Tritace combo 10 mg. / 5 mg. 28 capsules

What is Tritace Combo and what it is used for

The Tritace Combo contains two active substances: ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors). Amlodipine belongs to a group of medicines called calcium antagonists.

Ramipril acts as:
• Reduce the production of substances in your body that may increase your blood pressure;
• causes expansion and relaxation of the blood vessels;
• It helps to pump blood from the heart to your entire body.

Amlodipine acts as:
Relaxes and enlarges blood vessels, so blood circulation facilitates.

The Tritace Combo is used to treat hypertension (high blood pressure) in patients whose blood pressure is well controlled with amlodipine and ramipril co-administered at the same doses as in the Triace Combo but as separate medicines.

2. What you need to know before taking the Tritace Combo

Do not take the Tritace combo:
- If you are allergic to ramipril, amlodipine (s), other ACE inhibitors or some other calcium antagonists or any of the other ingredients of this medicine (listed in section 6). This may be itching, reddening of the skin or difficulty in breathing.
- If you have ever had a serious allergic reaction called angioedema. Signs include itching, hives (urticaria), flushing of the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty in breathing and swallowing.
- If you are on dialysis or any other type of blood filtration, the Triace Combo is not suitable for the equipment used.
- If you have kidney problems due to decreased renal blood supply (renal artery stenosis).
- During the last 6 months of pregnancy (see section "Pregnancy, breast-feeding and fertility" below).
- If you have diabetes or have impaired kidney function and are being treated with a medicine to lower the blood pressure that contains aliskiren.
- If your blood pressure is abnormally low or unstable. Your doctor needs evaluation.
- If you have narrowing of the heart aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart can not deliver enough blood to the body).
- If you suffer from heart failure after a heart attack.

Do not take the Tritace Combo if any of the above applies to you. If you are not sure, ask your doctor before taking the Triace Combo.

Warnings and precautions
Talk to your doctor before taking the Triace Combo. Tell your doctor if any of the following applies to you:

If you have problems with your heart, liver or kidneys.
If you have lost lots of body fluids or salts (by vomiting, diarrhea, more sweating than usual if you are on a low-salt diet, if you are taking diuretics for a long time or have been on dialysis).
If allergy to bee or axle sting allergy is to be treated (desensitization).
If anesthesia persists in an operative or dental procedure. You may need to stop your treatment with the Triace Combo a day earlier, ask your doctor for advice.
If you have elevated potassium in the blood (in the blood test).
If you are taking medicines or are in a condition that can lower your blood sodium levels. Your doctor may conduct regular blood tests specifically to check your blood sodium levels, especially if you are elderly.
If you are taking medicines called mTOR inhibitors (eg temsirolimus, everolimus, sirolimus) or vildagliptin, as they may increase the risk of developing angioedema as a serious allergic reaction.
If you are suffering from collagenosis (scleroderma or systemic lupus).
If you are taking any of the following medicines used to treat high blood pressure:
angiotensin II receptor blocker (ARB) (also known as sartans - for example valsartan, telmisartan, irbesartan), 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 Accept the Triace Combo".
- If you have had a rapid increase in blood pressure (hypertensive crisis);
- If you are elderly and your dose should be increased;
- If you have a dry cough that lasts for a long time;
- If your blood pressure does not decrease enough. These drugs are less effective in black patients.

At any time of treatment, a severe allergic reaction may occur, which occurs with sudden swelling of the lips and face, tongue and throat, neck, possibly on the hands and feet, difficulties in swallowing or breathing, urticaria or hoarseness (angioedema ") Black people may have a higher risk of such a condition, and if you experience such symptoms, you should let them know
Erythromycin, clarithromycin (for infections caused by bacteria);
- Trimethoprim and co-trimoxazole (for infections caused by bacteria);
- Verapamil, diltiazem (medicines used to treat heart disease or high blood pressure);
- Dantrolene (infusion at severe body temperature deviations);
- Tacrolimus (used to control the immune response of your body, allowing your body to receive a transplanted organ);
- Simvastatin (a cholesterol lowering drug).

Please tell your doctor if you are taking any of the following medicines whose actions can be changed by the Trials combo:
- medicines for diabetes, such as oral glucose lowering drugs and insulin. The Triathic Combo can lower your blood sugar. Check your blood sugar levels carefully while you are taking the Triace Combo;
- lithium (for mental problems). The Triace Combo can increase the amount of lithium in your blood. The amount of lithium should be closely monitored by your doctor;
- simvastatin (a cholesterol lowering drug). The Triacet Combo can increase the amount of simvastatin in your blood.

If any of the above applies to you (or you are not sure), talk to your doctor before taking the Triace Combo.

A trio combo with food, drinks and alcohol
The Triace Combo can be taken with or without food.
Drinking alcohol with the Triace Combo can make you feel dizzy or overwhelmed. Talk to your doctor about how much you can drink while taking the Triacet Combo, as medicines used to lower blood pressure and alcohol may have complementary effects.

Grapefruit or grapefruit juice should not be consumed by people taking the Triace Combo because they lead to an increase in the blood of the active ingredient amlodipine, which may cause unpredictable blood pressure lowering.

Pregnancy, breastfeeding and fertility
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 not take the Triace Combo during pregnancy.
If you become pregnant while taking the Triacet Combo, tell your doctor immediately. In planned pregnancy, therapy should be replaced with a suitable alternative.

Breastfeeding
You should not take the Triace Combo if you are breast-feeding.
You should talk to your doctor before taking any medicine.

Fertility
There is insufficient data on the potential effect on fertility.

Driving and using machines
The triathic combo may affect your ability to drive and operate machinery. If the Triace Combo makes you feel sick, dizzy or tired, or causes you headaches, do not drive or operate machinery, and contact your doctor immediately. This can happen especially at the beginning of treatment or when switching to other medications.

3. How to take the Triace Combo

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
If you have the feeling that the effect of the Triace Combo is too strong or too weak, talk to your doctor or pharmacist.

Take this medicine orally at the same time each day, before or after a meal.
Swallow the capsules whole with liquid.
Do not take the Triace Combo with grapefruit juice.
The Triacet Combo should be given once a day.
The doctor may change the dose depending on the effect of the medication.
The maximum daily dose is one 10 mg / 5 mg capsule.

Elderly
Your doctor will recommend a lower starting dose and a slower adjustment of the treatment.

Use in children and adolescents
Triacets Combo is not recommended in children and adolescents under 18 because there is no information available in this population.

If you take more Triacets Combo than you should
Taking too many capsules can cause a decrease in blood pressure. You may experience dizziness, dizziness, tiredness or weakness. If the fall in blood pressure is very severe, shock may occur. You may feel your skin cold and damp and lose consciousness. Talk to a doctor or go to the nearest emergency medical center immediately. Do not drive to the hospital, ask someone else to take you or call for an ambulance. Take the medicine pack with you so your doctor can understand what you have taken.

If you have missed a Troyes combo
If you have missed taking the medicine, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking the Triace Combo
Your doctor will advise you how long to take your medicine. Your condition may resume if you stop taking your medicine before you are advised 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.

Stop taking the Triace Combo and seek a doctor immediately if you notice any of the following serious side effects - you may need urgent medical treatment:
- Swelling of the face, lips or throat that hinder swallowing or breathing, as well as itching and rash. This may be a sign of a severe allergic reaction to the Triace Combo.
- Severe skin reaction including rash, mouth sores, worsening of existing skin disease, redness, blistering or skin peeling (eg Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) or other allergic reactions.

The frequency of the above side effects was classified as unknown (can not be estimated from the available data).

Instantly contact a doctor if you get:
- Increased heart rate, irregular or excessive palpitation, chest pain, tightness in the chest or more serious problems including heart attack and stroke.
- Shortness of breath or cough. These may be signs of lung problems.
- Easier bruising, longer bleeding than normal, any bleeding (e.g., gum bleeding), purple spots covering the skin; easier infections, sore throat and fever, feeling tired, dizzy or pale skin. These may be signs of blood or bone marrow problems.
Strong pain in the stomach that can spread to the back. This may be a sign of pancreatitis (inflammation of the pancreas).
- Fever, chills, tiredness, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:
Please tell your doctor if any of these things become serious or continue for more than a few days.

Very common: may affect more than 1 in 10 people:
- Swelling of the ankles (edema).

Common (may affect 1 to 10 people):
- Drowsiness (especially at the beginning of treatment);
- Palpitations (feeling of heartbeat), redness;
- Headache or tiredness, weakness;
- Feeling dizzy. It is more likely to occur at the onset of Tricicle Combo or when the dose is increased;
- Seizure, hypotension (abnormally low blood pressure), especially when suddenly standing up from a lying or sitting position;
- Dry irritant cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath;
- Abdominal pain, stomach or intestinal pain, changes in the usual intestinal peristalsis (including diarrhea or constipation), indigestion, nausea or vomiting;
- Skin rash with or without edema
- Chest pain;
- Disturbed vision, double vision;
- Getting or pain in the muscles;
- Blood tests showing elevated potassium levels in the blood.

Uncommon (may affect up to 1 in 100 people):
- Mood changes, insomnia;
- Tremor, malaise;
- Blurred vision;
- Sneezing / runny nose caused by inflammation of the lining of the nose (rhinitis);
- Acid, dry mouth;
- Hair loss, increased sweating, skin pruritus, red spots on the skin, change in skin color;
- Disturbed urination, frequent urinary urgency, increased urination frequency;
- Inability to get an erection, sexual inability to men, reduced sexual desire in men or women;
- Discomfort or breast enlargement in men;
- Common or muscle pain, back pain;
- Increase or decrease in body weight;
- Disturbed balance (vertigo);
- Itching and unusual skin sensations such as tingling, tingling, pricking, burning or cracking (paraesthesia), loss of pain;
- Loss or change in taste;
- Sleep problems;
- Feeling of anxiety, anxiety, more nervousness or insecurity than usual;
- Obstructed nose, difficulty in breathing or worsening of asthma
- Swollen intestine, called "intestinal angioedema," in which there are symptoms such as abdominal pain and vomiting;
- Loss or decrease in appetite (anorexia);
- Accelerated or irregular heartbeat;
Swollen hands or legs. This may be a sign of retention of more fluid in the body;
- Fever;
- Increased white blood cell count (eosinophilia) found in blood tests
- Blood tests showing changes in liver, pancreas or kidney function.

Rare (may affect up to 1 in 1,000 people):
- A sense of insecurity or confusion;
- Red and swollen tongue;
- Severe scaling or peeling of the skin, itchy, raised rash;
- nail problems (for example, loss or separation of the nail from the nail bed);
- Skin rash or bruising
- Urticaria;
- Skin patches and cold limbs;
- Red, itchy, swollen or wrinkling eyes;
- Disturbed hearing or ringing in the ears;
- Blood
5. How to store a Tritace combo

Store below 30 ° C.
Store in the original package in order to protect from light.
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.

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 is the Tritace combo?
- The active substances are:
10 mg / 5 mg, hard capsules: Each capsule contains 10 mg ramipril and amlodipine besilate equivalent to 5 mg amlodipine.
- The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate, anhydrous, pregelatinised maize starch, sodium starch glycollate (type A), sodium stearyl fumarate, red iron oxide (E172), titanium dioxide (E171), gelatin.

What the Tritace Combo looks like and what the package contains
Triacets Combo 10 mg / 5 mg hard capsules: hard gelatin capsules, lid: matte, pink in color, body: matte, white in color. Capsule contents: white or off-white powder.

The Tritace Combo is available in blister packs containing 28, 30, 32, 56, 60, 90, 91, 96, 98 or 100 capsules.
Not all pack sizes may be marketed.

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