Lyrinel XL 5mg & 10mg prolonged release tablets
*Company:
Janssen Sciences IrelandStatus:
DiscontinuedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 17 April 2020
File name
IE PIL-Lyrinel-08Apr20-Clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
5 mg:
Butylhydroxytoluene (E321), cellulose acetate 398-10, hypromellose 5 cp, polyethylene glycol 3350, magnesium stearate, polyethylene oxide 200K, polyethylene oxide 2000K, sodium chloride, black iron oxide (E172), ferric oxide yellow (E172) and lactose anhydrous.
Film coat: ferric oxide yellow (E172), hypromellose 3 cp and 6 cp, propylene polyethylene glycol 400, polysorbate 80 and titanium dioxide (E171).
Printing Ink: black iron oxide (E172), hypromellose 6 cp and propylene glycol.
10 mg:
Butylhydroxytoluene (E321), cellulose acetate 398-10, hypromellose 5 cp, polyethylene glycol 3350, magnesium stearate, polyethylene oxide 200K, polyethylene oxide 2000K, sodium chloride, black iron oxide (E172), ferric oxide red (E172) and lactose anhydrous.
Film coat: ferric oxide red (E172), hypromellose 3 cp and 6 cp, propylene polyethylene glycol 400, polysorbate 80 and titanium dioxide (E171).
Printing Ink: black iron oxide (E172), hypromellose 6 cp and propylene glycol.
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Name of the member state |
Name of the medicinal product |
|
Greece |
LYRINEL |
|
Ireland |
LYRINEL XL |
|
Italy |
LYRINEL |
|
|
|
|
United Kingdom |
LYRINEL XL |
Updated on 17 April 2020
File name
IE SmPC-Lyrinel-08Apr20-Clean.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
5 mg:
butylhydroxytoluene (E321), cellulose acetate 398‑10, hypromellose 5 cp, polyethylene glycol 3350, magnesium stearate, polyethylene oxide 200K, polyethylene oxide 2000K, sodium chloride, black iron oxide (E172), ferric oxide yellow (E172) and lactose anhydrous.
Film coat: ferric oxide yellow (E172), hypromellose 3 cp and 6 cp, propylene polyethylene glycol 400, polysorbate 80 and titanium dioxide (E171).
Printing Ink: black iron oxide (E172), hypromellose 6 cp and propylene glycol.
10 mg:
butylhydroxytoluene (E321), cellulose acetate 398‑10, hypromellose 5 cp, polyethylene glycol 3350, magnesium stearate, polyethylene oxide 200K, polyethylene oxide 2000K, sodium chloride, black iron oxide (E172), ferric oxide red (E172) and lactose anhydrous.
Film coat: ferric oxide red (E172), hypromellose 3 cp and 6 cp, propylene polyethylene glycol 400, polysorbate 80 and titanium dioxide (E171).
Printing Ink: black iron oxide (E172), hypromellose 6 cp and propylene glycol.
Updated on 02 May 2019
File name
ie-lyrinel-pil-en-MAH Transfer and II-039-C17-26apr19-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
Updated on 02 May 2019
File name
Lyrinel-XL 5 and 10mg-ie-SmPC-mah transfer and II-039-C17-26apr19-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 April 2019
File name
ie-lyrinel-pil-en-mah transfer-C16-29mar19-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 12 April 2019
File name
Lyrinel XL-5 and 10mg-IE-SmPC-mah transfer-C16-29mar19-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 December 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 December 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2
Older People Elderly
Section 4.8
Additional advere events included under 'Not known' frequency category:
Psychiatric disorders - symptoms of depression, dependence (in patients with history of drug or substance abuse)
Gastrointestinal disorders - Pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other medicinal products that decrease intestinal motility)
Updated on 07 December 2016
File name
PIL_9532_996.pdf
Reasons for updating
- New PIL for new product
Updated on 07 December 2016
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 February 2016
Reasons for updating
- Change to date of revision
- Change of distributor details
Updated on 03 August 2015
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 31 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to further information section
- Change to date of revision
Updated on 01 September 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2: Excipient(s) with known effect: Each LYRINEL XL prolonged release tablet contains 0.03 mg lactose.
4.2: administrative change
4.3: administrative change
4.4: Additional information regarding anticholinergics. Additional conditions listed for caution.
4.5: Additional information regarding anticholinergic activity of oxybutynin and regarding concomitant use with CYP3A4 inhibitors
4.6: Use of Lyrinel XL during breastfeeding is not recommended.
4.8: Additional adverse drug reactions listed, wording added regarding reporting of adverse events
5.2: Deletion of second paragraph re pharmacokinetic parameters. Additional of information regarding linearity/non-linearity
10: 31 July 2014
Updated on 29 August 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
Updated on 08 February 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
1. Addition of new ADRs: Abdominal discomfort, Chest discomfort, Dysphonia, Fluid retention, Frequent bowel movements, Nasal congestion, Oropharyngeal pain, Residual urine and Throat irritation
2. Deletion of 111 terms
3. Revision of ADRs’ frequencies
4. Revision of “List of adverse reactions” paragraph to include CT information
5. Deletion of “Undesirable effects noted with other oxybutyn formulations” paragraph
6. Addition of “Description of selected adverse reactions” paragraph
Updated on 08 February 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 12 October 2012
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to section 5.2: Addition of information on Distribution and Paediatric Popluation. Amendments to Absorption and Metabolism and excretion
Change to section 5.3: Minor administrative change from Preclinical to Non-clinical.
Change to section 10: 09 October 2012
Updated on 29 May 2012
Reasons for updating
- Change to section 4 - Clinical particulars
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.1 Therapeutic indications:
Rewording - deletion of elderly
Section 4.2 Posology and method of administration:
Inclusion of missed dose advice, elderly patients dosage adjustment, info on why to be swallowed whole.
Section 4.3 Contraindications:
Oxybutynin is replaced by active substance
Section 4.4 Special warnings and precautions for use:
Inclusion of angioedema and related info
Section 4.5 Interactions:
Inclusion of paediatric population paragraph
Section 4.6 Fertility, pregnancy and lactation:
Pregnancy – reworded to not recommended; breast-feeding – reworded to should not be used; addition of fertility paragraph
Section 4.7 Effects on ability to drive:
Addition of has minor influence
Section 4.8 Undesirable effects:
Addition of summary of safety profile intro; addition of anaphylactic reaction and angioedema (not known); hypersensitivity moved from rare to uncommon; addition of paediatric population trial info and adverse reaction table of ADRs.
Section 4.9 Overdose:
Deletion of “Adults: 0.5 to 2.0 mg i.v. slowly, repeated after 5 minutes if necessary, up to a maximum of 5 mg.” and dosage of diazepam.
Updated on 28 May 2012
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 03 January 2012
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
For the full list of excipients, see Section 6.1.
Section3:
Lyrinel XL 5 mg prolonged release tablets: Round yellow coloured tablet, approximately 7.5 mm in diameter, printed with “5 XL" on one side in black ink.
Lyrinel XL 10 mg prolonged release tablets: Round pink coloured tablet, approximately 7.5 mm in diameter, printed with “10 XL" on one side in black ink.
Section 6.1:
5 mg
butylhydroxytoluene (E321), cellulose acetate 398-10,, hypromellose 5 cp, macrogol 3350, magnesium stearate, macrogol 200 000, macrogol 2 000 000, sodium chloride, black iron oxide (E172), ferric oxide yellow (E172) and lactose anhydrous.
Film coat: ferric oxide yellow (E172), hypromellose 3 cp and 6 cp, macrogol 400, polysorbate 80 and titanium dioxide (E171).
Printing Ink: black iron oxide (E172), hypromellose 6 cp and propylene glycol.
10 mg
butylhydroxytoluene (E321), cellulose acetate 398-10, hypromellose 5 cp, macrogol 3350, magnesium stearate, macrogol 200 000, macrogol 2 000 000, sodium chloride, black iron oxide (E172), ferric oxide red (E172) and lactose anhydrous.
Film coat: ferric oxide red (E172), hypromellose 3 cp and 6 cp, macrogol 400, polysorbate 80 and titanium dioxide (E171).
Printing Ink: black iron oxide (E172), hypromellose 6 cp and propylene glycol.
Section 10:
December 2011
Updated on 22 December 2011
Reasons for updating
- Change to, or new use for medicine
- Change to further information section
- Change to date of revision
Updated on 19 September 2011
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.1:
Adults and Elderly
For the symptomatic treatment of urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with unstable bladder.
Children over the age of 6 years
The symptomatic treatment of detrusor hyperreflexia secondary to a neurogenic condition.
Paediatric population
Oxybutynin hydrochloride is indicated in children over 5 years of age for:
- Urinary incontinence, urgency and frequency in unstable bladder conditions due to idiopathic overactive bladder or neurogenic bladder disorders (detrusor overactivity).
- Nocturnal enuresis associated with detrusor overactivity, in conjunction with nondrug therapy, when other treatment has failed.
Section 4.2
…/
Children over the age of 5 6 years
Initial dose of 5 mg once a day increased in 5 mg increments up to a maximum of 15 mg once a day.
Lyrinel XL is not recommended for use in children below age of 5 6 years, due to a lack of data on safety and efficacy (see sections 5.1 and 5.2).
/…
Section 4.4
Paediatric population
Oxybutynin hydrochloride is not recommended for use in children below age 5 years due to insufficient data on safety and efficacy.
There is limited evidence supporting the use of Oxybutynin in children with monosymptomatic nocturnal enuresis (not related to detrusor overactivity).
In children over 5 years of age, Oxybutynin hydrochloride should be used with caution as they may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.
Updated on 14 September 2011
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
Updated on 22 June 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
Change to section 2 - Qualitative and quantitative composition |
Excipient: Each Lyrinel XL prolonged release tablet contains 0.03 mg lactose.
|
|
Change to section 6.1 - List of excipients |
5 mg Butylhydroxytoluene (E321), cellulose acetate 398-10, hypromellose 5 cp , macrogol 3350, magnesium stearate, macrogol 200 000, macrogol 2 000 000, sodium chloride, black iron oxide (E172), ferric oxide yellow (E172) and lactose anhydrous. Film coat: ferric oxide yellow (E172), hypromellose 3 cp and 6 cp, macrogol 400, polysorbate 80 and titanium dioxide (E171) Printing Ink: black iron oxide (E172), hypromellose 6 cp, propylene glycol and purified water. 10 mg Butylhydroxytoluene (E321), cellulose acetate 398-10, hypromellose 5 cp, macrogol 3350, magnesium stearate, macrogol 200 000, macrogol 2 000 000, sodium chloride, black iron oxide (E172), ferric oxide yellow (E172) and lactose anhydrous. Film coat: ferric oxide red (E172), hypromellose 3 cp and 6 cp, macrogol 400, polysorbate 80 and titanium dioxide (E171) Printing Ink: black iron oxide (E172), hypromellose 6 cp, propylene glycol and purified water.
|
|
Change to section 6.3 - Shelf life |
Lyrinel XL 5mg: 2 years Lyrinel XL 10mg: 18 months
|
|
Change to section 6.6 - Special precautions for disposal and other handling |
Do not remove or swallow the sachet of granules in the bottle. This contains desiccant, which keeps the tablets dry
|
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Change to section 9 - Date of renewal of authorisation |
27th August 2004/14th June 2010
|
|
Change to section 10 - Date of revision of the text |
June 2011 |
Updated on 20 June 2011
Reasons for updating
- Change of trade or active ingredient name
- Change to, or new use for medicine
- Change to storage instructions
- Change to further information section
- Change to date of revision
Updated on 01 December 2010
Reasons for updating
- Change to storage instructions
Updated on 25 September 2009
Reasons for updating
- Change to MA holder contact details
Updated on 07 July 2009
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
Change to section 4.8 – Undesirable effects |
Addition of memory impairment as an ADR |
|
Change to section 10 – Date of revision of text |
June 2009 |
Updated on 29 June 2009
Reasons for updating
- Change to date of revision
- Change due to harmonisation of PIL
Updated on 06 November 2008
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
Change to section 4.8 Undesirable effects |
Updated Table |
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Change to section 10 Date of revision of text |
October 2008 |
Updated on 19 August 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
X |
Change to section 7 – Marketing Authorisation Holder |
Address changed to new site address |
|
X |
Change to section 10 – Date of revision of text |
August 2008 |
Updated on 19 August 2008
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder address
Updated on 05 June 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
Change to section 1 – trade name NAME OF THE MEDICINAL PRODUCT
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Minor Change |
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Change to section 2 – quantitative and qualitative composition |
Minor Change |
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Change to section 3 – pharmaceutical form |
Minor Change |
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Change to section 4.2 – Posology and |Method of Administration |
Minor Change |
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Change to section 4.3 – Contra-indications |
Minor Change |
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Change to section 4.4 – Special Warnings and Precautions for Use |
Major Change |
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Change to section 4.5 –Interaction with other medicinal products and other forms of interaction |
Minor Change |
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Change to section 4.6 – Pregnancy and Lactation |
Minor Change |
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Change to section 4.7 - Effects on Ability to Drive and Use Machines |
Minor Change |
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Change to section 4.9 - Overdose |
Minor Change |
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Change to section 5.2 - Pharmacokinetic properties |
Minor Change |
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Change to section 5.3 - Preclinical Safety Data |
Minor Change |
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Change to section 10 – Date of revision of text |
Change to June 2008 |
Updated on 14 November 2006
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 November 2006
Reasons for updating
- Change to, or new use for medicine
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 06 November 2006
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
4.1 |
Therapeutic Indications |
New indication added Children over the age of 6 years The symptomatic treatment of detrusor hyperreflexia secondary to a neurogenic condition. |
|
4.2 |
Posology and method of administration |
Text deleted The safety and efficacy of Lyrinel XL have not been established in patients under 18 years. The use of Lyrinel XL in children is not recommended. Text inserted Children over the age of 6 years Initial dose of 5mg once a day increased in 5mg increments up to a maximum of 15mg once a day. The safety and efficacy of Lyrinel XL has not been established in patients less than 6 years. |
|
4.3 |
Contraindications |
Text inserted Porphyria |
|
4.4 |
Special Warnings and Precautions for Use |
Text inserted Heat stroke added to following sentence When oxybutynin is used in patients with fever or in high environmental temperatures, this can cause heat prostration, or heat stroke due to decreased sweating. |
|
4.8 |
Undesirable effects |
Text inserted Night terror added to following sentence Additional rare adverse events reported from worldwide post-marketing experience with oxybutynin chloride include hallucinations, convulsions, night terror and erectile dysfunction. |
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5.1 |
Pharmacodynamic properties |
Text inserted
Children over the age of 6 years: in children with detrusor hyperreflexia secondary to a neurogenic condition, oxybutynin, in combination with clean intermittent urinary catheterisation, has been shown in open uncontrolled studies to increase mean urine volume per catherisation, increase maximum cystometric capacity and decrease mean detrusor pressure at maximum cystometric capacity. |
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5.2 |
Pharmacokinetic properties |
Text inserted Limited data suggest that the pharmacokinetics of Lyrinel XL is similar in adults and children aged 8 years and above. The pharmacokinetics of Lyrinel XL have not been investigated in patients with renal or hepatic insufficiency. Text deleted The pharmacokinetics of Lyrinel XL tablets have not been investigated in children, nor in patients with renal or hepatic insufficiency. |
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10. |
DATE OF REVISION OF THE TEXT |
Changed to 18th July 2006 |
Updated on 21 November 2005
Reasons for updating
- Change to drug interactions
- Change to side-effects
Updated on 18 November 2005
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 April 2005
Reasons for updating
- New PIL for new product
Updated on 04 April 2005
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)