Package Insert: Information for the User

Tarka 180 mg/ 2 mg Modified Release Capsules

verapamil hydrochloride / trandolapril

Read this package insert carefully before starting to take this medication, because it contains important information for you.

• Keep this package insert, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Tarka 180 mg/2 mg capsules are "modified release," meaning the capsules release the medication slowly over several hours.

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

Tarka belongs to the group of blood pressure-lowering medications (also known as antihypertensives).

Tarka contains two medications in a single preparation:

• A calcium channel blocker (verapamil).

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

Do not take Tarka if:

• You are allergic to trandolapril or other ACE inhibitors, verapamil, or any of the other components of this medication (listed in section 6).
• You (or a family member) have ever had a severe allergic reaction to any other ACE inhibitor, such as swelling in the face, tongue, or throat (angioneurotic edema).
• 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 second- or third-degree heart block (abnormal heart signal that causes a very slow heartbeat) or an abnormal heart signal that causes periods of very rapid heartbeat (Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome).
• You have problems with your heart valves or have the sick sinus syndrome (irregular heartbeat) and you are not wearing a pacemaker.
• You have hypertrophic obstructive cardiomyopathy (swelling of the heart muscles).
• You have liver problems, including ascites (fluid in the abdomen).
• You have kidney failure or require dialysis.
• You have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.
• You have a condition in which the adrenal gland produces too many hormones (primary aldosteronism).
• You are taking a medication that contains ivabradina for the treatment of certain heart diseases.
• You are more than three months pregnant. (It is even better to avoid Tarka in early stages of pregnancy - see pregnancy section).
• 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 medication used to treat a type of chronic heart failure in adults, since the risk of angioedema (rapid swelling under the skin in an area 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 beginning of treatment and with changes in dosage if:

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

- An angiotensin II receptor blocker (ARB) (also known as "sartanes" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

- Aliskiren.

-You are taking any of the following medications, as the risk of angioedema may increase:

• 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 diabetes.

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in your blood at regular intervals. See also the information under the heading “Do not take Tarka”.

• You are following a strict low-sodium diet, have dehydration, diarrhea, or vomiting, or are being treated with diuretics or other medications that may alter your potassium levels.

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

Heart conditions:

• Slow or irregular heartbeat.
• Your doctor has diagnosed a first-degree heart block (electrical block in the heart that causes a very slow heartbeat) or left ventricular dysfunction (the left side of your heart is not pumping properly).

Other situations:

• You are taking Tarka with other medications that affect the immune system (e.g., ciclosporins), or have any immune system disease such as systemic lupus erythematosus (a condition that causes joint pain, skin rashes, and fever) or scleroderma (a condition characterized by skin thickening and hair loss), as the risk of decreased white blood cell counts increases.
• You have neuromuscular diseases 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 could be) pregnant. It is not recommended to use Tarka during the early stages of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby (see pregnancy section).
• You are breastfeeding (see Pregnancy and Breastfeeding section).
• You are undergoing LDL apheresis (removal of cholesterol from the blood using a machine).

Allergic reactions:

• In rare cases, some patients have experienced severe allergic reactions after taking ACE inhibitors, such as Tarka. These reactions are more common in black people and may cause facial, lip, tongue, and throat swelling (angioneurotic edema). Severe allergic reactions may also affect the intestines and cause abdominal pain (with or without nausea and vomiting) (intestinal angioedema).If any of these symptoms occur, stop taking Tarka and seek immediate medical attention.

Children and adolescents:

Do not administer this medication to children or adolescents under 18 years of age.

Other medications and Tarka:

Some medications may cause adverse reactions if taken with Tarka. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription or any medication made from plants.

Particularly inform your doctor if you are taking any of the following medications:

ACE 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.

Medications to prevent heart problems or high blood pressure:Any medication used to control heart rhythm (such as beta-blockers, digoxin, or other medications used to control irregular heartbeats) 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 blocker (ARB) or aliskiren (see also the information under the headings “Do not take Tarka” and “Warnings and precautions”).

Medications to treat mental health conditions:Any medication to treat depression or psychosis, such as imipramine, lithium, midazolam, buspirone, or other tranquilizers.

Medications to treat HIV:Such as ritonavir, an antiviral agent.

Medications used to prevent organ transplant rejection:Such as ciclosporin, tacrolimus, and other medications that belong to the mTOR inhibitor group (e.g., everolimus, sirolimus, and others). See the Advertencias and precautions section.

Medications to treat pain or reduce inflammation such as:

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

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

Medications to treat diabetes:Such as insulin or diabetes tablets.Verapamil may reduce the hypoglycemic effect of metformin.

Medications to treat seizures or epilepsy:Such as phenytoin, carbamazepine, and phenobarbital.

Medications to treat indigestion or stomach ulcers:Such as antacids and cimetidine.

Other medications that may interact with Tarka:

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

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

Taking Tarka with food, drinks, and alcohol:

• Avoid taking alcohol while taking Tarka. You may experience a greater 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 Tarka side effects.

Pregnancy and breastfeeding:

Pregnancy:

You must tell your doctor if you think you are pregnant (or could be). Your doctor will usually 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 another medication instead of Tarka. Tarka is not recommended in the early 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:

Inform your doctor if you are breastfeeding or about to start breastfeeding. Tarka is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you want to breastfeed, especially if your baby is newborn or premature.

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

Driving and using machinery:

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

Until you are sure how Tarka affects you, do not drive a vehicle or use hazardous tools or heavy machinery.

Tarka contains:

Sodium:

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

Lactose:

This medicationcontains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Therecommended doseis one modified-release Tarka capsule taken once a day 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, consult your doctor or pharmacist immediately, as some situations may require emergency medical treatment.

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

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 that the dose was forgotten.

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects have been reported for Tarka:

Inform 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 may affect up to 1 in 10,000 people), you may need urgent medical attention.

The following are common side effects(they may affect up to 1 in 10 people):

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

The following side effects areuncommon(they may affect up to 1 in 100 people):

• Allergic reactions (such as hives and itching).
• Drowsiness.
• Tremors.
• Consciousness of heartbeats (palpitations).
• Chest pain.
• Nausea, abdominal pain.
• Problems in the stomach and intestines.
• Diarrhea.
• Sweating.
• Frequent urination.
• Abnormal liver function tests.
• Elevated blood lipid levels (hyperlipidemia).
• Facial edema.

The following side effects arerare(they may affect up to 1 in 1,000 people):

• Loss of appetite.
• Fainting.
• Hair loss.
• Herpes labialis (Herpes simplex).
• Increased bilirubin levels in the blood that causes a yellowish color of the skin or the white of the eyes (hyperbilirubinemia).
• Increased levels of nitrogen-containing compounds, such as urea and creatinine (azotemia).
• Certain skin problems.

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

• Bronchitis (inflammation of the upper respiratory tract).
• Sinusitis (nasal congestion).
• Hypoventilation/pressure in the chest.
• Fatigue.
• Weakness.
• Aggression, anxiety, depression, nervousness.
• Difficulty maintaining balance.
• Difficulty sleeping.
• Pinpricks in the skin, sensation of heat/cold.
• Alterations in taste.
• Visual problems (e.g., blurred vision).
• Yellowish color of the skin or the white of the eyes (jaundice).
• Inflammation of the pancreas or liver.
• Vomiting.
• Bile duct obstruction.
• Dry mouth and throat.
• Changes in red or white blood cell counts that may lead to bruising, bleeding, or decreased resistance to infection.
• Reactions in the skin such as allergic reactions that producehives, irritation, inflammation of the skin, skin rash with itching, increased red patches,hives withscabs or blisters.
• Muscle or joint pain, muscle weakness.
• Erectile dysfunction.
• Enlargement of the breasts (in men).
• Irregular, rapid contractions of the upper heart chambers due to conduction problems (atrial fibrillation), chest pain, jaw pain, and back pain, caused by physical exertion, and due to cardiac blood flow problems (angina pectoris) / heart attack / rapid or slow heartbeats.
• Stroke.
• Sudden reduction in renal function.
• Swelling caused by fluid accumulation.
• Changes in potassium levels in the blood.
• Changes in blood pressure.
• Loss of consciousness.

The following side effects are of unknown frequency (the frequency cannot be estimated from the available data):

• A potentially fatal allergic reaction that causes a painful, red, or purple rash and blisters on the skin and mucous membranes of the mouth.
• Redness of the skin, acne, dry skin.
• Urinary tract infection.
• Increased appetite.
• Elevated blood cholesterol levels, high blood sugar, decreased sodium levels in the blood, elevated uric acid levels in the blood.
• Hallucinations.
• Decreased libido.
• Muscle spasms.
• Migraine.
• Ocular disorders, e.g., inflammation of the eyelids, eyelid mucosa.
• Abnormal heart rhythm, abnormal ECG.
• Varicose veins on the surface of the skin.
• High blood pressure.
• Inflammation of the upper respiratory tract, nasal congestion, productive cough, inflammation of the throat, mouth, and sore throat, nasal bleeding, difficulty breathing.
• Vomiting blood, belching.
• Back pain, pain in the limbs of the arms or legs, bone pain, joint pain, joint stiffness, muscle spasms.
• Fever, feeling unwell, general malaise.

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

• Increased breakdown of red blood cells, which may cause fatigue.
• Confusion.
• Tinnitus in the ears.
• A brief interruption in blood supply to a part of the brain, which may cause a temporary alteration in vision, speech, or movement.
• Sinus infection or redness and swelling of the sinuses.
• Redness and inflammation of the nasal mucosa.
• Language infection or redness and swelling of the tongue.
• A temporary reduction in airways in the lungs, making breathing difficult.
• Severe allergic reactions that may affect the intestines and cause abdominal pain (with or without nausea and vomiting) (intestinal angioedema).
• Abnormal intestinal movements, which may cause a bloated abdomen, stomach pain, and constipation.
• Abnormal bile flow in the liver, causing the white part of the eyes to turn yellow.
• A potentially fatal allergic reaction that produces blisters and peeling on the skin.
• Abnormal renal function tests.
• Movement disorders such as extreme restlessness, unwanted movements, and disturbance of desired movements.
• Excessive milk secretion, increased levels of prolactin (female hormone) in the blood that stimulates milk production.
• Overgrowth of the gums 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 the 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 does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep Tarka out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging.

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

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Tarka:

The active principles are: trandolapril and hydrochloride of verapamil

Each capsule contains:

180 mg of hydrochloride of verapamil.

2 mg of trandolapril

The other components are:

Ingredients of the verapamil coated tablet:

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

Ingredients of the trandolapril granule:

Maize starch, lactose monohydrate, povidone, sodium stearate fumarate.

Ingredients of the hard gelatin capsule:

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

Appearance of the product and contents of the package:

Tarka is presented in the form of modified-release capsules of pale pink color.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible 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 medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Greece:Tarka 180 mg/2 mg Kaps?ki eleγχ?µeνηςαποδ?σμευσης

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

Spain:Tarka 180 mg /2 mg modified-release capsules

Last review date of this leaflet:January 2021

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/