Irbesartan and hydrochlorothiazide Doc Generici: detailed information

PATIENT LEAFLET: INFORMATION FOR THE USER

IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generics 150 mg/12.5 mg tablets, 300 mg/12.5 mg tablets, 300 mg/25 mg 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 could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generics is and what it is used for
What you need to know before taking IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generics
How to take IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generics
Possible side effects
How to store IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generics
Contents of the pack and other information

1. WHAT IS IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici AND WHAT IS IT USED FOR?

IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici 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 its receptors located in the
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
reduction in blood pressure.
Hydrochlorothiazide belongs to a group of medicines (so-called thiazide diuretics) that
increase urine production, thereby lowering blood pressure.
The two active ingredients in IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici work together
to reduce blood pressure to a greater extent than either medicine alone.
IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici 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 DOC Generici

Do not take IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici:

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 other medicines containing sulfonamide derivatives
if you are more than 3 months pregnant. It is better to avoid IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici even in the early stages of pregnancy (see Pregnancy)
if you have severe liver or kidney problems
if you have difficulty urinating
if your doctor has determined that you have persistently high levels of calcium or low levels of potassium 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 DOC Generici if you are in any of the following conditions:

excessive vomiting or diarrhoea
if you suffer from kidney disorders or have had a kidney transplant
if you suffer from heart problems
if you suffer from liver disorders
if you suffer from diabetes
if you suffer from systemic lupus erythematosus (also known as lupus or SLE)
if you suffer from primary hyperaldosteronism (a condition related to excessive production of the hormone aldosterone, causing sodium retention and, consequently, increased blood pressure)
if you are taking any of the following medicines used to treat high blood pressure:
an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
aliskiren
if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, especially 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 DOC Generici.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.
See also the section “Do not take IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici”.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant).
IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici is not recommended during early pregnancy, and must not be taken after the first three months of pregnancy, as it may cause severe harm to the unborn child if taken during this period (see Pregnancy).
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 excessively rapid heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici)
if you have noticed an increase in skin sensitivity to sunlight, with symptoms of sunburn (such as redness, itching, swelling, rash)
if you are due to undergo surgery or need to take anaesthetics
if you experience vision changes or pain in one or both eyes while taking IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici. This could be a sign that you are developing glaucoma, an increase in pressure inside the eye(s). You should stop treatment with IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici and contact your doctor immediately.

Talk to your doctor, pharmacist, or nurse before taking IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici

if you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after taking IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici. If left untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition.

Hydrochlorothiazide, contained in this medicine, may produce positive results in anti-doping tests.
Children and adolescents
IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici must not be administered to children and adolescents (under 18 years of age).
Other medicines and IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici
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 DOC Generici may interact with other medicines. Preparations containing lithium should not be taken together with IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici unless under strict medical supervision.
Your doctor may consider it necessary to adjust your dose and/or take additional precautions:
If you are taking an ACE inhibitor or aliskiren (see also section “Do not take IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici” and “Warnings and precautions”).
You may need blood tests if you are using:

potassium supplements
salt substitutes containing potassium
potassium-sparing agents or other diuretics
certain laxatives
medicines for the treatment of gout
vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral medications 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, cancer treatment medicines, painkillers or arthritis medicines, or colestyramine and colestimide, cholesterol-lowering resins.
IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici with food and drink
IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici can be taken with or without food.
Due to the hydrochlorothiazide contained in IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici, if you drink alcohol during treatment with this medicine, you may feel more dizzy when standing up, especially when changing from a sitting to a standing position.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will usually advise you to stop taking IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici before starting pregnancy or as soon as you know you are pregnant, and will recommend another medicine instead.
IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici is not recommended during pregnancy, and must not be taken after the first three months of pregnancy, as it may cause serious harm to the unborn child if taken beyond the third month of pregnancy.
Breast-feeding
IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.
Driving and using machines
No studies on the ability to drive and use machines have been performed. It is unlikely that IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici affects the ability to drive vehicles or operate machinery. However, dizziness or fatigue may occasionally occur during treatment for high blood pressure. If this happens to you, talk to your doctor before driving or operating machinery.
IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici contains lactose. If your doctor has told you that you have an intolerance to certain sugars (e.g., lactose), contact him before taking this medicine.

3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici

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 DOC Generici 150 mg/12.5
mg tablets is one or two tablets daily.
The recommended dose of IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici 300 mg/12.5
mg and IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici 300 mg/25 mg is one
tablet daily.
IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici will be prescribed by your doctor if
your previous therapy has not sufficiently reduced your blood pressure. Your doctor will advise you
on how to switch from your previous treatment to IRBESARTAN AND HYDROCHLOROTHIAZIDE
DOC Generici.
Method of administration
IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici 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 DOC Generici with or without food. Try to
take the medicine at the same time every day. It is important to continue treatment unless otherwise
instructed by your doctor.
Maximum blood pressure-lowering effect is achieved within 6–8 weeks after starting treatment.
If you take more IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici than you should
If you accidentally take too many tablets, contact your doctor immediately.
Children must not take IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici
IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici must not be given to children under
18 years of age. If a child swallows any tablets, contact your doctor immediately.
If you forget to take IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to
compensate for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Some of these effects may be serious and may require medical attention.
Rare cases of skin allergic 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 DOC Generici and contact your doctor immediately.

The frequency of the adverse 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
Not known: frequency cannot be estimated from available data

Adverse effects reported in clinical studies in patients treated with IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici include:

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

Nausea/vomiting
Urinary disorders
Fatigue
Dizziness (also when changing from a sitting or lying position to standing)
Blood tests may show increased levels of an enzyme measuring muscle and heart function (creatine kinase) or increased levels of substances measuring kidney function (azotemia, creatinine). If any of these adverse effects cause you problems, inform your doctor.

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

Diarrhea
Hypotension
Weakness
Rapid heartbeat
Hot flushes
Swelling
Sexual dysfunction (problems with sexual activity)
Blood tests may show decreased levels of potassium and sodium in the blood. If any of these adverse effects cause you problems, inform your doctor.

Adverse effects reported after marketing authorization of IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici
Some adverse effects have been reported after marketing of IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici. The adverse effects with unknown frequency are:
headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and renal dysfunction, elevated 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, adverse effects associated with each component cannot be excluded.

Adverse effects associated with irbesartan in monotherapy
In addition to the adverse effects listed above, chest pain and reduced platelet count (blood cells essential for blood clotting) have been reported.

Adverse effects associated with hydrochlorothiazide in monotherapy
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 disorders; depression; blurred vision; absence of white blood cells, which may lead to frequent infections and fever; reduced platelet count (a blood cell essential for blood clotting), reduced red blood cell count (anemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness and pale appearance; kidney problems; lung problems including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to sunlight; inflammation of blood vessels; a skin disorder characterized by peeling of the skin over the entire body; cutaneous lupus erythematosus, identified by a rash that may appear on the face, neck and scalp; allergic reactions; muscle weakness and muscle spasms; altered heartbeat; drop in blood pressure upon changing body position; swelling of the salivary glands; elevated blood sugar levels; sugar in urine; increases in certain types of blood fats; elevated levels of uric acid in the blood which may cause gout.

It is known that adverse effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

Not known (frequency cannot be estimated from available data)

Skin and lip cancer (non-melanoma skin cancer)
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)

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IRBESARTAN AND HYDROCHLOROTHIAZIDE DOC Generici

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 blister after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 PACKAGE AND OTHER INFORMATION

What IRBESARTAN and HYDROCHLOROTHIAZIDE DOC Generici contains

The active substances are: irbesartan and hydrochlorothiazide. Each tablet of IRBESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 150 mg/12.5 mg tablets contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Each tablet of IRBESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 300 mg/12.5 mg tablets contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Each tablet of IRBESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 300 mg/25 mg tablets contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
The other components are: povidone K29-32, magnesium stearate (E572), microcrystalline cellulose (E460), monohydrate lactose, sodium croscarmellose (E468), anhydrous colloidal silica, hydrogenated castor oil, maize starch.

Description of the appearance of IRBESARTAN and HYDROCHLOROTHIAZIDE DOC Generici and contents of the pack
The tablets of IRBESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 150 mg/12.5 mg tablets are white, cylindrical, biconvex, with the imprint IH1 on one side.
The tablets of IRBESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 300 mg/12.5 mg tablets are white, cylindrical, biconvex, with the imprint IH12 on one side.
The tablets of IRBESARTAN and HYDROCHLOROTHIAZIDE DOC Generici 300 mg/25 mg tablets are white, cylindrical, biconvex, with the imprint IH25 on one side.
IRBESARTAN and HYDROCHLOROTHIAZIDE DOC Generici tablets are supplied in packs of 14, 28, 56 or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturer
Laboratorios Liconsa S.A.
Avda. Miralcampo, no 7
Poligono Industrial Miralcampo
19200 AZUQUECA DE HENARES (Guadalajara)
Spain

This leaflet was last updated on