Document: Amlodipin Accord tablet ENG PL change

• Amlodipin Accord tablet PL
• Amlodipin Accord tablet ENG PL

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Children and adolescents

Amlodipin Accord hasnotbeenstudiedinchildrenundertheageof6years.Amlodipin Accord shouldonlybe usedfor hypertensioninchildrenandadolescentsfrom6yearsto17yearsofage(seesection3).

Formoreinformation,talktoyourdoctor.

Othermedicines and Amlodipin Accord

Tellyourdoctororpharmacistifyouaretaking, haverecentlytaken or might takeanyothermedicines..

Amlodipin Accord mayaffectorbeaffectedby othermedicines,suchas:

• ketoconazole, itraconazole (anti-fungal medicines)

• ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)

• rifampicin, erythromycin, clarithromycin (antibiotics)

• hypericum perforatum (St. John’s Wort)

• verapamil, diltiazem (heart medicines)

• dantrolene (infusion for severe body temperature abnormalities)

• tacrolimus (medicine used to alter the way your immune system works)

• simvastatin (cholesterol lowering medicine)

• cyclosporine (an immunosuppressant)

Amlodipin Accord mayloweryourbloodpressureevenmoreifyouarealreadytakingothermedicinestotreat yourhighbloodpressure.

Amlodipin Accord withfoodanddrink

GrapefruitjuiceandgrapefruitshouldnotbeconsumedbypeoplewhoaretakingAmlodipin Accord.Thisis becausegrapefruitandgrapefruitjuicecanleadtoanincreaseinthebloodlevelsoftheactive ingredientamlodipine,whichcancauseanunpredictableincreaseinthebloodpressureloweringeffect of Amlodipin Accord.

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.

Pregnancy

The safety of amlodipine in human pregnancy has not been established.

Breast-feeding

Itisnotknownwhetheramlodipineispassedintobreastmilk.

Drivingandusingmachines

Amlodipin Accord mayaffectyourabilitytodriveorusemachines.Ifthetabletsmakeyoufeelsick, dizzyortired,orgiveyouaheadache,donotdriveorusemachinesandcontactyourdoctor immediately.

3. HowtotakeAmlodipin Accord

Alwaystakethis medicineexactlyasyourdoctor or pharmacisthastoldyou.Checkwithyourdoctoror phamacistifyouarenotsure.

Therecommended initial doseis5 mgoncedaily.Thedosecanbeincreasedto10mgonce daily.

Thismedicinecanbeusedbeforeorafterfoodanddrinks.Youshouldtake thismedicineat thesame timeeachdaywithadrinkofwater.DonottakeAmlodipin Accord withgrapefruitjuice.

Use in children and adolescents

Forchildrenandadolescents(6-17yearsold),therecommendedusualstartingdoseis2.5mgaday. Themaximumrecommendeddoseis5mgaday.Amlodipine2.5mgisnotcurrentlyavailableandthe

2.5mgdosecannotbeobtainedwithAmlodipin Accord 5mgtabletsasthesetabletsarenotmanufacturedto breakintotwoequalhalves.

Itisimportanttokeeptakingthetablets.Donotwaituntilyourtabletsarefinished beforeseeingyourdoctor.

IfyoutakemoreAmlodipin Accord thanyoushould

Takingtoomanytabletsmaycauseyourbloodpressuretobecomeloworevendangerouslylow.You mayfeeldizzy,lightheaded,faintorweak.Ifbloodpressuredropissevereenoughshockcanoccur.

Yourskincouldfeelcoolandclammyandyoucouldloseconsciousness.Seekimmediatemedical attentionifyoutaketoomanyAmlodipin Accord.

IfyouforgettotakeAmlodipin Accord

Donotworry.Ifyouforgettotakeatablet, leaveoutthatdosecompletely.Takeyournext doseattherighttime.Donottakeadoubledosetomakeupforaforgottendose.

IfyoustoptakingAmlodipin Accord

Yourdoctorwilladviseyouhowlongtotakethismedicine.Yourconditionmayreturnifyoustop usingthismedicinebeforeyouareadvised.

Ifyouhaveanyfurtherquestionsontheuseofthismedicine,askyourdoctororpharmacist.

4. Possiblesideeffects

Likeall medicines,this medicinecancausesideeffects,althoughnoteverybodygetsthem.

Visityourdoctorimmediatelyifyouexperienceanyofthefollowingsideeffects aftertakingthismedicine.

• Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing

• _{Swelling of eyelids, face or lips}

• _{Swelling of the tongue and throat which causes great difficulty breathing}

• Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions

• Heart attack, abnormal heart beat

• Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell

Thefollowing verycommonside-effecthasbeenreported.If this causes you problems or if it

lasts for more than one week, you should contact your doctor.

Very common: may affect more than 1 in 10 people

• Ankle swelling (oedema)

Thefollowingcommon side effects have been reported.Ifanyofthesecauseyouproblemsorifthey

lastformorethanoneweek,youshouldcontactyourdoctor.

Common:may affect up to 1 in 10 people

• Headache, dizziness, sleepiness (especially at the beginning of treatment)

• _{Palpitations (awareness of your heart beat), flushing}

• _{Abdominal pain, feeling sick (nausea)}

• Altered bowel habits, diarrhoea, constipation, indigestion,

• Tiredness, weakness

• Visual disturbances, double vision

• Muscle cramps

Otherside-effectsthathavebeenreportedincludethefollowinglist.Ifanyofthesegetserious,orif younoticeanyside-effectsnotlistedinthisleaflet,pleasetellyourdoctororpharmacist.

Uncommon:may affect up to 1 in 100 people

• Mood changes, anxiety, depression, sleeplessness

• _{Trembling, taste abnormalities, fainting}

• _{Numbness or tingling sensation in your limbs; loss of pain sensation}

• _{Ringing in the ears}

• _{Low blood pressure}

• _{Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)}

• _Cough

• _{Dry mouth, vomiting (being sick)}

• _{Hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration}

• Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine

• _{Inability to obtain an erection; discomfort or enlargement of the breasts in men}

• _{Pain, feeling unwell}

• _{Joint or muscle painback pain}

• _{Weight increase or decrease}

Rare:may affect up to 1 in 1,000 people

Veryrare:may affect up to 1 in 10,000 people

• Decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage)

• Excess sugar in blood (hyperglycaemia)

• _{A disorder of the nerves which can cause weakness, tingling or numbness}

• _{Swelling of the gums}

• _{Abdominal bloating (gastritis)}

• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests

• Increased muscle tension

• _{Inflammation of blood vessels, often with skin rash}

• _{Sensitivity to light}

• Disorders combining rigidity, tremor, and/or movement disorders

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. HowtostoreAmlodipin Accord

Keep this medicine out of the sight and reach of children.

Donotusethis medicine after theexpirydatewhichisstatedonthecarton and blisterafter“EXP”.Theexpiry datereferstothelastdayofthatmonth.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines viawastewaterorhouseholdwaste.Askyourpharmacisthowto throw awaymedicines younolongeruse.Thesemeasureswillhelpprotecttheenvironment.

6. Contents of the pack and other information

WhatAmlodipin Accord contains

Amlodipin Accord 5 mg tablets:

The active substance is amlodipine. Each tablet contains 5 mg amlodipine (as besilate).

Theotheringredientsare: microcrystallinecellulose,sodiumstarchglycolate, magnesium stearate, disodium hydrogen citrate, crospovidone, croscarmellose sodium.

Amlodipin Accord 10 mg tablets:

The active substance is amlodipine. Each tablet contains 10 mg amlodipine (as besilate).

The other ingredients are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, disodium hydrogen citrate, crospovidone, croscarmellose sodium.

WhatAmlodipin Accord lookslikeandcontentsofthepack

Amlodipin Accord 5mgtablets:

White, approximately 6.6 mm round, biconvextablets.

Amlodipin Accord 10mgtablets:

White, approximately 8.5 mm round, biconvextablets

Pack sizes

blister packs:

5mg: 10, 14, 20, 28, 30, 50, 60, 90, 98 and 100 tablets

10mg: 10, 14, 20, 28, 30, 50, 60, 90, 98 and 100 tablets

Notallpacksizesmaybemarketed.

MarketingAuthorisationHolderand Manufacturer

Tobecompletednationally

ThismedicinalproductisauthorisedintheMemberStatesoftheEEAunderthefollowing names:

Name of the Member State	Name of the medicinal product
Austria	Amlodipin Accord 5/10 mg Tabletten
Belegium	Amlodipine Accord Healthcare 5/10 mg Comprimés/ Tabletten
Czech Republic	Amlodipin Accord 5/10 mg Tablety
Germany	Amlodipin Accord 5/10 mg Tabletten
Denmark	Amlodipin Accord 5/10 mg Tabletter
Estonia	Amlodipine Accord 5/10 mg
Greece	Amlodipine Accord 5/10 mg δισκία
Italy	AMLODIPINA ACCORD 5 /10 MG COMPRESSE
Lithuania	Amlodipine Accord 5/10 mg tabletės
Latvia	Amlodipine Accord 5/10 mg tablets
Netherlands (The)	Amlodipine (als besilaat) Accord 5/10 mg tabletten
Poland	Amlodipine Accord
Portugal	Amlodipina Accord
Romania	Amlodipina Accord 5/10 mg comprimate
Sweden	Amlodipin Accord 5/10 mg tabletter

Thisleafletwaslastrevisedin

2016-05-11