natgillin/translations-raw huggingface dataset:
“Treatment of osteoporosis in men at increased risk of fracture.
"Zdravljenje osteoporoze pri moških s povečanim tveganjem za zlom.
During post-marketing experience the following reactions have been reported (frequency unknown):
Po izdaji zdravila v promet so poročali o naslednjih reakcijah (pogostnost ni znana):
Osteoclastic activity is inhibited, but formation and binding of the osteoclasts is not affected.
Delovanje osteoklastov je zavrto, vendar pa njihova tvorba in vezava nista prizadeti.
Like all medicines, Alendronate HEXAL can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Alendronat HEXAL neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Alendronate HEXAL tablets contain lactose.
Alendronat HEXAL tablete vsebujejo laktozo.
In two three-year studies of almost identical design, with post-menopausal women (alendronate 10 mg: n=196; placebo: n=397) the overall safety profiles for alendronate 10 mg daily and placebo were similar.
V dveh skoraj enako zasnovanih triletnih študijah na pomenopavznih ženskah (Alendronat HEXAL 10 mg: n=196; placebo: n=397) sta bila skupna varnostna profila Alendronata HEXAL 10 mg dnevno in placeba podobna.
Studies in rats show that alendronate is initially distributed to soft tissues after intravenous administration of 1 mg/kg, but is then rapidly redistributed to the skeleton or excreted in the urine.
Študije pri podganah kažejo, da se alendronska kislina po intravenski aplikaciji 1 mg/kg najprej porazdeli v mehka tkiva, vendar se nato hitro prerazporedi v kosti ali se izloči z urinom.
Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4).
Dejavniki tveganja naj bi bili tudi diagnoza raka, kemoterapija, radioterapija, kortikosteroidi in slaba ustna higiena (glejte poglavje 4.4).
The tablets are supplied in triplex blister (PVC/PE/PVDC/AL) packaging.
Tablete so na voljo v pakiranju s tremi pretisnimi omoti (PVC/PE/PVDC/AL).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malapsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Studies in female rats showed that treatment with alendronate during pregnancy was associated with dystocia during parturition, which was related to hypocalcaemia.
Študije pri podganjih samicah so pokazale, da je zdravljenje z Alendronatom HEXAL med nosečnostjo povezano z distocijo med porodom, ki je bila povezana s hipokalcemijo.
6) After swallowing your Alendronate HEXAL, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins.
6) Ko pogoltnete tableto Alendronat HEXAL, počakajte vsaj 30 minut, preden zaužijete prvo hrano, pijačo ali drugo zdravilo v tem dnevu, vključno z antacidi, dodatki kalcija in vitamini.
Patients must therefore wait for at least 30 minutes after taking alendronate before taking any other oral medicine (see section 4.2).
Bolniki morajo zato po zaužitju Alendronata HEXAL počakati vsaj 30 minut, preden peroalno vzamejo katerokoli drugo zdravilo (glejte poglavje 4.2).
The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate.
Pomožne snovi so mikrokristalna celuloza, laktoza monohidrat, premrežen natrijev karmelozat, magnezijev stearat.
The CHMP has recommended the granting of the Marketing Authorisation and the amendment of the Summary of Product Characteristics, labelling, package leaflet of the Reference Member State accordingly for Alendronate HEXAL and associated names (see Annex I) 10 mg tablets.
CHMP je priporočil odobritev dovoljenja za promet in dopolnila Povzetka glavnih značilnosti zdravila, označevanja in Navodila za uporabo za referenčno državo članico za zdravilo Alendronate HEXAL 10 mg tablete in z njim povezana imena (glejte Dodatek I).
In osteoporosis studies alendronate was effective when it was given at least 30 minutes before the first meal or drink of the day.
V študijah osteoporoze je bil Alendronat HEXAL učinkovit pri jemanju vsaj 30 minut pred prvim dnevnim obrokom hrane ali pijače.
In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during treatment with alendronate.
Pri bolnikih s temi boleznimi je treba med zdravljenjem z Alendronatom HEXAL spremljati serumski kalcij in simptome hipokalcemije.
This medicinal product is authorised in the Member States of the EEA under the following names:>
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: Švedska
The FIT study included two placebo-controlled trials in which alendronate was given daily (5 mg daily for two years and 10 mg daily for a further one or two years).
Študija FIT je vključevala dvoje s placebom nadzorovanih preskušanj, v katerih so bolnice jemale Alendronat HEXAL vsak dan (5 mg dnevno dve leti in 10 mg dnevno nadaljnje leto ali dve).
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronate HEXAL if taken at the same time.
Verjetno je, da bodo dodatki kalcija, antacidi in nekatera peroralna zdravila motila absorpcijo Alendronata HEXAL, če jih boste vzeli istočasno.
In clinical trials there was no age-related difference with regard to efficacy or safety profiles of alendronate.
V kliničnih preskušanjih ni bilo nobene od starosti odvisne razlike v učinkovitosti ali varnosti Alendronata HEXAL.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <{DD/MM/YYYY}> <{DD month YYYY}> <[To be completed nationally]>
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET {DD/MM/LLLL} {DD mesec LLLL} [Izpolni država članica]
What is Alendronate HEXAL and what is it used for Before you take Alendronate HEXAL How to take Alendronate HEXAL Possible side effects
Kaj je zdravilo Alendronat HEXAL in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Alendronat HEXAL Kako jemati zdravilo Alendronat HEXAL Možni neželeni učinki
The reduction in height was less after treatment with alendronate, relative to placebo (-0.6 mm and -2.4 mm respectively, p=0.02).
Znižanje višine je bilo po zdravljenju z Alendronatom HEXAL manjše kot pri placebu (-0,6 mm v primerjavi z -2,4 mm, p=0,02).
The risk of severe oesophageal side effects is thought to be greater in patients who do not take alendronate correctly and/or continue to take alendronate after developing symptoms indicative of oesophageal irritation.
Kaže, da je tveganje za pojav hudih neželenih učinkov v požiralniku večje pri bolnikih, ki Alendronata HEXAL ne jemljejo pravilno in/ali nadaljujejo z jemanjem Alendronata HEXAL po pojavu simptomov, ki kažejo na draženje požiralnika.
In this study alendronate daily reduced the incidence of ≥1 new vertebral fracture by 47 % (alendronate 7.9 % versus placebo 15.0 %).
V tej študiji je dnevno jemanje Alendronata HEXAL zmanjšalo pojavnost ≥1 novega zloma vretenc za 47% (Alendronat HEXAL 7,9% v primerjavi s placebom 15,0%).
In this study, in a subgroup analysis of osteoporotic women (37 % of the total population who fulfilled the definition of osteoporosis given above) a significant difference was seen in the incidence of hip fractures (alendronate 1.0 % versus placebo 2.2 %, a reduction of 56 %) and in the incidence of ≥1 vertebral fracture (2.9 % versus 5.8 %, a reduction of 50 %).
V tej študiji so pri analizi podskupine žensk z osteoporozo (37% celotne populacije, ki je ustrezala zgoraj navedeni definiciji osteoporoze) opazili pomembno razliko v pojavnosti zlomov kolka (Alendronat HEXAL 1,0% v primerjavi s placebom 2,2%, zmanjšanje za 56%) in pojavnosti ≥1 zloma vretenc (2,9% v primerjavi z 5,8%, zmanjšanje za 50%).
4) Do not take Alendronate HEXAL at bedtime or before getting up for the day.
4) Zdravila Alendronat HEXAL ne vzemite zvečer ali preden zjutraj vstanete.
Compared with an intravenous reference dose, the mean oral bioavailability of alendronate in women was 0.64 % for doses ranging from 5 to 70 mg given after an overnight fast and two hours before a standardised breakfast.
V primerjavi z intravenskim referenčnim odmerkom je bila srednja peroralna biološka uporabnost Alendronata HEXAL pri ženskah 0,64% za odmerke med 5 do 70 mg, vzete zjutraj na tešče in dve uri pred standardiziranim zajtrkom.
Please store in the original package in order to protect from moisture.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX
PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA
• Alendronate HEXAL tablets should be swallowed whole.
• Alendronat HEXAL tablete je treba pogoltniti cele.
The efficacy of alendronate 10 mg and alendronate 5 mg once daily in men and women treated with steroids (at least 7.5 mg/day of prednisone or equivalent, median dose 10 mg/day) was demonstrated in two one-year studies of practically identical design.
Učinkovitost Alendronata HEXAL 10 mg in Alendronata HEXAL 5 mg enkrat dnevno pri moških in ženskah, ki se zdravijo s steroidi (najmanj 7,5 mg/dan prednizona ali ekvivalenta, povprečni odmerek 10 mg/dan), je bila dokazana v dveh skoraj enako zasnovanih enoletnih študijah.
A number of patients in the clinical trials received oestrogen (intravaginally, transdermally or orally) concomitantly with alendronate.
Številni bolniki so v kliničnih preskušanjih prejemali estrogen (intravaginalno, transdermalno ali peroralno) sočasno z Alendronatom HEXAL.
As there is a risk of worsening of the underlying disease, caution should be observed if alendronate is given to patients with active upper gastrointestinal tract problems, such as dysphagia, oesophageal disease, gastritis, duodenitis or ulcers, or in cases of recent (during the last year) severe gastrointestinal disease such as gastric ulcer, active gastrointestinal bleeding or surgery in the upper gastrointestinal tract other than pyloroplasty (see section 4.3).
Ker obstaja tveganje za poslabšanje obstoječe bolezni, je potrebna previdnost pri dajanju Alendronata HEXAL bolnikom z aktivnimi težavami zgornjega dela prebavil, kot so disfagija, bolezen požiralnika, gastritis, vnetje dvanajstnika ali razjede, ali v primeru hujše bolezni prebavil v zadnjem času (v zadnjem letu), kot so želodčna razjeda, aktivna krvavitev iz prebavil ali kirurški poseg v zgornjem delu prebavil razen piloroplastike (glejte poglavje 4.3).
Concentrations of active substance in plasma following therapeutic oral doses are too low for analytical detection (<5 ng/ml).
Plazemske koncentracije zdravilne učinkovine po peroralnih terapevtskih odmerkih so za analitsko določitev prenizke (<5 ng/ml).
Important information about some of the ingredients of Alendronate HEXAL Alendronate HEXAL contains lactose.
Pomembne informacije o nekaterih sestavinah zdravila Alendronat HEXAL Alendronat HEXAL vsebuje laktozo.
If taken at the same time, it is likely that foods and drinks (including mineral water), calcium supplements, antacids and some oral medicines will affect the absorption of alendronate.
Ob hkratnem jemanju lahko hrana in pijača (vključno z mineralno vodo), dodatki kalcija, antacidi in nekatera peroralna zdravila vplivajo na absorpcijo alendronske kisline.
Treatment of osteoporosis in men at increased risk of fracture.
Zdravljenje osteoporoze pri moških s povečanim tveganjem za zlom.
There are insufficient data regarding the use of alendronate in pregnant women.
Ni zadostnih podatkov o uporabi Alendronata HEXAL pri nosečnicah.
Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
O osteonekrozi čeljusti, ki je običajno povezana s puljenjem zoba in/ali lokalno okužbo (vključno z osteomielitisom), so poročali pri bolnikih z rakom, katerih zdravljenje je vključevalo predvsem intravensko aplicirane difosfonate.
Take special care with Alendronate HEXAL Tell your doctor - if you suffer from kidney problems - if you have any swallowing or digestive problems - if you have low blood calcium levels.
Bodite posebno pozorni pri jemanju zdravila Alendronat HEXAL Zdravniku povejte - če imate težave z ledvicami, - če imate kakšne težave pri požiranju ali s prebavo, - če imate nizke vrednosti kalcija v krvi.
5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronate HEXAL and contact your doctor.
5) Če se pojavijo težave ali bolečine pri požiranju, bolečine v prsih ali zgaga oz. stopnjevanje težav z zgago, prenehajte jemati zdravilo Alendronat HEXAL in se posvetujte z zdravnikom.
Preclinical studies have demonstrated a preference for localisation of alendronate to sites where active resorption takes place.
Predklinične študije so pokazale, da se alendronska kislina lokalizira predvsem v predelih, kjer poteka aktivna resorpcija.
The increases in BMD with alendronate 10 mg once daily were the same as for alendronate 5 mg once daily in all patients, with the exception of postmenopausal women who were not being treated with oestrogen.
Zvišanja MGK pri jemanju Alendronata HEXAL 10 mg enkrat dnevno so bila enaka kot pri jemanju Alendronata HEXAL 5 mg enkrat dnevno pri vseh bolnikih, z izjemo žensk po menopavzi, ki se niso zdravile z estrogenom.
Osteoporosis is defined as bone mineral density (BMD) of the spine or hip 2.5 standard deviations below the mean value of a normal young population or as a previous fragility fracture, irrespective of bone mineral density.
Osteoporoza je opredeljena kot mineralna gostota kosti (MGK) hrbtenice ali kolkov za 2,5 standardne deviacije pod povprečno vrednostjo, ki velja za normalno mlado populacijo, ali kot predhoden primer zloma zaradi krhkosti, do katerega pride ne glede na mineralno gostoto kosti.
A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated.
Dokazano je zmanjšanje pojavnosti vretenčnih, ne pa tudi nevretenčnih zlomov.
After two years of treatment with alendronate 10 mg/day, BMD increased on average by 5.3 % in the spine, by 2.6 % in the femoral neck, by 3.1 % in the trochanter, and by 1.6 % for the skeleton as a whole, relative to placebo (p<0.001 for all measurement points).
Po dveh letih zdravljenja z Alendronatom HEXAL 10 mg/dan, se je MGK v povprečju zvečala za 5,3% v hrbtenici, za 2,6% v vratu stegnenice, za 3,1% v trohantru in za 1,6% v okostju celotnega telesa, v primerjavi s placebom (p < 0,001 za vse točke merjenja).
To assist delivery to the stomach and thus reduce the risk of irritation/side effects locally and in the oesophagus (see section 4.4)
Za hiter prehod v želodec in zmanjšanje tveganja za draženje/neželene učinke lokalno in v požiralniku (glejte poglavje 4.4)
Consult your doctor before you begin any exercise programme.
Preden začnete s programom vadbe, se posvetujte s svojim zdravnikom.
If you miss a dose, just take one tablet on the morning after you remember.
Če ste pozabili vzeti zdravilo Alendronat HEXAL Če pozabite vzeti odmerek, vzemite eno tableto naslednje jutro, potem ko se spomnite.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Bolnikom, pri katerih se med zdravljenjem z difosfonati razvije osteonekroza čeljusti, se lahko zaradi kirurškega posega na zobeh stanje poslabša.
Rare (≥1/10,000, <1/1000): Hypersensitivity reactions including urticaria and angioedema.
Redki (≥1/10.000, <1/1.000): preobčutljivostne reakcije, vključno z urtikarijo in angioedemom.
White to off-white, capsule-shaped tablet, embossed "AN 10" on one side and "Arrow logo" on the other.
Tableta v obliki kapsule, bele ali skoraj bele barve, ki ima na eni strani vtisnjeno oznako "AN 10", na drugi strani pa "Arrow logo".
What Alendronate HEXAL looks like and contents of the pack Alendronate HEXAL are available as white to off-white, capsule-shaped tablet, embossed "AN 10" on one side and "Arrow logo" on the other.
Izgled zdravila Alendronat HEXAL in vsebina pakiranja Alendronat HEXAL je na voljo kot tableta v obliki kapsule, bele do skoraj bele barve, ki ima na eni strani vtisnjeno oznako "AN 10", na drugi strani pa "Arrow logo".
Alendronate given to pregnant rats caused hypocalcaemia-related dystocia (see section 5.3).
Pri brejih podganah, ki so prejemale Alendronat HEXAL, je le-ta povzročil distocijo, povezano s hipokalcemijo (glejte poglavje 5.3).
Alendronate HEXAL has been shown to reduce the risk of spine and hip fractures in women and spine fractures in men.
Izkazalo se je, da Alendronat HEXAL zmanjša tveganje za zlome hrbtenice in kolka pri ženskah in zlome hrbtenice pri moških.
Causes of osteoporosis other than oestrogen deficiency, ageing and glucocorticoid use should be considered.
Poleg pomanjkanja estrogena, staranja in uporabe glukokortikoidov je treba preučiti tudi druge vzroke za osteoporozo.
Use in impaired hepatic function No dose adjustment is necessary.
Uporaba pri bolnikih z motnjami v delovanju jeter Prilagajanje odmerka ni potrebno.
In the patients treated with alendronate, the proportion of patients who suffered one or more vertebral fractures was reduced by 48 % (alendronate 3.2 % versus placebo 6.2 %).
Delež bolnic, ki so se zdravile z Alendronatom HEXAL in so imele enega ali več zlomov vretenc, se je znižal za 48% (Alendronat HEXAL 3,2% v primerjavi s placebom 6,2%).
In addition, other amendments to the Summary of Product Characteristics, labelling and package leaflet not in relation with the outcome of the referral procedure were included in accordance with the Guideline on Summary of Product Characteristics, excipient guideline and the latest Quality Review of Document templates.
Poleg tega so bila v skladu s smernicami o povzetku glavnih značilnosti, o pomožnih snoveh in zadnjimi predlogami za pregledovanje kakovosti dokumentov, vključena tudi druga dopolnila Povzetka glavnih značilnosti zdravila, označevanja in Navodila za uporabo, ki niso povezana z rezultatom napotitvenega postopka.
In addition, alendronate 10 mg and alendronate 5 mg were effective irrespective of age (<65 years as against ≥65 years), gender, baseline BMD, baseline bone turnover and concomitant use of a number of common medicines.
Poleg tega sta bila Alendronat HEXAL 10 mg in Alendronat HEXAL 5 mg učinkovita ne glede na starost (<65 let v primerjavi z ≥65 let), spol, MGK na začetku študije, kostno presnovo na začetku študije in sočasno uporabo številnih pogosto uporabljanih zdravil.
These side effects may worsen if patients continue to take Alendronate HEXAL after developing these symptoms.
Ti neželeni učinki se lahko stopnjujejo, če bolnik nadaljuje z jemanjem zdravila Alendronat HEXAL potem, ko so se simptomi že pojavili.
dizziness swelling in the hands or legs lack or loss of strength osteonecrosis (death of bone tissue)
omotica otekanje rok in nog pomanjkanje ali izguba moči ostenekroza (odmrtje kostnega tkiva) otekanje sklepov
Laboratory values: In clinical trials, asymptomatic, slight and transient decreases in serum calcium and serum phosphate were observed in approx. 18 and 10 % respectively of the patients taking alendronate 10 mg/day versus 12 and 3 % respectively of those taking placebo.
Izvidi laboratorijskih preiskav: V kliničnih preskušanjih so opazili asimptomatska, blaga in prehodna znižanja serumskega kalcija pri približno 18% bolnikov in serumskega fosfata pri približno 10% bolnikov, ki so jemali Alendronat HEXAL 10 mg na dan, v primerjavi z znižanjem serumskega kalcija pri približno 12% bolnikov in serumskega fosfata pri 3% bolnikov, ki so jemali placebo.
Take one Alendronate 10 mg tablet once daily.
Vzemite eno tableto Alendronata HEXAL 10 mg enkrat na dan.
- the literature provided by the applicant provide evidence that 10 mg daily could increase bone mineral density both at vertebral as well as non vertebral level in men with primary osteoporosis, - an effect on non-vertebral fractures has nonetheless not been demonstrated in this population.
- literatura, ki jo je predložil vlagatelj, je pokazala, da lahko 10 mg alendronata dnevno poveča mineralno gostoto kosti v vetrebralnem kot tudi v nevertebralnem okostju moških s primarno osteoporozo, - učinek na nevertebralne zlome kosti v tej populaciji kljub vsemu ni bil dokazan,
In these women the increases (relative to placebo) with alendronate 10 mg once daily were greater than for alendronate 5 mg once daily in the spine (4.11 % versus 1.56 %) and trochanter (2.84 % versus 1.67 %).
Pri teh ženskah so bila zvečanja (v primerjavi s placebom) pri zdravljenju z Alendronatom HEXAL 10 mg enkrat dnevno večja kot pri zdravljenju z Alendronatom HEXAL 5 mg enkrat dnevno v hrbtenici (4,11% v primerjavi z 1,56%) in trohantru (2,84% v primerjavi z 1,67%).
• Patients should not lie down within 30 minutes of taking Alendronate HEXAL tablets.
• Bolnik ne sme leči prej kot 30 minut po zaužitju Alendronat HEXAL tablet.
Eye disorders: Rare (≥1/10,000, <1/1000): Uveitis, scleritis, episcleritis
Očesne bolezni: Redki (≥1/10.000, <1/1.000): uveitis, skleritis, episkleritis
Very rare, not known: perforation of the oesophagus was reported in isolated cases
Zelo redki, ni znano: v posameznih primerih so poročali o perforaciji požiralnika
10 mg per tablet
Peroralna uporaba 10 mg na tableto
Do not lie down within 30 minutes of taking Alendronat HEXAL
Ne ulezite se prej kot 30 minut po zaužitju tablete Alendronat HEXAL!
Patients should be informed that the risk of oesophageal problems may increase if they do not follow these instructions.
Bolnikom je treba povedati, da neupoštevanje teh navodil lahko poveča tveganje za težave s požiralnikom.
During post-marketing experience the following side effects have been reported (frequency unknown):
Po izdaji zdravila v promet so poročali o naslednjih neželenih učinkih (pogostnost ni znana):
The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans.
Srednja vrednost volumna porazdelitve v stanju dinamičnega ravnovesja (brez kosti) je pri ljudeh najmanj 28 litrov.
The fracture-preventing effect of increasing bone density with alendronate 10 mg or alendronate 5 mg in corticosteroidinduced osteoporosis has not been established.
Učinek preprečevanja zlomov zaradi zvečanja kostne gostote z Alendronatom HEXAL 10 mg ali Alendronatom HEXAL 5 mg pri osteoporozi, povzročeni s kortikosteroidi, ni bi ugotovljen.
There is no specific information available with regard to overdosage with alendronate.
Posebne informacije v zvezi s prevelikim odmerjanjem Alendronata HEXAL niso na voljo.
General disorders and administration site conditions: asthenia, peripheral oedema
Splošne težave in spremembe na mestu aplikacije: astenija, periferni edem
Therefore, somewhat greater accumulation of alendronate in bone might be expected in patients with impaired renal function (see section 4.2).
Zato se pri bolnikih z motnjami v delovanju ledvic lahko pričakuje nekoliko večje kopičenje alendronske kisline v kosteh (glejte poglavje 4.2).
Symptomatic hypocalcaemia, generally in connection with predisposing conditions (see.
Simptomatska hipokalcemija, običajno povezana s predispozicijami (glejte poglavje 4.4).
Nervous system disorders: dizziness
Bolezni živčevja: omotica
Alendronate HEXAL is effective only if taken when your stomach is empty.
Alendronat HEXAL je učinkovit samo, če ga vzamete na tešče.
Nervous system disorders: Common (≥1/100, <1/10): Headache
Bolezni živčevja: Pogosti (≥1/100, <1/10): glavobol
Alendronate is not recommended for patients with impaired renal function if the GFR is less than 35 ml/min (see section 4.2).
Zdravilo Alendronat HEXAL se ne priporoča bolnikom z motnjami v delovanju ledvic, pri katerih je hitrost glomerulne filtracije manjša od 35 ml/min (glejte poglavje 4.2).
Very common: ≥ 1/10
Zelo pogosti (≥1/10)
Post-menopausal osteoporosis:
Pomenopavzna osteoporoza: