Gabapentin Brown & Burk 400 mg capsules hard – patient leaflet, side effects, dosage

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:

• Not known (frequency cannot be estimated from the available data) anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)
• 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.

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 Brown & Burk.

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 infections, 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 (may affect up to 1 in 100 people):

• Allergic reactions 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 levels (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):

• Loss of consciousness
• Decrease in blood glucose levels (most

often observed in patients with diabetes)

• Trouble breathing, shallow breaths

(respiratory depression)

After marketing Gabapentin 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 (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 fibers

(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

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 Yellow Card Scheme

Website: 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.

6. contents of the pack and other information

The active substance is gabapentin.

Each hard-capsule, contains either 100 mg, 300 mg or 400 mg of gabapentin.

The other ingredients are:

Capsule contents:

Maize starch

Talc

Capsule shell:

Gelatin

Sodium laurilsulfate

100 mg capsules: Titanium dioxide (E171) 300 mg capsules: Titanium dioxide (E171), yellow iron oxide (E172)

400 mg capsules: Titanium dioxide (E171), red and yellow iron oxide (E172)

The 100 mg capsules are white hard capsules containing a white crystalline powder. The capsule length is 15.70 mm.

The 300 mg capsules are yellow hard capsules containing a white crystalline powder. The capsule length is 19.00 mm.

The 400 mg capsules are orange hard capsules containing a white crystalline powder. The capsule length is 21.20 mm.

Supplied in blister packs of 10, 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000 capsules.

Also supplied in plastic containers of 300, 400 or 500 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Brown & Burk UK Ltd

5 Marryat Close Hounslow West Middlesex

TW4 5DQ UK.

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

UK: Gabapentin Brown & Burk 100mg/300mg/400mg Capsules, Hard DE: Gabapentin-Micro Labs 100mg/300mg/400mg Hartkapseln

This leaflet was last revised in April 2019

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