GABAPENTIN BROWN & BURK 600 MG FILM-COATED TABLETS - 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, flulike symptoms.

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• 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 (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 or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at

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 film-coated tablet contains either 600 mg or 800 mg of gabapentin.

The other ingredients are:

Tablet core:

Hydroxypropyl­cellulose

Magnesium stearate

Film-coating:

Hydroxypropyl­cellulose

Talc

The 600mg tablets are white to off white, oval, biconvex film-coated tablets, engraved with ‘600’ on one side and plain on the other. Tablet dimensions: 18.00 (length), 9.20 (width).

The 800mg tablets are white to off white, oval, biconvex, film-coated tablets, engraved with ‘800’ on one side and plain on the other. Tablet dimensions: 19.20 (length), 10.00 mm (width).

Supplied in blister packs of 10, 20, 30, 45, 50, 60, 84, 90, 100, 200 or 500 tablets.

Also supplied in plastic containers of 100 tablets.

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 600mg/800mg Film-coated Tablets

DE: Gabapentin-Micro Labs 600mg/800mg Filmtabletten

This leaflet was last revised in April 2019

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