Package Insert: Patient Information

Telmisartán/HidroclorotiazidaViso Farmacéutica80 mg/25 mg tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

Telmisartán/HidroclorotiazidaViso Farmacéuticais a combination of two active principles, telmisartán and hidroclorotiazida, in a tablet. Both substances help control high blood pressure.

• Telmisartán belongs to a group of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, increasing blood pressure. Telmisartán blocks the effect of angiotensin II, causing blood vessels to relax and blood pressure to decrease.

• Hidroclorotiazida belongs to a group of medications known as thiazide diuretics, which increase urine production, also reducing blood pressure.

High blood pressure, if left untreated, can damage blood vessels in various organs, which can cause, in some cases, heart attacks, heart failure or renal failure, strokes or blindness. Generally, there are no symptoms of high blood pressure before damage occurs, so it is essential to measure it regularly to verify that it is within the normal range.

Telmisartán/HidroclorotiazidaViso Farmacéuticais used totreat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with telmisartán alone.

Do not takeTelmisartan/HidroclorotiazideViso Farmacéutica:

• if you are allergic to telmisartan or any of the other components of this medication (listed in section 6).
• if you are allergic to hidroclorotiazide or any sulfonamide-derived medication.
• if you are more than 3 months pregnant. (It is also important to avoid this medication at the beginning of pregnancy, see the pregnancy section).
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease.
• if you have severe kidney disease.
• if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not improve with treatment.
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

If your case is any of the above, do not take the tablets and inform your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor before starting to take telmisartan/hidroclorotiazide if you have or have ever had any of the following conditions or diseases:

• Low blood pressure (hypotension) that may occur if you are dehydrated (excessive loss of body water) or have electrolyte deficiency due to diuretic treatment, low-salt diet, diarrhea, vomiting, or hemodialysis.
• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of blood vessels to one or both kidneys).
• Liver disease.
• Heart problems.
• Diabetes.
• Gout.
• Elevated aldosterone levels (retention of water and salts in the body along with imbalance of several blood minerals).
• SLE (systemic lupus erythematosus), a disease in which the body's immune system attacks the body itself.
• The active ingredient hidroclorotiazide may cause a rare reaction that produces decreased vision and eye pain. This may be symptoms of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased pressure in your eye and may appear between hours and weeks after takingTelmisartan/HidroclorotiazideViso Farmacéutica.If not treated, it may cause permanent damage to your vision.

Consult your doctor before takingTelmisartan/HidroclorotiazideViso Farmacéutica:

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

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

- aliskirén

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood (e.g. potassium) at regular intervals. See also the information under the heading “Do not take Telmisartan/Hidroclorotiazide Viso Farmacéutica”.

• if you are taking digoxina.
• if you have had skin cancer or if you develop a skin lesion during treatment.
• The treatment with hidroclorotiazide, particularly long-term treatment with high doses, may increase the risk of developing certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking telmisartan/hidroclorotiazide.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazide in the past. If you experience severe shortness of breath or difficulty breathing after takingTelmisartan/HidroclorotiazideViso Farmacéutica, seek medical attention immediately.

If you suspect that you are (or may be) pregnant, inform your doctor. Telmisartan/Hidroclorotiazide is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered after that time (see the pregnancy section).

The treatment with hidroclorotiazide may cause an electrolyte imbalance in your body. Typical symptoms of an electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and abnormally elevated heart rate (more than 100 beats per minute). If you experience any of these effects, you should inform your doctor.

You should also inform your doctor if your skin becomes more sensitive to the sun, with symptoms of sunburn (such as redness, itching, swelling, blisters) that appear more quickly than usual.

If you are to undergo surgery (surgery) or anesthesia, you should inform your doctor that you are taking this medication.

These tablets may be less effective in reducing blood pressure in black patients.

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

Children and adolescents

This medication is not recommended for children and adolescents up to 18 years of age.

Other medications and Telmisartan/Hidroclorotiazide Viso Farmacéutica:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor may need to change the dose of these medications or take other precautions. In some cases, you may need to stop taking one of the medications. This applies especially to the following medications when taken at the same time as Telmisartan/Hidroclorotiazide:

• Medications containing lithium for treating certain types of depression.
• Medications associated with low potassium levels in the blood (hypokalemia), such as other diuretics, laxatives (e.g. ricin oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and its derivatives.
• Medications that may increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and immunosuppressants like ciclosporin (a medication) and other medications like heparin sodium (an anticoagulant).
• Medications that are affected by changes in potassium levels in the blood, such as heart medications (e.g. digoxina) or medications to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol) and other medications like certain antibiotics (e.g. ciprofloxacin, pentamidine) or certain medications for allergic reactions (e.g. terfenadine).
• Medications for treating diabetes (insulins or oral agents like metformin).
• Colestiramine and colestipol, medications for reducing blood cholesterol levels.
• Medications for increasing blood pressure, such as noradrenaline.
• Relaxants, such as tubocurarina – Calcium supplements and/or Vitamin D supplements.
• Anticholinergic medications (medications used to treat a variety of conditions such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia) like atropine and biperiden.
• Amantadina (medications used to treat Parkinson's disease and also used to treat and prevent certain diseases caused by viruses).
• Other medications used to treat high blood pressure, corticosteroids, analgesics (such as nonsteroidal anti-inflammatory drugs [NSAIDs]), medications for cancer treatment, gout, or arthritis.
• If you are taking an ACEI or aliskirén (see also the information under the headings “Do not take Telmisartan/Hidroclorotiazide Viso Farmacéutica” and “Warnings and precautions”).

• Digoxina.

Telmisartan/Hidroclorotiazide may increase the effect of other medications to lower blood pressure or medications that may potentially lower blood pressure (e.g. baclofen, amifostine). Additionally, the decrease in blood pressure may be exacerbated by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when getting up. You should inform your doctor about the need to adjust the dose of your other medications while using Telmisartan/Hidroclorotiazide Viso Farmacéutica.

The effect of Telmisartan/Hidroclorotiazide Viso Farmacéutica may be reduced when taking NSAIDs (nonsteroidal anti-inflammatory drugs, such as aspirin or ibuprofen).

Taking Telmisartan/Hidroclorotiazide Viso Farmacéutica with food and alcohol

You can take Telmisartan/Hidroclorotiazide Viso Farmacéutica with or without food.

Avoid taking alcohol until you have spoken with your doctor. Alcohol may further reduce your blood pressure and/or increase the risk of feeling dizzy or weak.

Pregnancy and lactation

Pregnancy

You should inform your doctor if you suspect that you are (or may be) pregnant. Your doctor will usually advise you to stop taking this medication before becoming pregnant or as soon as you become pregnant, and will recommend taking another medication instead. These tablets are not recommended during pregnancy, and they should not be taken if you are more than 3 months pregnant, as they may cause serious harm to your baby if used after the third month of pregnancy.

Lactation

You should inform your doctor if you are to initiate or are in the lactation period, as this medication is not recommended during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed.

Driving and operating machinery

Some people may feel dizzy or tired when taking Telmisartan/Hidroclorotiazide. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan/Hidroclorotiazide Viso Farmacéutica contains lactose

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

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

The recommended dose is one tablet per day.

Try to take one tablet every day at the same time.

You can take the tablets with or without food. You should swallow them with water or another non-alcoholic beverage.

It is essential that you take the tablets every day until your doctor tells you otherwise.

If your liver does not function correctly, the normal dose should not exceed 40 mg/12.5 mg once a day.

If you take moreTelmisartan/Hidroclorotiazida Viso Farmacéuticathan you should

If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeats. Slow heartbeats, dizziness, vomiting, and reduced kidney function, including kidney failure, have also been described. Due to the hydrochlorothiazide component, you may also experience notably low blood pressure and low potassium levels in the blood, which can lead to nausea, drowsiness, and muscle cramps and/or irregular heartbeats associated with the concomitant use of medications such as digitalis or certain antiarrhythmic treatments.

Contact your doctor or pharmacist immediately or the nearest hospital emergency service or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If you forgot to takeTelmisartan/Hidroclorotiazida Viso Farmacéutica

If you forget to take a dose, do not worry, take it as soon as you remember and then take the next dose at the usual time. If you miss a day, take the usual dose the next day. Do not take a double dose to compensate for the missed doses.

If you haveany other questionsabout the use of this medication,askyour doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious and require immediate medical attention:

If you experience any of the following symptoms, you should visit your doctor immediately:

Sepsis* (also known as "blood infection"), is a severe infection that involves a systemic inflammatory reaction, rapid skin and mucous membrane swelling (angioedema), blistering and peeling of the skin's outer layer (toxic epidermal necrolysis); these side effects are rare (can affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and visit their doctor immediately.

If these side effects are not treated, they can be fatal. An increased incidence of sepsis with telmisartan alone has been observed; however, it cannot be ruled out forTelmisartan/HidroclorotiazidaViso Farmacéutica.

Possible side effects ofTelmisartan/HidroclorotiazidaViso Farmacéutica:

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

• Dizziness

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

• Decreased potassium levels in the blood
• Anxiety, fainting (syncope)
• Sensation of tingling, numbness (paresthesia)
• Dizziness (vertigo)
• Fast heart rate (tachycardia),
• Heart rhythm disturbances,
• Low blood pressure or sudden drop in blood pressure when standing up
• Shortness of breath (dyspnea)
• Diarrhea
• Flatulence
• Dry mouth
• Back pain, muscle spasms, muscle pain, chest pain
• Impotence (inability to achieve or maintain an erection)
• Increased uric acid levels in the blood.

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

• Pneumonitis (inflammation of the lungs)
• Activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks the body itself, causing joint pain, skin rashes, and fever)
• Sore throat, sinusitis
• Feeling of sadness (depression)
• Difficulty falling asleep (insomnia)
• Visual disturbances
• Difficulty breathing
• Abdominal pain, constipation, abdominal distension (dyspepsia), general discomfort (vomiting)
• Gastritis (inflammation of the stomach)
• Liver function disturbances (Japanese patients are more prone to experiencing this side effect)
• Redness of the skin (erythema)
• Allergic reactions such as itching or rashes
• Increased sweating
• Hives (urticaria)
• Joint pain (arthralgia) and limb pain
• Muscle cramps
• Pseudogripal syndrome
• Pain
• Low sodium levels
• Increased creatinine, liver enzymes, or creatine phosphokinase levels in the blood.

Adverse reactions reported with each active ingredient separately may occur withTelmisartan/HidroclorotiazidaViso Farmacéutica,although they have not been observed in clinical trials with this medicine.

Possible side effects of telmisartan alone:

In patients taking telmisartan alone, the following side effects have been reported:

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

• Upper respiratory tract infection (e.g., sore throat, sinusitis, common cold)
• Urinary tract infections
• Anemia, high potassium levels
• Slow heart rate (bradycardia)
• Renal function disturbances including acute renal failure
• Weakness
• Cough.

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

• Low platelet count (thrombocytopenia), increased levels of certain white blood cells (eosinophilia)
• Severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions, drug rash)
• Low blood sugar levels (in diabetic patients), stomach discomfort, eczema (a skin disorder)
• Joint pain (arthralgia)
• Tendonitis
• Low hemoglobin levels (a protein in the blood)
• Drowsiness.

Very rare side effects(can affect up to 1 in 10,000 people):

• Progressive fibrosis of lung tissue (interstitial lung disease)**

Unknown frequency (cannot be estimated from available data):

• Intestinal angioedema: intestinal swelling has been reported with symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products.

* The event may have been a coincidence or related to an unknown mechanism.

** Cases of progressive fibrosis of lung tissue have been reported during telmisartan use. However, it is unknown if telmisartan was the cause.

Possible side effects of hydrochlorothiazide alone:

In patients taking hydrochlorothiazide alone, the following side effects have been reported:

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

• Discomfort (nausea)
• Low magnesium levels in the blood.

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

• Low platelet count, which increases the risk of bleeding and hematoma formation (small purple-red marks on the skin or in other tissues caused by bleeding),
• High calcium levels in the blood,
• Headache.

Very rare side effects (can affect up to 1 in 10,000 people):

• Metabolic acidosis due to low chloride levels in the blood.
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Side effects of unknown frequency(frequency cannot be estimated from available data):

• Salivary gland inflammation
• Decreased number (or even absence) of blood cells, including low red and white blood cell counts,
• Severe allergic reactions (e.g. hypersensitivity, anaphylactic reactions),
• Loss of appetite,
• Anxiety, dizziness,
• Blurred or yellowish vision, decreased vision, and eye pain (possible signs of fluid accumulation in the eye's vascular layer [choroidal hemorrhage] or acute myopia or acute angle-closure glaucoma),
• Vasculitis necrotizante (inflammation of blood vessels), pancreatitis, stomach discomfort,
• Jaundice (yellowing of the skin or eyes),
• Pseudolupus syndrome (a condition that mimics a disease called systemic lupus erythematosus in which the body's immune system attacks the body itself),
• Skin disorders such as vasculitis, increased sensitivity to sunlight, skin rash, redness of the skin, blistering of the lips, eyes, or mouth, skin peeling,
• Fever (possible signs of erythema multiforme),
• Weakness,
• Renal inflammation or dysfunction,
• Glucosuria (glucose in the urine),
• Fever,
• Electrolyte imbalance,
• High cholesterol levels in the blood,
• Decreased blood volume,
• Increased blood glucose levels, difficulty controlling blood glucose levels/orine in patients with diabetes mellitus, or blood fat.

Skin cancer or lip cancer (non-melanoma skin cancer)

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directlythrough theSpanish System for 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.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

You must conserve your medication in the original packaging to protect the tablets from moisture.

Do not use this medication if you observe that the tablets are discolored.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications that you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition ofTelmisartan/HydrochlorothiazideViso Pharmaceutical

The active principles are telmisartan and hydrochlorothiazide.

Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.

The other components are crospovidone (type A), hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, povidone, colloidal anhydrous silica, sodium hydroxide, stearate of fumaric acid and sodium, talc, red iron oxide (E 172), yellow iron oxide (E 172).

Appearance of the product and contents of the package

The Telmisartan/Hydrochlorothiazide Viso Pharmaceutical 80 mg/25 mg tablets are biconvex, two-layer, non-coated tablets in the shape of a capsule, where the hydrochlorothiazide layer is light yellow, with the inscription “425”, and the telmisartan layer is orange mottled to reddish-brown, without inscription. The hydrochlorothiazide layer may contain reddish-brown spots.

The Telmisartan/Hydrochlorothiazide Viso Pharmaceutical tablets are presented in blister packs of 14, 28, 30, 56, 90 or 98 tablets. Some package sizes may only be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoke Myto

Czech Republic

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

Viso Pharmaceutical, S.L.U.

c/ Retama 7, 7th Floor

28045 Madrid

Spain

This medication is authorized in the EEA member states with the following names:

Last review date of this leaflet:March 2025

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