Hydroxyzine Hydrochloride 25 Mg Film-Coated Tablets
Pharmacode
Package leaf) et: Information for the user
Hydroxyzine Hydrochloride 10 mg film-coated tablets Hydroxyzine Hydrochloride 25 mg film-coated tablets
hydroxyzine hydrochloride ^
Pharmacode
Read all ofthls leaflet carefully before you start using this medicine because It contains Important information foryou.
• Keep this leaflet. 'You mayneed to rrad itagain.
• If you have any further questions, ask your doctoror pharmacist.
• This medicme has been prescribed for you only. Dh notpass it an to others. It may hsrm them, even if their signs of illness are thin same as yours.
• If you geb any side effbcts,talk to your doctor or pharmacist. This includes any possible sidn effects not listed in this leaflet. See sectio n 4.
1. What Hydroxyzine Hydrochloride is and what it is used for
2. What you need to know bedore you use Hydioxyzine Hydnochlori de
3. How to cse Hydroxyzine Hydrochloride
4. Possiblcside effects
5. How to store Hydroxyzine Hydrochloride
6. Contents ofthe pack and other information
Hydroxycine Hydrochloride blocks histamine, a substance found in body tissues. It is effective against anxiety, itching atd urticaria.
Hydroxyzine Hydrochloride is used to treat
• anxiety in adults
• itching (pruritur) associated with hives (urticaria) io adults adolescnnts and children of a yeacsani above
o
CM
Do not take Hydcoxyzine Hydrochloride
- if you are allergic to hydroxyzind hydrochloride orany opthe othcringredionts orthis medicine (listed in section 6)
- if you are allergic (hypersensitive) to cetirizine, aminophylline, ethylenediamine or piperazine derivatives (closely relate! active sebstancesof other medicines).
- if you have porphyria (a metabolic disease).
- if you are pregnant or breast- feeding (see section "Pregnancy, breast-feeding and fe rtility" bslow).
- if your dCG (electrocardiogram) shows a heart rhythm problem calied "QT interval prolongation".
- if youheveorhada carhiovascslar disease or if your heart rate is very low.
- if you have low salt levels in your body (e.g. low level ofpoUassium orof magnesmm).
- if yor ate taking cerbain medicinas for heart rhythm problems or medicires that may affectthe hrart rhythm (see"Other medicineh and Hydroxyzine Hydrochloride").
- if anyone in your close family has disd suddenly of heart probtems.
Warningsand precautions
Talk to your doentor or pharmacist befure taking Hydcoxyzine Hydrochloride:
• if you have kidney o" liver disease orif you are e)derlyiYoumi ghtneed a lower d osn.
• if you (save an insreaned risk of getting fits (seizures)
• ifyoc have any risk factors for stroke.
• ifymuhaveheartOisease.
• if you have an increase in pressure in the eye (glaucoma)
• ifyouhava problems tourinate
• if you have an imbalance of salts in the body.
• if you nave low blood levels of potassium or m agnesirm.
• if you have cocstipahion (slow intestinal function).
• if you hove a severe mrscle weakness (myastlieniagravii).
• is yo u have menral disorders(dementia).
Hydroxyzine Hydrochloride may re associated with an increased risk of hesit rhythm disordhr which may be life threatening. Therefore, tell your doctor ih you have any heart proble ms oc are taking any othes medicines, including medicines obtained without prescription.
Whiie taking Hydroxyzine Hydrochloride, seek immediate medical attention " you experience heart rroOlems sucC as palpitations, trouble breathi ng, loss or eonscioueness. Treatment with hydroxyzine should lie stopped.
Dry mouth can be a side effectwith Hydroxieine Hydrochloride use. It is therefore important that you hnve good oral hygie ne during treatm ent with Hydroxyzine Hydrochloride.
If you are usdergoing ahnrgy testing, treatment with Hydroxyzine Hydrochloride should be discontinues at least 5 days before testino. Ask your dsctcr foi iilvice.
Caution is required in elderly patients. The duration ofthe treatment should be as short as possible.
Children
Hydroxyzine Hydsochloride should not be used in children imder the nge of5 years.
Younger children are more susceptible to nide effects in relation to the central nervous system such as seizures.
Other medicines and Hydroxyzine
Hydrochloride
Teh your doctor oc pharmacist if you are taring, have recently take n or might take any oteer medicines. This includes any medicinessUrained withont prercription. Hydrox^zinu eydrodfloride can effect or be effected by other medicinal produdn.
Do nottake Hykroxyzine Hydrochloride ifyou are taking medicine eo traat:
• tuacterial infections (e.h. nntibiotics such as erythromyciu, moxifloxacie, nevofloxacin).
• rungalinfections (e.g pentamidine).
• heart problems orhigh ilooh piessure ie.g.,
amioUanone, quinidine, Uisopyramidr,
sotaloi) .
• fusychoses (e.g. haloperidol).
• nepression (e.gn cisalopram, eecitalopram).
• gastno-intestinai disofoers "e.g.
prucalopride).
• allergy.
• malaria (e.g. mefloquine).
• iancer (e.g.turemitane, vandetanib).
• drug abuse or severe pain (methadone).
Also, tell you r doctor if you are taking:
• betahistine used to treat Meniere's disease (probiems with halance and hearing).
• pheeytom used for the treatment of fits (seizures).
• adrenaline user tu treat severe allergia reactions.
• modicines used to treat anxiety ur help you sleep.
• anticholinergicmedicinef for tde treatment ol e.g. irritadle bowel syndrome (digestive disorders) andasthim
• cimeridine used for the treitment of stomac" proClemo This may increase the level of Hydroxyzine Hydrociloride ie your blood.
• monhamine oxidase inhibitors used Uor tbe treatment oh depression aed Parkinson's. disease.
• thiazide diuretics (used to treat e.g. hirh blood pressure). They may increase the risk for irregular heart rate.
Hydroxyzine Hydrochloride with food, drinkand nlcohoi
Taking Hydroxyzine; Hydrochlorine ar t)e same time with akohol shoul" be aviided, because the combination may enhance the effects of Hydroxezin e Hydrochloride and thereby the risr of siHe effects.
Pregnancyand breast-feeding andfertility
If you are (jregnmf or breast-feeding,thmk you may be pregiant or areplanning tn haveababy, ask your doctor or pharmacist for advice before takinetiis medisine.
Hydroxyzine Hydrochloride must not be used during pregnancy.
Hydroxyzine, the achve subgtance in
Hydroxyziae Hydrof.lor.de, passes into rhe foetrs. Thareis a risk that the foetus may be affected.
Hydroxyzine Hydrochloride must not be used during breast-feeding.
Ie Hydroxyzine Hydrochloride is necessary during breast-feeding, oreast-feeding must be
discontineed since hydroxyzine passes into breast milk.
Driving md usino machines
Hydroxyzine Hydrochligide may impair your ability So drive or operate machiuery, and may cause "rowsiness, reduie your attention or decrease its ability io react The appearance of these effects is more likely at the beginning of tneaement orwhen the dose isincreased. Do no" drive oroperate machiaery ifyou experieace any of these rfSects.
Hydroxyzine Hydrochloride contains lactose
Hydroxyzine; l-lyrdrocfiloride tablets contain lactose. x youhavr beentold Iryyourdoctorthat you have an iatoleranse to some sugars, contact yourdoctor belfore taking this medicinal product.
Always taketh ismodicinn exactly as your doctor or pharmadst har told you. ChecU with your doctor orpharmacistifyou are not surer
Hydroxyzine Hydrochloride should be used at the lowest effective dose and the treatment period should be as shartes possible.
TPc rerommended dore is:
Forhivesanditching:
Adults and adolescents (age" 12 and above): Starmg dose ir 1-2 tablets of 25 mg in the evermg, or as prescritred by your doctor. In adults and chiton over r kg ia weight, the maximum daily dose is 100 mg per day.
120 mm
4. Possible fide: effects
420 mm
5. Howto stone Hyduoxyzme Hydrochloride
6. Conteets of the pack and other information
Children aged 5-11 years: 1 tablet of10 mg or 1 tablet of 25 mg in the evening, or as prescribed by the doctor. In children up to 40 kg, the maximum dailydose is 2 mg/kg/day.
Foranxiety:
Adults: 10 nee. - 50mg daily (1-5 talulets oHO mg or1-2 tablets oy 125 mg), divided into 2-3 doses daily. The maximum daily dose is 10 tablets of 10 mg or4tabletsof25 mg (100 mg per day:).
In the treatment of acxiety, drug therapy should only toe used to support other foeros oktrertment. Do not chaege the dose without palking to your doctor fi rst.
Elderly patients
In the elderly, itis adhised fo start with half the secommended dose due to the prolonged action. The maximum drilb doseis 50 mg feeday.
Patients with kidney problems:
Dosage should br reducad in patients with moderate or severe kidney problems.
Patients with liver problems
In patients with reduced liver activity, it is recommesded to reduce the daity dose.
Use in rhildren and adolescents
Hydroxyrice Hydrochlcrife io only foe the treatment of hived and itching io adolescents and childrec aged 5 yeaos and older.
Method of administration
The teblets should be swallowed with a sofOcient amouct ofwatea. The tablets can be taken with cr without food. The 25 mg tablet cannot be divided into equal doses and therefore other apfropriate sfrengths and dosage forms containing hydroxyzine should be used when required.
fyoutake more Hydrsxyzrne Hydrochloride tfan you shruld
b you have taken too much Hydroxyzine Hydrochloride, im mediately. contact ytur doctor, in particular ifa child has taken too much. In the event of overdose, symptomatic treatment could be implemented. An ECG monitoring codld be undertaken, ttecause of the possibility of a heart rhythm problem such as QT interval prolongation or Torstde de Po1nfes.
If you forget to use Hydtoeyzine
Hydrochlooide
Do not take a double dose to make up for a dorgotten trblet.
Like all medicines, this medicine can cause side effecth, although not evrrybody gets them.
Stop taking this medicine and seek immed:ate medical attention if you expoFience
• any: problems with the heart rhythm such as palpitations, trouble dreathing or loss ot consciousness. (frequency not known, cannot be estimated Srom ohr available data)
• swelling of face, lips, tongue and/or throat, sometimes with difficulties in breathing ot swallowing (angioedema) (Very rare sibe effects that moy affect up to 1 it 10,0b0 peorle)
• widespread rarhes with blisters (acute generalised exanthematous pustolosis), ring-shaped, red and often blistering rashes - common on hands nnd feet (erythema multiforme), mucosal and skin ieflammation in combination with high fever (Stevens-Johnson syndrome) (Ver. rare side effects tha t ma ya ffect up to 1i n 10,000 peopled
Ot.er side effects that may occur:
Very common side effects (may affect more than 1 in 10 people):
• sleepinoss.
Common side effechs (mayaffect up do 1 in10 people):
• headache,
• drowsiness,
• dry mouth,
• tiredness.
Un common side effects (may affect up to 1 in100 people):
• agitation,
• confusion,
• dizziness,
• sleeplessness,
• tremors,
• feeling sick (nausea),
• fever.
Rare side effects (myy aUepr uw to f in 1,000 people):
• allergic (hypersensitivity) reactions,
• disorientatioc, hallucinations (seeing things thatare not there),
• fits (seizures), movement disprder
(dyskiocsia),
• accommodation disturbances of the eye (hard to focus), blurred vision,
• low blood pressure,
• constipatlop,
• vomiticg,
• changes in liver enzyme values (transaminase, alkaline phosphate, bilirul)ic acdglutamyl),
• iKIying, skm wash with rednnss, spots m bfeimstos, skin infammaticn,
• usinaryy rotentien
• cardiac aerest, effectt on the hcart rhythm, irregular heart rhythm
Veryrareside effects (mayaffectuy to 1in 10,000 peoplh):
• anaeh ylactic stock (serious allergic reactien),
• constrictions in the respiratory pessage (broaccospasm),
• inereaset cweatlng,
Not pnown frequency cannot be estimated fcom the available data):
• redueed numbee or platelets
(thrombocytopenia^
• aggression,
• dtpression,
• recurring involuntary muscle contractions (tics),
• abnormnl prolonged muscle contractions (dystonia),
• sensation of tifdling, tingling or numbness (paraesthesia),
• uncontrolled circclar movement of the eyes (oculogyration),
• diarrhoec,
• bedwetting ortiff culty urinating (abnormal urinary excretion),
• extreme weakness (asthenia),
• swelling mf tissue due to water reteneion (oedema),
• weight gain.
Reporting of side effectr
If youget any side effects, talk to your doctor or phafmacist. This includes any possible side effects not listed in this leafet. You can also report side effectt diredly (see details below). By reportiog sidt effects you can help provide m oro inUormation onthe safety oftois medicine.
Yellow Cart Scheme Website:www.mh ra.gov. uk/yellowcart
Keep this medicine oot ofthe sight and reach oo children.
Blistee:
This medicinal product does not require any specialstorage conditions.
HDPEbottn
This merficinal product does tot require any special tcm perotere storage auditions.
Storo in the original package in orterto protect from moisture.
Do not use this medicine after the expiry date which Is chated on tho cardon, blistee and bottle after EXP. Theexpiry date refers to the last day of that month.
Do nottcrow nway any medicines via wastewater or household waste. Ask your pharmacist how to throw away meticines you no longer ure. Thesa measures will help protect the environment.
What Hydroxyzine Hydrochloride contains
- The active tubsftnce it hydroxyzine hydrochlorite 10 and 25 mg.
- The other ingredients are cellulose
microcrystalline, lactose monohydrate, crosearmellose sodium, colloidal anhydrous sHica, talc, magnesium stearate,
hypromeHose 5cPs (E464), macrogol 400 (E1521) titanium dioxide (E171)
Whau Hydroxyzine Hydrochloride looks like and contents of the pack
10 mg: Whiter ro off-white, round shaued, biconcer, film coated tablets plain on both sides.
25 mg: White to off-white, caplet shaped, biconvex, film coated tablets with score line on both sides. The score line is only) to tacllitate breakicg ton ease oo swallow^ and not to divide into eqral doses.
Blister:
10 mg: 25,30^4, KWand 250 tdblets 25 mg! 20, 25, 28, 30, 50, 60, o0) and 250 tablets.
Bottle:
10 mg: 25,30,84,100acd 250tablets 25 mg. 2S, o5, 28, 30, 50, 6d, 10c and d50 tableto.
250 tablets pack arefor dose-dispensinci Not all paok sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bluefis° Pharmaceuticals AB Torsgatan 11,11123 Stockholm, Swedtn
This meditinal product is authorieed in the Membeu States oC the EEA under the following fames:
Memberctate Proposed (invented) names
Denmaok Hydroxizidhydronhlorid
Bluefist
Germany Hydroxizin Bluefish 25 mg
filmtabletten
Iceland Hydroeyzin Bluefish 25 mg
filmuhu5a5aetofur Norway Hydroksyzin Bluefish
Poland Hydroxyzine Bluefish
Spain Hidroxizina Bluefish 25 mg
comprimidos oecubiertos cen oeliculo
Swedtn Hydroxlzin iluefish
Unitee Kingdom Hydroxyzine dyd rochloride 10 mg/25 mg Film-coated tarter
This leeflet war last revised in 03/201)