medication_name stringlengths 6 170 | section_title stringclasses 42
values | text stringlengths 0 47.1k |
|---|---|---|
Gabapentin 100 mg capsules | Date of first authorisation/renewal of the authorisation | 07th August 2013
10. |
Gabapentin 100 mg capsules | Date of revision of the text | 04/2019
LEGAL CATEGORY
POM |
Gabapentin 100mg capsules | Name of the medicinal product | Gabapentin Milpharm 100 mg capsules, hard
2. |
Gabapentin 100mg capsules | Qualitative and quantitative composition | Each 100 mg hard capsule contains 100 mg gabapentin.
For the full list of excipients, see section 6.1
3. |
Gabapentin 100mg capsules | Pharmaceutical form | Capsule, hard
Gabapentin 100 mg capsules, hard, imprinted with 'D' on white cap and '02' on white body, containing white to off-white crystalline powder.
4. |
Gabapentin 100mg capsules | 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 100mg 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 100mg capsules | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Gabapentin 100mg 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 100mg 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, sedation and death associated with gabapentin when coadministered with CNS depressants, including opioids,. In some of these reports, the authors considered the combinati... |
Gabapentin 100mg 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 100mg 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 100mg 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 (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1,000) ... |
Gabapentin 100mg 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 ga... |
Gabapentin 100mg 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, includin... |
Gabapentin 100mg 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 100mg capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsule Fill:
Maize starch
Talc
Capsule Shell:
Titanium dioxide (E171)
Sodium lauril sulfate
gelatin
Printing ink
Shellac
Propylene glycol
Black iron oxide
Potassium hydroxide
6.2 |
Gabapentin 100mg capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gabapentin 100mg capsules | Pharmaceutical particulars - Shelf life | Shelf life
3 years.
In use shelf life for HDPE bottle pack: 12 months
6.4 |
Gabapentin 100mg capsules | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store below 25°C.
Blister pack: Store in the original package.
HDPE bottle pack: Store in the original container.
6.5 |
Gabapentin 100mg capsules | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Blister pack of clear PVC/PVdC – Aluminium foil:
10, 20, 30, 50, 60, 90, 100 and 200 capsules, hard.
HDPE bottle with polypropylene cap containing silica gel desiccant:
100, 200 and 1000 capsules, hard.
Not all pack sizes may be marketed
6.6 |
Gabapentin 100mg capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements.
7. |
Gabapentin 100mg capsules | Marketing authorisation holder | Milpharm Limited
Ares, Odyssey Business Park
West End Road, South Ruislip HA4 6QD
United Kingdom
8. Marketing authorisation number(s)
PL 16363/0285
9. |
Gabapentin 100mg capsules | Date of first authorisation/renewal of the authorisation | 23/12/2010
10. |
Gabapentin 100mg capsules | Date of revision of the text | 12/06/2023 |
Gabapentin 100mg Hard, Capsules | Name of the medicinal product | Gabapentin Strides 100 mg capsules, hard
2. |
Gabapentin 100mg Hard, Capsules | Qualitative and quantitative composition | Each 100 mg hard capsule contains 100 mg of gabapentin.
For the full list of excipients, see section 6.1.
3. |
Gabapentin 100mg Hard, Capsules | Pharmaceutical form | Capsule, hard
Gabapentin 100 mg capsules, hard: Opaque white cap and opaque white body imprinted with 'S617/100 mg' on cap with edible blue ink and '' on body with edible green ink. Filled with white to off white powder. Capsule size is mm ± 0.4 mm.
4. |
Gabapentin 100mg Hard, Capsules | 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 100mg 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 100mg 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 100mg 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 100mg 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 100mg 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 100mg 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 100mg 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 100mg 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 100mg 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 100mg 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 tumours was found only in male rats at the highest dose. Peak plas... |
Gabapentin 100mg Hard, Capsules | Pharmaceutical particulars - List of excipients | List of excipients
Mannitol (E421)
Maize starch
Talc (E553b)
Magnesium stearate (E572)
Capsule shell:
Gelatin (E441)
Titanium dioxide (E171)
Printing ink:
Cap:
Shellac (E904) (in blue ink)
Indigo carmine aluminium lake (E132) (in blue ink)
Propylene glycol
Body:
Shellac (E904)
Iron oxide Yellow (E172) (in green i... |
Gabapentin 100mg Hard, Capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gabapentin 100mg Hard, Capsules | Pharmaceutical particulars - Shelf life | Shelf life
HDPE bottle packs and carton blister:
3 years
6.4 |
Gabapentin 100mg 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 100mg Hard, Capsules | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Packed in a HDPE bottle with a white plastic closure and supplied in packs of 20, 30, 50, 60, 84, 90, 98, 100, 200, 500 or 1000 capsules.
Packed in blisters of PVC/PVDC in 10, 20, 30, 50, 60, 90, 100, 200's pack sizes.
Not all pack sizes may be marketed.
6.6 |
Gabapentin 100mg Hard, Capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements.
7. |
Gabapentin 100mg Hard, Capsules | Marketing authorisation holder | Strides Pharma UK Ltd.
Unit 4, The Metro Centre,
Dwight Road, Watford,
WD18 9SS, United Kingdom
8. Marketing authorisation number(s)
PL 13606/0232
9. |
Gabapentin 100mg Hard, Capsules | Date of first authorisation/renewal of the authorisation | 08/06/2020
10. |
Gabapentin 100mg Hard, Capsules | Date of revision of the text | 02/06/2023 |
Gabapentin 300 mg capsules | Name of the medicinal product | Gabapentin 300 mg capsules.
2. |
Gabapentin 300 mg capsules | Qualitative and quantitative composition | Each 300mg capsule contains 300 mg gabapentin.
Excipients:
Each 300 mg capsule contains 50.50 mg lactose (as monohydrate).
For a full list of excipients, see section 6.1.
3. |
Gabapentin 300 mg capsules | Pharmaceutical form | Hard capsules (capsules):
Yellow hard capsule, imprinted with “300” and containing a white crystalline powder.
4. |
Gabapentin 300 mg capsules | 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 300 mg capsules | Clinical particulars - Posology and method of administration | Posology and method of administration
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 in this sect... |
Gabapentin 300 mg capsules | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1..
4.4 |
Gabapentin 300 mg capsules | 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 300 mg 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 300 mg capsules | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
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 malformations and ... |
Gabapentin 300 mg 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 300 mg 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 ( 1/1000 to < 1/100); rare ( 1/10000 to < 1/1000); ... |
Gabapentin 300 mg capsules | 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 300 mg 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 300 mg 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 tumours was found only in male rats at the highest dose. Peak plas... |
Gabapentin 300 mg capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsules fill:
lactose monohydrate;
maize starch;
talc.
Capsule shell:
gelatin;
titanium dioxide (E171);
yellow iron oxide (E172).
Printing ink:
shellac;
iron oxide black (E172);
propylene glycole.
6.2 |
Gabapentin 300 mg capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable
6.3 |
Gabapentin 300 mg capsules | Pharmaceutical particulars - Shelf life | Shelf life
Three years
6.4 |
Gabapentin 300 mg capsules | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not store above 30°C.
6.5 |
Gabapentin 300 mg capsules | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
PVC/aluminium foil blister packs
Supplied in packs of 100 capsules.
6.6 |
Gabapentin 300 mg capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements.
7. |
Gabapentin 300 mg capsules | Marketing authorisation holder | Rivopharm UK Ltd
30th Floor, 40 Bank Street
Canary Wharf,
London E14 5NR
United Kingdom
8. Marketing authorisation number(s)
PL 33155/0092
9. |
Gabapentin 300 mg capsules | Date of first authorisation/renewal of the authorisation | 07th August 2013
10. |
Gabapentin 300 mg capsules | Date of revision of the text | 04/2019
LEGAL CATEGORY
POM |
Gabapentin 300mg capsules | Name of the medicinal product | Gabapentin Milpharm 300 mg capsules, hard
2. |
Gabapentin 300mg capsules | Qualitative and quantitative composition | Each 300 mg hard capsule contains 300 mg gabapentin.
For the full list of excipients, see section 6.1
3. |
Gabapentin 300mg capsules | Pharmaceutical form | Capsule, hard
Gabapentin 300 mg capsules, hard, imprinted with 'D' on yellow cap and '03' on yellow body, containing white to off-white crystalline powder.
4. |
Gabapentin 300mg capsules | 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 300mg 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 300mg capsules | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Gabapentin 300mg 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 300mg 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, sedation and death associated with gabapentin when coadministered with CNS depressants, including opioids. In some of these reports, the authors considered the combinatio... |
Gabapentin 300mg 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 malforma... |
Gabapentin 300mg 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 300mg 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 (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1,000) ... |
Gabapentin 300mg 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 ga... |
Gabapentin 300mg 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, includin... |
Gabapentin 300mg 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 300mg capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsule Fill:
Maize starch
Talc
Capsule Shell:
Yellow iron oxide (E172)
Titanium dioxide (E171)
Sodium lauril sulfate
gelatin
Printing ink
Shellac
Propylene glycol
Black iron oxide
Potassium hydroxide
6.2 |
Gabapentin 300mg capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gabapentin 300mg capsules | Pharmaceutical particulars - Shelf life | Shelf life
3 years.
In use shelf life for HDPE bottle pack: 12 months
6.4 |
Gabapentin 300mg capsules | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store below 25°C.
Blister pack: Store in the original package.
HDPE bottle pack: Store in the original container.
6.5 |
Gabapentin 300mg capsules | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Blister pack of clear PVC/PVdC – Aluminium foil:
10, 20, 30, 50, 60, 90, 100 and 200 capsules, hard.
HDPE bottle with polypropylene cap containing silica gel desiccant:
100, 200 and 1000 capsules, hard.
Not all pack sizes may be marketed
6.6 |
Gabapentin 300mg capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements.
7. |
Gabapentin 300mg capsules | Marketing authorisation holder | Milpharm Limited
Ares, Odyssey Business Park
West End Road, South Ruislip HA4 6QD
United Kingdom
8. Marketing authorisation number(s)
PL 16363/0286
9. |
Gabapentin 300mg capsules | Date of first authorisation/renewal of the authorisation | 23/12/2010
10. |
Gabapentin 300mg capsules | Date of revision of the text | 12/06/2023 |
Gabapentin 400 mg capsules | Name of the medicinal product | Gabapentin 400 mg capsules.
2. |
Gabapentin 400 mg capsules | Qualitative and quantitative composition | Each 400mg capsule contains 400 mg gabapentin.
Excipients:
Each 400 mg capsule contains 67.33 mg lactose (as monohydrate).
For a full list of excipients, see section 6.1.
3. |
Gabapentin 400 mg capsules | Pharmaceutical form | Hard capsules (capsules):
Orange hard capsule, imprinted with “400” and containing a white crystalline powder.
4. |
Gabapentin 400 mg capsules | 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 400 mg 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 400 mg capsules | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipientslisted in section 6.1..
4.4 |
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