Leaflet: information for the user

Irbesartan/Hydrochlorothiazide Almus 300 mg/12.5 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, because 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Irbesartan/Hydrochlorothiazide Almus 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. Storage of Irbesartan/Hydrochlorothiazide Almus

6. Contents of the pack and additional information

Irbesartan/Hydrochlorothiazide Almus is an association of two active principles, irbesartan and

hydrochlorothiazide. Irbesartan belongs to a group of medications known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to blood vessel receptors, causing them to contract. This results in an increase in blood pressure.

Irbesartan prevents the binding of angiotensin-II to these receptors, relaxing blood vessels and reducing blood pressure. Hydrochlorothiazide belongs to a group of medications (called thiazide diuretics) that increase the amount of urine eliminated, reducing blood pressure. The two active principles of Irbesartan/Hydrochlorothiazide Almus act together to achieve a decrease in blood pressure greater than that obtained with each one separately.

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

Do not take Irbesartán/Hidroclorotiazida Almus

• if you areallergic(hypersensitive) to irbesartán, or to any of the other components of Irbesartán/Hidroclorotiazida Almus

• if you areallergic(hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medication

• if you aremore than 3 months pregnant. (In any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section)

• if you havesevere liver or kidney problems

• if you havedifficulty urinating

• if your doctor detects that you havepersistently elevated calcium levels or low potassium levels in your blood

• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that containsaliskirén

Irbesartán/Hidroclorotiazida Almus should not be administered to children and adolescents (under 18 years).

Warnings and precautions

Consult your doctor before starting to take Irbesartán/Hidroclorotiazida Almus:

• if you haveexcessive vomiting or diarrhea

• if you havekidney problemsor if you have had akidney transplant

• if you haveheart problems

• if you haveliver problems

• if you havediabetes

• if you havelupus erythematosus(also known as lupus or LES)

• if you haveprimary aldosteronism(a condition related to the production of high levels of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).

• if you are taking any of the following medications used to treat high blood pressure (hypertension):

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

- aliskirén

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartán/Hidroclorotiazida.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Irbesartán/Hidroclorotiazida Almus, seek medical attention immediately.

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

See also the information under the heading “Do not take Irbesartán/Hidroclorotiazida Almus”.

If you are pregnant, if you suspect you may be pregnant, or ifyou plan to become pregnant, inform your doctor. Irbesartán/Hidroclorotiazida Almus is not recommended for use at the beginning of pregnancy (first 3 months), and in any case, it should not be administered after the third month of pregnancy because it may cause serious harm to your baby (see Pregnancy section).

You should also consult your doctor:

• if you are following alow-sodium diet

• if you experience any of the following symptoms:thirst, dry mouth, generalized weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, which may indicate excessive hydrochlorothiazide effect (contained in Irbesartán/Hidroclorotiazida Almus)

• if you experience an increase insensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, blisters) that occur more quickly than usual

• ifyou are to be operated on(surgical intervention) orif you are to receive anesthetics.

• if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within hours or weeks after taking irbesartán/hidroclorotiazide. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing this.

• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Irbesartán/Hidroclorotiazida Almus. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartán/Hidroclorotiazida Almus on your own.

Use in athletes:

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

Use of Irbesartán/Hidroclorotiazida Almus with other medications

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

Diuretics, such as hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Almus, may affect other medications. Do not take with Irbesartán/Hidroclorotiazida Almus preparations containing lithium without your doctor's supervision.

You may need to have blood tests if you take:

• potassium supplements

• potassium-sparing salt substitutes

• medications that save potassium or other diuretics (tablets that increase urine production)

• some laxatives

• medications used to treat gout

• vitamin D supplements

• medications to control heart rate

• diabetes medications (oral agents or insulin)

You should also inform your doctor if you are taking:

• other medications to lower your blood pressure

• steroids

• cancer medications

• analgesics

• medications for arthritis

• cholestyramine or colestipol resins to reduce cholesterol in the blood.

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

If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Irbesartán/Hidroclorotiazida Almus” and “Warnings and precautions”.

Taking Irbesartán/Hidroclorotiazida Almus with food and drinks

Irbesartán/Hidroclorotiazida Almus can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Almus, if you drink alcohol while taking this medication, you may experience a greater sense of dizziness when standing up, especially when getting up from a seated position.

Pregnancy and lactation

Pregnancy

You should inform your doctor if you are pregnant, if you suspect you may be pregnant, orif you plan to become pregnant. Your doctor will usually advise you to stop taking Irbesartán/Hidroclorotiazida Almus before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Irbesartán/Hidroclorotiazida Almus is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Lactation

Inform your doctor if you plan to initiate or are in the lactation period, as Irbesartán/Hidroclorotiazida Almus is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery. It is unlikely that Irbesartán/Hidroclorotiazida Almus will affect your ability to drive vehicles or operate machinery. However, during hypertension treatment, you may occasionally experience dizziness or fatigue. If you experience these symptoms, consult your doctor before driving or operating machinery.

Irbesartán/Hidroclorotiazida Almus contains lactose and sodium

If your doctor has advised you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1mmolof sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dose

The usual dose of Irbesartán/Hidroclorotiazida Almus is one or two tablets per day. In general, your doctor will prescribe Irbesartán/Hidroclorotiazida Almus when previous treatments you received did not sufficiently reduce your blood pressure. Your doctor will indicate how to switch from previous treatments to Irbesartán/Hidroclorotiazida Almus.

Administration form

Irbesartán/Hidroclorotiazida Almus is administered byoral route. The tablets must be swallowed with a sufficient amount of liquid (e.g. a glass of water). You can take Irbesartán/Hidroclorotiazida Almus with or without food. You should try to take your daily dose at the same time every day. It is essential that you continue taking Irbesartán/Hidroclorotiazida Almus until your doctor advises you otherwise.

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

If you take more Irbesartán/Hidroclorotiazida Almus than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Children should not take Irbesartán/Hidroclorotiazida Almus Irbesartán/Hidroclorotiazida Almus 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 Irbesartán/Hidroclorotiazida Almus If you accidentally forget to take a dose, simply take your usual dose when it is next due. Do not take a double dose to compensate for the missed doses. If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some of these side effects can be serious and may require medical attention.

In rare cases, skin allergic reactions (skin rash, urticaria) have been reported in patients treated with irbesartan, as well as localized inflammation in the face, lips, and/or tongue.

If you experience any of the following symptoms or have difficulty breathing, stop taking Irbesartán/Hidroclorotiazida Almus and contact your doctor immediately.

The side effects reported in clinical studies for patients treated with Irbesartán/Hidroclorotiazida Almus were:

Frequent side effects(affect between 1 and 10 in every 100 patients):

• nausea/vomiting,

• urinary abnormalities,

• fatigue

• dizziness (including that which occurs 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 nitrogen in the blood, creatinine).

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

Rare side effects(may affect up to 1 in every 1,000 patients):

• diarrhea,

• low blood pressure,

• fainting,

• palpitations,

• flushing,

• fluid retention (edema)

• sexual dysfunction (alterations in sexual function).

• Blood tests may show low levels of sodium and potassium in your blood.

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

Side effects since the marketing of Irbesartán/Hidroclorotiazida Almus

The frequency of these side effects is unknown. These side effects are: headache, tinnitus, cough, alteration of taste, indigestion, joint and muscle pain, liver function alterations, kidney insufficiency, elevated levels of potassium in your blood, and allergic reactions such as skin rash, urticaria, facial swelling, lip, mouth, tongue, or throat swelling.

As with all combinations of two active principles, the side effects associated with each component cannot be excluded.

Side effects associated only withirbesartan

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

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

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

Side effects associated with hydrochlorothiazide in monotherapy:

Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or white of the eyes); pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting; sleep disturbances; depression; blurred vision; lack of white blood cells, which may lead to frequent infections, fever; decreased platelet count (essential blood cells for blood clotting), decreased red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath when exercising, dizziness, and paleness; kidney disease; lung disorders including pneumonia or fluid accumulation in the lungs; increased skin sensitivity to the sun; inflammation of blood vessels; a skin disease characterized by peeling of the skin all over the body; cutaneous lupus erythematosus, identified by a rash that may appear on the face, neck, and scalp; allergic reactions; muscle weakness and spasms; alteration of heart rhythm; decreased blood pressure after a change in body position; swelling of salivary glands; high blood sugar levels; sugar in the urine; increases in some types of blood fats; high levels of uric acid in the blood, which may cause gout.

Very rare: Acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency(cannot be estimated from available data): Cancer of the skin and lips (non-melanoma skin cancer), decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

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

If you consider any of the side effects you are experiencing to be severeor if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possibleside effect that does not appear in this leaflet.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the carton and on the blister after CAD.

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

This medication does not require special storage conditions. Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at theSIGREofthe pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Irbesartán/Hidroclorotiazida Almus

• The active principles are irbesartan and hydrochlorothiazide. Each Irbesartán/Hidroclorotiazida Almus 300 mg/12.5 mg tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

• The other components are lactose monohydrate, maize pregelatinised starch, microcrystalline cellulose, sodium croscarmellose, magnesium stearate (core), lactose monohydrate, hypromellose 15 cP, macrogol 3350, titanium dioxide (E171), yellow and red iron oxides (E172) (coating).

Appearance of the product and contents of the packaging

The Irbesartán/Hidroclorotiazida Almus 300 mg/12.5 mg tablets are pink/pale pink, oval, convex, and scored on one side. The score is to facilitate the swallowing of the tablet and not to divide it into equal doses. Irbesartán/Hidroclorotiazida Almus 300 mg/12.5 mg tablets are available in blister-type packaging with 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal

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

Irbesartán/Hidroclorotiazida Almus 300 mg/12.5 mg film-coated tablets – Portugal

Last review date of this leaflet: February 2025

The detailed and updated information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/