TARLODIX 5 mg/5 mg HARD CAPSULES

1. What is Tarlodix and what is it used for

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

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.

Amlodipine works by:

• Relaxing and widening your blood vessels, allowing blood to pass 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 given separately at the same dose as in this combination.

2. What you need to know before you take Tarlodix

Do not takeTarlodix:

• If you are allergic to amlodipine, ramipril (active substances), 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 high (see section "Other medicines and Tarlodix").
• 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, this medicine 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, breastfeeding, and fertility").
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If your blood pressure is abnormally low or unstable. Your doctor will need to assess you.
• If you have a narrowing of the aortic valve in your heart (aortic stenosis) or cardiogenic shock (a situation where your heart is unable to supply enough blood to your body).
• If you have heart failure after a heart attack.

Do not take this medicine if you have any of the above conditions. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

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

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

• If you have heart, liver, or kidney problems.
• If you have recently had a heart attack.
• If you have lost a lot of salt and water due to vomiting, diarrhea, excessive sweating, low-salt diets, or long-term use of diuretics, or if you are undergoing dialysis.
• If you are going to have an allergy test to reduce your sensitivity to bee or wasp stings (desensitization).
• If you are going to have an anesthetic, for example, for dental surgery. You may need to stop taking this medicine a 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 medicines or have conditions that may lower the levels of sodium in your blood. Your doctor may perform regular blood tests to check the levels of sodium in your blood, especially if you are elderly.
• If you are taking any of the following medicines used to treat high blood pressure:
• • Angiotensin II Receptor Antagonists (ARAII) (e.g., valsartan, telmisartan, irbesartan), especially if you have diabetic kidney problems.
  • Aliskiren.

Your doctor may need to check 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 Tarlodix".

• Tell your doctor if you think you are (or might become) pregnant. Ramipril is not recommended in the first 3 months of pregnancy and may cause harm to your baby after 3 months of pregnancy (see section "Pregnancy and breastfeeding").
• • If you have severe increases in blood pressure (hypertensive crises).
  • If you are elderly and need a dose increase.
  • If you have a persistent dry cough for a long time.
  • If your blood pressure does not decrease. Medicines of this type seem to be less effective in black patients.
  • If you are taking any of the following medicines, the risk of angioedema may increase:
  • • Neprilysin inhibitors (e.g., racecadotril, a medicine used to treat diarrhea).
    • Medicines used to prevent organ rejection and cancer, such as mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus).
    • Vildagliptin, a medicine used to treat diabetes.
    • Sacubitril/valsartan (see section 2 "Do not take Tarlodix").

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

Taking Tarlodixwith food, drinks, and alcohol

This medicine can be taken with or without food.

Drinking alcohol with this medicine may make you feel dizzy or lightheaded. If you are concerned about how much you can drink while taking this medicine, talk to your doctor or pharmacist. Talk to your doctor about how blood pressure-lowering medicines and alcohol can have additive effects.

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

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

You should not take this medicine during the first 12 weeks of pregnancy and should not take it at all after 13 weeks, as its use during pregnancy may be harmful to your baby. If you become pregnant while taking this medicine, inform your doctor immediately. A switch to a suitable alternative treatment should be made before a planned pregnancy.

Breastfeeding

You should not take this medicine while breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Fertility

There is not enough data on the effect on fertility.

Driving and using machines

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

Tarlodix contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Tarlodix

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 the effect of this medicine 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 take this medicine with grapefruit juice. This medicine 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.

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

Elderly patients

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

Use in children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age, as there is no data available for this population.

If you take more Tarlodix than you should

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

Taking too many capsules can cause your blood pressure to be too 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 clammy, and you may lose consciousness. Inform your doctor or go to the emergency department of the nearest hospital. Do not drive to the hospital, have someone drive you or call an ambulance. Bring the medicine package with you to show the doctor what you have taken.

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 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 make up for forgotten doses.

If you stop taking Tarlodix

Your doctor will tell you for how long you should take this medicine. Your condition may come back 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 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 swallowing or breathing difficult, 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 including skin rash, mouth ulcers, worsening of a pre-existing skin condition, redness, blistering, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme) (very rare adverse reactions).
• Vision 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 can occur on one or both sides, or dizziness and vertigo, confusion, loss of coordination, or drooping of one side of the face - these are symptoms of interrupted blood flow to the brain - stroke (adverse reactions of unknown frequency).

Consult your doctor immediately if you experience:

• Faster heart rate, irregular or strong heartbeats (palpitations) (frequent adverse reactions), chest pain, chest tightness, or more serious problems, such as heart attack and stroke (infrequent adverse reactions).
• Sudden wheezing, shortness of breath, or difficulty breathing (frequent adverse reactions). These may be signs of lung problems.
• Bruising more easily, bleeding for longer than usual, any sign of bleeding (e.g., bleeding gums), purple spots, skin spots, or infections more easily than usual, sore throat, and fever, feeling tired, fainting, dizziness, or having pale skin. These may be signs of blood or bone marrow problems (adverse reactions of unknown frequency).
• Severe stomach pain that can radiate to the back. This could be a sign of pancreatitis (inflammation of the pancreas) (infrequent 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, low blood pressure (abnormally low blood pressure), especially when standing or sitting up quickly.
• Dry, tickly cough, inflammation of the nasal passages (sinusitis), or bronchitis.
• Abdominal pain, diarrhea, constipation, indigestion, feeling sick or queasy (vomiting).
• Skin rash with or without a raised area.
• Chest pain.
• Palpitations (awareness of your heartbeat), flushing.
• Muscle cramps or muscle pain.
• Blood tests showing higher than usual potassium levels in the blood.
• Swelling (edema) of the ankle.

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

• Acid reflux.
• Balance problems (vertigo).
• Itching and unusual skin sensations such as numbness, tingling, prickling, burning, or crawling on the skin (paresthesia), loss of pain sensation.
• Loss or change in the taste of things.
• Stuffy 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 decreased appetite (anorexia).
• Joint pain, back 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.
• Tremor.
• Ringing in the ears.
• Sneezing/nasal secretion caused by inflammation of the nasal lining (rhinitis).
• Dry mouth.
• Hair loss, red spots on the skin, skin discoloration.
• Urination disorder, increased need to urinate, especially at night, increased number of times urinating during the day.
• Impotence, sexual dysfunction in men, breast tenderness or enlargement in men, decreased sexual desire in men or women.
• Pain, discomfort.
• Weight gain or loss.

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

• Feeling of shaking or confusion.
• Red and swollen tongue.
• Skin with peeling or severe peeling, rash with bumps and itching.
• Nail problems (e.g., loosening or separation of a nail from its bed).
• Skin rash or bruising.
• Inflammation of blood vessels, often with skin rash.
• Spots on the skin and cold extremities.
• Red, itchy, swollen, or tearful eyes.
• Disturbed hearing.
• Blood tests showing a decrease in the number of red blood cells, white blood cells, or platelets (which can result in unusual bruising or 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).
• Gum swelling.
• Abdominal swelling (gastritis).
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests.
• Increased muscle tension.
• Disorders that combine stiffness, tremors, and/or movement disorders.

Frequency not known (frequency cannot be estimated from the available data)

• Tremor, rigid posture, masked face, slow movements, and unsteady gait.
• Concentrated urine (dark-colored), feeling or being sick, having muscle cramps, confusion, and convulsions that may be due to inadequate secretion of ADH (antidiuretic hormone). If you have these symptoms, contact your doctor as soon as possible.

Other reported adverse effects:

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 usual sodium levels in the blood.
• Fingers on the hands and feet changing color when cold and then tingling or feeling pain when warmed (Raynaud's phenomenon).
• Slowed or impaired reactions.
• Burning sensation.
• 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 is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Tarlodix

Keep this medicine 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 medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Tarlodix Composition

• The active ingredients are:

Each capsule contains amlodipine besylate equivalent to 5 mg of amlodipine and 5 mg of ramipril.

• The other ingredients are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized corn starch, sodium carboxymethyl potato starch (type A), sodium stearyl fumarate, red iron oxide (E172), titanium dioxide (E171), and gelatin.

Appearance of Tarlodix and Package Contents

Tarlodix 5 mg/5 mg hard capsules: hard gelatin capsule, approximately 19 mm in length, with the opaque cap pink and the opaque body white, printed in black "R 5 mg A 5 mg". The contents of the capsules are a white or almost white powder.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31 - 2ª planta

28023 Madrid

Spain

Manufacturer

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 under the following names:

Denmark: Tarlodix

Spain: Tarlodix 5 mg/5 mg hard capsules

Date of the last revision of this leaflet: July 2024

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