Tritamlo 10 mg/10 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tritamlo 10 mg/10 mg hard capsules

amlodipine/ramipril

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Tritamlo is and what it is used for

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

Amlodipine works by:

• Relaxing and widening blood vessels, allowing blood to pass through them more easily.

Ramipril works by:

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

Tritamlo is used to treat hypertension (high blood pressure) in patients whose blood pressure is adequately controlled with amlodipine and ramipril taken simultaneously as separate tablets at the same dose as that contained in the Tritamlo combination.

2. What you need to know before taking 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 redness, 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 beneath the skin in areas such as the throat) is high (see section “Other medicines and Tritamlo”).

• if your blood pressure is abnormally low or unstable. Your doctor should evaluate you.

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

  • if you have heart failure following a heart attack.
  • if you have ever had a serious allergic reaction known as "angioedema." Symptoms include itching, hives, red marks on the hands, feet, and throat, swelling 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 failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tritamlo.

Inform your doctor if any of the following situations apply to you:

• If you have severe increases in blood pressure (hypertensive crises).
• If you are elderly and require a dose increase.
• If you have heart, liver, or kidney problems.
• If you have lost large amounts of salts or fluids due to vomiting, diarrhea, excessive sweating, low-salt diets, long-term use of diuretics, or if you are undergoing dialysis.
• If you are undergoing treatment to reduce allergy to bee or wasp stings (desensitization).
• If you are to receive an anesthetic, for example during a dental procedure. You may need to stop taking Tritamlo one day beforehand. 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 medicines used to treat high blood pressure (hypertension):

??Angiotensin II Receptor Antagonists (ARBs) (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 information under the heading “Do not take Tritamlo”.

Children and adolescents

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

Other medicines and Tritamlo

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

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

If you are taking an Angiotensin II Receptor Antagonist (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 medicines. These may reduce the effect of Tritamlo:

• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indometacin, 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 monitor your blood pressure.
• Medicines used to treat bacterial infections: rifampicin (an antibiotic for treating tuberculosis), erythromycin, clarithromycin.
• Hypericum perforatum (St. John's wort for treating depression).

Inform your doctor if you are taking any of the following medicines. They may increase the likelihood of experiencing adverse effects when taken together 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 Tritamlo.

• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indometacin, and aspirin).

• Medicines used to treat cancer (chemotherapy).

• Medicines to prevent organ rejection after transplantation, such as ciclosporin.

• 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 (used to lower uric acid 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 (administered by infusion for serious 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, allowing acceptance of a transplanted organ).

• Clarithromycin (for bacterial infections).

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

• Medicines for diabetes such as oral hypoglycemics or insulin. Tritamlo may reduce your blood sugar levels. Monitor your blood sugar levels while taking Tritamlo.
• Lithium (for mental health conditions). Tritamlo may increase the amount of lithium in the blood. Your doctor should closely monitor your blood lithium levels.
• Simvastatin (a medicine 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 medicines, as they increase the risk of angioedema:

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

If any of the above situations apply 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 increased 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, speak with your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You must not take Tritamlo during the second and third trimesters of pregnancy. Its use is also not recommended during the first trimester. 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 medicine instead of Tritamlo.

Breastfeeding

You must not take Tritamlo while breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or about to start, inform your doctor before taking Tritamlo.

Fertility

There are insufficient 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 after taking Tritamlo, do not drive or operate machinery and contact your doctor immediately. This may occur especially at the beginning of treatment or when changing formulations.

3. How to take Tritamlo

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

If you feel 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, with or without food. Swallow the capsule whole with liquid. Do not crush or chew the capsules.

Do not take Tritamlo with grapefruit juice.

Tritamlo should be administered once daily.

Your doctor may adjust the dose depending on how it affects you.

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

Elderly

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

Use in children and adolescents

The use of Tritamlo is not recommended in children and adolescents under 18 years of age, as there is no available data for this population group.

If you take more Tritamlo than you should

Taking too many capsules may cause your blood pressure to become low or dangerously low. You may feel dizzy or weak, and if the drop in blood pressure is severe enough, you may go into 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. Take the medicine packaging with you so you can show the doctor what you have taken.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine 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 make up for forgotten doses.

If you stop taking Tritamlo

Your doctor will advise you on how long you should take this medicine. Your condition may return if you stop treatment with this medicine before your doctor recommends.

If you have any further 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 everyone will experience them.

Stop taking Tritamlo and consult a doctor immediately if you notice any of the following serious adverse effects (you may require urgent medical treatment):

• Swelling of the face, lips, or throat causing difficulty swallowing or breathing, together with itching and skin rash. This could be a sign of a severe allergic reaction to Tritamlo.
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, intense itching, blistering, peeling and swelling of the skin, swelling of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme), or other allergic reactions.

The frequency of the above-mentioned adverse effects is classified as not known (cannot be estimated from available data).

Contact your doctor immediately if you experience:

• Faster heartbeat, irregular or forceful heartbeat (palpitations), chest pain or tightness, or more serious problems such as heart attack or stroke.
• Difficulty breathing or cough. These may be symptoms of lung problems.
• Bruising, bleeding lasting longer than normal, any sign of bleeding (e.g., bleeding gums), purpura, rashes, 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 may be signs of blood or bone marrow problems.
• Severe stomach pain that may radiate to the back. This could be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, 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 adverse 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).
• Asthenia, feeling of tiredness (fatigue).
• Drowsiness, dizziness, headache. This is more likely when you start taking Tritamlo or begin taking a higher dose.
• Double vision (diplopia).
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or getting up quickly.
• Dry cough, inflammation of the sinuses (sinusitis) or bronchitis, difficulty breathing.
• Changes in bowel habits (diarrhea and constipation), abdominal pain, indigestion, malaise, nausea, and vomiting.
• Skin rash, with or without inflammation.
• Chest pain.
• Muscle cramps or muscle pain.
• Blood tests showing higher than normal potassium levels.

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

• Mood changes, insomnia.
• Tremor, weakness, pain, malaise.
• Visual disturbances, blurred vision, ringing in the ears (tinnitus).
• Sneezing/nasal discharge caused by inflammation of the nasal lining (rhinitis).
• Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration.
• Urinary disorders: increased need to urinate, especially at night, and increased frequency of urination.
• Impotence, sexual dysfunction in men, reduced sexual desire in men or women.
• Breast discomfort or enlargement in men.
• Muscle or joint pain, back pain.
• Weight gain or weight loss.
• Balance problems (dizziness).
• Itching and unusual skin sensations such as numbness, tingling, prickling, burning, loss of pain sensation.
• Loss or change in taste (ageusia or dysgeusia).
• Sleep problems.
• Feeling depressed, anxious, or nervous.
• Nasal congestion, difficulty breathing, or worsening of asthma.
• Intestinal inflammation called "intestinal angioedema" presenting symptoms such as abdominal pain, gastritis, and constipation, dry mouth.
• Inflammation of the pancreas (pancreatitis).
• Loss or decrease of appetite (anorexia).
• Increased or irregular heartbeats (arrhythmias), including bradycardia, ventricular tachycardia, and atrial fibrillation.
• Fever.
• Increase in certain white blood cells (eosinophilia).
• Blood tests show changes in liver function (increased liver enzymes and/or bilirubin), pancreas (increased pancreatic enzymes), and kidneys (increased blood urea and creatinine).
• 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.
• Skin spots and cold extremities.
• Redness of the eyes, itching, swelling (conjunctivitis).
• Hearing problems.
• Blood tests show a decrease in the number of red blood cells, white blood cells, platelets, or hemoglobin levels.

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

• Increased sensitivity to sunlight.
• High blood sugar (hyperglycemia).
• Gum inflammation.
• 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.
• Light sensitivity.
• Disorders combining rigidity, tremor, and/or movement disorders.

Frequency not known:

• Mouth ulcers.
• Psoriasis.
• Concentrated urine (dark-colored), malaise or nausea, muscle cramps, confusion, and seizures which may 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 unbalanced gait with shuffling steps.

Other reported adverse effects:

• Difficulty concentrating.
• Blood tests showing very low blood cell counts.
• Blood tests showing lower than normal sodium levels.
• Color changes in fingers and toes when exposed to cold, and tingling or painful sensations when exposed to heat (Raynaud's phenomenon).
• Slowness or difficulty reacting.
• Change in the perception of smells (parosmia).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tritamlo

Store below 30°C.

Keep in the original container to protect from light.

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tritamlo

• The active substances are amlodipine and ramipril. Each capsule contains amlodipine besilate equivalent to 10 mg of amlodipine and 10 mg of ramipril.
• The other components are:

Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized corn starch, low-moisture pregelatinized corn starch, sodium starch glycolate (type A) from potato, 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 contents of the pack

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

Tritamlo is available in blister packs, in containers 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 most recent review of this leaflet: September 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/