Triapin

Package leaflet: Information for the user

Triapin 5 mg/5 mg prolonged-release tablets

ramipril/felodipine
Please read this leaflet carefully before you start taking this medicine because 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. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform 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 taking Triapin
3. How to take Triapin
4. Possible side effects
5. How to store Triapin
6. Contents of the pack and other information

1. What Triapin is and what it is used for

Triapin 5 mg/5 mg prolonged-release tablets (also referred to as 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 formation of substances that raise blood pressure, thereby relaxing and widening blood vessels.
• Felodipine belongs to a group of medicines called “calcium antagonists”. It relaxes and widens blood vessels. This helps lower blood pressure.

Triapin tablets are used to treat high blood pressure (hypertension). High blood pressure increases the risk of developing health problems such as heart disease, kidney disease, and stroke. This medicine lowers blood pressure and reduces the risk of these complications.

2. What you need to know before taking Triapin

Do not take Triapin if:

• You are allergic to ramipril or another ACE inhibitor, felodipine or another calcium antagonist, or any of the other ingredients of this medicine (listed in section 6).
• You have previously had a serious allergic reaction called “angioedema”. Symptoms include itching, hives, red patches 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 a more severe episode of this condition.
• You are currently taking or have recently taken sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.
• You have heart problems such as heart failure, heart obstructions, unstable angina, a heart condition called “second- or third-degree atrioventricular block”, have previously had a heart attack (acute myocardial infarction) or a stroke (a disturbance in blood circulation in the brain).
• You have severe kidney disease.
• You are on dialysis.
• You have severe liver disease.
• You are pregnant, trying to become pregnant, or breastfeeding (see “Pregnancy and breastfeeding” below).
• You have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
  Do not take this medicine if any of these situations apply to you. If you are unsure, consult your doctor or pharmacist before taking Triapin.

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

• You have kidney disease, diabetes mellitus, or are taking medicines that increase potassium levels. Your doctor may prescribe regular blood tests, particularly to monitor potassium levels in your blood.
• You are taking medicines or have conditions that may reduce sodium levels in your blood. Your doctor may prescribe regular blood tests, particularly to monitor sodium levels in your 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 have renal artery disease.
• You have narrowing of the main blood vessel leaving the heart (aortic stenosis) or a heart muscle disease (hypertrophic cardiomyopathy).
• You have any other heart disease.
• You have systemic lupus erythematosus or scleroderma.
• You have liver disease.
• You are about to undergo anesthesia or surgery.
• You are taking medicines that reduce the number of certain blood cells.
• You are of Black African or African-Caribbean origin, as this medicine may be less effective in lowering your blood pressure and may cause more side effects.
• You are about to receive treatment to reduce the effects of an allergy to bee or wasp stings (desensitization).
• You are undergoing a treatment where your blood is processed 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 prevent further gum problems, such as gum overgrowth.
• You are taking any of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor antagonist (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
  • aliskiren.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also 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, including those without a prescription and herbal remedies.
This is because Triapin may alter how other medicines work. Likewise, other medicines may alter how Triapin works.
In particular, inform 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 may 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 bipolar disorder
• 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 transplants
• Tacrolimus – a medicine used to prevent rejection of a transplanted organ such as a kidney or liver
• Sirolimus, everolimus (to prevent transplant rejection)
• Racecadotril (for diarrhea)
• Temsirolimus (for cancer)
• Cytostatic agents – 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 perforatum)

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also “Do not take Triapin” and “Warnings and precautions”).

If you are unsure whether any of these situations 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 salt intake in your diet may reduce the effectiveness 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 to become pregnant. This is because the medicine may harm the unborn child.
• You are breastfeeding or planning to breastfeed. This is because small amounts of the medicine may pass into breast milk. If you think you may have become pregnant while taking Triapin, inform your doctor immediately. Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
You may experience dizziness or feel lightheaded after taking this medicine. If this occurs, do not drive or operate machinery.

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

3. How to take Triapin

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Triapin is for adults only. 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 drink. Do not break, chew, or suck 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 once daily
• If you are already taking diuretics (medicines to increase urine production), your doctor may stop or reduce the dose of your diuretic 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 have, inform your doctor or go immediately to the nearest hospital emergency department. Take the medicine pack with you so that the 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 forget to take a dose and remember on the same day:

• Take it as soon as you remember
• Take your usual dose the next day

If you forget to take a dose and remember only the next day:

• Take your usual dose of Triapin
• Do not take a double dose to make up for the missed dose

If you stop taking Triapin
Continue treatment for as long as your doctor tells you to. Do not stop taking this medicine just because you feel better. If you stop, your blood pressure may rise again.
If you have any questions about how to use 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 Triapin and contact your doctor immediately if you experience 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 skin rash. These may be symptoms of a severe allergic reaction to Triapin
• Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin disease, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Contact your doctor immediately if you experience:

• Rapid heartbeat, irregular or forceful heartbeat (palpitations), 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
• Bruising more easily, bleeding longer than usual, any signs of bleeding (for example, bleeding gums), purple spots, skin spots or increased frequency of infections, sore throat or fever, feeling of fatigue, fainting, dizziness or pale skin. These may be symptoms of blood or bone marrow problems
• Severe stomach pain that may spread to the 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 (liver inflammation) or liver damage.

Other side effects include:
Inform your doctor if any of the following conditions become severe or persist for more than a few days.
Very common (may affect more than 1 in 10 people)

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

Common (may affect up to 1 in 10 people)

• Headache or feeling tired
• Dizziness. This is more likely when starting Triapin treatment or increasing the dose
• Fainting, hypotension (unusually low blood pressure), especially when standing up or rising quickly
• Flushing
• Dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
• Stomach or intestinal pain, diarrhoea, indigestion, nausea or vomiting
• Skin rash with or without swellings
• Chest pain
• Muscle cramps or muscle pain
• Blood tests show higher than normal potassium levels.

Uncommon (may affect up to 1 in 100 people)

• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, prickling, burning or crawling sensations (paraesthesia)
• Loss or change in taste
• Sleep problems
• Depressed mood, anxiety, increased nervousness or irritability
• Stuffy nose, breathing difficulties or worsening of asthma
• Intestinal swelling called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting and diarrhoea
• Heartburn, constipation or dry mouth
• Increased frequency of urination during the day
• Increased sweating
• Loss of appetite or reduced appetite (anorexia)
• Rapid or irregular heartbeat
• Blurred vision
• Joint pain
• Fever
• Erectile dysfunction in men, reduced sexual desire in men and women
• Increased number of certain white blood cells (eosinophilia) detected in blood tests
• Abnormal liver, pancreas or kidney function tests detected in blood tests.

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

• Feeling faint or confused
• Swollen and red tongue
• Severe peeling or shedding of the skin, itching, rash with pustules
• Nail problems (such as nail loss or separation of the nail from its bed)
• Skin rash or bruising
• Skin spots and cold extremities
• Red, swollen, watery or itchy eyes
• Hearing disturbances and ringing in the ears
• Feeling weak
• Decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin concentration, detected in blood tests
• Reduced sexual function in men and women

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

• Increased sensitivity to sunlight
• Mild swelling or bleeding of the gums
• Higher blood sugar levels detected in blood tests

Other side effects reported:
Inform your doctor if any of the following conditions become severe or persist for more than a few days.

• Difficulty concentrating
• Mouth swelling
• Blood tests showing too low a number of blood cells
• Blood tests showing low sodium levels in the blood
• Concentrated (dark-coloured) urine, feeling unwell or malaise, muscle cramps, confusion and seizures which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor promptly
• Fingers of hands and feet changing colour when cold, and tingling or pain when warmed (Raynaud's phenomenon)
• Breast enlargement in men
• Slowed or altered reactions
• Burning sensation
• Change in perception of smells
• Hair loss.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the pack after "Exp". The expiry date refers to the last day of the month.
Store the tablets in the original packaging at a temperature below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Triapin contains

• The active substances in Triapin are: ramipril and felodipine.
• Triapin 5 mg/5 mg tablets contain 5 mg of ramipril and 5 mg of felodipine.
• The other components are: hypromellose, hydroxypropyl cellulose, anhydrous lactose, maize starch, microcrystalline cellulose, polyethylene glycol, polyoxyl 40 hydrogenated castor oil, propyl gallate, sodium aluminium silicate, sodium stearyl fumarate, iron oxides (E172), titanium dioxide (E171), and paraffin.

Description of the appearance of Triapin and the pack contents

• Triapin 5 mg/5 mg tablets are reddish-brown in colour and are engraved with “H/OE” on one side and “5” on the other side.
• Triapin is available in blister packs containing 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, Italy
Manufacturers:
Chinoin Private Co. Ltd – Veresegyhaz, Hungary
Sanofi Aventis Deutschland GmbH - Industriepark Höchst, Brüningstraße 50, D-65926 Frankfurt am Main, Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Ireland, Italy, Portugal, Spain, United Kingdom: Triapin
Portugal: Triapin Mite
Belgium, Luxembourg: Tazko
Greece: Triacor
Germany: Delmuno.

This leaflet was last approved on: