Download Nifed 10mg Capsules PIL here - Rowex Ltd

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