Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Bronchitol

Bronchitol 40 mg inhalation powder, hard capsules · Abschnitt 4.8 · PDF-Seite 6

HOS-123863 · Präparat HOS-095743

Frequencies are defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≥1/100,000 to <1/10,000); not known (cannot be estimated from the available data).

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Nebenwirkungen · Bronchitol

Bronchitol 40 mg inhalation powder, hard capsules · Abschnitt 4.8 · PDF-Seite 6

HOS-123864 · Präparat HOS-095743

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

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Nebenwirkungen · Bronchitol

Bronchitol 40 mg inhalation powder, hard capsules · Abschnitt 4.8 · PDF-Seite 6

HOS-123865 · Präparat HOS-095743

Table 1: Frequency of adverse reactions with Bronchitol in the phase 3 studies (initiation dose assessment and/or treatment phase) System organ class Frequency Adverse Reaction Infections and infestations Uncommon Bacterial disease carrier, Bronchitis, Bronchopneumonia, Lung infection, Oral candidiasis, Pharyngitis, Staphylococcal infection, Upper respiratory tract infection Metabolism and nutrition Uncommon Decreased appetite, CF related diabetes, disorders Dehydration Psychiatric disorders Uncommon Initial insomnia, Morbid thoughts Nervous system disorders Common Headache Uncommon Dizziness Ear and labyrinth disorders Uncommon Ear pain Respiratory, thoracic and Common Cough, Haemoptysis, mediastinal disorders Oropharyngeal pain, Wheezing Uncommon Productive cough, Throat irritation, Asthma, Bronchospasm, Forced expiratory volume decreased, Rhinorrhoea, Dyspnoea, Dysphonia, Hyperventilation, Obstructive airways disorder, Respiratory tract congestion, Sputum discoloured, Hypoxia Gastrointestinal disorders Common Post-tussive vomiting, Vomiting Uncommon Nausea, Diarrhoea, Eructation, Flatulence, Gastrooesophageal reflux disease, Glossodynia, Retching, Stomatitis, Abdominal pain upper, Aphthous Stomatitis, Odynophagia

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Nebenwirkungen · Bronchitol

Bronchitol 40 mg inhalation powder, hard capsules · Abschnitt 4.8 · PDF-Seite 6–7

HOS-123866 · Präparat HOS-095743

6  Skin and subcutaneous tissue Uncommon Acne, Cold sweat, Pruritus, Rash, Rash pruritic disorders Musculoskeletal and Uncommon Musculoskeletal chest pain, Arthralgia, Back connective tissue disorders pain, Joint stiffness, Musculoskeletal pain Renal and urinary disorders Uncommon Urinary incontinence General disorders and Common Condition aggravated, Chest discomfort administration site Uncommon Pyrexia, Fatigue, Influenza like illness, Hernia conditions pain, Malaise, Chest pain Investigations Uncommon Blood alkaline phosphatase increased, Bacteria or fungus sputum test positive Adverse reactions that occurred only with the initiation dose assessment (MTT) are dehydration, forced expiratory volume decreased, hypoxia, diarrhoea, abdominal pain upper, aphthous stomatitis, odynophagia, chest pain and blood alkaline phosphatase increased.

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Nebenwirkungen · Bronchitol

Bronchitol 40 mg inhalation powder, hard capsules · Abschnitt 4.8 · PDF-Seite 7

HOS-123867 · Präparat HOS-095743

Description of selected adverse reactions Twenty seven (7.1%) out of 378 patients who undertook the mannitol tolerance test (MTT) in study 301, 18 (5.3%) out of 341 patientsin study 302 and 25 (5.1%) out of 486 patients in Study 303 had a positive (MTT). In study 301, overall the most frequently reported adverse reactions during the MTT were cough in 20 (5.3%) subjects, wheezing/bronchospasm in seven (1.9%) subjects and chest discomfort in six (1.6%) subjects. In study 302 the most frequent adverse reaction reported during the MTT was cough in seven patients (2.1%),and in study 303 the most frequently reported adverse reaction from the MTT was also cough in eight patients (1.6%).

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Nebenwirkungen · Bronchitol

Bronchitol 40 mg inhalation powder, hard capsules · Abschnitt 4.8 · PDF-Seite 7

HOS-123868 · Präparat HOS-095743

Paediatric population (6 to 17 years of age) Frequency, type and severity of adverse reactions in children are similar to those observed in adults.

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Nebenwirkungen · Bronchitol

Bronchitol 40 mg inhalation powder, hard capsules · Abschnitt 4.8 · PDF-Seite 7

HOS-123869 · Präparat HOS-095743

Initiation dose (6 to 17 years of age) The most commonly observed adverse reaction associated with the use of Bronchitol during the initiation dose assessment with the paediatric population is cough (4.8% of patients).

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Nebenwirkungen · Bronchitol

Bronchitol 40 mg inhalation powder, hard capsules · Abschnitt 4.8 · PDF-Seite 7

HOS-123870 · Präparat HOS-095743

The most important adverse reaction associated with the use of Bronchitol during the initiation dose assessment with the paediatric population is bronchospasm.

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Nebenwirkungen · Bronchitol

Bronchitol 40 mg inhalation powder, hard capsules · Abschnitt 4.8 · PDF-Seite 7

HOS-123871 · Präparat HOS-095743

Therapeutic dose regimen(6 to 17 years of age) The most commonly observed adverse reaction associated with the use of Bronchitol is cough. This was observed in 7.8% of patients compared to 3.8% of patients in the control arm. The most important adverse reaction associated with the use of Bronchitol is haemoptysis.

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Nebenwirkungen · Bronchitol

Bronchitol 40 mg inhalation powder, hard capsules · Abschnitt 4.8 · PDF-Seite 7

HOS-123872 · Präparat HOS-095743

Table 2: Frequency of adverse reactions with Bronchitol in the phase 3 studies (initiation dose assessment and/or treatment phase) – paediatric population (6 to 17 years of age) System organ class Frequency Adverse Reaction Psychiatric disorders Uncommon Initial insomnia Nervous system Common Headache Uncommon Dizziness Ear and labyrinth disorders Uncommon Ear Pain Respiratory, thoracic and Common Cough, Condition aggravated, Haemoptysis, mediastinal disorders Oropharyngeal pain, Chest discomfort, Wheezing, Asthma, Productive cough Uncommon Bronchitis, Bronchopneumonia, Dysphonia, Hyperventilation, Sputum Discoloured, Throat irritation, Pharyngitis, Upper respiratory tract infection, Bronchospasm, Dyspnoea, Chest pain Gastrointestinal disorders Common Vomiting, Post-tussive vomiting Uncommon Nausea, Odynophagia, Retching Skin and subcutaneous tissue Uncommon Pruritus, Pruritic rash disorders

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Nebenwirkungen · Bronchitol

Bronchitol 40 mg inhalation powder, hard capsules · Abschnitt 4.8 · PDF-Seite 7–8

HOS-123873 · Präparat HOS-095743

7  Musculoskeletal and Uncommon Musculoskeletal chest pain connective tissue disorders Renal and urinary disorders Uncommon Urinary incontinence General disorders and Uncommon Pyrexia administration site conditions Investigations Common Bacteria sputum identified Adverse reactions that occurred only with initiation dose assessment (MTT) are bronchospasm, chest pain, odynophagia and retching

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Nebenwirkungen · Bronchitol

Bronchitol 40 mg inhalation powder, hard capsules · Abschnitt 4.8 · PDF-Seite 8

HOS-123874 · Präparat HOS-095743

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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Wechselwirkungen · Tobi Podhaler

TOBI Podhaler 28 mg inhalation powder, hard capsules · Abschnitt 4.5 · PDF-Seite 6

HOS-124607 · Präparat HOS-095897

Concomitant use of TOBI Podhaler with diuretic compounds (such as ethacrynic acid, furosemide, urea or intravenous mannitol) is not recommended. Such compounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): furosemide (HOS-089060) ethacrynic acid (HOS-124608) mannitol (HOS-085847) urea (HOS-086903)

Wechselwirkungen · Triumeq

Triumeq 50 mg/600 mg/300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 13

HOS-129272 · Präparat HOS-096703

Sorbitol Sorbitol solution (3.2 g, 10.2 g, Single dose lamivudine When possible, avoid chronic 13.4 g)/Lamivudine oral solution 300 mg coadministration of Triumeq with medicinal products containing sorbitol Lamivudine: or other osmotic acting poly-alcohols or AUC ↓ 14%; 32%; 36% monosaccharide alcohols (eg: xylitol, mannitol, lactitol, maltitol). Consider Cmax ↓ 28%; 52%, 55%. more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided. Potassium channel blockers Fampridine (also known as Fampridine ↑ Co-administration of dolutegravir has dalfampridine)/Dolutegravir the potential to cause seizures due to increased fampridine plasma concentration via inhibition of OCT2 transporter; co-administration has not been studied. Fampridine co- administration with Triumeq is contraindicated (see section 4.3). Antacids and supplements

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): maltitol (HOS-085849) xylitol (HOS-085846) dalfampridine (HOS-124191) mannitol (HOS-085847) lactitol (HOS-085848) potassium (HOS-086929) sorbitol (HOS-085845)

Wechselwirkungen · Triumeq

Triumeq 5 mg/60 mg/30 mg dispersible tablets · Abschnitt 4.5 · PDF-Seite 50

HOS-129363 · Präparat HOS-096703

Sorbitol Sorbitol solution (3.2 g, 10.2 g, Single dose lamivudine When possible, avoid chronic 13.4 g)/Lamivudine oral solution 300 mg coadministration of Triumeq with medicinal products containing sorbitol Lamivudine: or other osmotic acting poly-alcohols or AUC ↓ 14%; 32%; 36% monosaccharide alcohols (eg: xylitol, mannitol, lactitol, maltitol). Consider Cmax ↓ 28%; 52%, 55%. more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided. Potassium channel blockers Fampridine (also known as Fampridine ↑ Co-administration of dolutegravir has dalfampridine)/Dolutegravir the potential to cause seizures due to increased fampridine plasma concentration via inhibition of OCT2 transporter; co-administration has not been studied. Fampridine co- administration with Triumeq is contraindicated (see section 4.3). Antacids and supplements Magnesium/ Dolutegravir ↓ Magnesium/ aluminium-containing aluminium-containing AUC ↓ 74% antacids should be taken well separated antacids/Dolutegravir Cmax ↓ 72% in time from the administration of Triumeq (minimum 2 hours after or 6 (Complex binding to hours before the intake of Triumeq). polyvalent ions) Calcium Dolutegravir ↓ - When taken with food, Triumeq and supplements/Dolutegravir AUC ↓ 39% supplements or multivitamins containing Cmax ↓ 37% calcium, iron or magnesium can be taken C24 ↓ 39% at the same time. (Complex binding to - If Triumeq is taken in a fasted state, polyvalent ions) such supplements should be taken a Iron supplements/Dolutegravir Dolutegravir ↓ minimum 2 hours after or 6 hours before AUC ↓ 54% the intake of Triumeq. Cmax ↓ 57% C24 ↓ 56%

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): maltitol (HOS-085849) calcium (HOS-085615) iron (HOS-085656) xylitol (HOS-085846) dalfampridine (HOS-124191) mannitol (HOS-085847) lactitol (HOS-085848) potassium (HOS-086929) magnesium (HOS-085165) sorbitol (HOS-085845)

Wechselwirkungen · Delstrigo

Delstrigo 100 mg/300 mg/245 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 13–14

HOS-141212 · Präparat HOS-098610

13  Recommendation concerning Medicinal product by Effects on medicinal product levels co-administration with therapeutic area geometric mean ratio (90 % CI)* doravirine/lamivudine/tenofovir disoproxil Immunosuppressants Interaction not studied with doravirine or doravirine/lamivudine/tenofovir Monitor blood concentrations of tacrolimus disoproxil. tacrolimus and sirolimus as the sirolimus dose of these agents may need to Expected: be adjusted. doravirine ↓ tacrolimus, sirolimus (Induction of CYP3A) Kinase inhibitors Interaction not studied with Co-administration should be doravirine or avoided. If co-administration doravirine/lamivudine/tenofovir cannot be avoided, a 100 mg dose disoproxil. of doravirine should be taken dabrafenib daily, approximately 12 h after the Expected: dose of ↓ doravirine doravirine/lamivudine/tenofovir (Induction of CYP3A) disoproxil. Miscellaneous Single dose lamivudine oral solution When possible, avoid chronic co- 300 mg administration of doravirine/lamivudine/tenofovir lamivudine disoproxil with medicinal AUC 14 %; 32 %; 35 % products containing sorbitol or sorbitol solution (3.2 g, Cmax 28 %; 52 %; 55 % other osmotic acting poly-alcohols 10.2 g, 13.4 g)/lamivudine (e.g., xylitol, mannitol, lactitol, maltitol). Consider more frequent monitoring of HIV-1 viral load when chronic co-administration cannot be avoided. Opioid analgesics doravirine

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) maltitol (HOS-085849) dabrafenib (HOS-109452) xylitol (HOS-085846) mannitol (HOS-085847) lactitol (HOS-085848) tacrolimus (HOS-085202) sirolimus (HOS-085172) sorbitol (HOS-085845)

Wechselwirkungen · Dovato

Dovato 50 mg/300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10–11

HOS-142841 · Präparat HOS-098886

10 Cytotoxics Cladribine/Lamivudine Interaction not studied. Concomitant use of Dovato with cladribine is not recommended (see In vitro lamivudine section 4.4). inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting. Some clinical findings also support a possible interaction between lamivudine and cladribine. Miscellaneous Sorbitol Sorbitol solution (3.2 g, 10.2 g, Single dose lamivudine When possible, avoid chronic 13.4 g)/Lamivudine oral solution 300 mg. coadministration of Dovato with medicinal products containing sorbitol Lamivudine: or other osmotic acting poly-alcohols or AUC  14%; 32%; 36% monosaccharide alcohols (eg: xylitol, mannitol, lactitol, maltitol). Consider Cmax  28%; 52%, 55%. more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided. Potassium channel blockers Fampridine (also known as Fampridine  Co-administration of dolutegravir has dalfampridine)/Dolutegravir the potential to cause seizures due to increased fampridine plasma concentration via inhibition of OCT2 transporter; co-administration has not been studied. Fampridine co- administration with Dovato is contraindicated (see section 4.3). Antacids and supplements Magnesium/ Dolutegravir  Magnesium/ aluminium-containing aluminium-containing AUC  74% antacids should be taken well separated antacids/Dolutegravir Cmax  72% in time from the administration of Dovato (minimum 2 hours after or (Complex binding to 6 hours before). polyvalent ions) Calcium Dolutegravir  - When taken with food, Dovato and supplements/Dolutegravir AUC  39% supplements or multivitamins containing (fasted intake) Cmax  37% calcium, iron or magnesium can be taken C24  39% at the same time. (Complex binding to - If Dovato is taken in a fasted state, polyvalent ions) such supplements should be taken a Iron supplements/Dolutegravir Dolutegravir  minimum 2 hours after or 6 hours before (fasted intake) AUC  54% the intake of Dovato. Cmax  57% C24  56% The stated reductions in dolutegravir (Complex binding to exposure were observed with the intake polyvalent ions) of dolutegravir and these supplements

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): maltitol (HOS-085849) calcium (HOS-085615) iron (HOS-085656) xylitol (HOS-085846) dalfampridine (HOS-124191) mannitol (HOS-085847) lactitol (HOS-085848) potassium (HOS-086929) magnesium (HOS-085165) sorbitol (HOS-085845) cladribine (HOS-085842)