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Plenachol® D Capsules The only range of liquid 1MG/ML STRENGTH
3

NEW
(Colecalciferol) omeprazole products, licensed

from one month
from one month
20 000 IU x 10 pack & 40 000 IU x 7 pack

• • Carefully selected
• Trusted by primary and
Indicated as prevention and treatment of vitamin D deficiency. As an adjunct to specific therapy
for osteoporosis in patients with vitamin D deficiency or at risk of Vitamin D insufficiency. secondary care healthcare ingredients, no propylene
professionals. glycol, ethanol or sugar.
• • Format allows for
• Natural ﬂ avourings. 1mg/ml
is strawberry ﬂ avoured. mg/kg dosing.
Gelatin Strawberry is the most
FREE popular ﬂ avour with • The range allows for 5mg,

1
children . 2mg/ml and 10mg and 20mg dosing
with a single 5ml dose.
4mg/ml are mint ﬂ avoured.
Gelatin Free • • Uniquely the 1mg/ml
• Ambient storage until
Suitable for Vegetarians constituted. strength can be mixed
with baby’s milk to aid
Kosher and Halal Certified administration.

Licenced Medicine

Manufactured in the UK
Making a happy difference
Prescribing Information: Making a ha pp y diff er ence

Plenachol D 3 (Colecalciferol) 20 000 IU and 40 000 IU Capsules
for patients with GORD*
Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Presentation: Each Plenachol D3 20 000 IU capsule contains patients who are susceptible to form calcium-containing renal calculi formulation should be used. There are no or limited amount of data
equivalent to 0.5 mg vitamin D3. Each Plenachol D3 40 000 IU capsule (kidney stone); severe renal impairment; children under 12 years from the use of colecalciferol in pregnant women. The recommended
contains equivalent to 1.0 mg vitamin D3. due to their inability to swallow capsules and/or the potential risk of daily intake for pregnant women is 400 IU, however, in women who *Gastro-Oesophageal Reﬂ ux Disease
Indications: Prevention and treatment of vitamin D deficiency. As an choking; hypervitaminosis D. are considered to be vitamin D deficient a higher dose may be required.
adjunct to specific therapy for osteoporosis in patients with vitamin D Warnings and Precautions: Use with caution in patients with Vitamin D and its metabolites are excreted in breast milk. Vitamin Abbreviated Prescribing Information: Omeprazole 1 mg/ml, Powder for Oral Suspension. Consult Summary of Product Characteristics for one week, which may be repeated. Treatment and prevention of NSAID-associated gastric and duodenal ulcers: 20mg once daily, for 4
deficiency or at risk of Vitamin D insufficiency. impairment of renal function. The effect on calcium and phosphate D can be prescribed while the patient is breast-feeding if necessary, before prescribing. Presentation: White/off-white/slightly yellow powder, each ml of reconstituted suspension contains 1 mg of omeprazole. weeks, which may be repeated. Treatment of reﬂ ux esophagitis: 20mg once daily for 4 weeks, which may be repeated. Severe esophagitis
Therapeutic Indications: Omeprazole Oral Suspension is indicated for treatment of reﬂ ux esophagitis; Symptomatic treatment of heartburn
40mg once daily for 8 weeks. Long-term management of patients with healed reﬂ ux esophagitis: 10 – 40mg once daily. Treatment of
Dosage and Administration: Adults: Prevention: 20 000 IU levels should be monitored, and the risk of soft tissue calcification though this supplementation does not replace the administration of and acid regurgitation in gastro-esophageal reﬂ ux disease in children aged 1 – 12 months of age. Posology and Method of Administration: symptomatic gastro-esophageal reﬂ ux disease: 10-20mg daily. Paediatric population: 1 month to 1 year: 1mg/kg once daily.1 year
a month. Higher doses may be required in certain situations, as should be taken into account. Caution is required in patients receiving vitamin D to the neonate. There is no data regarding treatment with Omeprazole Oral Suspension should be taken on an empty stomach following reconstitution, at least 30 minutes before a meal. The oral 10 – 20mg once daily. 2 years of age 20 – 40mg once daily. Reﬂ ux esophagitis: Treatment 4 – 8 weeks. Symptomatic treatment o
detailed below. Treatment: 40 000 IU/week for 7 weeks, followed treatment for cardiovascular disease. Use with caution in patients vitamin D3 and its effects on fertility. suspension should not be mixed or administered with any drinks or foods other than milk. Omeprazole can be administered via nasogastric heartburn and acid regurgitation in gastro-esophageal reﬂ ux disease: Treatment 2 – 4 weeks. Children over 4 years of age and adolescents:
Treatment of duodenal ulcer caused by H. pylori: 10 – 20mg depending on weight + suitable antibiotic twice daily for one week. Special
(NG) or percutaneous endoscopic gastrostomy (PEG) tubes. Paediatric population aged 1 month to 12 months: Omeprazole 1 mg/ml
by maintenance therapy (equivalent to 1400-2000 IU/day, such as with sarcoidosis, due to a possible increase in the metabolism of Adverse Events include: See SmPC for details of adverse events. oral suspension should be used for patients weighing ≥ 2 kg to ≤ 5 kg. 1 mg/kg body weight once daily is recommended. Individual dose populations: Dose adjustment is not needed in patients with impaired renal function. In patients with impaired hepatic function a daily dose
one 40 000 IU capsule or two to three 20 000 IU capsules per month, vitamin D in its active form. In these patients the serum and urinary measurements ≤ 2 ml are not indicated. The treatment time is 4-8 weeks for reﬂ ux esophagitis and 2–4 weeks for heartburn and acid of 10 – 20mg may be sufﬁ cient. Dose adjustment is not needed in the elderly. Method of administration: Oral suspension should be taken
may be required. Follow-up 25(OH)D measurements should be made calcium levels should be monitored. Allowances should be made Presentation and Price: 20 000 IU capsules x 10 £9.00; 40 000 IU regurgitation in gastro-esophageal reﬂ ux disease. Dose adjustment is not needed in patients with impaired renal function. Contraindications: on an empty stomach, at least 30 minutes before a meal. Omeprazole can be administered via nasogastric (NG) or percutaneous endoscopic
gastrostomy (PEG) tubes. Contraindications: Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients.
Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients listed and concomitant use with nelﬁ navir.
approximately three to four months after initiating maintenance for the total dose of vitamin D in cases associated with treatments capsules x 7 £10.50 Special Warnings and Precautions for use: Caution should be exercised when used as Omeprazole may alleviate symptoms of malignancy Omeprazole must not be used with nelﬁ navir. Special Warnings and Precautions for use: Caution should be exercised when used as
therapy to confirm that the target level has been achieved). already containing vitamin D, foods enriched with vitamin D, cases Legal Category: POM and delay diagnosis. Concomitant use with atazanavir is not recommended. Omeprazole may reduce the absorption of vitamin B12 and the Omeprazole may alleviate symptoms of malignancy and delay diagnosis. Concomitant use with atazanavir is not recommended. Omeprazole
Adolescents 12-18 years old: Prevention: 20 000 IU every 6 weeks. using milk enriched with vitamin D, and the patient’s level of sun Further information is available from: potential for interactions with drugs metabolised through CYP2C19 should be considered. Severe hypomagnesaemia has been reported in may reduce the absorption of vitamin B12 and the potential for interactions with drugs metabolised through CYP2C19 should be considered.
Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) like omeprazole for at least three months,
patients treated with proton pump inhibitors (PPIs) like omeprazole for at least three months, and in most cases for a year. Increased risk of
Treatment: 20 000 IU once every 2 weeks for 6 weeks (followed by exposure. There is no clear evidence for causation between vitamin D Accord-UK Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS. hip, wrist and spine fracture in high doses and over long durations (>1 year) should be considered. Severe cutaneous adverse reactions are and in most cases for a year. Increased risk of hip, wrist and spine fracture in high doses and over long durations (>1 year) should be
maintenance therapy equivalent to 400-1000 IU/day, such as one 20 supplementation and renal stones, but the risk is plausible, especially Marketing Authorisation Numbers: reported in association with omeprazole treatment. Treatment should be discontinued in case of suspected acute tubulointerstitial nephritis considered. Severe cutaneous adverse reactions are reported in association with omeprazole treatment. Treatment should be discontinued in
000 IU capsule per month). Children under 12 years old: Should not be in the context of concomitant calcium supplementation. The need PL 20075/0672 and PL 20075/0673 and subacute cutaneous lupus erythematosus. Omeprazole treatment should be stopped for at least 5 days before Increased Chromogranin case of suspected acute tubulointerstitial nephritis and subacute cutaneous lupus erythematosus. Omeprazole treatment should be stopped
given due to the risk of choking. Certain populations are at high risk for additional calcium supplementation should be considered for Date of PI Preparation: November 2022 measurements. Slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter are associated with proton pump for at least 5 days before Increased Chromogranin measurements. Slightly increased risk of gastrointestinal infections such as Salmonella
and Campylobacter are associated with proton pump inhibitors. Care should be exercised in patients with reduced kidney function or patients
inhibitors. Care should be exercised in patients with reduced kidney function or patients on a controlled potassium diet as this medicine
of vitamin D deficiency and may require monitoring of serum 25 (OH) individual patients. Calcium supplements should be given under close Document number: UK-01695 contains 54.3 mg (1.39 mmol) potassium per ml or 271.5 mg (6.95 mmol) of potassium per 5 ml dose. Allergic reactions may be on a controlled potassium diet as this medicine contains 54.3 mg (1.39 mmol) potassium per ml or 271.5 mg (6.95 mmol) of potassium
D and higher doses. These include patients who are institutionalised, medical supervision. Oral high-dose vitamin D (500 000 IU by single caused by the excipient sodium methyl para hydroxybenzoate. Risk for neonatal jaundice should be considered and patients with fructose per 5 ml dose. Allergic reactions may be caused by the excipient sodium methyl para hydroxybenzoate. Patients with fructose intolerance
hospitalised, obese, dark skinned, being evaluated for osteoporosis; annual bolus) was reported to result in increased risk of fractures intolerance should not take this medicine as it contains maltitol. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle should not take this medicine as it contains maltitol. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not
applicable. Legal Category: Prescription only medicine. The reported adverse reactions are: Leukopenia, thrombocytopenia, Agranulocytosis,
notice (if relevant): N/A. Legal Category: POM. The reported adverse reactions are: Leukopenia, thrombocytopenia, Agranulocytosis,
using certain concomitant medications (e.g., anticonvulsant in the elderly. Treatment with vitamin D can unmask previously Adverse events should be reported. pancytopenia, Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock, Hyponatraemia, Hypomagnesaemia; Pancytopenia, Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock, Hyponatraemia, Hypomagnesaemia,
medications, glucocorticoids); patients with limited sun exposure due undiagnosed primary hyperparathyroidism. Adjusted serum calcium Reporting forms and information can be hypocalcaemia, hypokalaemia, Insomnia, Agitation, confusion, depression, Aggression, hallucinations, Headache, Dizziness, paraesthesia, Hypocalcaemia, Hypokalaemia, Insomnia, Agitation, Confusion, Depression, Aggression, Hallucinations, Headache, Dizziness, Paraesthesia,
to protective clothing or consistent use of sun screens, malabsorption levels should be checked 1 month after completing the loading somnolence, Taste disturbance, Blurred vision, Vertigo, Bronchospasm, Abdominal pain, constipation, diarrhoea, ﬂ atulence, nausea/vomiting, Somnolence, Taste disturbance, Blurred vision, Vertigo, Bronchospasm, Abdominal pain, Constipation, Diarrhoea, Flatulence, Nausea/Vomiting,
Fundic gland polyps (benign), Dry mouth, Stomatitis, Gastrointestinal candidiasis, Microscopic colitis, Increased liver enzymes, Hepatitis with
fundic gland polyps (benign), Dry mouth, stomatitis, gastrointestinal candidiasis, Microscopic colitis, Increased liver enzymes, Hepatitis with
(including inflammatory bowel disease and coeliac disease); patients regimen or after starting vitamin D supplementation in case primary found at www.mhra.gov.uk/yellowcard or without jaundice, Hepatic failure, encephalopathy in patients with pre-existing liver disease, Dermatitis, pruritus, rash, urticaria, Alopecia, or without jaundice, Hepatic failure, Encephalopathy in patients with pre-existing liver disease, Dermatitis, Pruritus, Rash, Urticaria, Alopecia,
recently treated for vitamin D deficiency, and requiring maintenance hyperparathyroidism has been unmasked. Certain groups may be at an Adverse events should also be reported to photosensitivity, acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Photosensitivity, Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Subacute cutaneous lupus erythematosus,
therapy. Method of administration: Swallow capsules whole with increased risk of hypercalaemia with this treatment regimen and they Accord-UK LTD on 01271 385257 or email Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), Subacute cutaneous lupus erythematosus, Fracture of Fracture of the hip, wrist or spine, Arthralgia, Myalgia, Muscular weakness, Tubulointerstitial nephritis (with possible progression to renal
the hip, wrist or spine, Arthralgia, myalgia, Muscular weakness, Tubulointerstitial nephritis (with possible progression to renal failure),
failure), Gynaecomastia, Malaise, Peripheral oedema, and Increased sweating. Pack Size and NHS Price: Each bottle contains 90ml of oral
water, preferably with food. should be monitored by measuring adjusted serum calcium levels. Gynaecomastia, Malaise, peripheral oedema, Increased sweating. Pack Size and NHS Price: Each bottle contains 90ml of oral suspension of suspension of which at least 75ml is intended for dosing. 2mg/ml x 90 ml - £124.00 4mg/ml x 90 ml - £234.00. Marketing Authorisation
Contraindications: Hypersensitivity to colecalciferol or any of the Fertility, Pregnancy & Lactation: In pregnancy and lactation the medinfo@accord-healthcare.com which at least 75ml is intended for dosing- £111.00. Marketing Authorisation Number: PL 34111/0005. Marketing Authorisation Holder: Number: 2mg/ml –PL 34111/0002, 4mg/ml – PL 34111/0003. Marketing Authorisation Holder: Xeolas Pharmaceuticals Limited,
excipients, hypercalcaemia and/or hypercalciuria; nephrolithiasis, or high strength formulation is not recommended and a low strength Xeolas Pharmaceuticals Limited, Hamilton Building, DCU, Glasnevin, Dublin 9, Ireland. Date of Preparation: July 2023. Hamilton Building, DCU, Glasnevin, Dublin 9, IRELAND. Date of Preparation: July 2023. ROS000019-029 October 2023
Abbreviated Prescribing Information: Omeprazole 2mg/ml and 4mg/ml, Powder for Oral Suspension. Consult Summary of Product Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard
UK-05795 | Date of Preparation: February 2024 Characteristics before prescribing. Presentation: The reconstituted suspension will be a white / off-white / brownish suspension containing Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400.
2mg/ml or 4mg/ml omeprazole. Therapeutic Indications: Adults: Treatment of duodenal ulcers, gastric ulcers, NSAID-associated gastric and
duodenal ulcers, reﬂ ux esophagitis, symptomatic gastro-esophageal reﬂ ux disease, prevention of relapse of duodenal ulcers, gastric ulcers,
in combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease, long-term management of Reference 1. Generation R. What ﬂ avour would children choose for their medicine? Available at https://generationr.org.uk/
patients with healed reﬂ ux esophagitis. Paediatric use: Children over 1 month of age: treatment of reﬂ ux esophagitis, symptomatic treatment what-ﬂ avour-would-children-choose-for-their-medicines/ Accessed September 2023.
of heartburn and acid regurgitation in gastroesophageal reﬂ ux disease. Children over 4 years of age and adolescents: In combination with
antibiotics in treatment of duodenal ulcer caused by H. pylori. Posology and Method of Administration: Adults: Treatment and prevention of Rosemont Pharmaceuticals Ltd. Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds LS11 9XE
5 5
or call us on 01904 558 350
relapse of duodenal ulcers, gastric ulcers: 10 – 40mg once daily. H. pylori eradication 20 – 40mg once or twice daily + suitable antibiotic T +44 (0)113 244 1400 E infodesk@rosemontpharma.com Sales/Customer Service: T +44 (0) 113 244 1999 W www.rosemontpharma.com
19/10/2023 16:32
ROS000019-029 - Omeprazole Press Ad - A4 - Oct 2023.indd 1
ROS000019-029 - Omeprazole Press Ad - A4 - Oct 2023.indd 1 19/10/2023 16:32

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