TELMISARTAN/HYDROCHLOROTHIAZIDE NORMON 40 mg/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan/Hydrochlorothiazide Normon 40 mg/12.5 mgtablets EFG

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

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

Contents of the pack

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

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

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

• Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, causing the blood vessels to relax and your blood pressure to decrease.
• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase the amount of urine produced, leading to a decrease in your blood pressure.

High blood pressure, if left untreated, can damage the blood vessels of various organs, which can sometimes lead to a heart attack, heart failure, kidney failure, stroke, or blindness. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly check your blood pressure to ensure it is within the normal range.

Telmisartan/Hydrochlorothiazide Normon is usedforthe treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled with telmisartan alone.

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

Do not take Telmisartan/Hydrochlorothiazide 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 other sulfonamide-derived medicines.
• If you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medicine during the first trimester of pregnancy - see section Pregnancy).
• If you have severe liver problems, such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease.
• If you have severe kidney disease or anuria (less than 100 ml of urine per day).
• If your doctor determines that you have low potassium 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 blood pressure-lowering medicine containing aliskiren.

If any of the above applies to you, inform your doctor or pharmacist before taking Telmisartan/Hydrochlorothiazide Normon.

Warnings and precautions

Consult your doctor before starting to take Telmisartan/Hydrochlorothiazide 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 an electrolyte deficiency due to treatment with diuretics, 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.
• High aldosterone levels (water and salt retention in the body along with an imbalance of various minerals in the blood).
• Systemic lupus erythematosus (also called "lupus" or "SLE"), a disease in which the body's immune system attacks the body itself.
• The active ingredient hydrochlorothiazide may cause a rare reaction, leading to decreased vision and eye pain. These symptoms can be indicative of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and may appear within hours to weeks after taking Telmisartan/Hydrochlorothiazide Normon. If left untreated, it can 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 skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Telmisartan/Hydrochlorothiazide Normon.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartan/Hydrochlorothiazide Normon. Your doctor will decide whether to continue treatment.

Do not stop taking Telmisartan/Hydrochlorothiazide Normon on your own.

Consult your doctor before starting to take Telmisartan/Hydrochlorothiazide 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 need to check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also the information under the heading "Do not take Telmisartan/Hydrochlorothiazide Normon".

• If you are taking digoxin.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Telmisartan/Hydrochlorothiazide Normon, seek medical attention immediately.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. The use of Telmisartan/Hydrochlorothiazide Normon is not recommended during the first trimester of pregnancy (first 3 months) and should not be taken after the third month of pregnancy as it may cause serious harm to your baby (see section Pregnancy).

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 an abnormally rapid 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, blistering) that appear more quickly than usual.

If you are going to undergo surgery or anesthesia, inform your doctor that you are taking Telmisartan/Hydrochlorothiazide Normon.

Telmisartan/Hydrochlorothiazide Normon may be less effective in lowering blood pressure in black patients.Children and adolescents

The use of Telmisartan/Hydrochlorothiazide Normon is not recommended in children and adolescents up to 18 years of age.

Taking Telmisartan/Hydrochlorothiazide Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases, it may be necessary to stop taking one of these medicines, especially if you are taking any of the following medicines with Telmisartan/Hydrochlorothiazide Normon:

• Medicines containing lithium for the treatment of certain types of depression.
• Medicines associated with low potassium levels in the blood (hypokalemia), such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), adrenocorticotropic hormone (ACTH), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), and acetylsalicylic acid and derivatives.
• Iodinated contrast product used in the context of an imaging examination.
• Medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporine (an immunosuppressive medicine), and other medicines like sodium heparin (an anticoagulant).
• Medicines whose effects are affected by changes in potassium levels in the blood, such as heart medicines (e.g., digoxin) or medicines to control your heart rate (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines like some antibiotics (e.g., sparfloxacin, pentamidine) or some medicines for treating allergic reactions (e.g., terfenadine).
• Medicines for the treatment of diabetes (insulins or oral agents like metformin).
• Colestyramine and colestipol, medicines 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 (medicines used to treat a variety of disorders such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia) like 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, pain relievers (such as non-steroidal anti-inflammatory drugs (NSAIDs)), medicines for the treatment of cancer, gout, or arthritis.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Telmisartan/Hydrochlorothiazide Normon" and "Warnings and precautions").
• Digoxin.

Telmisartan/Hydrochlorothiazide Normon may increase the ability of other medicines to lower blood pressure or medicines that may potentially lower blood pressure (e.g., baclofen, amifostine).

Additionally, the decrease in blood pressure may be enhanced by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. You should inform your doctor about the need to adjust the dose of your other medicines while taking Telmisartan/Hydrochlorothiazide Normon.

The effect of Telmisartan/Hydrochlorothiazide Normon may be reduced when using non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin or ibuprofen).

Taking Telmisartan/Hydrochlorothiazide Normon with food and drink

You can take Telmisartan/Hydrochlorothiazide Normon with or without food.

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

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Generally, your doctor will advise you to stop taking Telmisartan/Hydrochlorothiazide Normon before you become pregnant or as soon as you find out you are pregnant, and recommend that you take another blood pressure-lowering medicine instead.

The use of Telmisartan/Hydrochlorothiazide Normon is not recommended during pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby when administered after this time.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding, as Telmisartan/Hydrochlorothiazide Normon is not recommended for use in women during breast-feeding. Your doctor may decide to give you a treatment that is more suitable if you want to breast-feed.

Driving and using machines

Some patients feel dizzy, faint, or experience spinning when taking Telmisartan/Hydrochlorothiazide Normon. If you experience any of these effects, do not drive or use machines.

Use in athletes

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

Telmisartan/Hydrochlorothiazide Normon contains sodium

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

Telmisartan/Hydrochlorothiazide Normon contains lactose

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

3. How to take Telmisartan/Hydrochlorothiazide Normon

Follow exactly the instructions of administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

If your liver is not working properly, the usual dose should not exceed 40 mg of telmisartan once a day.

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, you may also experience significantly 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 concomitant use of medicines like digitalis or certain antiarrhythmic treatments.

Contact your doctor, pharmacist, or the nearest hospital emergency department or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

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 continue as before. If you do not take your tablet one day, take your normal dose the next day. Do not takea double dose to make up for forgotten doses.

If you have any further questions on 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 all people suffer from them.

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

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

Sepsis* (often called "blood infection"), is a serious infection that involves an inflammatory reaction of the entire body, rapid swelling of the skin and mucous membranes (angioedema, including fatal outcome), blistering and peeling of the outer layer of the skin (toxic epidermal necrolysis); these adverse effects are rare (may affect up to 1 in 1,000 people) or very rare (toxic epidermal necrolysis; may 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 adverse effects are not treated, they can be fatal. An increase in the incidence of sepsis has been observed with telmisartan alone; however, it cannot be ruled out for Telmisartan/Hidroclorotiazida Normon.

Possible Adverse Effects of Telmisartan/Hidroclorotiazida Normon:

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

Dizziness.

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

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

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

Lung inflammation (bronchitis), sore throat, inflammation of the paranasal sinuses, increased uric acid levels, low sodium levels, feeling of sadness (depression), difficulty falling asleep (insomnia), sleep disorder, vision disturbance, blurred vision, breathing difficulties, abdominal pain, constipation, abdominal distension (dyspepsia), general malaise (vomiting), stomach inflammation (gastritis), liver function disorder (Japanese patients show a greater tendency to experience this adverse effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia), and pain in the limbs (pain in the legs), 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), pseudogrippal illness, pain, increased levels of creatinine, liver enzymes, or creatine phosphokinase in the blood.

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

Telmisartan

The following additional adverse effects have been described 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, red blood cell deficiency (anemia), high potassium levels, slow heart rate (bradycardia), cough, kidney function disorder including acute kidney failure, weakness.

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

Low platelet count (thrombocytopenia), increased levels of certain white blood cells (eosinophilia), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), 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 in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported after the use of similar products.

• This may have been a casual finding or be related to a currently unknown mechanism.

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

Hidroclorotiazida

The following additional adverse effects have been described in patients taking hidroclorotiazida alone:

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

High levels of fats in the blood.

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

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

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

Acute kidney 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 calcium levels in the blood, high blood sugar levels, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), excess bile salts in the blood (cholestasis), photosensitivity reaction, uncontrolled blood sugar levels in patients with a diagnosis of diabetes mellitus, sugar in the 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 of white blood cells (leukopenia, agranulocytosis), severe allergic reactions (e.g., hypersensitivity), increased pH due to low chloride levels in the blood (acid-base imbalance, hypochloremic alkalosis), acute respiratory distress (signs include severe respiratory distress, 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), inflammation of blood vessels (necrotizing vasculitis).

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

Sialadenitis, skin and lip cancer (non-melanoma skin cancer), blood cell deficiency (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 blood vessels in the skin, 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 accompanied by symptoms related to the brain or nerves (nausea, progressive disorientation, lack of interest or energy) have been reported.

Reporting Adverse Effects

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

5. Storage of Telmisartan/Hidroclorotiazida Normon

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

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

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Telmisartan/Hidroclorotiazida Normon

The active ingredients are telmisartan and hidroclorotiazida.

Each tablet contains 40 mg of telmisartan and 12.5 mg of hidroclorotiazida.

The other ingredients are:

Mannitol (E-421)

Povidone

Crospovidone

Magnesium stearate

Meglumine

Sodium hydroxide (E-524)

Lactose monohydrate

Microcrystalline cellulose

Hypromellose

Sodium carboxymethyl starch type A (potato starch)

Yellow iron oxide (E-172)

Appearance and Packaging of the Product

Tablets.

Bilayer tablets, round, white and yellow in color.

Aluminum/aluminum blister pack.

Blister pack with 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 Last Revision of this Leaflet:February 2025

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