TELMISARTAN/HYDROCHLOROTHIAZIDE VISO FARMACÉUTICA 80 mg/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Telmisartan/HydrochlorothiazideViso Pharmaceutical80 mg/12.5 mg EFG tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Telmisartan/Hydrochlorothiazide Viso Pharmaceutical and what is it used for
2. What you need to know before you take Telmisartan/Hydrochlorothiazide Viso Pharmaceutical
3. How to take Telmisartan/Hydrochlorothiazide Viso Pharmaceutical
4. Possible side effects
5. Storage of Telmisartan/Hydrochlorothiazide Viso Pharmaceutical
6. Contents of the pack and other information

1. What is Telmisartan/Hydrochlorothiazide Viso Pharmaceutical and what is it used for

Telmisartan/Hydrochlorothiazide Viso Pharmaceutical is a combination of two active substances, telmisartan and hydrochlorothiazide, in one tablet. Both substances help to control high blood pressure.

• Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, so that your blood vessels relax and your blood pressure is reduced.

• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase urine production, also lowering blood pressure.

High blood pressure, if left untreated, can damage blood vessels in various organs, which can lead to heart attacks, heart failure, or kidney failure, strokes, or blindness in some cases. Usually, there are no symptoms of high blood pressure before damage occurs, so it is important to have your blood pressure checked regularly to make sure it is within the normal range.

Telmisartan/HydrochlorothiazideViso Pharmaceuticalis used totreat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with telmisartan alone.

2. What you need to know before you take Telmisartan/Hydrochlorothiazide Viso Pharmaceutical

Do not takeTelmisartan/HydrochlorothiazideViso Pharmaceutical:

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to hydrochlorothiazide or to any sulfonamide-derived medication.
• if you are more than 3 months pregnant. (It is also important to avoid this medication at the start of pregnancy, see the section on pregnancy.)
• 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 failure and are being treated with a blood pressure medication that contains aliskiren.

If any of the above applies to you, do not take the tablets and inform your doctor or pharmacist before taking this medicine.

Warnings and precautions

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

• Low blood pressure (hypotension) that may occur if you are dehydrated (excessive loss of body water) or have an electrolyte deficiency due to treatment with diuretics, low-salt diet, diarrhea, vomiting, or hemodialysis.
• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart problems.
• Diabetes.
• Gout.
• High aldosterone levels (water and salt retention in the body along with an imbalance of various minerals in the blood).
• Systemic lupus erythematosus (also called "lupus" or "SLE"), a disease in which the body's immune system attacks itself.
• The active ingredient hydrochlorothiazide may cause a rare reaction that produces decreased vision and eye pain. It can be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and may appear between hours and weeks after taking Telmisartan/Hydrochlorothiazide Viso Pharmaceutical. If left untreated, it can cause permanent vision damage.

Consult your doctor before taking Telmisartan/Hydrochlorothiazide Viso Pharmaceutical:

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

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

Your doctor may check 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 Telmisartan/Hydrochlorothiazide Viso Pharmaceutical".

• if you are taking digoxin.
• if you have had skin cancer or if you develop a skin lesion during treatment.
• Treatment with hydrochlorothiazide, particularly long-term treatment with high doses, may increase the risk of developing certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking telmisartan/hydrochlorothiazide.
• 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 Telmisartan/Hydrochlorothiazide Viso Pharmaceutical, seek medical attention immediately.

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

Treatment with hydrochlorothiazide can cause an electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, somnolence, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and abnormally high 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 going 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 andTelmisartan/HydrochlorothiazideViso Pharmaceutical:

Inform your doctor or pharmacist if you are taking, have recently taken, 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 is especially applicable 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), sodium penicillin G (an antibiotic), and salicylic acid and its derivatives.
• Medications that can increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and ACE inhibitors, cyclosporine (an immunosuppressive medication), and other medications like sodium heparin (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 for mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medications like certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medications for treating allergic reactions (e.g., terfenadine).
• Medications for treating diabetes (insulins or oral agents like metformin).
• Colestyramine and colestipol, medications to lower blood fat levels.
• Medications to increase blood pressure, such as noradrenaline.
• Muscle relaxants, such as tubocurarine – Calcium and/or Vitamin D supplements.
• Anticholinergic medications (medications used to treat a variety of disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia) like atropine and biperiden.
• Amantadine (medications used to treat Parkinson's disease and also used to treat and prevent certain viral diseases).
• Other medications used to treat high blood pressure, corticosteroids, pain relievers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medications for treating cancer, gout, or arthritis.
• If you are taking an ACE inhibitor 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 ability of other medications to lower blood pressure or medications that can 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 standing up. You should inform your doctor about the need to adjust the dose of your other medications while using Telmisartan/Hydrochlorothiazide Viso Pharmaceutical.

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

TakingTelmisartan/HydrochlorothiazideViso Pharmaceuticalwith food and alcohol

You can take Telmisartan/Hydrochlorothiazide Viso Pharmaceutical with or without food.

Avoid drinking alcohol until you have talked to your doctor. Alcohol can further lower your blood pressure and/or increase the risk of feeling dizzy or weak.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you suspect that you are (or may be) pregnant. Generally, your doctor will 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 you should not take them 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.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as these tablets are not recommended during this period. Your doctor may decide to administer a treatment that is more suitable if you wish to breastfeed.

Driving and using machines

Some people feel dizzy or tired when taking Telmisartan/Hydrochlorothiazide. If you feel dizzy or tired, do not drive or use machines.

Telmisartan/HydrochlorothiazideViso Pharmaceuticalcontains lactose

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

3. How to take Telmisartan/Hydrochlorothiazide Viso Pharmaceutical

Follow exactly the administration instructions of 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 drink.

It is important that you take the tablets every day until your doctor tells you to stop.

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/HydrochlorothiazideViso Pharmaceuticalthan you should

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

Contact your doctor or pharmacist or the emergency department of the nearest hospital or call the Toxicology 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 forget to takeTelmisartan/HydrochlorothiazideViso Pharmaceutical

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 do not take your tablet one day, take the usual dose the next day. Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

Sepsis* (frequently called "blood infection"), is a serious infection that involves an inflammatory reaction of the entire body, rapid swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer layer of the skin (toxic epidermal necrolysis); these adverse 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 adverse effects are not treated, they can be fatal. An increase in the incidence of sepsis has been observed with telmisartan alone; however, it cannot be ruled out for Telmisartan/Hydrochlorothiazide Viso Farmacéutica.

Possible Adverse Effects of Telmisartan/Hydrochlorothiazide Viso Farmacéutica:

Common adverse effects (may affect up to 1 in 10 people):

• Dizziness

Uncommon adverse effects (may affect up to 1 in 100 people):

• Decrease in potassium levels in the blood
• Anxiety, fainting (syncope)
• Feeling 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
• Erectile dysfunction (inability to have or maintain an erection)
• Increased levels of uric acid in the blood.

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

• Lung inflammation (bronchitis)
• Activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks itself, causing joint pain, skin rashes, and fever)
• Sore throat, inflammation of the paranasal sinuses
• Feeling of sadness (depression)
• Difficulty falling asleep (insomnia)
• Visual disturbances
• Breathing difficulties
• Abdominal pain, constipation, abdominal distension (dyspepsia), general malaise (vomiting)
• Stomach inflammation (gastritis)
• Alteration in liver function (Japanese patients show a greater tendency to experience this adverse effect)
• Redness of the skin (erythema)
• Allergic reactions such as itching or rash
• Increased sweating
• Hives (urticaria)
• Joint pain (arthralgia) and pain in the limbs
• Muscle cramps
• Pseudoinfluenza syndrome
• Pain
• Low sodium levels
• Increased levels of creatinine, liver enzymes, or creatine phosphokinase in the blood.

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

Possible Adverse Effects of Telmisartan Alone:

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

Uncommon adverse effects (may affect up to 1 in 100 people):

• Upper respiratory tract infection (e.g., sore throat, inflammation of the paranasal sinuses, common cold)
• Urinary tract infections
• Red blood cell deficiency (anemia), high potassium levels
• Slow heart rate (bradycardia)
• Alteration in kidney function, including acute kidney failure
• Weakness
• Cough.

Rare adverse effects (may 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 upset, eczema (a skin disorder)
• Joint pain (arthrosis)
• Tendon inflammation
• Decrease in hemoglobin (a blood protein)
• Drowsiness.

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

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

Frequency not known (cannot be estimated from available data):

• Intestinal angioedema: swelling in the intestine has been reported, with symptoms such as abdominal pain, nausea, vomiting, and diarrhea after using similar products.

• The event may have been a casual finding or related to a currently unknown mechanism.

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

Possible Adverse Effects of Hydrochlorothiazide Alone:

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

Common adverse effects (may affect up to 1 in 10 people):

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

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

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

Very rare adverse 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 breathing difficulties (symptoms include severe breathing difficulties, fever, weakness, and confusion).

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

• Salivary gland inflammation
• Decrease in the number (or even absence) of cells in the blood, including low red and white blood cell counts,
• Severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions),
• Decrease or loss of appetite,
• Restlessness, dizziness,
• Blurred or yellowish vision, decreased vision, and eye pain (possible signs of fluid accumulation in the vascular layer of the eye [choroidal effusion] or acute angle-closure glaucoma),
• Vasculitis (inflammation of blood vessels), pancreatitis, stomach upset,
• Yellowing of the skin or eyes (jaundice),
• Pseudolupus syndrome (a condition that mimics a disease called systemic lupus erythematosus in which the body's immune system attacks 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,
• Kidney inflammation or alteration of its function,
• Glucose in the urine (glucosuria),
• Fever,
• Alteration of electrolyte balance,
• High cholesterol levels in the blood,
• Decrease in blood volume,
• Increased glucose levels in the blood, difficulty controlling glucose levels in the blood/urine in patients with a diagnosis of diabetes mellitus, or fat in the blood.

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

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 that is 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 adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Telmisartan/Hydrochlorothiazide Viso Farmacéutica

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

Do not use this medicine after the expiration date stated on the carton after EXP. The expiration date is the last day of the month indicated.

You should store your medicine in the original package to protect the tablets from moisture.

Do not use this medicine if you notice that the tablets are discolored.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Telmisartan/Hydrochlorothiazide Viso Farmacéutica

The active ingredients are telmisartan and hydrochlorothiazide.

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

The other ingredients are crospovidone (type A), hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, povidone, colloidal anhydrous silica, sodium hydroxide, sodium stearyl fumarate, and talc, iron oxide red (E 172).

Appearance of the Product and Package Contents

Telmisartan/Hydrochlorothiazide Viso Farmacéutica 80 mg/12.5 mg tablets are biconvex, two-layer, uncoated tablets in a capsule shape, where the hydrochlorothiazide layer is white or almost white with the inscription "424", and the telmisartan layer is speckled orange to reddish-brown, without inscription. The hydrochlorothiazide layer may contain reddish-brown spots.

Telmisartan/Hydrochlorothiazide Viso Farmacéutica tablets are available in blister packs of 14, 28, 30, 56, 90, or 98 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoke Myto

Czech Republic

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicine is authorized in the EEA member states under the following names:

Date of the Last Revision of this Leaflet:March 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/