CONVERIDE 300 mg/25 mg Comprimidos Revestidos Por Película

Patient:Information for the patient

Converide 150 mg/12.5 mg film-coated tablets

Converide 300 mg/12.5 mg film-coated tablets

Converide 300 mg/25 mg film-coated tablets

Irbesartan/hydrochlorothiazide

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 pass it on to others even if their symptoms are the same as yours.It may harm them.

• If you experience any side effects, talk to your doctor or pharmacist.Even if they do not appear in this leaflet, see section 4.

1.What Converide is and what it is used for

2.What you need to know before you start taking Converide

3.How to take Converide

4.Possible side effects

5Storage of Converide

6.Contents of the pack and additional information

Converide 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 Converide act together to achieve a decrease in blood pressure greater than that obtained with each one separately.

Converide is used to treat high blood pressure, when treatment with only irbesartan or only hydrochlorothiazide does not provide adequate control of blood pressure.

Do not take Converide:

• if you areallergicto irbesartan, or to any of the other components ofthis medication (listed in section 6).
• if you areallergicto hydrochlorothiazide or any other medication derived from sulfonamides.
• 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 haveserious liver or kidney problems.
• if you havedifficulty urinating.
• if your doctor detects that you have persistently elevated levels of calcium or low levels of potassium in your blood.
• if you havediabetes or kidney insufficiencyand are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

Consult your doctorbefore starting to take Converideandin any of the following cases:

• if you haveexcessive vomiting or diarrhea.
• if you havekidney problemsor have had akidney transplant.
• if you haveheart problems.
• if you haveliver problems.
• if you havediabetes.
• if you experiencelow blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing, pallor, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes.
• if you havelupus erythematosus(also known as lupus or SLE).
• if you haveprimary aldosteronism(a condition related to the excessive production 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 (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

• 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 Converide.
• 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 Converide, seek medical attention immediately

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Converide. Your doctor will decide whether to continue treatment. Do not stop taking Converide on your own.

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 Converide”.

If you are pregnant, if you suspect you may be pregnant(or if you plan to become pregnant), inform your doctor. Converide 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 (see Pregnancy section).

You must also inform your doctor:

• if you are following alow-sodium diet.
• if you experience any of these symptoms:thirst, dry mouth, generalized weakness, drowsiness, muscle pain or cramps, nausea, vomiting, orrapid heartbeats, as they may indicate excessive hydrochlorothiazide effect (contained in Converide).
• 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 undergo surgery(surgical intervention) orif you are to receive anesthetics.
• if you experiencediminished vision or eye pain in one or both eyeswhile taking Converide. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased pressure in the eye (glaucoma) and may occur within a few hours to a week after taking Converide. 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 higher risk of developing it. You must interrupt Converide treatment and seek medical attention immediately.

The hydrochlorothiazide contained in this medication may cause positive results in doping control.

Children and adolescents

Converide should not be administered to children and adolescents (under 18 years old).

Taking Converide with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

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

• If you are taking an angiotensin-converting enzyme inhibitor (ACEI) or aliskiren (see also the information under the headings “Do not take Converide” and “Warnings and precautions”).

You may need to have blood tests if you take:

• potassium supplements
• sodium-free salt substitutes containing potassium
• potassium-sparing diuretics (tablets that increase urine production)
• some laxatives
• medications used to treat gout
• vitamin D supplements
• medications to control heart rhythm
• diabetes medications (oral agents such as repaglinide or insulin)
• carbamazepine (a medication for epilepsy treatment).

You should also inform your doctor if you are taking other medications to lower your blood pressure, steroids, cancer medications, analgesics, medications for arthritis, or cholestyramine or colestipol resins to reduce cholesterol in the blood.

Taking Converide with food and alcohol

Converidecan be taken with or without food.

Due to the hydrochlorothiazide contained in Converide, if you drink alcohol while taking this medication, you may experience increased dizziness when standing up, especially when getting up from a seated position.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant(or if you plan to become pregnant), consult your doctor or pharmacist before using this medication.

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may be pregnant(or if you plan to become pregnant). Your doctor will usually advise you to stop taking Converide before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Converide 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 on.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding. Converide is not recommended for breastfeeding mothers and 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

It is unlikely that Converide 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.

Converide contains lactose. If your doctor has told you that youhavelactose intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”

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

Dose

The recommended dose of Converide is one tablet per day. In general, your doctor will prescribe Converide when previous treatments you received have not sufficiently reduced your blood pressure. Your doctor will instruct you on how to switch from previous treatments to Converide.

Administration Form

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

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

The groove is only for breaking the tablet if it is difficult to swallow whole.

Use in Children and Adolescents

Children should not take Converide

Converide should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If You Take More Converide Than You Should

If you accidentally take too many tablets, contact your doctor immediately.

If You Forget to Take Converide

If you accidentally forget to take a dose, simply take your regular dose when it is due next. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, 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 casesskin 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 above symptoms or have difficulty breathing, stop taking Converide and contact your doctor immediately.

The side effects reported in clinical studies for patients treated withirbesartan/hydrochlorothiazidewere:

Frequent side effects(may affect up to 1 in 10 people):

• Nausea/vomiting
• Urinary abnormalities
• Fatigue
• Dizziness (including dizziness that 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 (blood urea nitrogen, creatinine).

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

Infrequent side effects(may affect up to 1 in 100 people):

• Diarrhea
• Low blood pressure
• Fainting
• Tachycardia
• Redness
• 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 since the marketing of irbesartan/hydrochlorothiazide

Since the marketing of irbesartan/hydrochlorothiazide, some side effects have been reported. The side effects observed with unknown frequency are: headache, tinnitus, cough, alteration of taste, indigestion, joint and muscle pain, liver function alterations, and 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. Also, rare cases of jaundice (yellowing of the skin and/or white of the eyes) have been observed.

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

Side effects associated only with irbesartan

In addition to the side effects described above, chest pain, severe allergic reactions (anaphylactic shock), decreased red blood cell count (anemia - symptoms may include fatigue, headaches, difficulty breathing during exercise, dizziness, and paleness), and decreased platelet count (a blood cell essential for blood clotting) and low blood sugar levels have been observed.

Rare side effects(may affect up to 1 in 1000 people):

Intestinal angioedema: swelling in the intestine that is accompanied by 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 (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; pulmonary alterations 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 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; alteration of heart rhythm; reduction of 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 side effects (may affect up to 1 in 10,000 people):

Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency(the frequency cannot be estimated from the available data):skin and lip cancer (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.

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 that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

For the product packaged in opaque PVC/PVDC-Alu blisters: This medication does not requireany special storage temperature. Store in the original packaging to protect it from moisture.

For the product packaged in transparent PVC/PE/PVDC-Alu blisters:This medication does not requireany special storage temperature. Store in the original packaging to protect it from moisture and light.

Do not usethis medicationafter the expiration date that appears onthe box and the blister,after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the drains or in the trash. Dispose of the packaging and medicines that you no longer need at thePharmaceutical Take-Back Pointof the pharmacy. If in doubt, ask your pharmacisthow to dispose ofthe packaging and themedicines that you no longerneed. In this way, you will help protect the environment.

Composition of Converide

• The active principles are irbesartan and hydrochlorothiazide.

Each film-coated tablet of Converide 150 mg/12.5 mg contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

Each film-coated tablet of Converide 300 mg/12.5 mg contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

Each film-coated tablet of Converide 300 mg/25 mg contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.

• The other components are lactose monohydrate, pregelatinized starch, anhydrous colloidal silica, croscarmellose sodium E468, microcrystalline cellulose PH-102, E460, magnesium stearate E572, hypromellose E464, macrogol 3000, titanium dioxide E171, iron oxide red E172 (only for the 300/12.5 mg dosage).

Appearance of the product and contents of the package

Converide 150 mg/12.5 mg film-coated tablets: White, round, convex film-coated tablets with a diameter of 9.5 mm.

Converide 300 mg/12.5 mg film-coated tablets: Film-coated tablets in capsule shape, pink, convex, annotated on one side, engraved with "MC" on the other side, with dimensions 17.5 x 8 mm.

Converide 300 mg/25 mg film-coated tablets: Film-coated tablets in capsule shape, white, convex, annotated on one side, engraved with "MC" on the other side, with dimensions 17.5 x 8 mm.

Packages of 14, 28, 30, 56, 60, 84, 90, 98, and 100 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Medochemie Iberia, S.A.

Rua José Maria Nicolau, nº6, 7ºB,

São Domingos de Benfica, 1500 662 Lisboa,

Portugal

Responsible for manufacturing

Medochemie Ltd – Central Factory

1-10 Constantinoupoleos Street, 3011, Limassol,

Cyprus

Medochemie Ltd (Factory AZ)

2 Michael Erakleous Street, Agios Athanassios

Industrial Area, 4101, Agios Athanassios, Limassol

Cyprus

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this prospectus: January 2025

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/