Product Overview

Product & Indication Link to SmPC Link to PIL
Actos® and Competact®
pioglitazone hydrochloride/metformin hydrochloride

Actos® (pioglitazone) is indicated as second or third line treatment of type 2 diabetes mellitus as described below:(1)

as monotherapy

- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance

as dual oral therapy in combination with:

- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin

- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea

as triple oral therapy in combination with:

- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy

- Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.

After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent rountine reviews that the benefit of pioglitazone is maintained.

Actos® 15 mg, 30 mg, 45 mg tablets SmPC

Actos® 15 mg, 30 mg, 45 mg tablets PIL

Competact® (pioglitazone/metformin) is indicated as second line treatment of type 2 diabetes mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.(2)

After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.(2)

Competact® 15 mg/850 mg film-coated tablets SmPC Competact® 15 mg/850 mg film-coated tablets PIL
Adcetris®▼
brentuximab vedotin

Adcetris® is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD)(3)

Adcetris® is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT)(3)

Adcetris® is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):(3)

-  following ASCT, or

- following at least two prior therapies when ASCT or multi -agent chemotherapy is not a treatment option

Adcetris® is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL)(3)

Adcetris® is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy(3)

Adcetris® 50 mg powder for concentrate for solution for infusion SmPC Adcetris® 50 mg powder for concentrate for solution for infusion PIL

Alofisel®▼
darvadstrocel

 

Alofisel® is indicated for the treatment of complex perinal fistulae in adult patients with nonactive/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.  Alofisel should be used after conditioning of fistula.(4)

(Alofisel is marketed by Takeda UK under license from TiGenix)

 

Alofisel® 5 million cells/mL suspension for injection SmPC Alofisel® 5 million cells/mL suspension for injection PIL

Alunbrig®▼
(brigatinib)

Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. (5)

Alunbrig ® tablets SmPC 

Alunbrig ® tablets PIL 

Amias®
candesartan cilexetil

Amias® is indicated for the:(6)

- Treatment of essential hypertension in adults

- Treatment of hypertension in children and adolescents aged 6 to <18 years

- Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) when Angiotensin Converting Enzyme (ACE) inhibitors are not tolerated or as add-on therapy to ACE inhibitors in patients with symptomatic heart failure, despite optimal therapy, when mineralocorticoid receptor antagonists are not tolerated

 

Amias® tablets SmPC Amias® tablets PIL

Calcichew® & Calcichew® D3
portfolio calcium carbonate ± colecalciferol

Calcichew® 500 mg Chewable Tablets are to be chewed as a supplement source of calcium in the correction of dietary deficiencies or when normal requirements are high.

Calichew® 500 mg Chewable Tablets may be used as an adjunct to conventional therapy in the prevention and treatment of osteoorosis. They may be used as a phosphate binding agent in the management of renal failure in patients on renal dialysis.(7)

Calcichew®-500 mg chewable tablets SmPC Calcichew®-500 mg chewable tablets PIL

Calcichew® D3 Chewable Tablets should be used only as a therapeutic and not as a food supplement when the diet is deficient or when normal requirement of both components is increased.

Calcichew® D3 Chewable Tablets may be used as an adjunct to specific therapy for osteoporosis or as a therapeutic supplement in established osteomalacia, in pregnant patients at high risk of needing such a therapeutic supplementation or in malnutrition when dietary intake is less than that required.(8)

Calcichew® D3 chewable tablets SmPC Calcichew® D3 chewable tablets PIL

Calcichew® Forte Chewable Tablets are to be chewed as a supplement source of calcium in the correction of dietary deficiencies or when normal requirements are high.

Calcichew® Forte Chewable Tablets may be used as an adjunct to conventional therapy in the prevention and treatment of osteoporosis. They may be used as a phosphate binding agent in the management of renal failure in patients on renal dialysis.(9)

Calcichew® Forte chewable tablets SmPC Calcichew® Forte chewable tablets PIL

Calcichew®-D3 1000 mg/800 IU Once Daily chewable tablets are indicated for:

- Prevention and treatment of vitamin D and calcium deficiency in the elderly.

- Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.(10)

Calcichew®-D3 1000 mg/800 IU once daily chewable tablets SmPC Calcichew®-D3 1000 mg/800 IU once daily chewable tablets PIL

Calcichew®-D3 500 mg/400 IU Film-coated Tablets are indicated for:
- Prevention and treatment of vitamin D and calcium deficiency in the elderly.

- Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.(11)

Calcichew®-D3 500 mg/400 IU cfilm-coated tablets SmPC Calcichew®-D3 500 mg/400 IU film-coated tablets PIL

Calcichew®-D3 Forte 500 mg/400 IU Chewable Tablets are indicated for:
- The treatment and prevention of vitamin D/calcium deficiency (characterised by raised serum alkaline phosphatase levels associated with increased bone loss, raised levels of serum PTH and lowered 25-hydroxyvitamin D) particularly in the housebound and institutionalised elderly subjects.

- The supplementation of Viatmin D and calcium as an adjunct to specific therapy for osteoporosis, in pregnancy, in established vitamin D dependent osteomalacia, and in other situations requiring therapeutic supplmentation of malnutrition.(12)

Calcichew®-D3 Forte 500 mg / 400 IU chewable tablets SmPC Calcichew®-D3 Forte 500 mg / 400 IU chewable tablets PIL
Condyline®
podophyllotoxin cutaneous solution

Condyline® cutaneous solution is indicated for the topical treatment of condylomata acuminata (warts) affecting the penis or the female external genitalia.(13)

Condyline® SmPC Condyline® PIL
Edarbi®
azilsartan medoxomil potassium

Edarbi® is indicated for the treatment of essential hypertension in adults.(14)

 

Edarbi® tablets SmPC Edarbi® tablets PIL
Entyvio®
vedolizumab

Entyvio® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis or moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.(15)

Entyvio® 300 mg powder for concentrate for solution for infusion SmPC Entyvio® 300 mg powder for concentrate for solution for infusion PIL
Instanyl®
fentanyl citrate nasal spray

Instanyl® is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.

Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.(16)

 

 

 

 

 

Instanyl® 50 mcg/dose nasal spray, solution in single-dose container SmPC

Instanyl®  100 mcg/dose nasal spray, in single solution container SmPC

Instanyl®  200 mcg/dose nasal spray, in single solution container SmPC 

Instanyl® 50 mcg/dose nasal spray PIL

Instanyl® 100 mcg/dose nasal spray PIL

Instanyl® 200 mcg/dose nasal spray PIL

Matrifen®
fentanyl transdermal patches

Matrifen® transdermal patches are indicated in adults for:(17) 

- Severe chronic pain that requires continuous long term opioid administration

And in children for:(17) 
- Long term management of severe chronic pain in children receiving opioid therapy from 2 years of age

Matrifen® SmPC Matrifen® PIL
Mepact®
mifamurtide

Mepact® is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection.

It is used in combination with post-operative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis.(18)

Mepact® 4 mg powder for suspension for infusion SmPC Mepact® 4 mg powder for suspension for infusion PIL

Ninlaro®▼
ixazomib citrate

Ninlaro® in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.(19)

Ninlaro® 2.3 mg hard capsules SmPC

Ninlaro® 3 mg hard capsules SmPC

Ninlaro® 4 mg hard capsules SmPC

Ninlaro® 2.3 mg hard capsules PIL

Ninlaro® 3 mg hard capsules PIL

Ninlaro® 4 mg hard capsules PIL

 

Protium® IV & Pantoprazole gastro-resistant tablets
pantoprazole sodium sesquihydrate

Pantoprazole 20 mg gastro-resistant tablets are indicated in adults and adolescents 12 years of age and above for the treatment of:(20) 

- Symptomatic gastro-oesophageal reflux disease

- For long-term management and prevention of relapse in reflux oesophagitis

And in adults for the:(20)

- Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment

Pantoprazole® 20 mg gastro-resistant tablets SmPC Pantoprazole® 20 mg gastro-resistant tablets PIL

Pantoprazole 40 mg gastro-resistant tablets are indicated in adults and adolescents 12 years of age and above for the treatment of:(21) 

- Reflux oesophagitis

And in adults for the: 

- Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers 
- Gastric and duodenal ulcer 
- Zollinger-Ellison syndrome and other pathological hypersecretory conditions

 Pantoprazole® 40 mg gastro-resistant tablets SmPC Pantoprazole® 40 mg gastro-resistant tablets PIL 

Protium® i.v. 40 mg powder for solution for injesction is indicated for adults for the treatment of: (22) 

- Reflux oesophagitis
- Gastric and duodenal ulcer 
- Zollinger-Ellison-syndrome and other pathological hypersecretory conditions

Protium® 40 mg i.v. powder for solution for injection SmPC Protium® 40 mg i.v. powder for solution for injection PIL
Prostap® SR DCS and Prostap® 3 DCS
leuprorelin acetate

Prostap® SR DCS and Prostap® 3 DCS are indicated for:(23)

- Metastatic prostate cancer

- Locally advanced prostate cancer, as an alternative to surgical castration

- As an adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer

- As an adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression

- As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer

- Management of endometriosis, including pain relief and reduction of endometriotic lesions

- Treatment of central precocious puberty in girls under 9 years of age and boys under 10 years of age

Prostap® 3 DCS SmPC Prostap® 3 DCS PIL

In addition, Prostap® SR DCS is also indicated for:(24)

- Endometrial preparation prior to intrauterine surgical procedures including endometrial ablation or resection

- Preoperative management of uterine fibroids to reduce their size and associated bleeding

Prostap® SR DCS SmPC Prostap® SR DCS PIL
TachoSil® sealant matrix
human fibrinogen and human thrombin medicated sponge

TachoSil® is indicated in adults for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, for suture support in vascular surgery where standard techniques are insufficient, and for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery.(25)

TachoSil® sealant matrix SmPC TachoSil® sealant matrix PIL
Vipdomet®
alogliptin benzoate and metformin hydrochloride

Vipdomet® is indicated in the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus: 
- As an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin

- In combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone

- In combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control(26)

 

Vipdomet® 12.5 mg/1000 mg film-coated tablets SmPC

 

Vipdomet® 12.5 mg/1000 mg film-coated tablets PIL

Vipidia®
alogliptin benzoate

Vipidia® is indicated in adullts aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.(27)

 

 

 

 

 

Vipidia® 6.25mg film-coated tablets SmPC

Vipidia® 12.5mg film- coated tablets SmPC 

Vipidia®25mg film-coated tablets SmPC

Vipidia® 6.25mg film-coated tablets PIL

Vipidia® 12.5mg film-coated tablets PIL

Vipidia® 25mg film-coated tablets PIL

 

Please refer to the Summary of Product Characteristics for details on the full side-effect profile and drug interactions of the medicines refered to above. Adverse events should be reported.

Reporting forms and information can be found at https:yellowcard.mhra.gov.uk/ 
Adverse events should also be reported to Takeda UK Ltd on 01628 537900

 

"The black triangle denotes that additional monitoring is required in relation to adverse reactions.  This allows quick identification of new safety information."

 

References

1. Actos® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

2. Competact® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

3. Adcetris®▼Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

4. Alofisel®▼Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

5. Alunbrig®▼Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

6. Amias® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

7. Calcichew® 500 mg Chewable Tablets Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

8. Calcichew® D3 Chewable Tablets Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

9. Calcichew® Forte Chewable Tablets Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

10. Calcichew® D3 1000 mg/800 IU Once Daily chewable tablets Summary of Product Characteristics, Takeda UK Limited . Available from www.medicines.org.uk. Last accessed May 2019

11. Calcichew® D3 500 mg/400 IU film-coated tablets Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

12. Calcichew® D3 Forte Chewable Tablets Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

13. Condyline® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

14. Edarbi® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

15. Entyvio® Summary of Product Characteristics, Takeda UK Ltd. Available from www.medicines.org.uk. Last accessed May 2019

16. Instanyl® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

17. Matrifen® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

18. Mepact® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

19. Ninlaro®▼ Summary of Product Characteristics, Takeda UK Ltd. Available from www.medicines.org.uk. Last accessed May 2019

20. Pantoprazole 20 mg gastro-resistant tablets Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

21. Pantoprazole 40 mg gastro-resistant tablets Summary of Product Characteristics, Takeda UK Limited. Available www.medicines.org.uk. Last accessed May 2019

22. Protium® IV Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk.
Last accessed May 2019

23. Prostap® SR DCS Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

24. Prostap® 3 DCS Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

25. TachoSil® sealant matrix Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019

26. Vipdomet® Summary of Product Characteristics, Takeda UK Ltd. Available from www.medicines.org.uk. Last accessed May 2019

27. Vipidia® Summary of Product Characteristics, Takeda UK Ltd. Available from www.medicines.org.uk. Last accessed May 2019

 

 

UK/WBC/1707/0007c(3) Date of Preparation: May 2019