CARVEDILOLO 3.125 mg Coated tablet

Содержание инструкции

1. Carvedilolo ratiopharm 3.125 mg tablets, 6.25 mg tablets, 12.5 mg tablets, 25 mg tablets
   1. BEFORE TAKING CARVEDILOL RATIOPHARM
   2. HOW TO TAKE CARVEDILOLO TEVA
   3. POSSIBLE SIDE EFFECTS
   4. HOW TO STORE CARVEDILOLO TEVA
   5. FURTHER INFORMATION

Carvedilolo ratiopharm 3.125 mg tablets, 6.25 mg tablets, 12.5 mg tablets, 25 mg tablets

carvedilol

Generic medicine
Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

CONTENTS OF THIS LEAFLET:

1. What is Carvedilolo ratiopharm and what it is used for

2. Before you take Carvedilolo Teva

3. How to take Carvedilolo Teva

4. Possible side effects

5. How to store Carvedilolo Teva

6. Further information

1. WHAT IS CARVEDILOLO RATIOPHARM AND WHAT IT IS USED FOR

Carvedilol belongs to a group of medicines called "beta-blockers". Beta-blockers cause blood vessels to relax
and widen and slow down the heart rate, so that the heart beats more slowly and
reduces blood pressure.
Carvedilolo ratiopharm is used for:

• the treatment of angina;
• controlling high blood pressure.

Carvedilolo ratiopharm can also be used in combination with other therapies for the treatment
of heart failure.

2. BEFORE TAKING CARVEDILOL RATIOPHARM

DO NOT take Carvediloloratiopharm:

• if you are allergic (hypersensitive) to carvedilol or any of the excipients of this medicine;
• if you suffer from or have suffered from asthma or other lung diseases, unless you have first consulted your doctor or pharmacist;
• if you have heart problems (e.g., a "heart block" or unstable heart failure), since Carvedilolo ratiopharm is not indicated for some people who suffer from certain heart problems;
• if you suffer from a particular type of chest pain called Prinzmetal's angina;
• if your heartbeat is unusually slow or you have very low blood pressure that sometimes causes dizziness, fainting or a feeling of lightheadedness when you stand up;
• if you are taking verapamil or diltiazem by injection or infusion (through an IV);
• if you have a problem related to the levels of acids present in the blood ("metabolic acidosis");
• if you have liver problems;
• if you have a pheochromocytoma (a growth on one of the adrenal glands), unless it is adequately controlled by medicines.

Take particular care with Carvedilolo ratiopharm
Tell your doctor before starting to take this medicine:

• if you have diabetes, as the warning signs announcing low blood sugar levels (hypoglycemia) may be less noticeable than usual;
• if you have kidney problems;
• if you have Raynaud's syndrome or peripheral vascular disease that causes cooling of hands and feet or tingling;
• if you have thyroid problems;
• if you have suffered in the past from severe allergic reactions or are taking desensitization therapy to prevent allergies, e.g. to bee or wasp stings;
• if you suffer from psoriasis (patches of thickened, painful skin);
• if you wear contact lenses, as Carvedilolo ratiopharm can cause dry eyes;
• if you have had problems during the taking of debrisoquine (used to treat high blood pressure).

Taking Carvedilolo ratiopharm with other medicines
Consult your doctor or pharmacist if you are taking or have recently taken any other medicines
including those available without a prescription and herbal medicines. This is because Carvedilolo ratiopharm
can affect the action of some medicines. Also, some medicines can affect the action of
Carvediloloratiopharm:

• other medicines specific for the heart or for high blood pressure;
• antiarrhythmics, e.g. amiodarone;
• calcium antagonists, e.g. amlodipine, diltiazem, verapamil, nifedipine;
• digitalis medicines, e.g. digoxin;
• nitrates, e.g. glycerol trinitrate;
• guanethidine, reserpine, methyldopa;
• clonidine;
• monoamine oxidase inhibitors (used to treat depression), e.g. moclobemide;
• barbiturates, e.g. amylobarbitone (a sleeping pill);
• phenothiazines, e.g. prochlorperazine (against vomiting and nausea);
• antidepressants, e.g. amitriptyline, fluoxetine (used for the treatment of depression);
• cyclosporine (used after an organ transplant);
• insulin or tablets for the treatment of diabetes;
• non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen (used to relieve pain, stiffness and inflammation of aching bones, joints and muscles);
• corticosteroids (used to reduce inflammation), e.g. beclometasone;
• oestrogen therapies (used as contraceptives or as hormone replacement therapies);
• rifampicin (used for the treatment of tuberculosis);
• cimetidine (used for the treatment of ulcers);
• ketoconazole (used for the treatment of fungal infections);
• haloperidol (used in mental illnesses);
• erythromycin (an antibiotic used for bacterial infections);
• sympathomimetics (used for the nervous system), e.g. ephedrine;
• ergotamine (used for the treatment of migraine);
• neuromuscular blocking agents (muscle relaxants used in anesthesia), e.g. atracurium besylate.

Tell the hospital or dentist if you are taking Carvedilolo ratiopharm tablets and have to undergo an
operation that involves anesthesia.

Taking Carvedilolo ratiopharm with food and drink
Do not drink alcohol while taking Carvedilolo Teva.

Pregnancy and breastfeeding
If you are pregnant, planning a pregnancy or breastfeeding, you should not take this medicine unless
your doctor prescribes it.

Driving and using machines
Carvedilolo ratiopharm may reduce your reactivity and you may feel dizzy while taking Carvedilolo
Teva. This is more likely at the beginning of treatment, if the treatment is changed and when you drink alcohol. If
you experience this side effect, avoid driving and using machines.

Important information about some excipients of Carvedilolo ratiopharm
Patients intolerant to lactoseshould be aware that Carvedilolo ratiopharm tablets contain a
small amount of lactose. If your doctor has told you that you are intolerant to some sugars, contact
him/her before taking this medicinal product.

3. HOW TO TAKE CARVEDILOLO TEVA

Always take Carvedilolo ratiopharm exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.

• The tablets should be swallowed preferably with a glass of water.
• Your doctor may subject you to monitoring at the beginning of treatment or in case of an increase in the dose. This may require blood and urine tests. The usual dose is: Hypertension
• Adults:the usual starting dose is 12.5 mg once a day for the first two days, followed by a recommended dose of 25 mg once a day. If necessary, your doctor may gradually increase the dose. The maximum dose taken at a time is 25 mg and the maximum dose taken per day is 50 mg.
• Elderly:the usual starting dose is 12.5 mg once a day. If necessary, your doctor may increase the dose.

Angina

• Adults:the usual starting dose is 12.5 mg twice a day for two days, followed by a recommended dose of 25 mg twice a day. If necessary, your doctor may gradually increase the dose. The maximum daily dose is 50 mg twice a day.
• Elderly:the usual starting dose is 12.5 mg twice a day for two days, followed by a recommended dose of 25 mg twice a day, which is the maximum daily dose.

Heart failure
The tablets should be taken with food to reduce the risk of a drop in blood pressure
when getting up, resulting in dizziness, lightheadedness or fainting.

• Adults:the usual starting dose is 3.125 mg twice a day for 2 weeks. Your doctor may gradually increase the dose to 25 mg twice a day. The maximum dose is 25 mg twice a day for patients with a body weight of less than 85 kg. Patients with a body weight greater than 85 kg may take a maximum dose of 50 mg twice a day.

Liver or kidney problems
If you have liver or kidney problems, your doctor may prescribe you a lower dose.

Elderly
Your doctor may decide to subject you to more careful monitoring if you are elderly.

Children and adolescents (under 18 years of age)
Carvedilolo ratiopharm is not recommended in children and adolescents under 18 years of age.

If you take more Carvedilolo ratiopharm than you should
In the event that you (or another person) ingest more tablets together, or if you think a child has
ingested one or more tablets, contact the nearest emergency room or doctor immediately. Overdose
can cause low blood pressure (resulting in weakness, tremor and fainting), wheezing, vomiting, seizures, severe slowing of the heartbeat, heart failure/attack, breathing problems and loss of consciousness.

If you forget to take Carvedilolo ratiopharm
If you forget to take a dose, do so as soon as you remember unless it is close to the time of the
next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Carvedilolo ratiopharm
Do not suddenly stop taking the tablets as side effects may occur. If
it is necessary to stop treatment, your doctor will gradually reduce the dose.
If you have any doubts about the use of the product, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Carvedilolo ratiopharm can cause side effects, although not everybody will experience them.
Side effects are less likely if you are taking this medicine for angina or hypertension
compared to treatment for heart failure.

Possible side effects in patients treated for heart failure
Very common (affecting more than 1 in 10 people):

• Dizziness
• Headache
• Heart problems
• Feeling weak or tired
• Low blood pressure (dizziness or feeling faint)
• Slowing of the heartbeat, dizziness or fainting when getting up (due to a drop in pressure);

Common (affecting less than 1 in 10 people but more than 1 in 100 people):

• Airway infection (bronchitis), lungs (pneumonia), nose and throat
• Urinary tract infections
• Anemia
• Weight gain
• Increased cholesterol (fat) in the blood
• Loss of control of blood sugar levels in people with diabetes
• Depression
• Vision problems, dry or painful eyes, eye irritation
• Slowing of the heartbeat
• Swelling of hands, ankles or feet
• Circulation problems, fluid retention
• Fainting or dizziness when standing up (due to a drop in pressure)
• Worsening of cold extremities in patients who suffer from Raynaud's disease or have circulation problems.
• Breathing problems
• Nausea, stomach pain, vomiting
• Diarrhea
• Pain in hands and feet
• Kidney problems, including changes in urination

Uncommon (affecting less than 1 in 100 people but more than 1 in 1000 people):

• Sleep problems
• Feeling faint, fainting
• Numbness or tingling
• Heart problems, chest pain
• Skin problems (cracks, rashes, itching, dry skin patches)
• Hair loss
• Impotence (difficulty getting or maintaining an erection).

Rare (affecting less than 1 in 1000 people but more than 1 in 10,000 people):

• Decrease in the number of platelets in the blood (which causes unusual bleeding or unexplained bruising)
• Blocked nose

Very rare (affecting less than 1 in 10,000 people):

• Low number of white blood cells in the blood
• Allergic reactions
• Changes in liver function
• Incontinence problems in women

In diabetic patients, changes in blood sugar levels and worsening of
glycemic control may occur.
If your condition or symptoms worsen, you should inform your doctor; it may be necessary to
modify the dose of Carvedilolo ratiopharm or other medicines you are taking.
If any of the side effects worsen, or if you notice any other side effect

5. HOW TO STORE CARVEDILOLO TEVA

Keep Carvedilolo ratiopharm out of the reach and sight of children.
Do not store at a temperature above 25 ºC.
Do not use Carvedilolo ratiopharm after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of the month. An abbreviation for the expiry date (e.g. EXP) may
be present on the outer packaging and on the blister.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. FURTHER INFORMATION

What Carvedilolo ratiopharm tablets contain:

• The active ingredient is carvedilol.
• Each 3.125 mg tablet contains 3.125 mg of the active ingredient carvedilol.
• Each 6.25 mg tablet contains 6.25 mg of the active ingredient carvedilol.
• Each 12.5 mg tablet contains 12.5 mg of the active ingredient carvedilol.
• Each 25 mg tablet contains 25 mg of the active ingredient carvedilol.
• The other excipients are lactose monohydrate, povidone, crospovidone, anhydrous colloidal silica and magnesium stearate. The tablets contain the following colorants:
• 3.125 mg tablets: yellow and red iron oxide (E172)
• 6.25 mg tablets: yellow iron oxide (E172)
• 12.5 mg tablets: red iron oxide (E172)

Description of the appearance of Carvedilolo ratiopharm and contents of the pack
Carvedilolo ratiopharm tablets are round, flat, with a fracture line on one side and on the other side
the inscription “CVL” embossed on the top. In addition:

• 3.125 mg tablets are light peach colored and have the inscription "T1" on the bottom.
• 6.25 mg tablets are light yellow to yellow in color and have the inscription "T2" on the bottom.
• 12.5 mg tablets are light mottled brick red in color and have the inscription "T3" on the bottom.
• 25 mg tablets are white to off-white in color and have the inscription "T4" on the bottom.
• 3.125 mg tablets are available in packs of 28, 30, 50 and 100 tablets.
• 6.25 mg, 12.5 mg and 25 mg tablets are available in packs of 14, 28, 30, 50, 56 and 100 tablets.

*Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Teva Italia S.r.l. – Via Messina, 38 – 20154 Milano

Manufacturer
Pharmachemie B.V. – Swensweg, 5 – 2003 RN Haarlem (Netherlands)
Teva UK Ltd. – Brampton Road, Hampden Park – BN22 9AG Eastbourne – East Sussex (England)
Teva Pharmaceutical Works Private Limited Company - Pallagi str. 13 – H-4042 Debrecen (Hungary)
Teva Operations Poland Sp. z o.o.,Mogilska 80 Str. 31‐546 Kraków
BE Carvedilol Teva 6.25mg, 12.5mg Tablets
CZ Carvedilol-Teva 6.25mg, 12.5mg & 25mg
DK Carvedilol Teva 3.125mg, 6.25mg, 12.5mg & 25mg Tablets
DE Carvedilol-Teva 3.125mg, 6.25mg, 12.5mg & 25mg Tablets
ES Carvedilol Teva, 6.25mg, & 25mg Tablets EFG
HU Carvol 3.125mg, 6.25mg, 12.5mg & 25mg tablet
IE Carvedilol 3.125mg, 6.25mg, 12.5mg & 25mg Tablets
IT Carvedilolo ratiopharm 3.125mg, 6.25mg, 12.5mg & 25mg Compresse
LT Carvedilolum 123ratio3.125mg, 6.25mg, 12.5mg & 25mg tablets
PL 3.125mg, 6.25mg, 12.5mg & 25mg tablets
PT Carvedilol Teva 3.125mg, 6.25mg, 12.5mg & 25mg Comprimidos
SE Carvedilol Teva 25mg Tablet
SK Carvedilol-Teva 6.25mg, 12.5mg & 25mg
UK Teva Carvedilol 3.125mg, 6.25mg, 12.5mg & 25mg Tablets