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Prescribing Information: Sukkarto SR (metformin hydrochloride) 500mg, 750mg or 1000mg prolonged-release tablets. Composition: Each 500mg tablet contains 390mg metformin base; 750mg contains 585mg metformin base; 1000mg contains 780mg metformin base. Refer to Summary of Product Characteristics (SmPC) before prescribing. Therapeutic Indications: Type 2 diabetes mellitus. Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with impaired glucose tolerance and/or impaired fasting glucose and/or increased HbA1C who are at risk and progressing towards type 2 diabetes mellitus despite lifestyle modifications for 3–6 months. Posology: Adults. Dosage and Administration: Monotherapy and combination with other oral antidiabetic agents: Starting dose of one 500mg SR tablet once daily with evening meals. Adjust dose on the basis of blood glucose measurements every 10 to 15 days in increments of 500mg, to a maximum dose of 2000mg, until glycaemic control achieved. A slow increase of dose may improve gastro-intestinal tolerability. If glycaemic control is not achieved consider Sukkarto SR 1000mg twice daily with food; then consider standard metformin tablets to a maximum of 3000mg daily. If transferring from another oral antidiabetic agent: discontinue and initiate Sukkarto SR at the dose indicated above. For patients already treated with metformin, the dose of Sukkarto SR should be equivalent to the daily dose of metformin in tablets (prolonged or immediate release). Combination with insulin: Usual starting dose of Sukkarto SR is one 500mg tablet once daily or the equivalent daily dose of metformin in tablets (prolonged or immediate release) up to a maximum of 1500mg or 2000mg for patients on 750mg or 1000mg tablets, respectively, with the evening meal; adjust insulin dose according to blood glucose measurements. Elderly: Adjust metformin dosage based on renal function; regular assessment of renal function is necessary. Children: Sukkarto SR should not be used in children. Contraindications: Hypersensitivity; acute metabolic acidosis (including lactic acidosis or diabetic ketoacidosis); diabetic pre-coma; severe renal failure (glomerular filtration rate [GFR] < 30mL/min); acute conditions with potential to alter renal function (including dehydration, severe infection or shock); acute or chronic disease which may cause tissue hypoxia (including acute and unstable heart failure, respiratory failure, recent myocardial infarction or shock); hepatic insufficiency; acute alcohol intoxication; alcoholism. Precautions and warnings: Lactic acidosis: metformin should be discontinued and contact with a healthcare professional recommended if dehydrated. Patients/care-givers should be informed of risk of lactic acidosis and if suspected metformin should be discontinued and immediate medical attention sought. Renal function: GFR should be assessed before initiation and at least annual thereafter, elderly patients and those with creatinine levels at the upper limit of normal should be checked two to four times a year. Special caution should be exercised in situations where renal function may become impaired. Regularly monitor cardiac and renal function in patients with stable chronic heart failure. Discontinue Sukkarto SR prior to using iodinated contrast agents, do not reinstitute until 48 hours afterwards and renal function is stable. Discontinue at the time of surgery with general, spinal or epidural anaesthesia and do not reinstate until 48 hours afterwards when renal function has been re-evaluated as stable. Patients should continue on their prescribed diet. Usual diabetes monitoring should be performed regularly. Caution advised when used in combination with insulin or other oral antidiabetics (e.g. sulphonylureas or meglitinides) due to possible hypoglycaemia. Interactions: Avoid alcohol and alcohol containing medications. Closely monitor renal function when using selective cyclooxygenase II inhibitors, ACE-inhibitors, angiotensin II receptor antagonists and diuretics. More frequent blood glucose monitoring required and dose adjustments may be necessary when using glucocorticoids (systemic and local) and sympathomimetics. Dose adjustment may be required during co-administration of organic cation transporters. Pregnancy & Lactation: During and prior to pregnancy, patients should not be treated with metformin but insulin is recommended to maintain glucose levels and lower the risk of foetal malformations. Metformin is excreted into breast milk. No adverse effects were observed in breast-fed newborns/infants; a decision should be made whether to discontinue nursing. Effects on ability to drive and use machines: Metformin alone does not affect the ability to drive or operate machinery. However, there is a risk of hypoglycaemia when used in combination with other anti-diabetic agents. Undesirable effects: Very common (≥1/10): nausea, vomiting, diarrhoea, abdominal pain, loss of appetite (most frequent during therapy initiation and majority resolve spontaneously). Common (≥1/100 to <1/10): taste disturbances. Very rare (<1/10,000): decrease of vitamin B12 absorption, lactic acidosis, isolated reports of liver function test abnormalities, hepatitis resolving upon discontinuation, skin reactions (erythema, pruritus, urticaria). Please refer to relevant SmPC for full information on adverse events. Overdose: Hypoglycaemia has not been seen with metformin doses of up to 85g although lactic acidosis has occurred in such circumstances. High overdose or concomitant risks may lead to lactic acidosis which is a medical emergency and must be treated in hospital. Legal category: POM. Marketing Authorisation Numbers: Sukkarto SR 500mg: PL 20117/0110; 750mg: PL 20117/0277; 1000mg: PL 20117/0111. Price: 56 tablets Sukkarto SR 500mg: £2.38; 750mg: £2.87; 1000mg: £3.82. Marketing Authorisation Holder: Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK

Date of Preparation: June 2020
SUK/PI/27390-0620

Please refer to full SmPC text before prescribing. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Morningside Healthcare Ltd.'s Medical Information Department on Tel: 0116 478 0322.

Prescribing Information: Zintasa (mesalazine) 400mg enteric-coated tablets. Composition: Each tablet contains 400mg mesalazine and <1mmol sodium (23mg) therefore are essentially ‘sodium-free’. Always refer to the full Summary of Product Characteristics (SmPC) before prescribing. Posology: Adults and children aged ≥6 years. Indication: To treat mild to moderate ulcerative colitis and maintain ulcerative colitis in remission. Dosage & Administration: Adults: 6 tablets per day in divided doses (with concomitant corticosteroids when indicated) for acute disease and 3–6 tablets per day in divided doses for maintenance therapy. Children: individually determined and body-weight adjusted; 30–50mg/kg/day (max 75mg/kg/day) in divided doses for active disease and 15–30mg/kg/day for maintenance therapy. Total dose: should not exceed 4g/day in active disease and 2g/day during maintenance therapy. Contraindications: History of sensitivity to salicylates or renal sensitivity to sulphasalazine; confirmed severe renal impairment (glomerular filtration rate [GFR] <20ml/min) hypersensitivity to the active substance or to any of the excipients. Precautions and Warnings: Should be swallowed whole with water; do not break, crush or chew. Use with caution in elderly patients and only in those with normal renal function. Should be used with extreme caution in patients with confirmed mild to moderate renal impairment. Monitor renal function prior to initiation and periodically during treatment; discontinue if renal function deteriorates. Due to very rare incidences of serious blood dyscrasias, perform haematological investigations for any unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Discontinue if evidence or suspicion of blood dyscrasia exists. Nephrolithiasis (including 100% mesalazine stones) has been reported with mesalazine use; ensure adequate fluid intake during treatment. Interactions: Avoid concurrent lactulose or related agents as these may reduce colonic luminal pH and therefore inhibit disintegration of coating and mesalazine release. Concurrent nephrotoxic agents (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] or azathioprine) may increase risk of renal reactions. Concurrent azathioprine or mercaptopurine may increase risk of leucopenia. Pregnancy and Lactation: No data regarding teratogenicity are available. Following sulphasalazine therapy, placental transfer and breast milk excretion of mesalazine is negligible. Use with caution and only if potential benefits outweigh risks during pregnancy. Unless essential, avoid during nursing. Effects on ability to drive and use machinery: Can cause nausea, if this occurs driving, operating machinery, and other activities requiring full alertness should be avoided. Adverse Events: Predominantly gastrointestinal (nausea, diarrhoea, vomiting and abdominal pain), headache has also been reported. Rare and usually reversible on withdrawal, reports of: leucopenia, neutropenia, agranulocytosis, aplastic anaemia and thrombocytopenia, alopecia, peripheral neuropathy, pancreatitis, abnormalities of hepatic function and hepatitis, myocarditis and pericarditis, allergic and fibrotic lung reactions, lupus erythematosus-like reactions and rash (including urticaria), drug fever, interstitial nephritis and nephrotic syndrome. Very rare associations with symptomatic exacerbation of colitis, Stevens Johnson syndrome and erythema multiforme. Renal failure and nephrolithiasis have also been reported. Mesalazine-induced nephrotoxicity should be suspected if renal dysfunction develops during treatment. Please refer to relevant SmPC for full information on adverse events. Overdose: No specific antidote; gastric lavage, intravenous transfusion of electrolytes and standard supportive measures are recommended. Legal Category: POM. Price: 120 tablets £15.50. Marketing Authorisation Number: PL 20117/0335. Marketing Authorisation Holder: Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK.

Date of Preparation: May 2020
Code: ZIN/PI/27406-0520

Please refer to full SmPC text before prescribing. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Morningside Healthcare Ltd.'s Medical Information Department on Tel: 0116 478 0322.

Prescribing Information:Bimizza® 150 microgram (mcg)/20mcg uncoated tablets (Bimizza 150/20); Cimizt® 150mcg/30mcg uncoated tablets (Cimizt 150/30); Levest® 150mcg/30mcg coated tablets (Levest 150/30); Yacella® 0.03 milligrams (mg)/3mg uncoated tablets (Yacella 0.03/3). Composition: Bimizza: 150mcg desogestrel and 20mcg ethinylestradiol. Cimizt: 150mcg desogestrel and 30mcg ethinylestradiol. Levest: 150mcg levonorgestrel and 30mcg ethinylestradiol. Yacella: 0.03mg ethinylestradiol and 3mg drospirenone. Always refer to the full Summary of Product Characteristics (SmPC) before prescribing. Indication: Oral contraception. The decision to prescribe should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE compares with other combined hormonal contraceptives (CHCs). Not indicated during pregnancy. Levest: Recognised gynaecological indications for such oestrogen and progesterone combinations. Bimizza: Safety and efficacy in adolescents <18 years of age has not yet been established. Yacella: Not indicated prior to menarche. Dosage & Administration: One tablet daily, at about the same time, for 21 consecutive days, starting on Day 1 of the normal menstrual cycle. Start each subsequent pack after a 7-day tablet-free interval, (beginning on the same day of the week as the first pack) when a withdrawal bleed will occur usually on the 2nd or 3rd day (of the tablet-free interval) but may not have finished before the next pack is started. Please refer to the relevant SmPC for full advice on starting combined oral contraceptives (COCs), switching from a different contraceptive method, and management of incorrect use/missed tablets or gastrointestinal disturbances (including vomiting and diarrhoea). Contraindications: Please refer to the relevant SmPC for full details. Presence, history, risk/high risk of, or hereditary or acquired predisposition for VTE or arterial thromboembolism (ATE), including: current VTE on anticoagulants; major surgery with prolonged immobilization; history of deep venous thrombosis, pulmonary embolism, myocardial infarction, prodromal conditions (angina pectoris or transient ischaemic attack [TIA]), stroke or migraine with focal neurology; presence of multiple risk factors for VTE or ATE or a serious risk factor for ATE (diabetes mellitus with vascular symptoms, severe hypertension or severe dyslipoproteinaemia); cerebrovascular disease (stroke). Presence or history of severe hepatic disease (e.g. active viral hepatitis and severe cirrhosis) with currently abnormal liver function tests or liver tumours. Concomitant ombitasvir/paritaprevir/ritonavir or dasabuvir. Hypersensitivity to active substance or excipients of the tablet, rare hereditary problems of galactose intolerance or glucose-galactose malabsorption. Bimizza and Cimizt: Pancreatitis or history thereof if associated with severe hypertriglyceridaemia. Bimizza, Levest and Yacella: Total lactase deficiency. Cimizt: Lapp lactase deficiency. Bimizza, Cimizt and Yacella: Undiagnosed vaginal bleeding. Cimizt and Yacella: Known or suspected sex-steroid influenced malignancies. Bimizza: Known or suspected estrogen-dependent tumours or pregnancy; endometrial hyperplasia. Levest: Presence or a history of breast cancer; rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency; concomitant glecaprevir/pibrentasvir, sofosbuvir/velpatasvir/voxilaprevir. Yacella: Severe renal insufficiency or acute renal failure. Precautions & Warnings: Please refer to the relevant SmPC for full information and for information on other conditions reported with COC usage. Take a complete history, conduct a physical examination and rule out pregnancy prior to starting or resuming COC use. Weigh benefits of COC use against possible risks and discuss with the patient before use. Instruct patients to read the user leaflet carefully and adhere to advice; draw attention to the information on VTE and ATE, and ensure the woman understands the risk of her CHC/COC compared with other CHCs containing levonorgestrel, norgestimate or norethisterone. Include full discussion of individual risk factors, (how risks are highest during the first ever year of use or following a pill-free interval of at least a month), known risk factors and the symptoms of VTE and ATE, and advise patients what to do in the event of a suspected thrombosis, or first appearance of risk factors. Advise patients to seek urgent medical attention and inform the healthcare professional that they are taking a CHC if VTE symptoms occur. CHCs are associated with increased risk of VTEs, ATEs (myocardial infarction) and cerebrovascular accidents (TIAs). If multiple risk factors for ATE and/or VTE are present they may constitute a contraindication; total risk should be considered before prescribing. Increased risk of thromboembolism during pregnancy and the 6-week period of puerperium must be considered. Discontinue if thrombosis is suspected or confirmed. Please consult SmPC for full information on risk factors for and symptoms of VTE and ATE. Advise women not to smoke if they wish to use a CHC/COC; smokers ≥35 years of age should be strongly advised to use a different method of contraception if they continue to smoke. Patients who develop an increase in frequency or severity of migraine should discontinue use and seek medical advice. A possible increased risk of cervical cancer has been reported with long-term COC use. In rare cases benign (and even rarer cases malignant), hepatic tumours have been reported in users of oral contraceptives or after the use of hormonal substances. Risk of endometrial and ovarian cancer is reduced with 50mcg ethinylestradiol, whether this applies to lower-dosed COCs remains unconfirmed. Slightly increased risk of breast cancer has been reported in COC users, though no direct causation has been shown. This may be due to an earlier diagnosis, biological effects of the pill or a combination of both. The excess number of breast cancer diagnoses in current/recent COC users is small vs overall risk of breast cancer. Age of discontinuation is the most important risk factor for breast cancer in COC users; risk gradually declines up to 10 years after termination, at which point there appears to be no excess risk. Possible increased risk of breast cancer should be discussed with the user and weighed against the benefits of COCs, taking into account the evidence that they offer substantial protection against the risk of developing certain other cancers (ovarian and endometrial). Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use. Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment. CHC/exogenous estrogen may induce/exacerbate symptoms of angioedema in women with hereditary angioedema. Acute or chronic disturbances of liver function may necessitate discontinuation until liver function returns to normal. Discontinue if cholestatic jaundice/cholestatis-related pruritus previously experienced during pregnancy or sex steroid use recurs. Monitor patients with diabetes during the first months of use. Chloasma may occasionally occur, especially in women with history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation during use. Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases. As with all COCs irregular bleeding may occur, especially during the first months of use (may include bleeding frequency, intensity or duration); evaluate bleeding after approximately 3 cycles. If bleeding irregularities occur after 3 months, or previously regular cycles, further diagnostic procedures should be considered. Presence or family history of hypertriglyceridaemia may increase risk of pancreatitis when using CHC/COCs. Patients should be advised to contact their physician in the event of aggravation, exacerbation or first appearance of any of the aforementioned conditions so discontinuation can be considered. Additional Product Specific Precautions & Warnings: Bimizza, Cimizt and Yacella: Discontinue if clinically relevant increases in blood pressure occur or in the case of preexisting hypertension with either constantly elevated blood pressure or inadequate response to antihypertensives. Worsening of endogenous depression, epilepsy, Crohn’s disease and ulcerative colitis have been reported during COC use. Bimizza: May be associated with up to twice the risk of VTEs vs CHCs which contain levonorgestrel, norgestimate or norethisterone. In the event of STI/HIV risk the correct and consistent use of condoms is recommended (either alone or with another contraceptive method). Levest: Consider stopping prior to long-term immobilization due to surgery or trauma. Products that contain levonorgestrel, such as Levest, norgestimate or norethisterone are associated with the lowest risk of VTE. Discontinue at least 4 weeks in advance of major elective surgery, any surgery to the legs, medical treatment for varicose veins or prolonged immobilization; do not resume until 2 weeks after complete remobilisation. If undergoing emergency surgery thrombotic prophylaxis is usually indicated. Undiagnosed vaginal bleeding that is suspicious for underlying conditions should be investigated. Advise women to contact their physician in the event of aggravation or first appearance of any of the following conditions so discontinuation can be considered: diabetes mellitus with mild vascular disease or mild nephropathy, retinopathy or neuropathy; hypertension that is adequately controlled (systolic >140 to159mm Hg or diastolic >90 to 94mm Hg); porphyria; obesity; migraine; cardiovascular diseases. Discontinue immediately in the event of: first occurrence or exacerbation of migrainous or unusually frequent/severe headaches; sudden disturbances of vision, hearing or other perceptual disorders; first signs of thrombosis/blood clots; pain and tightness in the chest; jaundice, hepatitis or whole body pruritus; significant rise in blood pressure; severe upper abdominal pain/liver enlargement; clear exacerbation of conditions known to be capable of deterioration during oral contraception or pregnancy. Certain chronic diseases may occasionally deteriorate during the use of COCs. Women with hyperlipidaemias are at increased risk of arterial disease. Consider discontinuation in the event of: jaundice and/or pruritus related to cholestatis, gallstone formation, systemic lupus erythematosus, herpes gestationis, otosclerosis-related hearing loss, sickle cell anaemia, renal dysfunction, hereditary angioedema, any other condition the patient experienced exacerbation of during previous COC use/pregnancy. Efficacy may be reduced in the event of missed tablets, vomiting, diarrhoea or concomitant medication. When stopping oral contraception non-hormonal contraception should be used to ensure contraceptive protection is maintained. Yacella: Contains E110 (sunset yellow FCF) and E102 (tartrazine) which may cause allergic reactions. If anticoagulant therapy is started, adequate alternative contraception should be initiated due to teratogenicity of anticoagulant therapy. Risk assessment and patient factsheet regarding VTE and ATE are available at: https://www.medicines.org.uk/emc/rmm/1702/Document and https://www.medicines.org.uk/emc/rmm/1701/Document. Check serum potassium during first treatment cycle in patients with renal insufficiency and pre-treatment serum potassium in the upper treatment range, particularly during concomitant use of potassium sparing medicinal products. Interactions: Refer to the relevant SmPC for full details. Consult prescribing information of concomitant medications for potential interactions. Certain medications may increase COC clearance and lead to contraceptive failure and/or breakthrough bleeding. Medicinal or herbal products that induce hepatic microsomal enzymes (cytochrome P450 3A4 enzymes) can increase clearance of sex hormones (enzyme induction can be observed after a few days of treatment), and may decrease effectiveness of COCs, including: barbiturates, phenytoin, phenobarbital, primidone, bosentan, carbamazepine, rifampicin, rifabutin, HIV-medication, and possibly: oxycarbazepine, modafinil, topiramate, felbamate, griseofulvin, some HIV protease inhibitors (e.g. ritonavir, nelfinavir, nevirapine, efavirenz), other antiretroviral agents, non-nucleoside reverse transcriptase inhibitors (e.g. efavirenz) and products containing Hypericum perforatum (St. John’s Wort). Contraceptive failures have also been reported with antibiotics. Women on short-term treatment with medications known to have potential interactions with COCs (including antibiotics) should use a barrier method during concomitant use and for 7 days following discontinuation (28 days for rifampicin or hepatic enzyme-inducing medicinal products). An alternative unaffected/reliable/non-hormonal method of contraception is recommended for women on long-term treatment with hepatic enzyme-inducing active substances. If concomitant medicinal product administration runs beyond the end of the tablets in the COC blister pack, the next pack should be started without the usual tablet-free interval. COCs may interfere with the metabolism of other compounds and therefore increase (cyclosporin) or decrease (lamotrigine) their plasma and tissue concentrations. COCs may influence the results of certain laboratory tests, including biochemical parameters of the liver, thyroid, adrenal and renal function, serum levels of proteins, parameters of carbohydrate metabolism, parameters of coagulation and fibrinolysis. Additional Product Specific Interactions: Bimizza: Co-administration of many combinations of HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors and/or combinations with Hepatitis C virus medicinal products, can impact plasma concentrations of progestins, including etonogestrol, the active metabolite of desogestrel or estrogens. Levest: Strong/moderate CYP3A4 inhibitors such as azole antifungals (e.g. itraconazole, voriconazole, fluconazole) may decrease clearance of COCs; macrolides (e.g. erythromycin) can increase plasma concentrations of the oestrogen or the progestin or both; concomitant medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (with or without ribavirin), glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir may increase risk of ALT elevations. Yacella: HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors (including HCV inhibitors) have variable effects on COC clearance during co-administration, therefore consult prescribing information for HIV/HCV medications prior to concomitant use (in case of any doubt additional barrier contraceptive methods should be used); concomitant etoricoxib may increase plasma concentrations of CHCs containing ethinylestradiol; ethinylestradiol may inhibit clearance of CYP1A2 substrates leading to weak (e.g. theophylline) or moderate (e.g. tizanidine) increases in their plasma concentration; concomitant medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (with or without ribavirin) may increase risk of ALT elevations, therefore switch Yacella-users to an alternative contraceptive method prior to initiation of this combination regimen (Yacella can be restated 2 weeks after treatment completion). Bimizza and Yacella: concomitant administration of strong or moderate CYP3A4 inhibitors may also increase serum concentrations of estrogens or progestins, including etonogestrol. Pregnancy & Lactation: Not indicated during pregnancy; treatment should be withdrawn immediately if pregnancy occurs. Not recommended during breastfeeding. Increased risk of VTE during the postpartum period should be considered when re-starting. Levest: Minute amounts of active substance are excreted within breast milk, this may affect the child, particularly in the first 6 weeks post-partum. Effects on ability to drive & use machinery: Levest: No or negligible influence. Bimizza, Cimizt and Yacella: No studies on the effect on the ability to drive and use machinery have been performed, however, none observed for other COC users. Adverse Events: Refer to relevant SmPC for full information on adverse events. The most commonly reported adverse event in COC users in headache. COC use is also associated with an increased risk of ATE and VTE, hypertension, liver tumours and chloasma. In women with hereditary angioedema exogenous estrogen may induce of exacerbate symptoms of angioedema. Additional Product Specific Adverse Reactions: Bimizza: Common (≥1/100 to <1/10): depressed or altered mood, headache, nausea, abdominal pain, breast pain or tenderness, weight increase. Uncommon (≥1/1,000 to <1/100): fluid retention, decreased libido, migraine, vomiting, diarrhoea, rash, urticaria, breast enlargement. Cimizt: Very common (>1/10): irregular bleeding, weight increase. Common/uncommon (<1/10 to >1/1,000): fluid retention, decreased libido, depressed or altered mood, headache, dizziness, nervousness, migraine, hypertension, nausea, vomiting, acne, rash, urticaria, amenorrhoea, breast pain, breast tenderness, breast hypertrophy, metrorrhagia. Levest: Common (≥1/100 to <1/10): nausea, abdominal pain, weight increase, depressed or altered mood, breast tenderness, breast pain. Yacella: Common (≥1/100 to <1/10): depressed mood, headache, migraine, nausea, menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness, leukorrhoea, vaginal moniliasis. Overdose: Levest: No serious effects have been reported with overdose. Bimizza, Cimizt and Yacella: No data available; nausea, vomiting and slight vaginal bleeding have been reported with COC overdose (may even occur in girls before their menarche). Legal Category: POM. Price: 3 x 21 tablets: Bimizza: £5.04; Cimizt: £3.80; Levest: £1.80; Yacella: £8.30. Marketing Authorisation Number: Bimizza: PL 20117/0091; Cimizt: PL 20117/0231; Levest: PL 20117/0044; Yacella: PL 20117/0134. Marketing Authorisation Holder: Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP United Kingdom.

Date of Preparation: July 2020
Code: COM/PI/27333-0720

Please refer to full SmPC text before prescribing. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Morningside Healthcare Ltd.'s Medical Information Department on Tel: 0116 478 0322.

Prescribing Information: Vensir XL (venlafaxine) 75mg, 150mg, 225mg prolonged-release (PR) hard capsules. Composition: 75mg capsules contain venlafaxine hydrochloride equivalent to 75mg venlafaxine. 225mg capsules contain venlafaxine hydrochloride equivalent to 225mg venlafaxine. 150mg capsules contain 150mg venlafaxine hydrochloride equivalent to 150mg venlafaxine; 0.3968mg Sunset yellow FCF (E110) which may cause allergic reactions; <1mmol sodium (23mg) therefore are essentially ‘sodium-free’. Always refer to the full Summary of Product Characteristics (SmPC) before prescribing. Indications: Treatment of major depressive disorder, generalized anxiety disorder, social anxiety disorder or panic disorder (with or without agoraphobia). Prevention of recurrence of major depressive episodes (MDE). Not recommended for children and adolescents. Dosage & Administration: MDE: 75mg once daily. If necessary, dose increases at ≥2 week intervals can be made up to 375mg/day; if clinically warranted due to symptom severity, increases can be made more frequently (minimum every 4 days). Continue treatment for at least 6 months following remission; longer-term treatment may be appropriate for prevention of recurrence. Generalized anxiety disorder/social anxiety disorder: 75mg once daily. If necessary, dose increases at ≥2 week intervals can be made up to 225mg/day (although there is no evidence that higher doses confer addition benefits for social anxiety disorder). Panic disorder: 37.5mg/day for 7 days then 75mg/day. If necessary, dose increases at ≥2 week intervals can be made up to 225mg/day. All indications: Swallow whole with fluid (do not divide, crush, chew or dissolve) and food at approximately the same time each day. Patients may be switched from venlafaxine immediate-release tablets to the nearest equivalent daily dosage of Vensir XL PR capsules. Contraindications: Hypersensitivity to the active substance or any of the excipients; concomitant or use in the past 14 days of, irreversible monoamine oxidase inhibitors (MAOIs); age <18 years. Warnings and Precautions: Treatment should be reassessed regularly. Due to risk of dose-related adverse events, the lowest effective dose should be maintained and dose adjustments require prior clinical evaluation. Treat for a sufficient period, usually several months or longer. Withdrawal symptoms are common, particularly in abrupt discontinuation. Avoid abrupt discontinuation; reduce dosage gradually over several weeks/months to reduce risk of withdrawal reactions. If intolerable withdrawal symptoms occur, withdraw more gradually or resume previously prescribed dose. Use with caution in elderly patients; no specific dose adjustments are required, always use lowest effective dose and carefully monitor during dose adjustment. Dosage individualisation may be desirable for patients with renal or hepatic impairment due to inter-individual variability in clearance. In mild/moderate hepatic impairment consider a 50% dose reduction; in severe cases use with caution, weighing potential benefits against the risks and consider >50% dose reduction. Use with caution if glomerular filtration rate (GFR) is 30–70 ml/min; reduce dose by 50% if GFR is <30 ml/min or patient requires haemodialysis. All patients should be closely monitored until significant remission occurs as risk of suicidal thoughts, self-harm and suicide persist until this point. Improvement may not occur during the first few weeks (or more) of treatment and risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events or ideation should receive careful monitoring, especially during early treatment and following dose adjustments. Patients (and caregivers) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour/thoughts or unusual changes in behaviour, and advised to seek immediate medical advice if these symptoms present. Closely monitor patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma. Screen for hypertension prior to use and review after initiation, dose increases and periodically; pre-existing hypertension should be controlled prior to initiation. Use with caution in patients with: underlying conditions that might be compromised by increases in blood pressure or heart rate, patients predisposed to bleeding (concomitant anticoagulant/platelet inhibitor use), history/family history of bipolar disorder, history of aggression, recent history of myocardial infarction or unstable heart disease. Use with caution and closely monitor patients with history of convulsions; discontinue in any patient who develops seizures. Consider risks and benefits prior to use in patients at high risk of serious cardiac arrhythmia or QTc prolongation. Hyponatraemia and/or Syndrome of Inappropriate Antidiuretic Hormone secretion may occur. Measurement of serum cholesterol levels should be considered during long-term treatment. Co-administration with weight loss agents is not recommended. Increasing dose in patients who develop akathisia/psychomotor restlessness may be detrimental. Advise the importance of dental hygiene as dry mouth may occur which increases risk of caries. Insulin and/or oral anti-diabetic dosage may require adjustment as venlafaxine may alter glycaemic control. May cause false positives on urine immunoassay screening tests for phencyclidine and amphetamine during use and for several days following discontinuation. SNRIs may cause symptoms of sexual dysfunction, long-lasting symptoms may continue despite discontinuation. Interactions: Allow at least 7 days after Vensir XL discontinuation before starting an irreversible non-selective MAOI or a reversible MAOI. Combination treatment with a reversible, selective MAOI is not recommended; venlafaxine may be administered <14 days following discontinuation of a reversible MAOI. Concomitant use of linezolid (antibiotic and weak reversible non-selective MAOI) should not occur. Potentially life-threatening serotonin syndrome may occur with venlafaxine treatment; particularly with concomitant use of agents that may affect the serotonergic neurotransmitter system (including SSRIs, SNRIs, triptans, amphetamines, lithium, sibutramine, St. John’s Wort [Hypericum perforatum], fentanyl and its analogues, tramadol, dextromethorphan, tapentadol, pethidine, methadone and pentazocine), medicinal agents that impair serotonin metabolism (such as MAOIs) e.g. methylene blue, serotonin precursors (such as tryptophan supplements) antipsychotics, other dopamine antagonists or lithium. Concomitant use of serotonin precursors are not recommended. Use with caution in patients prescribed: CNS-active substances, CYP3A4 inhibitors, imipramine, haloperidol, metoprolol, ECT therapy. Avoid concomitant use of medicinal products which prolong the QTc interval. Increased levels of clozapine temporally associated with adverse events including seizures have been reported with the addition of venlafaxine. Patients should be advised to avoid alcohol during therapy. Pregnancy & Lactation: Only use during pregnancy if expected benefits outweigh any possible risk. Venlafaxine and its active metabolite are excreted in breast milk; risk to the child cannot be excluded therefore decision to use vs breastfeed should be made, taking into account benefit of breast-feeding to the child and benefit of Vensir XL to the woman. Effects on ability to drive and use machinery: Any psychoactive medicinal product may impair judgement, thinking and motor skills; caution patients on their ability to drive or operate hazardous machinery. Adverse Events: Very common (>1/10): insomnia, headache, dizziness, sedation, nausea, dry mouth, constipation, hyperhidrosis (including night sweats). Common (≥1/100 to <1/10): decreased appetite, confusional state, depersonalisation, abnormal dreams, nervousness, decreased libido, agitation, anorgasmia, akathisia, tremor, paresthesia, dysgeusia, visual impairment, accommodation disorder (including blurred vision), mydriasis, tinnitus, tachycardia, palpitations, hypertension, hot flushes, dyspnoea, yawning, diarrhoea, vomiting, rash, pruritus, hypertonia, urinary hesitation or retention, pollakiuria, menorrhagia, metrorrhagia, erectile dysfunction, ejaculation disorder, fatigue, asthenia, chills, weight loss or gain, increased cholesterol. Uncommon (≥1/1,000 to <1/100): Mania, hypomania, hallucinations, derealization, abnormal orgasm, bruxism, apathy, syncope, myoclonus, balance disorder, abnormal coordination, dyskinaesia, orthostatic hypotension, hypotension, gastrointestinal haemorrhage, abnormal liver function test, urticaria, alopecia, ecchymosis, angioedema, photosensitivity reaction, urinary incontinence. Rare (≥1/10,000 to <1/1,000): agranulocytosis, aplastic anaemia, pancytopaenia, neutropaenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, hyponatraemia, delirium, Neuroleptic Malignant Syndrome, serotonin syndrome, convulsion, dystonia, angle-closure glaucoma, Torsade de Pointes, ventricular tachycardia, ventricular fibrillation, QT prolongation, interstitial lung disease, pulmonary eosinophilia, pancreatitis, hepatitis, Stevens-Johnson syndrome, toxic necrolysis, erythema multiforme, rhabdomyolysis. Most commonly reported withdrawal symptoms: dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation, anxiety, nausea, vomiting, tremor and headache and flu syndrome are the most commonly reported reactions. Generally, these events are mild to moderate and self-limiting; however, in some patients they may be severe and/or prolonged. Please refer to relevant SmPC for full information on adverse events. Overdose: most commonly reported events: tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, convulsion, and vomiting; other reported events: electrocardiographic changes (e.g., QT interval or QRS prolongation, bundle branch block), ventricular tachycardia, bradycardia, hypotension, vertigo, and death. No specific antidote for venlafaxine overdose is known. General supportive and symptomatic measures are recommended; monitor cardiac rhythm and vital signs. Activated charcoal may limit active substance absorption, gastric lavage may be indicated if performed soon after ingestion/in symptomatic patients. Induction of emesis is not recommended if there is a risk of aspiration. Legal Category: POM. Price: Basic NHS Cost: 28 capsules of 75mg: £2.60; 150mg: £3.90; 225mg: £21.90. Marketing Authorisation Numbers: 75mg PL 20117/0067; 150mg PL 20117/0068; 225mg PL 20117/0157. Marketing Authorisation Holder: Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK.

Date of Preparation: May 2020
Code: VENS/PI/27391-0520

Please refer to full SmPC text before prescribing. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Morningside Healthcare Ltd.'s Medical Information Department on Tel: 0116 478 0322.