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 you need to.
• If you have 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 their symptoms 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 antagonists. 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

• after the third month of pregnancy (it is also recommended to avoid taking Teldipin in early pregnancy - see "Pregnancy");

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;
• hyperaldosteronism (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:

• angiotensin-converting enzyme (ACE) inhibitor, such as enalapril, lisinopril, ramipril, especially if the patient has diabetic kidney disease,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium). 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 baby (see "Pregnancy").
In the event 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 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, angiotensin II receptor antagonists, heparin, and trimethoprim (an antibiotic);
• diuretics - especially if taken in high doses with Teldipin, as they may cause excessive water loss from the body and low blood pressure (hypotension);
• ACE inhibitor 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 patient's immune system);
• simvastatin (a medicine that lowers cholesterol levels);
• cyclosporin (an immunosuppressive medicine).

The effect of Teldipin 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 when taken with 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 another medicine they are taking while taking 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 may increase the levels of the active substance amlodipine in the blood, which may cause unpredictable enhancement of the blood pressure-lowering effect of Teldipin. 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 confirmed 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 baby if taken after 3 months of pregnancy.
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 impair 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, with or without food. 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 the event of a very significant decrease in blood pressure, shock may occur. The patient's skin may become cool and moist, and they may lose consciousness.
Up to 24-48 hours after taking the medicine, shortness of breath due to excessive fluid accumulation in the lungs (pulmonary edema) may occur.

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 tablet is not taken on one day, the patient 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 serious 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 all over the body, 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 associated with 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),
• decrease in red blood cell count (anemia),
• high potassium levels,
• feeling sad (depression),
• difficulty sleeping,
• fainting,
• feeling of spinning (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 of weakness,
• 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 serious infection with an inflammatory response throughout the body, which can be life-threatening);
• increase in a type of white blood cell (eosinophilia), low platelet count (thrombocytopenia),
• severe allergic reaction (anaphylactic reaction), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, low blood pressure),
• low blood sugar levels (in diabetic patients),
• restlessness, drowsiness,
• vision disturbances,
• fast heart rate (tachycardia),
• dry mouth, nausea, vomiting,
• 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 angioedema that can cause death),
• joint pain, muscle pain, tendon pain,
• flu-like symptoms,
• decrease in hemoglobin levels (a protein in the blood), increase in uric acid levels, increase in 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 angioedema of the intestine 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.
The causal relationship between telmisartan and this condition has not been established.
Side effects associated with 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 movements, diarrhea, constipation, indigestion,
• fatigue, weakness,
• vision disturbances, double vision,
• muscle cramps,
• edema of the ankles.

The following side effects have also been reported. If any of these side effects worsen or occur, the patient 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 limbs, loss of pain sensation,
• ringing in the ears,
• low blood pressure,
• rhinitis (inflammation of the nasal mucosa),
• cough,
• dry mouth, nausea, vomiting,
• hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration,
• urinary disorders, 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 increase or decrease.

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

• disorientation.

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

• decrease in white blood cell count, decrease in platelet count, which can lead to easy bruising and bleeding (blood cell damage),
• increase in blood sugar levels (hyperglycemia),
• nerve disorders that can lead to weakness, numbness, or tingling,
• gum swelling,
• abdominal bloating (gastritis),
• liver function disorders, liver inflammation, jaundice, increased liver enzyme activity, or creatine phosphokinase levels in the blood,
• increased muscle tone,
• vasculitis (inflammation of blood vessels), often with accompanying skin rash,
• photosensitivity.

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

• tremors, stiffness, mask-like face, slow movements, and dragging of the feet when walking, unsteady gait.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Teldipin

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special storage temperature requirements for this medicine.
The medicine should be stored in its original packaging to protect it 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
Phone: 22 57 37 500

Date of last revision of the leaflet: 27.04.2025