GABAPENTIN WOCKHARDT 300 MG HARD CAPSULES - patient leaflet, side effects, dosage

2. what you need to know before you take gabapentin capsules

Do not take Gabapentin Capsules

• if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Gabapentin Capsules

• if you suffer from kidney problems your doctor may prescribe a different dosing schedule
• if you are on haemodialysis (to remove waste products because of kidney failure), tell your doctor if you develop muscle pain and/or weakness
• if you develop signs such as persistent stomach pain, feeling sick and being sick contact your doctor immediately as these may be symptoms of acute pancreatitis (an inflamed pancreas)
• if you have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen.

Cases of abuse and dependence have been reported for gabapentin from the post-marketing experience. Talk to your doctor if you have a history of abuse or dependence.

A small number of people being treated with anti-epileptics such as gabapentin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor Important information about potentially serious reactions

A small number of people taking Gabapentin Capsules get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. You need to know these symptoms to look out for while you are taking Gabapentin Capsules.

Read the description of these symptoms in section 4 of this leaflet under Contactyour doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious' Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems. You may also experience discoloration of your urine, and a change in blood test results (notably blood creatine phosphokinase increased). Ifyou experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentin Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor (or pharmacist) if you are taking or have been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems. Medicines containing opioids such as morphine If you are taking any medicines containing opioids (such as morphine), please tell your doctor or pharmacist as opioids may increase the effect of Gabapentin Capsules. In addition, combination of Gabapentin with opioids may cause symptoms like sleepiness, sedation, decrease in breathing, or death. Antacids for indigestion

If Gabapentin Capsules and antacids containing aluminium and magnesium are taken at the same time, absorption ofGabapentin Capsules from the stomach may be reduced. It is therefore recommended that Gabapentin Capsules are taken at the earliest two hours after taking an antacid.

Gabapentin

• is not expected to interact with other antiepileptic drugs or the oral contraceptive pill.
• may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital what you are taking.

Gabapentin Capsules with food

Gabapentin Capsules can be taken with or without food.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast-feeding, think you may be pregnant, you must tell your doctor straight away and discuss possible risks the medicine you are taking might pose to your unborn baby
• If you are planning to become pregnant you should discuss your treatment with your doctor or pharmacist as early as possible before you become pregnant
• You should not stop your treatment without discussing this with your doctor.

Pregnancy

Gabapentin Capsules should not be taken during pregnancy, unless you are told otherwise by your doctor. Effective contraception must be used" by women of child-bearing potential.

There have been very few studies specifically looking at the use of gabapentin in pregnant women. More research is needed to better understand the safety of use of gabapentin during pregnancy and whether it is associated with an increased risk of harm to the unborn child.

Some medicines used to treat epilepsy have reported an increased risk of harm to the developing baby, particularly when more than one seizure medication is taken at the same time. This means that where possible, your doctor should consider using one epilepsy medicine to control your epilepsy. Breast-feeding

Gabapentin, the active substance of Gabapentin Capsules, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed your baby while using Gabapentin Capsules.

Fertility

There is no effect on fertility in animal studies.

Driving and using machines

Gabapentin Capsules may produce dizziness, drowsiness and tiredness. You should not drive, operate complex machinery or take part in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.

Gabapentin Capsules contain lactose.

Gabapentin Capsules contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars. Contact your doctor before taking this medicinal product.

Gabapentin Capsules contain sodium.

This medicine contains less than 1mmol sodium (23mg) per 100mg, 300mg and 400mg hard capsules, that is to say essentially ‘sodium-free’.

3. how to take gabapentin capsules

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will determine what dose is appropriate for you.

Epilepsy, the recommended dose is

Adults and adolescents

Take the number of capsules as instructed. Your doctor will usually build up your dose gradually. The starting dose will generally be between 300 mg and 900 mg each day. Thereafter, the dose may be increased as instructed by your doctor, up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 separate doses, i.e. once in the morning, once in the afternoon and once in the evening.

Children aged 6 years and above

The dose to be given to your child will be decided by your doctor as it is calculated against your child’s weight. The treatment is started with a low initial dose which is gradually increased over a period of approximately 3 days. The usual dose to control epilepsy is 25–35 mg per kg per day. It is usually given in 3 separate doses, by taking the capsule(s) each day, usually once in the morning, once in the afternoon and once in the evening.

Gabapentin Capsules is not recommended for use in children below 6 years of age.

Peripheral Neuropathic Pain, the recommended dose is

Adults

Take the number of capsules as instructed by your doctor. Your doctor will usually build up your dose gradually. The starting dose will generally be between 300 mg and 900 mg each day. Thereafter, the dose may be increased as instructed by your doctor up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 separate doses, i.e. once in the morning, once in the afternoon and once in the evening.

If you have kidney problems or are receiving haemodialysis

Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys or are undergoing haemodialysis.

If you are an elderly patient (over 65 years of age) You should take the normal dose of Gabapentin Capsules unless you have problems with your kidneys. Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.

If you have the impression that the effect of Gabapentin Capsules is too strong or too weak, talk to your doctor or pharmacist as soon as possible

Method of administration

Gabapentin Capsules is for oral use. Always swallow the capsules with plenty of water.

Continue taking Gabapentin Capsules until your doctor tells you to stop.

If you take more Gabapentin Capsules than you ______should

Higher than recommended doses may result in an

• ■ increase in side effects including loss of ^-*-5 consciousness, dizziness, double vision, slurred speech, drowsiness and diarrhoea. Call your doctor – — or go to the nearest hospital emergency unit

immediately if you take more Gabapentin Capsules than your doctor prescribed. Take along any capsules that you have not taken, together with the container andthe label so that the hospital can easily tell what medicine you have taken.

If you forget to take Gabapentin Capsules

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gabapentin Capsules

Do not stop taking Gabapentin Capsules unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1 week. If you stop taking Gabapentin Capsules suddenly or before your doctor tells you, there is an increased risk of seizures.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:

• Breathing problems, such as trouble breathing or shallow breaths (respiratory depression) which if severe you may need emergency and intensive care to continue breathing normally.
• severe skin reactions that require immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these may be symptoms of a serious allergic reaction)
• persistent stomach pain, feeling sick and being sick as these may be symptoms of acute pancreatitis (an inflamed pancreas)
• A group of side effects that could include swollen lymph nodes (isolated small raised lumps under the skin), fever, rash, and inflammation of liver occurring together (hypersensitivity syndrome).
• Anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)
• Gabapentin Capsules may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have rash when you get this type of reaction. It may cause you to be hospitalized or to stop Gabapentin Capsules. Call your doctor right away if you have any of the following symptoms:
• skin rash
• hives
• fever
• swollen glands that do not go away
• swelling of your lip and tongue
• yellowing of your skin or of the whites of the eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections

Additionally, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents; seek medical advice should signs of suicidal ideation or behaviour emerge.

These symptoms may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin Capsules.

• If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness.

Other side effects include:

Very common: (may affect more than 1 in 10 people)

• Feeling drowsy, dizziness, lack of coordination
• Viral infection
• Feeling tired, fever.

Common: (may affect up to 1 in 10 people)

• Pneumonia, respiratory infection, urinary tract infection, infection, inflammation of the ear or other infections
• Low white blood cell counts
• Anorexia, increased appetite
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty with thinking
• Convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), difficulty with coordination, unusual eye movement, increased, decreased or absent reflexes
• Blurred vision, double vision
• Vertigo
• High blood pressure, flushing or dilation of blood vessels
• Difficulty breathing, bronchitis, sore throat, cough, dry nose
• Vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Facial swelling, bruises, rash, itch, acne
• Joint pain, muscle pain, back pain, twitching
• Difficulties with erection (impotence)
• Swelling in the legs and arms, difficulty with walking, weakness, pain, feeling unwell, flu-like

symptoms

• Decrease in white blood cells, increase in weight
• Accidental injury, fracture, abrasion.

Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly.

Uncommon: (may affect up to 1 in 100 people)

• Agitation (a state of chronic restlessness and unintentional and purposeless motions)
• Allergic reaction such as hives
• Decreased movement
• Racing heartbeat
• Difficulty swallowing
• Swelling that may involve the face, trunk and limbs
• Abnormal blood test results suggesting problems with the liver
• Mental impairment
• Fall
• Increase in blood glucose levels (most often observed in patients with diabetes)

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

• Loss of consciousness
• Decrease in blood glucose levels (most often observed in patients with diabetes)
• Trouble breathing, shallow breaths (respiratory depression)

After marketing Gabapentin Capsules the following side effects have been reported:

• Decreased platelets (blood clotting cells)
• Hallucinations
• Problems with abnormal movements such as writhing, jerking movements and stiffness
• Ringing in the ears
• Yellowing of the skin and eyes (jaundice), inflammation of the liver
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain
• Breakdown of muscle fibers (rhabdomyolysis)
• Change in blood test results (creatine phosphokinase increased)
• Problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
• Low blood sodium level

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store gabapentin capsules

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

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store below 25°C. Store in the original package.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Gabapentin Capsules contain

• The active substance is gabapentin.

Each capsule, hard contains either 100mg, 300mg or 400mg gabapentin.

• The other ingredients are lactose monohydrate, talc, maize starch, gelatin, titanium dioxide (E171), sodium lauryl sulfate, yellow iron oxide (E172) [300mg capsules only] and red iron oxide (E172) [400mg capsules only].
• The capsule printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, black iron oxide (E172) and purified water.

What Gabapentin Capsules look like and the contents of the pack

100mg: white, gelatin capsules marked with GA100. 300mg: yellow, gelatin capsules marked with GA300.

400mg: orange, gelatin capsules marked with GA400.

Gabapentin Capsules are available in transparent blister packs of 20, 50, 100 and 200 capsules, although not all pack sizes may be marketed.

Marketing Authorisation Holder:

Wockhardt UK Ltd,

Ash Road North,

Wrexham, LL13 9UF, UK

Manufacturer:

CP Pharmaceuticals Ltd,

Ash Road North, Wrexham, LL13 9UF, UK.

Other sources of information:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in August 2021

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