Irbesartan and hydrochlorothiazide PensA: detailed information

Patient Information Leaflet

Irbesartan and Hydrochlorothiazide Pensa 150 mg/12.5 mg tablets, 300 mg/12.5 mg tablets, 300 mg/25 mg tablets

Generic medicine
Irbesartan/hydrochlorothiazide
Please read all of this leaflet carefully before 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Irbesartan and Hydrochlorothiazide Pensa is and what it is used for
What you need to know before taking Irbesartan and Hydrochlorothiazide Pensa
How to take Irbesartan and Hydrochlorothiazide Pensa
Possible side effects
How to store Irbesartan and Hydrochlorothiazide Pensa
Package contents and other information

1. What Irbesartan and Hydrochlorothiazide Pensa is 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 medicines 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 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 Pensa work together to reduce blood pressure to a greater extent than either medicine used alone.
Irbesartan and Hydrochlorothiazide Pensa is used to treat high blood pressure when irbesartan or hydrochlorothiazide alone have not adequately controlled blood pressure.

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

Do not take Irbesartan and Hydrochlorothiazide Pensa

If you are allergic to the active substances, to any sulfonamide-derived medicines, or to any of the other ingredients of this medicine (listed in section 6).
If you are more than 3 months pregnant (it is better to avoid taking Irbesartan and Hydrochlorothiazide Pensa even in the early stages of pregnancy – see section “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 medicine
that lowers blood pressure and contains aliskiren

Warnings and precautions
Consult your doctor before taking Irbesartan and Hydrochlorothiazide Pensa if you are in any of the following conditions:

if you experience excessive vomiting or diarrhea
if you have kidney disorders or have had a kidney transplant
if you have heart disorders
if you have liver disorders
if you have 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 have systemic 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 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 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 during treatment with Irbesartan and Hydrochlorothiazide Pensa
if you experience vision changes 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 Pensa. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may have a higher risk of developing this condition.
if you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If shortness of breath or severe breathing difficulties occur after taking Irbesartan and Hydrochlorothiazide Pensa, consult a doctor immediately.

Your doctor may check 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 and Hydrochlorothiazide Pensa".
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Irbesartan and Hydrochlorothiazide Pensa 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 “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 abnormally fast heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan and Hydrochlorothiazide Pensa)
if you have noticed increased skin sensitivity to sunlight, with symptoms of sunburn (such as redness, itching, swelling, rash) occurring more quickly than usual
if you are scheduled for surgery or need to take anesthetics
if you experience changes in vision or pain in one or both eyes while taking
Irbesartan and Hydrochlorothiazide Pensa. This could be a sign of glaucoma, an increase in eye pressure. You should stop taking Irbesartan and Hydrochlorothiazide Pensa and consult your doctor immediately.

Hydrochlorothiazide, contained in this medicine, may lead to positive results in anti-doping tests.

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

Other medicines and Irbesartan and Hydrochlorothiazide Pensa
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 Pensa may interact with other medicines. Preparations containing lithium must not be taken together with Irbesartan and Hydrochlorothiazide Pensa 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 sections “Do not take Irbesartan and Hydrochlorothiazide Pensa” and “Warnings and precautions”).

You may need blood tests if you are using:

potassium supplements
salt substitutes containing potassium
potassium-sparing diuretics or other diuretics
certain laxatives
medicines for the treatment of gout
vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral antidiabetics such as repaglinide 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 treatments, painkillers, arthritis medicines, or cholestyramine and colestipol to lower cholesterol levels in the blood.

Irbesartan and Hydrochlorothiazide Pensa with food, drinks and alcohol
Irbesartan and Hydrochlorothiazide Pensa can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide Pensa, drinking alcohol during treatment with this medicine may increase the risk of dizziness, especially when standing up from a sitting or lying position.

Pregnancy, breastfeeding and fertility
Pregnancy
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 Pensa before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Irbesartan and Hydrochlorothiazide Pensa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the first trimester.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbesartan and Hydrochlorothiazide Pensa 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 on the ability to drive or use machines have been conducted. It is unlikely that Irbesartan and Hydrochlorothiazide Pensa affects the 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 Pensa contains lactose
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Irbesartan and Hydrochlorothiazide 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

Always take this medicine exactly as your doctor has instructed. 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 daily. Your doctor will prescribe Irbesartan and Hydrochlorothiazide Pensa 150 mg/12.5 mg if your previous treatment has not sufficiently lowered your blood pressure. Your doctor will advise you on how to switch from your previous treatment to Irbesartan and Hydrochlorothiazide Pensa.
If this dose does not adequately reduce your blood pressure, 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 daily.
Your doctor will prescribe Irbesartan and Hydrochlorothiazide Pensa 300 mg/12.5 mg if your previous treatment has not sufficiently lowered your blood pressure. Your doctor will advise you on how to switch from your previous treatment to Irbesartan and Hydrochlorothiazide Pensa.
If this dose does not adequately reduce your blood pressure, 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 daily.
This dose must not be increased.
Your doctor will prescribe Irbesartan and Hydrochlorothiazide Pensa 300 mg/25 mg if your previous treatment has not sufficiently lowered your blood pressure. Your doctor will advise you on how to switch from your previous treatment to Irbesartan and Hydrochlorothiazide Pensa.
If this dose does not adequately reduce your blood pressure, 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 (e.g. a glass of water). You may take Irbesartan and Hydrochlorothiazide Pensa with or without food. Try to take the medicine at the same time every day. It is important to continue therapy unless otherwise instructed by your doctor.
The maximum blood pressure-lowering effect is achieved after 6–8 weeks of starting treatment.

If you take more Irbesartan and Hydrochlorothiazide Pensa than you should
If you accidentally take too many tablets, contact your doctor immediately.

Children must not take Irbesartan and Hydrochlorothiazide Pensa
Irbesartan and Hydrochlorothiazide Pensa 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 Pensa
If you forget to take a dose, simply take the next dose as scheduled. 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 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 immediate 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 Pensa and contact your doctor immediately.

If you notice any of the following side effects, stop treatment with Irbesartan and Hydrochlorothiazide Pensa immediately and contact your doctor or go to the nearest hospital emergency department immediately.

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 in patients treated with a combination of irbesartan/hydrochlorothiazide include:

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

Feeling unwell (nausea, vomiting)
Urinary disorders
Feeling of fatigue (tiredness)
Dizziness (also when moving from a sitting or lying position to standing)
Blood tests may show increased levels of an enzyme that indicates how muscles and heart are functioning (creatine kinase), or of substances indicating kidney function (blood urea nitrogen, creatinine).

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

Orthostatic dizziness
Diarrhea
Low blood pressure, fainting, tachycardia, edema
Weakness
Increased heart rate
Hot flushes
Swelling of the extremities
Sexual dysfunction (problems related to sexual performance), changes in libido
Blood tests may show decreased levels of potassium and sodium in the blood
Yellowing of the skin and whites of the eyes (jaundice)

Not known (frequency cannot be estimated from the available data):

Headache
Ringing in the ears
Cough
Taste disturbances, indigestion
Joint and muscle pain (arthralgia and myalgia)
Hepatitis, abnormalities in liver function
Kidney 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 from the available data):

Increased tendency to bruise and bleed, possibly due to a reduced number of platelets (blood cells involved in clotting)
Decreased number of red blood cells (anaemia – symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness, and pale appearance)
Severe anaphylactic reactions (anaphylactic shock)
Hypoglycaemia

Side effects associated with hydrochlorothiazide alone

Not known (frequency cannot be estimated from the available data):

Stomach irritation
Stomach cramps, diarrhoea, constipation; anorexia; sialoadenitis
Jaundice (yellowing of the skin and/or whites of the eyes)
Pancreatic inflammation characterised by severe pain in the upper stomach area, often accompanied by nausea and vomiting
Sleep disturbances
Depression
Blurred vision
Xanthopsia
Aplastic anaemia, myelodepression, neutropenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Fever
Dizziness, paraesthesia, feeling of dizziness, restlessness
Decreased number of platelets (a key component in blood clotting), decreased number of red blood cells (anaemia), characterised by fatigue, headache, shortness of breath during exercise, dizziness, and pale appearance
Kidney problems
Lung problems including pneumonia or fluid accumulation in the lungs
Anaphylactic reactions, toxic epidermal necrolysis, necrotising vasculitis (vasculitis, cutaneous vasculitis), lupus-like skin reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, skin rash, urticaria
Muscle weakness and cramps
Irregular heartbeat; low 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 fats in the blood, elevated blood uric acid levels which may cause gout
Skin and lip cancer (non-melanoma skin cancer)
Sudden onset of impaired distance vision (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 people):

Acute breathing difficulty (symptoms 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 carton and
blister after Exp. The expiry date refers to the last day of the 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. Package contents and other information

What Irbesartan and Hydrochlorothiazide Pensa contains

The active substances 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 components are: povidone, magnesium stearate, microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, anhydrous colloidal silica, hydrogenated castor oil, maize starch.

Description of the appearance of Irbesartan and Hydrochlorothiazide Pensa and package contents
Irbesartan and Hydrochlorothiazide Pensa 150 mg/12.5 mg
White, elongated, biconvex tablets, with "1H1" engraved on one side.
Irbesartan and Hydrochlorothiazide Pensa 300 mg/12.5 mg
White, elongated, biconvex tablets, with "1H12" engraved on one side.
Irbesartan and Hydrochlorothiazide Pensa 300 mg/25 mg
White, elongated, biconvex tablets, with "1H25" engraved on one side.
Pack sizes of 14, 28, 56 and 98 film-coated tablets are available in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milano, Italy

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

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