GABAPENTIN STRIDES 800 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take gabapentin

Do nottake Gabapentin

• – if you aie alleigic fhypeisensitive) to gabapentin oi any of the othei ingredients of thismedicine flistedin section 6).

Warnings and precautions

Talkto youi doctoi oi phaimacistbefoie taking Gabapentin:

• – if you suffeifiom kidneypioblemsyoui doctoi maypiescnbe a different dosing

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• – if you aie onhaemodialysisfto remove waste pioducts because ofkidneyfailuie), tell youi doctoi if you develop muscle pain and/oi weakness

• – if you develop signs such as peisistent stomachpam, feeling sick andbeing sick contactyoui doctoi immediately asthesemaybe symptomsof acute pancreatitis faninfl amedpancieas)

• – if you have neivous system disoideis, iespiiatoiy disoideis, oi you aiemoie than 63 yeais old, youi doctoi maypiesciibe you a different dosingiegimen

Casesof abuse and dependence have beeniepoitedfoi gabapentin fiom thepost-maiketing expenence. Talk to youi doctoi if youhave a hstoiy of abuse oi dependence. A small numbei ofpeople beingtieatedwith anti-epileptics such as gabapentinhave hadthoughts ofhaiming oi kiUingthemselves. If at anytime youhave these thoughts, immediately contactyoui doctoi.

Important information aboutpotentially serious reactions

A. small numbei ofpeople takingGabapentin get an alleigic reaction oi potentially senous skinieachon, whichmay develop into moie senous pioblemsif they aie nottieated Youneedtoknowthe symptomstolook outfoi whil eyouaietaking Gabapentin

Read the description ofthese symptomsin section 4 ofthisleaflet under ‘Contact youi doctoi immediatelyf you expeiience any of the following symptoms aflei taking thismedicine asthey canbe seiious’

Muscle weakness, tenderness oi pain and paiticulaily, if atthe same time, youfeel unweU oi have ahi^tempeiatuie itmaybe causedby an abnoimal muscle breakdown whichcanbe lfe-thieateningan­dleadtokidney­pioblems.Youma­yalso expeiience discoloiation of youi uiine, and a change inbloodtestiesults fnotablyblood creatine phosphokinase increased) If you expenence any of these signs oi symptoms, please contactyoui doctoiimmediately.

Other medicinesand Gabapentin

Tell youi doctoi oi phaimacistif you aie taking have recently taken oi might take any othei medicines. Inpaiticulai, teU youi doctoi foi phaimacist) ifyou aie taking oi have beeniecentlytaking anymedicinesfoi convulsions, sleeping disoideis, depression anxiety, oi any othei neuiological oi psychiatric pioblems.

Medicines containing opioidssuch as morphine

If you aie taking anymedicmes containing opioids fsuch as moiphinie;, please tell youi doctoi oi phaimacistas opioidsmayinci­easethe effectofGabape­nUn.Inaddition, combination ofGabapentinwit­hopioidsmaycau­se symptomslike sleepiness and/oi deciease in breathing

Antacids lor indigestion

If Gabapentin and antacids containing aluminium andmagnesium aie taken at the same time, absoiptionofGa­bapentinfiom the stomachmaybeieduced Itistheiefoie iecommendedthat Gabapentinistaken atthe eailiesttwo houis aftei taking an antacid.

Gabapentin

• – is not expectedto inteiactwith othei antiepileptic diugs oi the oial contiaceptive pill. – mayinteifeie with some laboiatoiytests, if youiequiie aunne testtell youi doctoi oi hospital what you aie taking

Gabapentinwith food

Gabapentin canbe taken with oi withoutfood

Pregnancy,breast-feeding and fertility

• – If you aie pregnant oi think youmaybe pregnant, youmust tell youi doctoi straight away and discuss possibleiisksthe medicine you aie takingmightpose to youi unboin baby.

• – If you aie planningto become piegnantyou should discussyouitre­atment withyoui doctoi as eaily aspossible before youbecome pregnant.

• – Y ou shouldnotstop youi treatmentwithou­tdiscussingthis­with youi doctoi Pregnancy

Gabapentin shouldnot be taken duiingpie^ancy, unlessyou aie told otheiwise by youi doctoi. Effective contraceptionmust be usedbywomenof chld-beanngpotenUal. There have beenveiyfew studies specificallylooking atthe use of gabapentinin piesnantwomen Moieieseaichis­neededto bettei undeistandthe safetyof use of gabapentin duiingpiegnancy andwhethei itis associatedwith anincieasediisk of haim to the unborn child. Some medicines usedto tieat epilepsy have reported an incieasednsk ofhaim to the developing baby, paiUculailywhenmoie than one seizure medicationis taken atthe same time. This meansthatwheie possible, youi doctoi should considei using one epilepsy medicine to control youi epilepsy.

Contactyoui doctoiimmediatelyif youbecome pregnant, think youmightbe pregnant oiaie planningto become pregnant while takingGabapentin. Do not suddenly discontinue takingthis medicine asthismayleadto abieakthiough seizure, which couldhave senous consequencesfoi you andyouibaby

Breast-feeding

Gabapentin, the active substance ofGabapentinta­bletiispassedon­thioughhuman milk. Because the effect onthe babyisunknown, itisnotiecommen­dedto bieast-feed while usingGabapentin

Fertility

There is no effect onfeitilityin animal studies.

Driving and using machines

Gabapentinmay­pioduce dizziness, diowsiness andtiiedness. Youshouldnot diive, opeiate complex machineiy oitakepaitin othei potentiallyha­zaidous activities until youknow whethei thismedication affects youi abilityto peifoim these activities.

2. How to take Gabapentin

Always take thismedicine exactly as youi doctoi oi phaimacisthas toldyou. Check withyoui doctoi oi phaimacistif you aie not suie.

Youi doctoi will deteimine what dose is appiopiiate foi you.

Epilepsy, the recommended doseis

Adults and adolescents

Takethe numbei of tablets as instructed. Youi doctoi wiU usuallybuildup youi dose gradually The staiting dose will geneiallybe between300 mg and900 mg each day. Thereafter the dosemaybe increased as instructedbyyoui doctoi up to amaximum of 3600 mg each day andyoui doctoiwill tell youto takethisin3 sepaiate doses,i.e. once inthe moining once inthe afternoon and once inthe evening.

Children aged 6 years and above

The dose to be gvento youi child will be decidedbyyoui doctoi asitiscalculated againstyoui child'sweight The treatment is staitedwith a low initial dose whichis gaduallyincieased ovei apenodof appioximately 3 days. The usual doseto contiol epilepsyis 23–33 mgpeikg pei day. Itisusually given in3 sepaiate doses, by taking the tablet's) each day, usually once inthe morning once inthe afternoon and once in the evening.

Gabapentin isnot recommended for use inchildrenbelow 6 years ofage.

Peripheral Neuropathic Pain, the recommended doseis

Adults

Takethe numbei of tablets as instructedby youi doctoi. Y oui doctoi will usually build upj youi dose giadually. The staiting dose will geneiallybe between300 mg and 900 mig each day.

Theieaftei, the dosemaybe increased as instructedbyyoui doctoiup to amaximum of 3600 mg each day andyoui doctoiwill tell youto takethisin3 sepaiate doses,i.e. once inthe moining once inthe afternoon and once inthe evening.

Ifyou have kidneyproblemsorare receiving haemodialysis

Youi doctoi maypiescnbe a different dosing schedule and/oi dose if youhave pioblems withyoui kidneys oiaie undeigoing haemodialysis.

Ifyou are an elderlypatient (over 65 yearsofage)

youshouldtakethe noimal dose ofGabapentmun­lessyouhavepi­oblemswithyou­i kidneys. Youi doctoi maypiescnbe a different dosing schedule and/oi dose if youhave pioblems withyoui kidneys.

Ifyouhavethe impiessionthatthe effectofGabapen­tinistoo strongoitoowe­ak,talk to youi doctoi oi phaimacist as soon as possible.

Method ofadministration

Gabapentmisfoi oial use. Always swaUowthe tablets withplenty of water

The tablet canbe dividedinto equal halves.

Continue takingGabapen­ttnuntil youi doctoi teUs youto stop.

Ifyou take more Gabapentin than you should

Highei thaniecommended dosesmayiesultin aninciease in side effectsincludin­gloss of consciousness, dizziness, double vision, sluned speech, diowsiness and diaiihoea. Call youi doctoi oi go to the neaiesthospital emeigencyunitim­mediatelyifyou­take moie Gabapentinthanyoui doctoi piesciibed. Take along anytablets thatyouhave not taken, togethei withthe containei andthe label so thatthe hospital can easilytell what medicine youhave taken

Ifyou forgetto take Gabapentin

If youfoiget to take a dose, takeitas soon asyouiemembei­unlessitis time foi youi next dose. Do nottake a double dose tomakeupfoi afoigotten dose.

Ifyou stop taking Gabapentin

Do not stop takingGabapen­tinunless youi doctoitellsyouto. If youi treatmentis stoppedit shouldbe done giadually ovei aminimum of 1 week. Ifyou stop taking Gabapentin suddenly oi before youi doctoi tellsyou there is anincieasednsk of seizures.

If youhave anyfuithei questions onthe use of this medicine, ask youi doctoi oi phaimacist;

4. possible side effects

Likeall medicines, thismedicine can cause side effects, althoughnot eveiybody gets them.

Contactyoui doctoi immediatelyifyou expeiience any of the following symptoms aftei takingthismedicine asthey canbe seiious:

• – severe skinieactions thatiequiie immediate attention, swelling ofthe lips andface, skiniash andiedness, and/oihaii loss fthese maybe symptoms of a seiious alleigic reaction)

• – peisistent stomachpain, feeling sick andbeing sick asthese maybe symptoms of acute panaeatitisfa­ninflamedpanci­eas)

• – breathing pioblems, whichif severe youmayneed emeigency and intensive caieto continue breathing noimally

• – Gabapentinmay cause a senous oi Ufe-thieatening alleigic ieactionthatmay affect youi skin oi othei paits of youi body such asyouilivei oi blood cells. Youmay oi maynothave iashwhenyou getthistype ofieaction. Itmay cause youto be hospitalized oi to stop Gabapentin. Call youi doctoi nght awayif youhave any of the following symptoms: skiniash hives fevei
• swollen glands that do not go away
• swelling of youi Up and tongue
• yellowing of youi skin oiofthe whites of the eyes
• unusual biuising oibleeding
• severe fatigue oi weakness
• unexpectedmuscle pain
• fiequentinfections

These symptomsmaybe thefiist signs of a senousieaction. A doctoi should examine youto decide if you should continue takingGabapentin.

• – If you aie onhaemodialysis, tell youi doctoi if you develop muscle pain and/oi weakness.

Othei side effects include:

Very common (may affectmore than 1 in 10people)

• – viial infection

• – feeling diowsy, dizziness, lack of coordination

• – feelinghied, fevei

Common (may affect uptolin 10peopk)

• – pneumonia, iespiiatoiyin­fections, unnaytract infection, inflammation ofthe eaioi othei infections

• – low white blood cell counts

• – anorexia, increased appetite

• – angei towaids otheis, confusion, mood changes, depression, anxiety neivousness, difficulty with thinking

• – convulsions,je­ikymovements, difficultywith speaking loss of memoiy tiemoi, difficulty sleeping headache, sensitive skin, decieased sensation fnumbness), difficultywith coordination unusual eye movement, increased, decieased oi absent reflexes

• – bluiiedvision double vision

• – veitigo

• – highbloodpiessuie, flushing oi dilation ofbloodvessels

• – difficulty breathing bionchitis, soie thioat, cough diynose

• – vomitingfbeing sick), nausea ffeekng sick), pioblemswithteeth, inflamed gums, dianhoea, stomach pain, indigestion, constipation, diymouth oi thioat, flatulence

• – facial swelling biuises, iash, itch, acne

• – jointpain, muscle pain, back pain, twitching

• – difficulties with erection fimpotence)

• – swellinginthe legs and aims, difficulty withwalking weakness, pain, feeling unweU, flu-like symptoms

• – deciease in white blood cells, inciease in weight

• – accidental injuiy fiactuie, abiasion

Additionallyin cknical studiesin childien, aggressive behavioui andjeiky movements weie reported commonly.

Uncommon(may affect up to 1 in lOOpeopk)

• – agitationfa state of chionic restlessness andunintentional and puiposeless motions)

• – alleigic reaction such as hives

• – decieasedmovement

• – iacingheaitbeat

• – swellingthatma­yinvolve the face, trunk andlimbs

• – abnoimal blood test results suggestingpio­blemswiththe li­vei

• – mentalimpaiiment

• – fall

• – inciease in blood fucose levels fmost often obseivedinpati­entswith diabetes)

• – difficulty swallowing

Rare (may affect upto1in 1,000people)

• – deciease inblood glucose levels fmost often obseivedin patients with diabetes) – lossof consciousness

• – trouble breathing shallow breaths fiespiiatoiy depression)

After marketing Gabapentin the following side effects havebeen reported:

• – decieasedplatelets fblood clotting ceUs)

• – hallucinations

• – pioblems with abnoimal movements such as wnthingjeikin­gmovements and stiffness

• – iingingintheeais

• – a goup; of side effectsthat couldinclude swoUenlymphnodes fisolated small iaised lumps undei the skin), fevei, iash, and inflammation oflivei occuinngtogethei

• – yellowing of the skin and eyesfjaundice), inflammation of the livei

• – acute kidneyfailuie, incontinence

• – increased bieasttissue, bieast enlaigement

• – adveise eventsfoUowingthe abiupt discontinuation of gabapentin fanxiety, difficulty sleeping feeling sick,pain, sweating), chest pain

• – breakdown of muscle fibies fihabdomyolysis)

• – change inbloodtestiesults fcieatine phosphokinase increased)

• – pioblems with sexual functioningin­cludinginabili­tyto achieve a sexual climax, delayed ejaculation

• – low blood sodium level

• – anaphylaxis fsenous, potentiaUylife threatening alleigc reaction including difficulty breathing swelkng ofthe lips, thioat; andtongue, anidhypotension iequinng emeigency treatment)

Reporting ofside effects

If you get any side effects, talk to youi doctoi oi phaimacist. This includes anypossible side effects not listedinthisle­aflet. Youcan also iepoit side effects diiectlyviathe YellowCaid Scheme at: oi seaichfoi MHRA YeUow Caidinthe Goo^ePlay oi Apple App Stoie.By iepoiting side effectsyou can help piovidemoie infoimation onthe safety of this medicine.

5. how to store gabapentin

Keep this medicine out of the sight andieach of childien.

Do notuse this medicine afteithe expiiy date whichis stated on the caiton andthe bottle. The expiiy date iefeisto the last day of thatmonth.

Stoiebelow30°C. Piotectfiom light.

Do notthiow away anymedicines via wastewatei oi household waste. Ask youi phamacisthow to thiow awaymedicinesyouno longei use. These measuieswill help piotectthe enviionment.

• 6. Contentsof­thepackandother information

What Gabapentin contains

• – The active substance is gabapentin. Eachfilm-coatedtablet contains eithei 600 mg oi800 mg gabapentin.

• – The othei ingredients in Gabapentmfilm-coatedtablet aie:

maize staich, mannitol fE421), ciospovidorie, copovidone, talc fE333b), magnesium steaiate fE372), silica, coUoidal anhydious.

Film coating: Opadiywhite YS-1–18111 fconsistsof,tal­cfE333b), hydioxypiopyl­cellulose fE463)).

What Gabapentin lookslike and contents ofthe pack

The 600 mgtablets aie white to off white coloured film coated, elkptical shaped, lip bieak Une onboth sides, debossedwith“S” and“l” sepaiatedbylip bieak line on one side. Tablet size is 17.30 × 9.00 mm.

The800 mgtablets aie white to off white coloured film coated, elliptical shaped, lip ■

bieak line onboth sides, debossedwith“S” and“2’’ sepaiatedbylip bieak line on one side. Tablet size is 19.00 × 9.90 mm.

Packedinawhite opaque, iound cylindncal high-densitypolyethylene fHDPE) bottle, capped eithei with one ofthe below polypiopylene fPP) closure cap alongwithSilica gel bag

• – white polypiopylene fPP), childiesistantfCR) closure ffoiupto 100’s pack sizes),

• – white polypiopylene fPP), continuous thieadfCT) screw cap ffoi 200’s and300’s I