Leaflet: information for the user

Triapin 5 mg/5 mg

Prolonged-release tablets

ramipril/felodipine

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Triapin and what it is used for

2.What you need to know before starting to take Triapin

3.How to take Triapin

4.Possible side effects

5.Storage of Triapin

6.Contents of the pack and additional information

Triapin 5 mg/5 mg prolonged-release tablets (also referred to as Triapin tablets in this leaflet), contains two medications called ramipril and felodipine.

• Ramipril belongs to a group of medications called “angiotensin-converting enzyme inhibitors” (ACE inhibitors). It acts by inhibiting the production of substances that increase blood pressure and relaxing and dilating blood vessels.
• Felodipine belongs to a group of medications called “calcium antagonists”. It acts 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 may indicate that you are more prone to having problems such as heart disease, kidney disease and stroke. This medication reduces your blood pressure and reduces the risk of developing these problems.

Do not take Triapin tablets if:

• You are allergic to:
• • ramipril or any other angiotensin-converting enzyme (ACE) inhibitor
  • felodipine or any other calcium channel blocker
  • any of the other components of this medication (listed in section 6)

• You have ever had a severe allergic reaction called “angioedema”. Symptoms include itching, allergic rash (urticaria), red marks on hands, feet, and throat, throat and tongue inflammation, eye and lip inflammation, difficulty breathing and swallowing. Taking this medication may increase the risk of a more severe attack.
• You have taken or are taking sacubitrilo/valsartán, a medication used to treat a type of long-term (chronic) heart failure in adults.
• You have heart problems such as heart failure, heart blockage, unstable angina, a heart injury called second- or third-degree atrioventricular block, a heart attack (acute myocardial infarction) or a stroke (cerebral circulation alteration).
• You have severe kidney problems.
• You are undergoing dialysis.
• You have severe liver problems.
• You are pregnant, trying to become pregnant, or breastfeeding (see “Pregnancy and breastfeeding”).
• You have diabetes or kidney insufficiency and are being treated with a blood pressure medication containing aliskirén.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Triapin tablets if::

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

Your doctor may instruct you to have regular blood tests, particularly to monitor your potassium levels in the blood.

• You are taking medications or have conditions that may decrease sodium levels in your blood. Your doctor may instruct you to have regular blood tests, particularly to monitor your sodium levels in the blood, especially if you are an elderly person.
• If you are taking medications that may increase the risk of angioedema, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, or neprilisina inhibitors (e.g. racecadotrilo), or sacubitrilo/valsartán. For sacubitrilo/valsartán, see section 2 “Do not take Triapin tablets”.
• You have renal artery problems.
• You have aortic stenosis or hypertrophic cardiomyopathy.
• You have any other heart problems.
• You have systemic lupus erythematosus or scleroderma.
• You have liver problems.
• You are undergoing anesthesia or surgery.
• You are taking medications that decrease the number of certain blood cells.
• You are black, as the medication may have a lower effect on your blood pressure and more side effects.
• You are undergoing desensitization treatment for bee or wasp sting allergy.
• You are undergoing a procedure where blood is treated outside the body, such as “low-density lipoprotein apheresis”.
• You have gum inflammation that may be a sign of gingivitis or periodontitis. You may need to practice good 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 medications used to treat high blood pressure (hypertension):

- an angiotensin II receptor antagonist (ARA) (also known as “sartanes” – e.g. valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.

- aliskirén.

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

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

Use of Triapin tablets with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications purchased without a prescription, including herbal remedies. This is because Triapin tablets may affect the way other medications work. Also, some medications may affect the way Triapin tablets work.

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

• Sacubitrilo/valsartán - used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Triapin tablets”)
• Blood pressure medications, including those containing aliskirén, and other medications that lower blood pressure (nitrates, antipsychotics, narcotics, and anesthetics)
• Medications for HIV infection
• Procainamide - used to treat heart rhythm disorders
• Diuretics, which may increase potassium levels in the blood, such as amilorida, espironolactona, triamtereno
• Heparin - used to prevent blood clotting
• Lithium preparations - used to treat mania, depression, and manic-depressive illness
• Fenitoína, carbamazepina, and barbiturates. These medications are used to treat epilepsy, seizures, and convulsions. Barbiturates are also used to treat sleep problems
• Theophylline - used to treat asthma
• Sympathomimetic medications such as adrenaline, noradrenaline, or ephedrine (medications that act on the heart and blood vessels)
• Eritromicina, itraconazol, ketoconazol - used to treat infections
• Rifampicina - used to treat tuberculosis
• Alopurinol - used to treat gout
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used to relieve pain and inflammation
• Immunosuppressants - used to treat rheumatoid arthritis or after organ transplants
• Tacrolimus, which is a medication used to prevent organ transplant rejection, such as a kidney or liver transplant
• Sirolimus, everolimus (to prevent graft rejection)
• Racecadotrilo - used to treat diarrhea
• Temsirolimus (for cancer)
• Cytostatics - used to treat cancer
• Insulin, glibenclamida, metformina, vildagliptina, and other medications used to treat diabetes mellitus
• Glucocorticoids (“steroids”)
• Potassium salts
• Trimetoprim alone or in combination with sulfametoxazol used to treat infections.
• St. John's Wort.

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

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

If you are unsure whether 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 medication
• It is not recommended to take this medication with grapefruit juice
• The increase in salt in your diet may decrease the effect of this medication
• Take this medication on an empty stomach or after a light meal.

Pregnancy and breastfeeding

Do not take Triapin tablets if:

• You are pregnant, could become pregnant, or think you might be pregnant. This is because this medication may harm your baby
• You are breastfeeding or plan to breastfeed. This is because small amounts of the medication may pass into the mother's milk.

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

Driving and operating machines

After taking this medication, you may feel dizzy or lightheaded. If this occurs, do not drive or operate machines.

Triapin tablets contain lactose, hydroxyethylstearate (hydrogenated ricin oil and polyoxethylene), and sodium

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

This medication may cause stomach discomfort and diarrhea because it contains hydroxyethylstearate (hydrogenated ricin oil and polyoxethylene).

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Triapin tablets are only for adults. Do not administer to children.

How to take this medication

• Take this medication 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 beverage. Do not break, crush, or chew the tablets.
• Do not take your tablets with grapefruit juice or with alcohol.

How much to take

• The usual dose is1 tablet of Triapin 5 mg/5 mg once a day.
• Your doctor may start your treatment withTriapin 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 the elimination of water), your doctor may interrupt the treatment or reduce the dose of the diuretic before starting treatment with Triapin tablets.

Use in children

Triapin should not be administered to children.

If you take more Triapin than you should

If you take more Triapin than you should, consultwith your doctor or go to the nearest hospital emergency service. Bring the medication packaging with you, even if your doctor knows what you are taking. You may feel dizzy and nauseous because your blood pressure is too low.

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

If you forget to take Triapin

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

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

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

• Take only your usual dose of Triapin.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Triapin

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking Triapin tablets and consult a doctor immediately if you observe any of the following severe side effects - you may need urgent medical treatment:

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

Inform your doctor immediately if you experience:

• Faster or irregular heartbeat, chest pain, chest tightness, or more serious problems, including heart attack and stroke.
• Difficulty breathing or coughing. These may be signs of lung problems.
• Easy bruising, prolonged bleeding, any sign of bleeding (e.g., bleeding gums), appearance of red spots, skin patches, or catching infections more easily than usual, sore throat, and fever, feeling tired, fainting, dizziness, or pale skin. These may be symptoms of blood or bone marrow problems.
• Severe stomach pain that can radiate to your back. This may 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 may be signs of liver problems, such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:

Inform your doctor if any of the following side 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 may be a sign that your body is retaining more water than usual.

Common(may affect up to 1 in 10 people)

• Headache or fatigue.
• Sensation of dizziness. This usually occurs when you start taking Triapin tablets or begin taking a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or getting up quickly.
• Flush.
• Dry, irritating cough, nasal congestion (sinusitis), or bronchitis, difficulty breathing.
• Stomach or intestinal pain, diarrhea, indigestion, nausea, or vomiting.
• Skin rash with or without bumps.
• Chest pain.
• Muscle cramps or pain.
• Blood tests showing higher-than-normal potassium levels in your blood.

Uncommon(may affect up to 1 in 100 people)

• Balance problems (dizziness).
• Abnormal sensations in the skin, such as numbness, tingling, pinching, burning, or numbness (paresthesia).
• Loss or changes in taste.
• Sleep problems.
• Feeling depressed, anxious, more nervous than usual, or restless.
• Nasal congestion, difficulty breathing, or worsening of asthma.
• Inflammatory bowel disease, known as "intestinal angioedema," which presents symptoms such as abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Increased urine production throughout the day.
• Sweating more than usual.
• Loss or decrease in appetite (anorexia).
• Increased or irregular heartbeats.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence in men, reduced sex drive in men or women.
• Increased number of certain white blood cells (eosinophilia) in blood tests.
• Blood tests may show changes in liver, pancreas, or kidney function.

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

• Feeling unsteady or confused.
• Red, inflamed tongue.
• Severe skin peeling or exfoliation, itching, rash with blisters.
• Nail problems (e.g., partial or total nail detachment from the nail bed).
• Skin rash or hematoma.
• Skin patches and cold extremities.
• Red, inflamed, watery, and itchy eyes.
• Auditory problems and ear noises.
• Feeling weak.
• Blood tests show a decrease in red blood cells, white blood cells, or platelets, or hemoglobin levels.
• Decreased sexual function in men or women.

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

• Increased sensitivity to sunlight.
• Mild inflammation of the gums or bleeding of these.
• Blood tests show higher-than-normal sugar levels in your blood.

Other side effects have been reported:

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

• Difficulty concentrating.
• Inflammation of the mouth.
• Blood tests show very few blood cells in your blood.
• Blood tests show lower-than-normal sodium levels in your blood.
• Dark-colored urine, nausea, vomiting, muscle cramps, confusion, and seizures that may be due to inadequate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.
• Color change in your hands and feet due to cold and then tingling or pain when you warm up (Raynaud's phenomenon).
• Enlargement of male breasts.
• Diminished or altered reactions.
• Burning sensation.
• Olfactory disorders.
• Hair loss.

Reporting of side effects

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

Keep out of sight and reach of children.

Do not use this medication 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 disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Triapin

• The active principles 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, hydroxyestearate of macrogolglycerol (hydrogenated ricin oil and polyoxiethylenated) , propyl gallate, sodium aluminum silicate, sodium stearate fumarate, iron oxides (E172), titanium dioxide (E171), and paraffin.

Appearance of the product and content of the container

It may only be marketed in some sizes of packaging.