natgillin/translations-raw huggingface dataset:
På trods af den mulige forøgede risiko for bivirkninger ved højere doser kan en øgning af dosis overvejes efter 3 uger, hvis patienten ikke har responderet på initialdosis.
Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose.
Ifølge konsensusrapport fra WHO bør behandling med antidepressiva fortsættes i mindst 6 måneder.
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Der er ingen systematiske undersøgelser, der viser hvor lang tid man bør fortsætte fluoxetin- behandlingen; men idet OCD er en EMEA/ CHMP/ 46089/ 2006/ DA
EMEA/ CHMP/ 46089/ 2006/ EN Obsessive-compulsive disorder
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kronisk tilstand, vil det være rimeligt at overveje behandling udover 10 uger hos responderende patienter.
If no improvement is observed within 10 weeks, treatment with fluoxetine should be reconsidered.
5. 2 Farmakokinetiske egenskaber).
Due to higher plasma levels in lower weight children, the therapeutic effect may be achieved with lower doses (see section 5.2 Pharmacokinetic properties).
EMEA/ CHMP/ 46089/ 2006/ DA 4. 3 Kontraindikationer
EMEA/ CHMP/ 46089/ 2006/ EN
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Overfølsomhed overfor fluoxetin eller øvrige indholdsstoffer.
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Behandlingen skal seponeres, hvis patienten udvikler krampeanfald eller hvor disse EMEA/ CHMP/ 46089/ 2006/ DA
EMEA/ CHMP/ 46089/ 2006/ EN
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stiger i frekvens.
In paediatric trials, mania and hypomania were commonly reported (see section 4.8).
Fluoxetin bør undgås til patienter med dårligt kontrollerede anfaldslidelser/ epilepsi og patienter med kontrolleret epilepsi bør nøje monitoreres.
Rash, anaphylactoid events and progressive systemic events, sometimes serious (involving skin, kidney, liver or lung) have been reported.
Dette er sædvanligvis proportionalt med personens startvægt.
Weight loss may occur in patients taking Fluoxetine but it is usually proportional to baseline body weight.
I kliniske forsøg opstod der utilsigtede hændelser efter afbrydelse af
In addition, there is a possibility of an increased risk of suicidal behaviour in young adults.
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behandlingen hos ca.
This is most likely to occur within the first few weeks of treatment.
Det tilrådes derfor, at SÆRNAVN® ved afbrydelse af behandlingen nedtrappes gradvist over en periode på mindst én til to uger, alt efter patientens behov (se Seponeringssymptomer set i forbindelse med afbrydelse af behandling med SÆRNAVN® ", afsnit 4. 2 Dosering og indgivelsesmåde).
It is therefore advised that (Invented name)® should be gradually tapered when discontinuing treatment over a period of at least one to two weeks, according to the patient’ s needs (see "Withdrawal Symptoms Seen on Discontinuation of (Invented name)®", section 4.2 Posology and Method of Administration).
SÆRNAVN® oral opløsning indeholder saccharose:
(Invented name)® oral liquid contains sucrose:
Patienter med sjældne, arvelige problemer med fruktose intolerance, glucosegalactose malabsorption eller sucrase- isomaltase insufficiens bør ikke tage dette lægemiddel.
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
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Fluoxetin skal anvendes med forsigtighed under graviditet, specielt sent i graviditeten eller lige op til fødslen, da følgende bivirkninger er rapporteret for nyfødte: irritabilitet, tremor, hypotoni, vedvarende gråd, problemer med at sutte samt søvnproblemer.
Fluoxetine can be used during pregnancy, but caution should be exercised when prescribing to pregnant women, especially during late pregnancy or just prior to the onset of labour
4. 8 Bivirkninger EMEA/ CHMP/ 46089/ 2006/ DA
EMEA/ CHMP/ 46089/ 2006/ EN
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Bivirkninger vil kunne formindskes i intensitet og hyppighed ved fortsat behandling og bør generelt ikke lede til et ophør med behandlingen.
since the following effects have been reported in neonates: irritability, tremor, hypotonia, persistent crying, difficulty in sucking or in sleeping.
Fælles for alle SSRI- præparater er observeret følgende bivirkninger:
These symptoms may indicate either serotonergic effects or a withdrawal syndrome.
Generelt:
Lactation:
Overfølsomhed (f. eks. puritis, udslæt, urticaria, anafylaktiske reaktioner, vasculitis, serumsygdom- lignende reaktioner, angioødem) (se pkt.
Fluoxetine and its metabolite norfluoxetine, are known to be excreted in human breast milk.
4. 3 Kontraindikationer samt pkt.
Adverse events have been reported in breastfeeding infants.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen), kulderystelser, serotoninsyndrom, fotosensitivitet samt meget sjældent toksisk epidermal nekrolyse (Lyell syndrom).
If treatment with fluoxetine is considered necessary, discontinuation of breastfeeding should be considered; however, if breastfeeding is continued, the lowest effective dose of fluoxetine should be prescribed.
Fordøjelsessystem:
Effects on ability to drive and use machines
Gastrointestinale symptomer (f. eks. diarré, kvalme, opkastning, dyspepsi, dysfagi, smagsforvrængning), mundtørhed.
Although fluoxetine has been shown not to affect psychomotor performance in healthy volunteers, any psychoactive drug may impair judgement or skills.
Sjældne tilfælde af abnorme leverfunktionsundersøgelser.
Undesirable effects may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.
Meget sjældne tilfælde af idiosynkratisk hepatitis.
In common with other SSRIs the following undesirable effects have been seen:
Nervesystem:
Body as a whole:
Hallucinationer, manisk reaktion, konfusion, agitation, angst og relaterede symptomer (f. eks. nervøsitet), koncentrationsbesvær og tankeforstyrelser (f. eks. depersonalisering), panikanfald (disse symptomer kan skyldes den bagvedliggende sygdom), meget sjældent serotoninsyndrom.
Hypersensitivity (e. g. pruritis, rash, urticaria, anaphylactoid reaction, vasculitis, serum sickness-like reaction, angioedema) (see ‘ Contraindications’ and ‘ Warnings’), chills, serotonin syndrome, photosensitivity, very rarely Toxic Epidermal Necrolysis (Lyell syndrome).
Urogenitalsystem:
Digestive system:
Vandladningsbesvær, vandladningsfrekvens.
Gastrointestinal disorders (e. g. diarrhoea, nausea, vomiting, dyspepsia, dysphagia, taste perversion), dry mouth.
Forplantningssystem:
Abnormal liver function tests have been reported rarely.
Seksuel dysfunktion (forsinket eller udeblevet ejakulation og orgasme), priapisme, hypergalaktia.
Very rare cases of idiosyncratic hepatitis.
Diverse:
Nervous system:
Hårtab, gaben, synsforstyrrelser (f. eks. sløret syn, mydriasis), svedtendens, vasodilatation, ledsmerter, muskelsmerter, postural hypotension, ekkymose.
Headache, sleep abnormalities (e. g. abnormal dreams, insomnia), dizziness, anorexia, fatigue (e. g. somnolence, drowsiness), euphoria, transient abnormal movement (e. g., twitching, ataxia, tremor, myoclonus), seizures and rarely psychomotor restlessness/ akathisia (see section 4.4 Special warning and precautions for use).
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
Hallucinations, manic reaction, confusion, agitation, anxiety and associated symptoms (e. g. nervousness), impaired concentration and thought process (e. g. depersonalisation), panic attacks, suicidal thoughts and behaviour (these symptoms may be due to the underlying disease), very rarely serotonin syndrome.
Hyponatriæmi:
Urogenital system:
Disse var reversible ved seponering af fluoxetin.
Urinary retention, urinary frequency
Respirationssystemet:
Reproductive disorders:
Dyspnø kan være det eneste forudgående symptom.
Sexual dysfunction (delayed or absent ejaculation, anorgasmia), priapism, galactorrhoea.
Seponeringssymptomer set i forbindelse med afbrydelse af behandling med fluoxetin:
Miscellaneous:
Seponering af fluoxetin medfører ofte abstinenssymptomer.
Alopecia, yawn, abnormal vision (e. g., blurred vision, mydriasis), sweating, vasodilatation, arthralgia, myalgia, postural hypotension, ecchymosis.
De mest hyppigt rapporterede reaktioner er svimmelhed, sensibilitetsforstyrrelser (herunder paræstesi), søvnforstyrrelser (herunder søvnløshed og intense drømme), asteni, agitation eller angst, kvalme og/ eller opkastning, rysten og hovedpine er de mest hyppigt rapporterede reaktioner.
Other haemorrhagic manifestations (e. g., gynaecological haemorrhages, gastrointestinal bleedings and other cutaneous or mucous bleedings) have been reported rarely (see ‘ Precautions’, Haemorrhage).
Generelt er disse hændelser milde til moderate og er selvbegrænsende, men hos nogle patienter kan de være alvorlige og/ eller langvarige (se pkt.
Hyponatraemia (including serum sodium below 110 mmol/ l) has been rarely reported and appeared to be reversible when fluoxetine was discontinued.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
Some cases were possibly due to the syndrome of inappropriate antidiuretic hormone secretion.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
The majority of reports were associated with older patients, and patients taking diuretics or otherwise volume depleted.
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EMEA/ CHMP/ 46089/ 2006/ DA 5.
EMEA/ CHMP/ 46089/ 2006/ EN 5.
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Selektive serotoningenoptagshæmmere, ATC- kode:
Selective serotonin reuptake inhibitors, ATC code:
N06A B 03
N06A B03.
I disse to forsøg var de gennemsnitlige absolutte ændring i CDRS- R fra basis til endepunktet 20 for fluoxetin mod 11 for placebo, P=0, 002 og 22 for fluoxetin mod 15 for placebo, P < 0, 001.
In these two studies the mean absolute changes
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95%.
Fluoxetine is extensively bound to plasma proteins (about 95%) and it is widely distributed (Volume of Distribution:
Fluoxetin har en non- lineær farmakokinetisk profil med first- pass metabolisme i leveren.
Fluoxetine has a non-linear pharmacokinetic profile with first pass liver effect.
Udskillelse:
Elimination
Halveringstiden for fluoxetin er 4- 6 dage og for norfluoxetin 4- 16 dage.
The elimination half-life of fluoxetine is 4 to 6 days and for norfluoxetine 4 to16 days.
Rotter, som fik indgivet 30 mg/ kg, havde også mindskede femurlængder sammenlignet med kontrollerne og degeneration af skeletmuskel, nekrose og regeneration.
Rats administered 30 mg/ kg EMEA/ CHMP/ 46089/ 2006/ EN
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< [Udfyldes nationalt] > Benzoesyre Saccharose Glycerol Pebermynte- essens (indeholdende 0, 23% alkohol) Renset vand.
Benzoic Acid Sucrose Glycerin Mint flavour (containing 0.23% alcohol) Purified Water
Må ikke opbevares over 25°C
Do not store above 25ºC.
< [Udfyldes nationalt] >
< [To be completed nationally] > The pack may include a measuring cup or syringe.
Medicinflaske.
Special precautions for disposal
< Ikke alle pakningsstørrelser er nødvendigvis markedsført. >
No special requirements
6. 6 Særlige forholdsregler ved bortskaffelse og anden håndtering af produktet
MARKETING AUTHORISATION HOLDER
Ingen særlige forholdsregler.
< [See Annex I - To be completed nationally] >
< [Se bilag I - Udfyldes nationalt] >
EMEA/ CHMP/ 46089/ 2006/ EN< [To be completed nationally] >
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN
DATE OF REVISION OF THE TEXT
EMEA/ CHMP/ 46089/ 2006/ DA 10.
EMEA/ CHMP/ 46089/ 2006/ EN
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< [Udfyldes nationalt] >
LABELLING AND PACKAGE LEAFLET
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SÆRNAVN® 20 mg hårde kapsler < [Se bilag I - Udfyldes nationalt] > fluoxetinhydrochlorid
(Invented name)® 20 mg hard capsules< [See Annex I - To be completed nationally] > fluoxetine hydrochloride
Hver kapsel indeholder fluoxetinhydrochlorid svarende til 20 mg fluoxetin
Each capsule contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine.
< [Se bilag I - Udfyldes nationalt] >
< [See Annex I - To be completed nationally] >
Oral brug Læs indlægssedlen inden brug.
Read the package leaflet before use.
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Lot nr.
Lot:
SÆRNAVN® 20 mg
(Invented name)® 20 mg
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EMEA/ CHMP/ 46089/ 2006/ DA
EMEA/ CHMP/ 46089/ 2006/ EN PARTICULARS TO APPEAR ON THE OUTER PACKAGING
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OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL SÆRNAVN® 20 MG ORAL OPLØSNING
CARTONS FOR (Invented name)® 20 mg per 5 ml oral liquid
SÆRNAVN® 20 mg/ 5 ml oral opløsning < [Se bilag I - Udfyldes nationalt] > fluoxetinhydrochlorid
(Invented name)® 20 mg per 5 ml oral liquid< [See Annex I - To be completed nationally] > fluoxetine hydrochloride
Hver 5 ml indeholder fluoxetinhydrochlorid svarende til 20 mg fluoxetin
Each 5ml of oral liquid contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine
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SÆRNAVN® 20 mg/ 5 ml
(Invented name)® 20 mg per 5 ml
EMEA/ CHMP/ 46089/ 2006/ DA
EMEA/ CHMP/ 46089/ 2006/ EN PARTICULARS TO APPEAR ON THE BOTTLE CARTONS FOR PROZAC 20 mg per 5 ml oral liquid
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INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
INFORMATION FOR THE USER
SÆRNAVN® 20 mg hårde kapsler < [Se bilag I - Udfyldes nationalt] > fluoxetin (som hydrochlorid)
(Invented name)® 20mg hard capsules< [See Annex I - To be completed nationally] > fluoxetine (as hydrochloride)
nævnt i denne indlægsseddel, bør du fortælle det til din læge.
please tell your doctor or pharmacist.
Hvad SÆRNAVN® er, og hvad det anvendes til 2.
What (Invented name)® is and what it is used for 2.
Hvad du skal gøre, før du begynder at tage SÆRNAVN® 3.
Before you take (Invented name)® 3.
Hvordan du tager SÆRNAVN® 4.
How to take (Invented name)® 4.
Hvilke mulige bivirkninger SÆRNAVN® har 5.
Possible side effects 5.
Hvordan du opbevarer SÆRNAVN® 6.
How to store (Invented name)® 6.
SÆRNAVN® tilhører gruppen af SSRI- præparater.
(Invented name)® is one of a group of medicines called selective serotonin re-uptake inhibitor (SSRI) antidepressants.
Voksne: • Episoder med svær depression • Obsessiv- kompulsiv sygdom (OCD) • Bulimia nervosa:
Adults: • Major depressive episodes • Obsessive-compulsive disorder • Bulimia nervosa:
SÆRNAVN® er indiceret som supplement til psykoterapi til reduktion af spiseanfald og tvangsopkastninger
(Invented name)® is used alongside psychotherapy for the reduction of binge- eating and purging
Børn og unge fra 8 år: • Moderat til svær depressiv episode, hvis depressionen ikke responderer på psykologisk behandling efter 4- 6 sessioner.
• Moderate to severe major depressive disorder, if the depression does not respond to psychological therapy after 4– 6 sessions.
Du bør ikke tage SÆRNAVN® • hvis du er allergisk (overfølsom) over for det aktive stof eller et af de øvrige indholdsstoffer i SÆRNAVN®.
BEFORE YOU TAKE (Invented name)® Do not take (Invented name)® and tell your doctor or pharmacist if the following apply: • If you are allergic (hypersensitive) to fluoxetine or any of the other ingredients of (Invented name)®.
Du kan få alvorlige bivirkninger eller det kan ligefrem være dødligt.
An allergy may include rash, itching, swollen face or lips or shortness of breath. • If you are taking medicines known as non-selective monoamine oxidase inhibitors or reversible monoamine oxidase inhibitors type A (also called MAOIs) which are also used to treat depression), since serious or even fatal reactions can occur.
Du må først tage SÆRNAVN® to uger efter, du er holdt op med at tage en irreversibel MAO - hæmmer (for eksempel tranylcypromin).
Treatment with fluoxetine should only be started 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine).
EMEA/ CHMP/ 46089/ 2006/ DA Dog kan behandling med fluoxetin påbegyndes dagen
EMEA/ CHMP/ 46089/ 2006/ EN
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MAO- hæmmere kaldet MAO- A- hæmmere (for eksempel moclobemid).
However treatment with fluoxetine can be started the following day after discontinuation of certain MAOIs called reversible MAOI-A (for instance moclobemide)
Hvis du skal skifte fra SÆRNAVN® til en MAO- hæmmer, skal der gå mindst fem uger imellem.
Do not take any MAOIs for at least five weeks after you stop taking (Invented name)®.
Hvis SÆRNAVN® har været ordineret i længere tid og/ eller i en høj dosis, bør din læge overveje et mellemrum af længere varighed.
If (Invented name)® has been prescribed for a long period and/ or at a high dose, a longer interval needs to be considered by your doctor.
Eksempler på MOA- hæmmere er: nialamid, iproniazid, selegelin, moclobemid, phenelzin, tranylxypromin, isocarboxazid og toloxaton.
Examples of MAOIs include nialamide, iproniazide, selegeline, moclobemide, phenelzine, tranylcypromine, isocarboxazid and toloxatone.
Hvis du under behandlingen med SÆRNAVN® udvikler krampeanfald, eller hvis de bliver værre, skal du holde op med at tage SÆRNAVN®.
Take special care with (Invented name)® and tell your doctor or pharmacist if you:
I dette tilfælde kan det være at du oplever det så kaldte serotoninsyndrom eller neuroleptisk malignt syndrom.
• develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), stop taking the capsules straight away and contact your doctor immediately. • have epilepsy or have had a fit in the past; if you have a fit (seizure) or experience an increase in seizure frequency, contact your doctor immediately, the use of fluoxetine might need to be discontinued. • have suffered from mania in the past; if you have a manic episode, contact your doctor immediately, the use of fluoxetine might need to be discontinued. • have diabetes your doctor may need to adjust your dose of insulin or other antidiabetic treatment); • have liver problems (your doctor may need to adjust your dosage) • have heart problems • are taking diuretics (water tablets), especially when you are elderly; • are having ECT (electro-convulsive therapy) treatment; • have a history of bleeding disorders or you develop bruises or unusual bleeding. • are using medicinal products that effect the coagulation of blood (see ‘ Taking other medicines’). • start to experience fever, muscle stiffness or tremor, changes in your mental state like confusion, irritability and extreme agitation; you may suffer from the so called serotonin syndrome or neuroleptic malignant syndrome.
Kontakt derfor straks din læge, da din fluoxetin behandling muligvis skal stoppes. • Hvis du har selvmordstanker eller ønsker om at gøre skade på dig selv.
Although this syndrome occurs rarely it may result in potentially life threatening conditions, contact your doctor immediately, the use of fluoxetine might need to be discontinued. • have suicidal thoughts or want to harm your self.
SÆRNAVN® kan også være forbundet med en forøget risiko for selvmordsrelaterede hændelser i forbindelse med ordination for andre psykiske lidelser.
Other psychiatric conditions for which (Invented name)® is prescribed can also be associated with an increased risk of suicide-related events.
Anvendelse til børn og unge under 18 år SÆRNAVN® bør ikke anvendes til behandling af børn og unge under 18 år, medmindre det er indiceret, til moderate til svære depressive episoder hos børn og unge fra 8 år.
Use in children and adolescents aged 8 to 18 years of age:
Til trods for dette, vil din læge muligvis ordinere SÆRNAVN® til patienter under 18 år, fordi han/ hun vurderer, at det er i deres egen bedste interesse.
Despite this, your doctor may prescribe (Invented name)® for patients under 18 for moderate to severe major depressive episode in combination with psychological therapy because he/ she decides that this is in their best interests.
EMEA/ CHMP/ 46089/ 2006/ DA Anvendelse af anden medicin
EMEA/ CHMP/ 46089/ 2006/ EN Taking Other Medicines with (Invented name)®
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Hvis du tager eller for nylig har taget andre lægemidler, bør du oplyse din læge herom, også hvis der er tale om ikke- receptpligtige lægemidler.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, (up to five weeks ago) including medicines obtained without prescription.
• MAO- hæmmere (brugt til behandling af depression).
• MAO-inhibitors (used to treat depression).
Ikke- selektive MAO- hæmmere og MAO - hæmmere type A (moclobemid) bør ikke bruges samtidig med SÆRNAVN®, da der kan ske alvorlige eller dødlige reaktioner (serotoninsyndrom) (se Du bør ikke tage SÆRNAVN®).
Non-selective MAO-inhibitors and MAO-inhibitors type A (moclobemide) should not be used with (Invented name)® as serious or even fatal reactions (serotonin syndrome) can occur (see section “ Do not take (Invented name)®”).
MAO- hæmmere type B (selegelin) kan bruges sammen SÆRNAVN® givet at din læge overvåger dette nøje. • Litium, tryptophan, der kan være en forøget risiko for serotoninsyndrom ved brugen af disse lægemidler samtidig med SÆRNAVN®.
MAO- inhibitors type B (selegeline) can be used with (Invented name)® provided that your doctor monitors you closely. • lithium, tryptophan; there is an increased risk of serotonin syndrome when these drugs are co- administered with (Invented name)®.
Din læge vil udføre hyppigere opfølgninger ved samtidig brug af SÆRNAVN® og litium. • Phenytoin (til epilepsi), fordi SÆRNAVN® kan påvirke koncentrationen af dette lægemiddel i blodet, kan det være nødvendigt for din læge at introducere phenytoin med større forsigtighed og udføre hyppigere opfølgninger ved samtidig brug af SÆRNAVN®. • Clozapin (brugt til behandling af mentale lidelser), tramadol (smertestillende) eller triptaner (migrænemidler), for disse er der en forøget risiko for forøget blodtryk. • Flecain eller encainid (for hjerteproblemer), carbamazepin (til epilepsi), tricykliske antidepressiva (for eksempel imipramin, desipramin og amitriptylin), da SÆRNAVN® kan påvirke koncentrationen af dissee lægemidler i blodet, kan det være nødvendigt for din læge at nedsætte doseringen af disse ved samtidig brug af SÆRNAVN®. • Warfarin eller andre lægemidler brugt til at fortynde blodet, da SÆRNAVN® kan påvirke disse lægemidlers virkningen på blodet.
When fluoxetine is used in combination with lithium your doctor will carry out more frequent check-ups. • phenytoin (for epilepsy); because (Invented name)® may influence the blood levels of this drug, your doctor may need to introduce phenytoin more carefully and carry out check-ups when given with (Invented name)®. • clozapine, (used to treat certain mental disorders), tramadol (a painkiller) or triptans (for migraine); there is an increased risk of hypertension. • flecainide or encainide (for heart problems), carbamazepine (for epilepsy), tricyclic antidepressants (for example imipramine, desipramine and amitriptyline); because (Invented name)® may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with (Invented name)®. • warfarin or other medicines used to thin the blood; (Invented name)® may alter the effect of these medicines on the blood.
Hvis SÆRNAVN® behandling påbegyndes eller afsluttes mens du tages warfarin, skal læge udføre visse prøver. • Du bør ikke begynde at tage naturmedicinen Hyperikum medens du tager SÆRNAVN®, da dette kan resultere i en uønsket forøgelse af virkningen.
If (Invented name)® treatment is started or stopped when you are taking warfarin, your doctor will need to perform certain tests. • You should not start to take the herbal remedy St John’ s wort while you are being treated with (Invented name)® since this may result in an increase of undesirable effects.
Hvis du allerede tager Hyperikum, når du starter på SÆRNAVN® behandling, skal du stoppe med at tage Hyperikum og fortælle din læge dette ved næste konsultation.
If you are already taking St John’ s wort when you start on (Invented name)®, stop taking the St John’ s wort and tell your doctor at your next visit.
• SÆRNAVN® kan tages sammen med mad og drikke. • Du bør undgå at indtage alkohol, når du tager denne medicin.
Taking (Invented name)® with food or drink • You can take (Invented name)® with or without food, whichever you prefer. • You should avoid alcohol while you are taking this medicine.