Package Insert: Patient Information

Telmisartán/HidroclorotiazidaViso Farmacéutica80 mg/12,5 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 refer to 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/Hidroclorotiazida Viso Farmacéutica is 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 reducing blood pressure.

• 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/Hidroclorotiazida Viso Farmacéutica is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with telmisartán alone.

Do not takeTelmisartan/HydrochlorothiazideViso Pharmaceutical:

• if you are allergic to telmisartan or any of the other components of this medication (listed in section 6).
• if you are allergic to hydrochlorothiazide 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 aliskiren.

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/hydrochlorothiazide if you have or have 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 a salt 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 salt 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 hydrochlorothiazide 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 occur between hours and weeks after takingTelmisartan/HydrochlorothiazideViso Pharmaceutical.If not treated, it may cause permanent vision damage.

Consult your doctor before takingTelmisartan/HydrochlorothiazideViso Pharmaceutical:

• 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

- aliskiren

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/Hydrochlorothiazide Viso Pharmaceutical”.

• if you are taking digoxin.
• if you have had skin cancer or if you develop a skin lesion during treatment.
• The treatment with hydrochlorothiazide, 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 the sun and UV rays while taking telmisartan/hydrochlorothiazide.
• 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 takingTelmisartan/HydrochlorothiazideViso Pharmaceutical, seek medical attention immediately.

If you suspect you are (or may become) pregnant, inform your doctor. Telmisartan/Hydrochlorothiazide 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 from that point on (see the pregnancy section).

The treatment with hydrochlorothiazide 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/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking telmisartan/hydrochlorothiazide 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/Hydrochlorothiazide Viso Pharmaceutical:

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 adjust 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/Hydrochlorothiazide:

• 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. castor 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 such as 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. digoxin) or medications to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol) medications used to treat mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine) and other medications such as certain antibiotics (e.g. ciprofloxacin, pentamidine) or certain medications to treat allergic reactions (e.g. terfenadine).
• Diabetes medications (insulins or oral agents such as metformin).
• Cholestyramine and colestipol, medications to reduce blood cholesterol levels.
• Medications to increase blood pressure, such as noradrenaline.
• Muscle relaxants, such as tubocurarine – Calcium supplements and/or Vitamin D supplements.
• Anticholinergic medications (medications used to treat a variety of disorders such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia) such as atropine and biperiden.
• Amantadine (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]), cancer medications, gout, or arthritis.
• If you are taking an angiotensin-converting enzyme inhibitor (ACEI) or aliskiren (see also the information under the headings “Do not take Telmisartan/Hydrochlorothiazide Viso Pharmaceutical” and “Warnings and precautions”).

• Digoxin.

Telmisartan/Hydrochlorothiazide 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 taking Telmisartan/Hydrochlorothiazide Viso Pharmaceutical.

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

Taking Telmisartan/Hydrochlorothiazide Viso Pharmaceutical with food and alcohol

You can take Telmisartan/Hydrochlorothiazide Viso Pharmaceutical 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 you are (or may become) pregnant. Your doctor will usually advise you to stop taking this medication before becoming pregnant or as soon as you become pregnant, and 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/Hydrochlorothiazide. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan/Hydrochlorothiazide Viso Pharmaceutical 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 to 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 may 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 serious 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 (may 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 for Telmisartan/Hidroclorotiazida Viso Farmacéutica.

Possible side effects ofTelmisartan/HidroclorotiazidaViso Farmacéutica:

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

• Dizziness

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

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

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

• Pneumonitis (bronchitis)
• Activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks the body, causing joint pain, skin rashes, and fever)
• Sore throat, sinusitis
• Feeling sad (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)
• Flushes (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 in the blood.

The adverse reactions reported with each active ingredient separately may occur with Telmisartan/Hidroclorotiazida Viso 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(may 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(may affect up to 1 in 1,000 people):

• Low platelet count (thrombocytopenia), increased eosinophils
• Severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions, drug eruptions)
• Low blood sugar levels (in diabetic patients), stomach discomfort, eczema (a skin disorder)
• Joint pain (arthrosis)
• Tendonitis
• Low hemoglobin levels
• Drowsiness.

Very rare side effects(may 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 whether telmisartan was the cause.

Possible side effects of hidroclorotiazida alone:

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

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

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

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

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

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

• Increased pH (alteration of acid-base balance) due to low chloride levels in the blood.
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Unknown 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,
• Restlessness, dizziness,
• Blurred or yellowish vision, decreased vision, and eye pain (possible signs of fluid accumulation in the eye's vascular layer [choroidal effusion] or acute myopia or 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),
• 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 function disturbances,
• 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 you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition ofTelmisartán/HidroclorotiazidaViso Pharmaceutical Form

The active principles are telmisartan and hidroclorotiazida.

Each tablet contains 80 mg of telmisartan and 12.5 mg of hidroclorotiazida.

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).

Appearance of the product and contents of the package

The Telmisartan/Hidroclorotiazida Viso Pharmaceutical 80 mg/12.5 mg tablets are biconvex, two-layer, non-coated tablets in the shape of a capsule, where the layer of hidroclorotiazida is white or almost white with the inscription “424”, and the layer of telmisartan is orange speckled to reddish-brown, without inscription. The layer of hidroclorotiazida may contain reddish-brown spots.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible for manufacturing:

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 holder of the marketing authorization:

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/