Leaflet: information for the user

Telmisartán/Hidroclorotiazida Normon 80 mg/12,5 mgfilm-coated tablets EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Telmisartán/Hidroclorotiazida Normon is an association of two active principles, telmisartán and hidroclorotiazida in a tablet. Both active principles help to 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, thereby 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, resulting in a decrease in blood pressure.

High blood pressure, if left untreated, can damage blood vessels in various organs, which in some cases can cause a heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Therefore, it is essential to monitor blood pressure periodically to ensure it is within the normal range.

Telmisartán/Hidroclorotiazida Normon is usedforthe treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not controlled sufficiently when using telmisartán alone.

Do not take Telmisartán/Hidroclorotiazida Normon

• If you are allergic to telmisartán or any of the other components of this medication (listed in section 6).
• If you are allergic to hidroclorotiazida or other sulfonamide-derived medications.
• If you are more than 3 months pregnant. (In any case, it is best to avoid taking this medication also at the beginning of your pregnancy - see 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 or anuria (less than 100 ml of urine per day).
• If your doctor determines that you have low potassium levels or high calcium levels in your blood that do not improve with treatment.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

If any of the above occurs, inform your doctor or pharmacist before taking Telmisartán/Hidroclorotiazida Normon.

Warnings and precautions

Consult your doctor before starting to take Telmisartán/Hidroclorotiazida Normon if you have or have 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 a deficiency of salts due to diuretic treatment, low-sodium diet, diarrhea, vomiting, or hemofiltration.
• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels of one or both kidneys).
• Liver disease.
• Heart problems.
• Diabetes.
• Gout.
• Elevated aldosterone levels (retention of water and salts in the body along with imbalance of various minerals in the blood).
• Lupus erythematosus (also called "lupus" or "LES"), a disease in which the body's immune system attacks the body itself.
• The active ingredient hidroclorotiazida may cause a rare reaction, leading to a decrease in vision and eye pain. These symptoms may be indicative of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eye and may appear between hours and weeks after taking Telmisartán/Hidroclorotiazida Normon. If left untreated, it may lead to permanent vision loss.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Telmisartán/Hidroclorotiazida Normon.

Consult your doctor before starting to take Telmisartán/Hidroclorotiazida Normon

• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• • An angiotensin-converting enzyme inhibitor (ACEI) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • Aliskirén.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood (e.g. potassium) at regular intervals. See also the information under the heading "Do not take Telmisartán/Hidroclorotiazida Normon".

• If you are taking digoxina.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Telmisartán/Hidroclorotiazida Normon, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartán/Hidroclorotiazida Normon. Your doctor will decide whether to continue treatment. Do not stop taking Telmisartán/Hidroclorotiazida Normon in monotherapy

If you are pregnant, if you suspect you may be, or if you plan to become pregnant, inform your doctor. Telmisartán/Hidroclorotiazida Normon is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy because it may cause severe damage to your baby (see Pregnancy section).

Treatment with hidroclorotiazida 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 an abnormally fast heart rate (more than 100 beats per minute). If you experience any of these symptoms, inform your doctor.

You should also inform your doctor if you experience increased skin sensitivity to the sun with symptoms of sunburn (such as redness, itching, swelling, and blistering) that appear more quickly than usual.

If you are to undergo surgery (surgery) or anesthesia, inform your doctor that you are taking Telmisartán/Hidroclorotiazida Normon.

Telmisartán/Hidroclorotiazida Normon may be less effective in reducing blood pressure in black patients.

Children and adolescents

Telmisartán/Hidroclorotiazida Normon is not recommended for use in children and adolescents up to 18 years of age.

Taking Telmisartán/Hidroclorotiazida Normon with other medications

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 those other medications or take other precautions. In some cases, you may need to discontinue use of one or more of these medications, especially if you are using them with Telmisartán/Hidroclorotiazida Normon:

• Medications containing lithium for the treatment of 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 (adrenocorticotropic hormone), amphotericin (antifungal medication), carbenoxolone (used in the treatment of mouth ulcers), penicillin G sodium (an antibiotic), and aspirin and derivatives.
• Contrast agent containing iodine used in the context of an imaging examination.
• Medications that may increase potassium levels in the blood such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporine (immunosuppressant), and other medications such as heparin sodium (anticoagulant).
• Medications affected by changes in potassium levels in the blood such as heart medications (e.g. digoxina) or medications to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medications used to treat mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine), and other medications such as certain antibiotics (e.g. ciprofloxacin, pentamidine) or medications to treat allergic reactions (e.g. terfenadine).
• Medications for the treatment of diabetes (insulins or oral agents such as metformin).
• Colestiramine and colestipol, medications to reduce cholesterol levels in the blood.
• Medications to increase blood pressure, such as noradrenaline.
• Relaxants, such as tubocurarina.
• Calcium and/or vitamin D supplements.
• Anticholinergic medications (medications used to treat a variety of conditions such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia) such as atropine and biperiden.
• Amantadina (medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses).
• Other medications used to treat high blood pressure, corticosteroids, analgesics (such as nonsteroidal anti-inflammatory drugs (NSAIDs)), medications for cancer treatment, gout, or arthritis.
• ACE inhibitors or aliskirén (see also the information under the headings "Do not take Telmisartán/Hidroclorotiazida Normon" and "Warnings and precautions").
• Digoxina.
  

Telmisartán/Hidroclorotiazida Normon 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 standing up. Inform your doctor about the need to adjust the dose of your other medications while taking Telmisartán/Hidroclorotiazida Normon.

The effect of Telmisartán/Hidroclorotiazida Normon may be reduced when using NSAIDs (nonsteroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen).

Taking Telmisartán/Hidroclorotiazida Normon with food and alcohol

You can take Telmisartán/Hidroclorotiazida Normon with or without food.

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

Pregnancy and lactation

Pregnancy

Inform your doctor if you are pregnant, if you suspect you may be, or if you plan to become pregnant.

Generally, your doctor will advise you to stop taking Telmisartán/Hidroclorotiazida Normon before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead.

Telmisartán/Hidroclorotiazida Normon is not recommended for use during pregnancy and should not be administered after the third month of pregnancy because it may cause severe damage to your baby when administered from that point on.

Lactation

Inform your doctor if you plan to initiate or are in the lactation period, as Telmisartán/Hidroclorotiazida Normon is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed.

Driving and operating machinery

Some patients may feel dizzy, faint, or feel like everything is spinning when taking Telmisartán/Hidroclorotiazida Normon. If you experience any of these effects, do not drive or operate machinery.

Use in athletes

This medication contains hidroclorotiazida, which may produce a positive result in doping control tests.

Telmisartán/Hidroclorotiazida Normon contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

Telmisartán/Hidroclorotiazida Normon contains lactose

If your doctor has indicated that you have a 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 of Telmisartán/Hidroclorotiazida Normon is one tablet per day. Try to take one tablet every day at the same time. You can take Telmisartán/Hidroclorotiazida Normon with or without food. The tablets should be swallowed whole with a little water or other non-alcoholic beverage. It is essential to take Telmisartán/Hidroclorotiazida Normon every day until your doctor tells you otherwise.

If your liver does not function correctly, the usual dose should not exceed 40 mg of telmisartán once a day.

If you take more Telmisartán Hidroclorotiazida Normon than 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, pharmacist, or the nearest hospital emergency service immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Telmisartán/Hidroclorotiazida Normon

If you forget to take the medication, do not worry. Take the dose as soon as you remember and continue as before. If you miss a dose, take your normal dose the next day.Do not take a double dose to compensate for the missed doses.

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

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

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

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

Sepsis* (also known as "blood infection"), is a serious infection that involves a systemic inflammatory reaction, rapid skin and mucous membrane swelling (angioedema, including fatal outcome), blistering and peeling of the skin's outer layer (toxic epidermal necrolysis); these side effects are rare (can affect up to 1 in 1,000 people) or very rare (toxic epidermal necrolysis; can affect up to 1 in 10,000 people) 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 Normon.

Possible side effects of Telmisartan/Hidroclorotiazida Normon:

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

Dizziness.

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

Decreased potassium levels in the blood, anxiety, fainting (syncope), tingling sensation, numbness (paresthesia), dizziness (vertigo), rapid heart rate (tachycardia), heart rhythm disturbances, low blood pressure, sudden decrease in blood pressure upon standing, shortness of breath (dyspnea), diarrhea, dry mouth, flatulence, back pain, muscle spasms, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, and increased uric acid levels in the blood.

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

Pneumonia (bronchitis), sore throat, sinusitis, increased uric acid levels, low sodium levels, feeling of sadness (depression), insomnia, sleep disorder, vision disturbances, blurred vision, difficulty breathing, abdominal pain, constipation, abdominal distension (dyspepsia), general discomfort (vomiting), stomach inflammation (gastritis), liver function impairment (Japanese patients are more prone to experiencing this side effect), skin redness (erythema), allergic reactions such as itching or rashes, increased sweating, hives (urticaria), joint pain (arthralgia), and limb pain, muscle cramps, activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks the body itself, causing joint pain, skin rashes, and fever), flu-like illness, pain, increased creatinine levels, liver enzymes, or creatine phosphokinase in the blood.

The adverse reactions reported for one of the individual components may be potential adverse reactions of Telmisartan/Hidroclorotiazida Normon, although they have not been observed in clinical trials with this product.

Telmisartan

Additionally, the following side effects have been described in patients taking telmisartan alone:

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

Upper respiratory tract infection (e.g., sore throat, sinusitis, common cold), urinary tract infections, urinary tract infection, anemia, high potassium levels, slow heart rate (bradycardia), cough, kidney function impairment including acute kidney failure, weakness.

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

Low platelet count (thrombocytopenia), increased certain white blood cells (eosinophilia), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), low blood sugar levels (in diabetic patients), drowsiness, stomach discomfort, eczema (a skin disorder), drug-induced rash, toxic skin eruption, tendon pain (pseudotendinitis symptoms), decreased hemoglobin (a blood protein).

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

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

Unknown frequency

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

* This may have been a chance finding or related to an unknown mechanism.

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

Hidroclorotiazida

Additionally, the following side effects have been described in patients taking hydrochlorothiazide alone:

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

High levels of fats in the blood.

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

Nausea, low magnesium levels in the blood, decreased appetite.

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

Acute kidney failure.

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

Low platelet count (thrombocytopenia), which increases the risk of bleeding and hematoma formation (small red-purple marks on the skin or other tissues caused by bleeding), high calcium levels in the blood, high blood sugar levels, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), bile buildup in the blood (cholestasis), photosensitivity reaction, uncontrolled blood glucose levels in patients with a diagnosis of diabetes mellitus, glucose in the urine (glucosuria).

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

Abnormal hemolysis of red blood cells (hemolytic anemia), bone marrow failure, leukopenia, agranulocytosis, severe allergic reactions (e.g., hypersensitivity), alkalosis due to low chloride levels in the blood (acid-base balance disturbance), acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion), pancreatitis, pseudolupus syndrome (a disorder that resembles a disease called systemic lupus erythematosus in which the body's immune system attacks the body itself), necrotizing vasculitis.

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

Salivary gland inflammation, skin cancer and lip cancer (non-melanoma skin cancer), aplastic anemia, decreased vision and eye pain (possible signs of fluid accumulation in the eye's vascular layer (choroidal hemorrhage) or acute angle-closure glaucoma), 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 dysfunction.

In isolated cases, low sodium levels are accompanied by symptoms related to the brain or nerves (nausea, progressive disorientation, lack of interest or energy).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them through the Spanish System for the Pharmacovigilance of Medicines for Human Use.https:/www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

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

This medication does not require any special temperature for conservation.

Store in the original packaging to protect it from moisture.

Medications should not be thrown down the drains or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Telmisartan/Hydrochlorothiazide Normon Composition

The active principles are telmisartan and hydrochlorothiazide.

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

The other components are:

Mannitol(E-421)

Povidone

Crospovidone

Magnesium stearate

Meglumine

Sodium hydroxide(E-524)

Monohydrate lactose

Microcrystalline cellulose

Hydroxypropyl methylcellulose

Sodium carboxymethylcellulose type A (potato starch)

Iron oxidered (E-172)

Product appearance and container content

Tablets.

Bilayered, round, white and pink tablets.

Aluminum/aluminum blister.

Blister with 28 tablets.

Marketing Authorization Holder

NORMON, S.A. Laboratories

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Responsible for manufacturing

LICONSA, S.A. Laboratories

Avda. Miralcampo 7, Industrial Park Miralcampo

19200 Azuqueca de Henares, Guadalajara (SPAIN)

or

NORMON, S.A. Laboratories

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet:February 2025

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