Mandatory information for the Renal Care Book

Abseamed 1,000 IU/0.5 ml / 2,000 IU/1 ml / 3,000 IU/0.3 ml / 4,000 IU/0.4 ml / 5,000 IU/0.5 ml / 6,000 IU/0.6 ml / 8,000 IU/0.8 ml / 10,000 IU/1 ml solution for injection in a pre‑filled syringe. Active substance: Epoetin alfa. Composition: One pre‑filled syringe contains 1,000 IU / 2,000 IU / 3,000 IU / 4,000 IU / 5,000 IU / 6,000 IU / 8,000 IU / 10,000 IU corresponding to 8.4 ”g / 16.8 ”g / 25.2 ”g / 33.6 ”g / 42.0 ”g / 50.4 ”g / 67.2 ”g / 84.0 ”g epoetin alfa. Other ingredients: Sodium dihydrogen phosphate dihydrate; sodium monohydrogen phosphate dihydrate; sodium chloride; glycine; polysorbate 80; hydrochloric acid (for pH adjustment); sodium hydroxide (for pH adjustment); water for injections. Indications: For the treatment of symptomatic anaemia due to kidney disease (in children on haemodialysis, in adults on haemodialysis or peritoneal dialysis, and in adults with severe anaemia who are not yet on dialysis); for the treatment of anaemia in adults receiving chemotherapy against solid tumours, malignant lymphomas or multiple myeloma (bone marrow cancer) and who may require allogeneic blood transfusion; in adults with moderate anaemia who donate part of their blood prior to surgery to be given back during or after surgery; in adults with moderate anaemia scheduled for major orthopaedic surgery (e.g. hip or knee prosthesis) to reduce the possible need for allogeneic blood transfusions; for the treatment of anaemia in adults with a bone‑marrow disorder that causes severe disturbance of blood formation (myelodysplastic syndromes). Contraindications: Allergic reactions to epoetin alfa or any of the other ingredients; patients in whom erythroblastopenia (insufficient formation of red blood cells in the bone marrow) was diagnosed during previous treatment with an erythropoiesis‑stimulating agent (including Abseamed); patients with hypertension that cannot be adequately controlled with medicines; to stimulate red blood cell formation when autologous blood transfusion cannot be given during or after surgery; patients scheduled for major elective orthopaedic surgery (e.g. hip or knee surgery) who have severe heart disease or diseases of the veins and arteries, or who have recently had a heart attack or stroke, or who cannot take anticoagulant medicines. Side effects: Severe skin reactions including Stevens–Johnson syndrome and toxic epidermal necrolysis (reddish, target‑like or circular spots, often with central blistering on the trunk; skin detachment; ulcers of the mouth, throat, nose, genitals and eyes, often with fever and flu‑like symptoms at onset). Very common: diarrhoea; dyspepsia; vomiting; fever; respiratory tract disorders (stuffy nose and sore throat) in predialysis patients with renal insufficiency. Common: increased blood pressure; headache (especially sudden, stabbing migraine‑like headache); confusion or seizures; blood clots (including deep‑vein thrombosis and embolism) with chest pain, shortness of breath, painful swelling and redness, usually in the legs; cough; skin rash that may be due to an allergic reaction; bone or muscle pain; flu‑like symptoms (headache, joint pain, weakness, chills, fatigue, dizziness); redness, burning and pain at the injection site; swelling of ankles, feet or fingers; pain in arms or legs. Uncommon: high blood potassium (which may cause heart rhythm disorders) (very common in dialysis patients); seizures; nasal congestion or airway narrowing; allergic reaction; urticaria. Rare: symptoms of erythroblastopenia (unusual tiredness, light‑headedness, dizziness, shortness of breath); especially at the start of treatment, increase in the number of small blood cells (platelets, which normally help form blood clots); severe allergic reactions (swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing, itchy rash (hives)); blood disorders that may cause pain, dark urine, or increased sensitivity of the skin to sunlight (porphyria); blood clots (thrombosis) in the dialysis shunt or haemodialysis system (in haemodialysis patients). Warnings: Keep medicines out of the reach of children. For further details and instructions, see the Summary of Product Characteristics and Package Leaflet. Prescription‑only. Revision date: 07/2025. Marketing authorisation holder: MEDICE Arzneimittel PĂŒtter GmbH & Co. KG, 58638 Iserlohn, www.medice.de

Anti‑Kalium Na, granules. Active substance: Poly(styrene‑co‑divinylbenzene) sulfonic acid (92:8), sodium salt. Composition: 15 g granules contain 12 g poly(styrene‑co‑divinylbenzene) sulfonic acid (92:8), sodium salt, dried. Sodium content per gram of granules 76.0 – 92.4 mg. Other ingredients: Sorbitol (Ph. Eur.), aspartame, vanilla flavour (contains lactose), purified water. Indications: For the treatment of elevated serum potassium levels (hyperkalaemia). Contraindications: Allergic reactions to poly(styrene‑co‑divinylbenzene) sulfonic acid (92:8), sodium salt, or any other ingredients; serum potassium less than 5 mmol/l (hypokalaemia); elevated serum sodium (hypernatraemia); retention of too much sodium in the body due to reduced excretion; diseases with narrowing of the intestine; reduced bowel activity; in severe hypertension, intake only with appropriate caution and under accompanying monitoring due to increased sodium uptake. Side effects: Severe stomach pain, rectal pain; flatulence, severe constipation; severe nausea, vomiting; black, bloody or tarry stools, coughing up blood, vomit resembling coffee grounds. Possible: gastrointestinal disorders (ischaemia of the gastrointestinal wall, colitis, ulceration and necrosis in the gastrointestinal tract, which may lead to perforation and be fatal; occasional nausea, diarrhoea, gastrointestinal intolerance, loss of appetite (anorexia), occasional vomiting, constipation); especially in children, in rare cases massive stool retention after enema (rectal use) and in newborns gastrointestinal concretions after oral administration; blood in stools in preterm and newborn infants with low birth weight when exchange resin enemas are used (a causal role of concomitantly administered sorbitol cannot be excluded); intestinal strictures); metabolic disorders (decrease of potassium (hypokalaemia), increase of sodium (hypernatraemia) due to excessive exchange of potassium for sodium and increased sodium and water excretion; decreased magnesium (hypomagnesaemia) and calcium (hypocalcaemia)); respiratory disorders (acute inflammation of the airways (bronchitis, bronchopneumonia) in connection with swallowing or inhaling particles of the resin). Warnings: Keep medicines out of the reach of children. For further details and instructions, see the Summary of Product Characteristics and Package Leaflet. Prescription‑only. Revision date: 12/2021. Marketing authorisation holder: MEDICE Arzneimittel PĂŒtter GmbH & Co. KG, 58638 Iserlohn, www.medice.de

Calcitriol‑Nefro 0.25 ”g / 0.5 ”g soft capsules. Active substance: Calcitriol. Composition: One soft capsule Calcitriol‑Nefro 0.25 ”g or 0.5 ”g contains 0.25 ”g or 0.5 ”g calcitriol, respectively. Other ingredients: Butylated hydroxyanisole, butylated hydroxytoluene, medium‑chain triglycerides, gelatin, glycerol 85%, solution of partially dehydrated sorbitol (Ph. Eur.), iron(III) oxide E 172; Calcitriol‑Nefro 0.25 ”g additionally titanium dioxide E171. Indications: Renal osteodystrophy in patients with chronic renal insufficiency to correct disturbed calcium and phosphate metabolism. Contraindications: Hypersensitivity to the active substance or to other substances from the same group or to any of the other ingredients. All conditions associated with an increased calcium level in the blood (e.g. hyperparathyroidism). Side effects: Side effects are dose‑dependent and correspond to those observed with vitamin D overdose such as hypercalcaemia and hypercalciuria (increased calcium concentration in blood and urine). Hypercalcaemia induced by overdose may persist for weeks. Depending on dose and duration of treatment, severe and prolonged hypercalcaemia with its consequences (arrhythmias, nausea, vomiting, psychiatric symptoms, impaired consciousness, headache, constipation, neuromuscular excitability, polyuria, polydipsia, anorexia, weight loss, nephrolithiasis, nephrocalcinosis, extra‑osseous calcifications, dehydration, somnolence, coma) may occur. In the presence of concomitant hypercalcaemia (calcium > 10.4 mg/100 ml or 2.6 mmol/l) and hyperphosphataemia (phosphate > 5.6 mg/100 ml or 1.8 mmol/l), calcifications in soft tissues may rarely occur and are visible on X‑ray. In susceptible individuals, hypersensitivity reactions (pruritus, rash, urticaria and, very rarely, severe erythematous skin disorders) may occur. Dosage forms, pack sizes: Calcitriol‑Nefro 0.25 ”g: 20, 50, 100 soft capsules. Calcitriol‑Nefro 0.5 ”g: 20, 50, 100 soft capsules. Prescription‑only. Revision date: 09/2020.

Calciumacetat‑Nefro 500 mg / 700 mg / 950 mg film‑coated tablets. Active substance: Calcium acetate. Composition: One film‑coated tablet contains: calcium acetate 500 mg (equivalent to 126.7 mg calcium); calcium acetate 700 mg (equivalent to 177.4 mg calcium); calcium acetate 950 mg (equivalent to 240.2 mg calcium). Other ingredients: 500 mg + 700 mg: microcrystalline cellulose, povidone K 30, crospovidone type A (Ph. Eur.), magnesium stearate [vegetable] (Ph. Eur.), sucrose, hypromellose, macrogol 6000, talc. 950 mg: maize starch, sucrose, gelatin, sodium carboxymethyl starch (type A) (Ph. Eur.), croscarmellose sodium, magnesium stearate [vegetable] (Ph. Eur.), hypromellose, castor oil, saccharin sodium, orange flavour, talc. Indications: Hyperphosphataemia caused by chronic renal insufficiency in patients on dialysis treatment. Contraindications: Calciumacetat‑Nefro 500 mg/700 mg/950 mg must not be used in hypercalcaemia or in case of hypersensitivity to calcium acetate or any of the other ingredients. Side effects: Common: mild hypercalcaemia with muscle weakness, abdominal pain, constipation, nausea, vomiting, belching, flatulence, diarrhoea. Uncommon: persistent severe hypercalcaemia with possible lethargy, disorientation, drowsiness, in extreme cases coma, as well as possible decreased renal function, polydipsia, polyuria, nephrocalcinosis, renal calcifications, arrhythmia. Long‑term treatment with high‑dose calcium acetate is associated with hypercalcaemia and extra‑osseous calcifications including valve, vascular and soft‑tissue calcifications/calcinosis, as well as calciphylaxis. To avoid this risk, it is recommended to keep the dose of calcium acetate as low as possible and to titrate strictly to serum calcium and serum phosphate levels. Dosage form, pack sizes: Calciumacetat‑Nefro 500 mg: 100, 200 film‑coated tablets. Calciumacetat‑Nefro 700 mg: 100, 200 film‑coated tablets. Calciumacetat‑Nefro 950 mg: 100, 200 film‑coated tablets. Pharmacy‑only. Revision date: 500 mg/700 mg: 06/2021; 950 mg: 08/2021.

CC‑Nefro 500 mg film‑coated tablets. Composition: One film‑coated tablet contains 500 mg calcium carbonate (equivalent to 200 mg calcium). Other ingredients: povidone K 30, crospovidone, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate (Ph. Eur.) [vegetable], talc, titanium dioxide (E 171), macrogol 6000, lactose monohydrate, hypromellose, macrogol stearate 400. Indications: Elevated serum phosphate (hyperphosphataemia) in chronic renal insufficiency, particularly in patients on dialysis treatment. Contraindications: Hypersensitivity to the active substance or any of the other ingredients. CC‑Nefro must not be taken in hypercalcaemia, e.g. due to hyperparathyroidism, vitamin D overdose, paraneoplastic syndromes (with bronchial carcinoma, breast carcinoma, hypernephroma, plasmacytoma), bone metastases, sarcoidosis, immobilisation osteoporosis, and in achlorhydria. CC‑Nefro should only be used under ongoing monitoring of calcium and phosphate concentrations in blood and urine in renal insufficiency, absorptive or renal hypercalciuria, nephrocalcinosis, calcium kidney stones and hypophosphataemia. Side effects: Frequency not known: In renal insufficiency and long‑term intake of high doses, hypercalcaemia and metabolic alkalosis may occur. Patients with chronic renal failure receiving CC‑Nefro as a phosphate binder may develop hypercalcaemic episodes (sometimes severe and unpredictable); therefore, consistent regular monitoring of serum calcium and phosphate is essential. Feeling of fullness in the stomach due to formation of carbon dioxide (even if the recommended dose is observed); reduced phosphate absorption due to formation of poorly soluble calcium phosphate. Increased urinary calcium excretion which can promote stone formation (especially in the first months of calcium administration); in renal insufficiency and long‑term intake of high doses, hypercalciuria may occur. Vascular and soft‑tissue calcifications. To prevent soft‑tissue and vascular calcifications, a dose of calcium carbonate as low as possible is recommended, strictly oriented to serum calcium and serum phosphate levels. Dosage form, pack sizes: 100, 200 film‑coated tablets. Pharmacy‑only. Revision date: 02/2019.

FerMed 20 mg/ml solution for injection/infusion. Active substance: Iron. Composition: 1 ml FerMed contains 20 mg iron as iron sucrose (iron(III)‑hydroxide sucrose complex). Other ingredients: water for injections; sodium hydroxide solution. Indications: Intravenous treatment of iron deficiency when (oral) treatment with iron tablets is not possible or has not worked. Contraindications: Allergic reactions to the active substance or any of the other ingredients; severe hypersensitivity reactions to other injectable iron preparations; anaemia not caused by iron deficiency; iron overload or disorders of iron utilisation. Side effects: Allergic reactions: drop in blood pressure (dizziness, light‑headedness, blackout); facial swelling; shortness of breath; itching, rash and chest pain which may be a sign of a potentially severe allergic reaction called ‘Kounis syndrome’. Common: taste disturbances (metallic taste); decreased or increased blood pressure; nausea; reactions at the injection/infusion site (pain, irritation, itching, bruising or long‑lasting skin discolouration after extravasation). Uncommon: headache or dizziness; stomach pain or diarrhoea; vomiting; wheezing; dyspnoea; pruritus; rash; muscle twitching, cramps or pain; tingling (‘pins and needles’); increased tactile sensitivity; phlebitis; skin redness, burning; constipation; joint, limb and back pain; chills; weakness, fatigue; swelling of hands and feet; pain; increase of liver enzymes (ALT, AST, GGT) in blood; increased serum ferritin. Rare: syncope; drowsiness or somnolence; palpitations; discoloured urine; chest pain; sweating; fever; increased blood lactate dehydrogenase. Frequency not known: decreased alertness; confusion; loss of consciousness; anxiety; tremor; swelling of face, mouth, tongue or throat possibly leading to breathing difficulties; slow or fast pulse; circulatory collapse; phlebitis with thrombosis; acute airway constriction; itching; wheals; rash; cold sweats; malaise; pallor; sudden life‑threatening allergic reactions (anaphylactic shock); flu‑like symptoms (usually fever, muscle and joint pain) that may occur within hours or several days after administration. Warnings: Keep medicines out of the reach of children. For further details and instructions, see the Summary of Product Characteristics and Package Leaflet. Prescription‑only. Revision date: 06/2023. Marketing authorisation holder: MEDICE Arzneimittel PĂŒtter GmbH & Co. KG, 58638 Iserlohn, www.medice.de

Nefrocarnit solution for injection 1 g/5 ml / oral solution 1 g/3.3 ml. Active substance: Levocarnitine. Composition: Nefrocarnit injection: 1 ampoule (5 ml) contains 1 g levocarnitine. Other ingredients: water for injections, hydrochloric acid 36% (for pH adjustment). Nefrocarnit oral solution: 3.3 ml solution (= 1 measuring cup) contains 1 g levocarnitine. Other ingredients: purified water, sorbitol solution 70% (non‑crystallising), hydrochloric acid 36% (for pH adjustment), methyl‑4‑hydroxybenzoate, propyl‑4‑hydroxybenzoate. Warnings: Contains sorbitol, methyl‑4‑hydroxybenzoate and propyl‑4‑hydroxybenzoate. Indications: Treatment of carnitine deficiency in patients with dialysis‑related carnitine disorder (DCD). Contraindications: Hypersensitivity to the active substance or any of the other ingredients. Side effects: At therapeutic usual doses of 1–3 g levocarnitine, nausea and vomiting are occasionally observed. Very rarely, seizures have occurred after administration of levocarnitine, oral or intravenous. In patients with a pre‑existing seizure tendency, an increase in frequency and/or severity of seizures has been reported. Very rarely, after prolonged use and high doses, a fish‑like body odour may occur. Oral solution: methyl‑4‑hydroxybenzoate and propyl‑4‑hydroxybenzoate may cause hypersensitivity reactions, including delayed reactions. Dosage forms, pack sizes: Nefrocarnit injection: 10, 25, 100 ampoules. Hospital pack. Nefrocarnit oral solution in 50 ml bottles (packs of 1 and 3 × 50 ml). Injection: Prescription‑only. Oral solution: Pharmacy‑only. Revision date: 11/2018.

Nephrotrans 500 mg, gastro‑resistant soft capsules. Active substance: Sodium hydrogen carbonate. Composition: 500 mg of the active substance sodium hydrogen carbonate in a gastro‑resistant soft capsule. Other ingredients: Yellow wax, hydrogenated soybean oil (Ph. Eur.), partially hydrogenated soybean oil (DAB), refined rapeseed oil, (3‑sn‑phosphatidyl)choline from soybeans, iron(II,III) oxide (E 172), titanium dioxide (E 171), glycerol 85%, gelatin, solution of partially dehydrated sorbitol (Ph. Eur.), hydrochloric acid 25%, triethyl citrate (Ph. Eur.), methacrylic acid‑ethyl acrylate copolymer (1:1) (Ph. Eur.), polysorbate 80, sodium dodecyl sulfate, glyceryl monostearate, purified water. Indications: For the treatment of metabolic acidosis and for maintenance therapy to prevent recurrence of metabolic acidosis in chronic renal insufficiency (impaired renal function). Contraindications: Allergic reactions to sodium hydrogen carbonate, soy, peanuts, or any other ingredients; metabolic alkalosis; hypokalaemia; hypernatraemia; use in children under 14 years. Side effects: Very rare: allergic reactions to soybean oil. Other side effects: gastrointestinal complaints (flatulence, abdominal pain); long‑term use may promote the formation of calcium or magnesium phosphate stones in the kidney. Warnings: Keep medicines out of the reach of children. For further details and instructions, see the Summary of Product Characteristics and Package Leaflet. Prescription‑only. Revision date: 05/2023. Marketing authorisation holder: MEDICE Arzneimittel PĂŒtter GmbH & Co. KG, 58638 Iserlohn, www.medice.de

Nephrotrans 840 mg, gastro‑resistant soft capsules. Active substance: Sodium hydrogen carbonate. Composition: 840 mg of the active substance sodium hydrogen carbonate in a gastro‑resistant soft capsule. Other ingredients: Yellow wax, hydrogenated soybean oil (Ph. Eur.), partially hydrogenated soybean oil (DAB), refined rapeseed oil, (3‑sn‑phosphatidyl)choline from soybeans, iron(II,III) oxide (E 172), glycerol 85%, gelatin, solution of partially dehydrated sorbitol (Ph. Eur.), hydrochloric acid 25%, hypromellose, hydroxypropyl cellulose, talc, polyethylene glycol, methacrylic acid‑ethyl acrylate copolymer (1:1) (Ph. Eur.), polysorbate 80, sodium dodecyl sulfate, propylene glycol, glyceryl monostearate, purified water. Indications: For the treatment of metabolic acidosis and for maintenance therapy to prevent recurrence of metabolic acidosis in chronic renal insufficiency (impaired renal function). Contraindications: As for Nephrotrans 500 mg. Side effects and Warnings: As for Nephrotrans 500 mg. Revision date: 12/2022. Marketing authorisation holder: MEDICE Arzneimittel PĂŒtter GmbH & Co. KG, 58638 Iserlohn, www.medice.de

Phosphonorm 300 mg hard capsules. Active substance: Aluminium chloride hydroxide complex (9:8:19)·23 H2O. Composition: One hard capsule contains: aluminium chloride hydroxide complex (9:8:19)·23 H2O 300 mg. Other ingredients: Stearic acid, magnesium stearate (Ph. Eur.), colloidal silicon dioxide, titanium dioxide (E 171), gelatin, sodium dodecyl sulfate, macrogol 20000, purified water. Indications: To reduce phosphate absorption from the intestine in patients with renal insufficiency and elevated serum phosphate, particularly in patients on dialysis. Contraindications: Hypersensitivity to the active substance or any of the other ingredients, hypophosphataemia, constipation, colonic stenoses, infants and children up to 3 years of age, pregnancy. Side effects: Rare: high aluminium concentrations in blood, aluminium poisoning with aluminium deposition in nervous tissue (encephalopathy), constipation, aluminium poisoning with deposition in bone tissue (osteopathy and osteomalacia, especially in children), phosphate depletion. Dosage form, pack sizes: 100, 200, 500 (5 × 100) hard capsules. Hospital pack. Pharmacy‑only. Revision date: 01/2021.

Sevemed 800 mg film‑coated tablets. Active substance: Sevelamer carbonate. Composition: Each tablet contains 800 mg sevelamer carbonate. Excipient with known effect: each film‑coated tablet contains 286.25 mg lactose monohydrate. Core: lactose monohydrate, colloidal silicon dioxide, zinc stearate (Ph. Eur.). Film coating: hypromellose (E464), diacetylated monoglycerides. Indications: Sevemed is indicated for the treatment of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis; and for the treatment of hyperphosphataemia in adult patients with chronic renal insufficiency not on dialysis with serum phosphate ≄ 1.78 mmol/l. Sevemed should be used as part of a multi‑drug regimen that may include calcium supplements, 1,25‑dihydroxyvitamin D3 or an analogue thereof to control the development of renal bone disease. Contraindications: Hypersensitivity to the active substance or any of the other ingredients, hypophosphataemia, intestinal obstruction. Side effects: Very common: nausea, vomiting, upper abdominal pain, constipation. Common: diarrhoea, dyspepsia, flatulence, abdominal pain. Very rare: hypersensitivity (post‑marketing experience). Not known: bowel obstruction, ileus/subileus, intestinal perforation, gastrointestinal bleeding (post‑marketing experience), intestinal ulceration (post‑marketing experience), gastrointestinal necrosis (post‑marketing experience), colitis (post‑marketing experience), intestinal mass (post‑marketing experience), pruritus, rash, intestinal crystal deposition (post‑marketing introduction). Dosage form, pack sizes: Tablets in high‑density polyethylene bottles with polypropylene caps. Pack size: 1 × 180 film‑coated tablets per bottle. For further details and instructions, see the Summary of Product Characteristics and Package Leaflet. Prescription‑only. Revision date: 01/2022.

Vafseo 150 mg / 300 mg / 450 mg film‑coated tablets. Active substance: Vadadustat. Composition: One film‑coated tablet contains: 150 / 300 / 450 mg vadadustat. Other ingredients: microcrystalline cellulose (E 460), sodium starch glycolate (type A), hypromellose (E 464), colloidal silicon dioxide (E 551), magnesium stearate, poly(vinyl alcohol) (E 1203), macrogol (E 1521), talc (E 553b), titanium dioxide (E 171), iron(III) oxyhydroxide x H2O (E 172) (Vafseo 300 mg), iron(III) oxide (E 172) (Vafseo 450 mg), iron(II,III) oxide (E 172) (Vafseo 450 mg). Indications: Vafseo is used in adults with chronic maintenance dialysis for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD). Contraindications: Hypersensitivity to the active substance or any of the other ingredients. Special warnings as per section 4.4 of the SmPC. Side effects: Very common: hypertension, thromboembolic events, diarrhoea. Common: headache, seizures, hypotension, hypersensitivity, cough, constipation, nausea, vomiting, upper abdominal pain, increased liver enzymes. Uncommon: increased bilirubin in blood. Warnings: For further details and instructions, see the Summary of Product Characteristics and Package Leaflet. Prescription‑only. Revision date: 03/2025. Marketing authorisation holder: MEDICE Arzneimittel PĂŒtter GmbH & Co. KG, 58638 Iserlohn, www.medice.de

VelariqÂź 1 mg/ml solution for intravesical use. Active substance: Oxybutynin hydrochloride. Composition: 1 ml solution contains 1 mg oxybutynin hydrochloride; one scaled pre‑filled syringe with 10 ml solution contains 10 mg oxybutynin hydrochloride. Other ingredients: hydrochloric acid 10%, 0.9% sodium chloride solution. Indications: Suppression of neurogenic detrusor overactivity (NDO) in children from 6 years and in adults who empty their bladder by clean intermittent catheterisation and who are not adequately controlled with oral anticholinergics. Contraindications: Hypersensitivity to the active substance or any of the other ingredients; severe gastrointestinal diseases (e.g. severe ulcerative colitis and toxic megacolon); myasthenia gravis; narrow‑angle glaucoma and patients at risk for these conditions; concomitant oxygen therapy. Side effects: Urinary tract infection, asymptomatic bacteriuria, hyperprolactinaemia, increased prolactin (single), apathy, hallucinations, cognitive disorders, hyperactivity, insomnia, agoraphobia, disorientation, attention disorders, dizziness, headache, somnolence, fatigue, dysgeusia, clouded consciousness, loss of consciousness, anticholinergic syndrome, seizure, vertigo, dry eye, abnormal eye sensations, accommodation disorder, supraventricular tachycardia, hypotension, flushing, constipation, dry mouth, abdominal discomfort, lower and upper abdominal pain, nausea, dyspepsia, diarrhoea, hypohidrosis, rash, night sweats, urgency, proteinuria, haematuria, voiding disorders, pain at the instillation site, thirst, chest discomfort, feeling cold. Reduced oxygen saturation in the context of oxygen therapy. Children may be more sensitive to the effects of the product, in particular regarding psychiatric and CNS‑related adverse reactions. Side effects of anticholinergic therapy that were not observed with intravesical oxybutynin: vomiting, anorexia, decreased appetite, dysphagia, gastro‑oesophageal reflux disease, pseudo‑obstruction in at‑risk patients (elderly or those with constipation and treated with other medicines that reduce intestinal motility), confusion, agitation, anxiety, nightmares, paranoia, symptoms of depression, dependence on oxybutynin (in patients with a history of drug or substance abuse), arrhythmia, heat stroke, narrow‑angle glaucoma, increased intraocular pressure, dry skin, angioedema, urticaria, photosensitivity, hypersensitivity. Warnings: Contains sodium (3.5 mg/ml) as an excipient with known effect. Prescription‑only. For further details and instructions, see the Summary of Product Characteristics and Package Leaflet. Revision date: 06/2024. MEDICE Arzneimittel PĂŒtter GmbH & Co. KG, 58638 Iserlohn. No special storage conditions required; cartons contain pre‑filled syringes and sterile adapters as application aid. Further information at www.velariq.de