TELMISARTAN/AMLODIPINE KRKA 80 mg/5 mg TABLETS

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

1. What is Telmisartan/Amlodipine Krka and what is it used for

Telmisartan/Amlodipine Krka tablets contain two active ingredients, telmisartan and amlodipine. Both active ingredients 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, so that the blood vessels relax and your blood pressure is reduced.
• Amlodipine belongs to a group of medicines known as calcium channel blockers. Amlodipine prevents calcium from entering the wall of the blood vessels, which prevents the blood vessels from narrowing and reduces blood pressure.

This means that both active ingredients work together to prevent your blood vessels from becoming too narrow. As a result, the blood vessels relax and blood pressure is reduced.

Telmisartan/Amlodipine Krka is used to treat high blood pressure (hypertension) in adult patients who are already taking telmisartan and amlodipine in separate tablets at these doses.

2. What you need to know before you take Telmisartan/Amlodipine Krka

Do not take Telmisartan/Amlodipine 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 Telmisartan/Amlodipine Krka also at the start of your pregnancy - see section “Pregnancy”).
• If you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of bile from the liver and gall bladder) or other severe liver disease.
• If you have diabetes or kidney impairment and are being treated with a blood pressure 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 where your heart is unable to supply enough blood to the body).
• If you have heart failure after a heart attack.

If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan/Amlodipine Krka.

Warnings and precautions

Consult your doctor before starting to take Telmisartan/Amlodipine Krka if you have or have had any of the following disorders or diseases:

• Kidney disease or transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart problems.
• High levels of aldosterone (leading to water 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 low salt levels due to treatment with diuretics, 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 an elderly patient and your dose needs to be increased.

Consult your doctor before starting to take Telmisartan/Amlodipine Krka:

• If you are taking digoxin
• 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 check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also “Do not take Telmisartan/Amlodipine Krka”.

Consult 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 might become) pregnant. Telmisartan/Amlodipine Krka is not recommended at the start of pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

In case of surgery or anesthesia, you must inform your doctor that you are taking Telmisartan/Amlodipine Krka.

Telmisartan/Amlodipine Krka may be less effective in reducing blood pressure in black patients.

Children and adolescents

Telmisartan/Amlodipine Krka is not recommended for children and adolescents under 18 years.

Other medicines and Telmisartan/Amlodipine Krka

Tell 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.

This is especially important for the following medicines taken at the same time as Telmisartan/Amlodipine Krka:

• Medicines containing lithium for treating some types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, or certain antibiotics (e.g. trimethoprim).
• Diuretics, especially when taken in high doses with Telmisartan/Amlodipine Krka, may cause excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Telmisartan/Amlodipine 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 abnormalities of body temperature).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to alter the way your immune system works).
• Simvastatin (a medicine to lower cholesterol).
• Ciclosporin (an immunosuppressant).

The effect of Telmisartan/Amlodipine Krka may be reduced when using non-steroidal anti-inflammatory drugs (NSAIDs, e.g. acetylsalicylic acid or ibuprofen) or corticosteroids.

Telmisartan/Amlodipine Krka may increase the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may potentially lower blood pressure (e.g. baclofen, amifostine). Additionally, low blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this as dizziness when standing up. You should consult your doctor if you need to adjust the dose of your other medicine while taking Telmisartan/Amlodipine Krka.

Taking Telmisartan/Amlodipine Krka with food and drink.

Grapefruit juice and grapefruit should not be consumed by people who take Telmisartan/Amlodipine Krka. This is because grapefruit juice and grapefruit can cause an increase in the levels of the active ingredient amlodipine in the blood, which can lead to an unpredictable increase in the blood pressure-lowering effect of Telmisartan/Amlodipine Krka. Additionally, low blood pressure may be worsened by alcohol.

Pregnancy and breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

You must inform your doctor if you think you are (or might become) pregnant. Normally, your doctor will advise you to stop taking Telmisartan/Amlodipine Krka before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Telmisartan/Amlodipine Krka. Telmisartan/Amlodipine Krka is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. Telmisartan/Amlodipine Krka is not recommended for breast-feeding mothers, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn or was born prematurely.

Amlodipine has been shown to pass into breast milk in small amounts.

Driving and using machines

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

Telmisartan/Amlodipine Krka contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Telmisartan/Amlodipine Krka

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

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

It is important that you continue to take Telmisartan/Amlodipine Krka until your doctor tells you to stop.

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 or call the National Poison Information Service on 915 620 420, stating the name of the medicine and the amount you have taken.

Taking too many tablets may make your blood pressure fall or even make it dangerously low. You may feel dizzy, faint, tired, or weak. If the fall in blood pressure is severe enough, it may cause shock. You may feel your skin is cool and clammy, and you may lose consciousness.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion.

If you forget to take Telmisartan/Amlodipine Krka

If you forget to take your medicine, take your dose as soon as you remember and then 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 a forgotten dose.

If you stop taking Telmisartan/Amlodipine Krka

Your doctor will advise you how long to take your medicine. Your condition may come back if you stop using your medicine before you are advised to do so.

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", it is a severe infection with an inflammatory response of the whole body)
• Wheezing, chest pain or difficulty breathing
• Swelling of eyelids, face or lips
• Swelling of the tongue and throat that causes great difficulty breathing
• Severe skin reactions that include intense rash, hives, redness of the skin all over the body, intense itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heartbeats
• Inflamed pancreas that can cause intense abdominal and back pain accompanied by general discomfort

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)
• High potassium levels in the blood
• Feeling sad (depression)
• Difficulty falling asleep
• Fainting (syncope)
• Feeling of spinning (vertigo)
• Slow heart rate (bradycardia)
• Low blood pressure (hypotension)
• Dizziness when standing up (orthostatic hypotension)
• Difficulty breathing, cough
• Abdominal pain, diarrhea, discomfort in the abdomen, bloating, vomiting
• Itching, increased sweating, rash
• Back pain, muscle cramps, muscle pain (myalgia)
• Kidney failure, including acute kidney failure
• Chest pain, feeling of weakness
• Increased creatinine levels in the blood

Rare Adverse Effects(may affect up to 1 in 1,000 people):

• Sepsis* (often called "blood poisoning", it is a severe infection with an inflammatory response of the whole body that can lead to death)
• Increased levels of certain white blood cells (eosinophilia), low platelet count (thrombocytopenia)
• Severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure)
• Low blood sugar levels (in diabetic patients)
• Feeling anxious, drowsiness
• Vision problems
• Rapid heartbeats (tachycardia)
• Dry mouth, stomach discomfort, taste disturbance (dysgeusia)
• Abnormal liver function (Japanese patients are more likely to experience these side effects)
• Rapid swelling of the skin and mucous membranes that can also cause death (angioedema also with fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash
• Joint pain (arthralgia), pain in the limbs, pain in the tendons
• 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) **

Unknown(frequency cannot be estimated from the available data):

• Intestinal angioedema: swelling in the intestine has been reported with symptoms such as abdominal pain, nausea, vomiting, and diarrhea after using 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 if 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 more than a 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 more than a week, you should contact your doctor.

Common Side Effects(may affect up to 1 in 10 people):

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Palpitations (awareness of your heartbeat), flushing
• Abdominal pain, feeling of discomfort (nausea)
• Altered bowel habits, diarrhea, constipation, indigestion

• Fatigue, weakness

• Visual disturbances, double vision
• Muscle cramps

• Swelling of the ankles

Other side effects that have been reported include the following list. If any of these factors are severe, or if you notice any adverse effect not mentioned 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
• Feeling of numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal lining (rhinitis)
• Cough
• Dry mouth, vomiting (being sick)
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration
• Urination disorder, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or enlargement of the breasts in men
• Pain, discomfort
• Pain in the joints or muscles, back pain
• Weight gain or 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):

• Decreased number of white blood cells, decreased platelet count in the blood, which can cause unusual bruising or bleeding (red blood cell damage)
• High blood sugar levels (hyperglycemia)
• A nervous disorder that can cause weakness, tingling or numbness
• Gum swelling
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Sensitivity to light

Unknown(frequency cannot be estimated from the available data):

• Tremor, rigid posture, mask-like face, slow movements and unsteady gait

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 mentioned in this leaflet. You can also report them directly through the Spanish Medicines Agency's 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/Amlodipine Krka

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

Do not use this medicine after the expiry date that appears on the blister and on the carton after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the outer packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Telmisartan/Amlodipine Krka

• The active ingredients 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 besylate).

Telmisartan/Amlodipine Krka 80 mg/10 mg tablets

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

• The other ingredients (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 Package Contents

Telmisartan/Amlodipine Krka 80 mg/5 mg; Oval, biconvex tablets, light orange in color, with possible light or dark spots, marked with N3 on one side. Tablet dimensions: 17 mm.

Telmisartan/Amlodipine Krka 80 mg/10 mg; Oval, biconvex tablets, yellowish-brown in color, with possible light or dark spots, 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 packages containing:

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

Not all pack sizes may 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

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:April 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/).