Summary of Product Characteristics:

Oestrogel^® C: Estradiolum hemihydricum. I: Symptoms associated with estrogen deficiency due to natural or surgical menopause. Prevention or slowing of osteoporosis in postmenopausal patients at risk of fractures. Po: Apply 1 strip or 2 pumps of Oestrogel^® (1.5 mg of estradiol, 2.5 g of gel) daily to a large, dry area of the arms and shoulders. Allow to dry for 2 minutes before putting on clothing. Dosage should be adjusted individually. Maximum dose of 5 g gel/day (4 pumps). Supplement with a progestin in patients who have not undergone hysterectomy. Other people, particularly children, must not come into contact with the area of the body where the estradiol gel has been applied (to prevent secondary exposure to estradiol and the ethanol contained in the gel). Contraindications: Breast or endometrial cancer, estrogen-dependent neoplasia, untreated endometrial hyperplasia, vaginal bleeding of unknown origin, liver tumors, severe liver disease, thromboembolic disorders, porphyria, hypersensitivity to the components. Precautions: Annual general and gynecological examinations. Immediate discontinuation of treatment in case of: thromboembolic event, elevated blood pressure, jaundice, or deterioration of liver function, evident growth of fibroids, pregnancy. Close monitoring is required in cases of benign breast changes, risk of estrogen-dependent tumors, history of endometrial hyperplasia, leiomyoma, endometriosis, risk of thromboembolic events, hypertension, liver or biliary disorders, epilepsy, migraine, diabetes, systemic lupus erythematosus, asthma, otosclerosis, cardiac or renal dysfunction, prolactinoma, thyroid hormone replacement therapy, hereditary angioedema. IA: Enzyme inducers (particularly cytochrome P450 enzymes 3A4 and 3A5). Enzyme inhibitors: Azole antifungals or macrolides. Others: benzodiazepines, cyclosporine, imipramine, metoprolol, lamotrigine, cyclosporine, tacrolimus, fentanyl, or theophylline. G/A: Oestrogel^® is not indicated in premenopausal women or during breastfeeding. Adverse effects: Common: weight changes. Occasional: gastrointestinal disorders, gallstones, chloasma, heavy legs, changes in vaginal flora, breakthrough bleeding, withdrawal bleeding, endometrial hyperplasia, breast tenderness, breast cancer, headaches, migraines, application site reactions, pruritus, edema. Rare: venous thromboembolic events, myocardial infarction, stroke, liver function disorders, cholestasis. Very rare: anaphylaxis. P: 1 or 3 multi-dose containers with a 80 g dosing pump. 1 tube of 80 g with an applicator bar (currently not available commercially). List B. Detailed information: www.swissmedicinfo.ch. Marketing authorization holder: Vifor (International) Inc., St. Gallen. Information updated: August 2025.

Utrogestan^® C: progesterone. I: Oral: premenstrual syndrome, menstrual cycle disorders, premenopause, as an adjunct to estrogen therapy for vasomotor symptoms associated with natural menopause or following oophorectomy. Vaginal: Luteal phase supplementation in IVF cycles, spontaneous or induced cycles. Po: Oral: Premenstrual syndrome, menstrual irregularities: 200 to 300 mg/day for 10 days. Menopause: 200 mg/day in combination with estrogen for 12 to 14 days of the cycle. Vaginal: IVF: 200 mg twice daily for up to 12 weeks. Luteal phase supplementation during spontaneous or induced cycles: 200 to 300 mg/day for 10 days. Contraindications: neoplasia of the breast or genital organs, liver tumors, liver diseases (Rotor syndrome and Dubin-Johnson syndrome), cholestatic jaundice, genital bleeding of unknown origin, porphyria, thromboembolic diseases, cerebral hemorrhage, herpes gestationis, hypersensitivity to the ingredients, incomplete abortion, or ectopic pregnancy. PC: Thorough medical examination (to rule out a tumor of the genital tract or breast), annual gynecological examination, mammography, pregnancy test prior to initiating oral treatment. Immediate discontinuation of treatment if: thromboembolic events, abnormal liver function tests, hepatomegaly, jaundice, generalized pruritus, liver tumor, enlargement of a myoma, severe depression. IA: CYP3A4 inducers (antiepileptics, rifampicin, ritonavir, St. John’s wort), CYP3A4 inhibitors (itraconazole, voriconazole, clarithromycin, or erythromycin), others: cyclosporine, antidiabetics, smoking, alcohol abuse. ADRs: Oral use: Common: headache, amenorrhea, shortened menstrual cycle, or breakthrough bleeding. Occasional: drowsiness, dizziness, nausea, vomiting, diarrhea, constipation, cholestatic jaundice, rash, pruritus, urticaria, acne, chloasma, mastodynia. Unknown: anaphylactic shock. P: 100 mg: Packages of 30 and 90 soft capsules. 200 mg: Packages of 15 and 45 soft capsules. List B. Detailed information: www.swissmedicinfo.ch. Marketing authorization holder: Vifor (International) Inc., St. Gallen. Information updated: August 2025.

Progestan Luteal^® C: progesterone. I: Luteal phase supplementation as part of an assisted reproductive technology (ART) program in adult women. Dosage: 600 mg/day in 2 doses, one in the morning and the other at bedtime. Insert the capsule deep into the vagina. Begin treatment no later than the 3rd day after oocyte retrieval and continue at least until the end of the 7th week of pregnancy (GP). The exact duration of treatment must be determined individually by the physician. Treatment must be discontinued no later than the 12th GP or at the onset of menstruation. Contraindications: Breast or genital carcinoma, benign or malignant liver tumors (including history), severe hepatic insufficiency, jaundice, arterial or venous thromboembolic diseases, cerebral hemorrhages, thrombophlebitis, incomplete abortion, ectopic pregnancy, vaginal bleeding of unknown origin, porphyria, allergy to peanuts or soy, hypersensitivity to any of the components. PC: Complete medical examination before starting and regularly during treatment. Use the product only during the first trimester of pregnancy and vaginally. Any vaginal bleeding must always be investigated. Immediately discontinue treatment in case of: diagnosis of a missed abortion, thromboembolic events, abnormal liver function tests or hepatomegaly, onset of jaundice or generalized pruritus, suspected liver tumor, severe or recurrent depression. IA: CYP3A4 inducers (barbiturates, bosentan, carbamazepine, felbamate, oxcarbazepine, phenytoin, primidone, rifabutin, rifampin, ritonavir, topiramate, or herbal preparations containing St. John’s wort (Hypericum perforatum)), CYP3A4 inhibitors (itraconazole, voriconazole, clarithromycin, erythromycin, HIV protease inhibitors, or cobicistat), others: cyclosporine, bromocriptine. G/A: Not indicated during breastfeeding. Side Effects: Unknown: dizziness, pruritus, vaginal discharge, vaginal bleeding, local intolerance (burning, itching, or oily discharge), transient fatigue. P: Bottle containing 15 vaginal soft capsules. List B. Detailed information: www.swissmedicinfo.ch. Marketing authorization holder: Vifor (International) Inc., St. Gallen. Information updated: May 2025.

Progestan 400 mg, vaginal soft capsule. C: progesterone. I: Treatment of threatened miscarriage (abortus imminens, i.e., in the presence of bleeding during the first trimester of pregnancy) in adult women who have previously experienced at least 3 miscarriages. Po: 400 mg twice daily (morning and evening). Initiate treatment during the first trimester of pregnancy, as soon as the first signs of vaginal bleeding appear, and continue until the 16th week of pregnancy (GP). Contraindications: Suspected or confirmed carcinoma of the breast or genital organs, benign or malignant liver tumors (including history), severe hepatic insufficiency, jaundice, arterial or venous thromboembolic diseases, cerebral hemorrhages, thrombophlebitis, incomplete abortion, ectopic pregnancy, vaginal bleeding of unknown origin, porphyria, allergy to peanuts or soy, hypersensitivity to any of the ingredients. Precautions: A complete medical examination should be performed before starting treatment and regularly during treatment. Use the product only if there is a risk of miscarriage during the first trimester of pregnancy, up to the 16th week of gestation, and via the vaginal route. Any vaginal bleeding must always be investigated. Immediately discontinue treatment in the event of: diagnosis of a missed abortion, thromboembolic events, abnormal liver function tests or hepatomegaly, onset of jaundice or generalized pruritus, suspected liver tumor, severe or recurrent depression, and monitoring of blood glucose levels in diabetic women. IA: CYP3A4 inducers (barbiturates, bosentan, carbamazepine, felbamate, oxcarbazepine, phenytoin, primidone, rifabutin, rifampin, ritonavir, topiramate, or herbal preparations containing St. John’s wort (Hypericum perforatum)), CYP3A4 inhibitors (itraconazole, voriconazole, clarithromycin, erythromycin, HIV protease inhibitors, or cobicistat), others: cyclosporine, bromocriptine. G/A: Not indicated during breastfeeding. Adverse effects: Very rare: anaphylactic reactions. Frequency unknown: dizziness, pruritus, vaginal discharge, local intolerance (burning, itching, or oily discharge), transient fatigue. P: Bottle containing 15 soft vaginal capsules with 400 mg of micronized progesterone. List B. Detailed information: www.swissmedicinfo.ch. Marketing authorization holder: Vifor (International) Inc., St. Gallen. Information updated: June 2025.

Maltofer^®. C: iron in the form of iron(III) hydroxide-polymaltose complex. Film-coated tablet: 100 mg of iron; chewable tablet: 100 mg of iron; drops: 50 mg of iron per mL (=20 drops); syrup: 10 mg of iron per mL. I: Treatment of iron deficiency and iron-deficiency anemia. Dosage: For iron deficiency or iron-deficiency anemia: up to 1 year: 15–25 mg or 25–50 mg; 1 to 12 years: 25–50 mg or 50–100 mg; from 12 years of age: 50–100 mg or 100–300 mg per day. Premature infants: 2.5–5 mg of iron per kilogram of body weight (1–2 drops), daily for 3–5 months. Take during or immediately after meals.

Maltofer^® Fol. C: iron in the form of iron(III) hydroxide-polymaltose complex and folic acid. Chewable tablet: 100 mg of iron and 0.35 mg of folic acid. I: treatment of iron deficiency and iron-deficiency anemia with increased folic acid requirements during pregnancy and breastfeeding. Dosage: For iron-deficiency anemia: 2–3 tablets daily. For iron deficiency: 1 tablet daily. Take during or immediately after meals. Contraindications: Children and adolescents 12 years of age and younger.

Maltofer^® and Maltofer^® Fol. Contraindications: hypersensitivity or intolerance to the active ingredients or excipients; iron overload, iron utilization disorders, anemias not caused by iron deficiency. Precautions: during repeated blood transfusions, iron supplementation may cause iron overload. Treatment should be reconsidered if therapy is ineffective. ADRs: Very common: discoloration of stools. Common: diarrhea, nausea, constipation, abdominal pain. Uncommon: vomiting, regurgitation, gastritis, pruritus, rash, discoloration of teeth, headache. Drug Interactions: Maltofer: no known interactions with medications or food. Maltofer Fol: higher doses of folic acid may reduce the anticonvulsant effect of antiepileptic drugs such as carbamazepine, phenytoin, primidone, and barbiturates. G/A: No adverse effects on pregnancy or the health of the fetus or newborn have been demonstrated. Maltofer should only be taken during pregnancy or while breastfeeding after consulting a doctor. List D. Detailed information: www.swissmedicinfo-pro.ch. Distributor: Vifor Pharma Switzerland SA, Route de Moncor 10, CH-1752 Villars-sur-Glâne. Marketing Authorization Holder: Vifor (International) AG, CH-9001 St. Gallen. Information updated: June 2022.

Ferinject^®. C: Ferric carboxymaltose. I: Iron deficiency when treatment with oral iron is insufficiently effective, ineffective, or impossible. Po: The total cumulative dose of Ferinject must be calculated individually. Ferinject may be administered as an IV infusion (diluted in 0.9% NaCl) or as an IV injection (undiluted) at weekly doses of up to 1000 mg. Contraindications: Hypersensitivity to the active ingredient or to any of the excipients; known severe hypersensitivity to any other parenterally administered iron; anemia without confirmed iron deficiency; iron overload; first trimester of pregnancy. Precautions: Screen patients prior to each administration of Ferinject for adverse events related to previous administration of intravenous iron preparations. Qualified medical personnel must be immediately available and capable of assessing and treating anaphylactic reactions. Administer only in a facility equipped with all necessary resuscitation equipment. Monitor patients for at least 30 minutes after administration for signs and symptoms of a hypersensitivity reaction. Paravenous administration may cause brown discoloration and should therefore be avoided. Use with caution in cases of acute or chronic infections, asthma, or atopic allergies. Take into account the sodium content, which may reach up to 5.5 mg/mL. Parenteral iron may cause hypophosphatemia, which is generally transient and asymptomatic. Isolated cases of hypophosphatemia requiring treatment have been reported in patients who primarily had known risk factors and received a higher dose over an extended period. In cases of high-dose/long-term treatment and risk factors, monitor for hypophosphatemic osteomalacia. Consult a physician in case of arthralgia or bone pain. G/A: Contraindicated during the 1st trimester. Use during the 2nd and 3rd trimesters only under strict medical supervision. Fetal bradycardia may occur following a hypersensitivity reaction in the mother; the fetus must be monitored during administration. Adverse Effects: Common: hypophosphatemia, headache, facial flushing, dizziness, hypertension, nausea, injection/infusion site reactions. Uncommon: immediate-type hypersensitivity reactions, paresthesias, tachycardia, hypotension, rash, dyspnea, gastrointestinal disturbances, dysgeusia, rash, pruritus, urticaria, erythema, myalgia, arthralgia, muscle cramps, fever, fatigue, peripheral edema, chills, pain, elevated levels of AST, ALT, gamma-GT, LDH, and ALP. Contraindications: Concomitant administration with oral iron preparations reduces absorption. Pack sizes: 5 vials of 100 mg (2 ml) or 500 mg (10 ml), 1 vial of 500 mg (10 ml) or 1000 mg (20 ml). List B. Detailed information: www.swissmedicinfo-pro.ch. Marketing authorization holder: Vifor (International) Inc., CH-9001 St. Gallen. Distribution: Vifor Pharma Switzerland SA, CH-1752 Villars-sur-Glâne. Information updated: June 2025.

Feryxa^®. C: Ferric carboxymaltose. I: Iron deficiency when treatment with oral iron is insufficiently effective, ineffective, or impossible. Po: The total cumulative dose of Feryxa must be calculated individually. Feryxa may be administered as an IV infusion (diluted in 0.9% NaCl) or as an IV injection (undiluted) at weekly doses of up to 1000 mg. Contraindications: Hypersensitivity to the active ingredient or to any of the excipients; known severe hypersensitivity to any other parenterally administered iron; anemia without confirmed iron deficiency; iron overload; first trimester of pregnancy. Precautions: Screen patients prior to each administration of Feryxa for adverse events related to previous administration of intravenous iron preparations. Qualified medical personnel must be immediately available and capable of assessing and treating anaphylactic reactions. Administer only in a facility equipped with all necessary resuscitation equipment. Monitor patients for at least 30 minutes after administration for signs and symptoms of a hypersensitivity reaction. Paravenous administration may cause brown discoloration and should therefore be avoided. Use with caution in cases of acute or chronic infections, asthma, or atopic allergies. Take into account the sodium content, which may reach up to 5.5 mg/mL. Parenteral iron may cause hypophosphatemia, which is generally transient and asymptomatic. Isolated cases of hypophosphatemia requiring treatment have been reported in patients who primarily had known risk factors and received a higher dose over an extended period. In cases of high-dose/long-term treatment and risk factors, monitor for hypophosphatemic osteomalacia. Consult a physician in case of arthralgia or bone pain. G/A: Contraindicated during the 1st trimester. Use during the 2nd and 3rd trimesters only under strict medical supervision. Fetal bradycardia may occur following a hypersensitivity reaction in the mother; the fetus must be monitored during administration. Adverse Effects: Common: hypophosphatemia, headache, facial flushing, dizziness, hypertension, nausea, injection/infusion site reactions. Uncommon: immediate-type hypersensitivity reactions, paresthesias, tachycardia, hypotension, rash, dyspnea, gastrointestinal disturbances, dysgeusia, rash, pruritus, urticaria, erythema, myalgia, arthralgia, muscle cramps, fever, fatigue, peripheral edema, chills, pain, elevated levels of AST, ALT, gamma-GT, LDH, and ALP. Contraindications: Concomitant administration with oral iron preparations reduces absorption. Pack sizes: 5 vials of 100 mg (2 ml) or 500 mg (10 ml), 1 vial of 500 mg (10 ml) or 1000 mg (20 ml). List B. Detailed information: www.swissmedicinfo-pro.ch. Marketing authorization holder: Vifor (International) Inc., CH-9001 St. Gallen. Distribution: Vifor Pharma Switzerland SA, CH-1752 Villars-sur-Glâne. Information updated: June 2025.