Patient leaflet - Gabapentin Morningside 300 mg hard capsule
1. What Gabapentin Morningside Capsules are and what they are used for
This medicine has been prescribed for you for treating epilepsy and peripheral neuropathic pain.
It contains gabapentin which belongs to a class of medicines called gabapentinoids.
This medicine has been prescribed to you and should not be given to anyone else.
Gabapentinoids can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your prescriber should have explained how long you will be taking it for, when it is appropriate to stop and how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months. If this medicine is being used for the treatment of epilepsy you must continue to take it as prescribed by your doctor.
Gabapentin is used to treat:
- Various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). Your doctor will prescribe Gabapentin Morningside Capsules for you or your child 6 years of age and older to help treat your epilepsy when your current treatment is not fully controlling your condition. You or your child 6 years of age and older should take Gabapentin Morningside Capsules in addition to your current treatment unless told otherwise. Gabapentin Morningside Capsules can also be used on its own to treat adults and children over 12 years of age.
- Peripheral neuropathic pain (long lasting pain caused by damage to the nerves). A variety of different diseases can cause peripheral neuropathic pain (primarily occurring in the legs and/or arms), such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles etc..
2. What you need to know before you take
Gabapentin Morningside Capsules Do not take Gabapentin Morningside 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 prescriber before taking this medicine if you:
- 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
- before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs; it may mean you have a greater risk of becoming dependent on Gabapentin Morningside Capsules
- are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake
- have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
- feel you need to take more of Gabapentin Morningside Capsules to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication
- if you have myasthenia gravis (a disease causing muscle weakness) because this medicine may make your symptoms worse.
Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.
Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include:
- Trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating and dizziness.
Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Gabapentinoids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of gabapentinoids, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death. 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.
Dependence
Some people may become dependent on Gabapentin Morningside Capsules (a need to keep taking the medicine). They may have withdrawal effects when they stop using Gabapentin Morningside Capsules or reduce the dose (see section 3, “How to take Gabapentin Morningside Capsules” and “If you stop taking Gabapentin Morningside Capsules”). If you have concerns that you may become dependent on Gabapentin Morningside Capsules, it is important that you consult your doctor.
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
Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with gabapentin. Stop using gabapentin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Read the description of these symptoms in section 4 of this leaflet under ‘Contact your 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 discolouration of your urine, and a change in blood test results (notably blood creatine phosphokinase increased). If you experience any of these signs or symptoms, please contact your doctor immediately.
Other medicines and Gabapentin Morningside 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. In addition, combination of Gabapentin with opioids may cause symptoms like sleepiness, sedation, decrease in breathing, or death.
Antacids for indigestion
If Gabapentin Morningside Capsules and antacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin Morningside Capsules from the stomach may be reduced. It is therefore recommended that Gabapentin Morningside Capsules are taken at the earliest two hours after taking an antacid. Gabapentin Morningside Capsules:
- are 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 Morningside Capsules with food
Gabapentin Morningside Capsules can be taken with or without food.
Pregnancy, breast-feeding and fertility
- If you are pregnant, think you may be pregnant or are planning to have a baby, 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 as early as possible before you become pregnant
- If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine
- You should not stop your treatment without discussing this with your doctor.
Pregnancy
Gabapentin Morningside Capsules can be taken during the first trimester of pregnancy, unless you are told otherwise by your doctor.
If you plan to become pregnant or if you are pregnant or think you may be pregnant, talk to your doctor straight away.
If you have become pregnant and you have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor, as this may worsen your illness. Worsening of your epilepsy may put you and your unborn child at risk.
In a study reviewing data from women in Nordic countries who took gabapentin in the first 3 months of pregnancy, there was no increased risk of birth defects or problems with the development of brain function (neurodevelopment disorders). However, babies of women who took gabapentin during pregnancy had an increased risk of low birth weight and preterm birth.
Some medicines used to treat seizures 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.
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin Morningside Capsules. Do not suddenly discontinue taking this medicine as this may lead to a breakthrough seizure, which could have serious consequences for you and your baby. If used during pregnancy, gabapentin may lead to withdrawal symptoms in newborn infants. This risk might be increased when gabapentin is taken together with opioid analgesics (drugs for treatment of severe pain).
Breast-feeding
Gabapentin, the active substance of Gabapentin Morningside Capsules, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin Morningside Capsules.
Fertility
There is no effect on fertility in animal studies.
Driving and using machines
Gabapentin Morningside 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 Morningside 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.
3. How to take Gabapentin Morningside Capsules
Your prescriber should have discussed with you how long the course of capsules will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
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.
Use in 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 recommended 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 Morningside Capsules are not recommended for use in children below 6 years of age.
Package leaflet: Information for the user
Gabapentin Morningside 100 mg hard capsules Gabapentin Morningside 300 mg hard capsules Gabapentin Morningside 400 mg hard capsules Gabapentin
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 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 is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
Method of administration
Gabapentin is for oral use. Always swallow the capsules whole with plenty of water.
Continue taking Gabapentin until your doctor tells you to stop.
If you take more Gabapentin Morningside Capsules than you should
Higher than recommended doses may result in an increase in side effects including loss of consciousness, dizziness, double vision, slurred speech, drowsiness and diarrhoea. Call your doctor or go to your 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 and the label so that the hospital can easily tell what medicine you have taken.
If you forget to take Gabapentin Morningside 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 Morningside Capsules
Do not suddenly stop taking Gabapentin Morningside Capsules or reduce your dose. If you want to stop taking Gabapentin Morningside Capsules or reduce your dose, discuss this with your doctor first. They will tell you how to do this. If your treatment is stopped or your dose is reduced, it should be done gradually over a minimum of 1 week. After stopping a short or long-term treatment with Gabapentin Morningside Capsules or after reducing your dose, you need to know that you may experience certain side effects, so-called withdrawal effects. These effects can include seizures, anxiety, difficulty sleeping, feeling sick (nausea), pain, sweating, shaking, headache, depression, feeling abnormal, dizziness, and feeling generally unwell. These effects usually occur within 48 hours after stopping Gabapentin Morningside Capsules or reducing your dose. If you experience withdrawal effects, you should contact your doctor.If you have any further questions on the use of this medicine, ask your doctor, pharmacist.
4. Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Gabapentin Morningside Capsules and seek medical attention immediately if you notice any of the following symptoms:
- reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:
- 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)
- breathing problems, which if severe you may need emergency and intensive care to continue breathing normally
Gabapentin Morningside 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 a rash when you get this type of reaction. It may cause you to be hospitalised or to stop Gabapentin Morningside Capsules. Call your doctor right away if you have any of the following symptoms: - skin rash and redness and/or hair loss - hives
- fever
- swollen glands that do not go away
- swelling of your lips, face 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.
These symptoms may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin Morningside 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):
- Viral infection
- Feeling drowsy, dizziness, lack of coordination • Feeling tired, fever.
Common (may affect up to 1 in 10 people):
- Pneumonia, respiratory infection, urinary tract 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):
- Allergic reaction such as hives
- Decreased movement
- Racing heartbeat
- 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 level (most often observed in patients with diabetes)
- Agitation (a state of chronic restlessness and unintentional and purposeless motions)
Difficulty swallowing.
Rare (may affect up to 1 in 1,000 people):
- Decrease in blood glucose level (most often observed in patients with diabetes)
- Loss of consciousness
- Trouble breathing, shallow breaths (respiratory depression).
Unknown frequency: frequency cannot be estimated from the available data
- Dependence and addiction (see section “How do I know if I am tolerant or addicted?”)
- Worsening of myasthenia gravis (a disease causing muscle weakness).
After stopping a short or long-term treatment with Gabapentin Morningside capsule or after reducing your dose, you need to know that you may experience certain side effects, so-called withdrawal effects (see “If you stop taking Gabapentin Morningside Capsules”).
Since introduction to the market the following side effects have been reported
- Decreased platelets (blood clotting cells)
- Suicidal thoughts, 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 fibres (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 (Hyponatraemia)
- Anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment).
Drug Withdrawal
When you stop taking Gabapentin Morningside Capsules you may experience drug withdrawal symptoms, which include:
- Trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.
How do I know if I am tolerant or addicted?
If you notice any of the following signs whilst taking Gabapentin Morningside Capsules, it could be a sign that you have become addicted.
- You may feel the need to keep taking the medication for longer than your doctor recommended
- You feel you need to use more than the recommended dose
- You are using the medicine for reasons other than prescribed
- When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again. If you notice any of these signs, it is important you talk to your prescriber.
Reporting of the side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme www.mhra.gov.uk/yellowcard 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 Morningside 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 after “Exp.”. The expiry date refers to the last day of that month.
Do not store above 25°C. In order to protect from light and moisture, store in the original package.
Do not throw away any 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 Morningside Capsules contain
The active substance is gabapentin. Each hard capsule contains either 100 mg, 300 mg or 400 mg gabapentin.
The other ingredients in Gabapentin Morningside Capsules are:
Capsule contents:
Lactose monohydrate, Maize starch and Talc.
Capsule shell:
The 100 mg capsule shell (n°3, light green and ivory) contains: Quinoleine yellow (E104), Indigo carmine (E132), Titanium dioxide (E171), Yellow iron oxide (E172) and Gelatin.
The 300 mg capsule shell (n°0, dark green and white) contains: Yellow iron oxide (E172), Indigo carmine (E132), Titanium dioxide (E171) and Gelatin.
The 400 mg capsule shell (n°0, green and white) contains: Yellow iron oxide (E172), Indigo carmine (E132), Titanium dioxide (E171) and Gelatin.
What Gabapentin Morningside Capsules look like and contents of the pack
Capsule, hard
Gabapentin Morningside Capsules are packed in blister PVC+PVD/Al.
The available pack sizes are:
100 mg; 20, 50, 60, 90, 100 or 500 capsules, hard 300 mg and 400 mg: 30, 50, 60, 90, 100 or 500 capsules, hard
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd.
Unit C, Harcourt Way, Leicester, LE19 1WP, UK
Manufacturer
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n°11, 2700 – 486 Amadora, Portugal Atlantic Pharma – Produções Farmacêuticas S.A. Rua da Tapada Grande, n°2, Abrunheira
2710-089 Sintra, Portugal
Tecnimede – Sociedade Técnico-Medicinal, S.A. Quinta da Cerca, Caixaria, 2565-187 Dois Portos, Portugal Farmalabor – Produtos Farmacêuticos, S.A. Zona Industrial de Condeixa-a-Nova
3150-194 Condeixa-a-Nova, Portugal
Morningside Pharmaceuticals Ltd.
5 Pavilion Way, Loughborough, Leicestershire LE11 5GW, UK
Morningside Pharmaceuticals Ltd.
Second Floor, Boss Court, 7 Barton Close
Grove Park, Leicester, LE19 1SJ, UK
Aspire Pharma Ltd.
Second Floor, Boss Court, 7 Barton Close
Grove Park, Leicester, LE19 1SJ, UK
Aspire Pharma Ltd.
Unit 4, Rotherbrook Court, Bedford Road
Petersfield, GU32 3QG, UK
This medicinal product is authorised in the Member States of the EEA under the following names:
Italy: Gabapentina TecniGen
Portugal: Gabapentina Farmoz
Spain: Gabapentina Tecnigen
United Kingdom: Gabapentin 100 mg /
Gabapentin 300 mg / Gabapentin 400 mg