TRIAPIN 5 mg/5 mg Extended-Release Tablet

Зміст інструкції

1. Triapin 5 mg/5 mg prolonged-release tablets
   1. What is Triapin and what is it used for
   2. What you need to know before using Triapin
   3. How to take Triapin
   4. Possible side effects
   5. How to store Triapin
   6. Contents of the pack and other information

Triapin 5 mg/5 mg prolonged-release tablets

ramipril/felodipine

Read this leaflet carefully before you start to use 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 Triapin is and what it is used for
• 2. What you need to know before you use Triapin
• 3. How to use Triapin
• 4. Possible side effects
• 5. How to store Triapin
• 6. Contents of the pack and other information

1. What is Triapin and what is it used for

Triapin 5 mg/5 mg prolonged-release tablets (also called Triapin in this leaflet) contains two medicines called ramipril and felodipine.

• Ramipril belongs to a group of medicines called “Angiotensin Converting Enzyme Inhibitors” (ACE inhibitors). It works by preventing the production of substances that increase blood pressure and makes blood vessels relaxed and wide.
• Felodipine belongs to a group of medicines called “calcium antagonists”. It makes blood vessels relaxed and wide. This helps to lower blood pressure.

Triapin tablets are used to treat high blood pressure
(hypertension). High blood pressure can increase the likelihood that you will have
problems such as heart disease, kidney disease and stroke. This medicine lowers your
blood pressure and decreases the risk of these problems.

2. What you need to know before using Triapin

Do not take Triapin if:

• You are allergic to: ramipril or another ACE inhibitor or felodipine or another calcium antagonist or any of the other ingredients of this medicine (listed in section 6).
• You have already had a serious allergic reaction called “angioedema”. Symptoms include itching, hives, red marks on hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing. Taking this medicine may increase the risk of having a more serious attack of this condition.
• You have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.
• You suffer from heart problems such as heart failure, obstructions to the heart, unstable angina, a heart condition called “second or third degree atrioventricular block”, have already had a heart attack (acute myocardial infarction) or a stroke (disturbance of blood circulation in the brain).
• You suffer from a severe kidney disease.
• You are undergoing dialysis.
• You suffer from a severe liver disease.
• You are pregnant, trying to become pregnant or breastfeeding (see “Pregnancy and breastfeeding” below).
• You suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren Do not take this medicine if any of these conditions apply to you. If you are not sure, consult your doctor or pharmacist before taking Triapin.

Warnings and precautions
Talk to your doctor or pharmacist before taking Triapin if:

• You suffer from a kidney disease, diabetes mellitus or are taking medicines that increase potassium. Your doctor may prescribe blood tests at regular intervals, especially to check your blood potassium levels
• You are taking medicines or are in conditions where sodium levels in the blood may decrease. The doctor may prescribe blood tests at regular intervals, especially to check sodium levels in the blood, especially if you are elderly
• You are taking medicines that may increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril) or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Triapin if”
• You suffer from a disease of the renal artery
• You suffer from a narrowing of the main blood vessel leaving the heart (aortic stenosis) or a disease of the heart muscle (hypertrophic cardiomyopathy)
• You suffer from any other heart disease
• You suffer from systemic lupus erythematosus or scleroderma
• You suffer from a liver disease
• You are about to undergo anesthesia or surgery
• You are taking medicines that lower the number of certain blood cells
• You are of black race because this medicine may have less effect on your blood pressure and more side effects
• You are about to have treatment to reduce the effects of an allergy to bee or wasp stings (desensitization)
• You are having treatment where your blood is treated outside the body, such as “low-density lipoprotein apheresis”
• You have swollen gums which may be a sign of gingivitis or periodontitis. Careful dental hygiene may be necessary to avoid additional gum problems, such as an increase in gum size
• You are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes
• aliskiren.

The 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 in the section "Do not take TRIAPIN".

Other medicines and Triapin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, even those available without a prescription, including herbal medicines.
This is because Triapin can change the way other medicines work. Also other
medicines can change the way Triapin works.
In particular, tell your doctor if you are taking or are being treated with any of the following:

• Sacubitril/valsartan - used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Triapin if”)
• Medicines used to lower high blood pressure (antihypertensives), including those containing aliskiren, and other medicines that lower blood pressure (nitrates, antipsychotics, narcotics and anesthetics)
• Medicines used to treat HIV infection
• Procainamide - used to treat heart rhythm disorders
• Diuretic tablets that can cause high potassium levels in the blood such as amiloride, spironolactone, triamterene
• Heparin - used to thin the blood
• Lithium preparations - used to treat mania, depression and manic-depressive illness
• Phenytoin, carbamazepine and barbiturates. These medicines are usually used to treat epilepsy, seizures and convulsions. Barbiturates are also used for sleep problems
• Theophylline - used to treat asthma
• Sympathomimetics such as adrenaline, noradrenaline or ephedrine (medicines that act on the heart and blood vessels)
• Erythromycin, itraconazole, ketoconazole - used to treat infections
• Rifampicin - used to treat tuberculosis
• Allopurinol - used to treat gout
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used to relieve pain and inflammation
• Immunosuppressants - used in rheumatoid arthritis and after organ transplantation
• Tacrolimus which is a medicine used to prevent the body from rejecting a transplanted organ, such as a kidney or liver
• Sirolimus, everolimus (for transplant rejection prevention)
• Racecadotril (for diarrhea)
• Temsirolimus (for cancer)
• Cytostatic drugs - used to treat cancer
• Insulin, glibenclamide, metformin, vildagliptin and other medicines used for diabetes mellitus
• Glucocorticoids (“steroids”)
• Potassium salts
• Trimethoprim alone or in combination with sulfamethoxazole - used for infections
• St. John's Wort (hypericum)

The doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is stated in the section "Do not take TRIAPIN" and "Warnings and precautions“)

If you are not sure if any of these apply to you, consult your doctor or pharmacist before taking
Triapin.

Triapin with food and drink

• Taking the tablet with alcoholic beverages may increase the effects of the medicine
• It is recommended not to take this medicine with grapefruit juice
• Increasing the amount of salt in the diet may decrease the effects of this medicine
• Take the tablets on an empty stomach or after a light meal

Pregnancy and breastfeeding
Do not take Triapin if:

• You are pregnant, suspect you may be pregnant or are planning a pregnancy. This is because the medicine could harm the baby.
• You are breastfeeding or planning to do so. This is because small amounts of the medicine can pass into breast milk. If you think you may have become pregnant while taking Triapin, tell your doctor immediately. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
You may feel dizzy or lightheaded after taking this medicine. If
this happens, do not drive and do not use machinery.

Triapin contains lactose and hydrogenated castor oil
This medicine contains lactose, a type of sugar. If you have been diagnosed
with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains hydrogenated castor oil. It can cause stomach upset or diarrhea.

3. How to take Triapin

Always take this medicine exactly as your doctor has instructed. If you have any doubts
consult your doctor or pharmacist.
Triapin is only for adults. Do not give it to children.

Taking this medicine

• Take this medicine by mouth
• Take the tablets on an empty stomach or after a light meal
• Swallow the tablets whole with half a glass of water or another beverage. Do not break, chew or suck on the tablets.
• Do not take the tablets with grapefruit juice or alcoholic beverages

How much medicine to take

• Usually the dose is 1 tablet of Triapin 1 time a day
• If you are already taking diuretics (medicines to help you urinate), your doctor may stop or reduce the amount of diuretic to take before starting treatment with Triapin.

Use in children
Do not give Triapin to children.

If you take more Triapin than you should
If you have taken more Triapin than you should, inform your doctor or go immediately to the
emergency room of the nearest hospital. Bring the medicine package with you. This is so
that doctors know what you have taken. You may feel dizzy or lightheaded
because your blood pressure is too low.

If you forget to take Triapin
If you have forgotten to take a dose and remember it on the same day:

• Take it as soon as you remember
• The next day take your usual dose of Triapin

If you have forgotten to take a dose and remember it the next day:

• take your usual dose of Triapin
• do not take a double dose to make up for a missed dose.

If you stop taking Triapin
Continue treatment until your doctor tells you to stop. Do not stop taking this
medicine just because you feel better. If you stop, your blood pressure may rise again.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Triapin and contact 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, making it difficult to swallow or breathe, as well as itching and rash. These may be symptoms of a severe allergic reaction to Triapin
• Severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Tell your doctor immediately if you experience:

• Increased heart rate, irregular or strong heartbeat (palpitations), chest pain, feeling of 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
• Bruising more easily, bleeding for longer than usual, any sign of bleeding (for example bleeding gums), purplish spots, skin spots or getting infections more than usual, sore throat or fever, feeling tired, fainting, dizziness or paleness of the skin. These may be symptoms of problems with the blood or bone marrow
• Severe stomach pain that may spread to your back. This could be a symptom 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 symptoms of liver problems such as hepatitis (inflammation of the liver) or liver damage.

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

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

• Swelling of the arms and legs. This may be a sign that your body is retaining more water than usual

Common(may affect up to 1 in 10 people)

• Headache or feeling tired
• Feeling dizzy. This is more likely to happen when you start treatment with TRIAPIN or start taking a higher dose
• Fainting, low blood pressure (unusually low blood pressure), especially when standing up or getting up quickly
• Hot flushes
• Dry, tickly cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
• Stomach or intestinal pain, diarrhea, indigestion, nausea or vomiting
• Rash with or without swelling
• Chest pain
• Muscle cramps or pain
• Blood tests show a higher than normal level of potassium.

Uncommon(may affect up to 1 in 100 people)

• Balance problems (vertigo)
• Itching and unusual skin sensations such as numbness, tingling, prickling, burning or chafing (paresthesia)
• Loss or change of taste
• Difficulty sleeping
• Depressed mood, anxiety, increased nervousness than usual or irritability
• Blocked nose, difficulty breathing or worsening of asthma
• Swelling of the intestine called “intestinal angioedema” which presents with symptoms such as abdominal pain, vomiting and diarrhea
• Heartburn, constipation or dry mouth
• Increased amount of urine during the day
• Increased sweating than usual
• Loss or decrease of appetite (anorexia)
• Fast or irregular heartbeat
• Blurred vision
• Joint pain
• Fever
• Impotence in men, reduced sexual desire in men and women
• Increased number of certain white blood cells (eosinophilia) found during blood tests
• Changes in liver, pancreas or kidney function tests highlighted by blood tests.

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

• Feeling faint or confused
• Swollen and red tongue
• Severe flaking or peeling of the skin, itching, rash characterized by pustules
• Problems with nails (such as loss or separation of the nail from its bed)
• Rash or bruising
• Spots on the skin and cold extremities
• Red, swollen, watery or itchy eyes
• Hearing problems and ringing in the ears
• Feeling weak
• Decreased number of red blood cells, white blood cells or platelets in the blood or concentration of hemoglobin, highlighted by blood tests
• Reduced sexual function in men and women

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

• Increased sensitivity to the sun than usual
• Slight swelling of the gums or bleeding gums
• Higher levels of sugar in the blood highlighted by blood tests

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

• Difficulty concentrating
• Swelling of the mouth
• Blood tests showing a low number of blood cells
• Blood tests showing a low level of sodium in the blood
• Concentrated urine (dark in color), feeling unwell or sick, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms contact your doctor promptly
• Fingers and toes that change color when cooled and tingle or hurt when warmed (Raynaud’s phenomenon)
• Increase in breast volume in men
• Slowed or altered reactions
• Burning sensation
• Change in the perception of smells
• Hair loss.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Triapin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp”. The
expiry date refers to the last day of the month.
Store the tablets in the original package at a temperature below 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Triapin contains

• The active ingredients of Triapin are: ramipril and felodipine.
• Triapin 5 mg/5 mg tablets contains 5 mg of ramipril and 5 mg of felodipine
• The other ingredients are: hypromellose, hydroxypropyl cellulose, anhydrous lactose, corn starch, microcrystalline cellulose, polyethylene glycol, hydrogenated castor oil polyoxyl 40, propyl gallate, sodium aluminosilicate, sodium stearyl fumarate, iron oxides E172, titanium dioxide E171 and paraffin.

Description of the appearance of Triapin and contents of the pack

• Triapin 5 mg/5 mg tablets are reddish-brown in colour and have “H/OE” imprinted on one side and “5” on the other side
• Triapin is available in blister packs of 10, 14, 15, 21, 28, 30, 50, 98 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi S.R.L. – Viale L. Bodio, 37/B – Milan
Manufacturer:
Chinoin Private Co.Ltd – Veresegyhaz, Hungary
Sanofi Aventis Deutschland GmbH - Industriepark Höechst, Brüningstraβe 50, D-65926 Frankfurt
am Main, Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Ireland, Italy, Portugal, Spain, United Kingdom: Triapin
Portugal: Triapin Mite
Belgium, Luxembourg: Tazko
Greece: Triacor
Germany: Delmuno.