Teldipin

Leaflet attached to the packaging: patient information

Teldipin, 40 mg + 5 mg, tablets

Teldipin, 40 mg + 10 mg, tablets

Teldipin, 80 mg + 5 mg, tablets

Teldipin, 80 mg + 10 mg, tablets

Telmisartan + Amlodipine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Teldipin and what is it used for
• 2. Important information before taking Teldipin
• 3. How to take Teldipin
• 4. Possible side effects
• 5. How to store Teldipin
• 6. Contents of the packaging and other information

1. What is Teldipin and what is it used for

Teldipin contains two active substances - telmisartan and amlodipine. Both substances help control high blood pressure.

• Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body, causing blood vessels to constrict, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, resulting in the dilation of blood vessels and a decrease in blood pressure.
• Amlodipine belongs to a group of medicines called calcium channel blockers. It blocks the penetration of calcium ions into the cells of the blood vessel walls, which counteracts the constriction of blood vessels, thereby lowering blood pressure. The action of both substances prevents the constriction of blood vessels, resulting in the relaxation of blood vessels and a decrease in blood pressure.

Teldipin is used, instead of taking separate medicines, to treat high blood pressure (hypertension) in patients who are already taking telmisartan and amlodipine in the same doses as in Teldipin.

2. Important information before taking Teldipin

When not to take Teldipin

• if the patient is allergic to telmisartan, amlodipine, or any of the other ingredients of this medicine (listed in section 6);
• after the third month of pregnancy (it is also recommended to avoid taking Teldipin in early pregnancy - see "Pregnancy");
• if the patient has severe liver disease, such as cholestasis or biliary obstruction (disorders of bile flow from the liver and gallbladder) or any other severe liver disease;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has very low blood pressure (hypotension);
• if the patient has aortic stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart is unable to supply blood to meet the body's needs);
• if the patient has heart failure after a heart attack.

If any of the above conditions apply to the patient, they should inform their doctor or pharmacist before taking Teldipin.

Warnings and precautions

The patient should inform their doctor if they have or have had any of the following conditions or diseases:

• kidney disease or kidney transplant;
• renal artery stenosis (narrowing of the blood vessels of a single functioning kidney or both kidneys);
• liver disease;
• heart disease;
• increased aldosterone levels (water and salt retention in the body, along with electrolyte imbalance);
• low blood pressure (hypotension), which is more likely to occur if the patient is dehydrated (excessive water loss from the body) or has a low sodium level, due to the use of diuretics, a low-salt diet, diarrhea, or vomiting;
• high potassium levels in the blood;
• diabetes;
• recent heart attack;
• heart failure;
• significant increase in blood pressure (hypertensive crisis);
• need to increase the dose in elderly patients.

The patient should inform their doctor before taking Teldipin:

• if they are taking digoxin;
• if they are taking any of the following blood pressure-lowering medicines:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if the patient has kidney problems related to diabetes,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also "When not to take Teldipin" and "Warnings and precautions".

If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Teldipin, they should discuss this with their doctor. The doctor will decide on further treatment. The patient should not stop taking Teldipin on their own.

The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Teldipin in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy").

In case of planned surgery or anesthesia, the patient should inform their doctor about taking Teldipin.

Teldipin may be less effective in lowering blood pressure in black patients.

Children and adolescents

Teldipin is not recommended for use in children and adolescents under 18 years of age.

Teldipin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The doctor may recommend changing the dose of these medicines or taking other precautions. In some cases, it may be necessary to stop taking one of the medicines.

This is especially true for the following medicines taken with Teldipin:

• lithium used to treat certain types of depression;
• medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, or trimethoprim (an antibiotic);
• diuretics, especially if taken in high doses with Teldipin, which can cause excessive water loss from the body and low blood pressure (hypotension);
• ACE inhibitors or aliskiren (see also "When not to take Teldipin" and "Warnings and precautions");
• digoxin;
• ketokonazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infections);
• rifampicin, erythromycin, clarithromycin (medicines used to treat bacterial infections);
• Hypericum perforatum(St. John's Wort);
• verapamil, diltiazem (medicines used to treat heart diseases);
• dantrolene (a medicine used to treat severe body temperature disorders);
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that suppress the immune system);
• simvastatin (a medicine that lowers cholesterol levels);
• cyclosporine (an immunosuppressive medicine).

Teldipin's effect may be reduced when taken with non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin or ibuprofen) or corticosteroids.

Teldipin may lower blood pressure more than other blood pressure-lowering medicines or may enhance the blood pressure-lowering effect of medicines that lower blood pressure as an additional effect (e.g., baclofen, amifostine). Additionally, blood pressure lowering may be enhanced by alcohol, barbiturates, opioids/narcotics, or antidepressants. The symptom is dizziness when standing up. If necessary, the patient should consult their doctor about adjusting the dose of other medicines taken with Teldipin.

Teldipin with food, drink, and alcohol

The patient should not drink grapefruit juice or eat grapefruits while taking Teldipin, as grapefruits and grapefruit juice can cause an increase in the level of the active substance amlodipine in the blood, which may lead to unpredictable enhancement of Teldipin's blood pressure-lowering effect. Additionally, blood pressure may be further lowered when drinking alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Teldipin before planned pregnancy or as soon as pregnancy is detected and recommend another medicine instead of Teldipin. It is not recommended to take Teldipin in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus.

Breastfeeding

The patient should tell their doctor about breastfeeding or intending to breastfeed. It is not recommended to take Teldipin while breastfeeding. The doctor may recommend another medicine if the patient wants to breastfeed, especially if the baby is a newborn or premature.

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

Driving and using machines

Teldipin may affect the ability to drive and use machines. If the patient experiences nausea, dizziness, fatigue, or headache, they should not drive or operate machines and should contact their doctor immediately.

Teldipin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Teldipin

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

The recommended dose of Teldipin is one tablet per day.

The tablet should be swallowed with water, during or outside of meals. The medicine should be taken every day at the same time. The patient should not take Teldipin with grapefruit juice.

It is important to continue taking Teldipin for as long as the doctor recommends.

Taking a higher dose of Teldipin than recommended

If the patient accidentally takes too many tablets, they should immediately contact their doctor or pharmacist or go to the emergency department of the nearest hospital.

Taking too much of the medicine may cause a significant decrease in blood pressure. The patient may experience dizziness, a feeling of emptiness in the head, fainting, or weakness. In case of a very significant decrease in blood pressure, the patient may go into shock. The patient's skin may become cool and moist, and they may lose consciousness.

Up to 24-48 hours after taking the medicine, the patient may experience shortness of breath due to excessive fluid accumulation in the lungs (pulmonary edema).

Missing a dose of Teldipin

If the patient forgets to take a dose, they should not worry. They should take the missed dose as soon as they remember, and then take the next doses at the usual time. If the patient misses a tablet one day, they should take the next dose the next day. The patient should not take a double dose to make up for the missed dose.

Stopping Teldipin treatment

The doctor will decide how long the patient should take this medicine. If the patient stops taking the medicine earlier than recommended by the doctor, the disease may return.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Teldipin can cause side effects, although not everybody gets them.

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

• sepsis (also known as blood poisoning, a severe infection with an inflammatory response throughout the body);
• sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue or throat, causing severe breathing difficulties;
• severe skin reactions, including severe rash, hives, redness of the skin, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, abnormal heart rhythm;
• pancreatitis, which can cause severe stomach pain, radiating to the back, with very poor general condition.

Side effects related to TELMISARTAN:

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

• urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold),
• decreased red blood cell count (anemia),
• high potassium levels,
• feeling sad (depression),
• difficulty sleeping,
• fainting,
• feeling dizzy (vertigo),
• slow heart rate (bradycardia),
• low blood pressure (hypotension),
• dizziness when standing up (orthostatic hypotension),
• shortness of breath, cough,
• stomach pain, diarrhea, abdominal discomfort, bloating, vomiting,
• itching, increased sweating, rash,
• back pain, muscle cramps, muscle pain,
• kidney problems, including acute kidney failure,
• chest pain, feeling weak,
• increased creatinine levels in the blood.

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

• sepsis (also known as blood poisoning, a severe infection with an inflammatory response throughout the body, which can be life-threatening),
• increased white blood cell count, low platelet count, which can lead to easy bruising and bleeding (blood cell damage),
• severe allergic reaction (anaphylactic reaction), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, low blood pressure),
• low blood sugar levels (in diabetic patients),
• feeling anxious, drowsiness,
• vision disturbances,
• fast heart rate (tachycardia),
• dry mouth, nausea, gastrointestinal disturbances,
• abnormal liver function (more likely to occur in patients of Japanese origin),
• sudden swelling of the skin and mucous membranes, which can be life-threatening (angioedema, including fatal cases),
• joint pain, muscle pain, tendon pain,
• flu-like symptoms,
• decreased hemoglobin levels, increased uric acid levels, increased liver enzyme or creatine phosphokinase levels in the blood.

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

• progressive scarring of lung tissue (interstitial lung disease).**

Frequency not known(frequency cannot be estimated from the available data)

• angioedema of the intestine - similar products have been associated with intestinal angioedema with symptoms such as stomach pain, nausea, vomiting, and diarrhea

*This phenomenon may be coincidental or related to a mechanism that has not yet been identified.

**There have been reports of progressive scarring of lung tissue during treatment with telmisartan.

However, it has not been established whether telmisartan is the cause of this.

Side effects related to AMLODIPINE:

The following very common side effects have been reported. If any of these side effects bother the patient or persist for more than a week, they should consult their 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 side effects bother the patient or persist for more than a week, they should consult their doctor.

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

• headache, dizziness, drowsiness (especially at the beginning of treatment),
• palpitations (awareness of heart rhythm), sudden reddening of the skin, especially the face,
• stomach pain, nausea,
• change in bowel habits, diarrhea, constipation, gastrointestinal disturbances,
• fatigue, weakness,
• vision disturbances, double vision,
• muscle cramps,
• edema of the ankles.

Other side effects have been reported. If any of these side effects worsen or if the patient experiences any side effects not listed in the leaflet, they should inform their doctor or pharmacist.

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

• mood changes, anxiety, depression, insomnia,
• tremors, taste disturbances, fainting,
• numbness or tingling of the limbs, loss of pain sensation,
• ringing in the ears,
• low blood pressure,
• rhinitis (runny nose),
• cough,
• dry mouth, nausea, vomiting,
• hair loss, increased sweating, itching, skin rash, skin discoloration,
• urinary disturbances, increased need to urinate at night, increased frequency of urination,
• impotence, discomfort or enlargement of the breasts in men,
• pain, malaise,
• joint pain or muscle pain, back pain,
• weight gain or weight loss.

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

• confusion.

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

• decreased white blood cell count, decreased platelet count, which can lead to easy bruising and bleeding (blood cell damage),
• increased blood sugar levels (hyperglycemia),
• nerve disorders that can cause weakness, numbness, or tingling,
• gum swelling,
• gastritis (stomach inflammation),
• liver function disorders, liver inflammation, jaundice, increased liver enzyme levels in the blood,
• increased muscle tone,
• vasculitis (inflammation of blood vessels), often with accompanying skin rash,
• increased sensitivity to light.

Frequency not known(frequency cannot be estimated from the available data)

• tremors, stiffness, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Teldipin

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

There are no special storage instructions for the medicine.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Teldipin contains

• The active substances of Teldipin are telmisartan and amlodipine (in the form of amlodipine besylate). Teldipin, 40 mg + 5 mg, tablets Each tablet contains 40 mg of telmisartan and 5 mg of amlodipine (in the form of amlodipine besylate). Teldipin, 40 mg + 10 mg, tablets Each tablet contains 40 mg of telmisartan and 10 mg of amlodipine (in the form of amlodipine besylate). Teldipin, 80 mg + 5 mg, tablets Each tablet contains 80 mg of telmisartan and 5 mg of amlodipine (in the form of amlodipine besylate). Teldipin, 80 mg + 10 mg, tablets Each tablet contains 80 mg of telmisartan and 10 mg of amlodipine (in the form of amlodipine besylate). The other ingredients are povidone K30, sodium hydroxide, mannitol, microcrystalline cellulose, meglumine, sodium croscarmellose, yellow iron oxide (E 172), magnesium stearate (E 470b), red iron oxide (E 172) [only for 40 mg + 10 mg and 80 mg + 5 mg]. See section 2 "Teldipin contains sodium".

What Teldipin looks like and contents of the pack

Teldipin, 40 mg + 5 mg, tablets: light brown-yellow, round, biconvex tablets, with possible lighter and darker spots, with the marking N1 on one side. Tablet dimensions: diameter approximately 9 mm.

Teldipin, 40 mg + 10 mg, tablets: light orange, round, biconvex tablets, with possible lighter and darker spots, with the marking N2 on one side. Tablet dimensions: diameter approximately 9 mm.

Teldipin, 80 mg + 5 mg, tablets: light orange, oval, biconvex tablets, with possible lighter and darker spots, with the marking N3 on one side. Tablet dimensions: length approximately 17 mm.

Teldipin, 80 mg + 10 mg, tablets: light brown-yellow, oval, biconvex tablets, with possible lighter and darker spots, with the marking N4 on one side. Tablet dimensions: length approximately 17 mm.

Packaging:14, 28, 30, 56, 60, 84, 90, and 98 tablets in blisters in a cardboard box.

Not all pack sizes may be marketed.

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

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

In order to obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

Tel. 22 57 37 500

Date of last revision of the leaflet: 27.04.2025