Telmisartan/hydrochlorothiazide Viso Farmacéutica 80 mg/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Telmisartan/Hydrochlorothiazide Viso Farmacéutica 80 mg/25 mg 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it 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 Telmisartan/Hydrochlorothiazide Viso Farmacéutica is and what it is used for
2. What you need to know before taking Telmisartan/Hydrochlorothiazide Viso Farmacéutica
3. How to take Telmisartan/Hydrochlorothiazide Viso Farmacéutica
4. Possible adverse effects
5. How to store Telmisartan/Hydrochlorothiazide Viso Farmacéutica
6. Contents of the pack and other information

1. What Telmisartán/Hidroclorotiazida Viso Farmacéutica is and what it is used for

Telmisartán/Hidroclorotiazida Viso Farmacéutica is a combination of two active substances, telmisartán and hidroclorotiazida, in a single tablet. Both substances help control high blood pressure.

• Telmisartán 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, thereby increasing your blood pressure. Telmisartán blocks the effect of angiotensin II, allowing blood vessels to relax and reducing blood pressure.

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

If left untreated, high blood pressure can damage blood vessels in various organs and may lead, in some cases, to heart attacks, heart or kidney failure, stroke, or blindness. High blood pressure generally does not cause symptoms until damage has occurred, so it is important to measure it regularly to ensure it remains within the normal range.

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

2. What you need to know before taking Telmisartán/Hidroclorotiazida Viso Farmacéutica

Do not take Telmisartán/Hidroclorotiazida Viso Farmacéutica:

• if you are allergic to telmisartan or any of the other components of this medicine (listed in section 6).
• if you are allergic to hydrochlorothiazide or to any sulfonamide-derived medicines.
• if you are more than 3 months pregnant. (It is also important to avoid this medicine in early 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 blood potassium levels or high blood calcium levels that do not improve with treatment.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above apply 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 conditions or diseases:

• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic treatment, low-salt diet, diarrhoea, vomiting, or haemodialysis.
• 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 levels of aldosterone (water and salt retention in the body along with imbalance of several blood minerals).
• Systemic lupus erythematosus (also known as "lupus" or "SLE"), a disease in which the body's immune system attacks the body itself.
• The active substance hydrochlorothiazide may cause a rare reaction leading to vision loss and eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and may appear between hours and weeks after taking Telmisartán/Hidroclorotiazida Viso Farmacéutica. If left untreated, this may lead to permanent vision damage.

Consult your doctor before taking Telmisartán/Hidroclorotiazida Viso Farmacéutica:

• if you are taking any of the following medicines for high blood pressure:

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

• aliskiren

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 Telmisartán/Hidroclorotiazida Viso Farmacéutica”.

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

If you suspect you are (or might become) pregnant, inform your doctor. Telmisartán/Hidroclorotiazida is not recommended in early pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby when used from that stage onward (see the pregnancy section).

Treatment with hydrochlorothiazide may cause an electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and abnormally rapid heartbeat (more than 100 beats per minute). If you experience any of these effects, you must inform your doctor.

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

If you are scheduled for surgery (operation) or anaesthesia, you must inform your doctor that you are taking this medicine.

These tablets may be less effective in lowering blood pressure in patients of Black race.

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

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Telmisartán/Hidroclorotiazida Viso Farmacéutica:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may need to adjust the dose of these medicines or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially important for the following medicines when taken together with Telmisartán/Hidroclorotiazida:

• Medicines containing lithium used to treat certain types of depression.

• Medicines associated with low blood potassium levels (hypokalaemia), 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.

• Medicines that may increase blood potassium levels, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicines such as sodium heparin (an anticoagulant).

• Medicines affected by changes in blood potassium levels, such as medicines for the heart (e.g., digoxin) or medicines to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines to treat allergic reactions (e.g., terfenadine).

• Medicines for the treatment of diabetes (insulins or oral agents such as metformin).

• Cholestyramine and colestipol, medicines to lower blood fat levels.

• Medicines to increase blood pressure, such as noradrenaline.

• Muscle relaxants, such as tubocurarine – Calcium and/or vitamin D supplements.

• Anticholinergic medicines (used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anaesthesia), such as atropine and biperiden.

• Amantadine (used to treat Parkinson's disease and also used to treat and prevent certain viral diseases).

• Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines for cancer, gout, or arthritis.

• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also the information under the headings “Do not take Telmisartán/Hidroclorotiazida Viso Farmacéutica” and “Warnings and precautions”).

• Digoxin.

Telmisartán/Hidroclorotiazida may enhance the blood pressure-lowering effect of other medicines or medicines that may potentially lower blood pressure (e.g., baclofen, amifostine). In addition, the reduction in blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. Inform your doctor, as dose adjustments of your other medicines may be needed while using Telmisartán/Hidroclorotiazida Viso Farmacéutica.

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

Taking Telmisartán/Hidroclorotiazida Viso Farmacéutica with food and alcohol

You may take Telmisartán/Hidroclorotiazida Viso Farmacéutica with or without food.

Avoid alcohol until you have spoken with your doctor. Alcohol may further lower your blood pressure and/or increase the risk of dizziness or weakness.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you suspect you are (or might become) pregnant. Your doctor will generally advise you to stop taking this medicine before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative treatment. These tablets are not recommended during pregnancy, and must 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.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as these tablets are not recommended during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed.

Driving and using machines

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

Telmisartán/Hidroclorotiazida Viso Farmacéutica contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Telmisartan/Hydrochlorothiazide Viso Farmacéutica

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily.

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

You may take the tablets with or without food. Swallow them with water or another non-alcoholic drink.

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

If your liver is not functioning properly, the normal dose should not exceed 40 mg/12.5 mg once daily.

If you take more Telmisartan/Hydrochlorothiazide Viso Farmacéutica than you should

If you have accidentally taken too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney function including kidney failure have also been reported. Due to the hydrochlorothiazide component, markedly low blood pressure and low blood potassium levels may also occur, which can lead to nausea, drowsiness, muscle cramps, and/or irregular heartbeat, particularly when used concomitantly with medications such as digitalis or certain antiarrhythmic treatments.

Contact your doctor or pharmacist immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the package and the leaflet to the healthcare professional.

If you forget to take Telmisartan/Hydrochlorothiazide 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 your usual time. If you miss a tablet one day, take your usual dose the next day. Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, 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 adverse effects may be serious and require immediate medical attention:

If you experience any of the following symptoms, you must see your doctor immediately:

Sepsis* (commonly called “blood infection”)—a serious infection involving a systemic inflammatory response, rapid swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer layer of 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. Patients must stop taking the medicine and see their doctor immediately.

If these adverse effects are not treated, they may be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be ruled out for Telmisartan/Hydrochlorothiazide Viso Farmacéutica.

Possible adverse effects of Telmisartan/Hydrochlorothiazide Viso Farmacéutica:

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

• Dizziness

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

• Decreased potassium levels in blood
• Anxiety, fainting (syncope)
• Tingling or pins-and-needles sensation (paresthesia)
• Dizziness (vertigo)
• Rapid heartbeat (tachycardia)
• Irregular heart rhythm
• Low blood pressure or sudden drop in blood pressure upon 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 levels of uric acid in blood

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

• Inflammation of the lungs (bronchitis)
• Activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks its own tissues, causing joint pain, skin rashes, and fever)
• Sore throat, sinus inflammation
• Feeling of sadness (depression)
• Difficulty sleeping (insomnia)
• Vision disturbances
• Difficulty breathing
• Abdominal pain, constipation, abdominal bloating (dyspepsia), general discomfort (vomiting)
• Inflammation of the stomach (gastritis)
• Impaired liver function (this adverse effect is more commonly reported in Japanese patients)
• Skin redness (erythema)
• Allergic reactions such as itching or rash
• Increased sweating
• Hives (urticaria)
• Joint pain (arthralgia) and limb pain
• Muscle cramps
• Flu-like illness
• Pain
• Low sodium levels
• Increased levels of creatinine, liver enzymes, or creatine phosphokinase in blood

Adverse reactions reported with each active ingredient separately may also occur with Telmisartan/Hydrochlorothiazide Viso Farmacéutica, even if 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, sinus inflammation, common cold)
• Urinary tract infections
• Deficiency of red blood cells (anemia), high potassium levels
• Slow heart rate (bradycardia)
• Impaired kidney function including acute renal failure
• Weakness
• Cough

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

• Low platelet count (thrombocytopenia), increase in 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)
• Tendon inflammation
• Decreased 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 of the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported with similar products.

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

** Cases of progressive fibrosis of lung tissue have been reported during treatment with telmisartan. 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:

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

• Malaise (nausea)
• Low magnesium levels in blood

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

• Decreased platelet count in blood, increasing the risk of bleeding and bruising (small purple-red spots on the skin or other tissues due to bleeding)
• High calcium levels in blood
• Headache

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

• Increased pH (acid-base imbalance) due to low chloride levels in blood
• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion)

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

• Inflammation of the salivary gland
• Decreased number (or even absence) of blood cells, including low counts of red and white blood cells
• Severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions)
• Decreased 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], acute myopia, or acute angle-closure glaucoma)
• Inflammation of blood vessels (necrotizing vasculitis), pancreatitis, stomach discomfort
• Yellowing of the skin or eyes (jaundice)
• Pseudolupus syndrome (a condition mimicking systemic lupus erythematosus, in which the body's immune system attacks its own tissues)
• Skin disorders such as inflammation of skin blood vessels, increased sensitivity to sunlight, skin rash, skin redness, blistering of lips, eyes, or mouth, skin peeling
• Fever (possible signs of erythema multiforme)
• Weakness
• Inflammation of the kidney or impaired kidney function
• Glucose in urine (glucosuria)
• Fever
• Electrolyte imbalance
• High cholesterol levels in blood
• Decreased blood volume
• Increased blood glucose levels, difficulty controlling blood/urine glucose levels in patients diagnosed with diabetes mellitus, or increased blood lipids

Skin or lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store this medicine in its original container to protect the tablets from moisture.

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

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

6. Contents of the Pack and Other Information

Composition of Telmisartan/Hydrochlorothiazide Viso Farmacéutica

The active substances 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, manitol, meglumine, povidone, colloidal anhydrous silica, sodium hydroxide, stearoyl fumaric acid sodium, talc, iron oxide red (E 172), iron oxide yellow (E 172).

Appearance of the Product and Contents of the Pack

Telmisartan/Hydrochlorothiazide Viso Farmacéutica 80 mg/25 mg tablets are biconvex, two-layer, uncoated capsule-shaped tablets, in which the hydrochlorothiazide layer is light yellow with the imprint “425”, and the telmisartan layer is mottled orange to reddish-brown, without any imprint. The hydrochlorothiazide layer may contain reddish-brown specks.

Telmisartan/Hydrochlorothiazide Viso Farmacéutica tablets are available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets. Only certain 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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicinal product is authorized in the EEA Member States under the following names:

Date of last review of this leaflet: March 2025

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