Tarlo Dix Plus 5 mg/10 mg/25 mg hard capsules: detailed information

Package leaflet: Information for the user

Introduction

Package 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

amlodipine/ramipril/hydrochlorothiazide

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

Contents of the leaflet

What Tarlodix Plus is and what it is used for
What you need to know before taking Tarlodix Plus
How to take Tarlodix Plus
Possible side effects
How to store Tarlodix Plus
Contents of the pack and other information

1. What Tarlodix Plus is and what it is used for

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

Ramipril belongs to a group of medicines called ACE inhibitors (Angiotensin-Converting Enzyme inhibitors). It works as follows:

By reducing the production of substances that could increase blood pressure.
By causing your blood vessels to relax and widen.
By enabling the heart to pump blood more easily.

Amlodipine belongs to a group of medicines called calcium antagonists. It works as follows:

By relaxing and widening blood vessels, allowing blood to flow through them more easily.

Hydrochlorothiazide belongs to a group of medicines called "thiazide diuretics". It works as follows:

By 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 given separately at the same doses as those contained in this combination medicine.

2. What you need to know before taking Tarlodix Plus

Do not take Tarlodix Plus:

if you are allergic to amlodipine, ramipril, or hydrochlorothiazide (active substances), other calcium antagonists or ACE inhibitors, or any of the other components of this medicine (listed in section 6). It may cause itching, skin redness, or difficulty breathing.
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 ever had a severe allergic reaction called "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 have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (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 medicine may not be suitable for you.
if you have severe kidney problems.
if you are unable to urinate (anuria).
if you suffer from gout.
if you have liver failure.
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 following a heart attack.
if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Tarlodix Plus.

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

if you are elderly and require a dose increase.
if you have heart, liver, or kidney problems.
if you have recently had a heart attack.
if you have severe episodes of high blood pressure (hypertensive crises).
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 breastfeeding.
if you suffer from allergies or asthma.
if you are undergoing treatment to reduce allergy to bee or wasp stings (desensitization).
if you are to be given an anesthetic, for example during a dental procedure. You may need to stop taking Tarlodix Plus one day before; consult your doctor or pharmacist.
if you have high levels of potassium in your blood (shown in blood test results).
if your blood potassium level is too low (with or without symptoms such as muscle weakness, muscle cramps, or irregular heartbeat).
if your blood sodium level is too low (with or without symptoms such as fatigue, confusion, muscle cramps, or seizures).
if you are taking medicines or have a disease that can lower sodium levels in the blood. Your doctor should perform periodic blood tests, particularly to monitor blood sodium levels, especially if you are elderly.
if your blood calcium levels are high (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, or muscle contractions).
if you suffer from gout attacks (uric acid crystals in the joints).
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 you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus.
if you experience vision problems or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion), especially if you are at risk of developing glaucoma or are allergic to penicillin- or sulfonamide-containing medicines.
if you have photosensitivity reactions, you should stop taking this medicine.
if you have diabetes, your insulin dose may need adjustment or oral hypoglycemic agents may be required.
if you are taking any of the following medicines for treating hypertension (high blood pressure):
- Angiotensin II Receptor Antagonists (ARA-II) (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. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun and UV exposure while taking this medicine.
if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking Tarlodix Plus, seek medical attention immediately.

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

Inform your doctor if you think you are (or might be) pregnant. Tarlodix Plus is not recommended during the first 3 months of pregnancy and may cause serious 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, as there is no available information on safety and efficacy in this population.

Other medicines and Tarlodix Plus

Inform 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 receptor antagonist (ARA-II) or aliskiren (see also information under the headings "Do not take Tarlodix Plus" and "Warnings and precautions").

Inform your doctor if you are taking any of the following medicines. These may reduce the effectiveness of Tarlodix Plus:

Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, and acetylsalicylic acid).
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 that stimulate the heart, such as isoproterenol, dobutamine, dopamine, epinephrine.
Rifampicin (an antibiotic used to treat tuberculosis).
Hypericum perforatum (St. John’s wort, used to treat depression).
Chelating resins (substances mainly used in the treatment of elevated lipid levels in the blood).

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

Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, and acetylsalicylic acid).
Sacubitril/valsartan: used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Tarlodix Plus”).
Medicines to prevent organ transplant rejection, such as cyclosporine.
Medicines that may reduce potassium levels in the blood. These include medicines for constipation (laxatives), glucocorticoids, tetracosactide, amphotericin B (used for fungal infections), and ACTH (used to assess adrenal gland function).
Diuretics (water tablets) such as furosemide.
Desmopressin (used in diabetes or urinary problems).
Steroid medicines for inflammation, such as prednisolone.
Potassium supplements (including salt substitutes), potassium-sparing diuretics such as spironolactone, triamterene, amiloride, and other medicines that may increase blood potassium levels (e.g., trimethoprim alone or in combination with sulfamethoxazole for bacterial infections, and heparin (to thin the blood)).
Calcium tablets or other calcium supplements.
Allopurinol (used to lower uric acid in the blood).
Procainamide (for heart rhythm problems).
Cholestyramine (to reduce blood fat levels).
Carbamazepine, oxcarbazepine (for epilepsy).
Ketoconazole, itraconazole (antifungal medicines).
Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV).
Verapamil, diltiazem (medicines to treat heart disorders or high blood pressure).
Dantrolene (given by infusion for serious body temperature abnormalities).
Temsirolimus (for cancer).
Sirolimus, everolimus (to prevent graft rejection).
Vildagliptin (used to treat type 2 diabetes).
Racecadotril (used for diarrhea).
Tacrolimus (used to control the body’s immune response to accept a transplanted organ).
Other products that lower blood pressure, such as phosphodiesterase type 5 inhibitors (for erectile dysfunction), nitrates, alpha-blockers (used urologically to reduce tension in smooth muscles of the prostate and urethra), other medicines used for prostate disorders (alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, terazosin), tricyclic antidepressants, neuroleptics, phenothiazines, dopamine agonists, levodopa (used in Parkinson’s disease), baclofen (to treat muscle stiffness in diseases such as multiple sclerosis), amifostine.
Medicines that alter gastrointestinal motility, i.e., anticholinergic agents.
Citalopram, escitalopram (used for depression).
Difemanil (used in the treatment of peptic ulcer, gastric hyperacidity, and hyperhidrosis (excessive sweating)).
Medicines used to treat heart rhythm disorders (e.g., digitalis, dofetilide, ibutilide, hydroquinidine, disopyramide, amiodarone, dronedarone, sotalol, digoxin, quinidine).
Pentamidine (used to treat pneumonia caused by a fungus called Pneumocystis carinii).
Medicines used to treat schizophrenia and psychosis (e.g., amisulpride, chlorpromazine, cyamemazine, flupentixol, flufenazine, haloperidol, pipamperone, pipotiazine, sulpiride, sultopride, zuclopentixol).
Pimozide (used in Tourette syndrome).
Hydroxyzine (used to treat itching caused by allergies).
Medicines used for nausea and vomiting (e.g., domperidone, dolasetron, droperidol, levomepromazine).
Medicines used to treat malaria (e.g., arteether, chloroquine, halofantrine, lumefantrine, piperaquine).
Medicines used to treat allergic reactions (e.g., mizolastine, mequitazine).
Antibiotics for infections (e.g., amphotericin B, clarithromycin, erythromycin, levofloxacin, moxifloxacin, penicillin, spiramycin).
Methadone (to treat dependence on certain active substances).
Prucalopride (used to treat chronic constipation).
Tiapride (used to reduce hyperhidrosis, agitation, and tremor during alcohol withdrawal).
Vandetanib, toremifene (to treat certain types of cancer) and other cancer medicines (chemotherapy).
Vincamine (to treat neurological disorders related to aging).

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

Medicines for diabetes such as oral hypoglycemics or insulin. Tarlodix Plus may reduce your blood sugar levels. Monitor your blood sugar levels while taking Tarlodix Plus.
Lithium (for mental health conditions): Tarlodix Plus may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels.
Simvastatin (a cholesterol-lowering medicine): Amlodipine may increase simvastatin levels in the blood. Your doctor may need to reduce the simvastatin dose if you are taking Tarlodix Plus.
Quinine (for malaria).
Medicines containing iodine (contrast media), which may be used during imaging or X-ray procedures in hospital.
Oral anticoagulant medicines (blood thinners) such as warfarin.

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

Use in athletes

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

Tarlodix Plus with food, drinks, and alcohol

Tarlodix Plus can be taken with or without food.
Grapefruit or grapefruit juice should not be consumed by people taking Tarlodix Plus. This is because grapefruit and grapefruit juice may increase blood levels of amlodipine, potentially causing an unpredictable increase in the blood pressure-lowering effect of this medicine.
Drinking alcohol with Tarlodix Plus may make you feel dizzy or lightheaded. If you are concerned about how much alcohol you can drink while taking Tarlodix Plus, speak with your doctor or pharmacist. Discuss with your doctor how blood pressure-lowering medicines and alcohol may have additive effects.

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 inform your doctor if you think you are (or might be) pregnant. You should not take Tarlodix Plus during the first 12 weeks of pregnancy, and must not take it at all after week 13, as its use during pregnancy may harm the baby. If you become pregnant while taking Tarlodix Plus, inform your doctor immediately. If you are planning a pregnancy, consult your doctor, as they will advise you to take an alternative medicine.

Breastfeeding

You should not take Tarlodix Plus while breastfeeding. Inform your doctor if you are breastfeeding or plan to breastfeed before taking Tarlodix Plus.

Consult your doctor or pharmacist before taking any medicine.

Fertility

There are insufficient data on the effect on fertility.

Driving and using machines

This medicine may affect your ability to drive or operate machinery. If you feel unwell, dizzy, tired, or have a headache after taking this medicine, do not drive or operate machinery and contact your doctor immediately.

Tarlodix Plus contains sodium

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

3. How to take Tarlodix Plus

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

This medicine should be taken once daily.

Your doctor may adjust the dose depending on its effect on you.

Take this medicine at the same time each day, before or after meals.

Swallow the capsule whole with some liquid.

Do not crush or chew the capsules forcefully.

Do not take this medicine with grapefruit juice.

Hepatic and renal impairment

In patients with hepatic or renal impairment, doses may be adjusted.

Elderly patients

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

Use in children and adolescents

The use of this medicine is not recommended 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 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. Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty breathing, which may develop within 24–48 hours after ingestion. Inform your doctor or go immediately 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 medicine packaging with you so the doctor knows what you have taken.

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, indicating the medicine and the amount ingested.

If you forget to take Tarlodix Plus

If you forget to take a capsule, skip that dose 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 Plus

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 instructed to do so by your doctor.

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 Tarlodix Plus and consult a doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

Swelling of the face, lips, or throat causing difficulty swallowing or breathing, along with 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 a pre-existing skin disease, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).
Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion) (a very rare adverse effect that may affect up to 1 in 10,000 people).
Unexpected sunburn or dermatitis (a dry rash with bumps or blisters) on skin exposed to sunlight.

Contact your doctor immediately if you experience:

Sudden wheezing, shortness of breath, or difficulty breathing, faster heartbeat, irregular or forceful heartbeats (palpitations), chest pain, chest tightness, or more severe problems such as heart attack or stroke.
Difficulty breathing or cough. These may be symptoms of lung problems, including inflammation.
Bruising, bleeding longer than usual, any sign of bleeding (e.g., bleeding gums), purpura, rashes, or spots on the skin, or becoming more susceptible to infections than normal, 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, fatigue, 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.
Extreme tiredness (fatigue), nausea and vomiting, confusion or difficulty concentrating, swelling (edema), particularly around the hands, ankles, or face, increased urination, muscle cramps (spasms). These may be signs of kidney failure.
Unusual skin growths or spots, especially in areas exposed to the sun. These may be signs of non-melanoma skin cancer.

Other adverse effects:

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

Very common: may affect more than 1 in 10 people

Fluid retention (edema)
Hypokalemia
Hyperlipidemia

Common: may affect up to 1 in 10 people

Headache, dizziness, numbness associated with drowsiness (drowsiness; especially at the beginning of treatment), feeling of exhaustion (fatigue)
Awareness of your heartbeat (palpitations)
Swelling of the ankles
Low blood pressure (hypotension), especially when standing up or sitting down quickly (orthostatic hypotension), fainting (syncope), flushing
Dry cough, sinus inflammation (sinusitis) or bronchitis, difficulty breathing (dyspnea)
Abdominal pain, diarrhea, gastrointestinal inflammation, digestive disorders and abdominal discomfort (including dyspepsia), nausea, vomiting, changes in bowel habits (including diarrhea or constipation), loss of appetite (anorexia), spasms
Skin rash with or without inflammation, hives
Chest pain
Muscle cramps or pain (myalgia)
Blood tests showing lower than normal levels of magnesium and sodium in the blood
Feeling weak and feeble (asthenia)
Blood tests showing a decrease in platelet count (thrombocytopenia)
Blood tests showing higher than normal levels of uric acid or potassium in the blood
Inability to achieve an erection (impotence)
Visual disturbances (including double and blurred vision)

Uncommon: may affect up to 1 in 100 people

Swelling of the skin, mucous membranes, and surrounding tissues (angioedema/Quincke's edema; very rarely, airway obstruction resulting from angioedema can be fatal)
Swollen arms and legs (peripheral edema; this may be a sign that your body is retaining more water than normal)
Swelling of the intestine (intestinal angioedema)
Mood changes, depression, anxiety, nervousness, restlessness, sleep disturbances (insomnia)
Ringing in the ears (tinnitus)
Sneezing/runny nose (rhinitis), nasal congestion
Breathing difficulties (bronchospasm), including worsening of asthma
Dry mouth, upper abdominal pain, including gastritis
Inflamed pancreas (pancreatitis; fatal cases have been reported with ACE inhibitors)
Kidney failure including acute renal failure (marked decrease in urine output, urinary disorders, increased urination during the day, increased need to urinate at night (nocturia))
Presence of glucose in urine
Worsening of pre-existing proteinuria (more protein than usual in urine)
Feeling unwell (malaise)
Weight gain or loss
Dizziness, tremor
Hair loss (alopecia)
Itching (pruritus), small bleeding spots or areas of bleeding under the skin (purpura), skin discoloration, exanthem
Unusual skin sensations such as numbness, tingling, prickling, burning, or skin tingling (paresthesia), reduced skin sensation (hypoesthesia)
Loss (ageusia) or change in taste (dysgeusia)
Sweating more than usual (hyperhidrosis)
Heart attack (myocardial infarction), heart vessel disease (myocardial ischemia), chest tightness and pain (angina pectoris), increased (tachycardia) or irregular heartbeats (arrhythmia)
Reduced heart rate (bradycardia), designated cardiac rhythm disorders (atrial fibrillation, ventricular tachycardia)
Joint pain (arthralgia), back pain, general pain
Increased body temperature/fever (pyrexia)
Reduced sexual desire in men or women, enlargement of male breast (gynecomastia)
Increased number of certain white blood cells (eosinophilia) found during blood tests
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)

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

Feeling or being confused, balance disorders
Red and swollen tongue (glossitis)
Inflammation and peeling of the skin (exfoliative dermatitis)
Nail problems, e.g., weakness or separation of the nail from its bed (onycholysis)
Red, itchy, swollen, or watery eyes (conjunctivitis)
Hearing problems
Yellowing of the skin (cholestatic jaundice), hepatocellular damage
Narrowing of blood vessels (vascular stenosis)
Altered blood flow (hypoperfusion)
Blood tests showing a decrease in the number of red blood cells, white blood cells, platelets (including neutropenia or agranulocytosis, leukopenia), or in hemoglobin levels
Blood tests showing higher than normal blood sugar levels. If you have diabetes, this may worsen your condition
Sensitivity to light or sun (photosensitivity)
Hypercalcemia
Hypersensitivity reaction
- Inflammation of blood vessels accompanied by symptoms such as skin rash, purplish-red spots on the skin, fever (necrotizing vasculopathy)

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

Widespread skin rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
Inflammation of the liver (hepatitis, in most cases with cholestasis)
Skin rash, which may blister and appear as small whites (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Lupus erythematosus-type 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 failure
Blood tests showing red blood cells too damaged (hemolytic anemia)
Allergic reactions
Hypochloremic alkalosis
Breathing difficulty (including pneumonitis and pulmonary edema)

Frequency not known: frequency cannot be estimated from available data

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

Blood tests showing very low red and white blood cells and platelets (pancytopenia)
Anaphylactic or anaphylactoid reactions
Lumpy skin (pemphigus)
Increase in antinuclear antibodies
Attention disturbance
Inflammation of oral mucosa with small ulcers (aphthous stomatitis)
Aplastic anemia
Fingers of hands and feet changing color when cold, and tingling or painful sensation with heat (Raynaud's phenomenon)
Cerebral ischemia including ischemic stroke and transient ischemic attack
Impaired psychomotor skills
Burning sensation
Change in the way things smell (parosmia)
Acute liver failure, cholestatic and cytolytic hepatitis (an exceptional fatal outcome has been reported)
Skin inflammation (psoriasiform dermatitis), acute skin rash (pemphigoid or lichenoid exanthem), worsening of skin scaling or peeling (worsened psoriasis), mucosal rash (enantema)
Concentrated urine (dark color), feeling unwell or nausea, muscle cramps, confusion, and seizures which may be due to inadequate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.
Tremor, rigid posture, "mask-like" face, slow movements, and unbalanced gait
Sudden decrease in distant vision (acute myopia), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

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

5. Storage of Tarlodix Plus

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

Store below 30°C.

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

Medicines should not be disposed of via wastewater drains or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tarlodix Plus

The active substances 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.

Other components are:

Capsule contents: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized maize starch, sodium carboxymethyl starch from potato (type A), stearic fumarate and sodium.

Capsule shell: iron oxide red (E172), titanium dioxide (E171), gelatin, iron oxide black (E172) (only for the 5 mg/5 mg/12.5 mg and 10 mg/10 mg/25 mg strengths) and iron oxide yellow (E172) (only for the 5 mg/5 mg/25 mg, 5 mg/10 mg/25 mg and 10 mg/10 mg/25 mg strengths).

Appearance of the product and contents of the pack

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

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

Tarlodix Plus 5 mg/10 mg/25 mg are hard capsules: capsule with opaque dark pink cap and opaque yellow body.

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

Calle de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

This medicinal product is authorized in the European Economic Area member states under the following names:

Denmark: Ramipril/Amlodipin/Hydrochlorthiazid APC

Spain: 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

Date of the most recent review of this leaflet: December 2023

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