IRBESARTAN/HYDROCHLOROTHIAZIDE TARBIS 300 mg/25 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Irbesartan/Hydrochlorothiazide Tarbis 300 mg/25 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Irbesartan/Hydrochlorothiazide Tarbis and what is it used for

Irbesartan/Hydrochlorothiazide Tarbis 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 receptors in blood vessels, causing them to constrict. This results in an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure.

Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that increase the amount of urine excreted, reducing blood pressure.

The two active substances in Irbesartan/Hydrochlorothiazide Tarbis work together to achieve a greater reduction in blood pressure than either substance alone.

Irbesartan/Hydrochlorothiazide Tarbis is used to treat high blood pressure,when treatment with irbesartan or hydrochlorothiazide alone does not provide adequate control of blood pressure.

2. What you need to know before you take Irbesartan/Hydrochlorothiazide Tarbis

Do not take Irbesartan/Hydrochlorothiazide Tarbis

• if you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6).

• if you are allergicto hydrochlorothiazide or any other medicine belonging to the sulphonamide group.
• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medicine during pregnancy – see section Pregnancy)
• if you have severe liver or kidney problems
• if you have difficulty urinating
• if your doctor detects that you have persistently high levels of calcium or low levels of potassium in your blood
• if you have diabetes or kidney impairment and are being treated with a medicine containing aliskiren

Children and adolescents

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

Warnings and precautions

Consult your doctorbefore starting to take Irbesartan/Hydrochlorothiazide Tarbis or in the following cases:

• if you have excessive vomiting or diarrhoea
• if you have kidney problemsor have had a kidney transplant
• if you have heart problems
• if you have liver problems
• if you have diabetes
• if you have systemic lupus erythematosus(also known as lupus or SLE)
• if you have primary hyperaldosteronism(a condition related to excessive production of the hormone aldosterone, leading to sodium retention and increased blood pressure).
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Irbesartan/Hydrochlorothiazide Tarbis, seek medical attention immediately.
• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Irbesartan/Hydrochlorothiazide Tarbis”.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Irbesartan/Hydrochlorothiazide Tarbis is not recommended during the first three months of pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

You must also inform your doctor:

• if you are on a low-salt diet
• if you experience any of the following signs: feeling thirsty, dry mouth, weakness

• generalized weakness, feeling sleepy, muscle cramps or spasms, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Tarbis)
• if you experience an increased sensitivity of your skin to the sunwith symptoms of sunburn (such as redness, itching, swelling, blisters) that occur more quickly than usual
• if you are going to have surgery(surgical procedure) or if you are going to be given anaesthetics
• if you experience changes in your vision or pain in one or both eyeswhen taking this medicine. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or glaucoma, increased pressure in your eyes, and can occur within hours to a week after taking Irbesartan/Hydrochlorothiazide Tarbis. You should stop treatment with Irbesartan/Hydrochlorothiazide Tarbis and seek medical attention.

Use in athletes

This medicine contains hydrochlorothiazide, which may produce a positive result in doping tests.

Use of Irbesartan/Hydrochlorothiazide Tarbis with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Diuretics, such as hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Tarbis, may interact with other medicines. You should not take preparations containing lithium with Irbesartan/Hydrochlorothiazide Tarbis without your doctor's supervision.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Irbesartan/Hydrochlorothiazide Tarbis” and “Warnings and precautions”).

You may need to have blood tests:

• if you are taking potassium supplements
• if you are taking salt substitutes that contain potassium

• if you are taking potassium-sparing medicines or other diuretics (tablets that increase urine production)
• if you are taking certain laxatives
• if you are taking medicines used to treat gout
• if you are taking vitamin D supplements
• if you are taking medicines to control your heart rate
• if you are taking medicines for diabetes (oral agents or insulins)
• if you are taking carbamazepine (a medicine for the treatment of epilepsy)

It is also important to inform your doctor if you are taking other medicines to lower your blood pressure, steroids, medicines to treat cancer, painkillers, medicines for arthritis, or cholestyramine or colestipol resins to lower cholesterol in your blood.

Taking Irbesartan/Hydrochlorothiazide Tarbis with food, drinks, and alcohol

Irbesartan/Hydrochlorothiazide Tarbis can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Tarbis, if you drink alcohol while taking this medicine, you may experience increased dizziness when standing up, especially when getting up from a sitting or lying position.

Pregnancy, breastfeeding, and fertility

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Irbesartan/Hydrochlorothiazide Tarbis before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine to lower your blood pressure instead. Irbesartan/Hydrochlorothiazide Tarbis is not recommended during the first three months of pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are already breastfeeding, as Irbesartan/Hydrochlorothiazide Tarbis is not recommended for use during breastfeeding. Your doctor may decide to prescribe a different treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

No studies have been performed on the ability to drive and use machines. It is unlikely that Irbesartan/Hydrochlorothiazide Tarbis will affect your ability to drive or use machines. However, during treatment of high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, talk to your doctor before driving or using machines.

Irbesartan/Hydrochlorothiazide Tarbis contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Irbesartan/Hydrochlorothiazide Tarbis

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

Dose

The normal dose of Irbesartan/Hydrochlorothiazide Tarbis is one tablet per day. In general, your doctor will prescribe Irbesartan/Hydrochlorothiazide Tarbis when previous treatments you received did not sufficiently reduce your blood pressure. Your doctor will tell you how to switch from previous treatments to Irbesartan/Hydrochlorothiazide Tarbis.

Method of administration

Irbesartan/Hydrochlorothiazide Tarbis is taken orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). You can take Irbesartan/Hydrochlorothiazide Tarbis with or without food. Try to take your daily dose at the same time each day. It is important that you continue to take Irbesartan/Hydrochlorothiazide Tarbis until your doctor tells you to stop.

The maximum blood pressure-lowering effect should be achieved within 6-8 weeks after starting treatment.

If you take more Irbesartan/Hydrochlorothiazide Tarbis than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20.

Children should not take Irbesartan/Hydrochlorothiazide Tarbis

Irbesartan/Hydrochlorothiazide Tarbis should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you forget to take Irbesartan/Hydrochlorothiazide Tarbis

If you accidentally miss a dose, simply take your normal dose when it is due next. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Irbesartan/Hydrochlorothiazide Tarbis can cause side effects, although not everybody gets them.

Some of these effects may be serious and may require medical attention.

Rarely, cases of allergic skin reactions (skin rash, urticaria) have been reported in patients treated with irbesartan, as well as localized swelling in the face, lips, and/or tongue. If you have any of the above symptoms or experience shortness of breath, stop taking Irbesartan/Hydrochlorothiazide Tarbis and contact your doctor immediately.

The side effects reported in clinical studies for patients treated with Irbesartan/Hydrochlorothiazide were:

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

• nausea/vomiting
• urination abnormalities
• fatigue
• dizziness (including dizziness when standing up from a lying or sitting position)
• blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase) or elevated levels of substances that measure kidney function (urea, creatinine).

If any of these side effects get serious, talk to your doctor

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

• diarrhoea
• low blood pressure
• fainting
• rapid heartbeat
• flushing
• fluid retention (oedema)
• sexual dysfunction (changes in sexual function)
• blood tests may show low levels of sodium and potassium in your blood.

If any of these side effects get serious, talk to your doctor

Rare side effects(may affect up to 1 in 1,000 people)

• acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion).

Side effects reported since Irbesartan/Hydrochlorothiazide Tarbis has been marketed

Since the marketing of Irbesartan/Hydrochlorothiazide, some side effects have been reported. The frequency of these side effects is not known: headache, ringing in the ears, cough, altered taste, indigestion, joint and muscle pain, reduced platelet count, altered liver function, and kidney failure, elevated potassium levels in your blood, and allergic reactions such as skin rash, urticaria, swelling of the face, lips, mouth, tongue, or throat. Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

As with all combinations of two active substances, it cannot be excluded that side effects associated with each of the components may occur.

Side effects associated with irbesartan alone

In addition to the side effects described above, chest pain has also been reported.

Side effects associated with hydrochlorothiazide alone

Loss of appetite; stomach upset; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; low white blood cell count, which can lead to frequent infections, fever; reduced platelet count (cells essential for blood clotting), reduced red blood cell count (anaemia) characterized by tiredness, headaches, shortness of breath when exercising, dizziness, and paleness; kidney disease; lung disorders including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to the sun; blood vessel inflammation; a skin disease characterized by peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that can appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasms; altered heart rhythm; low blood pressure after changing body position; swelling of the salivary glands; high blood sugar; sugar in the urine; increased levels of certain types of fats in the blood; high levels of uric acid in the blood, which can cause gout; decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or glaucoma].

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

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan/Hydrochlorothiazide Tarbis

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 carton and on the blister after CAD. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point or any other pharmaceutical waste collection system available at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Irbesartan/Hydrochlorothiazide Tarbis

• The active ingredients are irbesartan and hydrochlorothiazide.
• Each film-coated tablet of Irbesartan/Hydrochlorothiazide Tarbis 300 mg/25 mg contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
• The other ingredients are lactose monohydrate, povidone K30 (E1201), microcrystalline cellulose PH101 (E572), anhydrous colloidal silica, sodium croscarmellose (E468), talc (E533b), magnesium stearate (E572), polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, iron oxide, red (E172), iron oxide, black (E172), iron oxide, yellow (E172).

Appearance of the Product and Package Contents

Irbesartan/Hydrochlorothiazide Tarbis 300 mg/25 mg are oval, biconvex, and dark pink film-coated tablets.

Irbesartan/Hydrochlorothiazide Tarbis is available in blister packs containing 28 film-coated tablets.

Marketing Authorization Holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

Sofarimex – Ind. Química e Farmacêutica, S.A.

Av. Indústrias – Alto do Colaride– Agualva

2735 – 214 Cacém

PORTUGAL

or

Farmaprojects, S.A.U.

Santa Eulàlia 240-242

08902 L’Hospitalet de Llobregat (Barcelona)

SPAIN

Date of Last Revision of this Leaflet:December 2021.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/