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

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Gabapentin Morningside Capsules are and what they are used for

2.    What you need to know before you take Gabapentin Morningside Capsules

3.    How to take Gabapentin Morningside Capsules

4.    Possible side effects

5.    How to store Gabapentin Morningside Capsules

6.    Contents of the pack and other information

1. What Gabapentin Morningside Capsules are and what they are used for

Gabapentin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to nerves).

The active ingredient in Gabapentin Morningside Capsules is gabapentin. 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 to help treat your epilepsy when your current treatment is not fully controlling your condition. You 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 to gabapentin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Gabapentin Morningside 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).

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 Morningside 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 the symptoms to look out for while you are taking Gabapentin Morningside Capsules.

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'

Other medicines and Gabapentin Morningside Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Medicines containing morphine If you are taking any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of gabapentin.

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 and drink

Gabapentin Morningside Capsules can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Gabapentin Morningside 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 no studies specifically looking at the use of gabapentin in pregnant women, but other medications 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. Therefore, whenever possible, you should try to take only one seizure medication during pregnancy and only under the advice of your doctor.

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 breakthrough seizure, which could have serious consequences for you and your baby.

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.

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

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will determine what dose is appropriate for you.

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

If you are an elderly patient (over 65 years of age), you should take the normal dose of Gabapentin Morningside 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.

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

Method and route of administration

Gabapentin Morningside Capsules are for oral use. Always swallow the capsules whole with plenty of water.

Epilepsy, the usual 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 of body weight 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.

Peripheral Neuropathic Pain, the usual 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 take more Gabapentin Momingside 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 the nearest hospital emergency unit immediately if you have taken more Gabapentin Morningside 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 Momingside 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 Momingside Capsules

Do not stop taking Gabapentin Morningside 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 Momingside 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, pharmacist or nurse.

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:

-    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)

-    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 rash when you get this type of reaction. It may cause you to be hospitalised or to stop Gabapentin Momingside 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

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 side-effects (which may affect more than 1 person in 10):

•    Viral infection

•    Feeling drowsy, dizziness, lack of coordination

•    Feeling tired, fever

Common side-effects (which may affect more than 1 person in 100):

•    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 side-effects (which may affect less than 1 person in

1000):

•    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

Since introduction to the market 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

•    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

•    Yellowing of the skin and eyes Qaundice)

•    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

•    Blood glucose fluctuations in patients with diabetes.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

5. How to store Gabapentin Momingside 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 30°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 either100 mg, 300 mg or 400 mg gabapentin.

-    The other ingredients in Gabapentin Morningside Capsules are: Capsule contents:

Lactose monohydrate Maize starch 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)

Gelatin

The 300 mg capsule shell (n°0, dark green and white) contains: Yellow iron oxide (E172)

Indigo carmine (E132)

Titanium dioxide (E171)

Gelatin

The 400 mg capsule shell (n°0, green and white) contains:

Yellow iron oxide (E172)

Indigo carmine (El32)

Titanium dioxide (E171)

Gelatin

What Gabapentin Momingside Capsules look like and contents of the pack

Hard Capsule

Gabapentin Momingside Capsules are packed in PVC+PVD/AI blisters.

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

Momingside Healthcare Ltd

115 Narborough Road

Leicester

LE3 0PA

UK

Manufacturer:

West Pharma - Produces de Especialidades FarmacSuticas, S.A.

Rua Joao de Deus, n°11, 2700-486 Amadora Portugal

Atlantic Pharma - Produces Farmaceuticas S.A.,

Rua da Tapada Grande, n.° 2, Abrunheira, 2710-089 Sintra Portugal

Tecnimede - Sociedade T6cnico-Medicinal, S.A.

Quinta da Cerca, Caixaria, 2565-187 Dois Portos Portugal

Farmalabor - Produtos Farmac§uticos, S.A.

Zona Industrial de Condeixa-a-Nova 3150-194 Condeixa-a-Nova Portugal

This leaflet was last revised in May 2014

FGM-0514