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Nifed 10mg Capsules PIL 05-12_Nifed 10mg 09/05/2013 17:21 Page 1Package leaflet: Information for the userNifed 10 mg Soft CapsulesNifedipineRead all of this leaflet carefully before you start taking this medicine because it contains importantinformation 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 signsof 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 inthis leafletIn this leaflet:1. What Nifed is and what it is used for2. What you need to know before you takeNifed3. How to take Nifed4. Possible side effects5. How to store Nifed6. Contents of the pack and other information1What Nifed is and what it is usedforNifed belongs to a group of medicines called calciumantagonists.Nifed is used to treat:• High blood pressure (essential hypertension)• A certain type of chest pain called angina pectoris• Raynaud’s phenomenon (a condition in which thesupply of blood to fingers, toes, nose and ears isdecreased intermittently).If you suffer from high blood pressure, Nifed works byrelaxing blood vessels so that blood passes throughthem more easily.If you suffer from angina, Nifed works by improvingblood supply to the heart muscle which then receivesmore oxygen and as a result chest pain is prevented.Nifed does not provide immediate relief of chest painfrom angina.If you suffer from Raynaud’s phenomenon, Nifed worksby widening blood vessels and improving bloodcirculation to your fingers and toes.2What you need to know before youtake NifedDo not take Nifed if you have any of the followingconditions:• allergy to nifedipine (active substance) or to any ofthe other ingredients (for a full list of ingredients seesection 6. ‘Further information’)• allergy to calcium antagonists known asdihydropyridines (the group of medicines to whichnifedipine belongs)• insufficient blood supply to your tissues, e.g. causedby severe heart troubles (cardiogenic shock)• you are within 4 weeks of a heart attack• narrowing of the aortic heart valve (aortic stenosis)• unstable angina• are pregnant, are trying to become pregnant or arebreast-feedingWarnings and precautionsTalk to your doctor before taking Nifed:• if you have low blood pressure• if you have reduced heart function• if you have diabetes• if you have angina• if you are having magnesium sulphate injectionswhile pregnant• if you have impaired liver function• if you are on dialysisRemind your doctor if you suffer from low bloodpressure and are prescribed Nifed for your angina orRaynaud’s syndrome, since your blood pressure maybe decreased further by this treatment.If you experience chest pains within 30 – 60 minutes oftaking your first dose of Nifed, contact your doctorbefore you take the next dose. Your doctor may wish tochange your treatment.Other medicines and NifedNifed and other medicines interact with each other.It is therefore important to tell your doctor if youtake any of the following medicines:• Medicines to treat high blood pressure, e.g.beta-blockers. Nifed may enhance the effects ofthese medicines.• Diltiazem (cardiac medicine) may intensify theeffect of Nifed.• Itraconazole, ketoconazole (antifungalmedicine) may intensify the effect of Nifed.• Rifampicin (antibiotic) may reduce the effect ofNifed.• Ritonavir (antiviral medicine) may intensify theeffect of Nifed.• Carbamazepine, phenobarbitone, phenytoin(anti-epileptics) may reduce the effect of Nifed.• Valproic acid (anti-epileptic) may intensify theeffect of Nifed.• Cisapride (stomach medicine) may intensify theeffect of Nifed.• Quinupristin/dalfopristin (antibiotics) mayintensify the effect of Nifed.• Tacrolimus (immunosuppressant) Nifed mayintensify the effect of this medicine.• Digoxin (heart medicine) may intensify the effect ofthis medicine.• Quinidine (heart medicine) may intensify the effectof Nifed. Nifed may alter the effect of this medicine.• Cimetidine (stomach ulcer medicine) may intensifythe effect of Nifed.• Erythromycin (antibiotic) may intensify the effect ofNifed.• Nefazodone, fluoxetine (antidepressant) mayintensify the effect of Nifed.• Ginkgo biloba (herbal product) may intensify theeffect of Nifed.Tell your doctor or pharmacist if you are taking, haverecently taken or might take any other medicines,including medicines obtained without a prescription.Nifed with food and drinkYou can take Nifed independently of food. You shouldnot take this medicine with grapefruit juice.Pregnancy and breast-feedingIf you are pregnant or become pregnant duringtreatment, do not take Nifed unless specificallyprescribed by your doctor.If you are breast-feeding, do not take Nifed. Pleasecontact your doctor.Ask your doctor or pharmacist for advice before takingany medicine.Driving and using machinesBe careful if you drive or operate machinery if you takethis medicine. Nifed may not directly affect your abilityto drive or operate machinery. However, side effectssuch as dizziness may interfere with this ability,particularly together with alcohol.continued on the next page >>

Nifed 10mg Capsules PIL 05-12_Nifed 10mg 09/05/2013 17:21 Page 23 How to take Nifed • nose bleed• impotenceAlways take this medicine exactly as your doctor hastold you. Check with your doctor or pharmacist if youare not sure.DosageAdultsThe usual dose is one capsule every 8 hours.The maximum dose recommended is two capsules every8 hours.ChildrenNifed is not recommended for use in children andadolescents below 18 years of age, because there areonly limited data on the safety and efficacy in thispopulation.Elderly patientsLower doses of this medicine may be prescribed.Follow your doctor’s instructions.Patients with reduced liver functionFollow your doctor’s instructionsMethod of administrationSwallow the capsules whole with a glass of water; youcan take them with or without food. You should not takethis medicine with grapefruit juice. This medicine is fororal use only.If you take more Nifed than you shouldContact your doctor, an emergency department ora pharmacy if you have taken more Nifed thanrecommended in the information leaflet or more thanyour doctor has prescribed.An overdose can cause severe low blood pressure andyour heartbeats to become irregular. Also, it may leadto dizziness, confusion, low blood oxygen levels andpossibly unconsciousness.If you forget to take NifedDo not take a double dose to make up for a forgottendose. If you forget to take a dose take it as soon as youremember it and then take the next dose at the right time.564 Possible side effectsIf you stop taking NifedDo not stop taking Nifed without talking to your doctor.If you have any further questions on the use of thismedicine, ask your doctor or pharmacist.Like all medicines, this medicine can cause side effects,although not everybody gets them.• unspecific pain• chillsRare: in less than 1 in 1,000 but more than 1 in10,000 patients treated• itching•hives• rash• pins and needles• an unpleasant abnormal sensation• swollen gumsVery rare: in less than 1 in 10,000• allergic reaction that may become severe and mayresult in a life-threatening outcome• breathing problems• vomitingNot known: cannot be estimated from theavailable data• worsening of a condition known as myasthenia gravisIf you get any side effects, talk to your doctor orpharmacist. This includes any possible side effectsnot listed in this leaflet.How to store NifedKeep this medicine out of the sight and reach ofchildren.Do not use this medicine after the expiry date which isstated on the carton and blister after ‘EXP’. The expirydate refers to the last day of that month.Do not store above 25°C. Store in the original packagein order to protect from moisture and light. The capsulesshould only be removed from the blister strip when youare about to take them.Do not throw away any medicines via wastewater orhousehold waste. Ask your pharmacist how to throwaway medicines you no longer use. These measures willhelp protect the environment.Contents of the pack and otherinformationWhat Nifed contains:• The active substance is nifedipine. Each capsulecontains 10 mg of nifedipine.• The other ingredients are macrogol 400, glycerol,saccharin sodium, menthol, racemic, gelatine, redferric oxide (E172), black ferric oxide (E172), yellowferric oxide (E172) and purified water.Common: in less than 1 in 10, but more than 1 in100 patients treated• headache• inflammation of the blood vessels• constipation• feeling unwellUncommon: in less than 1 in 100, but more than 1in 1,000 patients treated• allergic reactions• other allergic reactions causing swelling of the face,lips, tongue and/or throat, which may result in alife-threatening outcome•anxiety• sleep disorders• stomach pain• nausea• dry mouth• indigestion• wind (flatulence)• transient increase in liver enzymes• reddening of the skin• muscle cramps• joint swelling• increased need to urinate• painful urination• uncontrolled shaking (tremor)• vertigo• migraine• dizziness• problems with your eye-sight (visual disturbance)• a fast heartbeat• quick and strong heartbeat (palpitations)• low blood pressure• syncope• nasal congestionWhat Nifed looks like and the contents of the packA dark brown, oblong, soft gelatine capsule with asmooth shiny surface.Your capsule comes in• Blister packs of 100 capsules and 10 capsulessample pack. Not all pack sizes may be marketed.Marketing Authorisation Holder andManufacturersMarketing Authorisation Holder:Rowex Ltd., Bantry, Co. Cork, IrelandManufacturers:Salutas Pharma GmbH, Otto-von-Guericke Allee 1,39179 Barleben, GermanyRowa Pharmaceuticals Ltd., Bantry, Co. Cork, IrelandThis leaflet was last revised in 05/2012I.M. L/21b 05-1246110695