Carvedilolo Ratiopharm

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

CONTENTS OF THIS LEAFLET:
1. What Carvedilolo ratiopharm is and what it is used for
2. Before taking Carvedilolo ratiopharm
3. How to take Carvedilolo ratiopharm
4. Possible side effects
5. How to store Carvedilolo ratiopharm
6. Further information

1. WHAT CARVEDILOLO RATIOPHARM IS AND WHAT IT IS USED FOR
Carvedilol belongs to a group of medicines called "beta-blockers". Beta-blockers help relax and widen blood vessels and slow down heart rate, allowing the heart to beat more slowly and reducing blood pressure.

Carvedilolo ratiopharm is used for:

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

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

2. BEFORE TAKING CARVEDILOL RATIOPHARM

DO NOT take Carvedilol ratiopharm:

• if you are allergic (hypersensitive) to carvedilol or to any of the excipients of this medicine;
• if you have or have had asthma or other lung diseases, unless you have first consulted your doctor or pharmacist;
• if you have heart problems (e.g., "heart block" or unstable heart failure), since Carvedilol ratiopharm is not indicated for some people with certain heart conditions;
• 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 which sometimes causes dizziness, fainting, or lightheadedness when standing up;
• if you are receiving verapamil or diltiazem by injection or infusion (via an intravenous drip);
• if you have a problem related to acid levels in your blood ("metabolic acidosis");
• if you have liver problems;
• if you have phaeochromocytoma (a tumour on one of the adrenal glands), unless it is adequately controlled by medication.

Take special care with Carvedilol ratiopharm
Inform your doctor before starting to take this medicine:

• if you have diabetes, as warning signs of low blood sugar (hypoglycaemia) may be less obvious than usual;
• if you have kidney problems;
• if you have Raynaud's syndrome or peripheral vascular disease causing coldness, numbness, or tingling in hands and feet;
• if you have thyroid problems;
• if you have previously experienced severe allergic reactions or are undergoing desensitisation therapy to prevent allergies, e.g. to wasp or bee stings;
• if you suffer from psoriasis (patches of thickened, sore skin);
• if you wear contact lenses, as Carvedilol ratiopharm may cause dry eyes;
• if you have previously had problems while taking debrisoquine (used to treat high blood pressure).

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

• other specific medicines for the heart or high blood pressure;
• antiarrhythmics, e.g. amiodarone;
• calcium antagonists, e.g. amlodipine, diltiazem, verapamil, nifedipine;
• digitalis medicines, e.g. digoxin;
• nitrates, e.g. glyceryl trinitrate;
• guanethidine, reserpine, methyldopa;
• clonidine;
• monoamine oxidase inhibitors (used to treat depression), e.g. moclobemide;
• barbiturates, e.g. amobarbital (a sleeping pill);
• phenothiazines, e.g. prochlorperazine (for nausea and vomiting);
• antidepressants, e.g. amitriptyline, fluoxetine (used to treat depression);
• ciclosporin (used after organ transplantation);
• insulin or oral medicines for diabetes;
• non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen (used to relieve pain, stiffness and inflammation of painful bones, joints and muscles);
• corticosteroids (used to reduce inflammation), e.g. beclometasone;
• oestrogen therapies (used as contraceptives or hormone replacement therapy);
• rifampicin (used to treat tuberculosis);
• cimetidine (used to treat ulcers);
• ketoconazole (used to treat 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 to treat migraine);
• neuromuscular blocking agents (muscle relaxants used in anaesthesia), e.g. atracurium besilate.

Inform the hospital or your dentist if you are taking Carvedilol ratiopharm tablets and are due to undergo a procedure requiring anaesthesia.
Taking Carvedilol ratiopharm with food and drink
Do not drink alcohol while taking Carvedilol ratiopharm.
Pregnancy and breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, you must not take this medicine unless prescribed by your doctor.
Driving and using machines
Carvedilol ratiopharm may reduce your reaction speed and you may feel dizzy while taking Carvedilol ratiopharm. This is more likely at the beginning of treatment, when treatment is changed, or when you drink alcohol. If you experience this side effect, avoid driving or operating machinery.
Important information about some excipients of Carvedilol ratiopharm
Patients who are lactose intolerant should be aware that Carvedilol ratiopharm tablets contain a small amount of lactose. If your doctor has told you that you are intolerant to certain sugars, contact him or her before taking this medicinal product.

3. HOW TO TAKE CARVEDILOL TEVA

Always take Carvedilolo Teva exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

• Swallow the tablets with a glass of water.
• Your doctor may monitor you at the beginning of treatment or when the dose is increased. This may include blood and urine tests.

Usual dosage: Hypertension

• Adults: The usual starting dose is 12.5 mg once daily for the first two days. The recommended dose is then 25 mg once daily. If necessary, your doctor may gradually increase the dose. The maximum single dose is 25 mg and the maximum daily dose is 50 mg.
• Elderly: The usual starting dose is 12.5 mg once daily. If needed, your doctor may increase the dose.

Angina

• Adults: The usual starting dose is 12.5 mg twice daily for two days, then the recommended dose is 25 mg twice daily. If necessary, your doctor may gradually increase the dose. The maximum daily dose is 50 mg taken twice daily (i.e. 100 mg per day).
• Elderly: The usual starting dose is 12.5 mg twice daily for two days, then the recommended dose is 25 mg twice daily, which is also the maximum daily dose.

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

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

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

Elderly
Your doctor may decide to monitor you more closely if you are elderly.

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

If you take more Carvedilolo ratiopharm than you should
If you (or someone else) take more tablets than prescribed, or if you suspect that a child has ingested one or more tablets, contact your nearest emergency department or doctor immediately. Overdose may cause low blood pressure (with weakness, tremor, and fainting), wheezing, vomiting, seizures, severe slowing of the heart rate, heart failure/heart attack, breathing difficulties, and loss of consciousness.

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

If you stop taking Carvedilolo ratiopharm
Do not stop taking the tablets abruptly, as this may cause adverse effects. If treatment needs to be discontinued, your doctor will gradually reduce the dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Carvedilolo ratiopharm may cause adverse reactions, although not everyone experiences them.
Adverse reactions are less likely if you are taking this medicine for angina or hypertension than if you are being treated for heart failure.

Possible adverse reactions in patients treated for heart failure

Very common (affect more than 1 in 10 people):

• Dizziness
• Headache
• Heart problems
• Feeling weak or tired
• Low blood pressure (dizziness or lightheadedness)
• Slowing of the heartbeat, dizziness, or fainting when standing up (due to drop in blood pressure)

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

• Airway infection (bronchitis), lung infection (pneumonia), nose and throat infections
• Urinary tract infections
• Anaemia
• Weight gain
• Increased cholesterol (fat) in the blood
• Loss of blood sugar control in people with diabetes
• Depression
• Vision problems, dry, painful or irritated eyes
• Slowing of the heartbeat
• Swelling of hands, ankles or feet
• Circulatory problems, fluid retention
• Fainting or dizziness when standing up (due to drop in blood pressure)
• Worsening of cold extremities in patients with Raynaud's disease or circulatory problems
• Breathing problems
• Nausea, stomach discomfort, vomiting
• Diarrhoea
• Pain in hands and feet
• Kidney problems, including changes in urination

Uncommon (affect less than 1 in 100 but more than 1 in 1,000 people):

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

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

• Decrease in the number of platelets in the blood (leading to unusual bleeding or unexplained bruising)
• Nasal congestion

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

• Low white blood cell count
• Allergic reactions
• Changes in liver function
• Urinary incontinence in women

In diabetic patients, changes in blood sugar levels and worsening of glycaemic control may occur.
If your condition or symptoms worsen, you must inform your doctor; it may be necessary to adjust the dose of Carvedilolo ratiopharm or of other medicines you are taking.
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

5. HOW TO STORE CARVEDILOLO TEVA

Keep Carvedilolo ratiopharm out of the reach and sight of children.
Do not store above 25 °C.
Do not use Carvedilolo ratiopharm after the expiry date 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. OTHER INFORMATION

What Carvedilolo ratiopharm tablets contain:

• The active substance is carvedilol.
• Each 3.125 mg tablet contains 3.125 mg of the active substance carvedilol.
• Each 6.25 mg tablet contains 6.25 mg of the active substance carvedilol.
• Each 12.5 mg tablet contains 12.5 mg of the active substance carvedilol.
• Each 25 mg tablet contains 25 mg of the active substance carvedilol.
• The other ingredients are monohydrate lactose, povidone, crospovidone, anhydrous colloidal silica and magnesium stearate. The tablets contain the following colouring agents:
• 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 flat, round tablets with a break line on one side and the imprint “CVL” at the top on the other side. In addition:

• The 3.125 mg tablets are light peach-coloured and have the imprint "T1" at the bottom.
• The 6.25 mg tablets are light yellow to yellow and have the imprint "T2" at the bottom.
• The 12.5 mg tablets are light mottled brick-red and have the imprint "T3" at the bottom.
• The 25 mg tablets are white to off-white and have the imprint "T4" at the bottom.
• The 3.125 mg tablets are available in packs of 28, 30, 50 and 100 tablets.
• The 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 Authorisation Holder and Manufacturer
Teva Italia S.r.l. – Via Messina, 38 – 20154 Milano
Manufacturers
Pharmachemie B.V. – Swensweg, 5 – 2003 RN Haarlem (The 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
This package leaflet has been approved in the EEA Member States under the following names:
BE Carvedilol Teva 6.25mg, 12.5mg Tabletten
CZ Carvedilol-Teva 6.25mg, 12.5mg & 25mg
DK Carvedilol Teva 3.125mg, 6.25mg, 12.5mg & 25mg Tabletter
DE Carvedilol-Teva 3.125mg, 6.25mg, 12.5mg & 25mg Tabletten
ES Carvedilol Teva, 6.25mg, & 25mg Comprimidos EFG
HU Carvol 3.125mg, 6.25mg, 12.5mg & 25mg tabletta
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 tabletes
PL 3.125mg, 6.25mg, 12.5mg & 25mg tabletki
PT Carvedilol Teva 3.125mg, 6.25mg, 12.5mg & 25mg Comprimidos
SE Carvedilol Teva 25mg Tablett
SK Carvedilol-Teva 6.25mg, 12.5mg & 25mg
UK Teva Carvedilol 3.125mg, 6.25mg, 12.5mg & 25mg Tablets
This package leaflet was last approved in July 2011