Telmisartan/amlodipine Krka 80 mg/10 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Telmisartan/Amlodipine Krka 80 mg/5 mg tablets

Telmisartan/Amlodipine Krka 80 mg/10 mg tablets

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 this leaflet

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

1. What Telmisartán/Amlodipino Krka is and what it is used for

Telmisartán/Amlodipino Krka tablets contain two active substances, telmisartan and amlodipine. 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 reducing your blood pressure.
• Amlodipine belongs to a group of medicines known as calcium antagonists. Amlodipine prevents calcium from entering the wall of your blood vessels, thereby preventing the blood vessels from constricting, which reduces blood pressure.

This means that both active substances work together to prevent your blood vessels from becoming stiff. As a result, the blood vessels relax and blood pressure is lowered.

Telmisartán/Amlodipino Krka is used for the treatment of high blood pressure (hypertension) in adult patients who are already being treated with telmisartan and amlodipine as separate tablets at these doses.

2. What you need to know before taking Telmisartán/Amlodipino Krka

Do not take Telmisartán/Amlodipino Krka

• If you are allergic to telmisartan, amlodipine, or any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (In any case, it is better to avoid taking Telmisartán/Amlodipino Krka also during the early stages 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 other serious liver disease.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have low blood pressure (hypotension).
• If you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which your heart cannot supply enough blood to the body).
• If you suffer from heart failure following a heart attack.

If any of the above apply to you, tell your doctor or pharmacist before taking Telmisartán/Amlodipino Krka.

Warnings and precautions

Talk to your doctor before taking Telmisartán/Amlodipino Krka if you have or have had any of the following conditions or diseases:

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart problems.
• High levels of aldosterone (leading to fluid and salt retention in the body along with imbalance of various blood minerals).
• 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, diarrhea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.
• Recent heart attack.
• Heart failure.
• Severe increase in blood pressure (hypertensive crisis).
• You are elderly and your dose needs to be increased.

Talk to your doctor before starting Telmisartán/Amlodipino Krka:

• If you are taking digoxin.

• 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 “Do not take Telmisartán/Amlodipino Krka”.

Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking telmisartan/amlodipine. Your doctor will decide whether to continue treatment. Do not stop taking telmisartan/amlodipine on your own.

You must inform your doctor if you think you are (or could be) pregnant. Telmisartán/Amlodipino Krka is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used during this stage (see Pregnancy section).

If you are undergoing surgery or anesthesia, you must inform your doctor that you are taking Telmisartán/Amlodipino Krka.

Telmisartán/Amlodipino Krka may be less effective at lowering blood pressure in black patients.

Children and adolescents

Telmisartán/Amlodipino Krka is not recommended for children and adolescents under 18 years of age.

Other medicines and Telmisartán/Amlodipino Krka

Tell 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.

This is especially important for the following medicines when taken at the same time as Telmisartán/Amlodipino Krka:

• Medicines containing lithium used to treat certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, angiotensin II receptor antagonists, heparin, and the antibiotic trimethoprim.
• Diuretics, especially if taken in high doses together with Telmisartán/Amlodipino Krka, which may cause excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also information under the headings "Do not take Telmisartán/Amlodipino Krka" and "Warnings and precautions").
• Digoxin.
• Ketoconazole, itraconazole (antifungal medicines).
• Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV).
• Rifampicin, erythromycin, clarithromycin (for bacterial infections).
• Hypericum perforatum (St. John’s wort).
• Verapamil, diltiazem (heart medicines).
• Dantrolene (infusion for severe temperature regulation abnormalities).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to alter the way the immune system works).
• Simvastatin (a medicine to lower cholesterol).
• Cyclosporine (an immunosuppressant).

The effect of Telmisartán/Amlodipino Krka may be reduced when used with NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.

Telmisartán/Amlodipino Krka may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or of medicines that may potentially lower blood pressure (e.g., baclofen, amifostine). In addition, low blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this as dizziness upon standing. Consult your doctor if you need to adjust the dose of your other medicine while taking Telmisartán/Amlodipino Krka.

Taking Telmisartán/Amlodipino Krka with food and drinks

Grapefruit juice and grapefruit must not be consumed by people taking Telmisartán/Amlodipino Krka. This is because grapefruit juice and grapefruit can cause an increase in blood levels of the active ingredient amlodipine, which may lead to an unpredictable increase in the blood pressure-lowering effect of Telmisartán/Amlodipino Krka. In addition, low blood pressure may be worsened by alcohol.

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you think you are (or could be) pregnant. Your doctor will usually advise you to stop taking Telmisartán/Amlodipino Krka before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Telmisartán/Amlodipino Krka. Telmisartán/Amlodipino Krka is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Telmisartán/Amlodipino Krka is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

It has been shown that amlodipine passes into breast milk in small amounts.

Driving and using machines

Telmisartán/Amlodipino Krka may affect your ability to drive or use machines. If the tablets make you feel unwell, dizzy, tired, or give you a headache, do not drive or use machines and contact your doctor immediately.

Telmisartán/Amlodipino Krka contains sodium

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

3. How to take Telmisartan/Amlodipine Krka

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

The recommended dose of Telmisartan/Amlodipine Krka is 1 tablet daily.

You may take Telmisartan/Amlodipine Krka with a glass of water, with or without food. Try to take one tablet at the same time each day. Do not take Telmisartan/Amlodipine Krka with grapefruit juice.

It is important that you continue taking Telmisartan/Amlodipine Krka until your doctor tells you otherwise.

If you take more Telmisartan/Amlodipine Krka than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or the nearest hospital emergency department immediately, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.

Taking too many tablets may cause your blood pressure to drop or even become dangerously low. You may feel dizzy, lightheaded, fatigued, or weak. If the drop in blood pressure is severe enough, shock may occur. You may feel cold and clammy and could lose consciousness.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty breathing, which may develop within 24–48 hours after ingestion.

If you forget to take Telmisartan/Amlodipine Krka

If you forget to take your dose, take it as soon as you remember and continue as before. If you miss a dose one day, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Telmisartan/Amlodipine Krka

Your doctor will advise you on how long to take your medicine. Your condition may return if you stop taking the medicine before being instructed to do so.

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 must see your doctor immediately:

• Sepsis* (often called "blood infection", it is a severe infection with a systemic inflammatory response)
• Wheezing, chest pain, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat causing severe difficulty breathing
• Severe skin reactions including intense rash, hives, redness of the skin all over the body, intense itching, blisters, peeling, and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Heart attack, abnormal heartbeats
• Inflamed pancreas (pancreatitis) which may cause severe abdominal and back pain accompanied by general malaise

Possible adverse effects of TELMISARTAN

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

• Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold)
• Deficiency of red blood cells (anemia)
• Elevated blood potassium levels
• Feeling sad (depression)
• Difficulty falling asleep
• Fainting (syncope)
• Sensation of spinning (dizziness)
• Slow heart rate (bradycardia)
• Low blood pressure (hypotension)
• Dizziness upon standing (orthostatic hypotension)
• Difficulty breathing, cough
• Abdominal pain, diarrhea, stomach discomfort, bloating, vomiting
• Itching, increased sweating, skin rash
• Back pain, muscle cramps, muscle pain (myalgia)
• Kidney failure, including acute kidney failure
• Chest pain, feeling of weakness
• Increased blood creatinine levels

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

• Sepsis * (often called "blood poisoning", it is a severe infection with a systemic inflammatory response that may lead to death)
• Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia)
• Severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, facial swelling, or low blood pressure)
• Low blood sugar levels (in diabetic patients)
• Feeling anxious, drowsiness
• Vision problems
• Rapid heartbeats (tachycardia)
• Dry mouth, stomach discomfort, altered taste (dysgeusia)
• Abnormal liver function (Japanese patients are more likely to experience these side effects)
• Rapid swelling of the skin and mucosa, which may also be fatal (angioedema, including fatal outcomes), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash
• Joint pain (arthralgia), limb pain, tendon pain
• Flu-like illness
• Decreased hemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or creatine phosphokinase in the blood

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

• Progressive scarring of lung tissue (interstitial lung disease) **

Not known (frequency cannot be estimated from available data):

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

• The event may have occurred by chance or could be related to a currently unknown mechanism.

** Cases of progressive scarring of lung tissue have been reported during telmisartan intake. However, it is not known whether telmisartan was the cause.

Possible adverse effects of AMLODIPINE

The following very common side effect has been reported. If this causes you problems or lasts longer than one week, you should contact your doctor.

Very common side effects (may affect more than 1 in 10 people):

• Edema (fluid retention)

The following common side effects have been reported. If any of these cause you problems or last longer than one week, you should contact your doctor.

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

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of your heartbeat), flushing
• Abdominal pain, feeling unwell (nausea)
• Altered bowel habits, diarrhea, constipation, indigestion
• Tiredness, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of ankles

Other side effects that have been reported include the following list. If any of these are severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting
• Sensation of numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/nasal discharge due to inflammation of the nasal lining (rhinitis)
• Cough
• Dry mouth, vomiting (feeling sick)
• Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Inability to achieve an erection, discomfort or enlargement of the breasts in men
• Pain, discomfort
• Joint or muscle pain, back pain
• Weight gain or weight loss

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

• Confusion

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

• Decrease in the number of white blood cells, decrease in platelets in the blood, which may cause unusual bruising or easy bleeding (damage to red blood cells)
• High blood sugar (hyperglycemia)
• A nerve disorder that may cause weakness, tingling, or numbness
• Swelling of the gums
• Abdominal swelling (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Sensitivity to light

Not known (frequency cannot be estimated from available data):

• Tremor, rigid posture, mask-like face, slow movements, shuffling gait with imbalance

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan/Amlodipine Krka

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

Do not use this medicine after the expiry date which is stated on the blister and the outer carton after “EXP”. The expiry date refers to 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 should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan/Amlodipine Krka

• The active substances are telmisartan and amlodipine.

Telmisartan/Amlodipine Krka 80 mg/5 mg tablets

Each tablet contains 80 mg of telmisartan and 5 mg of amlodipine (as amlodipine besilate).

Telmisartan/Amlodipine Krka 80 mg/10 mg tablets

Each tablet contains 80 mg of telmisartan and 10 mg of amlodipine (as amlodipine besilate).

• The other components (excipients) are povidone K30, sodium hydroxide, mannitol, microcrystalline cellulose, meglumine, sodium croscarmellose, yellow iron oxide (E172), magnesium stearate (E470b), and red iron oxide (E172) [only for 80 mg/5 mg]. See section 2 "Telmisartan/Amlodipine Krka contains sodium".

Appearance of the product and contents of the pack

Telmisartan/Amlodipine Krka 80 mg/5 mg: Light orange, oval-shaped, biconvex tablets, which may have light or dark specks, marked with N3 on one side. Tablet dimensions: 17 mm.

Telmisartan/Amlodipine Krka 80 mg/10 mg: Light brownish-yellow, oval-shaped, biconvex tablets, which may have light or dark specks, marked with N4 on one side. Tablet dimensions: 17 mm.

Telmisartan/Amlodipine Krka 80 mg/5 mg and 80 mg/10 mg tablets are available in packs containing:

• 28, 30 and 100 tablets in blister packs
• 28 x 1, 30 x 1 and 100 x 1 tablets in perforated unit-dose blisters

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura, 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: April 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).