Irbesartan/hydrochlorothiazide Almus 300 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Irbesartan/Hydrochlorothiazide Almus 300 mg/25 mg film-coated tablets EFG

Read the entire 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, consult 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 irbesartan/hydrochlorothiazide Almus is and what it is used for

Irbesartan/Hydrochlorothiazide 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 prevents angiotensin-II from binding to these receptors, relaxing blood vessels and thereby reducing blood pressure. Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that lower blood pressure by increasing the amount of urine produced. The two active substances in Irbesartan/Hydrochlorothiazide Almus work together to achieve a greater reduction in blood pressure than either of them alone.

Irbesartan/Hydrochlorothiazide Almus is used to treat high blood pressure when treatment with irbesartan alone or hydrochlorothiazide alone does not provide adequate control of your 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 components 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 passing urine
• 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 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 involving excessive production of the hormone aldosterone, leading to sodium retention and, consequently, increased blood pressure)
• if you are taking any of the following medicines 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
  • aliskiren
  • if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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, contact your doctor 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 plan to become pregnant, you must inform your doctor. Use of Irbesartan/Hydrochlorothiazide Almus is not recommended during early pregnancy (first 3 months), and must not be used after the third month of pregnancy as it may cause serious 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 develop increased skin sensitivity to sunlight with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more quickly than usual
• if you are due to undergo surgery or will 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 have 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 produce positive results in doping tests.

Taking Irbesartan/Hydrochlorothiazide Almus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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 preparations containing lithium together with Irbesartan/Hydrochlorothiazide Almus without medical supervision.

You may need blood tests if you are taking:

• potassium supplements
• potassium-containing salt substitutes
• 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 insulins)

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

• other medicines to lower your blood pressure
• steroids
• 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 inhibitor (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 taking 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 plan to become pregnant. Your doctor will generally advise you to stop taking Irbesartan/Hydrochlorothiazide Almus before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Irbesartan/Hydrochlorothiazide Almus is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to your baby from that stage onward.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed, 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, particularly if your baby is a newborn or premature.

Driving and using machines

No studies on the ability to drive or use machines have been conducted. It is unlikely that Irbesartan/Hydrochlorothiazide Almus will affect your ability to drive vehicles or operate machinery. However, dizziness or fatigue may occasionally occur during antihypertensive treatment. If you experience these symptoms, talk to your doctor before driving or operating machinery.

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 given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist.

Dosage

The usual dose of Irbesartan/Hydrochlorothiazide Almus is one or two tablets daily. Generally, your doctor will prescribe Irbesartan/Hydrochlorothiazide Almus when previous treatments have not sufficiently lowered 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. Try to take your daily dose at the same time each day. It is important that you continue taking Irbesartan/Hydrochlorothiazide Almus unless your doctor advises 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medication and the amount ingested. Irbesartan/Hydrochlorothiazide Almus must not be given to children under 18 years of age. If a child accidentally 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 the missed dose.

If you have any further questions about using 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,
• urinary abnormalities,
• 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 these effects is unknown. These adverse effects include: headache, tinnitus (ringing in the ears), cough, altered taste, indigestion, joint and muscle pain, liver function abnormalities and kidney failure, elevated potassium levels in your blood, and allergic reactions such as rash, urticaria, swelling of the face, lips, mouth, tongue or throat.

As with all fixed combinations of two active substances, 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 every 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; low white blood cell count, which may lead to frequent infections and fever; reduced platelet count (blood cells essential for blood clotting), reduced 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 disease 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 muscle spasms; changes in heart rhythm; drop in blood pressure after changing 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 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 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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and 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 in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. 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 Irbesartán/Hidroclorotiazida Almus 300 mg/25 mg tablet contains 300 mg of irbesartan and 25 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, red and black iron oxides (E172) (coating).

Nature of the product and pack contents

Irbesartán/Hidroclorotiazida Almus 300 mg/25 mg tablets are pink/dark pink, oblong, biconvex and scored on one side. The score line is intended to facilitate swallowing and is not intended to divide the tablet into equal doses. Irbesartán/Hidroclorotiazida Almus 300 mg/25 mg film-coated tablets are available in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 300 mg/25 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/