TELMISARTAN/HYDROCHLOROTHIAZIDE RATIOGEN 80 mg/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan/Hydrochlorothiazide Ratiogen 80 mg/12.5 mg Film-Coated Tablets

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 Package Leaflet

1. What is Telmisartan/Hydrochlorothiazide Ratiogen and what is it used for
2. What you need to know before you take Telmisartan/Hydrochlorothiazide Ratiogen
3. How to take Telmisartan/Hydrochlorothiazide Ratiogen
4. Possible side effects
5. Storage of Telmisartan/Hydrochlorothiazide Ratiogen
6. Package Contents and Further Information

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

Telmisartan/Hydrochlorothiazide Ratiogen 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 excretion of urine, producing a decrease in 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, or kidney failure, stroke, or blindness. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to periodically check your blood pressure to ensure it is within the normal range.

Telmisartan/Hydrochlorothiazide Ratiogen is usedfor the treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by telmisartan alone.

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

Do not take Telmisartan/Hydrochlorothiazide Ratiogen:

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

Warnings and Precautions

Consult your doctor before starting to take Telmisartan/Hydrochlorothiazide Ratiogen 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 a deficiency of salts due to treatment with diuretics, low-sodium diet, diarrhea, vomiting, or hemodialysis.
• 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 levels of aldosterone (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 its own body
• The active substance 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 an increase in pressure in your eye and may appear between hours and weeks after taking Telmisartan/Hydrochlorothiazide Ratiogen. 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 and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Telmisartan/Hydrochlorothiazide Ratiogen.

Inform your doctor before starting to take Telmisartan/Hydrochlorothiazide Ratiogen:

• 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 electrolyte levels in your blood (e.g., potassium) at regular intervals. See also the information under the heading "Do not take Telmisartan/Hydrochlorothiazide Ratiogen".

• 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 Ratiogen, seek medical attention immediately.

Inform 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.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. The use of Telmisartan/Hydrochlorothiazide Ratiogen is not recommended during pregnancy and should not 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, somnolence, 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 Ratiogen.

Telmisartan/Hydrochlorothiazide Ratiogen may be less effective in reducing blood pressure in black patients.

Children and Adolescents

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

Use in Athletes

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

Other Medicines and Telmisartan/Hydrochlorothiazide Ratiogen

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 those other medicines or take other precautions. In some cases, it may be necessary to stop using one of these medicines, especially if you are using any of the following medicines with Telmisartan/Hydrochlorothiazide Ratiogen:

• 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), penicillin G sodium (an antibiotic), and acetylsalicylic acid and derivatives.
• Medicines that may 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 heparin sodium (an anticoagulant).
• Medicines that 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 certain antibiotics (e.g., sparfloxacin, pentamidine) or certain 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, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines for treating 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 Ratiogen" and "Warnings and Precautions".
• Digoxin.

Telmisartan/Hydrochlorothiazide Ratiogen may increase the ability of other medicines to lower blood pressure or of 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 using Telmisartan/Hydrochlorothiazide Ratiogen.

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

Taking Telmisartan/Hydrochlorothiazide Ratiogen with Food and Alcohol

You can take this medicine 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 Breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Telmisartan/Hydrochlorothiazide Ratiogen 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. The use of Telmisartan/Hydrochlorothiazide Ratiogen is not recommended during pregnancy and should not be administered after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

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

Driving and Using Machines

Some patients feel dizzy or tired when taking Telmisartan/Hydrochlorothiazide Ratiogen. If you feel dizzy or tired, do not drive or use machines.

Telmisartan/Hydrochlorothiazide Ratiogen Contains Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to Take Telmisartan/Hydrochlorothiazide Ratiogen

Follow exactly the instructions of administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose 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 Ratiogen 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, somnolence, and muscle cramps and/or irregular heartbeat associated with concomitant use of medicines like digitalis or certain antiarrhythmic treatments. Contact your doctor or pharmacist or the nearest hospital emergency department immediately.

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

If You Forget to Take Telmisartan/Hydrochlorothiazide Ratiogen

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 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, 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* (frequently 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), 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) 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 with telmisartan alone has been observed; however, it cannot be ruled out for Telmisartan/Hydrochlorothiazide ratiogen.

Possible Adverse Effects of Telmisartan/Hydrochlorothiazide ratiogen:

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 (vomiting), stomach inflammation (gastritis), alteration in liver function (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, muscle cramps, pseudoinfluenza syndrome, pain, low sodium levels, increased levels of creatinine, liver enzymes, or creatine phosphokinase in the blood.

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

Acute respiratory distress (symptoms include severe shortness of breath, fever, weakness, and confusion).

Adverse reactions reported for one of the individual components may be potential adverse reactions of Telmisartan/Hydrochlorothiazide ratiogen, 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), cough, alteration in kidney function 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, drug rash), low blood sugar levels (in diabetic patients), drowsiness, stomach upset, eczema (a skin disorder), arthrosis, tendon inflammation, 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 (cannot be estimated from available data):

Intestinal angioedema: inflammation 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 intake of telmisartan. However, it is unknown whether telmisartan was the cause.

Hydrochlorothiazide

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

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

Nausea, low magnesium levels in the blood.

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

Decrease in platelet count in the blood, which increases the risk of bleeding and hematoma formation (small purple-red marks on the skin or other tissues caused by bleeding), high calcium levels in the blood, headache.

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

Increased pH (alteration of acid-base balance) due to low chloride levels in the blood.

Frequency not known (cannot be estimated from available data)

Inflammation of the salivary gland, skin and lip cancer (non-melanoma skin cancer), decrease in the number (or even absence) of blood cells, including low red and white blood cell count, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or lost 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 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, skin rash, redness of the skin, blistering of the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or altered function, glucose in the urine (glucosuria), fever, alteration of electrolyte balance, high cholesterol levels in the blood, decreased blood volume, increased glucose levels in the blood, difficulty controlling blood sugar levels in patients with a diagnosis of diabetes mellitus, or fat in the blood.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet.

You can also report them directly 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/Hydrochlorothiazide ratiogen

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

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

For Al/Al blisters

This medicine does not require special storage conditions.

For Al/PVC/PVDC blisters

Do not store above 30°C.

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 your usual pharmacy. 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/Hydrochlorothiazide ratiogen

The active ingredients are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.

The other ingredients are magnesium stearate, meglumine, microcrystalline cellulose, povidone, potassium hydroxide, sodium carboxymethyl starch (type A), and mannitol (E421).

Appearance of the Product and Package Contents

Telmisartan/Hydrochlorothiazide ratiogen 80 mg/12.5 mg tablets are capsule-shaped, 9.0 x 17.0 mm with TH 12.5 engraved on both sides.

Package sizes

Blister: 28 tablets

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid

Spain

Manufacturer

Actavis Ltd.

BLB016

Bulebel Industrial Estate

Zejtun ZTN 3000 Malta

Date of the Last Revision 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/