TELMISARTAN/HYDROCHLOROTHIAZIDE KERN PHARMA 80/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan/Hydrochlorothiazide Kern Pharma 80 mg/12.5 mg tablets 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 and other information

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

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

Telmisartan/Hydrochlorothiazide Kern Pharma 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 your body produces, leading to a decrease in your blood pressure.

High blood pressure, if left untreated, can damage blood vessels in 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 is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled when using telmisartan alone.

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

Do not take Telmisartan/Hydrochlorothiazide Kern Pharma

• 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 gallbladder) or any other severe liver disease
• if you have severe kidney disease
• 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 problems and are being treated with a blood pressure medicine that contains aliskiren.

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

Warnings and precautions

Consult your doctor if you have or have had any of the following disorders or diseases:

• Low blood pressure (hypotension), which can occur if you are dehydrated (excessive loss of body water) or have a deficiency of salts due to treatment with diuretics, a low-sodium diet, diarrhea, vomiting, or hemodialysis.
• Kidney disease or transplant.
• Renal artery stenosis (narrowing of the blood vessels in 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 known as "lupus" or "SLE"), a disease in which the body's immune system attacks itself.
• The active ingredient hydrochlorothiazide may cause a rare reaction, leading to decreased vision or eye pain. These symptoms can be indicative of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to a week after taking Telmisartan/Hydrochlorothiazide Kern Pharma. If left untreated, it can lead to permanent vision loss.
• 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 Kern Pharma.
• 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, seek medical attention immediately.

Consult your doctor before starting to take Telmisartan/Hydrochlorothiazide Kern Pharma

• if you are taking any of the following medicines used to treat high blood pressure
• • An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially 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 Kern Pharma)

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartan/Hydrochlorothiazide Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Telmisartan/Hydrochlorothiazide on your own.

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. It is not recommended to use Telmisartan/Hydrochlorothiazide during the first trimester of pregnancy (first 3 months) and in no case should it be administered 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, pain or muscle 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.

Children and adolescents

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

Taking Telmisartan/Hydrochlorothiazide Kern Pharma 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 modify your dose and/or take other precautions. In some cases, it may be necessary to interrupt the use of some of these medicines, especially if you are using any of the following medicines with Telmisartan/Hydrochlorothiazide:

• 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), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), and acetylsalicylic acid and derivatives.
• Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors that may increase potassium levels in the blood.
• Medicines for the heart (e.g., digoxin) or medicines used to control your heart rate (e.g., quinidine, disopyramide).
• Medicines used to treat mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine).
• Other medicines used to treat high blood pressure, steroids, painkillers, medicines for the treatment of cancer, gout, or arthritis, and vitamin D supplements.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Telmisartan/Hydrochlorothiazide Kern Pharma" and "Warnings and precautions").

Telmisartan/Hydrochlorothiazide may increase the effect of other medicines to lower blood pressure, and you should inform your doctor about the need to adjust the dose of your other medicines while taking Telmisartan/Hydrochlorothiazide.

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will usually advise you to stop taking Telmisartan/Hydrochlorothiazide before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take a different blood pressure medicine instead. It is not recommended to use Telmisartan/Hydrochlorothiazide during pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered after this time.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as it is not recommended to administer Telmisartan/Hydrochlorothiazide to women during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed.

Driving and using machines

Some patients may feel dizzy or tired when treating high blood pressure. If you feel dizzy or tired, do not drive or use machinery.

Use in athletes

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

3. How to take Telmisartan/Hydrochlorothiazide Kern Pharma

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

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

If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.

If you take more Telmisartan/Hydrochlorothiazide Kern Pharma than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Telmisartan/Hydrochlorothiazide Kern Pharma

If you forget to take the 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 take a double dose to make up for forgotten doses.

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

4. Possible Adverse Effects

Like all medicines, Telmisartan/Hydrochlorothiazide Kern Pharma 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* (frequently called "blood infection"), a severe infection that involves an inflammatory reaction of the entire body, rapid swelling of the skin and mucous membranes (angioedema); these adverse effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients must stop taking the medication and visit their doctor immediately. If these adverse effects are not treated, they can be fatal. An increase in the incidence of sepsis with telmisartan alone has been observed; however, it cannot be ruled out for Telmisartan/Hydrochlorothiazide.

Possible Adverse Effects of Telmisartan/Hydrochlorothiazide:

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 heartbeats (tachycardia), alterations in heart rhythm, low blood pressure, sudden decrease 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 levels of uric acid in the blood.

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

Inflammation of the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks the body itself, causing joint pain, skin rashes, and fever), sore throat, inflammation of the paranasal sinuses, feeling of sadness (depression), difficulty falling asleep (insomnia), vision disturbances, breathing difficulties, abdominal pain, constipation, abdominal distension (dyspepsia), general malaise, stomach inflammation (gastritis), alteration in liver function (Japanese patients show a greater tendency to experience this adverse effect), rapid swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia), and pain in the limbs, muscle cramps, pseudogrippal illness, pain, increased levels of uric acid, low sodium levels, 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/Hydrochlorothiazide, 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, red blood cell deficiency (anemia), high potassium levels, slow heart rate (bradycardia), alteration in kidney function including acute kidney failure, weakness, cough.

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

Sepsis* (frequently called "blood infection", a severe infection that involves an inflammatory reaction of the entire body and can cause death), 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 upset, eczema (a skin disorder), osteoarthritis, tendon inflammation, decrease in hemoglobin (a blood protein), somnolence.

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

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

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

Intestinal angioedema: inflammation in the intestine has been reported, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after using 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 telmisartan treatment. However, it is unknown whether telmisartan was the cause.

Hydrochlorothiazide

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

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

Acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

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

Inflammation of the salivary gland, decrease in blood cell count, including low red and white blood cell count, low platelet count (thrombocytopenia); severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decrease or loss of appetite; restlessness, dizziness, decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma], inflammation of blood vessels (necrotizing vasculitis), pancreatitis, stomach upset, yellowing of the skin or eyes (jaundice), pseudolupus syndrome (a condition that mimics a disease called systemic lupus erythematosus in which the body's immune system attacks the body itself), skin disorders such as inflammation of blood vessels in the skin, increased sensitivity to sunlight or blistering and peeling of the skin's surface layer (toxic epidermal necrolysis), weakness, kidney inflammation or altered function, glucose in the urine (glucosuria), fever, altered electrolyte balance, high cholesterol levels in the blood, decreased blood volume, increased sugar or fat levels in the blood, skin and lip cancer (non-melanoma skin cancer).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Telmisartan/Hydrochlorothiazide Kern Pharma

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions. You should keep your medicine in its original packaging to protect the tablets from moisture.

Medicines should not be disposed of through 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 way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Telmisartan/Hydrochlorothiazide

• The active ingredients are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are sodium hydroxide, mannitol (E-421), cornstarch, microcrystalline cellulose, calcium carmellose, povidone (K-25), silicon dioxide, sodium stearyl fumarate.

Appearance of the Product and Package Contents

White or almost white oblong tablets.

Telmisartan/Hydrochlorothiazide Kern Pharma is available in blister packs containing 28 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Delorbis Pharmaceuticals Ltd., 17, Athion Street, Ergates Industrial Area,

Cyprus

or

Iberfar – Indústria Farmacêutica, S.A.,

Rua Consiglieri Pedroso, nº 121-123 – Queduz de Baixo,

Barcarena, 2745-557,

Portugal

Date of the Last Revision of this Leaflet: February 2025

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