TRIAPIN 5 mg/5 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Triapin 5 mg/5 mg

prolonged-release tablets

ramipril/felodipine

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Triapin and what is it used for
2. What you need to know before you take Triapin
3. How to take Triapin
4. Possible side effects
5. Storing 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 referred to as Triapin tablets in this leaflet), contain two medicines called ramipril and felodipine.

• Ramipril belongs to a group of medicines called “angiotensin-converting enzyme inhibitors” (ACE inhibitors). It works by inhibiting the production of substances that increase blood pressure and by relaxing and dilating blood vessels.
• Felodipine belongs to a group of medicines called “calcium antagonists”. It works by relaxing and dilating blood vessels. This helps to reduce blood pressure.

Triapin tablets are used to treat high blood pressure (hypertension). High blood pressure can indicate that you are more likely to have problems such as heart disease, kidney disease, and stroke. This medicine lowers your blood pressure and reduces the risk of you having these problems.

2. What you need to know before you take Triapin

Do not take Triapin tablets if:

• You are allergic to:
• • ramipril or any other ACE inhibitor
  • felodipine or any other calcium antagonist
  • any of the other ingredients of this medicine (listed in section 6).

• You have ever had a severe allergic reaction called “angioedema”. Symptoms include itching, hives, red marks on hands, feet, and throat, swelling of the throat and tongue, inflammation around the eyes and lips, difficulty breathing and swallowing. If you take this medicine, you may be at increased risk of having a more severe attack of this type.
• You have taken or are taking 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, obstruction in your heart, unstable angina, a heart condition called atrioventricular block of second or third degree, a heart attack (acute myocardial infarction), or a stroke (cerebrovascular disorder).
• You have severe kidney problems.
• You are having dialysis.
• You have severe liver problems.
• You are pregnant, trying to become pregnant, or are breastfeeding (see “Pregnancy and breastfeeding”).
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Do not take this medicine if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before taking Triapin tablets.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Triapin tablets if

• You have kidney problems, diabetes mellitus, or are taking medicines that increase potassium levels.

Your doctor may ask you to have regular blood tests, particularly to check the levels of potassium in your blood.

• You are taking medicines or have conditions that may decrease sodium levels in your blood. Your doctor may ask you to have regular blood tests, particularly to check the levels of sodium in your blood, especially if you are an elderly person.
• You are taking medicines that may increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), vildagliptin, or neprilysin inhibitors (NEP) (such as racecadotril) or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Triapin tablets”.
• You have problems with the renal artery.
• You have a narrowing of the main blood vessel that comes out of the heart (aortic stenosis) or a heart muscle disease (cardiomyopathy).
• You have any other heart problems.
• You have systemic lupus erythematosus or scleroderma.
• You have liver problems.
• You are going to have anesthesia or surgery.
• You are taking medicines that decrease the number of certain blood cells.
• You are black, as the medicine may have a lesser effect on your blood pressure and more side effects.
• You are being treated for allergy to bee or wasp stings (desensitization).
• You are having a procedure where your blood is treated outside your body, such as “low-density lipoprotein apheresis”.
• If you have gum inflammation that may be a sign of gingivitis or periodontitis. You may need careful dental hygiene to avoid additional problems with your gums, such as a condition that increases the size of your gums.
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Triapin tablets”.

Using Triapin tablets with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Triapin tablets may affect the way other medicines work. Also, some medicines may affect the way Triapin tablets work.

In particular, tell your doctor if you are taking or are being treated with any of the following medicines:

• Sacubitril/valsartan - used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Triapin tablets”)
• Medicines that lower high blood pressure (antihypertensives), including those that contain aliskiren, and other medicines that lower blood pressure (nitrates, antipsychotics, narcotics, and anesthetics)
• Medicines for HIV infection
• Procainamide - used to treat heart rhythm disorders
• Substances that promote water elimination (diuretics), which may increase potassium levels in the blood, such as amiloride, spironolactone, triamterene
• Heparin - used to prevent blood clotting
• Lithium preparations - used to treat mania, depression, and manic-depressive illness
• Phenytoin, carbamazepine, and barbiturates. These medicines are normally used to treat epilepsy, seizures, and convulsions. Barbiturates are also used to treat sleep problems
• Theophylline - used to treat asthma
• Sympathomimetic medicines 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 medicines (NSAIDs) - used to relieve pain and inflammation
• Immunosuppressants - used for rheumatoid arthritis or after organ transplants
• Tacrolimus, which is a medicine used to prevent rejection after an organ transplant, such as a kidney or liver
• Sirolimus, everolimus (to prevent graft rejection)
• Racecadotril - used for diarrhea
• Temsirolimus (for cancer)
• Cytostatics - 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.

Your doctor may need to change your dose and/or take other precautions:

• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Triapin tablets” and “Warnings and precautions”).

If you are not sure if you are in any of the above situations, consult your doctor or pharmacist before taking Triapin tablets.

Taking Triapin tablets with food and drinks

• If you take your tablet with alcohol, it may increase the effect of your medicine
• It is not recommended to take this medicine with grapefruit juice
• Increasing the amount of salt in your diet may decrease the effect of this medicine
• Take this medicine on an empty stomach or after a light meal.

Pregnancy and breastfeeding

Do not take Triapin tablets if:

• You are pregnant, might become pregnant, or think you may be pregnant. This is because the medicine may harm your baby
• You are breastfeeding or planning to breastfeed. This is because small amounts of the medicine may pass into breast milk.

If you become pregnant while taking Triapin tablets, you should immediately consult your doctor.

Driving and using machines

After taking this medicine, you may feel dizzy or lightheaded. If this happens, do not drive or use machines or tools.

Triapin tablets contain lactose, macrogolglyceride hydroxystearate (hydrogenated and polyoxyethylene castor oil) and sodium

This medicine contains lactose. Lactose is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine may cause stomach upset and diarrhea because it contains macrogolglyceride hydroxystearate (hydrogenated and polyoxyethylene castor oil).

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

3. How to take Triapin

Follow exactly the administration instructions of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist again.

Triapin tablets are for adults only. They should not be given to children.

Taking this medicine

• Take this medicine by mouth.
• Take the tablets with an empty stomach or after a light meal.
• Swallow the tablets whole with the help of half a glass of water or another drink. Do not break, crush, or chew the tablets.
• Do not take your tablets with grapefruit juice or alcohol.

How much to take

• The normal dose is 1 tablet of Triapin 5 mg/5 mg once a day.
• Your doctor may start your treatment with Triapin 2.5 mg/2.5 mg and then change to Triapin 5 mg/5 mg to increase the dose.
• The maximum dose is 1 tablet of Triapin 5 mg/5 mg once a day.
• If you are taking diuretics (medicines that promote water elimination), your doctor may stop the treatment or reduce the dose of the diuretic before starting treatment with Triapin tablets.

Use in children

Triapin should not be given to children.

If you take more Triapin than you should

If you take more Triapin than you should, talk to your doctor or go to the nearest hospital emergency department. Take the medicine pack with you, even if your doctor knows what you are taking. You may feel dizzy or lightheaded due to low blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Triapin

If you forget to take a dose and you remember on the same day:

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

If you forget to take the dose of Triapin and you remember the next day:

• Take only your usual dose of Triapin.
• Do not take a double dose to make up for the forgotten doses.

If you stop taking Triapin

Continue with the treatment until your doctor tells you to stop. Do not stop taking this medicine just because you feel better. If you stop the treatment, your blood pressure may increase again.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop treatment with Triapin tablets and consult a doctor immediately if you notice any of the following serious adverse effects - you may need urgent medical treatment:

• Swelling of the face, lips, or throat that can make swallowing or breathing difficult, as well as itching and rashes. These could be symptoms of a severe allergic reaction to Triapin.
• Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disorder, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Tell your doctor immediately if you experience:

• Faster heart rate, irregular or strong heartbeat (palpitations), chest pain, chest tightness, or more serious problems including heart attack and stroke.
• Difficulty breathing or coughing. These can be signs of lung problems.
• Easy bruising, longer bleeding than usual, any sign of bleeding (e.g., bleeding gums), appearance of red spots, patches on the skin, or getting infections more easily than usual, sore throat, and fever, feeling tired, fainting, dizziness, or having pale skin. These can be symptoms of blood or bone marrow problems.
• Severe stomach pain that can radiate to your back. This can be a symptom of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, or vomiting, yellowing of your skin or eyes (jaundice). These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other adverse effects include:

Tell your doctor if any of the following adverse effects worsen or last more than a few days:

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

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

Common(may affect up to 1 in 10 people)

• Headache or fatigue.
• Feeling dizzy. This usually occurs when you start taking Triapin tablets or start taking a higher dose.
• Fainting, low blood pressure (abnormally low blood pressure), especially when standing up or getting up quickly.
• Flushing.
• Dry, irritating cough, inflammation of your nasal sinuses (sinusitis), or bronchitis, difficulty breathing.
• Stomach or intestinal pain, diarrhea, indigestion, nausea, or vomiting.
• Skin rash with or without bumps.
• Chest pain.
• Cramps or muscle pain.
• Blood tests showing higher potassium levels than usual in your blood.

Uncommon(may affect up to 1 in 100 people)

• Balance problems (vertigo).
• Itching and abnormal sensations in the skin such as numbness, tingling, pinching, burning, or skin numbness (paresthesia).
• Loss or changes in taste.
• Sleep problems.
• Feeling depressed, anxious, more nervous than usual, or restless.
• Nasal congestion, difficulty breathing, or worsening asthma.
• Intestinal inflammation called "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Elimination of more fluid (urine) than usual throughout the day.
• Sweating more than usual.
• Loss or decrease in appetite (anorexia).
• Increased or irregular heartbeat.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence in men, reduced sexual desire in men or women.
• An increase in the number of certain white blood cells (eosinophilia) in blood tests.
• Blood tests may show changes in the functioning of your liver, pancreas, or kidneys.

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

• Feeling unstable or confused.
• Red and inflamed tongue.
• Severe scaling or peeling of the skin, itching, rash with blisters.
• Nail problems (e.g., partial or total nail detachment from the nail bed).
• Skin rash or hematoma.
• Spots on your skin and cold extremities.
• Red, inflamed, tearful eyes, and feeling of itching in the eyes.
• Hearing problems and noises in the ears.
• Feeling weak.
• Blood tests show a decrease in the number of red blood cells, white blood cells, or platelets, or in the amount of hemoglobin.
• Decreased sexual function in men or women.

Very Rare(may affect up to 1 in 10,000 patients)

• Increased sensitivity to the sun than usual.
• Mild inflammation of the gums or bleeding gums.
• Blood tests show higher sugar levels than usual in your blood.

Other adverse effects have been reported:

Tell your doctor if any of the following adverse effects worsen or last more than a few days.

• Difficulty concentrating.
• Mouth inflammation.
• Blood tests show very few blood cells in your blood.
• Blood tests show lower sodium levels than usual in your blood.
• Concentrated urine (dark color), nausea, or vomiting, muscle cramps, confusion, and convulsions that may be due to inadequate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.
• Change in finger and toe color due to cold and then tingling or feeling of pain when you warm up (Raynaud's phenomenon).
• Increased breast size in men.
• Diminished or altered reactions.
• Burning sensation.
• Smell disorders.
• Hair loss.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Triapin

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store the tablets in the packaging below 25°C.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Triapin

• The active ingredients of Triapin tablets are: ramipril and felodipine.

Triapin 5 mg/5 mg tablets contain 5 mg of ramipril and 5 mg of felodipine.

• The other components are: hydroxypropylcellulose, hydroxypropylmethylcellulose, anhydrous lactose, cornstarch, microcrystalline cellulose, polyethylene glycol, hydrogenated ricinoleic acid and polyoxyethylene, propyl gallate, sodium aluminum silicate, sodium stearyl fumarate, iron oxides (E172), titanium dioxide (E171), and paraffin.

Appearance of the Product and Package Contents

• Triapin 5 mg/5 mg are reddish-brown tablets engraved on one side with "H/OE" and on the other with "5".
• Triapin is presented in blisters of 10, 14, 15, 21, 28, 30, 50, 98, and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer

Opella Healthcare Hungary Limited Liability Company

(Opella Healthcare Hungary Ltd.)

Levai u.5., Veresegyhaz, 2112

Hungary

or

Sanofi-aventis deutschland GmbH

Industriepark Höchst

65926 Frankfurt

Germany

or

Sanofi Winthrop Industrie

30-36 Avenue Gustave Eiffel

37100 Tours

France

This medicine is authorized in the EEA member states with the following names:

Ireland, Italy, Portugal, Spain, United Kingdom: Triapin

Portugal: Triapin Mite

Belgium, Luxembourg: Tazko

Greece: Triacor

Germany: Delmuno

Date of the last revision of this prospectus: June 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/