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

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

Do not take Irbesartan/Hydrochlorothiazide Almus

• if you are allergic (hypersensitive) to irbesartan or any of the other ingredients of Irbesartan/Hydrochlorothiazide Almus
• if you are allergic (hypersensitive) to hydrochlorothiazide or any other sulfonamide-derived medication
• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medication during the start of 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 insufficiency and are being treated with a blood pressure-lowering medication containing aliskiren

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

Warnings and precautions

Consult your doctor before starting to take Irbesartan/Hydrochlorothiazide Almus:

• if you have excessive vomiting or diarrhea
• if you have kidney problems or have had a kidney transplant
• if you have heart problems
• if you have liver problems
• if you have diabetes
• if you have lupus erythematosus (also known as lupus or LES)
• if you have primary aldosteronism (a condition related to high production of the hormone aldosterone, leading to sodium retention and increased 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), especially if you have diabetes-related kidney problems.
  • aliskiren
  • if you have had skin cancer or if you 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan/Hydrochlorothiazide Almus.
  • 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 Almus, seek medical attention 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, inform your doctor. It is not recommended to use Irbesartan/Hydrochlorothiazide Almus at the start of pregnancy (first 3 months), and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

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, weakness, feeling sleepy, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as they may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Almus)
• if you experience increased sensitivity of your skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blisters) that occur more quickly than usual
• if you are going to have surgery (surgical intervention) or if you are going to be administered anesthetics.
• 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 pressure in the eye, and can occur within hours to weeks after taking irbesartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may have a higher risk of developing this.
• if you experience abdominal pain, nausea, vomiting, or diarrhea 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 medication contains hydrochlorothiazide, which may produce a positive result in doping tests.

Use of Irbesartan/Hydrochlorothiazide 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 Irbesartan/Hydrochlorothiazide Almus, may have an effect on other medications. You should not take preparations containing lithium with Irbesartan/Hydrochlorothiazide Almus without your doctor's supervision.

You may need to have blood tests if you take:

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

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

• other medications to lower your blood pressure
• steroids
• medications to treat cancer
• analgesics
• medications for arthritis
• cholestyramine or colestipol resins to reduce blood cholesterol levels.

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 Almus” and “Warnings and precautions”.

Taking Irbesartan/Hydrochlorothiazide Almus with food and drinks

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 medication, you may experience increased dizziness when standing up, especially when getting up from a seated position.

Pregnancy and breastfeeding

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 Almus before you become pregnant or as soon as you know you are pregnant and will recommend that you take another blood pressure-lowering medication instead. It is not recommended to use Irbesartan/Hydrochlorothiazide Almus at the start of pregnancy (first 3 months), and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as it is not recommended to administer Irbesartan/Hydrochlorothiazide Almus to women during this period. Your doctor may decide to administer a treatment that is more suitable if you wish to breastfeed, especially to newborns or premature babies.

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 use machines. However, during treatment for 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 Almus contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medication.

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

3. How to take irbesartan/hydrochlorothiazide Almus

Follow exactly the instructions of administration of this medication indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Dose

The normal dose of Irbesartan/Hydrochlorothiazide Almus is one or two tablets per day. In general, your doctor will prescribe Irbesartan/Hydrochlorothiazide Almus when previous treatments you received did not sufficiently reduce your blood pressure. Your doctor will indicate 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 can take Irbesartan/Hydrochlorothiazide Almus with or without food. You should try to take your daily dose at the same time every day. It is important that you continue taking Irbesartan/Hydrochlorothiazide Almus until your doctor advises you otherwise.

The 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Children should not take Irbesartan/Hydrochlorothiazide Almus. Irbesartan/Hydrochlorothiazide 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 Irbesartan/Hydrochlorothiazide Almus, 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 other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

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

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

Common side effects(affect 1 to 10 users in 100):

• nausea/vomiting,
• urination anomalies,
• fatigue
• dizziness (including that which occurs when standing up from a lying or seated 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.

Uncommon side effects(affect 1 to 10 users in 1,000):

• diarrhea,
• low blood pressure,
• fainting,
• rapid heartbeat,
• flushing,
• swelling due to 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 reported since the marketing of Irbesartan/Hydrochlorothiazide Almus

The frequency of these effects is unknown. These side effects are: headache, ringing in the ears, cough, alteration of taste, indigestion, pain in the joints and muscles, liver function alterations, and kidney failure, high levels of potassium in your blood, and allergic reactions such as skin rash, hives, swelling of the face, lips, mouth, tongue, or throat.

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

Side effects associated only with irbesartan

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

Rare side effects(may affect up to 1 in 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 whites of the eyes); pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can lead to frequent infections, fever; decreased number of platelets (blood cells essential for blood clotting), decreased number of red blood cells (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 sensitivity of the skin to the sun; inflammation of blood vessels; 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; alteration of heart rhythm; reduction of blood pressure after a change in body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increased levels of certain blood fats; high levels of uric acid in the blood, which can cause gout.

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

Frequency not known (cannot be estimated from the available data): Skin and lip cancer (non-melanoma skin cancer), 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].

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

If you consider any of the side effects you are experiencing to be seriousor 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 possible side effect not listed in this leaflet. You can also report them directly through 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 medication.

5. Storage of irbesartan/hydrochlorothiazide Almus

Keep out of sight and reach of children.

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

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

This medicine does not require special storage conditions. Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE. If in doubt, 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 Almus

• The active ingredients are irbesartan and hydrochlorothiazide. Each Irbesartan/Hydrochlorothiazide Almus 300 mg/25 mg tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
• The other ingredients are lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, magnesium stearate (core), lactose monohydrate, hypromellose 15 cP, macrogol 3350, titanium dioxide (E171), yellow, red, and black iron oxides (E172) (coating).

Appearance of the product and package contents

The Irbesartan/Hydrochlorothiazide Almus 300 mg/25 mg tablets are pink/dark pink, oblong, convex, and scored on one side. The score line is to facilitate swallowing of the tablet and not to divide it into equal doses. Irbesartan/Hydrochlorothiazide Almus 300 mg/25 mg tablets are available in blister packs of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

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

This medicine has been approved in the EEA Member States under the following names:

Irbesartan/Hydrochlorothiazide Almus 300 mg/25 mg film-coated tablets – Portugal

Date of the last revision of this leaflet: February 2025

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/