Irbesartan/hydrochlorothiazide Almus 150 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Irbesartan/Hydrochlorothiazide Almus 150 mg/12.5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What irbesartán/hidroclorotiazida Almus is and what it is used for

Irbesartán/Hidroclorotiazida Almus 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 leads to an increase in blood pressure.

Irbesartan blocks angiotensin-II from binding to these receptors, relaxing the blood vessels and thereby lowering blood pressure. Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that reduce blood pressure by increasing the amount of urine produced. The two active substances in Irbesartán/Hidroclorotiazida Almus work together to lower blood pressure more effectively than either one alone.

Irbesartán/Hidroclorotiazida Almus is used to treat high blood pressure when treatment with irbesartan alone or hydrochlorothiazide alone does not provide adequate control of blood pressure.

2. What you need to know before taking irbesartan/hydrochlorothiazide Almus

Do not take irbesartan/hydrochlorothiazide Almus

• if you are allergic (hypersensitive) to irbesartan or to any of the other ingredients of irbesartan/hydrochlorothiazide Almus

• if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicine

• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section)

• if you have severe liver or kidney problems

• if you have difficulty urinating

• if your doctor finds that you have persistently high calcium levels or low potassium levels in your blood

• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren

irbesartan/hydrochlorothiazide Almus must not be given to children and adolescents (under 18 years of age).

Warnings and precautions

Talk to your doctor before taking irbesartan/hydrochlorothiazide Almus:

• if you have excessive vomiting or diarrhoea
• if you have kidney problems or if you 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, which causes sodium retention and, in turn, increased blood pressure)
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  • aliskiren
• if you have 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/hydrochlorothiazide Almus.
• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking irbesartan/hydrochlorothiazide Almus, seek medical help immediately.

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 Almus”.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, you must inform your doctor. The use of irbesartan/hydrochlorothiazide Almus is not recommended during early pregnancy (first 3 months), and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby (see Pregnancy section).

You should also consult your doctor:

• if you are on a low-salt diet
• if you experience any of the following signs: feeling thirsty, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in irbesartan/hydrochlorothiazide Almus)
• if you experience increased skin sensitivity to sunlight with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more quickly than usual
• if you are going to have surgery or if you are to be given anaesthetics
• if you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to weeks after taking irbesartan/hydrochlorothiazide. 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 develop abdominal pain, nausea, vomiting, or diarrhoea after taking irbesartan/hydrochlorothiazide Almus. Your doctor will decide whether to continue treatment. Do not stop taking irbesartan/hydrochlorothiazide Almus on your own.

Use in athletes:

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

Use of irbesartan/hydrochlorothiazide Almus with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Diuretics such as hydrochlorothiazide contained in irbesartan/hydrochlorothiazide Almus may interact with other medicines. You must not take lithium-containing preparations together with irbesartan/hydrochlorothiazide Almus without medical supervision.

You may need blood tests if you take:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines or other diuretics (tablets that increase urine production)
• certain laxatives
• medicines used to treat gout
• vitamin D supplements
• medicines to control heart rhythm
• medicines for diabetes (oral agents or insulin)

It is also important to inform your doctor if you are taking:

• other medicines to lower your blood pressure
• corticosteroids
• cancer treatment medicines
• painkillers
• medicines for arthritis
• cholestyramine or colestipol resins to reduce blood cholesterol.

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

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

Taking irbesartan/hydrochlorothiazide Almus with food and drink

irbesartan/hydrochlorothiazide Almus can be taken with or without food.

Due to the hydrochlorothiazide contained in irbesartan/hydrochlorothiazide Almus, if you drink alcohol while being treated with this medicine, you may experience increased dizziness when standing up, especially when rising from a sitting position.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will usually advise you to stop taking irbesartan/hydrochlorothiazide Almus before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive medicine. irbesartan/hydrochlorothiazide Almus is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby when used from that time.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding, as irbesartan/hydrochlorothiazide Almus is not recommended for women during this period. Your doctor may choose a treatment more suitable for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

No studies on the ability to drive and use machines have been performed. It is unlikely that irbesartan/hydrochlorothiazide Almus will affect your ability to drive or operate machinery. However, during treatment for hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, speak with your doctor before driving or using machines.

irbesartan/hydrochlorothiazide Almus contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take irbesartan/hydrochlorothiazide Almus

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The usual dose of Irbesartan/Hydrochlorothiazide Almus is one or two tablets daily. In general, your doctor will prescribe Irbesartan/Hydrochlorothiazide Almus when previous treatments have not sufficiently reduced your blood pressure. Your doctor will advise you on how to switch from previous treatments to Irbesartan/Hydrochlorothiazide Almus.

Method of administration

Irbesartan/Hydrochlorothiazide Almus is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). You may take Irbesartan/Hydrochlorothiazide Almus with or without food. You should try to take your daily dose at the same time each day. It is important that you continue taking Irbesartan/Hydrochlorothiazide Almus until your doctor advises otherwise.

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

If you take more irbesartan/hydrochlorothiazide Almus than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. Irbesartan/Hydrochlorothiazide Almus must not be taken by children. Irbesartan/Hydrochlorothiazide Almus 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/hydrochlorothiazide Almus

If you accidentally miss a dose, simply take your next dose at the usual time. Do not take a double dose to make up for missed doses. If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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) have been reported in patients treated with irbesartan, as well as localized swelling of the face, lips and/or tongue.

If you experience any of the above symptoms or have shortness of breath, stop taking Irbesartan/Hydrochlorothiazide Almus and contact your doctor immediately.

Adverse effects reported in clinical studies for patients treated with Irbesartan/Hydrochlorothiazide Almus were:

Frequent adverse effects (affect between 1 and 10 out of every 100 patients):

• nausea/vomiting,
• abnormalities in urination,
• fatigue,
• dizziness (including dizziness upon 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 (blood urea nitrogen, creatinine).

If any of these adverse effects cause you problems, consult your doctor.

Uncommon adverse effects (affect between 1 and 10 out of every 1,000 patients):

• diarrhea,
• low blood pressure,
• fainting,
• tachycardia,
• flushing,
• swelling due to fluid retention (edema),
• sexual dysfunction (changes in sexual function),
• blood tests may show low levels of sodium and potassium in your blood.

If any of these adverse effects cause you problems, consult your doctor.

Adverse effects reported since marketing of Irbesartan/Hydrochlorothiazide Almus

The frequency of occurrence of these effects is unknown. These adverse effects include: headache, tinnitus, cough, altered taste, indigestion, joint and muscle pain, liver function abnormalities and kidney failure, elevated potassium levels in the blood, and allergic reactions such as rash, urticaria, swelling of the face, lips, mouth, tongue or throat.

As with all fixed-dose combination products, adverse effects associated with each individual component cannot be excluded.

Adverse effects associated solely with irbesartan

In addition to the adverse effects described above, chest pain has also been observed.

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

• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Adverse effects associated with hydrochlorothiazide in monotherapy:

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 upper abdominal pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which may lead to frequent infections and fever; decreased platelet count (blood cells essential for blood clotting), decreased red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath during exercise, dizziness, and paleness; kidney disease; lung disorders 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; cutaneous lupus erythematosus, identified by a rash that may appear on the face, neck, and scalp; allergic reactions; muscle weakness and spasms; changes in heart rhythm; reduction in blood pressure after a change in body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increases in certain types of blood fats; high levels of uric acid in the blood, which may cause gout.

Very rare: Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (cannot be estimated from available data): Skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of irbesartan/hydrochlorothiazide Almus

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the blister after EXP.

The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartán/Hidroclorotiazida Almus

• The active substances are irbesartan and hydrochlorothiazide. Each tablet of Irbesartán/Hidroclorotiazida Almus 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 (core), monohydrate lactose, hypromellose 15 cP, macrogol 3350, titanium dioxide (E171), yellow and red iron oxides (E172) (coating).

Appearance of the product and contents of the pack

Irbesartán/Hidroclorotiazida Almus 150 mg/12.5 mg tablets are pink/light pink in colour, oblong, convex, and scored on one side. The score line is intended to facilitate tablet swallowing and is not intended for dividing the tablet into equal doses. Irbesartán/Hidroclorotiazida Almus 150 mg/12.5 mg film-coated tablets are available in blister packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra, 2710-228

Portugal

This medicinal product has been approved in the Member States of the EEA under the following names:

Irbesartán/Hidroclorotiazida Almus 150 mg/12.5 mg film-coated tablets – Portugal

Date of the most recent review of this leaflet: February 2025

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