Teldipin 80 mg. / 10 mg. 28 tablets

What is Teldipin  and what is it used for?
Teldipin tablets contain two active substances called telmisartan and amlodipine. Each of these substances helps to control high blood pressure:
• Telmisartan belongs to a class of medicines called "Angiotensin II Receptor Antagonists." Angiotensin II is a substance in your body that causes blood vessels to contract, thus increasing your blood pressure.Telmisartan blocks the effect of angiotensin II, this way blood vessels are relaxed and your blood pressure decreases.
• Amlodipine belongs to a class of medicines called "calcium antagonists." Amlodipine stops the passage of calcium into the wall of the blood vessels, which prevents the blood vessels from contracting and thus also lowers blood pressure.
The actions of these two substances contribute to stopping the blood vessels. As a result, the blood vessels are relaxed and the blood pressure decreases.
Teldivin is used to treat high blood pressure (hypertension) in patients who have already taken telmisartan and amlodipine alone at the same doses instead of taking these two medicines alone.

2. What should you know before you take Teldipin?
Do not take Teldipin:
• if you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant after the third month (the use of Teldivin is also better avoided also in early pregnancy - see Pregnancy);
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with draining of the bile from the liver and the gall bladder) or other severe liver problems;
• if you have diabetes or have impaired kidney function and are being treated with a blood pressure lowering medication containing aliskiren;
• if you have severe hypotension (very low blood pressure);
• if you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to deliver enough blood to the body);
• if you suffer from heart failure after a heart attack. If any of the above applies to you, tell your doctor or pharmacist before taking Teldipin

Warnings and precautions
Talk to your doctor if you suffer or have ever suffered from any of the following conditions or illnesses:
• kidney disease or kidney transplantation;
• renal artery stenosis (narrowing of the blood vessels of one or both kidneys);
• liver disease;
• heart problem;
• elevated aldosterone levels (retention of water and salts in the body accompanied by disturbing the balance of various minerals in the blood);
• low blood pressure (hypotension) that may occur if you are dehydrated / excessive body water loss or if you have salt deficiency due to diuretic / detoxifying medicines, a low-salt diet, diarrhea or vomiting;
• Increased potassium levels in the blood;
• diabetes;
• a recent heart attack;
• heart failure;
• Very significant increase in blood pressure (hypertensive crisis);
• You are elderly and your dose should be increased.

Talk to your doctor before taking Tildipin:
• if you are taking digoxin;
• if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (for example, enalnalyl, lisinopril, ramipril), especially if you have kidney problems associated with diabetes;
- aliskiren.

Your doctor may periodically check your kidney function, blood pressure and the amount of electrolytes (eg potassium) in your blood. See also the information titled "Do not take Teldivin".

You should tell your doctor if you think you are pregnant (or you may become pregnant). Teldivin is not recommended in early pregnancy and should not be taken if you are pregnant after the 3rd month as it may cause serious harm to your baby if used during this period of pregnancy (see section on pregnancy).

In case of a surgical operation or anesthesia, you should tell your doctor that you are 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 up to 18 years of age.

Other medicines and Teldipin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Your doctor may need to change the dose of these medicines or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially true for the medicines listed below when taking Tildipine concomitantly:

• 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 (some draining medicines), angiotensin II receptor antagonists, heparin and the antibiotic trimethoprim;

• diuretics (drainage medicines), especially if taken in high doses together with Teldivin, can lead to excessive water loss of the body and low blood pressure (hypotension);

• if you are taking ACE inhibitors or aliskiren (see also the information titled "Do not take Tidipin" and "Warnings and precautions");

• digoxin;

• ketoconazole, itraconazole (antifungal medicines);

• ritonavir, indinavir, nelfinavir (the so-called protease inhibitors used to treat HIV);

• rifampicin, erythromycin, clarithromycin (antibiotics);

• St. John's wort (Hypericum perforatum);

• verapamil, diltiazem (heart medicines);

• dantrolene (an infusion of abnormally high body temperature abnormalities);

• tacrolimus (used to control your body's immune response, which allows your body to accept the transplanted organ);

• clarithromycin (used to treat bacterial infections);

• simvastatin (to treat elevated cholesterol levels);

• cyclosporin (immunosuppressant).

The effect of Teldivin may be reduced when co-administered with NSAIDs (non-steroidal anti-inflammatory drugs such as acetylsalicylic acid or ibuprofen) or corticosteroids.

Teldivir may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or medicines with a blood pressure lowering potential (such as baclofen, amyphosine). In addition, the blood pressure lowering effect can be enhanced 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 other medicines while taking Tildipin.

Teldipin with food, beverages and alcohol

Grapefruit juice and grapefruit juice should not be consumed by people taking Teldivin. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Tldidipin.

In addition, the effect of lowering blood pressure can be enhanced by alcohol.

Pregnancy and breastfeeding
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You should tell your doctor if you think you are pregnant (or may become pregnant). Your doctor will usually advise you to stop taking Tldidipine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Toldipin. Tildipine is not recommended in early pregnancy and should not be taken if you are pregnant after the third month as it may cause serious harm to your child if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breast-feeding or intend to breast-feed. Teldivin is not recommended for mothers who are breast-feeding and your doctor may prescribe another treatment if you want to breast-feed, especially if your child is newborn or was born prematurely.

Talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

Teldivir may affect your ability to drive or use machines. If your tablets make you feel sick, dizzy or tired or have a headache, do not drive or use machines and contact your doctor immediately.

Teldivin contains lactose and sorbitol
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How do you take Teldipin?
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of Teldivin is one tablet a day.
If you take more Telipin than you should

If you have accidentally taken too many tablets, contact your doctor, pharmacist or nearest emergency center immediately. Taking too many tablets may cause a decrease or drastic decrease in your blood pressure.

You may experience dizziness, vertigo or weakness. If the drop in blood pressure is drastic, you may get shocked. You may feel your skin cool and sticky and you may lose consciousness.

If you forget to take Teldipin

If you forget to take a dose, do not worry, take it as soon as you remember it and then continue taking it in the usual way. If you do not take your tablet the same day, take the usual dose the next day. Do not take a double dose to make up for the missed tablet.

If you stop taking Teldipin, your doctor will advise you how long to take your medicine. Your condition may resume if you stop using your medicine without advising you about it.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious and require immediate medical attention:

You should immediately contact your doctor if you experience any of the following symptoms:
• Sepsis (often called "blood poisoning" is a severe infection of the whole organism);
• Sudden wheezing, chest pain, shortness of breath or shortness of breath;
• Swelling of the eyelids, face or lips;
• Swelling of the tongue and throat, which causes great difficulty in breathing;
• Severe skin reactions including intense skin rash, urticaria, redness of the skin throughout the skin, itching of the skin, blistering, peeling and swelling of the skin, mucosal irritation (Stevens-Johnson syndrome) or other allergic reactions;
• Heart attack, impaired heart rhythm;
• Inflammation of the pancreas, which may result in severe abdominal pain and back pain accompanied by a feeling of severe general malaise.

Adverse reactions associated with the use of Teldipin:

Uncommon side effects (may affect up to 1 in 100 people):
• urinary tract infections, upper respiratory tract infections (eg sore throat, sore sinuses, colds);
• reduced number of red blood cells (anemia);
• high levels of potassium in the blood;
• feeling sad (depression);
• difficulty falling asleep, fainting (syncope);
• feeling of sowing (vertigo);
• slow heartbeat (bradycardia);
• low blood pressure (hypotension);
• Dizziness in straightening (orthostatic hypotension);
• shortness of breath, cough;
• abdominal pain, diarrhea, stomach discomfort, gas, vomiting;
• itching, increased sweating, rash;
• Back pain, muscle cramps, muscle pain (myalgia);
• renal impairment, including acute renal failure;
• chest pain, a feeling of weakness;
• increased blood creatinine levels.

Rare side effects (may affect up to 1 in 1,000 people):
• sepsis (often called "blood poisoning" is a severe infection of the whole organism that can lead to death);
• increase in the number of some white blood cells (eosinophilia), decreased platelet count (thrombocytopenia);
• severe allergic reaction (anaphylactic reaction), allergic reaction (eg rash, itching, difficulty in breathing, wheezing, swollen face or low blood pressure);
• low blood sugar (in diabetic patients);
• anxiety, sleepiness;
• Visual disturbance;
• Accelerated heart rhythm (tachycardia);
• dry mouth, irritable stomach, impaired sensation (dysgeusia);
• impaired hepatic function (patients of Japanese origin are more likely to develop this side effect);
• rapid swelling of the skin and mucous membranes which may lead to death (angioedema with fatal outcome), eczema (skin disorder), redness of the soft tissue, hives (urticaria), severe rash;
• joint pain (arthralgia), pain in the limbs, tendon pain;
• flu-like illness;
• decreased hemoglobin (blood protein), elevated levels of uric acid, elevated liver enzymes or blood creatine phosphokinase.

Very rare side effects (may affect 1 in 10,000 people):
• progressive adhesion (fibrosis) of pulmonary tissue (interstitial lung disease);

The event may have been accidental or may have been associated with an unknown mechanism.

Cases of progressive pulmonary adhesion have been reported during administration of telmisartan. However, it is not known whether telmisartan is the cause.

Adverse reactions associated with the use of Amlodipine:

The following very common side effects have been reported. If any occurs with you, or the reactions continue longer
Common side effects (may affect up to 1 in 10 people):
• headache, dizziness, drowsiness (especially at the beginning of treatment);
• palpitations (heart rhythm sensation);
• Eczema (skin disorder), reddening of the skin, hives (urticaria), severe drug rash;
• abdominal pain, malaise, (nausea);
• altered intestinal peristalsis, diarrhea, constipation, indigestion;
• fatigue, weakness;
• vision impairment, double vision;
• muscle cramps.

Other side effects that have been reported are listed below. If any of these gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon side effects (may affect up to 1 in 100 people):
• mood swings, anxiety, depression, insomnia;
• trembling, taste abnormalities, seizures;
• stiffness or numbness of the limbs, loss of pain sensation;
• noise in the ears;
• low blood pressure;
• sneezing / runny nose caused by inflammation of the lining of the nose (rhinitis);
Coughing;
• dry mouth, vomiting (fainting);
• hair loss, increased sweating, itchy skin, red spots on the skin, discoloration of the skin;
• urinary tract disorder, frequent urination at night, increased number of urination times;
• Inability to get erection, discomfort or breast enlargement in men;
• pain, malaise;
• joint or muscle pain, muscle cramps, back pain;
• increase or decrease weight.

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):
• a reduced number of white blood cells, a decrease in blood platelets, which may lead to abnormal bruising or bleeding (damage to red blood cells);
• increased blood sugar (hyperglycaemia);
• nervousness, which may lead to weakness, tingling or stiffness;
• swelling of the gums;
• bloating (gastritis);
• impaired hepatic function, liver inflammation (hepatitis), yellowing of the skin (jaundice), elevation of liver enzymes which may affect some medical tests;
• increased muscle tone;
• inflammation of the blood vessels, often with rash on the skin;
• sensitivity to light;
• Disturbances that combine rigidity (tremor), tremor and / or movement difficulties.
Not known (frequency can not be estimated from the available data):
• shaking, stiff posture, mask-like facial expression (jerky face), slow motion and leg traction, unsteady gait.

Reporting of side effects

If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet.

5. How to store Teldipin?

Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store below 30 degrees.
Store in the original package in order to protect from light.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information

What does Teldipin contain?

• The active substances are: telmisartan and amlodipine.

Teldipin 80 mg / 10 mg tablets:
Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besylate).

The other ingredients are: sodium hydroxide, povidone K30, meglumine, lactose monohydrate, sorbitol, yellow iron oxide (E172), magnesium stearate (E470b), sodium stearyl fumarate, mannitol, colloidal anhydrous silica, stearic acid.

What does Teldipin look like and what does it contain?
Teldivin 80 mg / 10 mg are elliptical, slightly biconvex, double-layered tablets. One side of the tablet is brownish-yellow, mosaic. The other side of the tablet is white or off-white and embossed with K1.

Dimensions: 18 mm x 9 mm.

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