Leaflet: information for the user

Tarlodix Plus 5 mg/5 mg/12.5 mg hard capsules

Tarlodix Plus 5 mg/5 mg/25 mg hard capsules

Tarlodix Plus 5 mg/10 mg/25 mg hard capsules

Tarlodix Plus 10 mg/10 mg/25 mg hard capsules

amlodipino/ramipril/hidroclorotiazida

Read this 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Tarlodix Plus contains three active substances called amlodipine, ramipril and hydrochlorothiazide.

Ramipril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. It works in the following way:

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

Amlodipine belongs to a group of medicines called calcium antagonists. It works in the following way:

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

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It works in the following way:

• Increasing urine production, which also lowers your blood pressure.

This medicine can be used to treat high blood pressure (hypertension) in adult patients, whose blood pressure is adequately controlled with amlodipine, ramipril and hydrochlorothiazide administered separately at the same time and at the same dose as the combination of this medicine.

Do not take Tarlodix Plus:

• if you are allergic to amlodipine, ramipril, or hydrochlorothiazide (active substances), other calcium antagonists, or inhibitors of the ACE or any of the other components of this medication (listed in section 6). You may experience itching, skin redness, or difficulty breathing.
• if you have aortic valve stenosis or cardiogenic shock (a situation where the heart is unable to supply enough blood to the body).
• if you have ever had a severe allergic reaction called "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 have taken or are taking sacubitril/valsartan, a medication used to treat a type of chronic heart failure in adults.
• if you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, treatment with this medication may not be suitable for you.
• if you have severe kidney problems
• if you are unable to urinate (anuria).
• if you have gout.
• if you have liver insufficiency.
• 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 your blood pressure is abnormally low or unstable.
• if you have heart failure after a heart attack.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication that contains aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tarlodix Plus.

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

• if you are an elderly person and need a dose increase.
• if you have heart, liver, or kidney problems.
• if you have had a recent heart attack.
• if you have severe high blood pressure (hypertensive crises).
• if you have lost a large amount of salt or fluid due to vomiting, diarrhea, excessive sweating, low-salt diets, long-term diuretic use, or dialysis.
• if you are breastfeeding.
• if you have allergies or asthma.
• 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, during a dental operation. You may need to stop taking Tarlodix Plus a day before; consult your doctor or pharmacist.
• if you have high levels of potassium in your blood (shown in blood test results).
• if your potassium level in the blood is too low (with or without symptoms such as muscle weakness, muscle spasms, or abnormal heart rhythm).
• if your sodium level in the blood is too low (with or without symptoms such as fatigue, confusion, muscle spasms, or seizures).
• if you are taking medications or have any disease that may decrease sodium levels in the blood. Your doctor should perform blood tests periodically, particularly to monitor sodium levels in the blood, especially if you are an elderly person.
• if your calcium levels in the blood are high (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, or muscle contractions).
• if you have gout attacks (crystals of uric acid in the joints).
• 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 transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
  • vildagliptin, a medication used to treat type 2 diabetes.
• if you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.
• if you have a decrease in vision or have eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion), especially if you are at risk of developing a condition called glaucoma or are allergic to penicillin or sulfonamide medications.
• if you have photosensitivity reactions, stop taking this medication.
• if you have diabetes, your insulin dose may need to be adjusted or you may require oral hypoglycemic agents.
• if you are taking any of the following medications used to treat high blood pressure:
• • Angiotensin II receptor antagonists (ARA) (e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskiren.
• if you have had skin cancer or develop an unexpected skin lesion during treatment. The use of hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking this medication.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Tarlodix Plus, seek medical attention immediately.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals. See also the information "Do not take Tarlodix Plus".

Inform your doctor if you think you are (or may be) pregnant.Tarlodix Plusis not recommended in the first 3 months of pregnancy and may cause severe harm to your baby after 3 months of pregnancy (see section "Pregnancy, breastfeeding, and fertility").

Children and adolescents

Tarlodix Plus is not recommended for children and adolescents under 18 years of age because there is no available information on safety and efficacy for this age group.

Other medications and Tarlodix Plus

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 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 Plus" and "Warnings and precautions").

Inform your doctor if you are taking any of the following medications. These may decrease the action ofTarlodix Plus:

• Medications used to relieve pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, and acetylsalicylic acid).
• Medications used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, or epinephrine. Your doctor will need to check your blood pressure.
• Medications that stimulate the heart, such as isoproterenol, dobutamine, dopamine, epinephrine.
• Rifampicin (antibiotic for treating tuberculosis).
• Hypericum perforatum (St. John's Wort for treating depression).
• Resin chelators (substances used mainly for treating high levels of lipids in the blood).

Inform your doctor if you are taking any of the following medications. These may increase the likelihood of experiencing adverse effects if taken in combination with Tarlodix Plus:

• Medications used to relieve pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, and acetylsalicylic acid).
• Sacubitril/valsartan: used to treat a type of chronic heart failure in adults (see section 2 "Do not take Tarlodix Plus").
• Medications used to prevent organ transplant rejection, such as ciclosporin.
• Medications that may decrease potassium levels in the blood. These include medications for constipation (laxatives), glucocorticoids, tetracosactide, amphotericin B (used for fungal infections), and ACTH (used to evaluate if your adrenal glands are functioning correctly).
• Diuretics (medications for urination) such as furosemide.
• Desmopressin (used in diabetes or urinary problems).
• Medications used for treating inflammation, such as prednisolone.
• Electrolyte supplements (e.g., potassium), diuretics that save potassium such as spironolactone, triamterene, amiloride, and other medications that may increase potassium levels in the blood (e.g., trimethoprim alone or in combination with sulfamethoxazole for bacterial infections, heparin for diluting the blood).
• Calcium tablets or other calcium supplements.
• Alopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Colestiramine (for reducing lipid levels in the blood).
• Carbamazepine, oxcarbazepine (for epilepsy).
• Ketoconazole, itraconazole (antifungal medications).
• Ritonavir, indinavir, nelfinavir (protease inhibitors used for treating HIV).
• Verapamil, diltiazem (medications for heart problems or high blood pressure).
• Dantrolene (for severe temperature-related anomalies).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (for preventing organ transplant rejection).
• Vildagliptin (used for treating type 2 diabetes).
• Racecadotril (used for diarrhea).
• Tacrolimus (used for controlling the body's immune response to accept the transplanted organ).
• Other medications that lower blood pressure, such as phosphodiesterase type 5 inhibitors (for erectile dysfunction), nitrates, alpha blockers (for urological use to reduce prostate muscle tension and urethral tension), other medications used for treating prostate problems (alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, terazosin), tricyclic antidepressants, neuroleptics, phenothiazines, dopamine agonists, levodopa used for Parkinson's disease, baclofen (for muscle rigidity in diseases such as multiple sclerosis), amifostine.
• Medications that alter gastrointestinal motility, i.e., anticholinergic agents.
• Citalopram, escitalopram (used for depression).
• Difemanil (used for treating peptic ulcers, hyperacidity, and for treating excessive sweating).
• Medications used for treating heart rhythm problems (e.g., digitals, dofetilide, ibutilide, hydquinidine, disopyramide, amiodarone, dronedarone, sotalol, digoxin, quinidine).
• Pentamidine (used for treating pneumonia caused by a fungus called Pneumocystis carinii).
• Medications used for treating schizophrenia and psychosis (e.g., amisulpride, chlorpromazine, ciamemazine, flupentixol, flufenazine, haloperidol, pipamperone, pipotiazine, sulpiride, sultopride, zuclopentixol).
• Pimozide (used for Tourette's syndrome).
• Hidroxizina (used for treating itching caused by allergies).
• Medications used for treating nausea and vomiting (e.g., domperidone, dolasetron, droperidol, levomepromazine).
• Medications used for treating malaria (e.g., artemisinin, chloroquine, halofantrine, lumefantrine, piperaquine).
• Medications used for treating allergic reactions (e.g., mizolastine, mequitazine).
• Antibiotics for treating infections (e.g., amphotericin B, clarithromycin, erythromycin, levofloxacin, moxifloxacin, penicillin, spiramycin).
• Methadone (for treating dependence on certain active principles).
• Prucaloprida (used for treating chronic constipation).
• Tiaprida (used for reducing excessive sweating, agitation, and tremors during alcohol withdrawal).
• Vandetanib, toremifeno (for treating certain types of cancer) and other cancer medications (chemotherapy).
• Vincamina (for treating neurological disorders related to aging).

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

• Medications for diabetes, such as oral hypoglycemic agents or insulin. Tarlodix Plus may lower your blood sugar levels. Monitor your blood sugar levels while taking Tarlodix Plus.
• Lithium (for mental health problems): Tarlodix Plus may increase lithium levels in the blood. Your doctor will closely monitor lithium levels in the blood.
• Simvastatin (cholesterol-lowering medication): Amlodipine may increase simvastatin levels in the blood. Your doctor will need to reduce the simvastatin dose if you are taking Tarlodix Plus.
• Quinine (for malaria).
• Medications that contain iodine (contrast medium), which may be used when undergoing an examination or radiography in the hospital.
• Oral anticoagulants (medications that dilute the blood) such as warfarin.

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

Use in athletes

This medication contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Tarlodix Plus with food, drinks, and alcohol

• Tarlodix Plus can be taken with or without food.
• Oranges or orange juice should not be consumed by people taking Tarlodix Plus. This is because oranges and orange juice may increase amlodipine levels in the blood, which may cause unpredictable blood pressure-lowering effects of this medication.
• Consuming alcohol with Tarlodix Plus may make you feel dizzy or disoriented. If you are concerned about how much you can drink while taking Tarlodix Plus, speak with your doctor or pharmacist. Discuss with your doctor how blood pressure-lowering medications and alcohol may have additive effects.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You must inform your doctor if you think you are (or may be) pregnant. Do not take Tarlodix Plus in the first 12 weeks of pregnancy, and do not take it at all after week 13, as its use during pregnancy may be harmful to the baby. If you become pregnant during treatment with Tarlodix Plus, inform your doctor immediately. If you are planning to become pregnant, consult your doctor, who will advise you to take another medication.

Breastfeeding

You must not take Tarlodix Plus during breastfeeding. Inform your doctor if you are breastfeeding or plan to start breastfeeding before taking Tarlodix Plus.

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 after taking this medication, do not drive or operate machines and contact your doctor immediately.

Tarlodix Plus contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be administered once a day.Your doctor may modify the dose depending on the effect it has on you.

This medication should be taken at the same time of day, before or after a meal.

Swallow the entire capsule with some liquid.

Do not crush or chew the capsules forcefully.

Do not take this medication with grapefruit juice.

Liver and kidney insufficiency

The doses may be modified in liver and kidney insufficiency.

Older patients

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

Use in children and adolescents

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

If you take more Tarlodix Plus than you should

Taking too many capsules may 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. Excess fluid may accumulate in the lungs (pulmonary edema) causing breathing difficulties that may develop within 24-48 hours after ingestion. Inform your doctor or go to the nearest hospital emergency department if you take too much Tarlodix Plus. 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 Plus

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 Plus

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

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 Tarlodix Plus 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 rash. This could be a sign of a severe allergic reaction to Tarlodix Plus.
• Severe skin reactions, including rash, mouth ulcers, worsening of an existing skin disease, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion) (a very rare side effect that can affect up to 1 in 10,000 people).
• Unexpected sunburn or dermatitis (a dry, itchy rash with blisters) on exposed skin.

Consult your doctor immediately if you experience:

• Sudden wheezing, shortness of breath, or difficulty breathing, faster heart rate, irregular heartbeats, or strong heart palpitations, chest pain, chest tightness, or more severe symptoms such as heart attack and stroke.
• Difficulty breathing or coughing. These may be symptoms of lung problems, including inflammation.
• Swollen areas, bleeding for longer than usual, any sign of bleeding (for example, bleeding gums), purpura, rashes, or spots on the skin, or getting infections more easily than usual, 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 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 may be signs of liver problems, such as hepatitis (inflammation of the liver) or liver damage.
• Extreme fatigue (fatigue), nausea, and vomiting, confusion, or concentration problems, swelling (edema), especially around the hands, ankles, or face, urinating more frequently, muscle cramps (muscle spasms). These may be signs of kidney failure.
• Unusual growths or spots on the skin, especially in sun-exposed areas. They may be signs of non-melanoma skin cancer.

Other side effects:

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

Very common: can affect more than 1 in 10 people

• Fluid retention (edema)
• Hypokalemia
• Hypolipidemia

Common: can affect up to 1 in 10 people

• Headache, dizziness, numbness associated with drowsiness (somnolence; especially at the beginning of treatment), feeling of exhaustion (fatigue)
• Consciousness of your heartbeats (palpitations)
• Swelling of the ankles
• Low blood pressure (hypotension), especially when standing or sitting quickly (orthostatic hypotension), fainting (syncope), redness
• Dry cough, sinusitis, or bronchitis, difficulty breathing (dyspnea)
• Abdominal pain, diarrhea, gastrointestinal inflammation, digestive disorders, and abdominal discomfort (including dyspepsia), nausea, vomiting, alteration of bowel habits (including diarrhea or constipation), loss of appetite (anorexia), spasms
• Rash on the skin with or without inflammation, urticaria
• Chest pain
• Muscle cramps or pain (myalgia)
• Blood tests showing lower than normal levels of magnesium and sodium in the blood
• Feeling weak and powerless (asthenia)
• Blood tests showing a decrease in the number of platelets (thrombocytopenia)
• Blood tests showing higher levels of uric acid or potassium in the blood
• Impotence (inability to get an erection)
• Visual disturbances (including double vision and blurred vision)

Rare: can affect up to 1 in 1,000 people

• Swelling of the skin, mucous membranes, and surrounding tissues (angioedema/Quincke's edema; very exceptionally, the resulting obstruction of the airways can have a fatal outcome)
• Swollen arms and legs (peripheral edema; this may be a sign that your body is retaining more water than normal)
• Intestinal swelling (intestinal angioedema)
• Changes in mood, depression, anxiety, nervousness, restlessness, sleep disorders (insomnia)
• Tinnitus (ringing in the ears)
• Runny nose, nasal discharge, or nasal congestion
• Difficulty breathing (bronchospasm), including worsening of asthma
• Dry mouth, upper abdominal pain, including gastritis
• Inflamed pancreas (pancreatitis; cases of death have been reported with ACE inhibitors)
• Acute kidney failure that includes acute renal failure (significant decrease in urine output, urinary disorders, urinating more frequently during the day, increased need to urinate at night (nocturia)
• Presence of glucose in urine
• Worsening of pre-existing proteinuria (more proteins than usual in the urine)
• Feeling unwell (malaise)
• Weight gain or loss
• Dizziness, tremors
• Hair loss (alopecia)
• Itching (pruritus), small bleeding spots or areas of bleeding on the skin (purpura), skin discoloration, exanthema
• Unusual sensations in the skin such as numbness, tingling, pinching, burning, or prickling (paresthesia), reduced skin sensation (hypoesthesia)
• Loss (ageusia) or change in the taste of things (dysgeusia)
• Excessive sweating (hyperhidrosis)
• Heart attack (myocardial infarction), cardiovascular disease (myocardial ischemia), chest tightness, and pain (angina pectoris), increased (tachycardia) or irregular heartbeats (arrhythmia)
• Reduced heartbeats (bradycardia), designated cardiac rhythm disorders (atrial fibrillation, ventricular tachycardia)
• Joint pain (arthralgia), back pain, general pain
• Increased body temperature/fever (pyrexia)
• Reduced sex drive in men or women, male breast enlargement (gynecomastia)
• Increased number of certain white blood cells (eosinophilia) found during a blood test
• Blood tests showing changes in liver function (increased liver enzymes and/or conjugated bilirubin), pancreas (increased pancreatic enzymes), or kidneys (increased creatinine)
• Cough
• Inflammation of blood vessels, often with skin rash (vasculitis, cutaneous vasculitis)

Very rare: can affect up to 1 in 10,000 people

• Generalized skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Inflammation of the liver (hepatitis, in most cases with cholestasis)
• Skin rash that can form blisters and appear as small white spots (dark centers surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).
• Type of lupus erythematosus reaction, reactivation of lupus erythematosus, necrotizing vasculitis, and toxic epidermal necrolysis.
• Enlargement of gum tissue (gingival hyperplasia)
• Increased muscle tone (hypertonia)
• Peripheral nervous system disease (peripheral neuropathy)
• Bone marrow insufficiency
• Blood tests showing red blood cells, white blood cells, and platelets that are too damaged (hemolytic anemia)
• Allergic reactions
• Alkalosis hypochloremia
• Difficulty breathing (including pneumonitis and pulmonary edema)

Frequency not known: the frequency cannot be estimated from available data

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

• Blood tests showing very few red and white blood cells and platelets (pancytopenia)
• Anaphylactic or anaphylactoid reactions
• Rough skin (pemphigus)
• Increased antinuclear antibodies
• Disturbance in attention
• Inflammation of the oral mucosa with small ulcers (aphthous stomatitis)
• Aplastic anemia
• Fingers and toes change color when cold and numbness or pain with heat (Raynaud's phenomenon)
• Cerebral ischemia that includes ischemic stroke and transient ischemic attack.
• Impaired psychomotor skills
• Feeling burned
• Change in the way things smell (parosmia)
• Acute liver failure, cholestatic and cytolytic hepatitis (a fatal outcome has been reported exceptionally)
• Inflammation of the skin (psoriasiform dermatitis), acute skin rash (exanthema pemphigoid or lichenoid), worsening of peeling or peeling of the skin (psoriasis exacerbated), inflammation of the mucosa (enanthema)
• Concentrated urine (dark color), feeling unwell or nausea, muscle cramps, confusion, and convulsions that 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 unsteady gait.
• Sudden decrease in distant vision (acute myopia), decrease in vision or eye pain due to high pressure (possible signs of accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma.
• Skin cancer and lip cancer (non-melanoma skin cancer)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:http://www.notificaram.es.By reporting adverse reactions, 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.

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 ofTarlodix Plus

The active principles are: amlodipine, ramipril and hydrochlorothiazide.

Tarlodix Plus 5 mg/5 mg/12.5 mg hard capsules:

One capsule contains 5 mg of amlodipine (6.934 mg as amlodipine besilate), 5 mg of ramipril and 12.5 mg of hydrochlorothiazide.

Tarlodix Plus 5 mg/5 mg/25 mg hard capsules:

One capsule contains 5 mg of amlodipine (6.934 mg as amlodipine besilate), 5 mg of ramipril and 25 mg of hydrochlorothiazide.

Tarlodix Plus 5 mg/10 mg/25 mg hard capsules:

One capsule contains 5 mg of amlodipine (6.934 mg as amlodipine besilate), 10 mg of ramipril and 25 mg of hydrochlorothiazide.

Tarlodix Plus 10 mg/10 mg/25 mg hard capsules:

One capsule contains 10 mg of amlodipine (13.868 mg as amlodipine besilate), 10 mg of ramipril and 25 mg of hydrochlorothiazide.

The other components are:

Capule content:microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized maize starch, carboxymethylstarch sodium salt (type A), stearate and sodium fumarate.

Capule coating:red iron oxide (E172), titanium dioxide (E171), gelatin, black iron oxide (E172) (only for 5 mg/5 mg/12.5 mg and 10 mg/10 mg/25 mg doses) and yellow iron oxide (E172) (only for 5 mg/5 mg/25 mg, 5 mg/10 mg/25 mg and 10 mg/10 mg/25 mg doses).

Appearance of the product and contents of the package

Tarlodix Plus5 mg/5 mg/12.5 mg are hard capsules: capsule with opaque pink cap and opaque light grey body.

Tarlodix Plus5 mg/5 mg/25 mg are hard capsules: capsule with opaque pink cap and opaque ivory body.

Tarlodix Plus5 mg/10 mg/25 mg are hard capsules: capsule with opaque dark pink cap and opaque yellow body.

Tarlodix Plus10 mg/10 mg/25 mg are hard capsules: capsule with opaque brown cap and opaque caramel body.

Tarlodix Plus is presented in blisters of 10, 28, 30, 60 or 100 hard capsules in cardboard boxes.

Only some package 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

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Danish:Ramipril/Amlodipin/Hydrochlorthiazid APC

Spanish:Tarlodix Plus 5 mg/5 mg/12.5 mg hard capsules

Tarlodix Plus 5 mg/5 mg/25 mg hard capsules

Tarlodix Plus 5 mg/10 mg/25 mg hard capsules

Tarlodix Plus 10 mg/10 mg/25 mg hard capsules

Last review date of this leaflet: December 2023

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es.