medication_name stringlengths 6 170 | section_title stringclasses 42
values | text stringlengths 0 47.1k |
|---|---|---|
Gabapentin 400 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 400 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 400 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 400 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 400 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 400 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 400 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 400 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 400 mg capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsules fill:
lactose monohydrate;
maize starch;
talc.
Capsule shell:
gelatin;
titanium dioxide (E171);
red and yellow iron oxide (E172).
Printing ink:
shellac;
iron oxide black (E172);
propylene glycole.
6.2 |
Gabapentin 400 mg capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable
6.3 |
Gabapentin 400 mg capsules | Pharmaceutical particulars - Shelf life | Shelf life
Three years
6.4 |
Gabapentin 400 mg capsules | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not store above 30°C.
6.5 |
Gabapentin 400 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 400 mg capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements.
7. |
Gabapentin 400 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 33155/0093
9. |
Gabapentin 400 mg capsules | Date of first authorisation/renewal of the authorisation | 07th August 2013
10. |
Gabapentin 400 mg capsules | Date of revision of the text | 04/2019
LEGAL CATEGORY
POM |
Gabapentin 400mg capsules | Name of the medicinal product | Gabapentin Milpharm 400 mg capsules, hard
2. |
Gabapentin 400mg capsules | Qualitative and quantitative composition | Each 400 mg hard capsule contains 400 mg gabapentin.
For the full list of excipients, see section 6.1
3. |
Gabapentin 400mg capsules | Pharmaceutical form | Capsule, hard
Gabapentin 400 mg capsules, hard, imprinted with 'D' on orange cap and '04' on orange body, containing white to off-white crystalline powder.
4. |
Gabapentin 400mg 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 400mg 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 400mg capsules | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Gabapentin 400mg 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 400mg 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 this a particu... |
Gabapentin 400mg 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 malformati... |
Gabapentin 400mg 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 400mg 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 400mg 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 400mg 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 400mg 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 400mg capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsule Fill:
Maize starch
Talc
Capsule Shell:
Red iron oxide (E172)
Yellow iron oxide (E172)
Titanium dioxide (E171)
Sodium lauril sulfate
gelatin
Printing ink
Shellac
Propylene glycol
Black iron oxide
Potassium hydroxide
6.2 |
Gabapentin 400mg capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gabapentin 400mg capsules | Pharmaceutical particulars - Shelf life | Shelf life
3 years.
In use shelf life for HDPE bottle pack: 12 months
6.4 |
Gabapentin 400mg 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 400mg 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, 200 and 300 capsules, hard.
HDPE bottle with polypropylene cap containing silica gel desiccant:
100, 200, 300 and 500 capsules, hard.
Not all pack sizes may be marketed
6.6 |
Gabapentin 400mg capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements.
7. |
Gabapentin 400mg 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 16363/0287
9. |
Gabapentin 400mg capsules | Date of first authorisation/renewal of the authorisation | 23/12/2010
10. |
Gabapentin 400mg capsules | Date of revision of the text | 12/06/2023 |
Gabapentin 600 mg film-coated tablets | Name of the medicinal product | Gabapentin Milpharm 600 mg film-coated tablets
2. |
Gabapentin 600 mg film-coated tablets | Qualitative and quantitative composition | Each film-coated tablet contains 600 mg gabapentin.
For the full list of excipients, see section 6.1.
3. |
Gabapentin 600 mg film-coated tablets | Pharmaceutical form | Film-coated tablet.
White, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with 'D' and '24' on either side of the break line on one side and plain on other side. The size is 17.3 mm X 9.0 mm
The tablet can be divided into equal doses.
4. |
Gabapentin 600 mg film-coated tablets | 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 s... |
Gabapentin 600 mg film-coated tablets | 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 600 mg film-coated tablets | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Gabapentin 600 mg film-coated tablets | 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 600 mg film-coated tablets | 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 combination... |
Gabapentin 600 mg film-coated tablets | 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 malfo... |
Gabapentin 600 mg film-coated tablets | 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 600 mg film-coated tablets | 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 < 1/100... |
Gabapentin 600 mg film-coated tablets | 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 600 mg film-coated tablets | 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 600 mg film-coated tablets | 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 600 mg film-coated tablets | Pharmaceutical particulars - List of excipients | List of excipients
Tablet core:
Maize Starch
Crospovidone (Type A)
Copovidone (VA 64)
Microcrystalline Cellulose (KG-1000)
Microcrystalline Cellulose (PH-102)
Magnesium Stearate
Coating material:
Hydroxypropyl cellulose
Talc
6.2 |
Gabapentin 600 mg film-coated tablets | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gabapentin 600 mg film-coated tablets | Pharmaceutical particulars - Shelf life | Shelf life
Blister: 3 years
HDPE: 2 years
6.4 |
Gabapentin 600 mg film-coated tablets | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store below 25°C.
6.5 |
Gabapentin 600 mg film-coated tablets | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Gabapentin film-coated tablets are packed in
Polyamide/Aluminium/PVC – Aluminium foil blister pack: 10, 20, 30, 50, 60, 90, 100, 200 and 500 tablets
HDPE container: 20 and 500 tablets
Not all pack sizes may be marketed.
6.6 |
Gabapentin 600 mg film-coated tablets | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. |
Gabapentin 600 mg film-coated tablets | Marketing authorisation holder | Milpharm Limited
Ares, Odyssey Business Park
West End Road, South Ruislip HA4 6QD
United Kingdom
8. Marketing authorisation number(s)
PL 16363/0269
9. |
Gabapentin 600 mg film-coated tablets | Date of first authorisation/renewal of the authorisation | 31/10/2013
10. |
Gabapentin 600 mg film-coated tablets | Date of revision of the text | 13/06/2023 |
Gabapentin 800 mg film-coated tablets | Name of the medicinal product | Gabapentin Milpharm 800 mg film-coated tablets
2. |
Gabapentin 800 mg film-coated tablets | Qualitative and quantitative composition | Each film-coated tablet contains 800 mg gabapentin.
For the full list of excipients, see section 6.1.
3. |
Gabapentin 800 mg film-coated tablets | Pharmaceutical form | Film-coated tablet.
White, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with 'D' and '25' on either side of the break line on one side and plain on other side. The size is 19.1 mm X 9.9 mm
The tablet can be divided into equal doses
4. |
Gabapentin 800 mg film-coated tablets | 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 s... |
Gabapentin 800 mg film-coated tablets | 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 in ... |
Gabapentin 800 mg film-coated tablets | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Gabapentin 800 mg film-coated tablets | 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 800 mg film-coated tablets | 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 combination... |
Gabapentin 800 mg film-coated tablets | 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 malfo... |
Gabapentin 800 mg film-coated tablets | 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 800 mg film-coated tablets | 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 800 mg film-coated tablets | 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 800 mg film-coated tablets | 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 800 mg film-coated tablets | 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 800 mg film-coated tablets | Pharmaceutical particulars - List of excipients | List of excipients
Tablet core:
Maize Starch
Crospovidone (Type A)
Copovidone (VA 64)
Microcrystalline Cellulose (KG-1000)
Microcrystalline Cellulose (PH-102)
Magnesium Stearate
Coating material:
Hydroxypropyl cellulose
Talc
6.2 |
Gabapentin 800 mg film-coated tablets | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gabapentin 800 mg film-coated tablets | Pharmaceutical particulars - Shelf life | Shelf life
Blister: 3 years
HDPE: 2 years
6.4 |
Gabapentin 800 mg film-coated tablets | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store below 25°C.
6.5 |
Gabapentin 800 mg film-coated tablets | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Gabapentin film-coated tablets are packed in
Polyamide/Aluminium/PVC – Aluminium foil blister pack: 10, 20, 30, 50, 60, 90, 100, 200 and 500 tablets
HDPE container: 20 and 500 tablets
Not all pack sizes may be marketed.
6.6 |
Gabapentin 800 mg film-coated tablets | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. |
Gabapentin 800 mg film-coated tablets | Marketing authorisation holder | Milpharm Limited
Ares, Odyssey Business Park
West End Road, South Ruislip HA4 6QD
United Kingdom
8. Marketing authorisation number(s)
PL 16363/0270
9. |
Gabapentin 800 mg film-coated tablets | Date of first authorisation/renewal of the authorisation | 31/10/2013
10. |
Gabapentin 800 mg film-coated tablets | Date of revision of the text | 13/06/2023 |
Gabapentin Amarox 100 mg hard capsules | Name of the medicinal product | Gabapentin Amarox 100 mg hard capsules
2. |
Gabapentin Amarox 100 mg hard capsules | Qualitative and quantitative composition | Each hard capsule contains 100 mg of gabapentin.
3. |
Gabapentin Amarox 100 mg hard capsules | Pharmaceutical form | Hard capsule
White to off white granular powder filled in size “3” hard gelatin capsules with white opaque cap imprinted with “H” in blue colour and white opaque body imprinted with “G1” in blue colour.
4. |
Gabapentin Amarox 100 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 100 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 100 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 100 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 100 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 100 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 100 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 100 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 100 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 100 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 100 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... |
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