qanastek/EMEA-V3 huggingface dataset:
75 Dosage adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see Section 4.2 Table 1).
Huwa meħtieġ aġġustament tad- doża f' pazjenti li għandhom funzjoni renali mnaqqsa jew li jkunu qegħdin jagħmlu ħemodijaliżi (ara Sezzjoni 4. 2 Tabella 1).
Pharmacokinetics in special patient groups
82 Farmakokinetika fi gruppi speċjali ta 'pazjenti
At therapeutic exposures, there was evidence of CNS clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight gain suppression).
83 sinjali kliniċi tas- CNS ta 'attività eċċessiva u tgħażżiż tas- snien u xi bidliet fit- tkabbir (trażżiż temporanju taż- żieda fil- piż tal- ġisem).
PVC/Aluminium blisters containing 14 or 56 hard capsules.
Folji tal- PVC/ Aluminju li fihom 14 jew 56 kapsula iebsa.
100 hard capsule PVC/Aluminium blister pack (non-perforated) Not all pack sizes may be marketed.
100 kapsula iebsa, f’ folji (mhux perforati) ġo pakkett tal- PVC/ Aluminju Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
LYRICA 300 mg hard capsules
LYRICA 300 mg kapsuli iebsin
Each hard capsule contains 300 mg of pregabalin.
Kull kapsula iebsa fiha 300 mg ta 'pregabalin.
Hard capsule White and orange, marked “Pfizer” on the cap and “PGN 300” on the body with black ink.
Kapsula iebsa Bajda u oranġjo, immarkata “ Pfizer ” fuq il- parti ta 'fuq u “ PGN 300 ” fuq il- parti ewlenija b' linka sewda.
79 Generalised Anxiety Disorder
86 Disturb ta 'Ansjetà Ġeneralizzata
The maximum dosage of 600 mg per day may be achieved after an additional week (see section 4.8).
Id- doża massima ta '600 mg kuljum tista' tinkiseb wara ġimgħa addizzjonali (ara sezzjoni 4. 8).
Table 1.
87 Tabella 1.
80 Use in children and adolescents
Użu fit- tfal u l- adoloxxenti
In controlled studies, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing.
Fi studji kontrollati, proporzjon ogħla ta ’ pazjenti ttrattati bi pregabalin irrappurtaw viżjoni mċajpra milli dawk ttrattati bi plaċebo, u fil- biċċa ‘ l kbira tal- pazjenti il- viżjoni iċċarat meta tkompla id - 88 dużaġġ.
Pregabalin may potentiate the effects of ethanol and lorazepam.
89 Pregabalin jista ’ jżid l- effetti ta ’ ethanol u lorazepam.
82 reactions were dizziness and somnolence.
L- aktar reazzjonijiet avversi li ġew irrapportati b' mod komuni kienu sturdament u ngħas.
Body System Immune system disorders
90 Sistema tal- Ġisem Disturbi fis- sistema immuni
Unknown frequency Ear and labyrinth disorders
Frekwenza mhux magħrufa Keratite Disturbi fil- widnejn u fis- sistema labirintika Komuni Rari Disturbi tal- qalb
83 Cardiac disorders Uncommon Rare
Mhux komuni Rari
Common Uncommon
91 Disturbi gastro- intestinali Komuni Mhux komuni
The following events have been: insomnia, headache, nausea, diarrhoea, flu syndrome, nervousness, depression, pain, sweating and dizziness.
Kienu msemmija l- episodji li ġejjin: nuqqas ta 'rqad, uġigħ ta' ras, dardir, dijarea, sindrome ta 'l- influwenza, nervożità, depressjoni, uġigħ, tagħriq u sturdament.
84 4.9 Overdose
4. 9 Doża eċċessiva
Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1).
92 Il- kura ta 'doża eċċessiva ta' pregabalin għandha tinkludi miżuri ġenerali ta 'sostenn u tista' tinkludi ħemodijaliżi jekk ikun meħtieġ (ara sezzjoni 4. 2 Tabella 1).
85 Generalised Anxiety Disorder
Disturb ta 'Ansjetà Ġeneralizzata
In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
93 Fi provi kliniċi kkontrollati (li damu 4- 8 ġimgħat) 52% tal- pazjenti kkurati bi pregabalin u 38% tal - pazjenti fuq il- plaċebo kellhom titjib ta 'mill- anqas 50% fil- punteġġ totali tal- HAM- A mil- linja bażika sal- punt finali.
86 Dosage adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see Section 4.2 Table 1).
Huwa meħtieġ aġġustament tad- doża f' pazjenti li għandhom funzjoni renali mnaqqsa jew li jkunu qegħdin jagħmlu ħemodijaliżi (ara Sezzjoni 4. 2 Tabella 1).
Linearity / non-linearity:
94 Lineari / mhux lineari:
87 similar to the mean human exposure, but an increased incidence of haemangiosarcoma was observed at higher exposures.
95 ta 'haemangiosarcoma f' esponimenti aktar għoljin.
88 6.6 Special precautions for disposal and other handling
96 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
89 ANNEX II
97 ANNESS II
Pfizer GmbH Arzneimittelwerk, Gödecke, Mooswaldallee 1, D-79090 Freiburg, Germany
Pfizer GmbH Arzneimittelwerk, Gödecke, Mooswaldallee 1, D- 79090 Freiburg, Il- Ġermanja
CONDITIONS OF THE MARKETING AUTHORISATION
KONDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
OTHER CONDITIONS
• KONDIZZJONIJIET OĦRA
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Il- MAH jimpenja ruħu li jwettaq l- istudji u attivitajiet addizzjonali ta 'farmakoviġilanza kif dettaljati fil- Pjan ta' Farmakoviġilanza.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
Għandu jiġi pprovdut Pjan aġġornat ta 'Ġestjoni tar- Riskju skond il- Linja Gwida tal- CHMP dwar Sistemi ta' Ġestjoni tar- Riskju għal prodotti mediċinali li jintużaw fil- bniedem.
91 ANNEX III
99 ANNESS III
LABELLING AND PACKAGING LEAFLET
TIKKETTA U FULJETT TA ’ TAGĦRIF
93 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
101 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER WRAPPER LABEL ON MULTIPACKS (2X56 HARD CAPSULES) WRAPPED IN FOIL (INCLUDING THE BLUE BOX)
TIKKETTA TA 'L- IPPAKKJAR TA' BARRA FUQ MULTIPACKS (2 X 56 kapsuli iebsin) IMKEBBIN ĠO FOLJA (INKLUŻ IL- KAXXA BLU)
LYRICA 25 mg hard capsules Pregabalin
LYRICA 25 mg kapsuli iebsin Pregabalin
Each hard capsule contains 25 mg pregabalin
Kull kapsula iebsa fiha 25 mg ta 'pregabalin.
This product contains lactose monohydrate
Dan il- prodott fih lactose monohydrate
112 (2 packs of 56) hard capsules
112 (2 pakketti ta '56) kapsula ebsin
Oral use Read the package leaflet before use
Użu orali Aqra l- fuljett ta 'tagħrif qabel l- użu
95 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
103 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton of blister pack (14, 21, 56,84, 100 and 56 (part of multipack) and perforated unit dose blister pack (100) for 25mg hard capsules
Kaxxa tal- pakkett ta 'folji (14, 21, 56, 84, 100 u 56 (parti minn multipack) u pakkett ta' folji ta 'doża waħda perforat (100) għal kapsuli iebsin ta' 25 mg
14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 56 hard capsules (part of multipack) 100 x 1 hard capsules
14- il kapsula iebsa 21 kapsula iebsa 56 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 56 kapsula iebsa (parti minn multipack) 100 x 1 kapsula iebsa
Sealed Pack Do not use if box has been opened
Pakkett Issiġillat Tużahx jekk il- kaxxa tkun miftuħa
96 9.
104 9.
97 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
105 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister pack (14, 21, 56, 84 and 100) and perforated unit dose blister pack (100) for 25mg hard capsules
Pakkett ta 'folji (14, 21, 56, 84 u 100) u pakkett ta' folji ta ’ doża waħda (100) perforat għal kapsuli iebsin ta '25 mg
Pfizer Ltd (as MA Holder logo)
Pfizer Ltd (bħala lowgo tad- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq)
98 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
106 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Blister pack (14, 21, 56, 84 and 100) and perforated unit dose blister pack (100) for 50 mg hard capsules
Pakkett ta 'folji (14, 21, 56, 84 u 100) u pakkett ta' folji ta ’ doża waħda (100) perforat għal kapsuli iebsin ta '50 mg
LYRICA 50 mg hard capsules Pregabalin
LYRICA 50 mg kapsuli iebsin Pregabalin
Each hard capsule contains 50 mg pregabalin
Kull kapsula iebsa fiha 50 mg ta 'pregabalin.
14 hard capsules 21 hard capsules 56 hard capsules84 hard capsules 100 hard capsules 100 x 1 hard capsules
14- il kapsula iebsa 21 kapsula iebsa 56 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 100 x 1 kapsula iebsa
100 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
108 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
101 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
109 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
LYRICA 75 mg hard capsules Pregabalin
LYRICA 75 mg kapsuli iebsin Pregabalin
Each hard capsule contains 75 mg pregabalin
Kull kapsula iebsa fiha 75 mg ta 'pregabalin.
112 (2 packs of 56) hard capsules
112 (2 pakketti ta '56) - il kapsula ebsin
103 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
111 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton of blister pack (14, 56, 100 and 56 (part of multipack)) and perforated unit dose blister pack (100) for 75 mg hard capsules
Kaxxa tal- pakkett ta 'folji (14, 21, 56, 84, 100 u 56 (parti minn multipack) u pakkett ta' folji ta 'doża waħda perforat (100) għal kapsuli iebsin ta' 75 mg
14 hard capsules 56 hard capsules 100 hard capsules 56 hard capsules (part of multipack) 100 x 1 hard capsules
14- il kapsula iebsa 56 kapsula iebsa 100 kapsula iebsa 56 kapsula iebsa (parti minn multipack) 100 x 1 kapsula iebsa
105 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
113 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister pack (14, 56 or 100) and perforated unit dose blister pack (100) for 75 mg hard capsules
Pakkett ta 'folji (14, 56 jew 100) u pakkett ta' folji ta ’ doża waħda (100) perforat għal kapsuli iebsin ta '75 mg
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
114 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bottle immediate packaging for 75 mg hard capsules – pack of 200
Pakkett li jmiss mal- flixkun għal kapsuli iebsin ta '75 mg - pakkett ta' 200
200 hard capsules
200 kapsula iebsa
107 11.
115 11.
108 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
116 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 100 mg hard capsules
Pakkett ta 'folji (21, 84 u 100) u pakkett ta' folji ta ’ doża waħda (100) perforat għal kapsuli iebsin ta '100 mg
LYRICA 100 mg hard capsules Pregabalin
Pregabalin
Each hard capsule contains 100 mg pregabalin
Kull kapsula iebsa fiha 100 mg ta 'pregabalin.
21 hard capsules 84 hard capsules 100 hard capsules 100 x 1 hard capsules
21 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 100 x 1 kapsula iebsa
110 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
118 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 100 mg hard capsules
Pakkett ta 'folji (21, 84 jew 100) u pakkett ta' folji ta ’ doża waħda (100) perforat għal kapsuli iebsin ta '100 mg
LYRICA 100 mg hard capsules Pregabalin
LYRICA 100 mg kapsuli iebsin Pregabalin
111 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
119 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
LYRICA 150 mg hard capsules Pregabalin
LYRICA 150 mg kapsuli iebsin Pregabalin
Each hard capsule contains 150 mg pregabalin
Kull kapsula iebsa fiha 150 mg ta 'pregabalin.
112 (2 packs of 56) hard capsules
112 (2 pakketti ta '56) - il kapsula iebsa
113 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
121 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton of blister pack (14, 56, 100 and 56 (part of multipack)) and perforated unit dose blister pack (100) for 150 mg hard capsules
Kaxxa tal- pakkett ta 'folji (14, 56, 100 u 56 (parti minn multipack) u pakkett ta' folji ta ’ doża waħda (100) perforat għal kapsuli iebsin ta '150 mg
115 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
123 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister pack (14, 56 or 100) and perforated unit dose blister pack (100) for 150 mg hard capsules
Pakkett ta 'folji (14, 56 jew 100) u pakkett ta' folji ta ’ doża waħda (100) perforat għal kapsuli iebsin ta '150 mg
116 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
124 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bottle immediate packaging for 150 mg hard capsules – pack of 200
Pakkett li jmiss mal- flixkun għal kapsuli iebsin ta '150 mg - pakkett ta' 200
118 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
126 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 200 mg hard capsules
Pakkett ta 'folji (21, 84 jew 100) u pakkett ta' folji ta ’ doża waħda (100) perforat għal kapsuli iebsin ta '100 mg
LYRICA 200 mg hard capsules Pregabalin
LYRICA 200 mg kapsuli iebsin Pregabalin
Each hard capsule contains 200 mg pregabalin
Kull kapsula iebsa fiha 200 mg ta 'pregabalin.
120 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
128 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 200 mg hard capsules
Pakkett ta 'folji (21, 84 jew 100) u pakkett ta' folji ta ’ doża waħda (100) perforat għal kapsuli iebsin ta '200 mg
121 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
129 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Blister pack (14, 56 or 100) and perforated unit dose blister pack (100) for 225 mg hard capsules
Pakkett ta 'folji (14, 56 jew 100) u pakkett ta' folji ta ’ doża waħda (100) perforat għal kapsuli iebsin ta '225 mg
LYRICA 225 mg hard capsules Pregabalin
LYRICA 225 mg kapsuli iebsin Pregabalin
Each hard capsule contains 225 mg pregabalin
Kull kapsula iebsa fiha 225 mg ta 'pregabalin.
14 hard capsules 56 hard capsules 100 hard capsules 100 x 1 hard capsules
14- il kapsula iebsa 56 kapsula iebsa 100 kapsula iebsa 100 x 1 kapsula iebsa
123 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
131 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
124 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
132 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
LYRICA 300mg hard capsules Pregabalin
LYRICA 300 mg kapsuli iebsin Pregabalin
Each hard capsule contains 300 mg pregabalin
Kull kapsula iebsa fiha 300 mg ta 'pregabalin.
11.
133 11.
126 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
134 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton of blister pack (14,56, 100 and 56 (part of multipack)) and perforated unit dose blister pack (100) for 300 mg hard capsules
Kaxxa tal- pakkett ta 'folji (14, 56, 100 u 56 (parti minn multipack) u pakkett ta' folji ta 'doża waħda perforat (100) għal kapsuli iebsin ta' 300 mg
LYRICA 300 mg hard capsules Pregabalin
LYRICA 300 mg kapsuli iebsin Pregabalin
128 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
136 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister pack (14, 56 or 100) and perforated unit dose blister pack (100) for 300 mg hard capsules
Pakkett ta 'folji (14, 56 jew 100) u pakkett ta' folji ta ’ doża waħda (100) perforat għal kapsuli iebsin ta '300 mg
129 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
137 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bottle immediate packaging for 300 mg hard capsules – pack of 200
Pakkett li jmiss mal- flixkun għal kapsuli iebsin ta '300 mg - pakkett ta' 200
132 P ACKAGE LEAFLET:
140 FULJETT TA 'TAGĦRIF:
LYRICA 25, 50, 75, 100, 150, 200, 225 and 300mg hard capsules (Pregabalin)
LYRICA 25, 50, 75, 100, 150, 200, 225 u 300mg kapsuli iebsin Pregabalin
Keep this leaflet.
- Żomm dan il- fuljett.
If you have further questions, ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek
This medicine has been prescribed for you personally and you should not pass it on to others.
Tista 'tagħmlilhom il- ħsara,
It may harm them, even if their symptoms are the same as yours.
anki jekk ikollhom l- istess sintomi bħal tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m' humiex
What LYRICA is and what it is used for 2.
X' inhu LYRICA u għalxiex jintuża 2.
Before you take LYRICA 3.
Qabel ma tieħu LYRICA 3.
How to take LYRICA 4.
Kif għandek tieħu LYRICA 4.
How to store LYRICA 6.
Kif taħżen LYRICA 6.
WHAT LYRICA IS AND WHAT IT IS USED FOR
X' INHU LYRICA U GĦALXIEX JINTUŻA
LYRICA belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD).
LYRICA jappartjeni għal grupp ta 'mediċini li jintużaw għall- kura ta' l- epilessija, l- uġigħ nevrotiku u d- Disturb ta 'Ansjetà Ġeneralizzata (GAD - Generalised Anxiety Disorder).
The safety and effectiveness of pregabalin in patients below the age of 18 years with peripheral and central neuropathic pain, epilepsy and Generalised Anxiety Disorder has not been established.
Is- sigurtà u l- effikaċja ta 'pregabalin f' pazjenti ta' taħt it- 18 - il sena b' uġigħ nevrotiku periferali u ċentrali, epilessija u Disturb ta 'Ansjetà Ġeneralizzata ma ġewx stabbiliti.
Peripheral and central neuropathic pain:
Uġigħ nevrotiku periferali u ċentrali:
LYRICA is used to treat long lasting pain caused by damage to the nerves.
LYRICA jintuża sabiex jiġi kkurat uġigħ fit- tul ikkawżat minn ħsara fin- nervituri.
A variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles.
Hemm numru ta 'mard li jista' jikkaġuna wġigħ nevrotiku periferali, bħad - dijabete jew il- ħruq ta 'Sant' Antnin.
Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles.
Is- sensazzjonijiet ta 'uġigħ li wieħed iħoss jistgħu jiġu deskritti bħala sħana, ħruq, tektik, uġigħ li jiġri minn parti għal oħra tal- ġisem, tniffid, uġigħ qawwi, bugħawwieġ, weġgħat, tnemnim, tinġiż.
Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue, and can have an impact on physical and social functioning and overall quality of life.
L- uġigħ nevrotiku periferali u ċentrali jista 'jkun assoċjat ukoll ma' bidliet fil- burdata, disturb fl- irqad, għeja, u jista 'jkollu impatt fuq il- funzjonament fiżiku u soċjali u fuq il- kwalità tal- ħajja in ġenerali.
Epilepsy:
Epilessija:
LYRICA is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
LYRICA tintuża sabiex tiġi kkurata ċerta forma ta 'epilessija (aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja) fl- adulti.
Your doctor will prescribe LYRICA for you to help treat your epilepsy when your current treatment is not controlling your condition.
It- tabib tiegħek jordnalek LYRICA biex jgħin fil - kura ta 'l- epilessija meta l- kura li tkun qed tieħu ma tkunx qiegħda tikkontrolla l- kondizzjoni tiegħek.
You should take LYRICA in addition to your current treatment.
LYRICA għandu jittieħed mal- kura li tkun qiegħed/ qiegħda tieħu.
LYRICA is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
LYRICA mhuwiex maħsub sabiex jintuża waħdu, iżda għandu dejjem jintuża ma 'trattament ieħor kontra l- epilessija.
Generalised Anxiety Disorder:
Disturb ta 'Ansjetà Ġeneralizzata:
LYRICA is used to treat Generalised Anxiety Disorder (GAD).
LYRICA jintuża għall- kura ta 'Disturb ta' Ansjetà Ġeneralizzata (GAD).
The symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control.
Is- sintomi ta 'GAD huma ansjetà eċċessiva fit- tul u tħassib li jkunu diffiċli biex tikkontrollahom.
GAD can also cause restlessness or feeling keyed up or on edge, being easily fatigued, having difficulty concentrating or mind going blank, feeling irritable, having muscle tension or sleep disturbance.
GAD jista 'jikkawża wkoll irrekwitezza jew tħossok eċċitat jew fuq ix- xwiek, tegħja malajr, diffikulta' biex tikkonċentra jew ma tiftakar xejn, tħossok irritabbli, ikollok tensjoni fil- muskoli jew disturb fl- irqad.
This is different to the stresses and strains of everyday life.
Dan huwa differenti mit- tensjonijiet tal- ħajja ta 'kuljum.
BEFORE YOU TAKE LYRICA
QABEL MA TIEĦU LYRICA
Do not take LYRICA if you are allergic (hypersensitive) to pregabalin or any of the other ingredients of Lyrica.
- jekk int allerġiku (tbati minn sensittività eċċessiva) għal pregabalin jew għal sustanzi oħra ta '
133 Take special care with LYRICA Some patients taking LYRICA have reported symptoms suggesting an allergic reaction.
141 Oqgħod attent ħafna b' LYRICA Xi pazjenti li jużaw LYRICA irrappurtaw sintomi li jindikaw reazzoni allerġika.
These symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash.
Dawn is- sintomi jinludu nefħa fil- wiċċ, fix- xofftejn, fl- ilsien, kif ukoll raxx diffus tal- ġilda.
Should you experience any of these reactions, you should contact your physician immediately.
Jekk tħoss kwalunkwe minn dawn is- sintomi għandek tkellem immedjatament lit- tabib tiegħek.
LYRICA has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
LYRICA ġie assoċjat ma 'sturdament u ngħas, li jistgħu jżidu l- okkorrenza ta' korriment aċċidentali (waqgħat) f' pazjenti anzjani.
Therefore, you should be careful until you are used to any effect the medication might have.
Għalhekk, inti għandek toqgħod attent sakemm tidra l- effetti li jista 'jkollha l- mediċina.
LYRICA may be associated with blurred vision or other changes in eyesight.
LYRICA jista jkun assoċċjat ma viżjoni mċajpra jew bdil ieħor fil- viżta.
You should immediately tell your doctor if you experience any change in vision.
Għandek tirreferi immedjament għand it- tabib tigħek jekk tesperjenza xi bidla fil- viżta.
Some patients with diabetes who gain weight while taking pregabalin may need an alteration in their diabetic medicines.
Xi pazjenti bid- dijabete li jżidu fil- piż waqt li jkunu qegħdin jieħdu pregabalin jista 'jkollhom bżonn bidla fil- mediċini li jkunu qegħdin jieħdu kontra d- dijabete.
Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity, that have similar side effects to Pregabalin and the severity of these effects may be increased when taken together.
Ċerti effetti sekondarji, bħan- ngħas, jistgħu jkunu aktar komuni, peress li l- pazjenti li jkollhom leżjoni fil- korda spinali jistgħu jkunu qegħdin jieħdu mediċini oħra biex jikkuraw, ngħidu aħna, uġigħ jew spastiċità, li jkollhom effetti sekondarji simili għal Pregabalin u s- severità ta 'dawn l- effetti tista' tiżdied meta jittieħdu flimkien.
There have been reports of congestive heart failure in some patients when taking Lyrica; these patients were mostly elderly with cardiovascular conditions.
Kien hemm rapporti ta ’ insuffiċjenza tal- qalb konġestiva f’ xi pazjenti meta kienu qed jieħdu Lyrica; dawn il- pazjenti kienu il- biċċa l’ kbira anzjani b’ kundizzjonijiet karjovaskulari.
Before taking this medication you should tell your doctor if you have a history of heart disease.
Qabel ma tieħu din il - mediċina għandek tgħid lit- tabib tiegħek jekk ikollok storja ta ’ mard tal- qalb.
Taking other medicines Before taking any new medication with LYRICA you should talk to your doctor.
Meta tieħu mediċini oħra Qabel ma tieħu xi medikazzjoni ġdida ma 'LYRICA inti għandek titkellem mat- tabib tiegħek.
LYRICA and certain other medicines may influence each other (interaction).
LYRICA u xi mediċini oħra jistgħu jaffettwaw lil xulxin (interazzjoni).
When taken with certain other medications, LYRICA may potentiate the adverse experiences seen with these drugs, including respiratory failure and coma.
Meta Lyrica tiġi meħuda ma ’ ċertu mediċini oħra, tista tqawwi l- episodji avversi li ntwerew b ’ dawn il- mediċini u li jinkludu insuffiċjenza respiratorja u koma.
The degree of dizziness, sleepiness and decreased concentration may be increased if LYRICA is taken together with medicinal products containing:
Il- livell ta 'sturdament, irqad u konċentrazzjoni mnaqqsa jista' jiżdied jekk LYRICA jittieħed ma 'prodotti mediċinali oħra li fihom:
Oxycodone – (used as a pain-killer) Lorazepam – (used for treating anxiety) Alcohol
Oxycodone – (użat biex itaffi l- uġigħ) Lorazepam – (użat għall- kura ta 'ansjetà) Alkoħol
LYRICA may be taken with oral contraceptives.
LYRICA jista 'jittieħed ma' kontraċettivi orali.
Taking LYRICA with food and drink LYRICA capsules may be taken with or without food.
Meta tieħu LYRICA ma ’ l- ikel u max- xorb Il- kapsuli LYRICA jistgħu jittieħdu ma 'l- ikel jew waħedhom.
It is advised not to drink alcohol while taking LYRICA
Huwa rakkomandat li wieħed ma jixrobx alkoħol waqt li jkun qed jieħu LYRICA
LYRICA should not be taken during pregnancy, unless you are told otherwise by your doctor.
LYRICA m' għandux jittieħed waqt it- tqala, sakemm it- tabib ma jgħidlekx mod ieħor.
Effective contraception must be used by women of child-bearing potential.
Għandha tintuża kontraċezzjoni effettiva f' nisa li jistgħu jinqabdu tqal.
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking LYRICA.
Ikkuntattja lit- tabib tiegħek immedjatament jekk tinqabad tqila, taħseb li tista 'tkun tqila jew qed tippjana biex tinqabad tqila waqt li tkun qed tieħu LYRICA.
It is not recommended to breast-feed your baby while using LYRICA as it is not known if LYRICA is excreted in the breast milk.
Mhux rakkomandat li tredda 'lit- tarbija tiegħek waqt li tkun qed tuża LYRICA billi mhux magħruf jekk LYRICA jitneħħiex fil- ħalib tas- sider.
Ask your doctor or pharmacist for advice before taking any medicine while breast-feeding.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina waqt li tkun qed tredda '.
134 Driving and using machines LYRICA may produce dizziness, sleepiness and decreased concentration.
142 Sewqan u tħaddim ta 'magni LYRICA jista' jikkawża sturdament, irqad u konċentrazzjoni mnaqqsa.
You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
Issuqx, tħaddimx makkinarju kumpless jew tinvolvi ruħek f' attivitajiet oħra li jistgħu jkunu perikolużi sakemm tkun taf jekk din il - mediċina taffettwax il- ħila tiegħek biex twettaq dawn l- attivitajiet.
Important information about some of the ingredients of LYRICA:
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'LYRICA:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta 'zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
HOW TO TAKE LYRICA
KIF GĦANDEK TIEĦU LYRICA
Always take LYRICA exactly as your doctor has instructed you.
Dejjem għandek tuża LYRICA skond il- parir tat- tabib.
Your doctor will determine what dose is appropriate for you.
It- tabib tiegħek jistabbilixxi liema doża hi adattata għalik.
LYRICA is for oral use only.
LYRICA huwa għal użu orali biss.
Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder:
Uġigħ nevrotiku periferali u ċentrali, epilessija jew Disturb ta 'Ansjetà Ġeneralizzata:
Take the number of capsules as instructed by your doctor.
Ħu l - ammont ta 'kapsuli kif ordnalek it- tabib tiegħek.
The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day.
Id- doża, li tiġi aġġustata għalik u għall- kondizzjoni tiegħek, ġeneralment tkun bejn 150 mg u 600 mg kuljum.
Your doctor will tell you to take LYRICA either twice or three times a day.
It- tabib tiegħek se jgħidlek biex tieħu LYRICA jew darbtejn jew tliet darbiet kuljum.
For twice a day take LYRICA once in the morning and once in the evening, at about the same time each day.
Fil- każ ta 'darbtejn kuljum ħu LYRICA darba filgħodu u darba fil- għaxija, bejn wieħed u ieħor fl- istess ħinijiet tal- ġurnata.
For three times a day take LYRICA once in the morning, once in the afternoon and once in the evening, at about the same time each day.
Għal tliet darbiet kuljum ħu LYRICA darba filgħodu, darba wara nofsinhar u darba filgħaxija, bejn wieħed u ieħor fl- istess ħinijiet tal- ġurnata.
If you have the impression that the effect of LYRICA is too strong or too weak, talk to your doctor or pharmacist.
Jekk ikollok l- impressjoni li l- effett ta 'LYRICA huwa qawwi żżejjed jew dgħajjef iżżejjed, tkellem mat- tabib jew ma' l- ispiżjar tiegħek.
If you are an elderly patient (over 65 years of age), you should take LYRICA normally except if you have problems with your kidneys.
Jekk int pazjent anzjan ('il fuq minn 65 sena), inti għandek tieħu LYRICA b' mod normali ħlief jekk ikollok problemi bil- kliewi.
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.
It- tabib tiegħek jista 'jordnalek skeda ta' dożaġġ u/ jew doża differenti jekk ikollok problemi bil- kliewi tiegħek.
Swallow the capsule whole with water.
Ibla 'l- kapsula sħiħa bl- ilma.
Continue taking LYRICA until your doctor tells you to stop.
Kompli ħu LYRICA sakemm it- tabib tiegħek jgħidlek biex tieqaf.
The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group.
Is- sigurtà u l- effikaċja fit- tfal u l- adoloxxenti (taħt it- 18 - il sena) ma ġietx stabbilita u għalhekk, pregabalin m' għandux jintuża f' dan il- grupp ta 'etajiet.
If you take more LYRICA than you should Call your doctor or go to the nearest hospital emergency unit immediately.
Jekk tieħu LYRICA aktar milli suppost Ċempel lit- tabib tiegħek jew mur immedjatament fit- taqsima ta 'l- emerġenza ta' l- eqreb sptar.
Take your box or bottle of LYRICA capsules with you.
Ħu l - kaxxa jew il- flixkun tal- kapsuli LYRICA miegħek.
If you forget to take LYRICA It is important to take your LYRICA capsules regularly at the same time each day.
Jekk tinsa tieħu LYRICA Importanti li tieħu l- kapsuli LYRICA tiegħek b' mod regolari fl- istess ħin tal- ġurnata.
If you forget to take a dose, take it as soon as you remember unless it is time for your next dose.
Jekk tinsa tieħu doża, ħudha malli tiftakar sakemm ma jkunx wasal il- ħin għad- doża li jmiss.
In that case, just carry on with the next dose as normal.
F' dak il- każ, kompli bid - doża li jmiss bħas- soltu.
Do not take a double dose to make up for a forgotten dose.
Tiħux doża doppja biex tpatti għad- doża li nsejt.
If you stop taking LYRICA Do not stop taking LYRICA unless your doctor tells you to.
Jekk tieqaf tieħu LYRICA Twaqqafx LYRICA sakemm it- tabib tiegħek ma jgħidlekx biex tagħmel dan.
If your treatment is stopped it should be done gradually over a minimum of 1 week.
Jekk il- kura tiegħek titwaqqaf, dan għandu jsir b' mod gradwali fuq perijodu minimu ta 'ġimgħa.
135 After stopping long and short-term pregabalin treatment, you need to know that you may experience certain side effects.
143 Wara li twaqqaf kura fit- tul jew qasir bi pregabalin, jeħtieġ li tkun taf li tista 'tesperjenza ċerti effetti sekondarji.
These include, trouble sleeping, headache, nausea, diarrhea, flu-like symptoms, nervousness, depression, pain, sweating, and dizziness.
Dawn jinkludu diffikulta 'biex torqod, uġigħ ta' ras, dardir, dijarea, sintomi bħall - influwenza, nervożità, depressjoni, uġigħ, tagħriq u sturdament.
It is not clear at this time whether these symptoms occur more commonly or severely if you have been taking pregabalin for a longer period of time.
Attwalment mhux ċar jekk dawn is - sintomi jseħħux b' mod aktar komuni jew sever jekk tkun ilek tieħu pregabalin għal perijodu ta 'żmien aktar fit- tul.
Like all medicines, LYRICA can have side effects, although not everyone gets them.
Bħal kull mediċina oħra, LYRICA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side-effects which may affect more than 1 person in 10 are listed below:
Effetti sekondarji komuni ħafna li jistgħu jaffettwaw aktar minn persuna waħda (1) minn kull għaxra (10) huma elenkati hawn isfel:
Dizziness, tiredness
• Sturdament, għeja
Common side-effects which may affect more than 1 person in 100 are listed below:
Effetti sekondarji komuni li jistgħu jaffettwaw aktar minn persuna waħda (1) minn kull mija (100) huma elenkati hawn isfel:
• Increased appetite • Feeling of elation, confusion, changes in sexual interest, irritability • Disturbance in attention, clumsiness, memory impairment, tremor, difficulty with speaking, tingling feeling • Blurred vision, double vision • Vertigo • Dry mouth, constipation, vomiting, flatulence • Difficulties with erection • Swelling of the extremities, feeling drunk, abnormal style of walking • Weight gain
• Żieda fl- aptit • Sensazzjoni ta 'ferħ kbir, konfużjoni, bidliet fl- interess sesswali, irritabilità • Nuqqas ta' attenzjoni, guffaġni, indeboliment tal- memorja, tregħid, diffikulta 'biex titkellem, sensazzjoni ta' tnemnim • Vista mċajpra, vista doppja • Vertigo • Ħalq xott, stitikezza, rimettar, gass fl- istonku • Diffikultajiet bl- erezzjoni • Nefħa ta 'l- estremitajiet, sensazzjoni ta' wieħed fis- sakra, mod mhux normali kif timxi • Żieda fil- piż
Uncommon side-effects which may affect more than 1 person in 1000 are listed below:
Effetti sekondarji mhux komuni li jistgħu jaffettwaw aktar minn persuna waħda (1) minn kull elf (1000) huma elenkati hawn isfel:
• Loss of appetite • Change in perception of self, restlessness, depression, agitation, mood swings, insomnia worsened, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy • Difficulty with thinking, numbness, unusual eye movement, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, fainting • Dry eyes, eye swelling, eye pain, weak eyes, watery eyes • Increased heart rate • Flushing, hot flushes • Difficulty breathing, dry nose • Swollen abdomen, increased saliva production, heartburn, numb around mouth • Sweating, rash • Muscle twitching, joint swelling, muscle cramp, muscle pain, joint pain, back pain, pain in limb, muscle stiffness • Difficulty with or painful urination, incontinence, • Weakness, fall, thirst, chest tightness
• Telf ta 'l- aptit • Bidla fil- mod kif tħares lejk innifsek, irrekwitezza, depressjoni, aġitazzjoni, bidliet fil- burdata, tbati aktar biex torqod, diffikulta' biex issib il- kelma, alluċinazzjonijiet, ħolm anormali, attakki ta 'paniku, apatija • Diffikulta' biex taħseb, tmewwit, moviment mhux normali ta 'l- għajnejn, movimenti bl- iskossi, tnaqqis fir- riflessi, attività akbar, sturdament meta tkun qiegħed bil- wieqfa, ġilda sensittiva, telf tat- togħma, sensazzjoni ta' ħruq, rogħda meta tiċċaqlaq, koxjenza mnaqqsa • Għajnejn xotti, nefħa fl- għajnejn, uġigħ fl- għajnejn, għajnejn dgħajfa, għajnejn idemmgħu • Taħbit tal- qalb aktar mgħaġġel • Fwawar, fwawar tal- menopawsa • Diffikulta 'biex tieħu nifs, imnieħer xott • Nefħa fiż- żaqq, produzzjoni akbar ta' bżieq, ħruq ta 'stonku, tmewwit madwar il- ħalq • Tagħriq, raxx • Ġbid fil- muskoli, nefħa fil- muskoli, bugħawwieġ, uġigħ fil- muskoli, uġigħ fil- ġogi, uġigħ fid - dahar, uġigħ fid- dirgħajn u fis- saqajn, ebusija fil- muskoli • Diffikulta' jew uġigħ biex tagħmel l- awrina, inkontinenza, volum anqas ta 'awrina • Indeboliment, waqgħat, għatx, tagħfis fis- sider
Rare side-effects which may affect less than 1 person in 1000 are listed below:
144 Effetti sekondarji rari li jistgħu jaffettwaw anqas minn persuna waħda (1) minn kull elf (1000) huma elenkati hawn isfel:
• Low blood pressure, coldness of hands and feet, high blood pressure • Cough, nasal congestion • Muscle damage • Breast pain, interruption in menstruation • High blood sugar • Increased sensitivity to noise
• Pressjoni tad- demm baxxa, idejn u saqajn kesħin, pressjoni tad- demm għolja • Sogħla, konġestjoni nażali • Ħsara fil- muskoli • Uġigħ fis- sider, waqfien fil- mestruwazzjoni • Zokkor għoli fid- demm • Sensittività akbar għall- ħsejjes • Disturbi fir- ritmu tal- qalb • Insuffiċjenza tal- kliewi, volum anqas ta’ awrina
Additional reactions reported from post marketing experience include heart failure; loss of consciousness; hypersensitivity and allergic reactions (which may include swollen face, swollen tongue, difficulty breathing, itchiness, inflammation of the eyes (keratitis), and a serious skin reaction characterized by rash, blisters, peeling skin and pain), mental impairment; urinary retention; diarrhoea; headache; and nausea.
Reazzjonijiet oħra rrapportati mill- esperjenza ta 'wara t- tqegħid fis- suq jinkludu insuffiċjenza tal- qalb, ħass ħażin, sensittività eċċessiva u reazzjonijiet allerġiċi, (dawn jistgħu jinkludu nefħa fil- wiċċ, lsien minfuħ, diffikulta ’ biex tieħu n- nifs, ħakk, infjammazzjoni fl- għajnejn (keratite) u reazzjoni serja fil - ġilda karatterizzata minn raxx, nfafet, ġilda mqaxxra u uġiegħ, indeboliment mentali, ritenzjoni urinarja, dijarea, uġigħ ta' ras, dardir, u ħakk.
If you experience swollen face or tongue or if your skin turns red and starts to blister or peel you should seek immediate medical advice.
Inti għandek tfittex parir mediku immedjat jekk tesperjenza nefħa fil- wiċċ jew fl- ilsien, jew jekk tiħmarlek il- ġilda u tibda titqaxxar jew ittella ’ l- imfafet.
HOW TO STORE LYRICA
KIF TAĦŻEN LYRICA
Keep LYRICA out of the reach and sight of children.
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali ma jeħtieġx ħażna speċjali.
Do not use LYRICA after the expiry date which is stated on the carton or bottle.
Tużax LYRICA wara d- data ta 'skadenza li tidher fuq il- kaxxa jew il- flixkun.
What LYRICA contains
X' fih LYRICA
The active substance is pregabalin.
- Is- sustanza attiva hi pregabalin.
Each hard capsule contains either 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg pregabalin.
Kull kapsula iebsa fiha 25 mg, 50 mg, 75 mg, 100 mg, 150 mg,
The other ingredients are: lactose monohydrate, maize starch, talc, gelatine, titanium dioxide (E171), sodium laurilsulphate, anhydrous colloidal silica, black ink, (which contains shellac, black iron oxide (E172), propylene glycol, potassium hydroxide) and water.
(E171), sodium laurilsulphate, andydrous colloidal silica, linka sewda (li fiha shellac, iron oxide iswed (E172), propylene glycol, potassium hydroxide) u ilma.
The 75, 100, 200, 225 and 300 mg capsules also contain red iron oxide (E172).
- Il- kapsuli ta '75, 100, 200, 225 u 300 mg fihom ukoll iron oxide aħmar (E172).
What LYRICA looks like and contents of the pack
145 Id- dehra ta 'LYRICA u l- kontenut tal- pakkett
LYRICA 25 mg capsules are white hard capsules, with “Pfizer” marked on the cap and “PGN 25” on the body.
ta 'fuq u “ PGN 25 ” fuq il- parti ewlenija.
LYRICA 50 mg capsules are white hard capsules, with “Pfizer” marked on the cap and “PGN 50”on the body.
Il- parti ewlenija tal- kapsula hi mmarkata b' faxxa sewda.
The capsule body is marked with a black band.
- Il- kapsuli LYRICA 75 mg huma kapsuli iebsin ta 'lewn abjad u oranġjo, bi “ Pfizer ” immarkata
LYRICA 75 mg capsules are white and orange hard capsules with “Pfizer” marked on the cap and “PGN 75” on the body.
fuq il- parti ta 'fuq u “ PGN 75 ” fuq il- parti ewlenija.
LYRICA 100 mg capsules are orange hard capsules, with “Pfizer” marked on the cap and “PGN 100” on the body.
parti ta 'fuq u “ PGN 100 ” fuq il- parti ewlenija.
LYRICA 150 mg capsules are white hard capsules, with “Pfizer” marked on the cap and “PGN 150” on the body.
parti ta 'fuq u “ PGN 150 ” fuq il- parti ewlenija.
137 LYRICA 200 mg capsules are light orange hard capsules, with “Pfizer” marked on the cap and “PGN 200” on the body.
- Il- kapsuli LYRICA 200 mg huma kapsuli iebsin ta 'lewn oranġjo ċar, bi “ Pfizer ” immarkata fuq
LYRICA 225 mg capsules are white and light orange hard capsules, with “Pfizer” marked on the cap and “PGN 225” on the body.
immarkata fuq il- parti ta 'fuq u “ PGN 225 ” fuq il- parti ewlenija.
LYRICA 300 mg capsules are white and orange hard capsules, with “Pfizer” marked on the cap and “PGN 300” on the body.
fuq il- parti ta 'fuq u “ PGN 300 ” fuq il- parti ewlenija.
LYRICA is available in seven pack sizes made of PVC with an aluminium foil backing: a 14 capsule pack containing 1 blister strip, a 21 capsule pack containing 1 blister strip, a 56 capsule pack containing 4 blister strips, a 84 capsule pack containing 4 blister strips, a 100 capsule pack containing 10 blister strips, a 112 (2 x 56) capsule pack and 100 x 1 capsules as perforated unit dose blisters.
LYRICA hu disponibbli f' pakketti ta 'sitt daqsijiet differenti magħmulin mill- PVC b' rinforz ta' folja ta 'l- aluminju: pakkett ta' 14- il kapsula li fih strixxa ta 'folji, pakkett ta' 21 kapsula li fih strixxa ta 'folji, pakkett ta' 56 kapsula li fih 4 strixxi ta 'folji, pakkett ta' 84 kapsula li fih 4 strixxi ta 'folji, pakkett ta ’ 100 kapsula li fih 10 folji, pakkett ta' 112 (2 x 56) - il kapsula u 100 x 1 kapsula bħala folji ta ’ doża waħda perforati.
In addition, LYRICA is available in an HDPE bottle containing 200 capsules for the 75, 150 and 300 mg strengths.
Barra minn hekk, LYRICA jinstab ukoll fi flixkun tal- HDPE li jesa '200 kapsula għall- qawwiet ta' 75, 150 u 30 mg.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
Marketing Authorisation Holder:
Id- detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
Pfizer Limited, Sandwich, Kent, CT13 9NJ, UK.
Pfizer Limited, Sandwich, Kent, CT13 9NJ, Ir- Renju Unit
Pfizer GmbH Arzneimittelwerk, Gödecke, Mooswaldallee 1, D-79090 Freiburg, Germany.
Pfizer GmbH Arzneimittelwerk, Gödecke, Mooswaldallee 1, D- 79090 Freiburg, Il- Ġermanja.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq
Magyarország PFIZER Kft.
Magyarország България PFIZER Kft.
Deutschland Pfizer Pharma GmbH Tel: +49 (0)721 6101 9000
Deutschland Nycomed Pharma GmbH Tel: +49 0 721 6101 9000
Τηλ.: +30 210 67 85 800
Τηλ: +30 210 67 85 800
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This leaflet was last approved in:
Dan il- fuljett kien approvat l- aħħar f '{data}:
What is Lysodren?
X’ inhu Lysodren?
Lysodren is a medicine that contains the active substance mitotane.
Lysodren huwa mediċina li fiha s- sustanza attiva mitotane.
It is available as white, round tablets (500 mg).
Huwa disponibbli bħala pilloli bojod, tondi (500 mg).
What is Lysodren used for?
Għal xiex jintuża Lysodren?
Lysodren is used to treat the symptoms of advanced adrenal cortical carcinoma (cancer of the outer layer of the adrenal gland).
Lysodren jintuża sabiex jiġu ttrattati s- sintomi ta ’ karċinoma avvanzata tal- kortiċi adrenali (kanċer tas - saff ta ’ barra tal- glandola adrenali).
It is used when the cancer is unresectable (cannot be removed by surgery), is metastatic (has spread to other parts of the body), or has relapsed (returned after treatment).
Huwa jintuża meta l- kanċer ma jkunx jista ’ jiġi maqtugħ (ma jistax jitneħħa b’ intervent kirurġiku), ikun metastatiku (infirex għal partijiet oħra tal- ġisem), jew reġa ’ ħareġ (reġa ’ tfaċċa wara l- kura).
Because the number of patients with adrenal cortical carcinoma is low, the disease is considered ‘ rare’, and Lysodren was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 12 June 2002.
Minħabba li n- numru ta ’ pazjenti b’ karċinoma fil- kortiċi adrenali huwa baxx, il- marda hija kkunsidrata ‘ rari ’, u Lysodren ġie kklassifikat bħala ‘ mediċina orfni ’ (mediċina użata f’ mard rari) fit - 12 ta ’ Ġunju 2002.
How is Lysodren used?
Kif jintuża Lysodren?
Treatment with Lysodren should be started and followed by a specialist who has suitable experience.
It- trattament b’ Lysodren għandu jinbeda u jiġi segwit minn speċjalista li għandu esperjenza adegwata.
The recommended starting dose in adults is 2 to 3 g per day, divided into two or three doses, taken with meals containing fatty food.
Id- doża tal- bidu rakkomandata fl- adulti hija 2 sa 3 grammi kuljum, maqsuma f’ żewġ jew tliet dożi, meħuda ma ’ ikliet li fihom ikel xaħmi.
A starting dose of 4 to 6 g per day can be used in patients who need urgent control of Cushing’ s syndrome (a set of symptoms of adrenal gland cancer caused by high hormone levels).
Doża inizjali ta ’ 4 sa 6 grammi fil- ġurnata tista ’ tintuża f’ pazjenti li jeħtieġu kontroll urġenti tas- sindromu ta ’ Cushing (sett ta ’ sintomi ta ’ kanċer tal- glandola adrenali kkawżati minn livelli għolja ta ’ ormoni).
The dose is increased in a stepwise manner until it reaches an ‘ optimal’ dose that gives the best results without causing unacceptable side effects.
Id- doża tiġi miżjuda pass pass sakemm tilħaq doża ‘ ottima ’ li tagħti l- aħjar riżultati mingħajr ma tikkawża effetti sekondarji mhux aċċettabbli.
The levels of the active substance in the blood should be monitored frequently, with the final target dose aiming to reach blood levels between 14 and 20 mg per litre.
Il- livelli tas- sustanza attiva fid- demm għandhom jiġu mmonitorjati b’ mod frekwenti, bid- doża finali fil- mira tipprova tilħaq livelli tad- demm ta ’ bejn 14 u 20 mg għal kull litru.
This is usually reached within three to five months.
Dan normalment jintlaħaq fi tliet jew ħames xhur.
Levels above 20 mg/ l may cause severe side effects without increasing the medicine ’ s effectiveness.
Livelli ‘ l fuq minn 20 mg/ l jistgħu jikkawżaw effetti sekondarji mingħajr ma tiġi miżjuda l- effikaċja tal- mediċina.
The dose may be reduced or treatment interrupted if the patient experiences side effects.
Id- doża tista ’ tiġi mnaqqsa jew it- trattament jiġi interrott jekk il- pazjent jesperjenza effetti sekondarji.
Treatment should continue as long as there is a benefit.
It- trattament għandu jissokta sakemm ikun hemm benefiċċju.
If there is no improvement in symptoms after three months of treatment at the optimal dose, treatment should be stopped.
Jekk ma jkun hemm l- ebda titjib fis - sintomi wara tliet xhur bit- trattament bid- doża ottima, it- trattament għandu jiġi mwaqqaf.
It should also be used with caution in elderly patients, with frequent monitoring of blood levels.
Hemm informazzjoni limitata dwar l- użu ta ’ Lysodren fit- tfal, iżda doża inizjali fil- ġurnata ta ’ 1. 5 sa 3. 5 grammi għal kull metru kwadru tas- superfiċje tal- ġisem (ikkalkulata billi jintużaw it- tul u l- piż tat - tifel/ tifla) hija rakkomandata.
Patients who take Lysodren should receive the ‘ Lysodren patient card ’ that they should carry with them in case of emergency, to inform healthcare professionals (such as doctors and nurses) that they are taking the medicine.
Il- pazjenti li jieħdu Lysodren għandhom jirċievu l - ‘ kartuna tal- pazjent Lysodren ’ li għandhom iġorru magħhom f’ każ ta ’ emerġenza, sabiex tinforma lill- professjonisti tal- kura tas- saħħa (bħat- tobba u l - infermiera) li qegħdin jieħdu din il- mediċina.
How does Lysodren work?
Kif jaħdem Lysodren?
The cortex of the adrenal gland produces steroid hormones.
Il- kortiċi tal- glandola adrenali jiżviluppa ormoni tal- isterojdi.
When this area develops cancer, levels of these hormones can increase, causing the symptoms of the disease.
Meta din iż- żona tiżviluppa kanċer, il - livelli ta ’ dawn l- ormoni jistgħu jiżdiedu, biex jikkawżaw is- sintomi tal- marda.