Irbesartan and hydrochlorothiazide Tecnigen: detailed information

Package Leaflet: Information for the User

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

Equivalent Medicine
Please read all of this leaflet carefully before you start taking this 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not pass it on to other people, 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, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Irbesartan and Hydrochlorothiazide TecniGen is and what it is used for.
What you need to know before taking Irbesartan and Hydrochlorothiazide TecniGen.
How to take Irbesartan and Hydrochlorothiazide TecniGen.
Possible side effects.
How to store Irbesartan and Hydrochlorothiazide TecniGen.
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 medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to its receptors located on 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 (so-called thiazide diuretics) that increase urine production, thereby lowering blood pressure. The two active ingredients in Irbesartan and Hydrochlorothiazide TecniGen work together to lower blood pressure more effectively than either medicine given alone.
Irbesartan and Hydrochlorothiazide TecniGen 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 TecniGen

Do not take Irbesartan and Hydrochlorothiazide TecniGen

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 other sulfonamide-derived medicine
if you are more than 3 months pregnant (use of Irbesartan and Hydrochlorothiazide TecniGen is also advised to be avoided during early pregnancy – see section on pregnancy)
if you have severe liver or kidney problems
if you have difficulty urinating
if your doctor has diagnosed you with 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, pharmacist, or nurse before taking Irbesartan and Hydrochlorothiazide TecniGen.

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 exposure to sunlight and UV rays while taking Irbesartan and Hydrochlorothiazide TecniGen.

Contact your doctor if any of the following conditions occur in you:

excessive vomiting or diarrhoea
if you have kidney disorders 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 subsequent increase in 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 diabetes-related kidney problems
- aliskiren

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the section "Do not take Irbesartan and Hydrochlorothiazide TecniGen".
You must inform 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 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 if taken during this period (see section on pregnancy).
In addition, 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 excessively rapid heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan and Hydrochlorothiazide TecniGen)
if you have noticed an abnormally increased skin sensitivity to sunlight, with symptoms of sunburn (such as redness, itching, swelling, blisters)
if you are scheduled for surgery or need to take anaesthetics
if you experience changes in vision or pain in one or both eyes while taking Irbesartan and Hydrochlorothiazide TecniGen. This could be a sign of glaucoma, an increase in eye pressure. You should stop treatment with Irbesartan and Hydrochlorothiazide TecniGen and consult your doctor immediately.

The hydrochlorothiazide contained in this medicine may lead to positive results in anti-doping tests.
For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
Irbesartan and Hydrochlorothiazide TecniGen must not be given to children and adolescents (under 18 years of age).
Other medicines and Irbesartan and Hydrochlorothiazide TecniGen
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 TecniGen may interact with other medicines. Medicines containing lithium should not be taken together with this medicine unless under strict medical supervision.
You may need blood tests if you are taking:

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 antidiabetics or insulin)
carbamazepine (a medicine used to treat epilepsy)

It is also important to inform your doctor if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, painkillers, medicines for arthritis, or cholesterol-lowering resins such as cholestyramine and colestipol.
Your doctor may consider it necessary to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also sections: "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, drinking alcohol during treatment with this medicine may increase the sensation of dizziness, especially when standing up from a sitting or lying position.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform 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 TecniGen before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. The use of Irbesartan and Hydrochlorothiazide TecniGen 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.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbesartan and Hydrochlorothiazide TecniGen is not recommended for women who are breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
No studies have been conducted on the ability to drive or operate machinery.
It is unlikely that Irbesartan and Hydrochlorothiazide TecniGen will affect your 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 TecniGen contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), contact him or her before taking this medicine.

3. How to take Irbesartan and Hydrochlorothiazide TecniGen

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any 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 daily.
Your doctor will prescribe this medicine if your previous treatment has not sufficiently lowered
your blood pressure. Your doctor will provide instructions on how to switch from your
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 may take this medicine with or
without food. Try to take each daily dose at the same time every day. It is important
to continue taking Irbesartan and Hydrochlorothiazide TecniGen 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 TecniGen than you should
If you have accidentally taken too many tablets, contact your doctor immediately.
Children must not take Irbesartan and Hydrochlorothiazide TecniGen
Irbesartan and Hydrochlorothiazide TecniGen 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 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 the missed dose.
If you have any questions 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 can 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 if you have difficulty breathing, stop taking Irbesartan and Hydrochlorothiazide TecniGen and contact your doctor immediately.

The side effects reported in clinical studies in patients treated with Irbesartan and Hydrochlorothiazide TecniGen were:

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

nausea/vomiting
urinary disorders
fatigue
dizziness (including when moving 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 (blood urea nitrogen, creatinine).

Inform your doctor if any of these side effects cause you problems.

Uncommon side effects (may affect from 1 to 10 users out of 1,000)

diarrhoea
low blood pressure
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.

Inform your doctor if any of these side effects cause you problems.

Side effects reported after the marketing of Irbesartan/Hydrochlorothiazide
Some side effects have been reported since Irbesartan/Hydrochlorothiazide has been marketed. Side effects with unknown frequency include headache, tinnitus (ringing in the ears), cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and renal dysfunction, elevated blood potassium levels, and allergic reactions such as rash, urticaria, and 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 individual component cannot be excluded.

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 disorders; depression; blurred vision; deficiency of white blood cells, which may lead to frequent infections and fever; decreased platelet count (blood cells essential for blood clotting), reduced number of red blood cells (anaemia) characterized by tiredness, headache, breathlessness 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 skin peeling over the entire body; cutaneous lupus erythematosus, identified by a skin rash that may appear on the face, neck and scalp; allergic reactions; muscle weakness and muscle cramps; irregular heartbeat; 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 fats in the blood; elevated levels of uric acid in the blood which may cause gout.

Frequency “not known”: skin and lip cancer (non-melanoma skin cancer).

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

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the website
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 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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Irbesartan and Hydrochlorothiazide TecniGen contains

The active substances 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 components are: monohydrate lactose, pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, magnesium stearate (tablet core); monohydrate lactose, 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 contents of the pack
Irbesartan and Hydrochlorothiazide TecniGen 150 mg/12.5 mg film-coated tablets are film-coated tablets ranging in colour from pink to light pink, oblong, convex, with a score line on one side.
Irbesartan and Hydrochlorothiazide TecniGen 150 mg/12.5 mg is available in packs containing 28-tablet blisters.
Not all pack sizes may be marketed.

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

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