GABAPENTIN STRIDES 100 MG CAPSULES HARD - patient leaflet, side effects, dosage

3. how to take gabapentin

Always take thismedicrne exacUyas your doctor or pharmacist has told you. Check withyour doctor or pharmacistifyou arenot sure.

Your doctorwill determinewhat doseis appropnate foryou.

Epilepsy, therecommended dose is

Adults and adolescents

Takethe number of capsules as instructed. Your doctor wiU usually build up your dose gradually. The starting dose will generally be between 300 mgand 900 mg each day Thereafter, the dose may beincreased as instructedby your doctor, up to amaamum of 3600 mg each dayandyour doctor will tell youto take thisin 3 separate doses, i.e. once inthe morning, once inthe afternoon and oncein the evening.

Childrenaged 6 years andabove

The dose tobe given to your child wiU be decided by your doctoras it is calculated againstyour child’s weight. The treatmentis started with a lowinitial dose which is graduallyincreased over apenod ofapproxmately 3 days. The usual dose to control epilepsy is 25–35 mgperkg per day Itis usually given in 3 separate doses, bytaking the capsule(s) each day, usually once n the morning, once inthe afternoon and once in the evening.

Gabapentin is not recommended forusein childrenbelow 6 years ofage.

Peripheral Neuropathic Pain, the recommended dose is

Ad^ … ...............

Takethe number of capsules as instructed byyour doctor Your doctor wiU usually buildup your dose gradually. The starting dose will generally bebetween 300 mgand 900 mg each day

Thereafter, the dose may beincreased as instructedby your doctorup to a maximum of 3600 mg each dayandyour doctorwill tell youto take thisin 3 separate doses, i.e. once inthe morning, once inthe afternoon and oncein the evening.

Ifyou havekidneyproblems or arereceiving haemodialysis

Your doctormayprescnbe a different dosing schedule and/or dose ifyouhave problems withyourkidneys orare undergoing haemodialysis.

Ifyouareanelder­lypatient (over 65 years ofage)

youshouldtakethe normal doseofGabapentrn unlessyouhave­problemswithy­our kidneys. Your doctormayprescnbe a different dosing scheduleand/or dose ifyouhave problems with yourkidneys.

If you have the impression that the effect of Gabapentin istoo strong or too weak, talk to your doctor or pharmacistas soonas possible.

Method of administration

Gabapentin is fOr oral use. Always swallowthe capsules withplenty ofwater

Continue taking Gabapentin until your doctortells you to stop.

Ifyou take more Gabapentintha­nyoushould

Higherthanrecom­mended doses mayresultinanin­creasein side effects including loss of consciousness, dizziness, double vision, slurred speech, drowsiness and diarrhoea. Call your doctor or go to thenearesthospital emergency unitimmediate­lyifyou take

Dimension: 130 × 600 mm more Gabapentrnthanyour doctorprescribed. Take along any capsules that you have nottaken, togetherwiththe containerand thelabel so thatthe hospital can easily tell whatmedicine you have taken.

Ifyou forgetto take Gabapentin

If you forget to take adose, take itas soonas you rememberunless itis time foryour next dose.Do nottake a double dose to make up fora forgotten dose.

If you stop taking Gabapentin

Do not stop taking Gabapentin unless your doctor teUs you to. Ifyourtreatment is stopped it should be done gradually overaminimum of 1 week. Ifyou stop taking Gabapentin suddenly orbefore your doctortells you, thereis an increasedrisk of seizures.

If youhave any further questions ontheuseofthis medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, althoughnot everybody gets them.

Contact your doctorimmedia­telyifyou experience any ofthe following symptoms aftertakingthis medicine as they canbe senous:

• – severe skinreactions that require immediate attention, swelling ofthelips and face, skinrash andredness, and/orhairloss (these maybe symptoms ofa serious allergic reaction)

• – persistent stomachpain, feeling sick andbeing sickas thesemay be symptoms of acute pancreatitis (an inflamed pancreas)

• – breathingproblems, whichif severeyou may need emergency and intensive care to continue breathing normally

• – Gabapentinmay cause a senous orlife-threatening allergic reachonthat may affect your skin or otherparts ofyourbody such as yourliver orblood cells. You may or may nothave rash whenyou getthistype ofreaction. It may cause youto be hospitalized orto stop Gabapentin. Call your doctorright away ifyouhave any of the following symptoms:

• skin rash
• hives
• fever
• swollen glands that do not go away
• swelling ofyourlip andtongue
• yellowing ofyour skin or ofthewhites ofthe eyes
• unusualbruisin­gorbleeding
• severe fatigue orweakness
• unexpectedmus­clepain
• frequent infections

These symptoms maybe thefirst signs ofa serious reaction. A doctor should examine youto decide if you should contrnuetaking Gabapentin.

• – Ifyouare onhaemodialysis, teU your doctorifyou develop musclepain and/or weakness.

Other side effects include:

Veiycommon (may affectmore than 1in10 people)

• – Viral infection

• – Feeling drowsy, dizziness, lack of coordination

• – Feeling tired, fever

Common (mayafectup tolin 10people)

• – Pneumonia, respiratoryin­fections, urmarytractin­fection, inflammation oftheear or other infections

• – LowwhitebloodceU counts

• – Anorexia, increasedappetite

• – Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty with thinking

• – Convulsions,jer­kymovements, difficulty with speaking, loss ofmemory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), difficultywith coordination, unusual eye movement, increased, decreased orabsent reflexes

• – Blurredvision, double vision

• – Vertigo

• – High blood pressure, flushing or dilation ofblood vessels

• – Difficultybre­athing, bronchitis, sore throat, cough, dry nose

• – Vomitmg(being sick), nausea(feeling sick), problems withteeth, inflamed gums, diarrhoea, stomachpain, indigestion, constipation, dry mouth orthroat, flatulence

• – Facial sweUing, bruises, rash, itch, acne

• – Jointpain,mus­clepam,backpa­in,twitchmg

• – Difficulties with erection (impotence)

• – Swellingin thelegs andarms, difficultywith walking, weakness, pain, feeling unwell,flu-like symptoms

• – Decrease inwhite blood ceUs, increase inweight

• – Accidental injury, fracture, abrasion

Additionally, in clinical studies in children, aggressivebeha­viourandjerky movements were reported commonly

Uncommon (may affect upto1in 100people)

• – Agitation(a state of chroricrestlessness and unintentional and purposeless motions)

• – Allergicreachon such as hives

• – Decreased movement

• – Racingheartbeat

• – Swellingthat mayinvolve the face, trunk andlimbs

• – Abnormal blood test results suggesting problems with theliver

• – Mental impairment

• – Fall

• – Increasein blood glucose levels (most often observed inpatients with diabetes)

• – difficulty swallowing

Rare (mayaffectup to 1 in1,000 people)

• – Decrease inblood glucose levels (most often observedin patients with diabetes)

• – Loss of consciousness

• – Troublebreathing, shallowbreaths (respiratory depression)

After marketing Gabapentin the following side effectshavebe­enreported:

• – Decreased platelets (blood clotting ceUs)

• – Hallucinations

• – Problemswith abnormal movements suchas writhmg,jerkmg movements and stiffness

• – Ringing inthe ears

• – A group ofside effects that couldinclude swollen lymph nodes (isolated small raisedlumps underthe skin), fever, rash, and inflammation ofliver occurring together

• – Yellowing ofthe skin and eyes (jaundice), inflammation ofthe liver

• – Acute kidney failure, incontinence

• – Increasedbreas­thssue, breast enlargement

• – Adverse events followingthe abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chestpain

• – Breakdownofmus­clefibres(rhab­domyolysis)

• – Changeinblood­testresults(cre­atrnephosphoki­naseincreased)

• – Problemswith sexual functioning includingmabilityto achieve a sexual climax, delayed ejaculation

• – Lowblood sodiumlevel

• – Anaphylaxis (senous, potentially life threateningaU­ergicreaction including difficultybre­athing, swelling oftheips, throat, andtongue, and hypotension requiring emergency treatment)

Reporting of side effects

If you get any side effects, talkto your doctor orpharmacist. This includes any possible side effects notlistedinthis leaflet. You can also report side effects directly via Yellow Card Schemeat: wwwmhra.gov.uk/y­eUowcard or search forMHRA Yellow Card inthe GooglePlay or Apple App Store.

By reporting side effects you canhelp providemorein­formation onthe safety ofthis medicine.

5. how to store gabapentin

Keep thismedicine out ofthe sightand reachof children.

Do not use this medicineafterthe expiry date which is stated on the carton andthe bottle. The expiry date refers to the last day ofthatmonth.

This medicinal product does notrequireany special storage conditions.

Do not throwaway anymedicines via wastewater or household waste. Ask your pharmacist howto throwaway medicines youno longeruse. These measureswill help protectthe environment.

• 6. Contents ofthepack and other information