Hipoten

Leaflet accompanying the packaging: information for the user

Hypoten 6.25 mg, 12.5 mg, 25 mg coated tablets
Carvedilol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Hypoten and what is it used for
• 2. Important information before taking Hypoten
• 3. How to take Hypoten
• 4. Possible side effects
• 5. How to store Hypoten
• 6. Contents of the packaging and other information

1. What is Hypoten and what is it used for

Hypoten belongs to a group of medicines called alpha and beta blockers. The active substance of the medicine, carvedilol,
expands blood vessels, lowers blood pressure, and reduces the resistance that the heart has to overcome when pumping blood. Carvedilol also has a calming effect on the heart rhythm. Carvedilol reduces the heart's need for oxygen and thus alleviates the symptoms of angina pectoris.
Hypoten is used to treat high blood pressure and angina pectoris (angina). Hypoten is also used as a supportive treatment for heart failure, where it improves heart function.
Note: The doctor may prescribe this medicine for a different use and/or in a different dose than the dose stated in the patient leaflet. Always follow the doctor's recommendations and the instructions in the patient leaflet.

2. Important information before taking Hypoten

When not to take Hypoten

• If the patient is allergicto carvedilol or any of the other ingredients of this medicine (listed in section 6).
• If the patient has asthmaor bronchospasm.
• If the patient has untreated or unstable chronic heart failureor certain types of conduction disorders(so-called atrioventricular block of degree II or III unless the patient has a pacemaker, or so-called sick sinus syndrome).
• If the patient has severe heart failure(cardiogenic shock).
• If the patient has very low heart rateor very low blood pressure.
• If the patient has a severe acid-base imbalance(metabolic acidosis, acidaemia).
• If the patient has phaeochromocytoma(a tumour of the adrenal gland) that is not being treated with medicines.
• If the patient has severe liver disease.
• If the patient is currently being treated intravenously with medicines used to treat high blood pressureor heart disease(verapamil or diltiazem).
• If the patient has experienced severe skin reactions, such as changes in the skin and mucous membranes or severe, widespread skin damage (exfoliative dermatitis).

Warnings and precautions

Before starting treatment with Hypoten, discuss the following with your doctor:

• if the patient has chronic heart failureassociated with
• low blood pressure,
• reduced blood flow and oxygen supply to the heart (ischaemic heart disease) and hardening of the arteries(atherosclerosis),
• and/or kidney disease. In this case, kidney function should be monitored; it may be necessary to reduce the dose of the medicine.
• if the patient has diabetes. Treatment with Hypoten may mask the symptoms of low blood sugar. Therefore, blood sugar levels should be regularly monitored.
• if the patient has severe breathing difficultiesthat are not being treated. Hypoten may worsen such breathing difficulties.
• if the patient wears contact lenses. Hypoten may reduce tear production.
• if the patient has Raynaud's syndrome(a condition that causes the fingers and toes to turn blue, become pale, and then red, accompanied by pain) or other peripheral vascular diseases. Hypoten may worsen these symptoms.
• if the patient has hyperthyroidismwith increased production of thyroid hormones. Hypoten may mask these symptoms.
• if the patient is going to have surgeryunder anaesthesia. The doctor responsible for the anaesthesia should be informed about the treatment with Hypoten in advance.
• if the patient has a very low heart rate (less than 55 beats per minute).
• if the patient has ever experienced a severe allergic reaction(e.g. to an insect bite or food) or if the patient is undergoing or is about to undergo desensitization treatment, as Hypoten may reduce the effectiveness of medicines used to treat such allergic reactions.
• if the patient has psoriasis.
• if the patient has phaeochromocytoma(a tumour of the adrenal gland).
• if the patient has a rare form of angina pectoris called Prinzmetal's angina, caused by spasm of the coronary arteries.
• if the patient has unstable or secondary hypertension(when blood pressure changes rapidly or when high blood pressure is caused by another condition).
• if the patient has orthostatic hypertension, a sudden drop in blood pressure when standing up.
• if the patient has acute myocarditis(inflammation of the heart muscle).
• if the patient has valvular heart disease(narrowing of the heart valves).

Children

There is not enough data on the efficacy and safety of carvedilol in children.

Hypoten and other medicines

Concomitant treatment with other medicines may affect the action of Hypoten, or Hypoten may affect the action of other medicines.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription. Remember to inform your doctor about ongoing treatment with Hypoten if the doctor is going to prescribe another medicine.
It is especially importantto inform your doctor if you are currently being treated with any of the following medicines:

• Digoxin(for the treatment of heart failure).
• Carbamazepine(a medicine used to treat epilepsy).
• Paroxetine, Fluoxetine, Bupropion(medicines used to treat depression).
• Cinacalcet(a medicine used to treat hyperparathyroidism).
• Fluconazole(a medicine used to treat fungal infections)
• Rifampicin(an antibiotic used to treat tuberculosis).
• Cimetidine(a medicine used to treat stomach ulcers, heartburn, and reflux).
• Cyclosporin(a medicine that suppresses the immune system, used to prevent organ rejection, and also used to treat certain rheumatic or dermatological diseases).
• Clonidine(a medicine that lowers blood pressure or is used to treat migraines).
• Verapamil, diltiazem, amiodarone(medicines used to treat heart rhythm disorders).
• Quinidine, disopyramide, mexiletine, propafenone, flecainide(so-called class I anti-arrhythmic medicines).
• Other medicines that lower blood pressure. When given together, carvedilol may enhance the blood pressure-lowering effect of these medicines (e.g. alpha receptor antagonists), as well as medicines that lower blood pressure as a side effect, e.g. barbiturates(used to treat epilepsy), phenothiazine derivatives(used to treat psychoses), tricyclic antidepressants(used to treat depression), vasodilatorsand alcohol.
• Insulinsor oral anti-diabetic medicines(that lower blood sugar levels), as their blood sugar-lowering effect may be enhanced, and the symptoms of low blood sugar may be masked.
• Sympathomimetics(medicines that stimulate the sympathetic nervous system).
• Dihydropyridine derivatives- calcium channel blockers (medicines used to treat high blood pressure and coronary artery disease, such as amlodipine and felodipine).
• Medicines that block nerve-muscle conduction(medicines that reduce muscle tension).
• Ergotamine derivatives(a medicine used to treat migraines).
• Certain painkillers(NSAIDs - non-steroidal anti-inflammatory drugs), estrogens(hormones), and corticosteroids(adrenal hormones), as they may reduce the blood pressure-lowering effect of carvedilol in certain situations.
• Medicines containing reserpine and monoamine oxidase inhibitors (MAOIs), as they may further reduce heart rate.
• Asthma inhalers, e.g. fenoterol, formoterol, salbutamol, terbutaline, salmeterol(inhalers that dilate the airways).

Hypoten with food, drink, and alcohol

Hypoten may enhance the effect of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is a risk of harm to the unborn child. Therefore, carvedilol may only be used during pregnancy if the doctor considers it necessary.
It is not known whether carvedilol passes into breast milk, so it should not be taken during breastfeeding.

Driving and using machines

At the beginning of treatment or after a dose increase, when changing medicines or together with alcohol, dizziness and fatiguemay occur. It is not known whether carvedilol at therapeutic doses impairs the ability to drive or operate machinery. If you experience dizziness or weakness while taking the medicine, avoid driving and other activities that require increased alertness.
The patient must personally decide whether they are able to drive a vehicle or perform other activities that require increased alertness. Due to the effects of medicines, or their side effects, taking medicines is one of the factors that can impair the ability to perform such activities safely. A description of these effects can be found in another part of the leaflet.
Read the entire leaflet carefully.

Hypoten contains lactose

This medicine contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Hypoten

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. If you think the medicine is too weak or too strong, talk to your doctor or pharmacist.
Swallow the tablet with at least half a glass of water.
Swallow the coated tablet with at least half a glass of water. The coated tablets can be taken with or without food. Patients with heart failure should always take the coated tablets with food to reduce the risk of dizziness when standing up.

Hypoten is available in the following strengths: 6.25 mg, 12.5 mg, and 25 mg.

Hypertension:

The usual dose is 1 tablet of Hypoten 12.5 mg (equivalent to 12.5 mg of carvedilol) once a day for the first two days, and then 2 tablets of Hypoten 12.5 mg (equivalent to 25 mg of carvedilol) once a day. Other strengths of Hypoten are available for this dosing regimen.

Angina pectoris:

The usual dose is 1 tablet of Hypoten 12.5 mg (equivalent to 12.5 mg of carvedilol) twice a day for two days, and then 2 tablets of Hypoten 12.5 mg (equivalent to 25 mg of carvedilol) twice a day. Other strengths of Hypoten are available for this dosing regimen.

Heart failure:

The usual starting dose is half a tablet of Hypoten 6.25 mg (equivalent to 3.125 mg of carvedilol) twice a day for two weeks. The dose may be increased gradually, usually at two-week intervals.
However, there may be a need to increase or decrease the dose. The doctor will recommend the appropriate change depending on the circumstances.

Taking a higher dose of Hypoten than recommended

If you have taken more than the recommended dose of Hypoten or if a child has accidentally taken the medicine, contact your doctor or hospital, or call the emergency services for an assessment of the risk and advice on what to do.
Symptoms of overdose may include feeling weak due to excessively low blood pressure, slow heart rate, and in severe cases, absence of single heartbeats. Shortness of breath, bronchospasm, malaise, decreased level of consciousness, and seizures may also occur.

Missing a dose of Hypoten

If you forget to take a dose (or more doses) of Hypoten, take the next dose at the usual time.
Do not take a double dose (or a larger dose) to make up for the missed dose (or missed doses).

4. Possible side effects

Like all medicines, Hypoten can cause side effects, although not everybody gets them.
Most side effects are dose-dependent and disappear after dose reduction or discontinuation of treatment. Some side effects may occur at the beginning of treatment and disappear spontaneously during continued treatment.
Stop taking the medicine and contact your doctor immediately if you experience any of the following side effects:

• slow or irregular heartbeat, dizziness, weakness, or breathing difficulties (occurring in more than 1 in 10 patients),
• breathing difficulties, asthma (in predisposed patients), pulmonary oedema (fluid in the lungs) (occurring in up to 1 in 10 patients),
• chest pain (angina pectoris) (occurring in up to 1 in 100 patients),
• allergic reactions (occurring in up to 1 in 10,000 patients),
• severe skin reactions, including changes in the skin and mucous membranes or severe skin damage (exfoliative dermatitis) (occurring in up to 1 in 10,000 patients).

Other side effects:
Very common(occurring in more than 1 in 10):

• dizziness (e.g. when standing up quickly), headaches,
• low blood pressure,
• fatigue.

Common(occurring in up to 1 in 10):

• bronchitis, pneumonia, upper respiratory tract infections, urinary tract infections,
• anaemia,
• weight gain, increased cholesterol levels, increased or decreased blood sugar levels in diabetic patients, fluid overload, fluid retention,
• depression, depressive states,
• visual disturbances, dry eyes, eye irritation,
• orthostatic hypotension (sudden drop in blood pressure when standing up), peripheral circulation disorders, e.g. cold hands and feet, peripheral vascular disease,
• nausea, diarrhoea, vomiting, indigestion, abdominal pain,
• limb pain,
• renal failure, impaired renal function in patients with atherosclerosis and/or impaired renal function, urinary disorders,
• oedema (swelling), pain.

Uncommon(occurring in up to 1 in 100):

• sleep disturbances,
• dizziness, fainting, abnormal sensations,
• skin reactions, hair loss,
• impotence.

Rare(occurring in up to 1 in 1,000):

• low platelet count,
• stuffy nose,
• constipation.

Very rare(occurring in up to 1 in 10,000):

• low white blood cell count,
• dry mouth,
• increased liver enzyme levels,
• urinary incontinence in women.

Dizziness, fainting, headaches, and fatigue usually occur in a mild form and mostly at the beginning of treatment.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hypoten

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Hypoten contains

• The active substanceis carvedilol.
• The other ingredientsare: microcrystalline cellulose, lactose monohydrate, crospovidone, povidone K-30, colloidal anhydrous silica, magnesium stearate, hypromellose 3cP, hypromellose 6cP, hypromellose 50cP, titanium dioxide (E 171), triethyl citrate, macrogol 8000, polydextrose.

What Hypoten looks like and contents of the pack.
6.25 mg coated tablets: white, oval, marked with "6.25" on one side, with a score line on both sides.
12.5 mg coated tablets: white, oval, with a score line on both sides, marked with "12.5" on one side.
25 mg coated tablets: white, oval, with a score line on both sides, marked with "25" on one side.
The 6.25 mg, 12.5 mg, and 25 mg tablets can be divided into two equal doses.
Pack sizes for 6.25 mg, 12.5 mg, and 25 mg tablets: 30 and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany
Date of last revision of the leaflet: 19.11.2018