YOUZAIN 600 mg AND 800 mg FILM-COATED TABLETS

gabapentin

Package leaflet: Information for the user

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 symptoms are the 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 Youzain Film-coated Tablets is and what it is used for

2.    What you need to know before you take Youzain Film-coated Tablets

3.    How to take Youzain Film-coated Tablets

4.    Possible side effects

5.    How to store Youzain Film-coated Tablets

6.    Contents of the pack and other information

1    What Youzain Film-coated Tablets is and what it is used for

Youzain belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves). The active substance inYouzain is gabapentin.

Youzain 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 Youzain for you to help treat your epilepsy when your current treatment is not fully controlling your condition.You should takeYouzain in addition to your current treatment unless told otherwise. Youzain can also be used on its own to treat adults and adolescents 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 Youzain Film-coated Tablets

Do not take Youzain 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 Youzain if you:

•    suffer from kidney problems, your doctor may prescribe a different dosing schedule

•    are on haemodialysis (to remove waste products because of kidney failure), tell your doctor if you develop muscle pain and/or weakness

•    develop signs such as persistent stomach pain, feeling and being sick contact your doctor immediately as these may be symptoms of acute pancreatitis (an inflamed pancreas).

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

A small number of people being treated with antiepileptics such as gabapentin have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately.

Important information about potentially serious reactions

A small number of people takingYouzain 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 Youzain.

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 Youzain

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

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 ofYouzain.

In addition, combination ofYouzain with opioids may cause symptoms like sleepiness and/or decrease in breathing.

Antacids for indigestion

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

Youzain:

•    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 what you are taking.

Pregnancy, 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 this medicine.

Pregnancy

Youzain 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 Youzain. 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 Youzain, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Youzain.

Fertility

There is no effect on fertility in animal studies

Driving and using machines

Youzain 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.

©■ How to take Youzain Film-coated Tablets

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.

Epilepsy - the recommended dose is

Adults and adolescents:

Take the number of tablets 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 tablet(s) each day, usually once in the morning, once in the afternoon and once in the evening.

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

Peripheral Neuropathic Pain - the recommended dose is

Adults:

Take the number of tablets 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.

For doses not realisable/practicable with this medicinal product other medicinal products are available.

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 Youzain 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.

24-Nov-2016