- Approval Id
- 3842f7a752fb2d31
- Drug Approval Emc Name
- Spasmonal 60 mg Hard Capsules
- Drug Name
- Spasmonal 60 mg Hard Capsules
- Company Address
- Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL
- Company Website
- http://www.mylan.com
- Company Telephone
- +44 (0)1707 853 000
- Company Medical Info Direct Line
- +44 (0)1707 853 000
- Company Medical Info Email
- info@mylan.co.uk
- Company Customer Care Direct Line
- +44 (0)1707 853 000 select option 2
- Company Medical Info Fax
- +44 (0)1707 261 803
- Company Stock Availability
- +44 (0)1707 853 000 select option 2
- Atc Code
- A03AX08
- Legal Category
- Pharmacy
- Authorisation Holder
- Mylan Products Ltd,
Station Close,
Potters Bar,
Hertfordshire,
EN6 1TL,
United Kingdom
- Authorisation Number
- PL 46302/0141
- Authorisation Date
- June 1998
- Instruction Authorisation Holder
- Mylan Products Ltd,
Station Close,
Potters Bar,
Hertfordshire,
EN6 1TL,
United Kingdom
- Instruction Authorisation Number
- PL 46302/0141
- Instruction Authorisation Date
- June 1998
- Instruction Composition
- Each capsule contains 60mg alverine citrate.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Hard capsules.
An opaque size 3 capsule with a grey cap and blue body, marked “SP 60”.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
The relief of smooth muscle spasm, in conditions such as irritable bowel syndrome, painful diverticular disease of the colon and primary dysmenorrhoea4.2 Posology and method of administration
\*\*Posology\*\*
\*\*\*Adults and the elderly\*\*\*
1or 2 capsules one to three times daily.
\*\*\*Children below the age of 12 years\*\*\*
Not recommended.
\*\*Method of administration\*\*
For oral use.4.3 Contraindications
• Paralytic ileus
• Intestinal obstruction
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.4.4 Special warnings and precautions for use
Additional warnings to be included in the Patient Information Leaflet:
If this is the first time you have had these symptoms, consult your doctor before using any treatment.
If any of the following apply do not use SPASMONAL 60 mg; it may not be the right treatment for you. See your doctor as soon as possible if:
- you are aged 40 years or over
- you have passed blood from the bowel
- you are feeling sick or vomiting
- you have lost your appetite or lost weight
- you are looking pale and feeling tired
- you are suffering from severe constipation
- you have a fever
- you have recently travelled abroad
- you are or may be pregnant
- you have abnormal vaginal bleeding or discharge
- you have difficulty or pain passing urine.
Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment\*\*.\*\*4.5 Interaction with other medicinal products and other forms of interaction
None stated.4.6 Pregnancy and lactation
Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in Preclinical studies is limited.4.7 Effects on ability to drive and use machines
May cause dizziness. Do not drive or use machinery if affected.4.8 Undesirable effects
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories:
Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data)
The following undesirable effects were observed:
\*\*Immune system disorders\*\*
| | |
| --- | --- |
| Not known | anaphylaxis, allergic reaction |
\*\*Nervous system disorders\*\*
| | |
| --- | --- |
| Not known | dizziness, headache |
\*\*Respiratory, thoracic and mediastinal disorders\*\*
| | |
| --- | --- |
| Not known | dyspnoea and/or wheezing |
\*\*Gastrointestinal disorders\*\*
| | |
| --- | --- |
| Not known | nausea |
\*\*Hepatobiliary disorders\*\*
| | |
| --- | --- |
| Not known | jaundice due to hepatitis (typically resolves on cessation of alverine), liver function test abnormal |
\*\*Skin and subcutaneous tissue disorders\*\*
| | |
| --- | --- |
| Not known | rash, itching |
\*\*\*\*Reporting of suspected adverse reactions\*\*\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
\*Symptoms:\*
Can produce hypotension and atropine-like toxic effects.
Management is as for atropine poisoning with supportive therapy for hypotension.
Fatality has occurred following overdose with very high doses.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other drugs for functional gastrointestinal disorders.
ATC code: A03 AX08
Alverine citrate is an antispasmodic with a direct action on smooth muscle.
Alverine citrate is a spasmolytic, which has a specific action on the smooth muscle of the alimentary tract and uterus, without affecting the heart, blood vessels and tracheal muscle at therapeutic doses.5.2 Pharmacokinetic properties
After oral administration, alverine is rapidly converted to its primary active metabolite, which is then further converted to two secondary metabolites. There is a high renal clearance of all metabolites indicating that they are eliminated by active renal secretion. The peak plasma level of the most active metabolite occurs between 1 and 1½ hours after oral dosing.
The plasma half-life averages 0.8 hours for alverine and 5.7 hours for the active primary metabolite.5.3 Preclinical safety data
Although preclinical data are limited, those available indicate that alverine citrate has no significant potential for toxicity at the proposed dose level.
Alverine citrate acts selectively on gut and uterine muscle, only affecting the heart, blood vessels and tracheal muscle at considerably higher doses.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Maize Starch
Magnesium Stearate
Capsule Shell:
Gelatin, E132, E171, E172
Printing ink: Shellac, Black Iron Oxide (E172), Propylene Glycol6.2 Incompatibilities
Not applicable.6.3 Shelf life
3 years.6.4 Special precautions for storage
Store in the original package in order to protect from moisture. Do not store above 25°C.6.5 Nature and contents of container
Plastic containers of 20 or 100 capsules; Aluminium foil/PVC /PVdC blister packs containing 3, 10, 12, 20, 90 or 100 capsules.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
- Instruction Content
- ## Composition
Each capsule contains 60mg alverine citrate.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Hard capsules.
An opaque size 3 capsule with a grey cap and blue body, marked “SP 60”.
## Clinical Particulars
4.1 Therapeutic indications
The relief of smooth muscle spasm, in conditions such as irritable bowel syndrome, painful diverticular disease of the colon and primary dysmenorrhoea4.2 Posology and method of administration
\*\*Posology\*\*
\*\*\*Adults and the elderly\*\*\*
1or 2 capsules one to three times daily.
\*\*\*Children below the age of 12 years\*\*\*
Not recommended.
\*\*Method of administration\*\*
For oral use.4.3 Contraindications
• Paralytic ileus
• Intestinal obstruction
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.4.4 Special warnings and precautions for use
Additional warnings to be included in the Patient Information Leaflet:
If this is the first time you have had these symptoms, consult your doctor before using any treatment.
If any of the following apply do not use SPASMONAL 60 mg; it may not be the right treatment for you. See your doctor as soon as possible if:
- you are aged 40 years or over
- you have passed blood from the bowel
- you are feeling sick or vomiting
- you have lost your appetite or lost weight
- you are looking pale and feeling tired
- you are suffering from severe constipation
- you have a fever
- you have recently travelled abroad
- you are or may be pregnant
- you have abnormal vaginal bleeding or discharge
- you have difficulty or pain passing urine.
Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment\*\*.\*\*4.5 Interaction with other medicinal products and other forms of interaction
None stated.4.6 Pregnancy and lactation
Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in Preclinical studies is limited.4.7 Effects on ability to drive and use machines
May cause dizziness. Do not drive or use machinery if affected.4.8 Undesirable effects
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories:
Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data)
The following undesirable effects were observed:
\*\*Immune system disorders\*\*
| | |
| --- | --- |
| Not known | anaphylaxis, allergic reaction |
\*\*Nervous system disorders\*\*
| | |
| --- | --- |
| Not known | dizziness, headache |
\*\*Respiratory, thoracic and mediastinal disorders\*\*
| | |
| --- | --- |
| Not known | dyspnoea and/or wheezing |
\*\*Gastrointestinal disorders\*\*
| | |
| --- | --- |
| Not known | nausea |
\*\*Hepatobiliary disorders\*\*
| | |
| --- | --- |
| Not known | jaundice due to hepatitis (typically resolves on cessation of alverine), liver function test abnormal |
\*\*Skin and subcutaneous tissue disorders\*\*
| | |
| --- | --- |
| Not known | rash, itching |
\*\*\*\*Reporting of suspected adverse reactions\*\*\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
\*Symptoms:\*
Can produce hypotension and atropine-like toxic effects.
Management is as for atropine poisoning with supportive therapy for hypotension.
Fatality has occurred following overdose with very high doses.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other drugs for functional gastrointestinal disorders.
ATC code: A03 AX08
Alverine citrate is an antispasmodic with a direct action on smooth muscle.
Alverine citrate is a spasmolytic, which has a specific action on the smooth muscle of the alimentary tract and uterus, without affecting the heart, blood vessels and tracheal muscle at therapeutic doses.5.2 Pharmacokinetic properties
After oral administration, alverine is rapidly converted to its primary active metabolite, which is then further converted to two secondary metabolites. There is a high renal clearance of all metabolites indicating that they are eliminated by active renal secretion. The peak plasma level of the most active metabolite occurs between 1 and 1½ hours after oral dosing.
The plasma half-life averages 0.8 hours for alverine and 5.7 hours for the active primary metabolite.5.3 Preclinical safety data
Although preclinical data are limited, those available indicate that alverine citrate has no significant potential for toxicity at the proposed dose level.
Alverine citrate acts selectively on gut and uterine muscle, only affecting the heart, blood vessels and tracheal muscle at considerably higher doses.
## Pharmaceutical Particulars
6.1 List of excipients
Maize Starch
Magnesium Stearate
Capsule Shell:
Gelatin, E132, E171, E172
Printing ink: Shellac, Black Iron Oxide (E172), Propylene Glycol6.2 Incompatibilities
Not applicable.6.3 Shelf life
3 years.6.4 Special precautions for storage
Store in the original package in order to protect from moisture. Do not store above 25°C.6.5 Nature and contents of container
Plastic containers of 20 or 100 capsules; Aluminium foil/PVC /PVdC blister packs containing 3, 10, 12, 20, 90 or 100 capsules.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
- Company Detail Path
- /organization/ceb5a3a8ba5ff317/mylan-laboratories-limited
