medication_name stringlengths 6 170 | section_title stringclasses 42
values | text stringlengths 0 47.1k |
|---|---|---|
Gabapentin Amarox 100 mg hard capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsule content
Mannitol
Starch,
Pregelatinised
Talc
CAP & Body
Titanium Dioxide (E171)
Gelatin
Sodium lauryl sulphate
Printing Ink
Shellac (E904)
Dehydrated Alcohol (E1510)
Isopropyl Alcohol
Butyl Alcohol
Propylene Glycol (E1520)
Strong Ammonia Solution (E527)
FD & C Blue # 2 Aluminum Lake (El32... |
Gabapentin Amarox 100 mg hard capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gabapentin Amarox 100 mg hard capsules | Pharmaceutical particulars - Shelf life | Shelf life
2 years.
6.4 |
Gabapentin Amarox 100 mg hard capsules | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 |
Gabapentin Amarox 100 mg hard capsules | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Clear PVC/PVDC-aluminium foil blister pack containing 100 hard capsules
6.6 |
Gabapentin Amarox 100 mg hard capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements
7. |
Gabapentin Amarox 100 mg hard capsules | Marketing authorisation holder | Amarox Limited
Congress House,
14 Lyon Road,
Harrow, Middlesex HA1 2EN,
United Kingdom
8. Marketing authorisation number(s)
PL 49445/0109
9. |
Gabapentin Amarox 100 mg hard capsules | Date of first authorisation/renewal of the authorisation | 06/10/2021
10. |
Gabapentin Amarox 100 mg hard capsules | Date of revision of the text | 15/03/2023 |
Gabapentin Amarox 300 mg hard capsules | Name of the medicinal product | Gabapentin Amarox 300 mg hard capsules
2. |
Gabapentin Amarox 300 mg hard capsules | Qualitative and quantitative composition | Each hard capsule contains 300 mg of gabapentin.
3. |
Gabapentin Amarox 300 mg hard capsules | Pharmaceutical form | Hard capsule
White to off white granular powder filled in size “1” hard gelatin capsules with white opaque cap imprinted with “H” in blue colour and white opaque body imprinted with “G2” in blue colour.
4. |
Gabapentin Amarox 300 mg hard capsules | Clinical particulars - Therapeutic indications | Therapeutic indications
Epilepsy
Gabapentin Amarox is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).
Gabapentin Amarox is indicated as monotherapy in the treatment of partial seizures with ... |
Gabapentin Amarox 300 mg hard capsules | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later i... |
Gabapentin Amarox 300 mg hard capsules | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Gabapentin Amarox 300 mg hard capsules | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug rash with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been rep... |
Gabapentin Amarox 300 mg hard capsules | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
There are spontaneous and literature case reports of respiratory depression and/or sedation associated with gabapentin and opioid use. In some of these reports, the authors considered this a particular concern with the combination of gabapentin an... |
Gabapentin Amarox 300 mg hard capsules | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy
Risk related to epilepsy and antiepileptic medicinal products in general
The risk of birth defects is increased by a factor of 2 – 3 in the offspring of mothers treated with an antiepileptic medicinal product. Most frequently reported are cleft lip, cardiovascular malfor... |
Gabapentin Amarox 300 mg hard capsules | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Gabapentin may have minor or moderate influence on the ability to drive and use machines. Gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms. Even, if they were only of mild or moderate degree, these undesirable effect... |
Gabapentin Amarox 300 mg hard capsules | Clinical particulars - Undesirable effects | Undesirable effects
The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency: very common (≥ 1/10); common (≥ 1/100 to< 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1... |
Gabapentin Amarox 300 mg hard capsules | Clinical particulars - Overdose | Overdose
Acute, life-threatening toxicity has not been observed with gabapentin overdoses of up to 49 g. Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, loss of consciousness, lethargy and mild diarrhoea. All patients recovered fully with supportive care. Reduced absorption of g... |
Gabapentin Amarox 300 mg hard capsules | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Absorption
Following oral administration, peak plasma gabapentin concentrations are observed within 2 to 3 hours. Gabapentin bioavailability (fraction of dose absorbed) tends to decrease with increasing dose. Absolute bioavailability of a 300 mg capsule is approximately 60%. Food, including... |
Gabapentin Amarox 300 mg hard capsules | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Carcinogenesis
Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/kg/day and to rats at 250, 1000, and 2000 mg/kg/day for two years. A statistically significant increase in the incidence of pancreatic acinar cell tumors was found only in male rats at the highest dose. Peak plasm... |
Gabapentin Amarox 300 mg hard capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsule content
Mannitol
Starch, Pregelatinised
Talc
CAP & Body
Titanium Dioxide (E171)
Gelatin
Sodium lauryl sulphate
Printing Ink
Shellac (E904)
Dehydrated Alcohol (E1510)
Isopropyl Alcohol
Butyl Alcohol
Propylene Glycol (E1520)
Strong Ammonia Solution (E527)
FD & C Blue # 2 Aluminum Lake (El32... |
Gabapentin Amarox 300 mg hard capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gabapentin Amarox 300 mg hard capsules | Pharmaceutical particulars - Shelf life | Shelf life
2 years.
6.4 |
Gabapentin Amarox 300 mg hard capsules | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 |
Gabapentin Amarox 300 mg hard capsules | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Clear PVC/PVDC-aluminium foil blister pack containing 100 hard capsules
6.6 |
Gabapentin Amarox 300 mg hard capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements
7. |
Gabapentin Amarox 300 mg hard capsules | Marketing authorisation holder | Amarox Limited
Congress House,
14 Lyon Road,
Harrow, Middlesex HA1 2EN,
United Kingdom
8. Marketing authorisation number(s)
PL 49445/0110
9. |
Gabapentin Amarox 300 mg hard capsules | Date of first authorisation/renewal of the authorisation | 06/10/2021
10. |
Gabapentin Amarox 300 mg hard capsules | Date of revision of the text | 15/03/2023 |
Gabapentin Amarox 400 mg hard capsules | Name of the medicinal product | Gabapentin Amarox 400 mg hard capsules
2. |
Gabapentin Amarox 400 mg hard capsules | Qualitative and quantitative composition | Each hard capsule contains 400 mg of gabapentin.
3. |
Gabapentin Amarox 400 mg hard capsules | Pharmaceutical form | Hard capsule
White to off white granular powder filled in size “0” hard gelatin capsules with white opaque cap imprinted with “H” in blue colour and white opaque body imprinted with “G3” in blue colour.
4. |
Gabapentin Amarox 400 mg hard capsules | Clinical particulars - Therapeutic indications | Therapeutic indications
Epilepsy
Gabapentin Amarox is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).
Gabapentin Amarox is indicated as monotherapy in the treatment of partial seizures with ... |
Gabapentin Amarox 400 mg hard capsules | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later i... |
Gabapentin Amarox 400 mg hard capsules | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Gabapentin Amarox 400 mg hard capsules | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug rash with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been rep... |
Gabapentin Amarox 400 mg hard capsules | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
There are spontaneous and literature case reports of respiratory depression and/or sedation associated with gabapentin and opioid use. In some of these reports, the authors considered this a particular concern with the combination of gabapentin an... |
Gabapentin Amarox 400 mg hard capsules | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy
Risk related to epilepsy and antiepileptic medicinal products in general
The risk of birth defects is increased by a factor of 2 – 3 in the offspring of mothers treated with an antiepileptic medicinal product. Most frequently reported are cleft lip, cardiovascular malfor... |
Gabapentin Amarox 400 mg hard capsules | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Gabapentin may have minor or moderate influence on the ability to drive and use machines. Gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms. Even, if they were only of mild or moderate degree, these undesirable effect... |
Gabapentin Amarox 400 mg hard capsules | Clinical particulars - Undesirable effects | Undesirable effects
The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency: very common (≥ 1/10); common (≥ 1/100 to< 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1... |
Gabapentin Amarox 400 mg hard capsules | Clinical particulars - Overdose | Overdose
Acute, life-threatening toxicity has not been observed with gabapentin overdoses of up to 49 g. Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, loss of consciousness, lethargy and mild diarrhoea. All patients recovered fully with supportive care. Reduced absorption of g... |
Gabapentin Amarox 400 mg hard capsules | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Absorption
Following oral administration, peak plasma gabapentin concentrations are observed within 2 to 3 hours. Gabapentin bioavailability (fraction of dose absorbed) tends to decrease with increasing dose. Absolute bioavailability of a 300 mg capsule is approximately 60%. Food, including... |
Gabapentin Amarox 400 mg hard capsules | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Carcinogenesis
Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/kg/day and to rats at 250, 1000, and 2000 mg/kg/day for two years. A statistically significant increase in the incidence of pancreatic acinar cell tumors was found only in male rats at the highest dose. Peak plasm... |
Gabapentin Amarox 400 mg hard capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsule content
Mannitol
Starch, Pregelatinised
Talc
CAP & Body
Titanium Dioxide (E171)
Gelatin
Sodium lauryl sulphate
Printing Ink
Shellac (E904)
Dehydrated Alcohol (E1510)
Isopropyl Alcohol
Butyl Alcohol
Propylene Glycol (E1520)
Strong Ammonia Solution (E527)
FD & C Blue # 2 Aluminum Lake (El32... |
Gabapentin Amarox 400 mg hard capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gabapentin Amarox 400 mg hard capsules | Pharmaceutical particulars - Shelf life | Shelf life
2 years.
6.4 |
Gabapentin Amarox 400 mg hard capsules | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 |
Gabapentin Amarox 400 mg hard capsules | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Clear PVC/PVDC-aluminium foil blister pack containing 100 hard capsules
6.6 |
Gabapentin Amarox 400 mg hard capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements
7. |
Gabapentin Amarox 400 mg hard capsules | Marketing authorisation holder | Amarox Limited
Congress House,
14 Lyon Road,
Harrow, Middlesex HA1 2EN,
United Kingdom
8. Marketing authorisation number(s)
PL 49445/0111
9. |
Gabapentin Amarox 400 mg hard capsules | Date of first authorisation/renewal of the authorisation | 06/10/2021
10. |
Gabapentin Amarox 400 mg hard capsules | Date of revision of the text | 15/03/2023 |
Gabapentin Brown & Burk 100 mg Capsules, hard | Name of the medicinal product | Gabapentin Brown & Burk 100 mg Capsules, hard
2. |
Gabapentin Brown & Burk 100 mg Capsules, hard | Qualitative and quantitative composition | Each 100 mg hard capsule contains 100 mg of gabapentin.
For a full list of excipients, see section 6.1.
3. |
Gabapentin Brown & Burk 100 mg Capsules, hard | Pharmaceutical form | Capsule, hard (capsule)
A two-piece, white opaque hard gelatine capsule, containing a white crystalline powder.
Capsule size '3'.
Capsule length: 15.70 mm.
4. |
Gabapentin Brown & Burk 100 mg Capsules, hard | Clinical particulars - Therapeutic indications | Therapeutic indications
Epilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).
Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without se... |
Gabapentin Brown & Burk 100 mg Capsules, hard | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later ... |
Gabapentin Brown & Burk 100 mg Capsules, hard | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Gabapentin Brown & Burk 100 mg Capsules, hard | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Suicidal ideation and behaviour
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suic... |
Gabapentin Brown & Burk 100 mg Capsules, hard | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
There are spontaneous and literature case reports of respiratory depression, sedation and death associated with gabapentin when co-administered with CNS depressants, including .opioid . In some of these reports, the authors considered the combina... |
Gabapentin Brown & Burk 100 mg Capsules, hard | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Fertility
There is no effect on fertility in animal studies (see section 5.3).
Pregnancy
Risk related to epilepsy and antiepileptic medicinal products in general
The risk of birth defects is increased by a factor of 2 – 3 in the offspring of mothers treated with an antiepileptic... |
Gabapentin Brown & Burk 100 mg Capsules, hard | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Gabapentin may have minor or moderate influence on the ability to drive and use machines. Gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms. Even, if they were only of mild or moderate degree, these undesirable effect... |
Gabapentin Brown & Burk 100 mg Capsules, hard | Clinical particulars - Undesirable effects | Undesirable effects
The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency (very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1,000 to < 1/100); rare ( 1/10,000 to < 1/1,00... |
Gabapentin Brown & Burk 100 mg Capsules, hard | Clinical particulars - Overdose | Overdose
Acute, life-threatening toxicity has not been observed with gabapentin overdoses of up to 49 grams. Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, loss of consciousness, lethargy and mild diarrhoea. All patients recovered fully with supportive care. Reduced absorption ... |
Gabapentin Brown & Burk 100 mg Capsules, hard | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Absorption
Following oral administration, peak plasma gabapentin concentrations are observed within 2 to 3 hours. Gabapentin bioavailability (fraction of dose absorbed) tends to decrease with increasing dose. Absolute bioavailability of a 300 mg capsule is approximately 60%. Food, including... |
Gabapentin Brown & Burk 100 mg Capsules, hard | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Carcinogenesis
Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/kg/day and to rats at 250, 1000, and 2000 mg/kg/day for two years. A statistically significant increase in the incidence of pancreatic acinar cell tumours was found only in male rats at the highest dose. Peak plas... |
Gabapentin Brown & Burk 100 mg Capsules, hard | Pharmaceutical particulars - List of excipients | List of excipients
Capsule content:
Maize starch
Talc
Capsule shell:
Gelatin
Sodium laurilsulfate
Titanium dioxide (E171)
6.2 |
Gabapentin Brown & Burk 100 mg Capsules, hard | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable
6.3 |
Gabapentin Brown & Burk 100 mg Capsules, hard | Pharmaceutical particulars - Shelf life | Shelf life
3 years
6.4 |
Gabapentin Brown & Burk 100 mg Capsules, hard | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not store above 30°C.
6.5 |
Gabapentin Brown & Burk 100 mg Capsules, hard | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
PVC/PVDC/aluminium foil blister packs
Polypropylene container with polypropylene cap
Blister packs of 10, 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000 capsules.
Polypropylene container of 300, 400, 500 capsules
Not all pack sizes may be marketed.
6.6 |
Gabapentin Brown & Burk 100 mg Capsules, hard | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements.
7. |
Gabapentin Brown & Burk 100 mg Capsules, hard | Marketing authorisation holder | Brown & Burk UK Ltd
5, Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK
8. Marketing authorisation number(s)
PL 25298/0076
9. |
Gabapentin Brown & Burk 100 mg Capsules, hard | Date of first authorisation/renewal of the authorisation | 21/11/2011 / 10/10/2016
10. |
Gabapentin Brown & Burk 100 mg Capsules, hard | Date of revision of the text | 17/01/2023 |
Gabapentin Brown & Burk 300 mg Capsules, hard | Name of the medicinal product | Gabapentin Brown & Burk 300 mg Capsules, hard
2. |
Gabapentin Brown & Burk 300 mg Capsules, hard | Qualitative and quantitative composition | Each 300 mg hard capsule contains 300 mg of gabapentin.
For a full list of excipients, see section 6.1.
3. |
Gabapentin Brown & Burk 300 mg Capsules, hard | Pharmaceutical form | Capsule, hard (capsule)
A two-piece, yellow opaque hard gelatine capsule, containing a white crystalline powder.
Capsule size'1'.
Capsule length: 19.00 mm.
4. |
Gabapentin Brown & Burk 300 mg Capsules, hard | Clinical particulars - Therapeutic indications | Therapeutic indications
Epilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).
Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without se... |
Gabapentin Brown & Burk 300 mg Capsules, hard | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later i... |
Gabapentin Brown & Burk 300 mg Capsules, hard | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Gabapentin Brown & Burk 300 mg Capsules, hard | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Suicidal ideation and behaviour
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of su... |
Gabapentin Brown & Burk 300 mg Capsules, hard | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
There are spontaneous and literature case reports of respiratory depression sedation and death associated with gabapentin when co-administered with CNS depressants, including opioids . In some of these reports, the authors considered the combinati... |
Gabapentin Brown & Burk 300 mg Capsules, hard | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Fertility
There is no effect on fertility in animal studies (see section 5.3).
Pregnancy
Risk related to epilepsy and antiepileptic medicinal products in general
The risk of birth defects is increased by a factor of 2 – 3 in the offspring of mothers treated with an antiepilepti... |
Gabapentin Brown & Burk 300 mg Capsules, hard | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Gabapentin may have minor or moderate influence on the ability to drive and use machines. Gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms. Even, if they were only of mild or moderate degree, these undesirable effect... |
Gabapentin Brown & Burk 300 mg Capsules, hard | Clinical particulars - Undesirable effects | Undesirable effects
The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency (very common (≥ 1/10); common (≥ 1/100 to< 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1... |
Gabapentin Brown & Burk 300 mg Capsules, hard | Clinical particulars - Overdose | Overdose
Acute, life-threatening toxicity has not been observed with gabapentin overdoses of up to 49 grams. Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, loss of consciousness, lethargy and mild diarrhoea. All patients recovered fully with supportive care. Reduced absorption ... |
Gabapentin Brown & Burk 300 mg Capsules, hard | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Absorption
Following oral administration, peak plasma gabapentin concentrations are observed within 2 to 3 hours. Gabapentin bioavailability (fraction of dose absorbed) tends to decrease with increasing dose. Absolute bioavailability of a 300 mg capsule is approximately 60%. Food, including... |
Gabapentin Brown & Burk 300 mg Capsules, hard | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Carcinogenesis
Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/kg/day and to rats at 250, 1000, and 2000 mg/kg/day for two years. A statistically significant increase in the incidence of pancreatic acinar cell tumours was found only in male rats at the highest dose. Peak plas... |
Gabapentin Brown & Burk 300 mg Capsules, hard | Pharmaceutical particulars - List of excipients | List of excipients
Capsule content:
Maize starch
Talc
Capsule shell:
Gelatin
Sodium laurilsulfate
Titanium dioxide (E171)
Yellow iron oxide (E172)
6.2 |
Gabapentin Brown & Burk 300 mg Capsules, hard | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable
6.3 |
Gabapentin Brown & Burk 300 mg Capsules, hard | Pharmaceutical particulars - Shelf life | Shelf life
3 years
6.4 |
Gabapentin Brown & Burk 300 mg Capsules, hard | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not store above 30°C.
6.5 |
Gabapentin Brown & Burk 300 mg Capsules, hard | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
PVC/PVDC/aluminium foil blister packs
Polypropylene container with polypropylene cap
Blister packs of 10, 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000 capsules.
Polypropylene container of 300, 400, 500 capsules
Not all pack sizes may be marketed.
6.6 |
Gabapentin Brown & Burk 300 mg Capsules, hard | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements.
7. |
Gabapentin Brown & Burk 300 mg Capsules, hard | Marketing authorisation holder | Brown & Burk UK Ltd
5, Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK
8. Marketing authorisation number(s)
PL 25298/0077
9. |
Gabapentin Brown & Burk 300 mg Capsules, hard | Date of first authorisation/renewal of the authorisation | 21/11/2011 / 10/10/2016
10. |
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