TARKA 180 mg / 2 mg EXTENDED-RELEASE CAPSULES

Introduction

Package Leaflet: Information for the User

Tarka 180 mg/ 2 mg modified-release capsules

verapamil hydrochloride / trandolapril

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Tarka and what is it used for
2. What you need to know before you take Tarka
3. How to take Tarka
4. Possible side effects
5. Storing Tarka

1. Contents of the pack and other information

1. What is Tarka and what is it used for

The Tarka 180 mg/2 mg capsules are of “modified release” type, which means that the capsules release the medicine slowly over several hours.

Tarka is indicated for the treatment of hypertension in patients whose blood pressure has been controlled with the combination verapamil 180 mg and trandolapril 2 mg.

Tarka belongs to a group of medicines that lower blood pressure (also called antihypertensives).

Tarka contains two medicines in one preparation:

• A calcium channel blocker (verapamil).

• An Angiotensin-Converting Enzyme (ACE) inhibitor (trandolapril).

2. What you need to know before you take Tarka

Do not take Tarka if:

• You are allergic to trandolapril or other ACE inhibitors, to verapamil or to any of the other ingredients of this medicine (listed in section 6).
• You (or a member of your family) have ever had a severe allergic reaction to any other ACE inhibitor, such as swelling of the face, lips, tongue or throat (angioedema).
• Your blood pressure is extremely low due to severe heart problems (e.g. during shock).
• You have recently had a severe heart attack.
• Your doctor has told you that you have heart failure or a heart block of second or third degree (electrical signal of the heart affected causing a very slow heartbeat) or an abnormal heart signal that causes periods of very rapid heartbeats (Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome).
• You have problems with your heart valves or suffer from sick sinus node syndrome (irregular heartbeat) and you do not have a pacemaker.
• You have hypertrophic cardiomyopathy (swelling of the heart muscle).
• You have liver problems, including conditions with fluid in the abdomen (ascites).
• You have kidney failure or require dialysis.
• You have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• You suffer from a condition where the adrenal gland produces too many hormones (primary aldosteronism).
• You are taking a medicine that contains ivabradine for the treatment of certain heart diseases.
• You are more than 3 months pregnant. (It is even better to avoid Tarka in the early stages of pregnancy - see section pregnancy).
• You are under 18 years old.
• You are being treated with injectable beta-blockers (except in intensive care units).

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 areas such as the throat) is high.

Consult your doctor or pharmacist if you have any doubts or are unsure about any of the situations listed above.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tarka, as they may want to closely monitor your blood pressure or take blood samples at the start of treatment and when changing doses if:

• You are an elderly patient.
• You are diabetic.
• You have damaged liver or kidneys, or have recently had a kidney transplant.
• You have had a heart attack or are at risk of having a heart attack.
• You are taking lithium (a medicine used to treat mania).
• You are taking digoxin (a medicine that controls your heartbeats).
• You are taking a “statin” (a medicine that lowers your cholesterol or blood fat levels).
• You are taking beta-blockers, including eye drops that contain timolol (a medicine that lowers eye pressure to treat glaucoma).
• You are taking any of the following medicines used to treat high blood pressure:

• An angiotensin II receptor blocker (ARB) (also known as "sartans" - e.g. valsartan, telmisartan, irbesartan), especially if you have diabetic kidney problems.
• Aliskiren.
• You are taking any of the following medicines, as the risk of angioedema may increase:
  • Racecadotril, a medicine used to treat diarrhea.
  • Medicines used to prevent organ transplant rejection and to treat cancer (e.g. temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medicine used to treat diabetes.

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

• You are on a strict salt-free diet, suffer from dehydration, diarrhea, or vomiting, or are being treated with diuretics or other medicines that may alter your potassium levels.

Tell your doctor if you are in any of the following situations:

Heart diseases:

• Slow or irregular heartbeat.
• Your doctor has diagnosed you with first-degree heart block (electrical block in the heart that causes a very slow heartbeat) or left ventricular dysfunction (the pumping of the left side of your heart is insufficient).

Other situations:

• You are using Tarka with other medicines that affect the immune system (e.g. cyclosporins), or suffer from an immune system disease such as systemic lupus erythematosus (a condition that causes joint pain, skin rashes, and fever) or scleroderma (a condition characterized by hardening and thickening of the skin with possible hair loss), as the risk of decreased white blood cell count increases.
• You suffer from neuromuscular disorders such as myasthenia gravis (chronic fatigue and muscle weakness), Lambert-Eaton syndrome, or advanced Duchenne muscular dystrophy.
• You are receiving injections to prevent allergic reactions to bee stings (desensitization therapy).
• You think you are (or might be) pregnant. It is not recommended to use Tarka during the first stages of pregnancy, and you should not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby (see section pregnancy).
• You are breastfeeding. See section Pregnancy and Breastfeeding.
• You are undergoing LDL apheresis (removal of cholesterol from the blood using a machine).

Allergic reactions:

• In very rare cases, some patients have experienced severe allergic reactions after taking ACE inhibitors, such as Tarka. These reactions are more common in the black population and can cause irritation, rash, and/or swelling of the face, lips, tongue, and throat (angioedema). Severe allergic reactions may also affect the intestine and cause abdominal pain (with or without nausea and vomiting) (intestinal angioedema). If you experience any of these symptoms, stop taking Tarka and seek immediate medical attention.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age.

Other medicines and Tarka

Some medicines may cause adverse reactions if taken with Tarka. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those obtained without a prescription or any herbal medicine.

In particular, tell your doctor if you are taking any of the following medicines:

NEP inhibitors, such as sacubitril (available in fixed-dose combination with valsartan) and racecadotril:the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase.

Medicines to prevent heart problems or high blood pressure:any medicine used to control heartbeat (such as beta-blockers, digoxin, or other medicines used to control irregular heart rhythm) or blood pressure. They may cause your blood pressure to drop too low or your heart rate to become too slow.

Your doctor may need to adjust your dose and/or take other precautions: if you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also the information under the headings “Do not take Tarka” and “Warnings and precautions”).

Medicines for psychological problems:any medicine for treating depression or psychosis, such as imipramine, lithium, midazolam, buspirone, or other tranquilizers.

Medicines for HIV:such as the antiviral agent ritonavir.

Medicines used to prevent organ transplant rejection:such as cyclosporin, tacrolimus, and other medicines that belong to the group of mTOR inhibitors (e.g. everolimus, sirolimus, and others). See section Warnings and precautions.

Medicines for pain relief or to reduce inflammation, such as:

• Steroids (e.g. cortisone or prednisone).
• Certain anti-inflammatory and analgesic medicines (e.g. naproxen, ibuprofen, aspirin, or opioids such as morphine).

Medicines to lower cholesterol or blood fat levels:such as statins (e.g. simvastatin, atorvastatin).

Medicines for diabetes:such as insulin or diabetes tablets. Verapamil may reduce the hypoglycemic effect of metformin.

Medicines for epilepsy or seizures:such as phenytoin, carbamazepine, and phenobarbital.

Medicines for indigestion or stomach ulcers:such as antacids and cimetidine.

Other medicines that may interact with Tarka:

• Medicines for asthma, such as theophylline.
• Medicines for infections or tuberculosis, such as rifampicin, clarithromycin, or erythromycin.
• Medicines for cancer, such as doxorubicin.
• Direct oral anticoagulants (DOACs) (medicines to prevent blood clot formation), such as dabigatran and rivaroxaban.
• Medicines to treat or prevent gout, such as allopurinol and colchicine.
• Medicines for rheumatoid arthritis: injectable gold salts.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Medicines used in surgery: tell your surgeon if you are taking Tarka before surgery, as Tarka may interfere with anesthetic gases or muscle relaxants or other medicines used during surgical procedures, such as dantrolene.

This is not a complete list of medicines that may interact with Tarka. Ask your doctor or pharmacist before taking any medicine with Tarka.

Taking Tarka with food, drinks, and alcohol

• Avoid drinking alcohol while taking Tarka. You may experience a greater than usual drop in blood pressure.
• Do not drink grapefruit juice while taking Tarka.
• Grapefruit juice may increase the amount of verapamil absorbed, which may increase the risk of adverse reactions to Tarka.

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant or think you may be pregnant (or are planning to become pregnant). Your doctor will normally advise you to stop taking Tarka before you become pregnant, or as soon as you find out you are pregnant, and recommend that you take a different medicine instead of Tarka. Tarka is not recommended during the first stages of pregnancy, and you should not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the first three months of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Tarka is not recommended for breastfeeding mothers, and your doctor may choose a different treatment if you wish to breastfeed, especially if your baby is newborn or premature.

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Your ability to drive safely or operate heavy machinery may be affected. You may feel tired or dizzy. Alcohol may increase these effects.

Do not drive a vehicle or use heavy machinery or tools until you know how Tarka affects you.

Tarka contains:

Sodium:

This medicine contains 27.9 mg of sodium (main component of cooking/table salt) per capsule. This is equivalent to 1.4% of the maximum recommended daily intake of sodium for an adult.

Lactose:

This medicinecontains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Tarka

Follow exactly the instructions of administration of this medicine given to you by your doctor. If you are not sure, ask your doctor or pharmacist again.

The recommended doseis one modified-release capsule of Tarka once daily, taken at the same time in the morning, before, with, or after breakfast. The capsule should be swallowed whole with a glass of water, without sucking, chewing, or crushing it.

If you take more Tarka than you should

If you think you have taken too much Tarka, contact your doctor or pharmacist immediately. Some situations may require emergency medical treatment.

If you take too much Tarka, you may feel dizzy due to low blood pressure and a slow pulse. Other symptoms that may occur if you take too much Tarka include: shock (sudden drop in blood pressure or heart rate), stupor, kidney failure, hyperventilation, tachycardia, palpitations, anxiety, and cough.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount taken.

If you forget to take Tarka

Take Tarka at the same time every day to avoid forgetting a dose of Tarka.

If you forget to take a dose, take the missed dose as soon as you remember, but always on the same day you forgot to take it.

Do not take a double dose to make up for forgotten doses.

If you stop taking Tarka

Do not stop taking Tarka unless your doctor advises you to do so.

If you stop taking Tarka, you may experience an increase in your blood pressure.

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. The following adverse effects have been reported for Tarka.

Tell your doctor immediately and stop taking Tarka,if you experience a severe allergic reaction that causes a skin rash with itching and/or swelling of the face, lips, eyelids, tongue, or throat. Although this is very rare (it can affect up to 1 in 10,000 people), you may need urgent medical attention.

The following are frequent adverse effects (may affect up to 1 in 10 people):

• Cough.
• Dizziness, headache, vertigo.
• Constipation.
• Sudden feeling of heat with reddening of the body.
• Fast or slow heartbeats (atrioventricular block).
• Sudden drop in blood flow through the body that can be fatal.
• Very low blood pressure.
• Low blood pressure when standing up or sitting down.

The following adverse effects are infrequent (may affect up to 1 in 100 people):

• Allergic reactions (such as rash and itching).
• Drowsiness.
• Tremors.
• Awareness of heartbeat (palpitations).
• Chest pain.
• Nausea, abdominal pain.
• Stomach and intestine problems.
• Diarrhea.
• Sweating.
• Frequent urination.
• Abnormal liver function tests.
• High levels of lipids in the blood (hyperlipidemia).
• Facial edema.

The following adverse effects are rare (may affect up to 1 in 1,000 people):

• Loss of appetite.
• Fainting.
• Hair loss.
• Cold sores (Herpes simplex).
• Increased amount of bile pigment in the blood, causing a yellowish color of the skin or the whites of the eyes (hyperbilirubinemia).
• Increased amount of nitrogen-containing compounds, such as urea, creatinine (azotemia).
• Certain skin problems.

The following adverse effects are very rare (may affect up to 1 in 10,000 people)

• Bronchitis (inflammation of the upper respiratory tract).
• Sinusitis (nasal congestion).
• Hypoventilation/chest pressure.
• Fatigue.
• Weakness.
• Aggression, anxiety, depression, nervousness.
• Difficulty maintaining balance.
• Difficulty sleeping.
• Pins and needles in the skin, feeling of heat/cold.
• Taste disturbances.
• Vision problems (e.g., blurred vision).
• Yellowish color of the skin or the whites of the eyes (jaundice).
• Inflammation of the pancreas or liver.
• Vomiting.
• Blockage of the bile ducts.
• Dry mouth and throat.
• Changes in red or white blood cell counts, which could lead to bruising, bleeding, or decreased resistance to infection.
• Skin reactions such as allergic reactions that cause hives, irritation, skin inflammation, itchy rash, increased red spots, scaly rash, or blisters.
• Muscle or joint pain, muscle weakness.
• Erectile dysfunction.
• Increased breast size (in men).
• Rapid irregular contractions of the upper chambers of the heart due to problems with the electrical impulse conduction (atrial fibrillation), chest pain, jaw and back pain, caused by physical exertion, and due to problems with cardiac blood flow (angina pectoris)/heart attack/rapid or slow heartbeats.
• Stroke.
• Sudden reduction in kidney function.
• Swelling caused by fluid accumulation.
• Changes in blood potassium levels.
• Changes in blood pressure.
• Loss of consciousness.

The following adverse effects have an unknown frequency (the frequency cannot be estimated from the available data):

• A potentially life-threatening allergic reaction that causes a painful red or purple rash and blisters on the skin and mouth mucosa.
• Redness of the skin, acne, dryness of the skin.
• Urinary tract infection.
• Increased appetite.
• Increased blood cholesterol levels, high blood sugar, decreased blood sodium levels, increased blood uric acid levels.
• Hallucinations.
• Decreased libido.
• Muscle spasms.
• Migraine.
• Eye disorders, such as eyelid inflammation, mucous membrane inflammation.
• Abnormal heart rhythm, abnormal ECG.
• Twisted veins on the skin surface.
• High blood pressure.
• Inflammation of the upper respiratory tract, congestion of the upper airways, productive cough, throat inflammation, mouth and throat pain, nosebleeds, difficulty breathing.
• Vomiting blood, gas.
• Back pain, pain in the arms or legs, bone pain, joint pain, stiffness in the joints, muscle spasms.
• Fever, feeling of discomfort, general malaise.

Some adverse reactions have not been seen in Tarka or its components, but have been seen in other similar medicines to Tarka:

• Increased breakdown of red blood cells, which can cause fatigue.
• Confusion.
• Ringing in the ears.
• A brief interruption in blood supply to a part of the brain, which can cause temporary vision, speech, or movement disturbances.
• Sinus infection or redness and swelling of the sinuses.
• Redness and inflammation of the nasal mucosa.
• Infection of the tongue or redness and swelling of the tongue.
• A temporary reduction in the airways in the lungs, making breathing difficult.
• Severe allergic reactions that can affect the intestine and cause abdominal pain (with or without nausea and vomiting) (intestinal angioedema).
• Abnormal movements in the intestines, which can cause a swollen abdomen, stomach pain, and constipation.
• Abnormal bile flow in the liver, causing the whites of the eyes to turn yellow.
• A potentially life-threatening allergic reaction that causes blisters and peeling of the skin.
• Abnormal kidney function tests.
• Movement disorders such as extreme restlessness, involuntary movements, and disturbance of desired movements.
• Milk secretion, higher than normal levels of prolactin (female hormone) in the blood that stimulates milk production.
• Gum growth over the teeth.
• Worsening of certain nervous and muscular disorders (such as myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy).
• Painful redness of the skin on the legs and arms.

This is not a complete list of adverse reactions. Some effects can only be found by measuring them in blood and with other medical tests.

Reporting of Adverse Effects

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

5. Storage of Tarka

Keep Tarka out of sight and reach of children.

Do not use this medicine after the expiration date stated on the carton.

The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Tarka Composition:

The active ingredients are: trandolapril and verapamil hydrochloride

Each capsule contains:

180 mg of verapamil hydrochloride.

2 mg of trandolapril

The other ingredients are:

Verapamil tablet coating ingredients:

Povidone, microcrystalline cellulose, sodium alginate, hypromellose (hydroxypropylmethylcellulose), magnesium stearate, hydroxypropylcellulose, macrogol 400, macrogol 6000, talc, anhydrous colloidal silica, sodium docusate, titanium dioxide (E 171).

Trandolapril granule ingredients:

Cornstarch, lactose monohydrate, povidone, sodium fumarate stearate.

Hard gelatin capsule ingredients:

Titanium dioxide (E 171), red iron oxide (E 172), gelatin, sodium lauryl sulfate.

Product Appearance and Package Contents:

Tarka is presented in the form of light pink opaque modified-release capsules.

Tarka 180 mg/2 mg is available in calendarized blister packs of 14, 20, 28, 30, 50, 56, 98, 100, 280, and 300 modified-release capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Famar A.V.E Anthoussa Plant

Anthoussa Avenue 7

Anthoussa Attiki, 15349

Greece

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Greece: Tarka 180 mg/2 mg Kaψ?κιa eλeγχ?µeνης αποδ?σμευσης

Netherlands: Tarka 180/2 mg, capsule met gereguleerde afgifte

Spain: Tarka 180 mg /2 mg cápsulas de liberación modificada

Date of the last revision of this prospectus:January 2021

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