TRITAMLO 10 mg/5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tritamlo 10 mg/5 mg Hard Capsules

amlodipine/ramipril

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

1. What is Tritamlo and what is it used for
2. What you need to know before you take Tritamlo
3. How to take Tritamlo
4. Possible side effects
5. Storing Tritamlo
6. Contents of the pack and other information

1. What is Tritamlo and what is it used for

Tritamlo contains two active substances: amlodipine and ramipril. Amlodipine belongs to a group of medicines called calcium antagonists and ramipril to a group called ACE inhibitors (Angiotensin-Converting Enzyme Inhibitors).

Amlodipine works by:

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

Ramipril works by:

• Reducing the production of substances that may increase blood pressure.
• Making your blood vessels relax and widen.
• Making your heart beat more easily and pump blood more efficiently.

Tritamlo is used to treat high blood pressure in patients whose blood pressure is adequately controlled with amlodipine and ramipril given separately at the same doses as in this combination.

2. What you need to know before you take Tritamlo

Do not take Tritamlo

• if you are allergic to amlodipine, ramipril, other calcium antagonists or ACE inhibitors, or to any of the other ingredients of this medicine (listed in section 6). This may cause itching, skin rash, or difficulty breathing.
• if you have taken or are currently taking sacubitril/valsartan, a medicine 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 increased (see section "Other medicines and Tritamlo").

• if your blood pressure is abnormally low or unstable. Your doctor should assess you.
• if you have a narrowing of the aortic valve in your heart (aortic stenosis) or cardiogenic shock (a situation where the heart is unable to supply enough blood to the body).
• if you have had a heart attack and have developed heart failure.
• if you have ever had a severe allergic reaction known as "angioedema". Symptoms include itching, hives, 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, Tritamlo may not be suitable for you.
• if you have kidney problems that reduce blood supply (renal artery stenosis).
• during the last 6 months of pregnancy (see section "Pregnancy and breastfeeding").
• if you have diabetes or kidney problems and are being treated with a medicine to lower blood pressure that contains aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tritamlo.

Tell your doctor if any of the following applies to you:

• If you have severe increases in blood pressure (hypertensive crises).
• If you are elderly and need a dose increase.
• If you have heart, liver, or kidney problems.
• If you have lost a lot of salts or fluids due to vomiting, diarrhea, excessive sweating, low-salt diets, or long-term diuretic use, or if you are undergoing dialysis.
• If you are going to undergo allergy treatment (desensitization) for bee or wasp stings.
• If you are going to be given an anesthetic, for example, for dental surgery. You may need to stop taking Tritamlo a day before. Consult your doctor or pharmacist.
• If you have high levels of potassium in your blood (as 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 medicines to treat high blood pressure:

Angiotensin II Receptor Antagonists (ARAII) (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 electrolyte levels (e.g., 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 population.

Other medicines and Tritamlo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

If you are taking an Angiotensin II Receptor Antagonist (ARAII) or aliskiren (see also the information under the headings "Do not take Tritamlo" and "Warnings and precautions").

Tell your doctor if you are taking any of the following medicines, as they may reduce the effect of Tritamlo:

• Pain and inflammation relievers (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, and aspirin).
• Medicines 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.
• Medicines used to treat bacterial infections: rifampicin (an antibiotic to treat tuberculosis), erythromycin, clarithromycin.
• Hypericum perforatum (St. John's Wort to treat depression).

Tell your doctor if you are taking any of the following medicines, as they may increase the risk of side effects when taken with Tritamlo:

• Sacubitril/valsartan (to treat 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.

• Pain and inflammation relievers (e.g., NSAIDs such as ibuprofen, indomethacin, and aspirin).
• Cancer medicines (chemotherapy).
• Medicines to prevent organ rejection after a transplant, such as cyclosporin.
• Diuretics such as furosemide.
• Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (to thin the blood).
• Steroid medicines for inflammation, such as prednisone.
• Allopurinol (to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Ketoconazole, itraconazole (antifungal medicines).
• Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV).
• Erythromycin, clarithromycin (antibiotics).
• Verapamil, diltiazem (medicines to treat heart disorders or high blood pressure).
• Dantrolene (in infusion for severe body temperature abnormalities).
• Trimethoprim and cotrimoxazole (for bacterial infections).
• Temsirolimus (for cancer).
• Everolimus (to prevent graft rejection).
• Tacrolimus (used to control the body's immune response to allow it to accept a transplanted organ).
• Clarithromycin (for bacterial infections).

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

• Diabetes medicines, such as oral hypoglycemic agents or insulin. Tritamlo may lower your blood sugar levels. Check your blood sugar levels while taking Tritamlo.
• Lithium (for mental health problems). Tritamlo may increase lithium levels in your blood. Your doctor will need to closely monitor your lithium levels.
• Simvastatin (a medicine to lower cholesterol). Tritamlo may increase simvastatin levels in your blood.
• Rifampicin, erythromycin, clarithromycin (antibiotics).

Tell your doctor if you are taking any of the following medicines, as they may increase the risk of angioedema:

• Racecadotril, a medicine used to treat diarrhea;
• Medicines used to prevent organ rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

If any of the above applies to you (or if you are unsure), talk to your doctor or pharmacist before taking Tritamlo.

Taking Tritamlo with food, drinks, and alcohol

Tritamlo can be taken with or without food.

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

Drinking alcohol with Tritamlo may make you feel dizzy or lightheaded. If you are concerned about the effect of alcohol on Tritamlo, talk to your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Tritamlo during the second and third trimesters of pregnancy. During the first trimester of pregnancy, it is not recommended. If you become pregnant during treatment with Tritamlo, consult your doctor immediately. If you are planning to become pregnant, consult your doctor, as they will advise you to take a different medicine 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 about to start breastfeeding, inform your doctor before taking Tritamlo.

Fertility

There is not enough data on the effect on fertility.

Driving and using machines

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

3. How to take Tritamlo

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

If you think that the effect of Tritamlo is too strong or too weak, consult your doctor or pharmacist.

Take this medicine at the same time each day, before or after food. Swallow the capsule whole with some liquid. Do not crush or chew the capsules.

Do not take Tritamlo with grapefruit juice.

Tritamlo should be taken once a day.

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

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

Elderly

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

Use in children and adolescents

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

If you take more Tritamlo than you should

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

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion.

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 Tritamlo

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Tritamlo

Your doctor will tell you for how long you should take this medicine. Your condition may recur if you stop taking this medicine before your doctor tells you to.

If you have any further questions on 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 taking Tritamlo 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 makes swallowing or breathing difficult, as well as itching and skin rash. This could be a sign of a severe allergic reaction to Tritamlo.
• Severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, intense itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme) or other allergic reactions.

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

Consult your doctor immediately if you experience:

• Faster heart rate, irregular or forced heartbeat (palpitations), pain or pressure in the chest, or more serious problems such as heart attack and stroke.
• Difficulty breathing or coughing. These can be symptoms of lung problems.
• Bruises, bleeding for longer than usual, any sign of bleeding (e.g., bleeding gums), purpura, rash, or spots on the skin, or getting infections more easily than usual, sore throat, and fever, feeling tired, weak, dizzy, or having pale skin. These can be signs of blood or bone marrow problems.
• Severe stomach pain that can reach the back. This could be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the 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:

Inform your doctor if any of the following symptoms worsen or last for 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).
• Asthenia, feeling tired (fatigue).
• Drowsiness, feeling dizzy, headache. This is more likely to occur when you start taking Tritamlo or start taking a higher dose.
• Double vision (diplopia).
• Fainting, low blood pressure (abnormally low blood pressure), especially when standing up or getting up quickly.
• Dry cough, inflammation of the paranasal sinuses (sinusitis) 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 pain.
• Blood tests showing higher than normal potassium levels.

Uncommon (may affect up to 1 in 100 people):

• Mood changes, insomnia.
• Tremors, weakness, pain, feeling unwell.
• Visual disturbances, blurred vision, ringing in the ears.
• Sneezing/nasal secretion caused by inflammation of the nasal lining (rhinitis).
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration.
• Urinary disorders: increased need to urinate, especially at night, and increased number of times urinating.
• Impotence, sexual dysfunction in men, reduced sexual desire in men or women.
• Discomfort or enlargement of the breasts in men.
• Muscle or joint pain, back pain.
• Weight gain or loss.
• Balance problems (vertigo).
• Itching and unusual sensations in the skin, such as numbness, tingling, pinching, burning, loss of pain sensation.
• Loss or change in the taste of things (ageusia or dysgeusia).
• Sleep problems.
• Feeling depressed, anxious, or nervous.
• Nasal congestion, difficulty breathing, or worsening of asthma.
• Inflammation of the intestine, known as "intestinal angioedema," which presents symptoms such as abdominal pain, gastritis, and constipation, dry mouth.
• Pancreatitis (inflammation of the pancreas).
• Loss or decreased appetite (anorexia).
• Increased or irregular heartbeats (arrhythmias), including bradycardia,

ventricular tachycardia, and atrial fibrillation.

• Fever.
• Increased number of certain white blood cells (eosinophilia).
• Blood tests showing changes in liver function (increased liver enzymes and/or bilirubin), pancreas (increased pancreatic enzymes), and kidneys (increased urea and creatinine in blood).
• Infarction.

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

• Feeling weak or confused.
• Red and swollen tongue (glossitis).
• Severe skin peeling, itching, rash.
• Nail problems (e.g., weakness or separation of the nail from its bed).
• Skin rash or bruising.
• Urticaria.
• Spots on the skin and cold extremities.
• Redness of the eyes, itching, swelling (conjunctivitis).
• Hearing problems.
• Blood tests showing a decrease in the number of red blood cells, white blood cells, platelets, or the amount of hemoglobin.

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

• Increased sensitivity to the sun.
• High blood sugar (hyperglycemia).
• Gingivitis (inflammation of the gums).
• Abdominal distension (gastritis).
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice).
• Increased muscle tension.
• Inflammation of blood vessels, often with skin rash.
• Sensitivity to light.
• Disorders combining stiffness, tremors, and/or movement disorders.

Frequency not known:

• Mouth ulcers.
• Psoriasis.
• Concentrated urine (dark color), feeling unwell, or nausea, muscle cramps, confusion, and convulsions that can be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible: tremors, rigid posture, "mask-like" face, slow movements, and unsteady gait.

Other reported adverse effects:

• Difficulty concentrating.
• Blood tests showing very few blood cells.
• Blood tests showing lower than normal sodium levels.
• Change in the color of the fingers of the hands and feet with cold and tingling or painful sensation with heat (Raynaud's phenomenon).
• Slowness or difficulty reacting.
• Change in the perception of smells (parosmia).

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: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Tritamlo

Store below 30°C.

Keep in the original package to protect from light.

Keep this medicine out of the sight and reach of children.

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

Medicines should not be thrown away through the sewage system or in the trash. Deposit the packages 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 packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tritamlo

• The active ingredients are amlodipine and ramipril. Each capsule contains amlodipine besylate equivalent to 10 mg of amlodipine and 5 mg of ramipril.
• The other components are:

Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized corn starch, low-humidity pregelatinized corn starch, type A potato starch glycolate, sodium stearyl fumarate, red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), and gelatin.

Appearance of the Product and Package Contents

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

Tritamlo is presented in blisters, in packages containing 30 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer

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

Date of the Last Revision of this Prospectus:September 2022

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/