Package Insert: Information for the Patient

Tarlodix10 mg/5 mg Hard Capsules

amlodipino/ramipril

Read this entire 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 may 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.

Tarlodix contains two active ingredients: amlodipine and ramipril. Amlodipine belongs to a group of medicines called calcium antagonists and ramipril to those called angiotensin-converting enzyme (ACE) inhibitors.

Ramipril acts:

• Reducing the production of substances that can increase blood pressure.
• Making its blood vessels relax and widen.
• Making it easier for the heart to pump blood.

Amlodipine acts:

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

This medicine is used to treat high blood pressure (hypertension), in patients whose blood pressure is adequately controlled with amlodipine and ramipril administered separately and at the same dose as presented by this medication combination.

Do not takeTarlodix:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

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

Your doctor may monitor your renal function, blood pressure and electrolyte levels (such as potassium) at regular intervals. See also the information under the heading “Do not take Tarlodix”.

• You must inform your doctor if you think you are (or could be) pregnant. Ramipril is not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see more information under the heading “Pregnancy and breastfeeding”).
• • If you have severe increases in blood pressure (hypertensive crises).
  • If you are an elderly person and need a dose increase.
  • If you have persistent dry cough for a long time.
  • If your blood pressure does not really decrease. These types of medications seem to be less effective in black people.
  • If you are taking some of the following medications, the risk of angioedema may increase:
  • • Neprilysin inhibitors (such as racecadotril, a medication used to treat diarrhea.
    • Medications used to prevent organ transplant rejection and for cancer such as mTOR inhibitors (for example mTOR inhibitors such as temsirolimus, sirolimus, everolimus).
    • Vildagliptin, a medication used to treat type 2 diabetes.
    • Sacubitril/valsartan (see section 2 – “Do not take Tarlodix”).

If you experience sudden swelling of your lips, face, tongue, throat and neck, possibly hands and feet, difficulty swallowing or breathing, urticaria or hoarseness (angioedema) may be a sign of an allergic reaction. This can occur at any time during treatment. Black people may have a higher risk of experiencing these symptoms. Inform your doctor immediately if you experience any of these symptoms.

Children and adolescents

This medication 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 Tarlodix

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

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

• Medications used to relieve pain and inflammation (such as non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetylsalicylic acid).

• 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.
• Rifampicin, erythromycin, clarithromycin (antibiotics), agents used to treat tuberculosis or other infections.
• Hypericum perforatum(St. John's Wort to treat depression).

Inform your doctor if you are taking any of the following medications. They may increase the likelihood of adverse effects if taken with Tarlodix:

• Sacubitril/valsartan to treat a type of chronic heart failure in adults (see section 2 “Do not take Tarlodix”).
• Tacrolimus, sirolimus, temsirolimus and everolimus (medications used to alter how your immune system works, allowing your body to accept the transplanted organ). See the section “Warnings and precautions”.
• Ciclosporina, an immunosuppressive medication used to prevent organ transplant rejection.
• Medications used to prevent organ rejection after a transplant such as ciclosporina.
• Medications used to relieve pain and inflammation (such as NSAIDs like ibuprofen or indomethacin and acetylsalicylic acid).
• Diuretics such as furosemide.
• Medications that may increase potassium levels in the blood such as spironolactone, triamterene, amiloride, potassium salts, supplements (including salt substitutes), trimethoprim alone or in combination with sulfamethoxazole (for infections) and heparin (to thin the blood).
• Medications used to treat inflammation such as prednisolone.
• Alopurinol (used to reduce uric acid in the blood).
• Procainamide (for heart rhythm problems).
• Vildagliptin (used to treat type 2 diabetes).
• racecadotril (used against diarrhea).
• Ketoconazole, itraconazole (antifungal medications).
• Ritonavir, indinavir, nelfinavir (the so-called protease inhibitors used to treat HIV).
• Verapamil, diltiazem (medications used to treat heart problems or high blood pressure).
• Dantrolene (infusion for severe body temperature abnormalities).

Your doctor may need to modify 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 Tarlodix” and “Warnings and precautions”).

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

• Medications for diabetes such as oral hypoglycemic agents or insulin. This medication may reduce your blood sugar levels. Monitor your blood sugar levels while taking this medication.
• Lithium (for mental health problems). This medication may increase lithium levels in the blood. Your doctor will need to closely monitor lithium levels in the blood.
• Simvastatin, a medication used to reduce cholesterol and triglyceride levels in the blood. Tarlodix may increase simvastatin levels in the blood.

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

Taking Tarlodix with food, drinks and alcohol

This medication can be taken with or without food.

Consuming alcohol with this medication may make you feel dizzy or disoriented. If you are concerned about how much you can drink while taking this medication, speak with your doctor or pharmacist. Speak with your doctor about how medications used to reduce blood pressure and alcohol may have additive effects.

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

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 medication.

Pregnancy

You should not takethis medicationin the first 12 weeks of pregnancy and should not take it at all from week 13, as its use during pregnancy may be harmful to the baby. If you become pregnant while takingthis medication, inform your doctor immediately. A change to an alternative suitable treatment should be made before a planned pregnancy.

Breastfeeding

You should not takethis medicationduring breastfeeding.

Consult your doctor or pharmacist before taking any medication.

Fertility

There is insufficient data on the effect on fertility.

Driving and operating machines

This medication may affect your ability to drive or operate machines. If you feel unwell, dizzy, tired or have a headache while taking this medication, 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.

Tarlodix contains sodium

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

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

If you feel that the effect of this medication is 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 take this medication with grapefruit juice. This medication should be taken 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.

If you are already taking diuretics (urine tablets), your doctor may suspend or reduce the amount of diuretic you take before starting treatment with Tarlodix.

Patients with advanced age

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

Use in children and adolescents

This medication is not recommended for use in children and adolescents under 18 years old as there are no available data for this population group.

If you take more Tarlodix than you should

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

Taking too many capsules may cause low or dangerously low blood pressure. 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 service. Do not drive to the hospital, have someone take you or call an ambulance. Bring the medication packaging with you to indicate to the doctor what you have taken.

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 forgot to take Tarlodix

If you forget to take a capsule, leave that capsule and take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Tarlodix

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 indicates.

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

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

Stop taking this medicine and consult a doctor immediately if you notice any of the following serious 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 rashes. This could be a sign of a severe allergic reaction to this medicine (adverse reactions of unknown frequency).
• Severe skin reactions that include skin rash, mouth ulcers, worsening of an existing skin condition, redness, blistering, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme) (very rare adverse reactions).
• Visual problems, such as blindness in one eye or double vision or difficulty speaking and understanding what others say or weakness or paralysis in your limbs, which may be on one or both sides or dizziness and vertigo, confusion, loss of coordination, or falling on one side of the face - these are symptoms of interruption of blood flow to the brain - stroke (adverse reactions of unknown frequency).

Consult your doctor immediately if you experience:

• Fast heart rate, irregular heartbeats, or strong palpitations (frequent adverse reactions), chest pain, chest tightness, or more serious problems, such as heart attack and stroke (rare adverse reactions).
• Sudden wheezing, shortness of breath, or difficulty breathing (frequent adverse reactions). These may be signs of lung problems.
• Easy bruising, prolonged bleeding, any sign of bleeding (e.g., bleeding gums), purple spots, skin spots, or increased susceptibility to infection, sore throat, and fever, feeling tired, fainting, dizziness, or pale skin. These may be signs of blood or bone marrow problems (adverse reactions of unknown frequency).
• Intense stomach pain that can reach the back. This could be a sign of pancreatitis (inflammation of the pancreas) (rare adverse reaction).
• 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 (inflammation of the liver) or liver damage (very rare adverse reactions).

Other side effects include:

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

Frequent (may affect up to 1 in 10 people):

• Headache, fatigue, or weakness.
• Drowsiness, feeling dizzy. This is more likely to happen when you start taking this medicine or start taking a higher dose.
• Visual disturbances, double vision, blurred vision.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting quickly.
• Dry, tickly cough, nasal congestion (sinusitis) or bronchitis.
• Abdominal pain, diarrhea, constipation, indigestion, feeling unwell or queasy (vomiting).
• Skin rash with or without raised areas.
• Chest pain.
• Palpitations (awareness of your heartbeats), flushing.
• Muscle cramps or pain.
• Blood tests showing higher-than-normal potassium levels in the blood.
• Swelling (edema) of the ankle.

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

• Heartburn.
• Balance problems (dizziness).
• Itching and unusual skin sensations such as numbness, tingling, pinching, burning, or crawling on the skin (paresthesia), loss of pain sensation.
• Loss or change in the taste of things.
• Blocked nose, difficulty breathing, or worsening of asthma.
• A swelling in your intestine called "intestinal angioedema" that presents with symptoms such as abdominal pain, vomiting, and diarrhea.
• Excessive sweating.
• Loss or decrease in appetite (anorexia).
• Back pain, joint pain.
• Fever.
• Increased number of certain white blood cells (eosinophilia) detected during a blood test.
• Blood tests showing changes in the functioning of your liver, pancreas, or kidneys.
• Mood changes, feeling anxious, more nervous than usual, or restless, depression, insomnia.
• Trembling.
• Tinnitus (ringing in the ears).
• Runny nose/secretion caused by inflammation of the nasal lining (rhinitis).
• Dry mouth.
• Hair loss, red spots on the skin, skin discoloration.
• Urination problems, increased need to urinate, especially at night, increased number of times you urinate during the day.
• Inability to get an erection, impotence in men, discomfort or breast enlargement in men, decreased sex drive in men or women.
• Pain, discomfort.
• Weight gain or loss.

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

• Feeling of trembling or confusion.
• Red, swollen tongue.
• Peeling or severe peeling of the skin, rash with blisters and itching.
• Nail problems (e.g., loosening or separation of a nail from its bed).
• Skin rash or hematomas.
• Inflammation of blood vessels, often with skin rash.
• Spots on the skin and cold extremities.
• Red, itchy, swollen, or watery eyes.
• Auditory disturbances.
• Blood tests showing a decrease in the number of red blood cells, white blood cells, or platelets (which may result in unusual bruising or easy bleeding) or in the amount of hemoglobin.

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

• Being more sensitive to the sun than usual.
• High blood sugar (hyperglycemia).
• Swelling of the gums.
• Abdominal swelling (gastritis).
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests.
• Increased muscle tension.
• Disorders that combine stiffness, trembling, and/or movement disorders.

Unknown frequency (frequency cannot be estimated from available data)

• Trembling, stiff posture, masked face, slow movements, and walking with feet dragging and unbalanced.
• Concentrated urine (dark-colored), feeling sick, having muscle cramps, confusion, and seizures that may be due to inadequate secretion of ADH (antidiuretic hormone). If you have these symptoms, contact your doctor as soon as possible.

Other adverse effects reported:

Inform your doctor if any of the following adverse effects become severe or last more than a few days.

• Difficulty concentrating.
• Swollen mouth.
• Blood tests showing lower-than-normal sodium levels in the blood.
• The fingers of the hands and feet change color when you're cold and then tingle or hurt when you warm up (Raynaud's phenomenon).
• Slow or impaired reactions.
• Feeling burned.
• Change in the way things smell.

Reporting of adverse effects

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

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

Store below 30°C.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Tarlodix

• The active principles are:

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 cornstarch, sodium carboxymethylstarch from potato (type A), stearate fumarate and sodium, red iron oxide (E172), titanium dioxide (E171), and gelatin.

Appearance of Tarlodix and content of the container

Tarlodix 10 mg/5 mg hard capsules: hard gelatin capsule, approximately 19 mm in length, with an opaque brown-red cap and an opaque white body that carries a black print “R 5 mg A 10 mg”. The content of the capsules is a white or almost white powder.

Tarlodix is available in blisters containing 28, 30, 32, 56, 60, 90, 91, 96, 98, or 100 capsules.

Only some container sizes may be marketed.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca,31 - 2nd floor

28023 Madrid

Spain

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

or

Adamed Pharma S.A.

ul. Szkolna, 33

95 054 Ksaweow

Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

Denmark:Tarlodix

Spain: Tarlodix 10 mg/5 mg hard capsules

Last review date of this leaflet: July 2024

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