Package Insert: Information for the Patient

Tritamlo 5 mg/10 mg Hard Capsules

amlodipino/ramipril

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Tritamlocontains two active principles: amlodipine and ramipril. Amlodipine belongs to a group of medications called calcium antagonists and ramipril to those called angiotensin-converting enzyme (ACE) inhibitors.

Amlodipine acts:

• Relaxing and widening blood vessels, so that blood can pass through them more easily.

Ramipril acts:

• Reducing the production of substances that can increase blood pressure.
• Making its blood vessels relax and widen.
• Making the heart pump blood more easily.

Tritamlois used to treat hypertension (high blood pressure), in patients whose blood pressure is adequately controlled with amlodipine and ramipril administered separately and at the same dose as the combination Tritamlo.

Do not take Tritamlo

-if you are allergic to amlodipine, ramipril, other calcium channel blockers or ACE inhibitors, or to any of the other components of this medication (listed in section 6). It may cause itching, skin redness or difficulty breathing.

• if you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high(see section “Other medications and Tritamlo”).

-if your blood pressure is abnormally low or unstable. Your doctor must evaluate you.

-if you have a narrowing of the aortic valve of the heart (aortic stenosis) or cardiogenic shock (a situation where the heart is unable to supply enough blood to the body).

• if you suffer from heart failure after a heart attack.
• if you have ever had a severe allergic reaction known as "angioedema". Symptoms include itching, urticaria, red marks on the hands, feet and throat, inflammation of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• if you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Tritamlomay not be suitable for you.
• if you have kidney problems that reduce blood supply (renal artery stenosis).
• in the last 6 months of pregnancy (see section "Pregnancy and breastfeeding”).
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

Do not take Tritamlo if you have any of the above circumstances. If you are unsure, consult with your doctor or pharmacist before taking Tritamlo.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tritamlo.

Inform your doctor if any of the following situations affect you:

- If you have severe increases in blood pressure (hypertensive crises).

- If you are an older person and need a dose increase.

- If you have heart, liver or kidney problems.

-If you have lost a large amount of salt or fluid due to vomiting, diarrhea, excessive sweating, on low-salt diets, on long-term diuretics or if you are undergoing dialysis).

-If you are undergoing a treatment to reduce the allergy to bee or wasp stings (desensitization).

-If you are to receive an anesthetic, for example in a dental operation. You may need to stop taking Tritamloone day before. Consult your doctor or pharmacist.

-If you have high levels of potassium in your blood (shown in blood test results).

-If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus.

- If you are taking any of the following medications used to treat high blood pressure (high blood pressure):

??Angiotensin II receptor blockers (ARBs) (for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

??Aliskiren.

Your doctor may need to monitor your kidney function, blood pressure and electrolyte levels (such as potassium) in your blood at regular intervals.

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

Children and adolescents

Tritamlo is not recommended for children and adolescents under 18 years of age because there is no information available for this age group.

Other medications and Tritamlo

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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

If you are taking an Angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Tritamlo” and “Warnings and precautions”).

Inform your doctor if you are taking any of the following medications. These may reduce the effect of Tritamlo:

-Medications used to relieve pain and inflammation (such as nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin and aspirin).

-Medications used to treat low blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, noradrenaline or adrenaline. Your doctor will need to check your blood pressure.

-Medications used to treat bacterial infections: rifampicin (antibiotic for tuberculosis), erythromycin, clarithromycin.

-Hypericum perforatum(St. John's Wort for depression).

Inform your doctor if you are taking any of the following medications. They may increase the risk of adverse effects if taken in combination withTritamlo:

• Sacubitril/valsartan (for treating a type of long-term heart failure). If you have been taking sacubitril/valsartan, wait 36 hours after taking your last dose of sacubitril/valsartan before starting to take Tritamlo.

• Medications used to relieve pain and inflammation (such as nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin and aspirin).
• Chemotherapy medications.
• Medications used to prevent organ rejection after a transplant, such as cyclosporin.
• Diuretics such as furosemide.
• Medications that can increase the amount of potassium in the blood, such as spironolactone, triamterene, amiloride, potassium salts and heparin (to thin the blood).
• Glucocorticoids for inflammation, such as prednisone.
• Alopurinol (used to lower uric acid in the blood).
• Procainamide (for heart rhythm problems).
• Ketoconazole, itraconazole (antifungal medications).
• Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV).
• Erythromycin, clarithromycin (antibiotics).
• Verapamil, diltiazem (medications for heart problems or high blood pressure).
• Dantrolene (for severe temperature abnormalities).
• Trimethoprim and co-trimoxazole (for bacterial infections).
• Temsirolimus (for cancer).
• Everolimus (to prevent organ rejection).
• Tacrolimus (used to control the body's immune response to allow it to accept the transplanted organ).
• Clarithromycin (for bacterial infections).

Inform your doctor if you are taking any of the following medications, as they may be affected by Tritamlo:

-Medications for diabetes such as oral hypoglycemic agents or insulin. Tritamlo may reduce your blood sugar levels. Check your blood sugar levels while taking Tritamlo.

-Lithium (for mental health problems). Tritamlo may increase the amount of lithium in the blood. Your doctor will need to closely monitor your lithium levels.

-Simvastatin (a medication to lower cholesterol). Tritamlo may increase the amount of simvastatin in the blood.

-Rifampicin, erythromycin, clarithromycin (antibiotics).

Inform your doctor if you are taking any of the following medications, as they increase the risk of angioedema:

• Racecadotril, a medication used to treat diarrhea;
• Medications used to prevent organ rejection and for cancer (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medication used to treat diabetes.

If any of the above circumstances affect you (or you are unsure), speak with your doctor or pharmacist before taking Tritamlo.

Taking Tritamlo with food, drinks and alcohol

Tritamlocan be taken with or without food.

Oranges or orange juice should not be consumed by people taking Tritamlo. This is because oranges and orange juice can lead to an increase in blood levels of amlodipine, which can cause an unpredictable increase in the blood pressure-lowering effect of Tritamlo.

Consuming alcohol with Tritamlomay make you feel dizzy or disoriented. If you are concerned about the effect of alcohol on Tritamlo, speak with your doctor or pharmacist.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take Tritamlo during the second and third trimesters of pregnancy. During the first trimester of pregnancy, its use is not recommended. If you become pregnant while taking Tritamlo, consult your doctor immediately. If you are planning to become pregnant, consult your doctor, as they will advise you to take another medication instead of Tritamlo.

Breastfeeding

Do not take Tritamlo during breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding, or are about to do so, inform your doctor before taking Tritamlo.

Fertility

There areinsufficientdata on the effect on fertility.

Driving and operating machines

Tritamlomay affect your ability to drive or operate machines. If you feel unwell, dizzy, tired or have a headache while taking Tritamlo, do not drive or operate machines and contact your doctor immediately. This may occur especially at the start of treatment or when changing the formulation.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

If you think the effect ofTritamlois too strong or too weak, consult your doctor or pharmacist.

Take this medication at the same time of day, before or after meals. Swallow the entire capsule with some liquid. Do not crush or chew the capsules.

Do not takeTritamlowith grapefruit juice.

Tritamloshould be administered once a day.

Your doctor may modify the dose depending on the effect it has on you.

The maximum daily dose is one 10 mg/10 mg capsule.

Seniors

Your doctor will reduce the initial dose and adjust the treatment gradually.

Use in children and adolescents

Tritamlois not recommended for use in children and adolescents under 18 years of age because there are no available data for this population group.

If you take more Tritamlo than you should

Taking too many capsules can cause your blood pressure to be low or dangerously low. You may feel dizzy or weak, and if the drop in blood pressure is severe enough, you may experience shock. Your skin may feel cold and moist, and you may lose consciousness. Inform your doctor or go to the nearest hospital emergency department. Do not drive to the hospital. Bring the medication packaging with you to indicate to the doctor what you have taken.

Excess fluid may accumulate in the lungs (pulmonary edema) causing breathing difficulties that may develop within 24-48 hours after ingestion.

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

If you forget to take Tritamlo

If you forget to take a capsule, take the next dose at the usual time.

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Tritamlo

Your doctor will indicate for how long you should take this medication. Your condition may recur if you interrupt treatment with this medication before the doctor's indicated time.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop taking Tritamlo and consult a doctor immediately if you notice any of the following severe 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 skin rash. This could be a sign of a severe allergic reaction to Tritamlo..

-Severe skin reactions that include intense skin rash, blisters, skin redness all over the body, intense itching, blister formation, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme) or other allergic reactions.

The frequency of the aforementioned side effects are classified as unknown (cannot be estimated from available data).

Consult your doctor immediately if you experience:

-Faster heart rate, irregular or forced heartbeat (palpitations), chest pain or discomfort, or more serious conditions such as heart attack and stroke.

-Difficulty breathing or coughing. These may be symptoms of lung problems.

-Bleeding, prolonged bleeding, any sign of bleeding (e.g., bleeding gums), purpura, rashes, or skin discoloration, or contracting infections more easily than normal, sore throat, and fever, feeling tired, weakness, dizziness, or pale skin. These may be signs of blood or bone marrow problems.

-Severe stomach pain that can radiate to the back. This could be a sign of pancreatitis (pancreas inflammation).

-Fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These may be signs of liver problems, such as hepatitis (liver inflammation) or liver damage.

Other side effects include:

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

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

• Fluid retention (edema).

Common (may affect up to 1 in 10 people)

-Palpitations, flushing.

-Swelling of the ankles (edema).

-Weakness, feeling tired (fatigue).

-Drowsiness, dizziness, headache. This is more likely to occur when starting to take Tritamlo or starting a higher dose.

-Diplopia (double vision).

-Fainting, hypotension (abnormally low blood pressure), especially when standing up or getting up quickly.

-Dry cough, sinusitis (inflammation of the nasal passages), or bronchitis, difficulty breathing.

-Alteration of bowel habits (diarrhea and constipation), abdominal pain,

indigestion, feeling unwell, nausea, and vomiting.

-Skin rash, with or without inflammation.

-Chest pain.

-Muscle cramps or joint pain.

-Abnormal blood tests showing elevated potassium levels.

Uncommon (may affect up to 1 in 100 people)

-Mood changes, insomnia.

-Tremor, weakness, pain, feeling unwell.

-Visual disturbances, blurred vision, tinnitus.

-Nasal congestion, difficulty breathing, or worsening asthma.

-Intestinal angioedema, which presents symptoms such as abdominal pain, gastritis, and constipation, dry mouth.

-Pancreatitis (pancreas inflammation).

-Loss of appetite (anorexia).

-Increased heart rate or irregular heartbeat (arrhythmias), including bradycardia,

ventricular tachycardia, and atrial fibrillation.

-Fever.

-Increased number of certain white blood cells (eosinophilia).

-Blood tests show changes in liver function (elevated liver enzymes and/or bilirubin), pancreas function (elevated pancreatic enzymes), and kidney function (elevated urea and creatinine in blood).

-Myocardial infarction.

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

-Feeling weak or confused.

-Red and swollen tongue (glossitis).

-Severe skin peeling, itching, and rash.

-Nail problems (e.g., weakness or separation of the nail from its bed).

-Skin rash or hematomas.

-Urticaria.

-Red spots on the skin and cold extremities.

-Conjunctivitis (redness, itching, and swelling of the eyes).

-Auditory problems.

-Blood tests show a decrease in the number of red blood cells, white blood cells, platelets, or hemoglobin.

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

-Increased sensitivity to the sun.

-Hyperglycemia (high blood sugar).

-Gingivitis (inflammation of the gums).

-Gastritis (inflammation of the stomach lining).

-Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice).

-Muscle tension increase.

-Inflammation of blood vessels, often with skin rash.

-Light sensitivity.

-Movement disorders combining rigidity, tremor, and/or movement disorders.

Frequency unknown:

-Mouth ulcers.

-Psoriasis.

-Dark-colored urine, feeling unwell, nausea, 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: tremors, rigid posture, "mask-like" face, slow movements, and unsteady gait.

Other side effects reported:

-Difficulty concentrating.

-Blood tests showing very few white blood cells.

-Blood tests showing low sodium levels.

-Color change in the fingers and toes with cold and numbness or painful sensation with heat (Raynaud's phenomenon).

-Slowness or difficulty reacting.

-Change in the perception of smells (parosmia).

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 the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Store below 30°C.

Store in the original packaging to protect it from light.

Keep this medication 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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tritamlo

• The active principles are amlodipino and ramipril.Each capsule contains amlodipino besilato equivalent to 5 mg of amlodipino and 10 mg of ramipril.
• The other components are:

Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized cornstarch, pregelatinized cornstarch with low moisture, sodium starch glycolate (type A), sodium stearate fumarate, iron oxide red (E172), titanium dioxide (E171), iron oxide yellow (E172), iron oxide black (E172), and gelatin.

Appearance of the product and content of the container

Tritamlo 5 mg/10 mg hard capsules are hard gelatin capsules with an opaque dark pink cap and an opaque white body. The capsules contain a white or almost white powder.

Tritamlo is presented in a blister pack, in containers that contain 30 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Responsible for manufacturing

Adamed Pharma S.A

Szkolna Street 33

95-054 Ksawerów

Poland

or

Adamed Pharma, S.A.

Marszalka Józefa Pilsudskiego Street 5

95-200 Pabianice

Poland

Last review date of this leaflet: September 2022

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