Irbesartan and hydrochlorothiazide Alter: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 150 mg/12.5 mg film-coated tablets

IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 300 mg/12.5 mg film-coated tablets
IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 300 mg/25 mg film-coated tablets
Irbesartan/hydrochlorothiazide
Generic medicine

Read 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may 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 ALTER is and what it is used for
What you need to know before taking IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER
How to take IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER
Possible side effects
How to store IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER
Contents of the pack and other information

1. WHAT IS IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER AND WHAT IS IT USED FOR?

IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 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 ALTER work together to reduce blood pressure to a greater extent than either medicine given alone.
IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER is used to treat high blood pressure when treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled your blood pressure.

2. WHAT YOU SHOULD KNOW BEFORE TAKING IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER

Do not take IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER

if you are allergic to irbesartan or to any of the ingredients of this medicine (listed in section 6).
if you are allergic to hydrochlorothiazide or to any sulfonamide-derived medicines.
if you are more than 3 months pregnant (it is better to avoid taking IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 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 blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Consult your doctor before taking IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER if you are in any of the following conditions:

excessive vomiting or diarrhoea.
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 ALTER.
if you have kidney disorders or have had a kidney transplant.
if you have heart problems.
if you have liver disorders.
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 subsequently increased 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 kidney problems related to diabetes.
- aliskiren.
If you have previously experienced respiratory or lung problems (including inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Irbesartan and Hydrochlorothiazide Alter, consult a doctor immediately.

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 ALTER”.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 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 when used 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 ALTER).
if you have noticed an increased, faster-than-normal sensitivity of the skin to sunlight, with symptoms of sunburn (such as redness, itching, swelling, rash).
if you are scheduled for surgery or need to take anaesthetics.
if you experience vision loss 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 several weeks after taking IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition. You must stop taking IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER and consult your doctor immediately.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER must not be given to children and adolescents (under 18 years of age).

Other medicines and IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER
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 ALTER may interact with other medicines. Medicines containing lithium must not be taken together with IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 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 sections “Do not take IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER” and “Warnings and precautions”).

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 gout treatment.
vitamin D supplements.
medicines to control heart rhythm.
medicines for diabetes (oral antidiabetic drugs 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 medications, or colestyramine and colestipol for lowering blood cholesterol levels.

IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER with food, drinks and alcohol
IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER can be taken with or without food.
Due to the hydrochlorothiazide contained in IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER, 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 ALTER before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 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 used beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 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 vehicles or operate machinery have been conducted. It is unlikely that IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER affects the ability to drive or operate machinery.
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 ALTER contains lactose and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
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 ALTER

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Dosage
The recommended dose of IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 150 mg/12.5 mg is one or two tablets daily.
The recommended dose of IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 300 mg/12.5 mg is one tablet daily.
The recommended dose of IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 300 mg/25 mg is one tablet daily.
IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER will be prescribed by your doctor if your previous therapy has not sufficiently lowered your blood pressure. Your doctor will advise you on how to switch from your previous treatment to IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER.
Method of administration
IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 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 ALTER 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 ALTER than you should
If you accidentally take too many tablets, contact your doctor immediately.
Children must not take IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER
IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 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 ALTER
If you forget to take a dose, take your next dose at the usual time. Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER may cause adverse reactions, although not everyone experiences them.
Some of these effects may be serious and may require medical intervention.
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 the above symptoms or have difficulty breathing, stop taking IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER and contact your doctor immediately.

The frequency of the adverse reactions listed below is defined using the following convention:
Common: may occur in up to 1 in 10 patients
Uncommon: may occur in up to 1 in 100 patients
Very rare: may occur in less than 1 in 10,000 patients

Adverse reactions reported in clinical studies in patients treated with IRBESARTAN AND HYDROCHLOROTHIAZIDE were:

Common adverse reactions (may occur in up to 1 in 10 patients)

nausea/vomiting
urinary disorders
fatigue
dizziness (also 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).

Uncommon adverse reactions (may occur in up to 1 in 100 patients)

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.

Very rare adverse reactions may occur in less than 1 in 10,000 patients

Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Adverse reactions reported after marketing of IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER
Following the marketing of IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER, some adverse reactions have been reported. The frequency of these adverse reactions is unknown:
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 reactions associated with each component cannot be excluded.

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

Adverse reactions associated with 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 accompanied by nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which may lead to frequent infections and fever; decreased platelet count (a component essential for blood clotting); reduced number of red blood cells (anemia) characterized by fatigue, headache, shortness of breath during physical exertion, 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; lupus erythematosus, identified by a rash that may appear on the face, neck, and scalp; allergic reactions; 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; increases in certain types of blood fats; elevated levels of uric acid in the blood which may cause gout; skin and lip cancer (non-melanoma skin cancer) (frequency not known); sudden-onset reduction in distance vision (acute myopia) (frequency not known), 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 (frequency not known).

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

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

5. HOW TO STORE IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER

Keep out of the sight and reach of children.
Do not use IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER after the expiry date stated
on the carton and blister after Exp. The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
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 ALTER contains

The active substances are: irbesartan and hydrochlorothiazide. Each film-coated tablet of IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 150 mg/12.5 mg contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet of IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 300 mg/12.5 mg contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet of IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 300 mg/25 mg contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
The excipients are: Tablet core: Monohydrate Lactose, Microcrystalline Cellulose, Hypromellose, Sodium Croscarmellose, Aerosil 200 (Colloidal Silicon Dioxide), Magnesium Stearate. Coating: Hypromellose, Titanium Dioxide, Glycerol Triacetate, Red and Yellow Iron Oxide.

Description of the appearance of IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER and contents of the pack

IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 150 mg/12.5 mg film-coated tablets are salmon-pink, round, film-coated tablets without a break line, with a diameter of 11 mm.

IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 150 mg/12.5 mg film-coated tablets are supplied in packs containing blisters of 14 or 28 tablets.

IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 300 mg/12.5 mg film-coated tablets are yellowish-brown, oblong, film-coated tablets without a break line, sized 17.0 mm x 7.5 mm.

IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 300 mg/12.5 mg film-coated tablets are supplied in packs containing blisters of 14 or 28 tablets.

IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 300 mg/25 mg film-coated tablets are salmon-pink, oblong, film-coated tablets without a break line, sized 17.0 mm x 7.5 mm.

IRBESARTAN AND HYDROCHLOROTHIAZIDE ALTER 300 mg/25 mg film-coated tablets are supplied in packs containing blisters of 14, 28 or 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder:
LABORATORI ALTER srl
Via Egadi, 7
20144 Milan, Italy

Manufacturer:
Laboratorios Alter, S.A.
c/ Mateo Inurria, 30 - 28036 Madrid – Spain

This patient information leaflet was last approved on