashes
• swelling of the extremities
• sexual dysfunction (problems related to sexual performance), changes in libido
• blood tests may show a decrease in the level of potassium and sodium in the blood
• yellowing of the skin and whites of the eyes (jaundice).

Not known (frequency cannot be estimated based on available data):

• headache
• ringing in the ears
• cough
• altered taste, indigestion
• joint and muscle pain (arthralgia and myalgia)
• hepatitis, abnormal liver function
• renal dysfunction
• increased potassium levels in the blood
• allergic reactions (rash, urticaria, localized swelling of the face, lips, mouth, tongue or throat).

As with any combination of two active substances, side effects associated with each individual component cannot be ruled out.

Side effects associated with irbesartan alone
Uncommon (may affect up to 1 in 100 people):

• chest pain. Not known (frequency cannot be estimated based on available data):
• more frequent bruising and bleeding which may be caused by a reduced number of platelets (blood cells that contribute to coagulation)
• decreased number of red blood cells (anemia - symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and paleness)
• severe anaphylactic reactions (anaphylactic shock)
• hypoglycemia.

Side effects associated with hydrochlorothiazide alone
Not known (frequency cannot be estimated based on available data):

• stomach irritation;
• stomach cramps, diarrhea, constipation; anorexia; sialadenitis
• 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;
• xanthopsia;
• Aplastic anemia, myelosuppression, neutropenia/agranulocytosis, hemolytic anemia, leukopenia, thrombocytopenia
• fever;
• Dizziness, paresthesia, feeling of faintness, agitation
• decreased number of platelets (essential component for blood coagulation), decreased number of red blood cells (anemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness and paleness;
• kidney disorders;
• lung problems including pneumonia or increased fluid in the lungs;
• anaphylactic reactions, toxic epidermal necrolysis, necrotizing angiitis (vasculitis, cutaneous vasculitis), lupus-like skin reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, skin rash, urticaria;
• muscle weakness and spasm;
• altered heartbeat; lowering of blood pressure following a change in body position;
• cough
• elevated blood sugar levels;
• sugar in the urine;
• electrolyte imbalance
• increased levels of certain types of fat in the blood, elevated uric acid levels in the blood which can cause gout.
• skin and lip cancer (non-melanoma skin cancer)
• rapid onset of distance vision impairment (acute myopia), decreased 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).

Very rare: (may affect up to 1 in 10,000)
Acute respiratory distress (signs include severe shortness of breath, fever, weakness and
confusion).
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 effects, including those not listed in this leaflet, please 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 Pensa

Keep this medicine out of the sight and reach of children.
Do not use Irbesartan and Hydrochlorothiazide Pensa after the expiry date stated on the pack and on the
blister after Exp. The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
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 protect the environment.

6. Contents of the pack and other information

What Irbesartan and Hydrochlorothiazide Pensa contains

• The active ingredients are: irbesartan and hydrochlorothiazide. Irbesartan and Hydrochlorothiazide Pensa 150 mg/12.5 mg:Each tablet of Irbesartan and Hydrochlorothiazide Pensa contains 150 mg of irbesartan (as irbesartan hydrochloride) and 12.5 mg of hydrochlorothiazide. Irbesartan and Hydrochlorothiazide Pensa 300 mg/12.5 mg:Each tablet of Irbesartan and Hydrochlorothiazide Pensa contains 300 mg of irbesartan (as irbesartan hydrochloride) and 12.5 mg of hydrochlorothiazide. Irbesartan and Hydrochlorothiazide Pensa 300 mg/25 mg:Each tablet of Irbesartan and Hydrochlorothiazide Pensa contains 300 mg of irbesartan (as irbesartan hydrochloride) and 25 mg of hydrochlorothiazide. The other ingredients are: povidone, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, hydrogenated castor oil, corn starch.

Description of the appearance of Irbesartan and Hydrochlorothiazide Pensa and contents of the pack

Irbesartan and Hydrochlorothiazide Pensa 150 mg/12.5 mg
white, oblong, biconvex tablets, with 1H1 imprinted on one side.

Irbesartan and Hydrochlorothiazide Pensa 300 mg/12.5 mg
white, oblong, biconvex tablets, with 1H12 imprinted on one side.

Irbesartan and Hydrochlorothiazide Pensa 300 mg/25 mg
white, oblong, biconvex tablets, with 1H25 imprinted on one side.
Packs of 14, 28, 56 and 98 film-coated tablets are available in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milan

Manufacturers responsible for batch release
LABORATORIOS LICONSA S.A.
Avda. Miralcampo, no 7
Poligono Industrial Miralcampo
19200 Azuqueca De Henares (Guadalajara) – Spain