Tarka retard 240 mg. / 4 mg. 28 capsules

Tarka active substances are verapamil hydrochloride extended release and trandolapril. One tablet Tarka extended release contains verapamil hydrochlorid SR and trandolapril-angiotensin converting enzyme (ACE inhibitor).

Other ingredients are: corn starch, lactose monohydrate, povidone, hypromellose, sodium stearyl fumarate, microcrystalline cellulose, sodium alginate, magnesium stearate, hyprolose, macrogol, talc, highly disperse silica, sodium docusate, titanium dioxide (E 171), iron oxide and hydroxide (E172).

Modified-release tablets consist of a layer containing verapamil hydrochloride sustained-release and a second layer containing the fast release trandolapril. Tarka is available in packs of 28 modified-release tablets. Pink, oval tablets engraved with the logo of "Knoll" and "182" on one side.

1. WHAT IS Tarka AND WHAT IT IS USED?

Tarka is a medicament comprising a combination of two active substances in different ways to lower blood pressure. Tarka use in essential hypertension in patients whose blood pressure has been normalized with the individual active substances at the same dosage.

Marketing authorization for use of the product:

Abbott GmbH & Co. KG, 65205 Wiesbaden, Germany.
ProizvoditelAbbott GmbH & Co. KG, 67061 Ludwigshafen, Germany.


2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE Tarka?

You should not take Tarka:

- With hypersensitivity (allergy) to trandolapril or any other ACE inhibitor and / or verapamil or to any of the excipients

- If you have swelling of the skin: and subcutaneous tissue (angioneurotic edema), where previous treatment with an ACE inhibitor;

- Hereditary angioedema or one without a known cause;

- Cardiovascular shock;

- A recent heart attack with complications;

- Severe cardiac conduction abnormalities (AV-blokII. Or Y. degree) and not wearing a pacemaker;

- If you have a breach in the conductivity of the left atrial (SA-block);

- If you have a breach in the origin of the cardiac impulse in the left atrium (syndrome sick sinus) and not wearing a pacemaker;

- Congestive heart failure;

- Atrial flutter / fibrillation in association with an accessory pathway (eg. WPW- syndrome) - Severe renal impairment (creatinine clearance <10 ml / min);

- If you are on dialysis;

- Severe hepatic impairment (liver cirrhosis) the collection of fluid in the abdomen (ascites);

- Narrowing of certain heart valve (mitral or aortna-);

- A thickening of the heart muscle with difficulty in ejection of blood (obstructive hypertrophic cardiomyopathy);

- Overproduction of the hormone aldosterone from the adrenal cortex (primary aldosteronism);

- Pregnancy; -laktatsiya;

- Use in children and adolescents (<18 years); Take special care with Tarka

- When stimulated renin-angiotensin-aldosterone system (eg. Water or salt deficiency due to the use of diuretics, low sodium diet, dialysis, diarrhea or vomiting; left ventricular failure, renovascular hypertension);

- With renal impairment or congestive heart failure, as this can cause acute worsening of renal function, increased levels of potassium in the blood;

- Increased elimination of normal secretory protein in the urine (proteinuria);

- Severely impaired hepatic function, as there is insufficient experience;

- If you develop swelling of the face, tongue, nasopharynx or extremities (angioneurotic edema), you should stop using the product and seek medical attention; with ACE inhibitors was observed greater incidence of angioneurotic edema in non-white patients than in Caucasian patients;

- A degree of renal impairment, in particular when it is associated with connective tissue disease, e. systemic lupus erythematosus, scleroderma, and in the treatment simunosupresivni products;

- During treatment with an ACE inhibitor may occur dry or nonproductive cough, which resolved after withdrawal of the medicinal product;

- In surgery requiring general anesthesia, because ACE inhibitors may cause hypotension;

- With slight disturbance in conduction of the heart;

- In slow heartbeat (less than 50 beats / min);

- Diseases where impaired neuromuscular conduction is (myasthenia gravis syndrome, Lambert-Eaton, advanced Duchenne muscular dystrophy);

- Hemodialysis patients;

- When LDL-apheresis is administered concomitantly with ACE inhibitors, due to the likelihood of life-threatening reactions;

Children and adolescents

Children and adolescents (<18 years) should not take Tarka.

Elderly

Tarka has been studied only in a limited number of elderly patients with hypertension. Available data indicate that the plasma concentrations of Tarka is higher in elderly patients compared with younger patients. In some elderly patients the fall in blood pressure may be more pronounced than others. Recommended assessment of renal function after initiation of treatment.

Pregnancy and lactation

Tarka should not be taken during pregnancy and lactation.

Effects on ability to drive and use machines

Although no effect on ability to drive and use machines can not even be ruled deterioration of attention, since Tarka may cause dizziness and fatigue. This is particularly true in concomitant use with alcohol.

Special attention

Tarka contains lactose, which is why you should tell your doctor if you have an intolerance to sugar. One tablet Tarka contains 1.12 mmol (25.76 mg) of sodium. If Wall sodium diet, you should keep in mind.

Interactions with other medicinal products

Please tell your doctor or pharmacist if you are taking other medicines or have recently taken any, although they were not subject to prescription. With concomitant use with the following medicines Tarka may affect their action:

Potassium-sparing diuretics or potassium supplements, should be avoided because of possible concurrent administration increase the potassium level in the blood, especially in patients with renal impairment.

Dantrolene: not recommended.

Medicines for lowering blood: potentiate the hypotensive action of Tagka. Diuretics, may experience an excessive drop in blood pressure, particularly in patients with salt and / or water deficit;

Lithium: amplification and attenuation of effects of lithium; may decrease the excretion of lithium.

Anesthetics, may increase the blood pressure lowering effect of some anesthetics. Narcotic drugs / antisihotitsi: possible hypotension upon standing (orthostatic hypertension).

Allopurinol (for gout), cytostatics (cancer), immunosuppressants (for suppression of the immune system), certain hormones (systemic corticosteroids), procainamide (medicines against cardiac arrhythmias) can lead to a decrease in white blood cells.

Medicines for heart (eg. Beta-blockers, antiarrhythmics, inhalation anesthetics) may occur undesired effects.

Quinidine (antiarrhythmics): in a few cases in patients with thickening of the heart muscle (hypertrophic cardiomyopathy) during concomitant use of verapamil (a component of Tarka) hypotension occurs.

Digoxin: possible 50-75% increase in plasma digoxin concentrations requiring dose reduction of digoxin.

Mgyurelaksanti: the effect of muscle relaxants may be potentiated. Tranquilizers / antidepressants in combination products containing imipramine increased risk of hypotension upon standing.

NSAIDs, may reduce the antihypertensive effect of Tarka, increase the potassium level in the blood and impair kidney function.

Antacids: decrease the bioavailability of trandolapril (one of the ingredients of Tarka). Sympathomimetics: may reduce the antihypertensive effect of Tarka.

Carbamazepine (for epilepsy), ciclosporin (to suppress the body's defenses) and theophylline (for asthma) may increase the levels of these medicines.

Rifampicin (for tuberculosis), phenytoin and phenobarbital (for epilepsy) reduce the effect of Tarka.

Cimetidine (medicine for lowering the acidity of the stomach) enhances the effect of Tarka.

Antidiabetic: enhanced low blood sugar.

Concomitant use of Tarka with food and drink

During the use of Tarka should not drink alcohol because of increased hypotensive effect of Tarka.

Tarka should not be taken with grapefruit juice, because verapamil (one of the active ingredients of Tarka) can increase its effect under the effect of grapefruit.

Food intake leads to delayed absorption of verapamil (one of the active ingredients of Tarka), which is why Tarka should be taken half an hour before breakfast.

3. HOW TO TAKE Tarka?

Always take Tarka according to the doctor's instructions. Ask your doctor or pharmacist if you are unsure.

Tarka tablets modified-release should be swallowed whole with sufficient liquid (preferably with a glass of water).

Unless otherwise prescribed the usual dosage is:

1 tablet Tarka modified-release, once daily in the morning, half an hour before breakfast. Tarka tablets should be swallowed whole. Please tell your doctor or pharmacist if you think the effect of Tarka is too strong or too weak.

If you take a large amount of Tarka:

The highest tested in clinical trials for the dose is 16 mg trandolapril. This dose does not cause symptoms of intolerance. Generally, overdose should lead to lower blood pressure.

Signs of an overdose of verapamil are depending on its effect on the cardiovascular system. These are lowering of blood pressure, heart failure and cardiac arrhythmias. If overdose is suspected, seek medical attention!

If you forget to take Tarka:

Do not take a double dose if you forgot the previous one.

Interruption of the use of Tarka:

With the exception of emergencies such as angioneurotic edema, Tarka should not be interrupted arbitrarily. Please talk first with your doctor.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

As with all medicines, Tarka can cause side effects.

When assessing the adverse effects the following definitions:

Very common: more than 1 in every 10 treated

Common: less than 1 in 10 and more than 1 100 people

There is often, less than 1 in 100 and more than 1 in 1,000

Rare less than 1 in 1000 and more than 1 in 10 000 treated

Very rarely: less than 1 in 10 000, including a single occasion

The following side effects have been observed during treatment with Tarka:

Common: Headache, constipation, flushing, cough, dizziness, vertigo;

Uncommon: allergic reaction, increased blood lipids, drowsiness, tremor, extending the transmission time of the cardiac impulse (AV-block I. rate), palpitations, stomach pain, diarrhea, gastrointestinal complaints, nausea, swelling of the face, itching, hives, sweating, frequent urination, pain in the chest, changes in liver function tests;

Rare: anorexia, seizures, hair loss, sores caused by herpes viruses, the manifestation of skin disease, rise in bilirubin;

Very rare: decreased number of white blood cells, decreased number of all blood cells, decreased number of blood platelets, aggressive behavior, anxiety, depression, nervousness, abnormal weight gain, insomnia, hypersensitivity, numbness, tingling, cold extremities, loss of consciousness or acute circulatory shock with loss of consciousness, change in taste, weakness, abnormal / blurred vision, angina pectoris, atrial fibrillation, severe conduction abnormalities (AV-block II. and III. level), slow heart rate, cardiac arrest, brain bleeding, swelling around the ankles, flushing, heart failure, sudden fall in blood pressure when standing up, increased heart rate, asthma, bronchitis, shortness of breath, sinus congestion, dry mouth, inflammation of the pancreas, vomiting, obstruction of the bile tract, inflammation of the liver, increase of some enzymes (lipase, gamma-GT, LDH), jaundice, angioneurotic edema, acute skin disease with severe systemic reactions (erythema multiforme), skin inflammation, psoriasis, urticaria, arthralgia, muscle weakness, muscle pain, acute renal failure, breast enlargement in men, impotence, increased potassium levels in the blood increase of certain enzymes in the blood (transaminases, alkaline phosphatase);

5. HOW TO STORE Tarka?

Keep in places out of sight and reach of children.

Do not use after the expiration stated on the label shelf life.

Store in the original container.

Store at temperatures below 25 ° C.