IRBESARTAN 150 mg /12.5 Mg Film-Coated Tablets

Зміст інструкції

1. Irbesartan and Hydrochlorothiazide TecniGen 150 mg/12.5 mg film-coated tablets
   1. What is Irbesartan and Hydrochlorothiazide TecniGen and what is it used for
   2. What you need to know before taking Irbesartan and Hydrochlorothiazide TecniGen
   3. How to take Irbesartan and Hydrochlorothiazide TecniGen
   4. Possible side effects
   5. How to store Irbesartan and Hydrochlorothiazide TecniGen
   6. Contents of the pack and other information

Irbesartan and Hydrochlorothiazide TecniGen 150 mg/12.5 mg film-coated tablets

Generic medicine

Read this leaflet carefully before 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, pharmacist or nurse.
• 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Irbesartan and Hydrochlorothiazide TecniGen 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 them to constrict. This leads to an
increase in blood pressure.
Irbesartan prevents the binding of angiotensin-II to these receptors, causing 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 TecniGen work together, resulting in a greater reduction in blood pressure
than that caused by the drugs administered individually.

Irbesartan and Hydrochlorothiazide TecniGen is used to treat high blood pressurewhen
treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled its
blood pressure.

2. What you need to know before taking Irbesartan and Hydrochlorothiazide TecniGen

Do not take Irbesartan and Hydrochlorothiazide TecniGen

• if you are allergicto irbesartan or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergicto hydrochlorothiazide, or to any other sulphonamide derivative medicine
• if you are pregnant for more than 3 months(it is advisable to avoid using Irbesartan and Hydrochlorothiazide TecniGen even during the early stages of pregnancy - see the section relating to pregnancy).
• if you have serious problems with your liveror 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 impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Irbesartan and Hydrochlorothiazide
TecniGen.

• 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 Hydrochlorothiazide TecniGen.

Tell your doctorif any of the following conditions occur in you:

• excessive vomiting or diarrhea
• 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 have 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

The doctor may check your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood at regular intervals.
See also what is stated under "Do not take Irbesartan and Hydrochlorothiazide TecniGen”.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Irbesartan and Hydrochlorothiazide TecniGen is not recommended in early pregnancy and must not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken during this period (see the section relating to 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 too fastwhich may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan and Hydrochlorothiazide TecniGen)
• if you have noticed an increase, faster than normal, in skin sensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, blisters)
• if you are going to have surgeryor receive anesthetics
• if you experience blurred vision or pain in one or both eyeswhile taking Irbesartan and Hydrochlorothiazide TecniGen. This could be a sign that glaucoma is developing, an increase in eye pressure. You should stop taking Irbesartan and Hydrochlorothiazide TecniGen and consult your doctor.

The hydrochlorothiazide contained in this medicine can give positive results in doping tests.
For athletes: the use of the drug without therapeutic need constitutes doping and may still result in a positive doping test.

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

Other medicines and Irbesartan and Hydrochlorothiazide TecniGen
Tell 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 TecniGen
can have an effect on other medicines. Preparations containing lithium should not
be taken with this medicine unless under strict medical control.

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 your 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, or arthritis medicines or colestyramine and colestipol resins to lower cholesterol levels in the blood.
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 Hydrochlorothiazide TecniGen” and "Warnings and precautions”).

Irbesartan and Hydrochlorothiazide TecniGen with food, drinks and alcohol
Irbesartan and Hydrochlorothiazide TecniGen can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide TecniGen, if you drink alcohol
during therapy with this medicine, while standing, you may feel more
dizzy, especially when moving from a sitting to an upright position.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). The doctor will usually advise you to stop taking Irbesartan and Hydrochlorothiazide TecniGen before starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Irbesartan and Hydrochlorothiazide TecniGen. The use of Irbesartan and Hydrochlorothiazide TecniGen is not recommended during pregnancy and must 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 TecniGen is not recommended for women who are breastfeeding and the doctor may
choose another treatment for you if you wish to breastfeed, especially if the baby is newborn or is
premature.

Driving and using machines
No studies have been performed on the ability to drive and operate machinery.
It is unlikely that Irbesartan and Hydrochlorothiazide TecniGen will affect your 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 vehicles or using machinery.

Irbesartan and Hydrochlorothiazide TecniGen contains lactose.
If your doctor has told you that you have an intolerance to some sugars (for example: lactose),
contact him before taking this medicine.

3. How to take Irbesartan and Hydrochlorothiazide TecniGen

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

Dosage
The recommended dose of Irbesartan and Hydrochlorothiazide TecniGen 150 mg/12.5 mg is one or two
tablets a day.
This medicine will be prescribed by your doctor if previous therapy has not sufficiently reduced
your blood pressure. The doctor will give you instructions on how to switch from
previous treatment to Irbesartan and Hydrochlorothiazide TecniGen 150 mg/12.5 mg.

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

Children should not take Irbesartan and Hydrochlorothiazide TecniGen
Irbesartan and Hydrochlorothiazide TecniGen should 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 TecniGen
If you accidentally forget to take a tablet, take the next one as usual.
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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, hives) as well as localized swelling of the face, lips and/or tongue have been reported.

If you experience any of the above symptoms or if you have difficulty breathing, stop taking
Irbesartan and Idroclorotiazide TecniGen and contact your doctor immediately.
The side effects reported in clinical studies in patients treated with Irbesartan and
Idroclorotiazide TecniGen were:

Common side effects(affect 1 to 10 users out of 100)

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

Tell your doctor if any of these side effects cause you problems.
Uncommon side effects(affect 1 to 10 users out of 1,000)

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

Tell your doctor if any of these side effects cause you problems.
Side effects reported after marketing authorization of Irbesartan/Idroclorotiazide
Some side effects have been reported after the marketing of
Irbesartan/Idroclorotiazide. Side effects with unknown frequency are: headache, ringing
in the ears, cough, taste disturbances, indigestion, joint and muscle pain, abnormalities in
liver function and kidney dysfunction, high levels of potassium in the blood and allergic
reactions such as rash, hives, 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
component cannot be ruled out.

Side effects associated with the use of irbesartan alone
In addition to the side effects listed above, chest pain has also been reported.

Side effects associated with the use of 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 can lead to frequent infections,
fever; decrease in the number of platelets (blood cells essential for blood clotting), decrease in the 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 skin sensitivity
to the sun; inflammation of blood vessels; a skin disorder characterized by scaling
of the skin all over the body; cutaneous 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 levels of
sugar in the blood; sugar in the urine; increased levels of certain types of fat in the blood; high levels
of uric acid in the blood, which can cause gout.
Frequency “not known”: skin cancer and lip cancer (non-melanoma skin cancer).
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, pharmacist or nurse. You can also report side effects
directly through the national reporting system at
http://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 TecniGen

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 package and blister after
“Exp.”. The expiry date refers to the last day of that 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 TecniGen contains

• The active ingredients are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan and Hydrochlorothiazide TecniGen 150 mg/12.5 mg contains 150 mg of Irbesartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: lactose monohydrate, pregelatinized maize starch, microcrystalline cellulose, sodium croscarmellose, magnesium stearate (tablet core); lactose monohydrate, hypromellose 15 cP, macrogol 3350, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172) (tablet coating).

Description of the appearance of Irbesartan and Hydrochlorothiazide TecniGen and pack contents
Irbesartan and Hydrochlorothiazide TecniGen 150 mg/12.5 mg film-coated tablets are
film-coated tablets, oblong, convex, with a pink to light pink colour, with a score line on one side.
Irbesartan and Hydrochlorothiazide TecniGen 150 mg/12.5 mg is available in packs containing
blisters of 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)

Manufacturer:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal
Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira,
2710-089 Sintra
Portugal