Gabapentin Nycomed
Package Leaflet: Information for the user
Gabapentin Takeda 100 mg, 300 mg and 400 mg capsules, hard
Gabapentin
Read all of this leaflet carefully before you start using 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. See section 4.
What is in this leaflet
1. What Gabapentin Takeda is and what it is used for
2. What you need to know before you use Gabapentin Takeda
3. How to use Gabapentin Takeda
4. Possible side effects
5 How to store Gabapentin Takeda
6. Contents of the pack and other information
What Gabapentin Takeda is and what it is used for
Gabapentin Takeda is used in the treatment of epilepsy in patients with partial epilepsy as add-on to other drugs against epilepsy when sufficient effect cannot be achieved with these.
Also, Gabapentin is used to treat pain caused by damage to the nerves, such as herpes zoster and neuropathic pain as a consequence of diabetes.
2. What you need to know before you use Gabapentin Takeda
Do not use Gabapentin Takeda:
- if you are allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6).
- if you have an acute inflammation of the pancreas.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before usingGabapentin Takeda
- if you have attacks causing momentary loss of conscience.
- if you have impaired kidney function.
-
if you get symptoms of inflammation of the pancreas (continued stomach trouble, sickness, repeated vomiting). Contact your doctor immediately.
-
if you have a history of psychosis.
-
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 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.
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 Takeda:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If Gabapentin Takeda is taken with acid-binding drugs against acidity and heartburn (so-called antacids), the effect of gabapentin decreases. Therefore, take Gabapentin Takeda at least 2 hours after antacids.
Gabapentin Takeda with food, drink and alcohol
Gabapentin Takeda can be taken independent of meals.
Drinking alcohol or using illegal drugs may increase possible side effects.
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
There is a risk that gabapentin may harm the foetus, but discontinuation of a treatment against epilepsy may also involve risks.
Gabapentin passes into breast milk, and influence on the breast-fed infant cannot be excluded. Therefore ask your doctor for advice.
Driving and using machines
Gabapentin may cause drowsiness and giddiness, which inhibit your reaction. It may therefore be dangerous to drive and operate machines. This should especially be taken into account in the beginning of the gabapentin treatment and in case of dose increase.
Gabapentin Takeda contains lactose
Each capsule of Gabapentin Takeda contains 17 mg, 50 mg respective 67 mg lactose. If you do not tolerate certain types of sugar you should contact your doctor before taking this medicine.
3. How to use Gabapentin Takeda
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The treatment usually starts with a capsule of 300 mg in the evening and is gradually increased to 3 doses daily according to your doctor’s prescription. The interval between evening and the next day’s morning dose should not exceed 12 hours.
If you have to reduce the dose or discontinue the gabapentin treatment, this must happen gradually and following your doctor’s instructions. Too prompt discontinuation of the treatment may involve risks of increase in number of epileptic attacks.
Gabapentin Takeda may be taken independent of meals. The capsules must be swallowed whole with minimum half a glass of liquid. The capsules must not be chewed.
Gabapentin Takeda should not be used in children under 12 years of age for treatment of epilepsy. Neither should Gabapentin Takeda be used in children and young people under 18 years of age for the treatment of neuropathic pain as a consequence of f.inst. herpes zoster infectionor diabetes.
If you have the impression that the effect of Gabapentin Takeda is too strong or too weak, talk to your doctor or pharmacist.
If you use more Gabapentin Takeda than you should
If you have taken too much medicine, tell your doctor.
If you forget to use Gabapentin Takeda
If you forget to take a single dose (f.inst. the last dose was taken more than 12 hours ago), you should contact your doctor who will decide whether an additional dose is necessary.
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.
Gabapentin 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.
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.
Other side effects are:
Common: may affect up to 1 in 10 people
Drowsiness, tiredness, giddiness, headache, sleeplessness, weight gain, loss of appetite, swelling, weakness, increased appetite, reduced muscle coordination, involuntary eye movements (nystagmus), tremor, memory loss, formication, muscle convulsions, increased or decreased reflexes or absence of reflexes, reduced awakeness, reduced ability to concentrate, abnormal thoughts, speech disorder, reduced memory, abnormal way of walking, vomiting, nausea, diarrhoea, dry mouth, reduced metabolism, indigestion, stomach pain, gum inflammation, feeling ill, nervousness, depression, confusion, changes in mood, restlessness, disturbed vision such as double or reduced vision, joint pain, muscle pain, low back pain, bone fractures, low value of white blood cells, dilated blood vessels, high blood pressure, congestion, inflammation of the throat, cough, itching, bruising, rashes, urinary incontinence, urinary tract infection, impotence.
Uncommon: may affect up to 1 in 100 people
Accidental injury, dizziness, confusion, increased sensitivity to touch, flatulence, depression, psychoses/hallucinations, aggression, changes in blood sugar, shortness of breath.
Rare: may affect up to 1 in 1,000 people
Reactions when the therapy is stopped such as pain, sweating and chest pain, dyskinesia, ringing in the ears (tinnitus), reduced number of blood platelets, changes in blood sugar in diabetic patients, rapid heartbeat, infection of the upper airways, nettle rashes, hair loss, acute kidney failure. Rare cases of swelling of the face and fingers (angioedema) have been reported. If you get swelling of the face, feet or ankles, lips, tongue and/or throat and larynx followed by difficulties to swallow or breathe, you must stop the treatment and immediately contact your doctor.
Very rare cases of allergic reaction in form of serious skin and mucous membrane inflammation have been reported.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Gabapentin Takeda
Keep this medicine out of the sight and reach of children.
Store below 30C
Do not use this medicine after the expiry date which is stated on the carton, label and/or blister after EXP. The expiry date refers to the last day of that month.
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 Takeda contains
-
The active substance is gabapentin 100 mg, 300 mg respectively 400 mg.
-
The other ingredients are lactose monohydrate, maize starch, talc, gelatin.
-
Colourants:
100 mg: Titanium dioxide (E 171)
300 mg: Titanium dioxide (E 171), iron oxide, yellow (E 172)
400 mg: Titanium dioxide (E 171), iron oxide, yellow and red (E 172)
What Gabapentin Takeda looks like and contents of the pack
Appearance
100 mg: White capsules, hard
300 mg: Yellow capsules, hard
400 mg: Orange capsules, hard
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Marketing Authorisation Holder and Manufacturer
To be completed nationally
This medicinal product is authorised in the Member States of the EEA under the following names:
Latvia, Lithuania and Sweden: Gabapentin Takeda 100 mg
Gabapentin Takeda 300 mg
Gabapentin Takeda 400 mg
This leaflet was last revised in
2016-02-11