Telmisartan/hydrochlorothiazide Normon 80 mg/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Telmisartan/Hydrochlorothiazide Normon 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, consult 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Telmisartán/Hidroclorotiazida Normon is a combination of two active substances, telmisartan and hydrochlorothiazide, in one tablet. Both active 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 your blood vessels to relax and thus reducing your blood pressure.
• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase your urine output, resulting in a decrease in blood pressure.

If left untreated, high blood pressure can damage the blood vessels of various organs and may eventually lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms before such damage occurs. Therefore, it is important to have your blood pressure checked regularly to ensure it remains within the normal range.

Telmisartán/Hidroclorotiazida Normon is used for the treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled with Telmisartán Normon 80 mg/12.5 mg, or in patients who have previously been stabilized on telmisartan and hydrochlorothiazide given separately.

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

Do not take Telmisartán/Hidroclorotiazida Normon

• 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 other sulfonamide-derived medicines.
• If you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during the early months of 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 serious liver disease.
• If you have severe kidney disease or anuria (less than 100 ml of urine per day).
• If your doctor finds 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, 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 disorders 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-sodium diet, diarrhoea, vomiting, or hemofiltration.
• 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 called “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 symptoms may indicate fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may appear from hours to weeks after taking Telmisartán/Hidroclorotiazida Normon. If untreated, this may lead to permanent vision loss.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip 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 medicines used to treat high blood pressure (hypertension):
  • 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 monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading “Do not take Telmisartán/Hidroclorotiazida Normon”.

• If you are taking digoxin.
• If you have previously experienced breathing 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 Normon, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Telmisartán/Hidroclorotiazida Normon. Your doctor will decide whether to continue treatment. Do not stop taking Telmisartán/Hidroclorotiazida Normon monotherapy without medical advice.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. Use of Telmisartán/Hidroclorotiazida Normon is not recommended during the first trimester of pregnancy (first 3 months), and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby (see Pregnancy section).

Treatment with hydrochlorothiazide may cause 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 symptoms, inform your doctor.

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

If you are scheduled for surgery or anesthesia, inform your doctor that you are taking Telmisartán/Hidroclorotiazida Normon.

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

Children and adolescents

The use of Telmisartán/Hidroclorotiazida Normon is not recommended in children and adolescents under 18 years of age.

Taking Telmisartán/Hidroclorotiazida Normon with other medicines

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 other medicines or take other precautions. In some cases, you may need to stop taking one of these medicines, especially if you are using any of the following together with Telmisartán/Hidroclorotiazida Normon:

• 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 (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), and acetylsalicylic acid and its derivatives.
• Iodinated contrast agents used during imaging procedures.
• 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 diabetes (insulins or oral agents such as metformin).
• Cholestyramine and colestipol, medicines used to reduce 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 spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid to anesthesia), such as atropine and biperiden.
• Amantadine (a medicine used to treat Parkinson’s disease and also to treat or 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 inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Telmisartán/Hidroclorotiazida Normon” and “Warnings and precautions”).
• Digoxin.

Telmisartán/Hidroclorotiazida Normon may enhance the blood pressure-lowering effect of other medicines or medicines that may potentially lower blood pressure (e.g. baclofen, amifostine).

Additionally, the blood pressure-lowering effect 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 taking Telmisartán/Hidroclorotiazida Normon.

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

Taking Telmisartán/Hidroclorotiazida Normon with food and alcohol

You may take Telmisartán/Hidroclorotiazida Normon 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 lactation

Pregnancy

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

Generally, your doctor will advise you to stop taking Telmisartán/Hidroclorotiazida Normon before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine.

Telmisartán/Hidroclorotiazida Normon is not recommended during pregnancy and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby when used from that time.

Lactation

Inform your doctor if you are breastfeeding or plan to breastfeed, as Telmisartán/Hidroclorotiazida Normon is not recommended for women during this period. Your doctor may choose a more suitable treatment if you wish to breastfeed.

Driving and using machines

Some patients may feel dizzy, faint, or experience vertigo (a sensation of spinning) when taking Telmisartán/Hidroclorotiazida Normon. If you experience any of these effects, do not drive or operate machinery.

Use in athletes

This medicine contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Telmisartán/Hidroclorotiazida Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

Telmisartán/Hidroclorotiazida Normon 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 Normon

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, please consult your doctor or pharmacist again.

The recommended dose of Telmisartan/Hydrochlorothiazide Normon is one tablet per day. Try to take one tablet every day at the same time. You may take Telmisartan/Hydrochlorothiazide Normon with or without food. The tablets should be swallowed whole with a little water or another non-alcoholic drink. It is important that you take Telmisartan/Hydrochlorothiazide Normon every day until your doctor tells you otherwise.

If your liver is not functioning properly, the usual dose should not exceed 40 mg of telmisartan once daily.

If you take more Telmisartan/Hydrochlorothiazide Normon than you should

If you accidentally take 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, pharmacist, or the nearest hospital emergency department immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Telmisartan/Hydrochlorothiazide Normon

If you forget to take your medicine, do not worry. Take the dose as soon as you remember, and then continue as before. If you miss a day, simply take your normal 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 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, including fatal outcomes), 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 very rare (toxic epidermal necrolysis; may affect up to 1 in 10,000 people), 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 Normon.

Possible adverse effects of Telmisartan/Hydrochlorothiazide Normon:

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

Decreased blood potassium levels, anxiety, fainting (syncope), tingling sensation, numbness (paresthesia), dizziness (vertigo), rapid heartbeat (tachycardia), heart rhythm disturbances, low blood pressure, sudden drop 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, increased blood uric acid levels, and dizziness.

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

Lung inflammation (bronchitis), sore throat, sinusitis, increased uric acid levels, low sodium levels, feeling of sadness (depression), difficulty sleeping (insomnia), sleep disturbances, vision disturbances, blurred vision, difficulty breathing, abdominal pain, constipation, abdominal distension (dyspepsia), general malaise (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), limb pain (leg 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 levels of creatinine, liver enzymes, or creatine phosphokinase in blood.

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

Telmisartan

The following additional adverse effects have been reported in patients taking telmisartan alone:

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

Upper respiratory tract infection (e.g. sore throat, sinusitis, common cold), urinary tract infections, bladder infection, deficiency of red blood cells (anemia), high potassium levels, slow heart rate (bradycardia), cough, kidney function impairment including acute renal failure, weakness, and dizziness.

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), low blood sugar levels (in diabetic patients), drowsiness, stomach discomfort, eczema (a skin disorder), drug rash, toxic skin rash, tendon pain (symptoms of pseudotendinitis), decreased hemoglobin (a blood protein).

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

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

Frequency not known

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

• This may have been a coincidental 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.

Hydrochlorothiazide

The following additional adverse effects have been reported in patients taking hydrochlorothiazide alone:

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

Elevated blood lipid levels.

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

Nausea, low blood magnesium levels, decreased appetite.

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

Acute renal failure.

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

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

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

Abnormal breakdown of red blood cells (hemolytic anemia), inability of the bone marrow to function properly, reduction in white blood cells (leukopenia, agranulocytosis), severe allergic reactions (e.g., hypersensitivity), increased pH due to low chloride levels in blood (acid-base imbalance, hypochloremic alkalosis), acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion), pancreatitis, pseudolupus syndrome (a disorder resembling systemic lupus erythematosus, in which the body's immune system attacks the body itself), inflammation of blood vessels (necrotizing vasculitis).

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

Inflammation of the salivary gland, skin and lip cancer (non-melanoma skin cancer), deficiency of blood cells (aplastic anemia), decreased vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), 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, kidney dysfunction.

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

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 not listed in this leaflet. You may also report them via the Spanish Pharmacovigilance System for Human Medicines: https:/www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan/Hydrochlorothiazide Normon

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 is the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan/Hydrochlorothiazide Normon

The active substances are telmisartan and hydrochlorothiazide.

Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.

The other components are:

Manitol (E-421)

Povidone

Crospovidone

Magnesium stearate

Meglumine

Sodium hydroxide (E-524)

Lactose monohydrate

Microcrystalline cellulose

Hypromellose

Sodium carboxymethylstarch type A (potato starch)

Yellow iron oxide (E-172)

Appearance of the product and contents of the pack

Tablets.

Bilayered, round tablets, white and yellow in colour.

Aluminium/aluminium blister pack.

Blister pack containing 28 tablets.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

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

Manufacturer

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara (SPAIN)

or

LABORATORIOS NORMON, S.A.

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

Date of the most recent review of this leaflet: April 2026

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