TRIAMLO 2.5 мг/5 мг Капсулы

Содержание инструкции

1. TRIAMLO 2.5 mg/5 mg, hard capsules, 5 mg/5 mg, hard capsules, 10 mg/5 mg, hard capsules, 5 mg/10 mg, hard capsules, 10 mg/10 mg, hard capsules
   1. What is TRIAMLO and what is it used for
   2. What you need to know before taking TRIAMLO
   3. How to take TRIAMLO
   4. Possible side effects
   5. How to store TRIAMLO
   6. Package Contents and Other Information

TRIAMLO 2.5 mg/5 mg, hard capsules, 5 mg/5 mg, hard capsules, 10 mg/5 mg, hard capsules, 5 mg/10 mg, hard capsules, 10 mg/10 mg, hard capsules

ramipril/amlodipine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What TRIAMLO is and what it is used for
• 2. What you need to know before you take TRIAMLO
• 3. How to take TRIAMLO
• 4. Possible side effects
• 5. How to store TRIAMLO
• 6. Contents of the pack and other information

1. What is TRIAMLO and what is it used for

TRIAMLO contains two active ingredients: 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 channel blockers.
Ramipril works as follows:

• It decreases the production of a substance in our body that could raise blood pressure;
• It relaxes the blood vessels and dilates them;
• It makes it easier for the heart to pump blood throughout the body.

Amlodipine works as follows:

• It relaxes and dilates the blood vessels, so that blood can flow through them more easily.

TRIAMLO is used to treat high blood pressure (hypertension), in patients in whom the
high blood pressure is adequately controlled with amlodipine and ramipril administered
simultaneously at the same dose as TRIAMLO, but as separate medicines.

2. What you need to know before taking TRIAMLO

Do not take TRIAMLO

• If you are allergic to ramipril or amlodipine, or to any other ACE inhibitor or calcium channel blocker, or to any of the other components of this medicine (listed in

section 6). Signs of an allergic reaction can include skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

• If you have had a severe allergic reaction called “angioedema”. The signs include itching, rash (hives), red marks on hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults. Talk to your doctor or pharmacist if you are using, have recently used or might use sacubitril/valsartan.
• If you are on dialysis or undergoing another type of blood filtration. Depending on the type of machine used, treatment with TRIAMLO may not be suitable for you.
• If you have kidney problems where the blood supply to the kidney is reduced (renal artery stenosis).
• During the last 6 months of pregnancy (see section below on "Pregnancy, breastfeeding and fertility”).
• If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• If your blood pressure is too low or unstable. Your doctor will need to make an assessment.
• If you have a narrowing of the aortic valve of the heart (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide sufficient blood to the body).
• If you suffer from heart failure after a heart attack.

Do not take TRIAMLO if any of the conditions mentioned above apply to you. If you are not
sure, talk to your doctor before taking TRIAMLO.

Warnings and precautions
Talk to your doctor or pharmacist before taking TRIAMLO.
Talk to your doctor if any of the following conditions apply to you:

• If you have problems with your heart, liver or kidneys.
• If you have lost a lot of salts or fluids (due to vomiting, diarrhea, sweating more than normal, following a low-salt diet, if you have been taking diuretics (water tablets) for a long time or if you are undergoing dialysis).
• If you are being treated to reduce your allergy to bee or wasp stings (desensitization).
• If you are receiving an anesthetic. This may be given for an operation or dental procedure. In such cases, you may need to stop taking TRIAMLO the day before; talk to your doctor to inform them.
• If you have high levels of potassium in your blood (detected by blood tests).
• If you are taking medicines or have conditions in which the level of sodium in your blood may decrease. Your doctor may ask you to have blood tests regularly, especially to check the levels of sodium in your blood, particularly if you are elderly.
• If you are taking medicines that can increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin or neprilysin inhibitors (NEP) (such as racecadotril).
• If you have a collagen-vascular disease such as scleroderma or systemic lupus erythematosus.
• You must tell your doctor if you think you may be pregnant (or might become pregnant). TRIAMLO is not recommended in the first 3 months of pregnancy and can cause serious harm to the baby after 3 months of pregnancy (see below “Pregnancy and breastfeeding”).
• If you are taking any of the following medicines used to treat high blood pressure:
• An angiotensin II receptor blocker (ARB) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• Aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood, at regular intervals. See also what is stated under "Do not take TRIAMLO”.
• If you have a severe increase in blood pressure (hypertensive crisis).
• If you are elderly and a dose increase is necessary.
• If you develop a dry cough that persists for a long time.
• If the blood pressure is not lowered sufficiently. Medicines of this type seem to be less effective in people of black skin.

If you suffer from sudden swelling of the lips and face, tongue and throat, neck, possibly also
of the hands and feet, difficulty swallowing or breathing, hives or hoarseness (angioedema).
This may be a sign of a serious allergic reaction. Such effects can occur at any
time during treatment. People with black skin may have a higher risk of
suffering from this condition. If you develop such symptoms, you should inform your doctor immediately.

Children and adolescents
TRIAMLO is not recommended for use in children and adolescents under 18 years of age
due to the lack of data in this patient population.

Other medicines and TRIAMLO
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Tell your doctor if you are taking any of the following
medicines. They can make the effect of TRIAMLO less effective:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, aspirin).
• Medicines used to treat low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, norepinephrine or epinephrine. Your doctor will need to check your blood pressure.
• Hypericum perforatum(St. John's wort used to treat depression).

Talk to your doctor if you are taking any of the following medicines. They may increase
the possibility of having undesirable effects if they are taken with TRIAMLO. Your doctor may
need to change the dose and/or take other precautions:

• Sacubitril/valsartan - used to treat a long-term (chronic) type of heart failure in adults (see also information in section 2 “Do not take TRIAMLO”).
• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacin and acetylsalicylic acid).
• Cancer medicines (chemotherapy).
• Medicines to prevent organ rejection after a transplant, such as cyclosporine.
• Diuretics (water tablets) such as furosemide.
• An angiotensin II receptor blocker (ARB) or aliskiren (see also what is stated under "Do not take TRIAMLO" and "Warnings and precautions”).
• Medicines that can increase the amount of potassium in the blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (to reduce blood clotting).
• Steroid medicines for inflammation such as prednisolone.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent transplant rejection).
• Vildagliptin (used to treat type II diabetes).
• Racecadotril (used for the treatment of diarrhea).
• Ketoconazole, itraconazole (medicines used to treat fungal infections).
• Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat patients with HIV).
• Rifampicin, erythromycin, clarithromycin (antibiotics used to treat bacterial infections).
• Trimethoprim and cotrimoxazole (for infections caused by bacteria).
• Verapamil, diltiazem (medicines used to treat heart disease or high blood pressure).
• Dantrolene (for infusion for severe abnormalities of body temperature).
• Tacrolimus (a medicine used to prevent transplant rejection as it reduces the activity of the immune system).
• Simvastatin (a medicine that lowers cholesterol levels in the blood).

Talk to your doctor if you are taking any of the following medicines. Their effect may be
influenced by TRIAMLO:

• Medicines for diabetes such as those used orally that lower glucose (blood sugar) in the blood and insulin. TRIAMLO may lower blood sugar levels. Carefully monitor your blood sugar (glucose) levels while taking TRIAMLO.
• Lithium (for mental health problems). TRIAMLO may increase the amount of lithium in your blood. Your doctor needs to check the amount of lithium in your blood carefully.
• Simvastatin (a medicine that lowers cholesterol levels in the blood). TRIAMLO may increase the amount of simvastatin in your blood.

If any of the conditions above apply to you (or you are not sure), talk
to your doctor before taking TRIAMLO.

TRIAMLO with food, beverages and alcohol
TRIAMLO can be taken with or without food.
Consuming alcohol during treatment with TRIAMLO may cause dizziness or a feeling of
mental confusion. If you want to know how much alcohol you can drink during therapy with TRIAMLO,
discuss this with your doctor, as the effects of medicines used to lower blood pressure
and the effects of alcohol can add up.
Grapefruit or grapefruit juice should not be consumed by people who are taking
TRIAMLO. This is because grapefruit or grapefruit juice can lead to an increase in the
level of the active substance amlodipine in the blood, which can cause an unpredictable
increase in the hypotensive (blood pressure lowering) effect of TRIAMLO.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning to become
pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You should not take TRIAMLO in the first 12 weeks of pregnancy and should definitely not take it
from the 13th week onwards because its use during pregnancy can be harmful to the baby.
If you become pregnant while taking TRIAMLO, tell your doctor immediately. The
switch to a suitable alternative treatment should be initiated before planning a
pregnancy.

Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts.
You should not take TRIAMLO if you are breastfeeding.
You should talk to your doctor or pharmacist before taking any medicine.

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

Driving and operating machinery
TRIAMLO may affect your ability to drive or operate machinery. If TRIAMLO makes you feel
unwell, causes dizziness or fatigue, or gives you a headache, do not drive or operate machinery and contact
your doctor immediately. This can occur especially at the beginning of treatment, or when
you are switching to TRIAMLO from therapies performed with other medicines.
TRIAMLO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is practically
“sodium-free”.

3. How to take TRIAMLO

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
If you feel that the effect of TRIAMLO is too strong or too weak, talk to your doctor
or your pharmacist.
Take this medicine by mouth at the same time of each day, before or after a meal.
Swallow the capsule whole with some liquid.
Do not take TRIAMLO with grapefruit juice.
TRIAMLO must be administered once a day.
The doctor may modify the dose based on the effect the medicine has on you.
The maximum daily dose is one capsule with a dosage of 10 mg/10 mg.

Elderly
The doctor will reduce the initial dose and adjust the treatment more slowly.

Use in children and adolescents
TRIAMLO is not recommended for use in children and adolescents under 18 years of age, as there is no
data available in this population.

Patients with impaired liver function
The doctor may prescribe a different dose.

If you take more TRIAMLO than you should
Taking too many capsules can cause a decrease in blood pressure to the point of
being potentially dangerous. You may feel dizzy, stunned, and weak. If the
drop in blood pressure is significant, shock may occur. You may feel cold and sweaty skin
and may lose consciousness. Talk to your doctor or go immediately to the emergency room of the nearest
hospital. Do not drive to the hospital, ask someone to take you or call an ambulance.
Bring the package of the medicine with you. This way the doctor is informed about what you have taken.

If you forget to take TRIAMLO
If you forget to take a capsule, skip that dose completely. 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 TRIAMLO
The doctor will tell you how long you should take the medicine. Your condition may
recur if you stop taking the medicine before it is recommended.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking TRIAMLO and consult your 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 makes it difficult to swallow or breathe, as well as itching and rash. This may be a sign of a severe allergic reaction to TRIAMLO.
• Severe skin reactions including rashes, ulcers in the mouth, worsening of a pre-existing skin disease, redness, blisters or peeling of the skin (such as in Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) or other allergic reactions. The frequency of the above-mentioned side effects is classified as not known (cannot be estimated based on available data).

Talk to your doctor immediately if you experience:

• Fast heartbeat, irregular or stronger heartbeat (palpitations), chest pain, feeling of tightness in the chest or more serious problems such as heart attack and stroke.
• Shortness of breath or cough. These may be signs of lung problems.
• Increased ease of bruising, bleeding for longer than usual, any sign of bleeding (e.g. bleeding gums), purple spots, blotches on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, fainting, dizziness or being pale. These may be signs of problems with the blood or bone marrow.
• Severe stomach pain that may radiate to the back. This could be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems, as well as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:
Tell your doctor if any of the following effects becomes serious or if it lasts for more than a few days.

Very common (may affect more than 1 in 10 people)

• Swelling of the ankles (edema).

Common (may affect up to 1 in 10 people)

• Drowsiness (especially at the beginning of treatment).
• Palpitations (feeling your heartbeat), hot flushes.
• Headache or feeling tired, weak.
• Feeling dizzy. This is more likely to happen when you start taking TRIAMLO or when you start taking a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when getting up or lying down quickly.
• Dry, tickly cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath.
• Abdominal, stomach or intestinal pain, altered bowel habits (including diarrhea or constipation), indigestion, feeling or being unwell.
• Rash with or without raised areas.
• Chest pain.
• Visual disturbances, double vision.
• Muscle cramps or pain.
• Blood tests showing more potassium than normal in the blood.

Uncommon (may affect up to 1 in 100 people)

• Mood changes, insomnia.
• Tremor, feeling unwell.
• Blurred vision.
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis).
• Heartburn, dry mouth.
• Hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration.
• Difficulty passing urine, increased need to urinate, especially at night, increased number of times you urinate.
• Inability to have an erection, sexual dysfunction in men, decreased sexual desire in men or women.
• Discomfort or enlargement of the breasts in men.
• Joint or muscle pain, back pain.
• Weight gain or loss.
• Balance problems (vertigo).
• Itching and unusual skin sensations such as numbness, tingling, prickling, burning or feeling something crawling on the skin (paresthesia), loss of pain sensation.
• Loss or alteration of taste.
• Sleep problems.
• Feeling depressed, anxious, more nervous than usual or restlessness.
• Blocked nose, difficulty breathing or worsening of asthma.
• A swelling in the intestine called “intestinal angioedema” which presents with symptoms such as abdominal pain and vomiting.
• Loss or decrease of appetite (anorexia).
• Irregular or increased heartbeat.
• Swelling of the arms and legs. This may be a sign that the body is retaining more fluid than normal.
• Fever.
• Blood tests showing an increase in some white blood cells (eosinophilia).
• Blood tests showing changes in liver, pancreas or kidney function.

Rare (may affect up to 1 in 1000 people)

• Feeling of shaking or confusion.
• Red and swollen tongue.
• Severe scaling or cracking of the skin, itching, raised rash.
• Nail problems (e.g. nail loss or separation of the nail from its bed).
• Rash or bruising.
• Hives.
• Spots on the skin and cold extremities.
• Red, swollen, itchy or watery eyes.
• Hearing problems and ringing in the ears.
• Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or the amount of hemoglobin.

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

• Increased sensitivity to the sun than usual.
• Excess sugar (glucose) in the blood (hyperglycemia).
• Swelling of the gums.
• Stomach swelling (gastritis).
• Impaired liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may have an effect on some medical tests.
• Increased muscle tension.
• Inflammation of blood vessels, often with a rash.
• Sensitivity to light.
• Disorders associated with stiffness, tremor and/or movement disorders.
• Nerve disorder that can cause weakness, tingling or numbness (peripheral neuropathy).

Not known (frequency cannot be estimated based on available data)

• Concentrated urine (dark in color), feeling unwell, muscle cramps, confusion and convulsions which may be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms contact your doctor immediately.
• Tremor, stiff posture, “mask-like” face, slow movements, unbalanced and shuffling gait.

Other side effects reported:
Tell your doctor if any of the following effects becomes serious or if it lasts for more than a few days.

• Difficulty concentrating.
• Swollen mouth.
• Blood tests showing too few circulating cells in the blood.
• Blood tests showing a decrease in sodium levels in the blood compared to normal values.
• Fingers and toes that change color when cold and then tingling or pain when warmed (Raynaud's phenomenon).
• Slowed or impaired reactions.
• Changes in the perception of smells.
• Psoriasis.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store TRIAMLO

Keep this medicine out of the sight and reach of children.
Store at a temperature below 30°C and in the original package to protect the medicine
from light.
Do not use this medicine after the expiry date which is reported on the box and on the blister after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What TRIAMLO contains

• The active ingredients are:

TRIAMLO 2.5 mg/5 mg:
Each capsule contains 2.5 mg ramipril and amlodipine besylate equivalent to 5 mg amlodipine.
TRIAMLO 5 mg /5 mg:
Each capsule contains 5 mg ramipril and amlodipine besylate equivalent to 5 mg amlodipine.
TRIAMLO 10 mg /5 mg:
Each capsule contains 10 mg ramipril and amlodipine besylate equivalent to 5 mg amlodipine.
TRIAMLO 5 mg/10 mg:
Each capsule contains 5 mg ramipril and amlodipine besylate equivalent to 10 mg amlodipine.
TRIAMLO 10 mg /10 mg:
Each capsule contains 10 mg ramipril and amlodipine besylate equivalent to 10 mg amlodipine.

• The other ingredients are: microcrystalline cellulose, dibasic calcium phosphate anhydrous, pregelatinized starch, sodium starch glycolate (type A), sodium stearyl fumarate, red iron oxide (E 172), titanium dioxide (E 171), gelatin, yellow iron oxide (E 172) (10 mg/10 mg), black iron oxide (E 172) (10 mg/10 mg)

Description of the appearance of TRIAMLO and package contents
TRIAMLO 2.5 mg/5 mg:
Hard gelatin capsules, cap: opaque, light pink in color, body: opaque, white in color.
Capsule content: white to off-white powder.
TRIAMLO 5 mg/5 mg:
Hard gelatin capsules, cap: opaque, pink in color, body: opaque, white in color.
Capsule content: white to off-white powder.
TRIAMLO 10 mg/5 mg:
Hard gelatin capsules, cap: opaque, dark pink in color, body: opaque, white in color.
Capsule content: white to off-white powder.
TRIAMLO 5 mg/10 mg:
Hard gelatin capsules, cap: opaque, reddish-brown in color, body: opaque, white in color.
Capsule content: white to off-white powder.
TRIAMLO 10 mg/10 mg:
Hard gelatin capsules, cap: opaque, brown in color, body: opaque, white in color.
Capsule content: white to off-white powder.
TRIAMLO is available in packs containing 28, 30, 32, 56, 60, 90, 91, 96, 98 or 100 capsules,
contained in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Sanofi S.p.A.
Viale L. Bodio, 37/B
20158 Milan

Manufacturers
Adamed Pharma S.A.
Szkolna 33 str., 95-054 Ksawerów
Poland
Adamed Pharma S.A.
Marszalka Jósefa Pilsudskiego 5 str, 95-200 Pabianice
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Slovak Republic Ramipril/Amlodipin Sanofi
Czech Republic Tritace Combi
Poland Amrap
Bulgaria Tritace combo
Italy, Greece, Cyprus Triamlo