+ All Categories
Home > Documents > Vera-Denk 240 Retardeffects not listed in this leaflet. See section 4. What is in this leaflet:...

Vera-Denk 240 Retardeffects not listed in this leaflet. See section 4. What is in this leaflet:...

Date post: 22-Feb-2020
Category:
Upload: others
View: 3 times
Download: 0 times
Share this document with a friend
2
Vera-Denk 240 Retard Sustained-release tablet – oral use Calcium inhibitor Active substance: verapamil Package leaflet: information for the user Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor or pharmacist. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1.What Vera-Denk 240 Retard is and what it is used for 2.What you need to know before you take Vera-Denk 240 Retard 3.How to use Vera-Denk 240 Retard 4.Possible side effects 5.How to store Vera-Denk 240 Retard 6.Contents of the pack and other information 1. What Vera-Denk 240 Retard is and what it is used for Vera-Denk 240 Retard is a medicine intended for the treatment of heart diseases associated with inadequate oxygenation of the heart muscle, as well as for the treatment of some heart rhythm dis- orders and the treatment of high blood pressure. Vera-Denk 240 Retard is used for: • Treatment of coronary heart disease (inadequate oxygenation of the heart muscle) in cases of – chronic stable angina pectoris (effort-associat- ed angina), – unstable angina pectoris (crescendo angina, angina at rest), – vasospastic angina pectoris (Prinzmetal angina, variant angina). • Treatment of heart rhythm disorders in cases of – paroxysmal supraventricular tachycardia (occa- sional accelerations of the heart rate originat- ing from the atrium), fibrillation/flutter of the heart with rapid AV transition (except WPW syndrome; see “Do not take Vera-Denk 240 Retard”). • Treatment of hypertension (high blood pressure) 2. What you need to know before you take Vera-Denk 240 Retard Do not take Vera-Denk 240 Retard: – if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). if you have certain heart rhythm or heart conduc- tion disorders (second and third degree atrioven- tricular block without a pacemaker, atrial fibrilla- tion/flutter), cardiogenic shock, uncontrolled heart failure, myocardial infarction with compli- cations, low blood pressure. – if you are receiving treatment with dantrolene (infusion), aliskiren (a treatment for high blood pressure), St John’s wort (a herb) or sertindole (a treatment for schizophrenia). – in children and adolescents. Warnings and precautions Use this medicine with caution: – in cases of heart failure. – in the presence of certain heart rhythm and heart conduction disorders (1st degree atrioventricular block, slowing of the heart rate). – in cases of liver failure. – in cases of neuromuscular diseases (myasthenia gravis, Lambert-Eaton syndrome or advanced Duchenne muscular dystrophy). – in elderly subjects. – in cases of impaired kidney function. If malaise, fever, jaundice and/or pain in the right side of the abdomen occurs, you must tell your doctor, who will assess whether it is necessary to perform a liver enzyme assay. Children and adolescents No data are available on the use of sustained- release verapamil tablets in children and adoles- cents. Other medicines and Vera-Denk 240 Retard Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medi- cines. This medicine must not be used in combination with dantrolene (as an infusion), asliskiren, St John’s wort and sertindole (see section “Do not take Vera-Denk 240 Retard”). This medicine must be avoided in combination with beta-blockers, esmolol (in cases of impaired left- ventricular function), colchicine, triazolam, amiodarone (with injectable verapamil), ivabra- dine, quinidine. To avoid any interactions between several medi- cines, you should systematically tell your doctor or pharmacist about any other treatment you receive. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is preferable not to use this medicine during the first and second trimesters of pregnancy. During the third trimester, this medicine should be used only on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor because he/she alone can assess the need to continue it. Verapamil is excreted in small quantities in human milk. The few cases described after oral treatment did not report any side effects in the infant. Moreover, plasma concentrations in the infant’s blood are practically undetectable. Conse- quently, if verapamil is specifically indicated in the mother, breast-feeding is possible with regular clin- ical monitoring of the infant. Driving and using machines Even when used correctly, Vera-Denk 240 Retard may alter the capacity to react in such a way that the ability to drive, use machines or work without a secure foothold/handhold is impaired. This applies particularly at the start of treatment, when increasing the dose or changing product, when first starting an additional medicine and in combi- nation with alcohol. Vera-Denk 240 Retard with food and drink It is advisable to avoid drinking alcohol as far as possible while you are taking Vera-Denk 240 Retard, because Vera-Denk 240 Retard increases the effects of alcohol. You should not consume any food or drink con- taining grapefruit while you are taking Vera- Denk 240 Retard, because grapefruit can increase the concentration of verapamil hydrochloride in the blood. Vera-Denk 240 Retard contains lactose Vera-Denk 240 Retard contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3. How to take Vera-Denk 240 Retard Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Dosage Vera-Denk 240 Retard must be dosed on a case-by- case basis, adjusted to the severity of the condi- tion. According to long-term clinical experience, the average dose for nearly all areas of use is between 240 mg and 360 mg daily. On maintenance treatment, it is advisable not to exceed the daily dose of 480 mg; a temporary increase is possible. Adults and adolescents weighing from 50 kg: Coronary heart disease (inadequate oxygenation of the heart muscle) 240 mg–480 mg verapamil hydrochloride daily, divided into 1 – 2 doses, i.e. ½ –1 tablet twice daily. Hypertension: 240–480 mg verapamil hydrochloride daily, divided into 1 – 2 doses, i.e. 1 tablet once daily in the morning. If not sufficiently effective, ½ –1 additional tablet in the evening. Heart rhythm disorders (paroxysmal supraventricu- lar tachycardia, atrial fibrillation/atrial flutter with rapid AV conduction [except in cases of WPW syn- drome]): 240–480 mg verapamil hydrochloride daily, divided into 2 doses, i.e. ½ –1 tablet twice daily. Liver failure In patients with liver failure, depending on the degree of severity, the effect of verapamil hydrochloride is increased and prolonged because of slower metabolism of the medicine. This is why the doctor must adjust the dosage with particular care and initiate treatment with low doses (for example, in patients with liver failure, starting with 40 mg verapamil hydrochloride 2–3 times daily, i.e. 80 mg – 120 mg verapamil hydrochloride daily). If Vera-Denk 240 Retard has been prescribed for you for pain and a crushing sensation (angina pec- toris) following a heart attack (myocardial infarc- tion), you must wait 7 days after the acute cardiac episode before starting to take the medicine. Method of administration Oral use. Take the medicine with some liquid (for example, a glass of water; no grapefruit), at mealtimes or just afterwards, without sucking or chewing it. Do not take Vera-Denk 240 Retard when lying down. If you have the impression that the effect of Vera- Denk 240 Retard is too strong or too weak, talk to your doctor. Duration of treatment The duration of treatment is not limited; it will be determined by the doctor. If you take more Vera-Denk 240 Retard than you should The following signs and symptoms may occur after accidental or deliberate ingestion of a large num- ber of Vera-Denk 240 Retard tablets: severe fall in blood pressure, heart failure, arrhyth- mia (for example, slower or more rapid heartbeat, heart conduction disorders), which may lead to cardiocirculatory shock and cardiac arrest. Loss of consciousness as far as coma, a rise in the blood sugar level, a fall in the concentration of potassium in the blood, a fall in the pH of the blood (metabol- ic acidosis), a lack of oxygen supply to the tissues (hypoxia), cardiocirculatory shock with fluid accu- mulation in the lungs (pulmonary oedema), impaired kidney function and cramp. Cases of death have been reported. In such cases, a doctor/emergency doctor should be contacted immediately and will initiate the necessary steps. If you forget to take Vera-Denk 240 Retard Do not take a double dose to make up for a forgot- ten dose, but continue the treatment as prescribed. If you stop taking Vera-Denk 240 Retard Do not interrupt or stop treatment with Vera- Denk 240 Retard without first discussing this with your doctor. After prolonged treatment, treatment with Vera- Denk 240 Retard must never be stopped abruptly, but always gradually. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. – The following have been observed: nausea, vom- iting, constipation that in some cases was severe, requiring treatment to be stopped. – Low blood pressure, oedema in the lower limbs, slowing of the heart rate, symptomatic heart fail- ure, cardiogenic shock, sudden facial flushing. – Hepatitis manifesting as jaundice and/or abdomi- nal pain, malaise, fever, or liver abnormalities evident purely from laboratory test results (increased liver enzyme levels) and reversible on discontinuation of the treatment. – Rarely: gingival hyperplasia (swelling of the gums), gingivitis, reversible on discontinuation of the treatment. – Headache, dizziness, tingling sensations, tremor, drowsiness. – Skin reactions (redness, sweating), hives, itching. – Sensations of vertigo. – Muscle weakness, muscle or joint pain. – Impotence, gynaecomastia (breast development in men), galactorrhoea (abnormal milk secretion). – Very rarely: disorders combining rigidity, tremor and/or abnormal movements. – Rare cases of allergy with difficulty breathing. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist check. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Vera-Denk 240 Retard – Keep this medicine out of the sight and reach of children. – Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month. – Shelf life: 48 months. – Store below 25 °C. – Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Vera-Denk 240 Retard contains – The active substance is verapamil hydrochloride. Each sustained-release tablet contains 240 mg verapamil hydrochloride. – The other ingredients are: Tablet core: Sodium alginate, povidone, lactose monohydrate, magnesium stearate, Tablet film-coating: Polyvinyl alcohol, talc, lecithin, xanthan gum, titanium dioxide Conditions of supply Medicinal product subject to medical prescription What Vera-Denk 240 Retard looks like and contents of the pack White, oblong, film-coated tablets, scored on both sides. Vera-Denk 240 Retard is available in the form of PVC/PVDC/aluminium blisters. Presentation: pack of 50 sustained-release tablets Marketing Authorisation Holder and Manufacturer DENK PHARMA GmbH & Co. KG Prinzregentenstr. 79 81675 München Germany Production site Göllstr. 1 84529 Tittmoning Germany 4930_0914_VeraD240Ret_420x148_Denk 11.08.14 17:02 Seite 1
Transcript
Page 1: Vera-Denk 240 Retardeffects not listed in this leaflet. See section 4. What is in this leaflet: 1.What Vera-Denk 240 Retard is and what it is used for 2.What you need to know before

Vera-Denk 240 RetardSustained-release tablet – oral useCalcium inhibitorActive substance: verapamil

Package leaflet: information for the user

Read all of this leaflet carefully before youstart taking this medicine because it containsimportant information for you.– Keep this leaflet. You may need to read it

again.– If you have any further questions, ask your

doctor or pharmacist.– This medicine has been prescribed for you

only. Do not pass it on to others. It may harmthem, even if their signs of illness are thesame as yours.

– If you get any side effects, talk to your doctoror pharmacist. This includes any possible sideeffects not listed in this leaflet. See section 4.

What is in this leaflet:1.What Vera-Denk 240 Retard is and

what it is used for2.What you need to know before you

take Vera-Denk 240 Retard3.How to use Vera-Denk 240 Retard4.Possible side effects5.How to store Vera-Denk 240 Retard6.Contents of the pack and other information

1.What Vera-Denk 240 Retard is and what it is used forVera-Denk 240 Retard is a medicine intended forthe treatment of heart diseases associated withinadequate oxygenation of the heart muscle, aswell as for the treatment of some heart rhythm dis-orders and the treatment of high blood pressure.

Vera-Denk 240 Retard is used for:• Treatment of coronary heart disease (inadequate

oxygenation of the heart muscle) in cases of – chronic stable angina pectoris (effort-associat-

ed angina), – unstable angina pectoris (crescendo angina,

angina at rest), – vasospastic angina pectoris (Prinzmetal angina,

variant angina).• Treatment of heart rhythm disorders in cases of – paroxysmal supraventricular tachycardia (occa-

sional accelerations of the heart rate originat-ing from the atrium), fibrillation/flutter of theheart with rapid AV transition (except WPWsyndrome; see “Do not take Vera-Denk 240Retard”).

• Treatment of hypertension (high blood pressure)

2.What you need to know beforeyou take Vera-Denk 240 RetardDo not take Vera-Denk 240 Retard:– if you are allergic to the active substance or any

of the other ingredients of this medicine (listed insection 6).

– if you have certain heart rhythm or heart conduc-tion disorders (second and third degree atrioven-tricular block without a pacemaker, atrial fibrilla-tion/flutter), cardiogenic shock, uncontrolledheart failure, myocardial infarction with compli-cations, low blood pressure.

– if you are receiving treatment with dantrolene(infusion), aliskiren (a treatment for high bloodpressure), St John’s wort (a herb) or sertindole (atreatment for schizophrenia).

– in children and adolescents.

Warnings and precautionsUse this medicine with caution:– in cases of heart failure.– in the presence of certain heart rhythm and heart

conduction disorders (1st degree atrioventricularblock, slowing of the heart rate).

– in cases of liver failure.– in cases of neuromuscular diseases (myasthenia

gravis, Lambert-Eaton syndrome or advancedDuchenne muscular dystrophy).

– in elderly subjects.– in cases of impaired kidney function.

If malaise, fever, jaundice and/or pain in the rightside of the abdomen occurs, you must tell yourdoctor, who will assess whether it is necessary toperform a liver enzyme assay.

Children and adolescentsNo data are available on the use of sustained-release verapamil tablets in children and adoles-cents.

Other medicines and Vera-Denk 240 RetardTell your doctor or pharmacist if you are taking,have recently taken or might take any other medi-cines.

This medicine must not be used in combinationwith dantrolene (as an infusion), asliskiren, StJohn’s wort and sertindole (see section “Do nottake Vera-Denk 240 Retard”).

This medicine must be avoided in combinationwith beta-blockers, esmolol (in cases of impairedleft- ventricular function), colchicine, triazolam,amiodarone (with injectable verapamil), ivabra-dine, quinidine.

To avoid any interactions between several medi-cines, you should systematically tell your doctor orpharmacist about any other treatment you receive.

Pregnancy and breast-feedingIf you are pregnant or breast-feeding, think youmay be pregnant or are planning to have a baby,ask your doctor or pharmacist for advice before taking this medicine.

It is preferable not to use this medicine duringthe first and second trimesters of pregnancy. During the third trimester, this medicine should beused only on the advice of your doctor.

If you discover that you are pregnant duringtreatment, consult your doctor because he/shealone can assess the need to continue it.

Verapamil is excreted in small quantities inhuman milk. The few cases described after oraltreatment did not report any side effects in theinfant. Moreover, plasma concentrations in theinfant’s blood are practically undetectable. Conse-quently, if verapamil is specifically indicated in themother, breast-feeding is possible with regular clin-ical monitoring of the infant.

Driving and using machinesEven when used correctly, Vera-Denk 240 Retardmay alter the capacity to react in such a way thatthe ability to drive, use machines or work without

a secure foothold/handhold is impaired. Thisapplies particularly at the start of treatment, whenincreasing the dose or changing product, whenfirst starting an additional medicine and in combi-nation with alcohol.

Vera-Denk 240 Retard with food and drinkIt is advisable to avoid drinking alcohol as far aspossible while you are taking Vera-Denk 240Retard, because Vera-Denk 240 Retard increasesthe effects of alcohol.

You should not consume any food or drink con-taining grapefruit while you are taking Vera-Denk 240 Retard, because grapefruit can increasethe concentration of verapamil hydrochloride inthe blood.

Vera-Denk 240 Retard contains lactoseVera-Denk 240 Retard contains lactose (milk sugar).If you have been told by your doctor that you havean intolerance to some sugars, contact your doctorbefore taking this medicine.

3. How to take Vera-Denk 240 RetardAlways take this medicine exactly as your doctor orpharmacist has told you. Check with your doctor orpharmacist if you are not sure.

DosageVera-Denk 240 Retard must be dosed on a case-by-case basis, adjusted to the severity of the condi-tion. According to long-term clinical experience,the average dose for nearly all areas of use isbetween 240 mg and 360 mg daily.

On maintenance treatment, it is advisable not toexceed the daily dose of 480 mg; a temporaryincrease is possible.

Adults and adolescents weighing from 50 kg:Coronary heart disease (inadequate oxygenation ofthe heart muscle)240 mg–480 mg verapamil hydrochloride daily,divided into 1–2 doses,i.e. ½ –1 tablet twice daily.

Hypertension:240–480 mg verapamil hydrochloride daily, dividedinto 1–2 doses,i.e. 1 tablet once daily in the morning.If not sufficiently effective, ½ –1 additional tablet inthe evening.

Heart rhythm disorders (paroxysmal supraventricu-lar tachycardia, atrial fibrillation/atrial flutter withrapid AV conduction [except in cases of WPW syn-drome]):240–480 mg verapamil hydrochloride daily, dividedinto 2 doses,i.e. ½ –1 tablet twice daily.

Liver failureIn patients with liver failure, depending on thedegree of severity, the effect of verapamilhydrochloride is increased and prolonged becauseof slower metabolism of the medicine. This is whythe doctor must adjust the dosage with particularcare and initiate treatment with low doses (forexample, in patients with liver failure, starting with40 mg verapamil hydrochloride 2–3 times daily, i.e.80 mg–120 mg verapamil hydrochloride daily).

If Vera-Denk 240 Retard has been prescribed foryou for pain and a crushing sensation (angina pec-toris) following a heart attack (myocardial infarc-tion), you must wait 7 days after the acute cardiacepisode before starting to take the medicine.

Method of administrationOral use.Take the medicine with some liquid (for example, aglass of water; no grapefruit), at mealtimes or justafterwards, without sucking or chewing it.Do not take Vera-Denk 240 Retard when lyingdown.If you have the impression that the effect of Vera-Denk 240 Retard is too strong or too weak, talk toyour doctor.

Duration of treatmentThe duration of treatment is not limited; it will bedetermined by the doctor.

If you take more Vera-Denk 240 Retard than youshouldThe following signs and symptoms may occur afteraccidental or deliberate ingestion of a large num-ber of Vera-Denk 240 Retard tablets:severe fall in blood pressure, heart failure, arrhyth-mia (for example, slower or more rapid heartbeat,heart conduction disorders), which may lead to cardiocirculatory shock and cardiac arrest. Loss ofconsciousness as far as coma, a rise in the bloodsugar level, a fall in the concentration of potassiumin the blood, a fall in the pH of the blood (metabol-ic acidosis), a lack of oxygen supply to the tissues

(hypoxia), cardiocirculatory shock with fluid accu-mulation in the lungs (pulmonary oedema),impaired kidney function and cramp. Cases ofdeath have been reported.In such cases, a doctor/emergency doctor shouldbe contacted immediately and will initiate the necessary steps.

If you forget to take Vera-Denk 240 RetardDo not take a double dose to make up for a forgot-ten dose, but continue the treatment as prescribed.

If you stop taking Vera-Denk 240 RetardDo not interrupt or stop treatment with Vera-Denk 240 Retard without first discussing this withyour doctor.

After prolonged treatment, treatment with Vera-Denk 240 Retard must never be stopped abruptly,but always gradually.If you have any further questions on the use of thismedicine, ask your doctor or pharmacist.

4. Possible side effectsLike all medicines, this medicine can cause sideeffects, although not everybody gets them.– The following have been observed: nausea, vom-

iting, constipation that in some cases was severe,requiring treatment to be stopped.

– Low blood pressure, oedema in the lower limbs,slowing of the heart rate, symptomatic heart fail-ure, cardiogenic shock, sudden facial flushing.

– Hepatitis manifesting as jaundice and/or abdomi-nal pain, malaise, fever, or liver abnormalities evident purely from laboratory test results(increased liver enzyme levels) and reversible ondiscontinuation of the treatment.

– Rarely: gingival hyperplasia (swelling of thegums), gingivitis, reversible on discontinuation ofthe treatment.

– Headache, dizziness, tingling sensations, tremor,drowsiness.

– Skin reactions (redness, sweating), hives, itching.– Sensations of vertigo.– Muscle weakness, muscle or joint pain.– Impotence, gynaecomastia (breast development

in men), galactorrhoea (abnormal milk secretion).– Very rarely: disorders combining rigidity, tremor

and/or abnormal movements.– Rare cases of allergy with difficulty breathing.

If any of the side effects gets serious, or if younotice any side effects not listed in this leaflet,please tell your doctor or pharmacist check.

Reporting of side effectsIf you get any side effects, talk to your doctor orpharmacist. This includes any possible side effectsnot listed in this leaflet. By reporting side effectsyou can help provide more information on the safety of this medicine.

5. How to store Vera-Denk 240 Retard– Keep this medicine out of the sight and reach of

children.– Do not use this medicine after the expiry date

which is stated on the carton and blister after“EXP”. The expiry date refers to the last day ofthat month.

– Shelf life: 48 months.– Store below 25°C.– Do not throw away any medicines via wastewater

or household waste. Ask your pharmacist how tothrow away medicines you no longer use. Thesemeasures will help protect the environment.

6. Contents of the pack and other informationWhat Vera-Denk 240 Retard contains– The active substance is verapamil hydrochloride.

Each sustained-release tablet contains 240 mgverapamil hydrochloride.

– The other ingredients are: Tablet core: Sodium alginate, povidone, lactose

monohydrate, magnesium stearate, Tablet film-coating: Polyvinyl alcohol, talc,

lecithin, xanthan gum, titanium dioxide

Conditions of supplyMedicinal product subject to medical prescription

What Vera-Denk 240 Retard looks like and contents of the packWhite, oblong, film-coated tablets, scored on bothsides.Vera-Denk 240 Retard is available in the form ofPVC/PVDC/aluminium blisters.Presentation: pack of 50 sustained-release tablets

Marketing Authorisation Holder and ManufacturerDENK PHARMA GmbH & Co. KGPrinzregentenstr. 7981675 MünchenGermany

Production siteGöllstr. 184529 TittmoningGermany

4930_0914_VeraD240Ret_420x148_Denk 11.08.14 17:02 Seite 1

Page 2: Vera-Denk 240 Retardeffects not listed in this leaflet. See section 4. What is in this leaflet: 1.What Vera-Denk 240 Retard is and what it is used for 2.What you need to know before

Vera-Denk 240 RetardComprimé à libération prolongée – voie oraleInhibiteur calciqueSubstance active : vérapamil

Notice : information de l’utilisateurVeuillez lire attentivement cette notice avantde prendre ce médicament car elle contientdes informations importantes pour vous.– Gardez cette notice. Vous pourriez avoir

besoin de la relire.– Si vous avez d’autres questions, interrogez

votre médecin, ou votre pharmacien.– Ce médicament vous a été personnellement

prescrit. Ne le donnez pas à d’autres per-sonnes. Il pourrait leur être nocif, même si lessignes de leur maladie sont identiques auxvôtres.

– Si vous ressentez un quelconque effet indési-rable, parlez-en à votre médecin, ou votrepharmacien. Ceci s’applique aussi à tout effetindésirable qui ne serait pas mentionné danscette notice. Voir rubrique 4.

Que contient cette notice : 1.Qu’est-ce que Vera-Denk 240 Retard et dans

quel cas est-il utilisé2.Quelles sont les informations à connaître

avant de prendre Vera-Denk 240 Retard3.Comment prendre Vera-Denk 240 Retard4.Quels sont les effets indésirables éventuels5.Comment conserver Vera-Denk 240 Retard6.Contenu de l’emballage et autres informations

1. Qu’est-ce que Vera-Denk 240 Retardet dans quel cas est-il utilisé Vera-Denk 240 Retard est un médicament destinéau traitement des maladies cardiaques associées àune oxygénation insuffisante du muscle cardiaque,ainsi qu’au traitement de certains troubles durythme cardiaque et au traitement de l’hyperten-sion artérielle.

Vera-Denk 240 Retard est utilisé pour le :• Traitement des maladies coronariennes (oxy -

génation insuffisante du muscle cardiaque) encas de– angine de poitrine chronique stable (angor de

charge),– angine de poitrine instable (angor crescendo,

angor de repos),– angine de poitrine vasospastique (angor de

Prinzmetal, angor variant).• Traitement des troubles du rythme cardiaque en

cas de – tachycardie paroxystique supraventriculaire

(accélérations occasionnelles du rythme car-diaque partant de l’oreillette), fibrillation/flut-ter du cœur avec transition AV rapide (hors syndrome WPW, voir « Ne prenez jamais Vera-Denk 240 Retard »).

• Traitement de l’hypertension artérielle (hyper -tonie)

2. Quelles sont les informations àconnaître avant de prendre Vera-Denk240 RetardNe prenez jamais Vera-Denk 240 Retard :– si vous êtes allergique à la substance active ou à

l’un des autres composants contenus dans cemédicament mentionnés dans la rubrique 6.

– si vous avez certains troubles du rythme ou de laconduction cardiaques (blocs auriculo-ventri -culaires du second et troisième degrés non appareillés, fibrillation/flutter auriculaire), chocd’origine cardiaque, insuffisance cardiaque nonéquilibrée, infarctus du myocarde avec compli -cations, hypotension artérielle.

– en cas de traitement par dantrolène (perfusion),aliskiren (traitement de l’hypertension), mille -pertuis (plante) ou sertindole (traitement de laschizophrénie).

– chez l’enfant et l´adolescent.

Avertissements et précautionsUtiliser ce médicament avec précaution :– en cas d’insuffisance cardiaque.– en présence de certains troubles du rythme et de

la conduction cardiaques (bloc auriculoventri -culaire du 1er degré, ralentissement du rythmecardiaque).

– en cas d’insuffisance hépatique.

– en cas de maladies neuromusculaires (myasthé-nie grave, syndrome de Lambert-Eaton ou dystro-phie musculaire de Duchenne avancée).

– chez le sujet âgé.– en cas d’altération de la fonction rénale.En cas de survenue de malaise, fièvre, jaunisseet/ou douleur du ventre du côté droit, vous devezavertir votre médecin qui jugera de la nécessité defaire un dosage des enzymes hépatiques (du foie).

Enfants et adolescentsAucune donnée n’est disponible sur l’utilisation descomprimés de vérapamil à libération prolongéechez les enfants et adolescents.

Autres médicaments et Vera-Denk 240 RetardInformez votre médecin ou pharmacien si vous prenez/utilisez, avez récemment pris /utilisé oupourriez prendre/utiliser tout autre médicament.

Ce médicament ne doit pas être utilisé en asso-ciation avec le dantrolène (en perfusion), l’asliski-ren, le millepertuis et le sertindole (« voir rubrique« Ne prenez jamais Vera-Denk 240 Retard »).

Ce médicament doit être évité en associationavec les bêta-bloquants, l’esmolol (en cas d’altéra-tion de la fonction ventriculaire gauche), la colchi-cine, le triazolam, l’amiodarone (avec le vérapamilinjectable), l’ivabradine, la quinidine.

Afin d’éviter d’eventuelles interactions entre plusieurs medicaments, il faut signaler systémati-quement tout autre traitement en cours à votremédecin ou à votre pharmacien.

Grossesse et allaitementSi vous êtes enceinte ou que vous allaitez, si vouspensez être enceinte ou planifiez une grossesse,demandez conseil à votre médecin ou pharmacienavant de prendre ce médicament.

Il est préférable de ne pas utiliser ce médicamentpendant les premier et deuxième trimestres degrossesse. Au cours du troisième trimestre, cemédicament ne sera utilisé que sur les conseils devotre médecin.

Si vous découvrez que vous êtes enceinte pen-dant le traitement, consultez votre médecin car luiseul peut juger de la nécessité de le poursuivre.

Le vérapamil est faiblement excrété dans le laitmaternel. Les quelques cas décrits après un traite-ment par voie orale n’ont pas rapporté d’effetsindésirables chez l’enfant. Par ailleurs, les concen-trations plasmatiques dans le sang de l’enfant ne

sont pratiquement pas détectables. En consé-quence, en cas d’indication spécifique du vérapamilchez la mère, l’allaitement est possible avec unesurveillance clinique régulière de l’enfant.

Conduite de véhicules et utilisation de machinesMême en cas d’utilisation conforme, Vera-Denk 240Retard peut modifier les capacités de réaction demanière à compromettre l’aptitude à conduire, àutiliser des machines ou à travailler sans sécurisa-tion. Ceci est particulièrement valable au début dutraitement, en cas d’augmentation de la dose et dechangement de préparation, ou au début de l’ajoutd’un médicament complémentaire ainsi qu’en asso-ciation avec l’alcool.

Vera-Denk 240 Retard avec des aliments et boissonsIl est recommandé d’éviter autant que possible deboire de l’alcool pendant la prise de Vera-Denk 240Retard, car Vera-Denk 240 Retard renforce les effetsde l’alcool.

Vous ne devriez pas consommer d’aliment ou deboisson contenant du pamplemousse pendant laprise de Vera-Denk 240 Retard, le pamplemoussepouvant augmenter la concentration de chlorhy-drate de vérapamil dans le sang.

Vera-Denk 240 Retard contient lactoseVera-Denk 240 Retard contient du lactose (sucre dulait). Si votre médecin vous a informé d’une intolé-rance à certains sucres, contactez-le avant de pren-dre ce médicament.

3. Comment prendre Vera-Denk 240 RetardVeuillez à toujours prendre ce médicament en sui-vant exactement les indications de votre médecinou pharmacien. Vérifiez auprès de votre médecinou pharmacien en cas de doute.

PosologieVera-Denk 240 Retard doit être dosé de manièreindividuelle, adaptée au degré de gravité de lamaladie. Selon la longue expérience clinique, ladose moyenne pour pratiquement tous lesdomaines d’utilisation se situe entre 240 mg et360 mg par jour.

En traitement d’entretien, il est recommandé dene pas dépasser la dose journalière de 480 mg ;une augmentation temporaire est possible.

Adultes et adolescents à partir d’un poids corporelde 50 kg :Maladie coronarienne (oxygénation insuffisante dumuscle cardiaque)240 mg – 480 mg de vérapamil chlorhydrate parjour, répartie en 1 – 2 doses, soit ½ – 1 comprimé 2 fois par jour.

Hypertension :240 – 480 mg de vérapamil chlorhydrate par jour,répartie en 1 – 2 doses,soit 1 comprimé 1 fois par jour le matin.En cas d’efficacité insuffisante, ½ – 1 comprimé supplémentaire le soir.

Troubles du rythme cardiaque (tachycardie paro -xystique supraventriculaire, fibrillation auriculaire/flutter auriculaire à conduction A-V rapide [sauf encas de syndrome de WPW]) :240 – 480 mg de vérapamil chlorhydrate par jour,répartis en 2 doses,soit ½ – 1 comprimé 2 fois par jour.

Insuffisance hépatiqueChez les insuffisants hépatiques, en fonction dudegré de gravité, l’effet du chlorhydrate de véra -pamil est renforcé et prolongé à cause d’une métabolisation ralentie du médicament. C’est pour-quoi le médecin doit adapter la posologie avec uneprudence particulière et instaurer le traitement par de faibles doses (p. ex. chez les patients insuffi-sants hépatiques, commencer avec 2–3 fois parjour 40 mg de vérapamil chlorhydrate, soit80 mg– 120 mg de vérapamil chlorhydrate parjour).

Si Vera-Denk 240 Retard vous a été prescritcontre une douleur et sensation d’oppression(angine de poitrine) après un infarctus du myo-carde, vous devez attendre 7 jours après l’épisodecardiaque aigu avant de commencer à prendre lemédicament.

Mode d´administrationVoie orale.Absorber le médicament sans le sucer et sans lecroquer avec du liquide (par exemple, un verred’eau, pas de pamplemousse), au moment desrepas ou juste après.Ne pas prendre Vera-Denk 240 Retard en positioncouchée.

Adressez-vous à votre médecin si vous avez l’impression que l’effet de Vera-Denk 240 Retard esttrop fort ou trop faible.

Durée du traitementLa durée du traitement n’est pas limitée, elle seradéterminée par le médecin.

Si vous avez pris plus de Vera-Denk 240 Retardque vous n’auriez dûLes signes et symptômes suivants peuvent appa -raitre après la prise accidentelle ou délibérée d’unnombre trop important de comprimés Vera-Denk 240 Retard :forte chute de tension, faiblesse cardiaque, arythmies (p. ex. battements cardiaques ralentis ouaccélérés, troubles de la conduction cardiaque),pouvant entrainer un choc cardio-circulatoire etl’arrêt du cœur. Perte de conscience jusqu’au coma,élévation de la glycémie, baisse de la concentrationde potassium dans le sang, chute du pH sanguin(acidose métabolique), carence d’apport d’oxygèneaux tissus (hypoxie), choc cardio-circulatoire avec accumulation de liquide dans les poumons(œdème pulmonaire), troubles de la fonctionrénale et crampes. Des cas de décès ont été rappor-tés.Dans de tels cas, il faut immédiatement contacterun médecin/urgentiste, qui prendra les mesuresnécessaires.

Si vous oubliez de prendre Vera-Denk 240 RetardNe prenez pas de dose double pour compenser ladose que vous avez oublié de prendre, mais pour-suivez le traitement selon la prescription.

Si vous arrêtez de prendre Vera-Denk 240 RetardNe pas interrompre ou arrêter le traitement avecVera-Denk 240 Retard sans en avoir d’abord discutéavec votre médecin.

Après un traitement de plus longue durée, untraitement par Vera-Denk 240 Retard ne doit jamaisêtre arrêté brusquement, toujours de manière pro-gressive.Si vous avez d’autres questions sur l’utilisation dece médicament, demandez plus d’informations àvotre médecin ou à votre pharmacien.

4. Quels sont les effets indésirableséventuelsComme tous les médicaments, ce médicament peutprovoquer des effets indésirables, mais ils ne sur-

viennent pas systématiquement chez tout lemonde.– Ont été observés nausées, vomissements, consti-

pation quelques fois sévère imposant l’arrêt dutraitement.

– Hypotension, oedème au niveau des membresinférieurs, ralentissement du rythme cardiaque,insuffisance cardiaque symptomatique, chocd’origine cardiaque, rougeur brusque du visage.

– Hépatite se manifestant par un ictère et/ou dou-leurs abdominales, malaises, fièvre, ou anomalieshépatiques purement biologiques (augmentationdes enzymes du foie) réversible à l’arrêt du traite-ment.

– Rarement : hyperplasie gingivale (gonflement desgencives), gingivite, réversibles à l’arrêt du traite-ment.

– Maux de tête, étourdissements, sensations defourmillement, tremblements, somnolence.

– Réactions cutanées (rougeur, transpiration), urti-caire, démangeaisons.

– Sensations vertigineuses.– Faiblesse musculaire, douleurs musculaires ou

articulaires.– Impuissance, gynécomastie (développement des

seins chez l’homme), galactorrhée (écoulementanormal de lait).

– Très rarement : troubles associant une rigidité,des tremblements et/ou des mouvements anor-maux.

– Rares cas d’allergie avec gêne respiratoire.Si vous remarquez des effets indésirables non mentionnés dans cette notice, ou si certains effetsindésirables deviennent graves, veuillez en infor-mer votre médecin ou votre pharmacien.

Déclaration des effets secondairesSi vous ressentez un quelconque effet indésirable,parlez-en à votre médecin ou votre pharmacien.Ceci s’applique aussi à tout effet indésirable qui neserait pas mentionné dans cette notice. En signa-lant les effets indésirables, vous contribuez à four-nir davantage d’informations sur la sécurité dumédicament.

5. Comment conserver Vera-Denk 240 Retard – Tenir hors de la vue et de la portée des enfants.– N’utilisez pas ce médicament après la date de

péremption indiquée sur l’emballage et le blister

après « EXP ». La date de péremption fait réfé-rence au dernier jour de ce mois.

– Durée de conservation : 48 mois. – À conserver à une température inférieure à 25°C.– Ne jetez aucun médicament au tout-à-l’égout ni

avec les ordures ménagères. Demandez à votrepharmacien d’éliminer les médicaments que vousn’utilisez plus. Ces mesures contribueront à proté-ger l’environnement.

6. Contenu de l’emballage et autres informationsCe que contient Vera-Denk 240 Retard– La substance active est le vérapamil chlorhydrate.

Chaque comprimé à libération prolongéecontient 240 mg de vérapamil chlorhydrate.

– Les autres composants sont : Noyau du comprimé : Sodium alginate, povidone ,

lactose monohydraté, stéarate de magnésium, Pelliculage du comprimé : Alcool polyvinyle, talc,

lécithine, gomme xanthane, dioxyde de titane

Conditions de délivranceMédicament soumis à prescription médicale

Aspect de Vera-Denk 240 Retard et contenu de l’emballage extérieurComprimés blancs, oblongues, pelliculés, avec unerainure sur les deux faces.Vera-Denk 240 Retard est disponible sous forme deplaquettes thermoformées en PVC/PVDC/alumi-nium.Présentation : boîte de 50 comprimés à libérationprolongée

Titulaire de l’Autorisation de Mise sur le Marché et FabricantDENK PHARMA GmbH & Co. KGPrinzregentenstr. 7981675 MünchenAllemagne

Site de productionGöllstr. 184529 TittmoningAllemagne

Vers. 4930/09.2014Mat.-Nr. 20004984

Revision of text: 06.2014

4930_0914_VeraD240Ret_420x148_Denk 11.08.14 17:02 Seite 2


Recommended