Telmisartan/hydrochlorothiazide Ratiogen 80 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Telmisartan/Hydrochlorothiazide ratiogen 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Telmisartán/Hidroclorotiazida ratiogen 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 blockers. 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 lowering your blood pressure.

• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase your urine output, resulting in a reduction of your blood pressure.

If left untreated, high blood pressure can damage the blood vessels of various organs, sometimes leading to heart attack, heart or kidney failure, stroke, or blindness. Often, there are no symptoms of high blood pressure 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 ratiogen is used for the 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 starting to take Telmisartan/Hydrochlorothiazide ratiopharm

Do not take Telmisartan/Hydrochlorothiazide ratiopharm if:

• 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 stages of your 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 any serious kidney disease or anuria (less than 100 ml of urine per day).

• if your doctor determines that you have low levels of potassium or high levels of calcium in the blood, which do not improve with treatment.

- if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medication containing aliskiren.

If any of the above applies to you, inform your doctor or pharmacist before taking Telmisartán/Hidroclorotiazida ratiogen.

Warnings and precautions

Consult your doctor before starting to take Telmisartán/Hidroclorotiazida ratiogen 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 salt deficiency due to treatment with diuretics, a low-sodium diet, diarrhea, 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
• Elevated levels of aldosterone (water and salt retention in the body along with imbalance of several blood minerals)
• Systemic lupus erythematosus (also known as "lupus" or "SLE"), a disease in which the body's immune system attacks the body itself
• The active ingredient hydrochlorothiazide may cause an uncommon 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 pressure in the eye and may appear from hours to weeks after taking Telmisartán/Hidroclorotiazida ratiogen. If left untreated, this may lead to permanent vision impairment.
• 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 exposure to sunlight and UV rays while taking Telmisartán/Hidroclorotiazida ratiogen.

Consult your doctor before starting to take Telmisartán/Hidroclorotiazida ratiogen:

• 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.
  • 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 Telmisartán/Hidroclorotiazida ratiogen".

• If you are taking digoxin.
• If you have previously experienced respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Telmisartán/Hidroclorotiazida ratiogen, seek medical attention immediately.

Consult 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 without medical advice.

If you are pregnant, suspect you might be pregnant, or plan to become pregnant, you must inform your doctor. Use of Telmisartán/Hidroclorotiazida ratiogen is not recommended during early pregnancy (first three months), and it must not be administered from the third month of pregnancy onward, as it may cause severe harm to your baby. See section "Pregnancy".

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 develop 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 ratiogen.

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

Children and adolescents

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

Use in athletes

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

Other medicines and Telmisartán/Hidroclorotiazida ratiogen

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 discontinue one of these medicines, especially if you are using any of the following together with Telmisartán/Hidroclorotiazida ratiogen:

• Medications containing lithium used to treat certain types of depression
• Medications associated with low blood potassium levels (hypokalemia), such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medication), carbenoxolone (used in the treatment of mouth ulcers), sodium penicillin G (an antibiotic), and acetylsalicylic acid and its derivatives.
• Iodinated contrast agents used during imaging procedures.
• Medications that may increase blood potassium levels, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medications such as sodium heparin (an anticoagulant).
• Medications affected by changes in blood potassium levels, such as heart medications (e.g., digoxin) or medications to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), medications used for mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medications such as certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medications used to treat allergic reactions (e.g., terfenadine).
• Medications for diabetes (insulin or oral agents such as metformin).
• Cholestyramine and colestipol, medications used to reduce blood fat levels.
• Medications to increase blood pressure, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Calcium and/or vitamin D supplements.
• Anticholinergic medications (used to treat various disorders such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia), such as atropine and biperiden.
• Amantadine (a medication used to treat Parkinson's disease and also to treat or prevent certain viral infections).
• Other medications 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 (ACEI) or aliskiren (see also the information under the headings "Do not take Telmisartán/Hidroclorotiazida ratiogen" and "Warnings and precautions").
• Digoxin.

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

Additionally, the reduction in blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness upon standing. Inform your doctor, as dose adjustments of your other medications may be necessary while using Telmisartán/Hidroclorotiazida ratiogen.

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

Taking Telmisartán/Hidroclorotiazida with food and alcohol

You may take this medicine with or without food.

Avoid alcohol until you have spoken with your doctor. Alcohol may further reduce your blood pressure and/or increase the risk of dizziness or weakness.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, suspect you might be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking Telmisartán/Hidroclorotiazida ratiogen before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medication. Use of Telmisartán/Hidroclorotiazida ratiogen is not recommended during pregnancy, and it must not be administered from the third month of pregnancy onward, as it may cause severe harm to your baby when used from that point.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding, as Telmisartán/Hidroclorotiazida ratiogen is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you intend to breastfeed.

Driving and use of machines

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

Telmisartán/Hidroclorotiazida ratiogen contains sodium

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

3. How to take Telmisartan/Hydrochlorothiazide ratiopharm

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily. Try to take one tablet each day at the same time. Telmisartan/hydrochlorothiazide can be taken 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 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 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, markedly low blood pressure and low blood potassium levels may also occur, which could 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 or pharmacist immediately or go to the nearest hospital emergency department.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Telmisartan/Hydrochlorothiazide ratiogen

If you forget to take your dose, do not worry. Take it as soon as you remember and continue as before. If you miss a 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 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 experiences them.

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

If you experience any of the following symptoms, you must see your doctor immediately:

Sepsis* (commonly called “blood infection”), a severe 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 Telmisartán/Hidroclorotiazida ratiogen.

Possible adverse effects of Telmisartán/Hidroclorotiazida ratiogen:

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

Dizziness.

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

Decreased blood potassium levels, anxiety, fainting (syncope), tingling sensation, pins and needles (paresthesia), dizziness (vertigo), rapid heartbeat (tachycardia), irregular heart rhythm, 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, and increased blood uric acid levels.

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

Lung inflammation (bronchitis), sore throat, sinusitis, elevated uric acid levels, low sodium levels, feeling of sadness (depression), difficulty sleeping (insomnia), sleep disorders, visual disturbances, blurred vision, difficulty breathing, abdominal pain, constipation, abdominal distension (dyspepsia), general malaise (vomiting), stomach inflammation (gastritis), liver function abnormalities (patients of Japanese origin 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 its own tissues, causing joint pain, skin rashes, and fever), flu-like illness, pain, increased levels of creatinine, liver enzymes, or creatine phosphokinase in the blood.

Adverse reactions reported for one of the individual components may also be potential adverse reactions of Telmisartán/Hidroclorotiazida ratiogen, even if not 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, 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), somnolence, stomach discomfort, eczema (a skin disorder), osteoarthritis, drug rash, toxic skin eruption, 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 (cannot be estimated from available data)

Intestinal angioedema: intestinal inflammation has been reported with similar products, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

• 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, glucose 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 the blood (acid-base imbalance, hypochloremic alkalosis), acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion), inflammation of the pancreas, pseudolupus syndrome (a disorder resembling systemic lupus erythematosus, in which the body's immune system attacks its own tissues), inflammation of blood vessels (necrotizing vasculitis).

Frequency not known (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 the skin blood vessels, 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 occur accompanied by brain- or nerve-related symptoms (nausea, progressive disorientation, lack of interest or energy).

Reporting of adverse effects

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

You can also report them directly 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. Conservation of Telmisartan/Hydrochlorothiazide ratiopharm

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

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

For Al/Al blisters

This medicine does not require any 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. Dispose of containers and unused medicines at the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan/Hydrochlorothiazide ratiogen

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

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

Appearance of the medicine and contents of the pack

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

Pack sizes

Blister pack: 28 tablets

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer

Actavis Ltd.

BLB016

Bulebel Industrial Estate

Zejtun ZTN 3000 Malta

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

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