Telmisartan/hydrochlorothiazide Viso Farmacéutica 40 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Telmisartan/Hydrochlorothiazide Viso Farmacéutica 40 mg/12.5 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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 side effects
5. How to store Telmisartan/Hydrochlorothiazide Viso Farmacéutica
6. Contents of the pack and other information

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

Telmisartan/Hydrochlorothiazide Viso Farmacéutica is a combination of two active substances, telmisartan and hydrochlorothiazide, in a single tablet. Both substances help 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, thereby increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, allowing blood vessels to relax and blood pressure to decrease.

• Hydrochlorothiazide 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, potentially leading in some cases to heart attacks, heart or kidney failure, stroke, or blindness. High blood pressure usually does not produce symptoms before such damage occurs, so it is important to measure it regularly to ensure it remains within the normal range.

Telmisartan/Hydrochlorothiazide Viso Farmacéutica is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled with telmisartan alone.

2. What you need to know before taking Telmisartan/Hydrochlorothiazide Viso Farmacéutica

Do not take Telmisartan/Hydrochlorothiazide Viso Farmacéutica:

• if you are allergic to telmisartan or to 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 finds 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-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 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 low salt levels due to treatment with diuretics, a 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 levels of aldosterone (fluid 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 ingredient 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, which may occur from hours to weeks after taking Telmisartan/Hydrochlorothiazide Viso Farmacéutica. If untreated, this may lead to permanent vision damage.

Consult your doctor before taking Telmisartan/Hydrochlorothiazide Viso Farmacéutica:

• if you are taking any of the following medicines used to treat 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 Telmisartan/Hydrochlorothiazide 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 developing 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 Telmisartan/Hydrochlorothiazide Viso Farmacéutica, seek medical attention immediately.

If you suspect you are (or might become) pregnant, inform your doctor. Telmisartan/Hydrochlorothiazide is not recommended during early pregnancy and must not be taken 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 heart rate (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 or anesthesia, you must inform your doctor that you are taking this medicine.

These tablets may be less effective in lowering 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 medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Telmisartan/Hydrochlorothiazide 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 Telmisartan/Hydrochlorothiazide:

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

• Medicines associated with low blood potassium levels (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.

• 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 heart medicines (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 (insulin or oral agents such as metformin).

• Cholestyramine and colestipol, medicines used 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 various disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia), 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]), cancer treatments, gout, or arthritis.

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

• Digoxin.

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

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

Taking Telmisartan/Hydrochlorothiazide Viso Farmacéutica with food and alcohol

You may take Telmisartan/Hydrochlorothiazide 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 usually advise you to stop taking this medicine before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative medicine. 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 feel dizzy or tired when taking Telmisartan/Hydrochlorothiazide. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan/Hydrochlorothiazide 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 as 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 potassium levels in the blood may also occur, which could lead to nausea, drowsiness, muscle cramps, and/or irregular heartbeats, 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, indicating the medication 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 day, simply take your usual dose the following day. Do not take a double dose to make up for missed 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 should see your doctor immediately:

Sepsis* (commonly called "blood infection") is 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, and 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 blood potassium levels
• Anxiety, fainting (syncope)
• Tingling or pins-and-needles sensation (paresthesia)
• Dizziness (vertigo)
• Rapid heartbeat (tachycardia)
• Heart rhythm disturbances
• 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 blood uric acid levels

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 its own tissues, causing joint pain, skin rashes, and fever)
• Sore throat, sinus inflammation
• Feeling of sadness (depression)
• Difficulty falling asleep (insomnia)
• Vision disturbances
• Difficulty breathing
• Abdominal pain, constipation, abdominal bloating (dyspepsia), general discomfort (vomiting)
• Stomach inflammation (gastritis)
• Liver function abnormalities (Japanese patients show a higher tendency to experience this adverse effect)
• 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 used 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)
• Kidney function disturbances 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: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported with similar products.

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

** 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 blood magnesium levels

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 caused by bleeding)
• High blood calcium levels
• Headache

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

• Increase in pH (disturbance of acid-base balance) due to low blood chloride levels
• 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], or 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 skin blood vessel inflammation, increased sensitivity to sunlight, skin rash, skin redness, blistering of the lips, eyes or mouth, skin peeling
• Fever (possible signs of erythema multiforme)
• Weakness
• Kidney inflammation or impaired kidney function
• Glucose in urine (glucosuria)
• Fever
• Electrolyte imbalance
• High blood cholesterol levels
• Decreased blood volume
• Increased blood glucose levels, difficulty controlling blood/urine glucose levels in patients diagnosed with diabetes mellitus, or fat in the blood

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 pack after EXP. The expiry date refers to the last day of the month indicated.

Store your medicine in the original packaging 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. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines 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 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.

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

Appearance of the product and contents of the pack

Telmisartan/Hydrochlorothiazide Viso Farmacéutica 40 mg/12.5 mg tablets are biconvex, two-layer, uncoated capsule-shaped tablets, in which the hydrochlorothiazide layer is white to almost white, imprinted with "423", and the telmisartan layer is speckled orange to reddish brown, without 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 some 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 from 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 EEA Member States under the following names:

Date of the most recent review 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/