Package leaflet: Information for the patient

Qsiva, 3.75 mg + 23 mg, modified-release hard capsules
Qsiva, 7.5 mg + 46 mg, modified-release hard capsules
Qsiva, 11.25 mg + 69 mg, modified-release hard capsules
Qsiva, 15 mg + 92 mg, modified-release hard capsules
phentermine + topiramate
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Qsiva is and what it is used for
Important information before taking Qsiva
How to take Qsiva
Possible side effects
How to store Qsiva
Contents of the pack and other information

1. What Qsiva is and what it is used for

Qsiva contains two active substances called phentermine and topiramate, which work together to reduce the patient's appetite. Taking both together helps reduce body weight more effectively than taking either one alone.
Qsiva is used in addition to a low-calorie diet and increased physical activity to help overweight or obese adults lose weight and maintain weight loss. It is recommended for:

obese patients with a body mass index (BMI) of 30 kg/m² or higher, or
overweight patients with a body mass index (BMI) of 27 kg/m² or higher who have weight-related medical problems such as high blood pressure, diabetes, or abnormal blood lipid levels

2. Important information before taking Qsiva

When not to take Qsiva:

if the patient is allergic to phentermine, topiramate or any of the other ingredients of this medicine (listed in section 6)
if the patient is allergic to medicines known as sympathomimetic amines, which are used to treat asthma, nasal congestion or eye disorders
if the patient is pregnant or of childbearing potential unless she is using a highly effective method of contraception (for further information, see section "Pregnancy and breastfeeding"). The patient should discuss with her doctor the most suitable method of contraception for her.
the patient must read the Patient Information leaflet provided by the doctor. A patient card reminding of the risks associated with pregnancy is included in the Qsiva packaging.
if the patient is taking monoamine oxidase inhibitors (MAOIs), or has taken them within the previous 14 days, such as:
- iproniazid: used to treat depression
- isoniazid: used to treat tuberculosis
- phenelzine, tranylcypromine: used to treat depression or Parkinson's disease
if the patient is taking other medicines intended to help with weight loss

Warnings and precautions
Before starting or while taking Qsiva, discuss with the doctor if:

the patient is of childbearing potential. Qsiva taken during pregnancy may harm the unborn child. A highly effective method of contraception must be used during treatment and for at least 4 weeks after the last dose of Qsiva. For further information, see section "Pregnancy and breastfeeding".
the patient is pregnant: Qsiva taken during pregnancy may harm the unborn child.
the patient has or has had mood disorders or depression. Qsiva may worsen these conditions. The doctor will closely monitor the patient if such conditions are present in their medical history. The patient should inform the doctor immediately if they notice unusual changes in mood or behaviour. Qsiva is not recommended for use in patients with:
- a history of recurrent major depression
- episodes of depression alternating with periods of abnormally elevated mood, known as bipolar affective disorders
- psychosis
- current moderate or more severe depression
the patient has had suicidal thoughts or attempted suicide. Qsiva may increase the frequency of suicidal thoughts. The patient should inform the doctor immediately if they experience suicidal thoughts.
the patient has heart or blood vessel problems. Qsiva may increase heart rate. Regular monitoring of resting heart rate by the doctor is recommended for all patients during treatment. The patient should inform the doctor if they experience a very rapid heartbeat at rest during treatment with Qsiva. Qsiva is not recommended for use in patients with:
- myocardial infarction within the past 6 months
- a high risk of cardiovascular problems, including advanced conditions such as stroke within the past 3 months, life-threatening irregular heart rhythm, or certain types of heart failure
the patient has had kidney stones, or if a close biological relative has had kidney stones, or if the patient has high calcium levels in the blood. Qsiva may increase the risk of kidney stones. Therefore, it is recommended that all patients taking Qsiva drink plenty of water daily.
the patient has serious eye problems

If the patient experiences sudden worsening of vision, blurred vision, or eye pain, they should
stop taking Qsiva and contact their doctor or pharmacist immediately.
These symptoms may be signs of eye disorders such as myopia or increased intraocular pressure.

the patient has too much acid in the blood. Qsiva may increase blood acid levels. The doctor may wish to regularly monitor acid and bicarbonate levels in the patient's blood and may reduce the dose or discontinue Qsiva treatment if necessary.
the patient has reduced kidney or liver function. Qsiva is not recommended for patients with severely impaired liver function, end-stage renal disease, or patients on dialysis.
the patient has hyperthyroidism. Qsiva is not recommended for use in patients with hyperthyroidism.

The active substance phentermine may increase the patient's energy or level of excitement, which
may potentially lead to abuse and dependence.
Children and adolescents
Qsiva is not recommended for use in children and adolescents under 18 years of age.
Qsiva and other medicines
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned
to be taken.
Do not take Qsiva and inform the doctor if the patient is taking:

other medicines intended to help with weight loss
monoamine oxidase inhibitors (MAOIs), or has taken them within the previous 14 days, such as:
- iproniazid: used to treat depression
- isoniazid: used to treat tuberculosis
- phenelzine, tranylcypromine: used to treat depression or Parkinson's disease

Also inform the doctor or pharmacist if the patient is taking:

another medicine containing phentermine or topiramate. Qsiva is not recommended as a substitute for these medicines.
hormonal contraceptives. Concurrent use with Qsiva may reduce the effectiveness of hormonal contraceptives and cause irregular bleeding. Contraceptive effectiveness may be reduced even in the absence of bleeding. An additional barrier method of contraception (such as condom or diaphragm/cervical cap) should be used. The patient should discuss with their doctor the best method of contraception to use during treatment with Qsiva. Irregular bleeding may occur. In such a case, the patient should continue using hormonal contraceptives and inform their doctor.
medicines that reduce alertness, such as:
- medicines used to treat epilepsy or for sedation
- sedatives, sleep-inducing or muscle-relaxing medicines, such as diazepam
- other medicines causing drowsiness
medicines that increase urine production (diuretics), such as hydrochlorothiazide. The doctor should monitor blood potassium levels when taking so-called potassium-wasting diuretics.
medicines used to treat epilepsy, such as phenytoin, carbamazepine, valproic acid
alfentanyl: a painkiller used during surgery with anaesthetics
fentanyl: a strong painkiller
cyclosporine: an immunosuppressant used to treat severe skin diseases, severe eye inflammation or joint inflammation
dihydroergotamine, ergotamine: medicines used to treat migraine
tacrolimus: a medicine used to prevent transplant rejection and to treat chronic or recurring non-infectious skin inflammation with severe itching
sirolimus: a medicine used to prevent transplant rejection
everolimus: a medicine used to treat cancer
lithium, imipramine, moclobemide, St. John's wort: medicines used to treat depression. Monitoring of lithium levels is recommended during Qsiva treatment.
pimozide: a medicine used to treat psychiatric disorders
digoxin: a medicine used to treat heart failure and irregular heartbeat
quinidine: a medicine used to treat irregular heart rhythm
proguanil: a medicine used to treat and prevent malaria
omeprazole: a medicine that reduces stomach acid secretion
medicines known as carbonic anhydrase inhibitors, such as:
- zonisamide: used to treat epilepsy
- acetazolamide: used to treat increased intraocular pressure, fluid retention disorders, breathing problems, altitude sickness, epilepsy
- dichlorphenamide: used to treat periodic paralysis
medicines used to treat diabetes, such as pioglitazone, metformin, glibenclamide, insulin. Regular monitoring of blood glucose levels is recommended during Qsiva treatment when taking any of these medicines. The doctor should also regularly monitor the patient's bicarbonate levels if metformin is being taken.

Qsiva and alcohol
Avoid drinking alcohol during treatment with Qsiva, as alcohol may increase the risk of
adverse effects.
Pregnancy and breastfeeding

Pregnancy Important advice for women of childbearing potential. Women of childbearing potential should discuss with their doctor other possible treatment options. A visit to the doctor should be scheduled at least once a year to review treatment and discuss risks. Do not take this medicine if the patient is pregnant.

This medicine must not be used if the patient could become pregnant unless she is using a
highly effective method of contraception.
Before starting Qsiva treatment in a woman of childbearing potential, a pregnancy test should
be performed.
Risks associated with the use of topiramate (one of the active substances in Qsiva, also used
in epilepsy treatment) during pregnancy:

Topiramate taken during pregnancy may have harmful effects and impair fetal development. The child has an increased risk of congenital malformations. In women taking topiramate, congenital malformations occur in approximately 4-9 out of 100 children. For comparison, the rate is 1-3 out of 100 children born to women who do not have epilepsy and do not take antiepileptic drugs. In particular, cleft lip (split upper lip) and cleft palate (split palate) have been observed. Male newborns may also have a developmental abnormality of the penis (hypospadias). These malformations may develop early in pregnancy, before the patient knows she is pregnant.
When Qsiva is used during pregnancy, the risk of autism spectrum disorders, intellectual disability, or attention deficit hyperactivity disorder (ADHD) in the child may be 2 to 3 times higher than in children born to women with epilepsy who do not take antiepileptic drugs.
When Qsiva is used during pregnancy, the child may be smaller and have lower than expected birth weight. In one study, 18% of children born to mothers taking topiramate during pregnancy were smaller and weighed less than expected, compared to 5% of newborns born to women without epilepsy who did not take antiepileptic drugs.

Need for contraception in women of childbearing potential:

Women of childbearing potential should discuss with their doctor the possibility of using alternative treatment options instead of Qsiva. If the decision is made to start Qsiva therapy, a highly effective method of contraception must be used during treatment and for at least 4 weeks after the last dose of Qsiva.
One highly effective contraceptive method (such as an intrauterine device) or two complementary methods of contraception (such as oral contraceptives combined with a barrier method such as condom or diaphragm/cervical cap) should be used. The patient should discuss with their doctor which contraceptive method is most appropriate.
If the patient is using hormonal contraceptives, topiramate may reduce their effectiveness. Therefore, an additional barrier method of contraception should be used. If irregular bleeding occurs, the patient should inform their doctor.
Immediately stop taking Qsiva and inform the doctor if menstruation does not occur or if pregnancy is suspected.

If the patient wishes to become pregnant while taking Qsiva:

Schedule an appointment with the doctor.
Do not discontinue contraception until this issue has been discussed with the doctor.

If the patient becomes pregnant or suspects she may be pregnant while taking Qsiva:

Schedule an urgent appointment with the doctor.
Immediately stop taking Qsiva and inform the doctor.

The doctor will inform the patient about the risks associated with using Qsiva during pregnancy.
The patient must read the Patient Information leaflet provided by the doctor.
A patient card reminding of the risks associated with topiramate use during pregnancy is
included in the Qsiva packaging.
Breastfeeding
Breastfeeding is not recommended during treatment with Qsiva, as the medicine may pass into
breast milk. The doctor will decide whether breastfeeding should be discontinued or Qsiva
stopped.
Driving and operating machinery
Avoid driving or operating machinery during treatment with Qsiva if the patient's reaction
ability is impaired. Drowsiness, dizziness, visual disturbances and blurred vision have been
reported with one of the active substances in Qsiva. The patient should wait until they know
how Qsiva affects them before engaging in such activities.
Qsiva, 3.75 mg + 23 mg, modified-release hard capsules
Qsiva contains sucrose
Qsiva contains a small amount of sugar called sucrose. If the patient has previously been
diagnosed with intolerance to certain sugars, they should consult their doctor before taking
the medicine.
Qsiva, 7.5 mg + 46 mg, 11.25 mg + 69 mg, and 15 mg + 92 mg, modified-release hard capsules
Qsiva contains sucrose, tartrazine and sunset yellow FCF
Qsiva contains a small amount of sugar called sucrose. If the patient has previously been
diagnosed with intolerance to certain sugars, they should consult their doctor before taking
the medicine.
The colouring agents tartrazine and sunset yellow FCF may cause allergic reactions.

3. How to take Qsiva

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
Treatment with Qsiva should be initiated and supervised by a doctor experienced in weight management.
Women of childbearing age should visit their doctor at least once a year to monitor treatment.
Your doctor will determine the appropriate dose for you.
Your doctor will start treatment with a low dose of 1 capsule of Qsiva 3.75 mg+23 mg once daily for
14 days. There may be reasons why your doctor will maintain this dose throughout treatment,
e.g. if you have kidney or liver disease. If you have kidney disease, your doctor may also start treatment
with a low dose every other day instead of daily.
The usual recommended dose is 1 capsule of Qsiva 7.5 mg+46 mg once daily after 14 days of taking
Qsiva 3.75 mg+23 mg capsules. You will take this dose for approximately 3 months. If during this time
you have not lost at least 5% of your initial body weight, your doctor may discontinue treatment.
If you have lost at least 5% of your initial body weight and tolerate treatment well, your doctor may
recommend continuing treatment at the same dose. If your body weight remains high and your doctor
decides to increase the dose, you will receive 1 capsule of Qsiva 11.25 mg+69 mg once daily for 14 days.
Then the dose may be increased to 1 capsule of Qsiva 15 mg+92 mg once daily. If stopping treatment
after high-dose therapy, it is recommended to do so gradually by taking the dose every other day for
at least 1 week before stopping treatment completely.
Your doctor will also want to closely monitor your progress. For this reason, you must attend all scheduled
appointments.
You should follow the diet, exercise, and lifestyle changes recommended by your doctor or dietitian.
Your doctor may recommend taking a daily multivitamin supplement.
Method of administration
The capsule should be swallowed whole, once daily in the morning, with a glass of water or another
sugar-free drink. Do not crush or chew the capsule. The capsules may be taken with or without food.
Taking more Qsiva than prescribed
In such a case, you should contact your doctor or go directly to hospital. Take the medicine packaging
with you.
Missing a dose of Qsiva

If you forget to take your dose in the morning, you may still take it until midday.
You should skip the missed dose if you do not remember until the afternoon. In this case, wait until the next morning and take your next daily dose as usual.
Do not take a double dose to make up for a missed dose.
If you miss more than 7 consecutive doses, consult your doctor about restarting treatment.

Stopping Qsiva treatment
Do not change the dose of Qsiva or stop treatment without your doctor's approval. Abruptly stopping
treatment increases the risk of seizures. Gradual dose reduction is recommended if you are taking
the highest dose and treatment needs to be discontinued.
You should contact your doctor for advice on weight management and possible adjustments to doses
of other medicines you may be taking.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions occur with the following frequency:
Very common (may occur in more than 1 in 10 people):

dry mouth
constipation
unusual sensations such as tingling, pricking, burning or numbness

Common (may occur in less than 1 in 10 people):

loss of appetite, taste disturbances
difficulty sleeping, depression, anxiety, irritability
headache
dizziness, difficulty concentrating, fatigue, memory impairment
reduced sense of touch or sensation
blurred vision, dry eye
sensation of rapid heartbeat
nausea, diarrhoea, abdominal pain, indigestion
hair loss
thirst, nervousness

Uncommon (may occur in less than 1 in 100 people):

urinary tract infection
deficiency of red blood cells
low blood potassium levels, low blood sugar levels
tissue swelling due to fluid accumulation, dehydration
increased appetite
nervousness
reduced or increased sex drive
mood changes, emotional disturbances
excitement, restlessness
confusion, emotional instability, lack of interest
sleep disturbances, including unusual dreams, nightmares
crying, stress, anger
panic attack, paranoia
partial or complete memory loss
drowsiness, lethargy
uncontrollable tremor
cognitive impairment, speech disturbances
reduced sense of taste
migraine
increased motor activity
nervous system disorders other than brain and spinal cord
fainting
condition causing an overwhelming urge to move the legs
impaired motor coordination
disturbances of smell
eye pain, eyelid spasm
unpleasant sensitivity of the eye to light
visual perception of light flashes in the visual field
double vision, itchy eyes
ringing in the ears
rapid heartbeat
sudden facial flushing
low or high blood pressure
cough, nosebleed
difficulty breathing
sore throat and voice organ
blocked sinuses or nose, postnasal drip
gas, belching
acid reflux from stomach into oesophagus, vomiting
itching, hives, rash, skin redness, dry skin
increased sweating, acne, unusual skin odour
unusual hair texture
pain in hands and feet, muscle pain, back pain, joint pain
muscle cramps, muscle weakness, muscle twitching
kidney stones
frequent need to urinate without passing large amounts of urine, difficulty urinating
increased nighttime urination
erectile dysfunction
menstrual disorders
weakness, unusual feelings
swelling of hands and (or) feet due to fluid accumulation
increased energy, chest pain, feeling of cold or heat
decreased blood levels: bicarbonates, potassium
abnormal liver function test results
reduced excretion of creatinine, a breakdown product of muscle tissue, by the kidneys

Rare (may occur in less than 1 in 1,000 people)

respiratory tract infection
sinusitis, influenza, bronchitis
fungal infection
ear infection
excess acid in the body due to metabolic disorder, gout
suicidal thoughts, aggression
inability to feel pleasure, including reduced motivation
grief reaction
teeth grinding, aversion to food
hallucinations, disorientation
stuttering
sensation of pricking and tingling
excessive tearing
increased intraocular pressure, conjunctival haemorrhage
deafness, ear pain
heart rhythm disorder causing very rapid activity in the heart atria, irregular heartbeat
deep vein thrombosis
dry throat, watery nasal discharge
bad breath, gum pain, tongue inflammation, burning tongue
haemorrhoidal nodules, infrequent bowel movements
gallstones or diseases caused by gallstones
inflammation of the gallbladder
brittle nails
muscle stiffness
unusual odour of urine
gait disturbances
falls
increased blood creatinine levels
increased blood glucose levels

Frequency not known (frequency cannot be determined from available data)

viral infection causing inflammation of the stomach and intestinal mucosa
hypersensitivity
excessive talkativeness, suicide attempt
seizures
pain in one or more nerves
temporary blindness, dilated pupils, clouding of the eye lens
certain eye diseases involving degeneration of the central area of the inner mucous membrane of the eye, which may lead to loss of central vision
hearing deterioration, accumulation of fluid in the middle ear
heart failure
nasal polyps, acute respiratory failure
difficulty swallowing, oral discomfort, vomiting reflex
severe allergic reaction causing swelling of the face or throat
acute kidney injury
foreign body sensation
decreased blood glucose levels
increased blood levels: glycated haemoglobin, thyroid-stimulating hormone, specific blood fats called triglycerides
eye inflammation (uveitis) with the following symptoms: eye redness, pain, light sensitivity, eye tearing, floaters or blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Qsiva

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Do not store above 30°C. Keep the container tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Qsiva contains
The active substances are phentermine and topiramate.
Qsiva 3.75 mg + 23 mg modified-release hard capsules
Each modified-release hard capsule contains 3.75 mg of phentermine (as hydrochloride) and 23 mg of topiramate.
Other ingredients: sucrose, corn starch, hypromellose 2910, microcrystalline cellulose, methylcellulose, ethylcellulose, povidone K30, talc (micronized), gelatin, titanium dioxide (E171), brilliant blue FCF (E133), erythrosine (E127), white printing ink (titanium dioxide (E171), shellac, propylene glycol, simethicone).
Qsiva 7.5 mg + 46 mg modified-release hard capsules
Each modified-release hard capsule contains 7.5 mg of phentermine (as hydrochloride) and 46 mg of topiramate.
Other ingredients: sucrose, corn starch, hypromellose 2910, microcrystalline cellulose, methylcellulose, ethylcellulose, povidone K30, talc (micronized), gelatin, titanium dioxide (E171), brilliant blue FCF (E133), erythrosine (E127), tartrazine (E102), orange yellow (E110), black printing ink (black iron oxide (E172), shellac, propylene glycol), white printing ink (titanium dioxide (E171), shellac, propylene glycol, simethicone).
Qsiva 11.25 mg + 69 mg modified-release hard capsules
Each modified-release hard capsule contains 11.25 mg of phentermine (as hydrochloride) and 69 mg of topiramate.
Other ingredients: sucrose, corn starch, hypromellose 2910, microcrystalline cellulose, methylcellulose, ethylcellulose, povidone K30, talc (micronized), gelatin, titanium dioxide (E171), tartrazine (E102), orange yellow (E110), black printing ink (black iron oxide (E172), shellac, propylene glycol).
Qsiva 15 mg + 92 mg modified-release hard capsules
Each modified-release hard capsule contains 15 mg of phentermine (as hydrochloride) and 92 mg of topiramate.
Other ingredients: sucrose, corn starch, hypromellose 2910, microcrystalline cellulose, methylcellulose, ethylcellulose, povidone K30, talc (micronized), gelatin, titanium dioxide (E171), tartrazine (E102), orange yellow (E110), black printing ink (black iron oxide (E172), shellac, propylene glycol).

What Qsiva looks like and contents of the pack
Qsiva is a modified-release hard capsule, 2.31 cm in length and 0.73 to 0.76 cm in diameter.
Qsiva 3.75 mg + 23 mg modified-release hard capsules
Qsiva 3.75 mg + 23 mg modified-release hard capsules have a violet cap printed with "VIVUS" and a violet body printed with "3.75/23".
Qsiva 7.5 mg + 46 mg modified-release hard capsules
Qsiva 7.5 mg + 46 mg modified-release hard capsules have a violet cap printed with "VIVUS" and a yellow body printed with "7.5/46".
Qsiva 11.25 mg + 69 mg modified-release hard capsules
Qsiva 11.25 mg + 69 mg modified-release hard capsules have a yellow cap printed with "VIVUS" and a yellow body printed with "11.25/69".
Qsiva 15 mg + 92 mg modified-release hard capsules
Qsiva 15 mg + 92 mg modified-release hard capsules have a yellow cap printed with "VIVUS" and a white body printed with "15/92".
Qsiva modified-release hard capsules are supplied in HDPE bottles containing 14 or 30 modified-release hard capsules, with a child-resistant closure and a desiccant.
Do not swallow the desiccant.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
VIVUS BV
Strawinskylaan 4117
1077 ZX Amsterdam
The Netherlands
[email protected]

Manufacturer
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1-2
73614 Schorndorf
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg hårde kapsler med modificeret udløsning
Croatia Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg tvrde kapsule s prilagođenim oslobađanjem
Czech Republic Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg tvrdé tobolky s řízeným uvolňováním
Finland Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg säädellysti vapauttavat kovat kapselit
Sweden Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg hårda kapslar med modifierad frisättning
Greece Qsymia 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg σκληρά καψάκια ελεγχόμενης αποδέσμευσης
Hungary Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg módosított hatóanyagleadású kemény kapszula
Iceland Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg hörð hylki með breyttan losunarhraða
Ireland Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg hard modified-release capsules
Lithuania Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg modifikuoto atpalaidavimo kietosios kapsulės
Malta Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg modified-release capsules, hard
Norway Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg harde kapsler med modifisert frisetting
Portugal Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg cápsulas de libertação modificada
Romania Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg capsule cu eliberare modificată
Slovenia Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg trde kapsule s prirejenim sproščanjem
Slovakia Qsiva 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg tvrdé kapsuly s riadeným uvoľňovaním

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (http://www.urpl.gov.pl/pl).