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Package leaflet: Information for the user

Gabapentin Milpharm 100 mg capsules, hard Gabapentin Milpharm 300 mg capsules, hard Gabapentin Milpharm 400 mg capsules, hard

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 or pharmacist.

-    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 same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Gabapentin Milpharm is and what it is used for

2.    What you need to know before you take Gabapentin Milpharm

3.    How to take Gabapentin Milpharm

4.    Possible side effects

5.    How to store Gabapentin Milpharm capsules

6.    Contents of the pack and other information

1. What Gabapentin Milpharm is and what it is used for

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

Gabapentin Milpharm 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 Milpharm for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Gabapentin Milpharm in addition to your current treatment unless told otherwise. Gabapentin Milpharm 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 Milpharm

DO NOT TAKE Gabapentin Milpharm

-    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 or pharmacist before taking Gabapentin

-    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 Milpharm 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 Milpharm.

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’

Notice: The HDPE bottle contains desiccant. Do not swallow.

Other medicines and Gabapentin Milpharm

Tell to your doctor or pharmacist if you are taking or have recently 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 Milpharm.

Antacids for indigestion

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

Gabapentin:

-    is not expected to interact with other antiepileptic medicines or the oral contraceptive pill.

-    may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital that you are taking.

Gabapentin Milpharm with food and drink and alcohol

Gabapentin Milpharm can be taken with or without food.

Pregnancy and breast-feeding and fertility

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 any medicine.

Pregnancy:

Gabapentin Milpharm 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 medicines used to treat seizures have reported an increased risk of harm to the developing baby, particularly when more than one seizure medicine is taken at the same time. Therefore, whenever possible you should try to take only one seizure medicine 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 Milpharm. 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.

Breast-feeding:

Gabapentin, the active substance of Gabapentin Milpharm, is passed on through human milk.

Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin Milpharm.

Driving and using machines

Gabapentin Milpharm 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 medicine affects your ability to perform these activities.

3. How to take Gabapentin Milpharm

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.

If you have the impression that the effect of Gabapentin Milpharm 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 Milpharm 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 Milpharm until your doctor tells you to stop.

Method and Route of Administration

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

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 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 Milpharm 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 take more Gabapentin Milpharm than you should

If you or someone else accidentally takes too many capsules, or if you think a child has swallowed any, contact your doctor or go to your nearest hospital casualty department immediately. As Gabapentin capsules may make you drowsy, it is recommended that you ask someone else to drive you to the doctor or hospital, or that you call an ambulance. Symptoms of an overdose are dizziness, double vision, slurred speech, loss of consciousness, drowsiness and mild diarrhoea.

If you forget to take Gabapentin Milpharm

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 Milpharm

Do not stop taking Gabapentin Milpharm 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 Milpharm 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 any of the following symptoms after taking this medicine as they can be serious:

•    severe skin reactions that require immediate attention, such as 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 Milpharm 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 Milpharm.

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 Milpharm.

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

Other side effects include:

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

•    Viral infection

•    Feeling drowsy, dizziness, lack of coordination

•    Feeling tired, fever

Common side-effects (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

•    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.

Uncommon side-effects (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.

•    Fall

•    Difficulty with thinking

•    High blood sugar (most often observed in patients with diabetes)

Rare side-effects which may affect less than 1 person in 1000 are listed below:

•    Low blood sugar (most often observed in patients with diabetes)

•    Loss of consciousness

Side-effects for which the frequency cannot be estimated based on the available data are listed below:

•    Low blood sodium level

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 coluld include swollen lymph nodes (isolated small raised lumps under the skin), fever, rash, and inflammation of liver occuring together.

•    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

•    Blood glucose fluctuations in patients with diabetes.

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 national reporting system listed in Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Gabapentin Milpharm 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/label/bottle after EXP. The expiry date refers to the last date of that month.

Store below 25^oC.

Blister pack: Store in the original package.

HDPE bottle pack: Store in the original container.

Use within 12 months after first opening the HDPE bottle.

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 to protect the environment.

6. Contents of the pack and other information

What Gabapentin Milpharm contains

-    The active substance is gabapentin.

Each 100 mg hard capsule contains 100 mg gabapentin.

Each 300 mg hard capsule contains 300 mg gabapentin.

Each 400 mg hard capsule contains 400 mg gabapentin.

-    The other ingredients are:

Capsule contents: Maize starch and talc.

Capsule shell:

100 mg: Titanium dioxide (E171), sodium lauril sulfate, gelatin.

300 mg: Yellow iron oxide (E172), titanium dioxide (E171), sodium lauril sulfate, gelatin.

400 mg: Red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), sodium lauril sulfate, gelatin.

Printing ink: Shellac, propylene glycol, black iron oxide, potassium hydroxide

What Gabapentin Milpharm looks like and contents of the pack

Capsule, hard.

Gabapentin Milpharm 100 mg capsules imprinted with ‘D’ on white cap and ‘02’ on white body, containing white to off-white crystalline powder.

Gabapentin Milpharm 300 mg capsules imprinted with ‘D’ on yellow cap and ‘03’ on yellow body, containing white to off-white crystalline powder.

Gabapentin Milpharm 400 mg capsules imprinted with ‘D’ on orange cap and ‘04’ on orange body, containing white to off-white crystalline powder.

Gabapentin Milpharm 100 mg capsules are available in:

-    Clear PVC/PVdC - Aluminium foil blister packs of 10, 20, 30, 50, 60, 90, 100 and 200 capsules, hard.

-    HDPE bottle with polypropylene closure containing silica gel desiccant: 100, 200 and 1000 capsules, hard.

Gabapentin Milpharm 300 mg capsules are available in:

-    Clear PVC/PVdC - Aluminium foil blister packs of 10, 20, 30, 50, 60, 90, 100 and 200 capsules, hard.

-    HDPE bottle with polypropylene closure containing silica gel desiccant: 100, 200 and 1000 capsules, hard.

Gabapentin Milpharm 400 mg capsules are available in:

-    Clear PVC/PVdC - Aluminium foil blister packs of 10, 20, 30, 50, 60, 90, 100, 200 and 300 capsules, hard.

-    HDPE bottle with polypropylene closure containing silica gel desiccant: 100, 200, 300 and 500 capsules, hard.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares, Odyssey Business Park, West End Road South Ruislip HA4 6QD United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate Hal Far, Birzebbugia, BBG 3000 Malta

This medicinal product is authorised in the Member States of the EEA under the following names:

Czech Republic Gabapentin Aurobindo 100 mg/ 300 mg/ 400 mg tvrde tobolky