Tarlo Dix 5 mg/10 mg hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tarlodix 5 mg/10 mg hard capsules

amlodipine/ramipril

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Package leaflet contents

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

1. What Tarlodix is and what it is 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 known as ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).

Ramipril works by:

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

Amlodipine works by:

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

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

2. What you need to know before taking Tarlodix

Do not take Tarlodix:

• If you are allergic to amlodipine, ramipril (active substances), other calcium antagonists or ACE inhibitors, or to any of the other components of this medicine (listed in section 6). It may cause itching, skin redness, or difficulty breathing.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, such as in 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, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, 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, lactation and fertility").
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If your blood pressure is abnormally low or unstable. Your doctor should evaluate you.
• If you have narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body).
• If you have heart failure following a heart attack.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 large amounts of salts or fluids due to vomiting, diarrhoea, excessive sweating, low-salt diets, long-term use of diuretics, or if you are undergoing dialysis.
• If you are undergoing treatment to reduce allergy to bee or wasp stings (desensitisation).
• If you are to receive an anaesthetic, for example during a dental procedure. You may need to stop taking this medicine one 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 reduce sodium levels in your blood. Your doctor may perform periodic blood tests, especially to monitor sodium levels, particularly if you are elderly.
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • Angiotensin II Receptor Antagonists (ARAII) (e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskiren.

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

• You should inform your doctor if you think you are (or could be) pregnant. Ramipril 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 and lactation” below).
  • If you have severe episodes of high blood pressure (hypertensive crises).
  • If you are elderly and require a dose increase.
  • If you have a persistent dry cough for a long time.
  • If your blood pressure is not actually decreasing. This type of medicine appears to be less effective in people of Black origin.
  • If you are taking any of the following medicines, your risk of developing angioedema may increase:
    • Neprilysin inhibitors (such as racecadotril, a medicine used to treat diarrhoea).
    • Medicines used to prevent organ transplant rejection and for 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 you experience sudden swelling of your lips, face, tongue, throat, and neck, possibly hands and feet, difficulty swallowing or breathing, hives, or hoarseness (angioedema), this may be a sign of an allergic reaction. This can occur at any time during treatment. People of Black origin may have a higher risk of experiencing these symptoms. Inform your doctor immediately if you develop any of these symptoms.

Children and adolescents

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

Other medicines and Tarlodix

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

Tell your doctor if you are taking any of the following medicines. These may reduce the effect of this medicine:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or 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.
• Rifampicin, erythromycin, clarithromycin (antibiotics), agents used to treat tuberculosis or other infections.
• Hypericum perforatum (St. John’s wort, used to treat depression).

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

• Sacubitril/valsartan for treating a type of chronic heart failure in adults (see section 2 “Do not take Tarlodix”).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the function of your immune system, allowing your body to accept a transplanted organ). See section “Warnings and precautions”.
• Cyclosporine, an immunosuppressant medicine used to prevent organ transplant rejection.
• Medicines to prevent organ rejection after transplantation, such as cyclosporine.
• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacina and acetylsalicylic acid).
• Diuretics such as furosemide.
• Medicines that may increase potassium levels in 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).
• Steroid medicines for inflammation, such as prednisolone.
• Allopurinol (used to reduce uric acid in blood).
• Procainamide (for heart rhythm problems).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used for diarrhoea).
• Ketoconazole, itraconazole (antifungal medicines).
• Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV).
• Verapamil, diltiazem (medicines used to treat heart conditions or high blood pressure).
• Dantrolene (infusion for severe body temperature abnormalities).

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

• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Tarlodix” and “Warnings and precautions”).

Tell your doctor if you are taking any of the following medicines, as they may be affected by this medicine:

• Medicines for diabetes such as oral hypoglycaemics or insulin. This medicine may lower your blood sugar levels. Monitor your blood sugar levels while taking this medicine.
• Lithium (for mental health conditions). This medicine may increase lithium levels in blood. Your doctor should closely monitor your blood lithium levels.
• Simvastatin, a medicine used to reduce cholesterol and fat (triglyceride) levels in blood. Tarlodix may increase simvastatin levels in blood.

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

Taking Tarlodix with 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 alcohol you can drink while taking this medicine, talk to your doctor or pharmacist. Discuss with your doctor how blood pressure-lowering medicines and alcohol may have additive effects.

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

Pregnancy, lactation, and fertility

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

Pregnancy

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

Lactation

You must not take this medicine during breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Fertility

There is 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 use machines and contact your doctor immediately. This may occur especially at the beginning of treatment or when changing formulations.

Tarlodix contains sodium

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

3. How to take Tarlodix

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

If you feel that the effect of 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 meals. Swallow the capsule whole with some liquid.

Do not take this medicine with grapefruit juice. This medicine should be taken once daily.

Your doctor may adjust the dose depending on its effect 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 are taking before starting treatment with Tarlodix.

Elderly patients

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

Use in children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years of age, 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 difficulties, which may develop 24–48 hours after ingestion.

Taking too many capsules may cause your blood pressure to become low or dangerously low. You may feel dizzy or weak, and if the drop in blood pressure is severe enough, you may go into shock. Your skin may feel cold and clammy, and you may lose consciousness. Inform your doctor or go immediately to the nearest hospital emergency department. Do not drive to the hospital—have someone take you or call an ambulance. Take the medicine packaging with you so the doctor can see what you have taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Tarlodix

If you forget to take a capsule, skip that dose and take the next dose at your usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Tarlodix

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

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 this medicine and consult a doctor immediately if you notice any of the following serious side effects (you may require urgent medical treatment):

• Swelling of the face, lips, or throat causing difficulty swallowing or breathing, together with itching and skin rash. This could be a sign of a severe allergic reaction to this medicine (adverse reactions with frequency not known).
• Severe skin reactions including skin rash, mouth ulcers, worsening of pre-existing skin disease, redness, blistering, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme) (very rare adverse reactions).
• Vision problems such as blindness in one eye, double vision, difficulty speaking or understanding what others say, weakness or paralysis in your limbs affecting one or both sides, dizziness and vertigo, confusion, loss of coordination, or drooping on one side of the face—these are symptoms of interrupted blood flow to the brain—stroke (adverse reactions with frequency not known).

Contact your doctor immediately if you experience:

• Faster heartbeat, irregular or strong heartbeats (palpitations) (frequent adverse reactions), chest pain, chest tightness, or more serious problems such as heart attack and stroke (uncommon adverse reactions).
• Sudden wheezing, shortness of breath, or difficulty breathing (frequent adverse reactions). These may be signs of lung problems.
• Bruising more easily, bleeding longer than normal, any sign of bleeding (e.g., bleeding gums), purple spots, skin spots, or getting 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 with frequency not known).
• Severe stomach pain that may extend to the back. This could be a sign of pancreatitis (inflammation of the pancreas) (uncommon adverse reaction).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (liver inflammation) or liver damage (very rare adverse reactions).

Other side effects include:

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

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

• Headache, tiredness, or weakness.
• Drowsiness, dizziness. This is more likely when you start taking this medicine or increase your dose.
• Visual disturbances, double vision, blurred vision.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting quickly.
• Dry, tickly cough, sinus inflammation (sinusitis), or bronchitis.
• Abdominal pain, diarrhoea, constipation, indigestion, feeling unwell or nausea (vomiting).
• Skin rash with or without raised areas.
• Chest pain.
• Palpitations (awareness of your heartbeat), flushing.
• Muscle cramps or muscle pain.
• Blood tests showing higher than normal potassium levels in the blood.
• Swelling (oedema) of the ankle.

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

• Heartburn.
• Balance problems (dizziness).
• Itching and unusual skin sensations such as numbness, tingling, prickling, burning, or crawling sensations on the skin (paraesthesia), loss of pain sensation.
• Loss or change in taste.
• Stuffy nose, difficulty breathing, or worsening of asthma.
• Swelling in the intestine called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting, and diarrhoea.
• Excessive sweating.
• Loss or decrease in 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 liver, pancreas, or kidney function.
• Mood changes, feeling anxious, more nervous than usual or restless, depression, insomnia.
• Tremor.
• Ringing in the ears.
• Sneezing/runny nose caused by inflammation of the nasal lining (rhinitis).
• Dry mouth.
• Hair loss, red spots on the skin, skin discoloration.
• Urination disorders, increased need to urinate, especially at night, increased frequency of urination during the day.
• Inability to achieve an erection, sexual dysfunction in men, discomfort or enlargement of the breasts in men, decreased sexual desire in men or women.
• Pain, discomfort.
• Weight gain or weight loss.

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

• Feeling shaky or confused.
• Red and swollen tongue.
• Scaly or severely peeling skin, rash with lumps 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.
• Skin spots and cold extremities.
• Red, itchy, swollen, or watery eyes.
• Disturbed hearing.
• 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 haemoglobin.

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

• Increased sensitivity to sunlight.
• High blood sugar (hyperglycaemia).
• Swollen gums.
• Abdominal swelling (gastritis).
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests.
• Increased muscle tension.
• Disorders combining stiffness, tremor, and/or movement disorders.

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

• Tremor, rigid posture, masked face, slow movements, shuffling gait with imbalance.
• Concentrated urine (dark-coloured), feeling or being unwell, 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.

Other reported adverse effects:

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

• Difficulty concentrating.
• Swollen mouth.
• Blood tests showing lower than normal sodium levels in blood.
• Fingers of hands and feet changing colour when cold, followed by tingling or 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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can 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

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

Store below 30°C.

Keep in the original packaging to protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tarlodix

• The active substances are:

Each capsule contains amlodipine besilate equivalent to 5 mg of amlodipine and 10 mg of ramipril.

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

Appearance of Tarlodix and contents of the pack

Tarlodix 5 mg/10 mg hard capsules: approximately 19 mm long, hard gelatin capsule with an opaque dark pink cap and an opaque white body printed in black with “R 10 mg A 5 mg”. The capsule contents consist of a white or almost white powder.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.
C/ 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

or

Adamed Pharma S.A.
ul. Szkolna, 33
95 054 Ksaweow
Poland

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

Denmark: Tarlodix
Spain: Tarlodix 5 mg/10 mg hard capsules

Date of the latest revision of this leaflet: July 2024

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